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Gene Therapy: Prospective Technology assessment in its societal context -

Gene Therapy: Prospective Technology assessment in its societal context (eBook)

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2011 | 1. Auflage
274 Seiten
Elsevier Science (Verlag)
978-0-08-047093-1 (ISBN)
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This book presents work that has been conducted as part of the research project 'Discourse on ethical questions of biomedicine' of the interdisciplinary Working Group Bioethics and Science Communication at the Max-Delbrueck-Center for Molecular Medicine (MDC)in Berlin-Buch, Germany. This book offers ground-breaking ideas on how the daily interworking of cutting-edge biomedical research assess the broader social context and its communication to stakeholders and the public. Editors cover three aspects: Scientific, Ethical and Legal, and Perception and Communication. This work establishes an international and interdisciplinary network of excellent researchers at the beginning of their careers, who brilliantly integrate their work into the different perspectives on gene therapy from the natural and social sciences, as well as the humanities and law.
* Discusses biological and cellular barriers limiting the clinical application of nonviral gene delivery
systems
* Addresses such questions as: Does patent granting hinder the development of Gene Therapy products?
* Offers insight in the future of public perception of gene therapy in Europe
* Provides details on how to communicate risks in gene therapy
This book presents work that has been conducted as part of the research project "e;Discourse on ethical questions of biomedicine"e; of the interdisciplinary Working Group Bioethics and Science Communication at the Max-Delbrueck-Center for Molecular Medicine (MDC)in Berlin-Buch, Germany. This book offers ground-breaking ideas on how the daily interworking of cutting-edge biomedical research assess the broader social context and its communication to stakeholders and the public. Editors cover three aspects: Scientific, Ethical and Legal, and Perception and Communication. This work establishes an international and interdisciplinary network of excellent researchers at the beginning of their careers, who brilliantly integrate their work into the different perspectives on gene therapy from the natural and social sciences, as well as the humanities and law.* Discusses biological and cellular barriers limiting the clinical application of nonviral gene deliverysystems* Addresses such questions as: Does patent granting hinder the development of Gene Therapy products?* Offers insight in the future of public perception of gene therapy in Europe* Provides details on how to communicate risks in gene therapy

Cover 1
Contents 6
Preface 12
Editorial: Building Interdisciplinarity in Research on Gene Therapy 14
Contributors 22
Section I Scientific Aspects 24
Identification of Genes Causing Autosomal Recessive Retinitis Pigmentosa 26
Introduction 27
Materials and Methods 28
Results 29
Discussion 33
References 35
Recombinant Adeno-Associated Viral Vectors for CNS Gene Therapy 40
Introduction 40
Biology of AAV 41
AAV Gene Transfer into the Nervous System 42
Safety Considerations 45
Conclusion 46
References 47
Controlling Adenoviral Gene Transfer in Heart By Catheter-Based Coronary Perfusion 56
Introduction 57
Methods 58
Results 63
Discussion 64
Conclusion 67
Acknowledgements 67
References 67
Biological and Cellular Barriers Limiting the Clinical Application of Nonviral Gene Delivery Systems* 70
Introduction 71
The Gene Transfer Mechanism 71
Specificity of Targeting Peptides during Transfection 73
The Need of Standardization 74
The Effect of Physicochemical Properties of DNA Complexes on Transfection 75
Understanding the Behavior of DNA Complexes inside the Cell 76
Rational Design of Heteroplexes with In Vivo Application 77
References 78
Designing Polymer-Based DNA Carriers for Non-Viral Gene Delivery: Have We Reached an Upper Performance Limit? 80
Introduction 80
How Should an Ideal Carrier Behave for Gene Delivery? 82
Basic Molecular Structure of Polymeric Carriers for Non-Viral Gene Delivery 85
Structural Improvement of Polymeric Vectors for Gene Delivery 88
What Could be done for Improving the Situation? 93
Summary and Last Remarks 95
Acknowledgements 95
References 95
Neurogenetic Imaging 100
Introduction 101
Background 101
Clinical Applications 103
Ethical Considerations and Social Implications 107
Conclusion 109
References 110
Implications of Fetal Gene Therapy for the Medical Profession 112
Ethical Objections to Fetal Gene Therapy 113
In Utero Gene Transfer as a New Therapeutical Option 114
The Medical Profession in the Context of Fetal Gene Therapy 115
References 117
Section II Ethical and Legal Aspects 120
Ethical Issues in Gene Therapy Research, An American Perspective 122
Introduction 122
Arguments in Favor of Gene Therapy Research 123
Arguments Against Gene Therapy Research 125
General Societal Concerns Regarding Gene Therapy Research 127
The American Approach to Gene Therapy Regulation 129
References 130
Do Germline Interventions Justify the Restriction of Reproductive Autonomy? 132
Introduction 133
What kind of Germline Interventions should be Investigated and what are Some of the Related Risks? 134
A Definition of Reproductive AutonomyŽ and Possible Degrees of its Limitation 136
Discussion 139
Summary 142
References 143
Ghost of Christmas PastŽ ...Eugenics and other Moral Dilemmas Surrounding Genetic Interventions: A Discussion in the Context of Virtue Ethics 146
Introduction 147
The Ghost of Christmas Past 148
The Ghost of Christmas Present 149
Introducing Virtue Ethics 152
Virtue Ethics, Therapy and Enhancement 155
Conclusions 163
References 164
Biomedical Research and Ethical Regulations in China: Some Observations about Gene Therapy, Human Research, and Struggles of Interest 166
Introduction 167
A Case of Gene Therapy – Facts, Figures and the Emergence of Policy 167
On Cultural Expectations 173
The Role of Researchers in Ethics Regulations and the International State of the Art: China’s Position 176
What it means for us? 179
References 180
Does Patent Granting Hinder the Development of Gene Therapy Products? 182
Public Discussion 183
Basic Facts about Patents 183
Patent Law and Gene Therapy 184
The Concerns 189
Patenting Conditions and Opposition Procedures in the case of the BRCA Genes 194
Conclusion and Outlook 197
References and Notes 199
On the Political Side of Gene Therapy, What can be Drawn from the French Situation 204
Gene Therapy in the French Societal Context 205
The Political Stakes of Gene Therapy: Towards a new French Policy-Style 210
Broadening the Scope: Gene Therapy from a Prospective Political Point of View 215
Conclusion 219
References and Notes 219
Further Reading 221
Extracts from Interviews 223
Section III Perception and Communication 224
How to Communicate Risks in Gene Therapy? 226
Introduction 227
Definitions – Clarity with Regard to Risk, Hazards and Uncertainty 228
Goal of Risk Communication 229
Core Problems of Risk Communication 230
Conclusion for Communication Regarding Gene Therapy 239
References 240
European Analysis of the Various Procedures Existing to Interrupt a Clinical Research Protocol Thanks to a French Example of Gene Therapy 246
Introduction 247
Material and Methods 248
Results 248
Discussion 250
Conclusion 250
References 251
The Future of Public Perception of Gene Therapy in Europe, an Educated Guess 252
Introduction: Risk Perception 253
Risk Perception towards Red and Green Biotechnology 254
Possible Factors that will Shape Future (Risk) Perception 259
Worldviews, Fractal Discourse and Terra Incognita 266
Brief Ideas on Management 268
Annex A. Parts of the Danish Consensus Conference on Gene Therapy (1995), Statements on Risk, Uncertainty and Attitudes towards Gene Therapy 269
References 270
Index 272

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