Niewöhner / Tannert Gene Therapy: Prospective Technology assessment in its societal context

1. Auflage 2011
ISBN: 978-0-08-047093-1
Verlag: Elsevier Science & Techn.
Format: EPUB
Kopierschutz: 6 - ePub Watermark

E-Book, Englisch, 274 Seiten

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

Autoren/Hrsg.

Niewöhner, Jörg

Tannert, Christof

Inhaltsverzeichnis

1;Cover;1
2;Contents;6
3;Preface;12
4;Editorial: Building Interdisciplinarity in Research on Gene Therapy;14
5;Contributors;22
6;Section I Scientific Aspects;24
6.1;Identification of Genes Causing Autosomal Recessive Retinitis Pigmentosa;26
6.1.1;Introduction;27
6.1.2;Materials and Methods;28
6.1.3;Results;29
6.1.4;Discussion;33
6.1.5;References;35
6.2;Recombinant Adeno-Associated Viral Vectors for CNS Gene Therapy;40
6.2.1;Introduction;40
6.2.2;Biology of AAV;41
6.2.3;AAV Gene Transfer into the Nervous System;42
6.2.4;Safety Considerations;45
6.2.5;Conclusion;46
6.2.6;References;47
6.3;Controlling Adenoviral Gene Transfer in Heart By Catheter-Based Coronary Perfusion;56
6.3.1;Introduction;57
6.3.2;Methods;58
6.3.3;Results;63
6.3.4;Discussion;64
6.3.5;Conclusion;67
6.3.6;Acknowledgements;67
6.3.7;References;67
6.4;Biological and Cellular Barriers Limiting the Clinical Application of Nonviral Gene Delivery Systems*;70
6.4.1;Introduction;71
6.4.2;The Gene Transfer Mechanism;71
6.4.3;Specificity of Targeting Peptides during Transfection;73
6.4.4;The Need of Standardization;74
6.4.5;The Effect of Physicochemical Properties of DNA Complexes on Transfection;75
6.4.6;Understanding the Behavior of DNA Complexes inside the Cell;76
6.4.7;Rational Design of Heteroplexes with In Vivo Application;77
6.4.8;References;78
6.5;Designing Polymer-Based DNA Carriers for Non-Viral Gene Delivery: Have We Reached an Upper Performance Limit?;80
6.5.1;Introduction;80
6.5.2;How Should an Ideal Carrier Behave for Gene Delivery?;82
6.5.3;Basic Molecular Structure of Polymeric Carriers for Non-Viral Gene Delivery;85
6.5.4;Structural Improvement of Polymeric Vectors for Gene Delivery;88
6.5.5;What Could be done for Improving the Situation?;93
6.5.6;Summary and Last Remarks;95
6.5.7;Acknowledgements;95
6.5.8;References;95
6.6;Neurogenetic Imaging;100
6.6.1;Introduction;101
6.6.2;Background;101
6.6.3;Clinical Applications;103
6.6.4;Ethical Considerations and Social Implications;107
6.6.5;Conclusion;109
6.6.6;References;110
6.7;Implications of Fetal Gene Therapy for the Medical Profession;112
6.7.1;Ethical Objections to Fetal Gene Therapy;113
6.7.2;In Utero Gene Transfer as a New Therapeutical Option;114
6.7.3;The Medical Profession in the Context of Fetal Gene Therapy;115
6.7.4;References;117
7;Section II Ethical and Legal Aspects;120
7.1;Ethical Issues in Gene Therapy Research, An American Perspective;122
7.1.1;Introduction;122
7.1.2;Arguments in Favor of Gene Therapy Research;123
7.1.3;Arguments Against Gene Therapy Research;125
7.1.4;General Societal Concerns Regarding Gene Therapy Research;127
7.1.5;The American Approach to Gene Therapy Regulation;129
7.1.6;References;130
7.2;Do Germline Interventions Justify the Restriction of Reproductive Autonomy?;132
7.2.1;Introduction;133
7.2.2;What kind of Germline Interventions should be Investigated and what are Some of the Related Risks?;134
7.2.3;A Definition of Reproductive AutonomyŽ and Possible Degrees of its Limitation;136
7.2.4;Discussion;139
7.2.5;Summary;142
7.2.6;References;143
7.3;Ghost of Christmas PastŽ ...Eugenics and other Moral Dilemmas Surrounding Genetic Interventions: A Discussion in the Context of Virtue Ethics;146
7.3.1;Introduction;147
7.3.2;The Ghost of Christmas Past;148
7.3.3;The Ghost of Christmas Present;149
7.3.4;Introducing Virtue Ethics;152
7.3.5;Virtue Ethics, Therapy and Enhancement;155
7.3.6;Conclusions;163
7.3.7;References;164
7.4;Biomedical Research and Ethical Regulations in China: Some Observations about Gene Therapy, Human Research, and Struggles of Interest;166
7.4.1;Introduction;167
7.4.2;A Case of Gene Therapy – Facts, Figures and the Emergence of Policy;167
7.4.3;On Cultural Expectations;173
7.4.4;The Role of Researchers in Ethics Regulations and the International State of the Art: China’s Position;176
7.4.5;What it means for us?;179
7.4.6;References;180
7.5;Does Patent Granting Hinder the Development of Gene Therapy Products?;182
7.5.1;Public Discussion;183
7.5.2;Basic Facts about Patents;183
7.5.3;Patent Law and Gene Therapy;184
7.5.4;The Concerns;189
7.5.5;Patenting Conditions and Opposition Procedures in the case of the BRCA Genes;194
7.5.6;Conclusion and Outlook;197
7.5.7;References and Notes;199
7.6;On the Political Side of Gene Therapy, What can be Drawn from the French Situation;204
7.6.1;Gene Therapy in the French Societal Context;205
7.6.2;The Political Stakes of Gene Therapy: Towards a new French Policy-Style;210
7.6.3;Broadening the Scope: Gene Therapy from a Prospective Political Point of View;215
7.6.4;Conclusion;219
7.6.5;References and Notes;219
7.6.6;Further Reading;221
7.6.7;Extracts from Interviews;223
8;Section III Perception and Communication;224
8.1;How to Communicate Risks in Gene Therapy?;226
8.1.1;Introduction;227
8.1.2;Definitions – Clarity with Regard to Risk, Hazards and Uncertainty;228
8.1.3;Goal of Risk Communication;229
8.1.4;Core Problems of Risk Communication;230
8.1.5;Conclusion for Communication Regarding Gene Therapy;239
8.1.6;References;240
8.2;European Analysis of the Various Procedures Existing to Interrupt a Clinical Research Protocol Thanks to a French Example of Gene Therapy;246
8.2.1;Introduction;247
8.2.2;Material and Methods;248
8.2.3;Results;248
8.2.4;Discussion;250
8.2.5;Conclusion;250
8.2.6;References;251
8.3;The Future of Public Perception of Gene Therapy in Europe, an Educated Guess;252
8.3.1;Introduction: Risk Perception;253
8.3.2;Risk Perception towards Red and Green Biotechnology;254
8.3.3;Possible Factors that will Shape Future (Risk) Perception;259
8.3.4;Worldviews, Fractal Discourse and Terra Incognita;266
8.3.5;Brief Ideas on Management;268
8.3.6;Annex A. Parts of the Danish Consensus Conference on Gene Therapy (1995), Statements on Risk, Uncertainty and Attitudes towards Gene Therapy ;269
8.3.7;References;270
9;Index;272