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1 - Medical Profession Sovereignty to Protect and Promote the Science and Evidence Base of US Medicine

Published online by Cambridge University Press:  30 August 2023

Michael J. Malinowski
Affiliation:
Louisiana State University
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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

Paul StarrAmerican Medical Association (AMA)science and evidence-based medicinemedical journal establishmentpenicillinWar Production Boardrandomized clinical trialsCorporate Practice of Medicine Doctrine (CPMD)Health Care Quality Improvement Actoff-label usenostrum peddlerspatent medicine manufacturersBiologics Control Actdiphtheria antitoxinsmallpox vaccineUS Public Health ServiceFederal Bureau of ChemistryCouncil on Pharmacy and ChemistryWiley ActAmerican Pharmacists AssociationSherley AmendmentsulfanilamideMassengillFederal Food, Drug, and Cosmetic ActFood and Drug Administration (FDA)Durham-Humphrey Amendmentpharmaceutical research and developmentdoctor-patient relationshippolio vaccinepharmaceutical pricingquackerynostrumsbarbituratesFrances Oldham KelseyKefauver–Harris (K–H) Amendmentscience advisory committeePrescription Drug User Fee Act (PDUFA)Food and Drug Administration Modernization Act (FDAMA)Milton FriedmanPaul SamuelsonDrug Price Competition and Patent Term Restoration ActHatch-WaxmanAbbreviated New Drug Application (ANDA)bioequivalenceMarcia Angellmedical devicesMedical Device Amendments510(k) applicationInstitute of Medicine (IOM)Government Accountability Office (GAO)Food and Drug Administration Amendments Act (FDAAA)opioid epidemicclinical discretionantidepressantspsychotropic drugscholesterol-lowering statinsPresident Trumphydroxychloroquinechloroquineemergency use authorization (EUA)science and evidence base of medicinetechnology transfer law and policyAmerican Medical Association House of DelegatesAmerican Medical Association Board of Trusteesemployer-provided health insuranceMary Huntmedical malpractice crisisJoint Commission on Accreditation of Healthcare OrganizationsabortionPartial-Birth Abortion Ban ActDobbs v. Jackson Women’s HealthGonzales v. OregonProgressive Eragood manufacturing practicesCREATES ActInvestigational New Drug (IND)compassionate usetreatment INDindustry user feesRick BrightAlex Azar
Type
Chapter
Information
Personal Genome Medicine
The Legal and Regulatory Transformation of US Medicine
, pp. 27 - 72
Publisher: Cambridge University Press
Print publication year: 2023

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