Nutrition and Genomics -

Nutrition and Genomics (eBook)

Issues of Ethics, Law, Regulation and Communication

David Castle, Nola Ries (Herausgeber)

eBook Download: PDF | EPUB
2009 | 1. Auflage
312 Seiten
Elsevier Science (Verlag)
978-0-08-092082-5 (ISBN)
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Nutrigenomics is the rapidly developing field of science that studies nutrient-gene interaction. This field has broad implications for understanding the interaction of human genomics and nutrition, but can also have very specific implications for individual dietary recommendations in light of personal genetics. Predicted applications for nutrigenomics include genomics-based dietary guidelines and personalized nutrition based on individual genetic tests. These developments have sweeping ethical, legal and regulatory implications for individuals, corporations and governments.

This book brings together experts in ethics, law, regulatory analysis, and communication studies to identify and address relevant issues in the emerging field of nutritional genomics. Contributing authors are experts in the social aspects of biotechnology innovation, with expertise in nutrigenomics.

From addressing the concern that nutrigenomics will transform food into medicine and undermine pleasures associated with eating to the latest in the science of nutrigenomics, this book provides a world-wide perspective on the potential impact of nutrigenomics on our association with food.

*Explores the rapidly developing, yet not fully understood, impact of nutrigenomics on the relationship to food medicalization, genetic privacy, nutrition and health.
*Provides ground for further exploration to identify issues and provide analysis to aid in policy and regulation development
*Provides ethical and legal insights into this unfolding science, as well as serving as a model for thinking about issues arising in other fields of science and technology
Nutrigenomics is the rapidly developing field of science that studies nutrient-gene interaction. This field has broad implications for understanding the interaction of human genomics and nutrition, but can also have very specific implications for individual dietary recommendations in light of personal genetics. Predicted applications for nutrigenomics include genomics-based dietary guidelines and personalized nutrition based on individual genetic tests. These developments have sweeping ethical, legal and regulatory implications for individuals, corporations and governments.This book brings together experts in ethics, law, regulatory analysis, and communication studies to identify and address relevant issues in the emerging field of nutritional genomics. Contributing authors are experts in the social aspects of biotechnology innovation, with expertise in nutrigenomics. From addressing the concern that nutrigenomics will transform food into medicine and undermine pleasures associated with eating to the latest in the science of nutrigenomics, this book provides a world-wide perspective on the potential impact of nutrigenomics on our association with food. Explores the rapidly developing, yet not fully understood, impact of nutrigenomics on the relationship to food medicalization, genetic privacy, nutrition and health Provides ground for further exploration to identify issues and provide analysis to aid in policy and regulation development Provides ethical and legal insights into this unfolding science, as well as serving as a model for thinking about issues arising in other fields of science and technology

