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
7 - Protecting and Promoting the Evidentiary-Science Base of Personal Genome Medicine/PGM
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
genomicsproteomicsbiotech revolutiongenomic revolutionpersonal genome medicineMendelian traitsMendelian diseasespositive predictive value (PPV)positive negative value (PNV)clinical penetranceclinical sensitivitySecretary’s Advisory Committee on Genetic Testing (SACGT)Oncormed23andMepatent medicinesAmerican Medical Association (AMA)AMA Counselprescription-only categorytechnology transfer law and policydirect-to-physician marketingdirect-to-consumer marketingUS medical educationmedical journal establishmentrecreational geneticsdirect-to-consumer genetic testingFood and Drug Modernization Act (FDAMA)drug television advertisingFood and Drug Administration Safety and Innovation Act (FDASIA)information and communication technologyAmerican Medical Association membershipdirect-to-consumer personal genome servicesnoninvasive prenatal tests (NIPTs)microdeletionsLabcorpQuest Diagnostics23andMe23andMe Holding Co.Lemonaid HealthtelehealthehealthCorporate Practice of Medicine DoctrineHealth Care Quality Improvement Act (HQIA)Anti-Kickback StatuteStark LawNational Academies of Science, Engineering, and Medicine (NASEM)Coordinated Framework for Regulation of Biotechnology ProductsHuman Genome Project (HGP)direct-to-consumer genomicspersonal genome sequencingpersonal genome testingDobbs v. Jackson Women's HealthClinical Laboratory Improvement AmendmentsClinical Laboratory Improvement Advisory Committee (CLIAC)Task Force on Genetic TestingAngelina effectgenetic health risk assessmentNeil HoltzmanHealth Insurance Portability and Accountability Act (HIPAA)HIPAA Privacy RuleHIPAA Security RuleAffordable Care Act (ACA)doctor–patient relationshippatient self-determinationopioid epidemicopioid public health crisisdirect-to-consumer genomicsdo-it-yourself genomics/DIY genomics510(k) process/applicationgenetic consumerismcommercial free speechsection 506(b)evidentiary-science base of US medicinecox-2 inhibitorscertificates of waiver (CWs)in vitro diagnostic tests (IVDs)provider-performed microscopy procedures (PPMs)medical profession self-regulationOffice of Technology Assessment (OTA)General Practice Research Database (GPRD)Medicines and Healthcare products Regulatory Agency (MHRA)real-world data (RWD)opioid addiction crisisopioid addiction public health emergencyOpioid Task ForceNational Commission on Combating Drug AddictionCommittee on Emerging Science, Technology, and Innovation (CESTI)Collingridge dilemmahealth-related personal genome testswww.ClinicalTrials.govGENCODECombined DNA Index System (CODIS)National DNA Index System (NDIS)National Practitioner Data Bank (NPDB)Food and Drug Administration Amendments Act (FDAAA)public-private networksAccelerating Medicines Partnership (AMP)Precision Medicine Initiative (PMI)Bespoke Gene Therapy Consortium (BGTC)Somatic Cell Genome Editing (SCGE) Consortiumcooperative research and development agreements (CRADAs)Biomedical Advanced Research and Development Authority (BARDA)Personal Genome Project (PGP)National Genomic Test DirectoryECRI InstituteInstitute for Safe Medication Practices (ISMP)International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)ICH Guidelines
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- Personal Genome MedicineThe Legal and Regulatory Transformation of US Medicine, pp. 365 - 434Publisher: Cambridge University PressPrint publication year: 2023