Personalized Medicine in the Making: Philosophical Perspectives from Biology to Healthcare (Human Perspectives in Health Sciences and Technology Book 3)

This book offers a multidisciplinary look at the much-debated concept of “personalized medicine”. By combining a humanistic and a scientific approach, the book builds up a multidimensional way to understand the limits and potentialities of a personalized approach in medicine and healthcare. The book reflects on personalized medicine and complex diseases, the relationship between personalized medicine and the new bio-technologies, personalized medicine and personalized nutrition, and on some ethical, political, economic, and social implications of personalized medicine. This volume is of interest to researchers from several disciplines including philosophy, bio-medicine, and the social sciences. Chapter 16, “The Impact of Fantasy” is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com. Foreword: The Social Trends Institute Acknowledgments Introduction A Title as a Reading Guide Personalized Medicine in the Making Philosophical Perspectives Personalized Medicine, Personalized Technology, and Personalized Healthcare Strategies References Contents Contributors Part I Personalized Medicine: From Biology to Clinics Why Precision Oncology Is Not Very Precise (and Why This Should Not Surprise Us) Introduction: What Is Precision Oncology? Some Preliminaries: Cancer Complexity and the Goals of Precision Oncology Two Case Studies: Avastin and TAILORx Upshots Conclusions References The Complexity of Tumor Heterogeneity: Limitations and Challenges of the Pharmacogenomics in Cancer Treatment Introduction The Promises and the Obstacles of Pharmacogenomics: A Critical Review Levels of Organization of Intratumor Heterogeneity Intratumor Heterogeneity from the Perspective of the SMT Intratumor Heterogeneity from the Perspective of the TOFT and the Systemic Models of Cancer Tumor Heterogeneity as a Complex Phenomenon Pharmacogenomics in the Light of the Complexity of Intratumor Heterogeneity Concluding Remarks References Conceptual and Theoretical Specifications for Accuracy in Medicine Introduction Theoretical Perspective on Organisms Applications and Extensions to Medicine References Personalized Treatments: Where Patient's History and Biological Background Meet Basic Definitions Promises and Premises of Personalized Medicine Limits of Personalized Medicine Unveil the Inadequacy of Pathogenesis Theories Disease as a Controversial Concept Disease as a Historical Process A Systems Biology Approach for Reframing the Concept of Human Disease Conclusions References Personalised Prevention: Increasing or Decreasing Over-Medicalisation, Overdiagnosis and Overtreatment? Introduction Recurring Ethical Issues in Preventive Medicine Personalised Prevention Increasing or Decreasing Issues of Over-Medicalisation, Overdiagnosis and Overtreatment? A Context of Pre-existing Over-Medicalisation, Overdiagnosis and Overtreatment The Wide Net of Preventive Screening Increasingly Sensitive Screening Techniques Personalisation and Risk Stratification Identification of Low Risk Patients The Example of Chronic Lymphocytic Leukemia (CLL) Changing Nosologies: A Bridge Between Personalised Prevention and Public Health Changing Perceptions and Labels From Diagnostic Categories to Staging in Psychiatry From Personalised Prevention to Public Health Conclusion References Making Feasible Personalized Nutrition: Between Science and Daily Habits Introduction Personalized Nutrition: Definition, Opportunities and Limits Digital Health: Definition, Opportunities and Limits Conclusions: Looking for an Optimal Equilibrium References Part II Personalized Technology: From Epistemology to Data Management Patient-Derived Organoids in Precision Oncology – Towards a Science of and for the Individual? Introduction What's So Special About Organoids? Organoids as Disease Models and Living Biobanks Organoids for Patient-Specific Drug Screening Personalized Medicine from a Population Perspective Concluding Remarks References Pharmacovigilance as Personalized Evidence Introduction Personalized Medicine and Pharmacovigilance E-Synthesis Motivation Aims and Scope Background A Very Short Introduction to Bayesian Epistemology Bayesian Networks General Approach Pharmacovigilance as Personalized Evidence Generating Causal Models/Hypotheses Using E-Synthesis Data and Theory Testing Causal Models/Hypotheses Confirming Models Likelihoods of Case Series From Models to Individual Patients Discussion References New Solutions to Biomedical Data Sharing: Secure Computation and Synthetic Data Introduction: Expectations of Stochastic and Algorithmic Production of Knowledge Based on Big Data A Europe Fit for the Digital Age? GDPR and the Health Data Sharing Challenge Alternative Modes for Dealing with the Issue of Sharing Health Data Synthetic Data A Novel Anonymisation Paradigm The Technology Interpretability 3D and 4D Synthetic Images and Genetic Synthetic Data Synthetic Data and Differential Privacy Caveats Synthetic Data and AI Biases Concluding Remarks: A Rich Health AI Ecosystem to Complement the GDPR References Realizing Personalized Medicine Using In Silico Tools: A Community Effort Introduction Systems Biology and Physiology-Based Modeling Artificial Intelligence and Mechanistic Modeling Building an In Silico Medicine Community The Virtual Physiological Human The Virtual Physiological Human Institute In Silico Medicine Community: Where Are we Now? Regulation Policy In Silico Personalized Medicine: Current Challenges Current Challenges for In Silico Medicine Growing the Community Conclusion References Part III Personalized Healthcare: From Ethics to Policies Exposomics in the Era of Personalized Medicine: A Critical Analysis Introduction Personalized Medicine and Its Moral Economy Exposomics to the Rescue of Personalized Medicine Rival Approaches to Exposomics Two Models for Exposomics as an Environmental Health Science Conclusion References Personalized Epigenetics: Prospects and Challenges Introduction Epigenetic Biomarkers and the 4 Ps of Personalized Medicine The 4th P Exposure and Responsibility The Environment Discourse: Anthropogenically Altered Environments Involuntary Exposure: The Developmental Origin of Health Inequalities Voluntary Exposure: The Individual Burden? Conclusion: From Personalized Epigenetics to Personomics References Personalized Medicine and Research Biobanking: From Traditional to New Informed Consent Generating a Need for Participatory Governance Introduction Information and Informed Consent: Which Model to Adopt? Alternatives to Traditional Informed Consent Dynamic Consent and the Beginning of an Active Participation Meta Consent and the Beginning of a Bottom-Up Approach Conclusions: Towards Models of Participatory Governance References Biobank Research and Data Protection Issues Under the GDPR Introduction Protecting Personal Information Personal Information and Informed Consent Informed Consent and Transparency under the GDPR The Research Exemption Under the GDPR Conclusion References Shedding Light on the Application of Pharmacogenomics to the United States Opioid Crises: A Relational Approach Introduction Background Information of the Opioid Epidemic Research Design Findings Discussion and Conclusion Appendix References The Impact of a Fantasy Introduction: Personalized and Precision Medicine as a Sociotechnical Imaginary The Imaginary of Precision Medicine Runs Counter to Knowledge “We Have Never Been Modern”: On Fantasies and Futures What Is a Stake? The Possible Impacts of a Fantasy The New That Cannot Be Born References Correction to: The Impact of a Fantasy Correction to:C. Beneduce, M. 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