Science, Society, and the Supermarket: The Opportunities and Challenges of Nutrigenomics

The new science of nutrigenomics and its ethical and societalchallenges

Gene–diet interactions which underlie relatively benignlactose intolerance to life–threatening conditions such ascardiovascular disease have long been known. But until now,scientists lacked the tools to fully understand the underlyingmechanisms that cause these conditions. In recent years, however,strides in human genomics and the nutritional sciences have allowedfor the advancement of a new science dubbed nutrigenomics.Although this science may lead to personalized nutrition anddietary recommendations that can mitigate, prevent, or curesickness, current oversight mechanisms and regulations for emergingdirect–to–public nutrigenomic tests are still in their infancy.

Science, Society, and the Supermarket: The Opportunities andChallenges of Nutrigenomics discusses the many ethical, legal,and social challenges presented by nutrigenomics. Concerning itselfwith the basic uses of nutrigenomic research as well as itsclinical and commercial aspects, this text sheds light on suchissues as:

Opportunities and challenges for nutrigenomics The science of nutrigenomics The ethics of nutrigenomic tests and information both in aclinical setting and by private third parties Alternatives for nutrigenomics service delivery Nutrigenomics and the regulation of health claims for foods anddrugs Equity and access to nutrigenomics in industrialized anddeveloping countries Intellectual property issues

By taking a proactive bioethical stance on the subject,Science, Society, and the Supermarket offers a thorough andtimely analysis on both the benefits and risks of nutrigenomics.Along with a thought–provoking examination of the issues, this bookprovides ethical guidelines and recommendations for further studyin policy and regulatory development.

Preface.

Acknowledgments.

1 NUTRITIONAL GENOMICS: OPPORTUNITIES AND CHALLENGES.

1.1 Introduction.

1.2 What is Nutritional Genomics?

1.3 Methodology and Approach of this Book.

1.4 Opportunities and Challenges for Nutrigenomics.

1.4.1 Improved health.

1.4.2 Personalized dietary advice.

1.4.3 Improved diet.

1.4.4 More development of health–enhancing food products.

1.4.5 Consumer empowerment.

1.4.6 Reducing health disparities.

1.4.7 Health care savings.

1.5 Challenges and a Road Map of This Book.

References.

2 THE SCIENCE OF NUTRIGENOMICS AND NUTRIGENETICS.

2.1 Introduction.

2.2 The Scientific Context.

2.2.1 Nutrigenomics.

2.2.2 Nutrigenetics.

2.3 The Case of MTHFR.

2.4 Room for Improvement.

2.4.1 Study design.

2.4.2 Epigenetics.

2.4.3 SNPs and haplotypes.

2.4.4 Dietary intake assessment.

2.4.5 Biomarkers.

2.4.6 Susceptibility and predictions.

2.4.7 Analytical and clinical validity.

2.4.8 Clinical utility.

2.5 Science and Technology Assessment.

2.6 Conclusion.

References.

3 THE ETHICS OF NUTRIGENOMIC TESTS AND INFORMATION.

3.1 Introduction.

3.2 Ethical Principles.

3.3 Nutrigenomics Testing in the Clinical Setting.

3.3.1 Informed consent.

3.3.2 Confidentiality.

3.3.3 Secondary information.

3.3.4 Families.

3.3.5 Genetic testing of children and adolescents.

3.4 Use of Nutrigenomics Information for Research.

3.5 Use of Nutrigenomics Information by Private ThirdParties.

3.5.1 Insurance.

3.5.2 Employment.

3.5.3 Legal and social responses to fears of discrimination.

3.6 Conclusion.

References.

4 ALTERNATIVES FOR NUTRIGENOMIC SERVICE DELIVERY.

4.1 Introduction.

4.2 Considerations for Nutrigenomic Service Delivery.

4.2.1 Strength of the science.

4.2.2 Regulatory environment.

4.2.3 Human resource capacity and professional competence.

4.2.4 Funding policy.

4.2.5 Professional politics and culture.

4.2.6 Consumers and patients.

4.3 Four Alternative Models.

4.3.1 Consumer model.

4.3.2 Health practitioner model.

4.3.3 Blended models.

4.3.4 Public health model.

4.4 Conclusion.

References.

5 NUTRIGENOMICS AND THE REGULATION OF HEALTH CLAIMS FOR FOODSAND DRUGS.

5.1 Introduction.

5.1.1 Genetic tests, service delivery, and geneticantidiscrimination.

5.2 Food Categories: Functional Foods, Nutraceuticals, MedicinalFoods, and Dietary Supplements.

5.2.1 Functional foods.

5.2.2 Nutraceuticals.

5.2.3 Medical or medicinal foods.

5.2.4 Dietary supplements.

5.3 Health–Related Claims Associated with Foods Compared toDrugs.

5.3.1 Structure function claims.

5.3.2 Health claims.

5.3.3 Medical food claims.

5.3.4 Disease risk reduction claims.

5.4 Nutrigenomic Information and the Regulation of FoodsCompared to Drugs.

5.4.1 The regulation of foods.

5.4.2 The regulation of drugs.

5.5 Food and Drug Regulations in Japan, the United States, andCanada.

5.5.1 Japan.

5.5.2 United States.

5.5.3 Canada.

5.6 Conclusion.

References.

6 NUTRIGENOMICS: JUSTICE, EQUITY, AND ACCESS.

6.1 Introduction.

6.2 Industrialized Country Context.

6.2.1 Individualized nutrigenomic testing.

6.2.2 Population–based nutrigenomics.

6.3 Developing Country Context.

6.3.1 Individualized nutrigenomic testing.

6.4 Nutrigenomics and Intellectual Property.

6.4.1 An issue of access to scientific information.

6.5 Conclusion.

References.

7 CONCLUSIONS AND RECOMMENDATIONS.

7.1 Introduction.

7.1.1 Nutrigenomic science.

7.1.2 Nutrigenomics and health information management.

7.1.3 Nutrigenomic service delivery.

7.1.4 Regulation of nutrigenomics.

7.1.5 Access and equity.

7.2 A Final Word.

Index.

David Castle, PhD, is Associate Professor in the Departmentof Philosophy at the University of Ottawa, Ontario, Canada.

Cheryl Cline, PhD, received her doctorate in philosophyfrom the University of Toronto in 2005. Her dissertation focused onanimal welfare issues at the intersection of ethics, law, andpolitics.

Abdallah S. Daar, MD, DPhil, is Professor of PublicHealth Sciences and Professor of Surgery, and Director of Ethicsand Policy at the McLaughlin Centre for Molecular Medicine,University of Toronto.

Charoula Tsamis is a research assistant at the JointCentre for Bioethics, University of Toronto.

Peter A. Singer, MD, is a Professor of Medicine at theUniversity of Toronto and University Health Network, and a SeniorScientist at the McLaughlin Centre for Molecular Medicine,University of Toronto.

" a worthy acquisition for any medical library alongwith students and instructors in nutrition and health care."( CHOICE, June 2007)

"This concise overview of nutritional genomics covers a varietyof topics surrounding this controversial topic." (Doody′s HealthServices)