Book contents
- Personal Genome Medicine
- Personal Genome Medicine
- Copyright page
- Dedication
- Contents
- Reader’s Note
- Acknowledgments
- Prologue
- 1 Medical Profession Sovereignty to Protect and Promote the Science and Evidence Base of US Medicine
- 2 US Integration of Government, Academia, and Industry
- 3 Direct-to-Consumer/DTC and Direct-to-Physician/DTP Biopharma Marketing in the US
- 4 The Evolution of Consumer Genetic Testing Services from Oncormed, Inc. to 23andMe Holding Co.
- 5 Vulnerability of the Science and Evidence Base of US Medicine
- 6 A Warning Label for Direct-to-Consumer/DTC Genetics and Genomics
- 7 Protecting and Promoting the Evidentiary-Science Base of Personal Genome Medicine/PGM
- Epilogue
- Index
6 - A Warning Label for Direct-to-Consumer/DTC Genetics and Genomics
Published online by Cambridge University Press: 30 August 2023
Book contents
- Personal Genome Medicine
- Personal Genome Medicine
- Copyright page
- Dedication
- Contents
- Reader’s Note
- Acknowledgments
- Prologue
- 1 Medical Profession Sovereignty to Protect and Promote the Science and Evidence Base of US Medicine
- 2 US Integration of Government, Academia, and Industry
- 3 Direct-to-Consumer/DTC and Direct-to-Physician/DTP Biopharma Marketing in the US
- 4 The Evolution of Consumer Genetic Testing Services from Oncormed, Inc. to 23andMe Holding Co.
- 5 Vulnerability of the Science and Evidence Base of US Medicine
- 6 A Warning Label for Direct-to-Consumer/DTC Genetics and Genomics
- 7 Protecting and Promoting the Evidentiary-Science Base of Personal Genome Medicine/PGM
- Epilogue
- Index
Summary
In the years following FDA approval of direct-to-consumer, genetic-health-risk/DTCGHR testing, millions of people in the US have sent their DNA to companies to receive personal genome health risk information without physician or other learned medical professional involvement. In Personal Genome Medicine, Michael J. Malinowski examines the ethical, legal, and social implications of this development. Drawing from the past and present of medicine in the US, Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercial personal genome sequencing and testing sectors and to assess their impact on the future of US medicine. Written in relatable and accessible language, the book also proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.
Keywords
physician discretionAmerican Medical Association (AMA)OncormedInstitutional review board (IRB)genomicsproteomicsepigeneticsgenetic testingproteomic testingcertified genetic counselor (CGC)National Society of Genetic Counselors (NSGC)American Society of Human GeneticsAmerican Board of Genetic Counseling (ABGC)genetic counselingnondirectivenessMelissa Richterevidence-based medicinegenetic health risk testing23andMe23andMe Holding Co.recreational geneticsSecretary’s Advisory Committee on Genetic Testing (SACGT)technology transfer law and policybiotechnology/biotech revolutiongenomic revolutionNational Academies of Science, Engineering, and Medicine (NASEM)lab-developed genetic tests (LDTs)noninvasive prenatal tests (NIPTs)genome sequenceprimary care physiciansfamily practice physicianspatient self-determinationpersonal genome medicinedo-it-yourself biology (DIY-Bio)biohackinghuman germline genetic engineeringCRISPRHe Jiankuigermline editingEthical Legal and Social Issues Research Program (ELSI)Human Genome Project (HGP)prescription privilegesin-home testingat-home testingLetsGetCheckedEveryWelllongevity testingall-cause mortality testingwellness genomics marketAmgenHuman Longevityhuman longevity care movementCraig Ventergenetic health risk testingprecision medicinepersonalized medicineMendelian traitsMendelian diseasesCenters for Mendelian Genomicsin vitro diagnostic tests (IVDs)noninvasive prenatal tests (NIPTs)microdeletionlab-developed tests (LDTs)home brew testsClinical Laboratory Improvement Amendments (CLIA)Concert GeneticsDobbs v. Jackson Women's Healthwhole-genome sequencingAnne WojcickiPersonal Genome Servicepositive predictive values (PPVs)negative predictive values (NPVs)patient comprehensionLemonaid HealthNational Human Genome Research Institute (NHGRI)off-label usedisease mongeringGeneWatchdiscretion to practice medicinedefensive medicinediagnostic testingindividualized patient careCurrent Procedural Terminology (CPT)CPT codesMichael YesleyFuture of Privacy ForumEric LanderFrancis CollinsCommon Rulepopulation genomics researchpopulation genetics researchsecondary studiesAll of Us Research ProgramHealth Insurance Portability and Accountability Act (HIPAA)protected health information (PHI)Genetic Information and Nondiscrimination Act (GINA)biobankgenetic genealogyinvestigative genetic genealogyLavender DoeGolden State KillerGEDMatchFamilyTreeDNACeCe MooreParabon NanolabsAncestry.cominformation and communication technologycybersecurity vulnerabilityRootsWebCalico SciencesIllumina, Inc.Belmont ReportNational Commission for the Protection of Human Subjectsdoctor–patient relationshippatient autonomypatient self-determinationparticipatory health movementCenter for Medicine in the Public InterestGATTACAFamily Traits Inheritance Calculatoropen consentHenrietta LacksHeLa cellsCoordinated Framework for the Regulation of BiotechnologyAccess to Genetic Counselor Services ActHIPAA Security RuleHIPAA Privacy RulePersonal Genome Project (PGP)510(k) clearance
- Type
- Chapter
- Information
- Personal Genome MedicineThe Legal and Regulatory Transformation of US Medicine, pp. 299 - 364Publisher: Cambridge University PressPrint publication year: 2023