Front Cover 1
Nutrition and Genomics 4
Copyright Page 5
Contents 6
List of Contributors 8
Acknowledgments 10
Editors Introduction 12
Chapter 1. Gene-Environment Interactions: Where are we and where should we be Going? 19
Summary 20
Introduction 20
Genes or environment? Limitations of the traditional approach to disease risk assessment 21
Cardiovascular risk factors 22
Gene–Smoking Interactions 22
Gene–Alcohol Interactions 23
Gene–Physical Activity Interactions 28
Gene–Diet Interactions 28
Statistical Methods for gene–environment interactions 33
Personalized nutrition and the consumer 36
Summary 37
References 37
Chapter 2. Translating Nutrigenomics Research into Practice: The Example of Soy Protein 43
Summary 44
Introduction 44
The Nutrition Science Axis 46
Soy Protein as a Cholesterol-Lowering Nutrient 46
Soy Proteins as Products by Process 47
Processing and Biochemical Characterization of Soy Proteins 50
The Proposed Minimum Information About a Dietary Protein (MIADP) standard 52
Characterized Soy Proteins Enables Mechanism of Action Research 54
Intersection of the Nutrition Science and Clinical Axes: Defining the ‘Response Phenotype’ 55
Conclusion 58
References 59
Chapter 3. Business Applications of Nutrigenomics: An Industry Perspective 63
Summary 64
Human genomics and the potential for business applications 64
Lessons from food industry activities 65
The genomics in nutrigenomics 66
Nutrigenomic tests in commercial application 68
Market acceptance of nutrigenomics 69
Regulatory hurdles for nutrigenomics 70
Regulation of genetic testing 71
Privacy and discrimination protection for nutrigenomic applications 75
Recommendations for improving the nutrigenomics business environment 76
Establishing an Industry Group 76
Incorporating an ethical framework into the business of nutrigenomics 76
The future for the business of nutrigenomics 77
References 78
Chapter 4. Regulation of Genetic Tests: An International Comparison 81
Summary 82
Introduction 82
Concerns about genetic tests 83
Regulatory frameworks 85
Regulation of medical devices 86
Registration 86
Quality assurance 86
Pre-market review 87
Truth-in-labeling 87
Post-marketing controls 87
Limitations of current regimes for regulating genetic tests as medical devices 88
Laboratory-developed tests and medical device regulations 88
Risk classification 89
Post-marketing surveillance 90
Regulation of clinical laboratories 91
Registration 91
Quality assurance 91
Pre-market review 91
Result reporting 92
Personnel 92
Limitations of current regimes for regulating clinical laboratories performing genetic tests 92
Lack of proficiency testing 92
Regional/national variation in regulation 92
Focus on analytic performance 93
Lack of transparency 93
Recent developments in regulation 93
Regulation options 95
Pre-market review and post-market controls 95
Test and laboratory registry 96
Enhanced role for third parties 97
Consumer education 98
Conclusion 98
References 99
Chapter 5. Risk-Based Regulation of Direct-to-Consumer Nutrigenetic Tests 103
Summary 104
Introduction 104
Types of DTC Genetic Tests on the Market 105
Potential Harms and Benefits of DTC Genetic Tests 107
Regulatory Initiatives regarding DTC Advertising and Sale of Genetic Tests 110
Prohibitions on DTC Genetic Tests 110
Permitting DTC Access to Lower-Risk Genetic Tests 112
Enforcement of Truth-in-Advertising Laws 114
Enhancing Information Disclosure 116
Conclusion 118
References 118
Chapter 6. The Impact of Genomics on Innovation in Foods and Drugs: Can Canadian Law Step Up to the Challenge? 121
Summary 122
Introduction 122
Food, Drugs and Genomic Promises 123
Food and Drug Development 125
The Development of New Food Products 126
Drug Development 128
Food and Drug Law 129
Food Law 130
Health Claims in Canadian Law 131
Pharmaceutical Drugs and Medical Devices 133
Does Genomics Require Regulatory Innovation? 134
References 138
Chapter 7. Placing Healthy Eating in the Everyday Context: Towards an Action Approach of Gene-Based Personalized Nutrition Advice 141
Summary 142
Introduction 142
Motivating change through a personalized approach 143
The theoretical basis for individual behavior change 143
Stage 1: Realizing that food influences health 144
Stage 2: Realizing the significance of healthy eating 145
Stage 3: Recognizing personal vulnerability 146
Stage 4 or 5: Deciding (not) to act 147
Stages 6 and 7: Healthy eating 148
The action approach towards healthy eating 150
The action approach applied to innovative personalized nutrition interventions 150
ICT based personalized nutrition intervention 151
Using genetic knowledge in personalized nutrition interventions 153
Final considerations 153
References 153
Chapter 8. Health Care Provider Capacity in Nutrition and Genetics A Canadian Case Study 157
Summary 158
Introduction 158
Ability 160
Knowledge 160
Ethical and Legal Awareness 168
Skills 170
Opportunity 171
Scope of Practice 171
Workload 172
Motivation 173
Attitudes 173
Confidence 173
Conclusion 173
References 174
Chapter 9. Advancing Knowledge Translation in Nutritional Genomics by Addressing Knowledge, Skills and Confidence Gaps of Registered Dietitians 179
Summary 180
Introduction 180
Part 1: Education and Training of Registered Dietitians 183
Surveys of Registered Dietitians in the UK and the USA 184
Canadian Situation: An Initial Analysis 185
Part 2: Strategies For Addressing Capacity Gaps 194
The Role of the Registered Dietitian in the Genomics Era 194
The Role of Education in the Development of a Nutritional Genomics Practitioner 196
Barriers and Opportunities to Moving Forward 196
Common Problems, Common Solutions 199
Progress to Date and Suggested Actions 200
Conclusion 202
References 203
Chapter 10. Understanding Hopes and Concerns about Nutrigenomics: Canadian Public Opinion Research Involving Health Care Professionals and the Public 205
Summary 206
Introduction 206
Communication Challenges for Nutrigenomics 208
Previous Public Opinion Research 209
Nutrigenomics Focus Groups 210
Pre-test 210
Media Article 211
Website 212
Scientific Fact Sheet on Nutrigenomics 212
Conclusions: Key Benefit and Risk Information to Inform the Public andHealth Care Professionals 215
References 222
Chapter 11. Pitching Products, Pitching Ethics: Selling Nutrigenetic Tests as Lifestyle or Medicine 223
Summary 224
Introduction 224
Between Hype and Concern 225
Nutrigenetics: Borderline science/practice 226
Empirical Study 228
Pitching wellness 229
Pitching medicine 231
Lifestyle advice 232
More medical advice 234
Discussion 235
References 238
Chapter 12. Framing Nutrigenomics for Individual and Public Health: Public Representations of an Emerging Field 241
Summary 242
Introduction 242
Interest in Nutrigenomics: The Research Agenda 243
Themes in Nutrigenomics 244
Scientific Literature 245
Research Groups 246
Private Companies 248
Popular Press 249
Critiquing the Claims 251
Dietary Information and Behavioral Change 252
Genetic Information and Behavioral Change 254
Nutrigenomics as a Public Health Strategy 256
Conclusion 258
References 258
Chapter 13. The Personal and the Public in Nutrigenomics 263
Summary 263
Introduction 264
Personalization – the Norm of Nutrigenomics 265
Public Health and Nutrigenomics 268
Public Health Applications of Nutrigenomics 272
Implementation and Evaluation 274
Conclusion 278
References 278
Chapter 14. Food Styles and the Future of Nutrigenomics 281
Summary 282
Introduction 282
Current normative assumptions on health and food in nutritional genomics 283
Functions of food: nutritional, cultural, social and aesthetic aspects 284
Lifestyles and food styles 286
How will current food styles react to nutrigenomics and the new relationship between food and drugs? 288
Peaceful coexistence and fair representation of food styles 289
Nutrigenomics and fair representation of food styles 290
Moral responsibility for health in different food styles 291
What is moral responsibility? 291
Moral responsibility for health 292
Responsibilities revisited 293
Conclusion 294
References 295
Chapter 15. Epilogue: Future Directions 299
Summary 299
Developing and Translating Nutrigenomic Science 300
Regulating Nutrigenomic Tests and Health Claims 301
Developing Professional Competency in Nutrigenomics 303
Communicating to the Public 303
Motivating Behavior Change 304
Expanding the Scope of Nutrigenomics 305
Index 307

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