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
5 - Vulnerability of the Science and Evidence Base of US Medicine
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
medical erroriatrogenic injurygenomicsgenomic revolutionbiotechbiotech revolutionproteomicsclinical genomicsdirect-to-consumer genomicsTheranosElizabeth Holmes23andMeEdisontechnology transfer law and policyHuman Genome Project (HGP)DNA sequencingclinical researchacademic medical centerscontract research organizations (CROs)medical science innovationfinancial conflicts of interestphysician-patient fiduciary relationshippatent medicinesAmerican Medical Association (AMA)Corporate Practice of Medicine DoctrineHealthcare Quality and Improvement Actmedical staff bylawsAnti-Kickback Statute/lawStark lawscience and evidence-based medicinemedical journal establishmentpatient self-determinationdoctor-patient relationship23andMecontinuing medical education (CME)health technology assessmentpersonal genome medicinemedical-industrial complexCurrent Procedural Terminology (CPT)business of medicinemanaged caredoctor shortageinformation and communications technologypoliticization of sciencepatient self-determinationCOVID-19 pandemicOperation Warp Speedhydroxychloroquineivermectinvaccine hesitancyanti-vaxxersreal-world dataemergency use authorization (EUA)surrogate endpointsclinical evidentiary standardsmanaged caremedical technology paradoxehealthtelehealthdistance medicinephysician discretionoff-label useCouncil on Graduate Medical EducationFood and Drug Modernization Act (FDAMA)Prescription Drug User Fee Act (PDUFA)partial-birth abortionfetal heartbeatabortion trigger lawsDobbs v. Jackson Women's Healthoriginalist jurisprudenceHouse Oversight CommitteeBiomedical Advanced Research and Development Authority (BARDA)Francis Collinspeer reviewscientific integritycommercially sponsored researchWashington Legal Foundationmedical journal subscription feesshareholder wealth maximization normNational Institutes of Health/NIH fundingdemand for research subjectssubject recruitmentpatient organizationsindustry financial supportpediatric studiesPediatric Research Equity ActBest Pharmaceuticals for Children ActPediatric Rulecox-2 inhibitorsSentinelpaper millsarticle ghostwritingcompany-sponsored studiesAccreditation Council for Continuing Medical Education (ACCME)physician thought leaders/influencers/key opinion leadersFDA Advisory Committeespharmaceutical sales representativesFederation of State Medical Boardsmedical practice guidelinesUS Preventive Services Task Force (USPSTF)Agency for Healthcare Research and Quality (AHRQ)Agency for Health Care Policy and Research (AHCPR)National Guideline Clearinghouse (NGC)National Quality Measures Clearinghouse (NQMC)good clinical practice guidelinesevidence-based practice guidelinescholesterol-lowering statinsHealth Technology Assessment NetworkInternational Network of Agencies for Health Technology Assessment (INAHTA)Health Technology Assessment international (HTAi)Pharmacoeconomics and Outcomes Research (ISPOR)Office of Technology Assessment (OTA)business of medicinehospital conversionsmanaged care networksCOVID-19 infodemicpersonal genome testingBayh-DoleInternational Committee of Medical Journal Editors (ICMJE)Clinical Practice Guidelines
- Type
- Chapter
- Information
- Personal Genome MedicineThe Legal and Regulatory Transformation of US Medicine, pp. 202 - 298Publisher: Cambridge University PressPrint publication year: 2023