Our systems are now restored following recent technical disruption, and we’re working hard to catch up on publishing. We apologise for the inconvenience caused. Find out more

Recommended product

Popular links

Popular links


Personal Genome Medicine

Personal Genome Medicine

Personal Genome Medicine

The Legal and Regulatory Transformation of US Medicine
Author:
Michael J. Malinowski, Louisiana State University
Published:
August 2023
Availability:
This ISBN is for an eBook version which is distributed on our behalf by a third party.
Format:
Adobe eBook Reader
ISBN:
9781009293372

Looking for an examination copy?

If you are interested in the title for your course we can consider offering an examination copy. To register your interest please contact [email protected] providing details of the course you are teaching.

    In the years following FDA approval of direct-to-consumer, genetic-health-risk testing, millions of people in the United States have sent their DNA to companies to receive personal genetic 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 U.S., 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 U.S. 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.

    • Applies the history of medicine in the U.S. to explain the present and to introduce regulatory proposals
    • Explains and draws from US technology transfer law and policy (TTLP), which integrates US government, industry, and academia in science research and development (R&D)
    • Addresses the subject matter in a multidisciplinary and interdisciplinary manner

    Reviews & endorsements

    ‘A critical analysis of the last century of informed consent, of current recreational genetics, and of the future of personalized genomic medicine. A meticulous and critical understanding of the novel ethical and legal issues. Personal Genome Medicine is a tour de force.’ Bartha Maria Knoppers, McGill University

    See more reviews

    Product details

    August 2023
    Adobe eBook Reader
    9781009293372
    0 pages
    This ISBN is for an eBook version which is distributed on our behalf by a third party.

    Table of Contents

    • Prologue: revolution, transition and transformation
    • 1. Medical profession sovereignty to protect and promote the science and evidence base of US medicine
    • 2. US integration of government, academia and industry: a catalyst for science-technology revolutions
    • 3. The proliferation of US Direct-to-Consumer (DTC) and Direct-to-Physician (DTP) biopharmaceutical marketing
    • 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 commercial Direct-to-Consumer (DTC) genetics
    • 7. Protecting and promoting the evidentiary-science base of Personal Genome Medicine (PGM)
    • Epilogue: the personal genome future of US medicine.
      Author
    • Michael J. Malinowski , Louisiana State University

      Michael J. Malinowski is the Ernest R. and Iris M. Eldred Endowed Professor of Law and the Lawrence B. Sandoz Jr. Endowed Professor of Law at the Paul M. Hebert Law Center, Louisiana State University. He has published extensively on biotechnology research and development (R&D), health care, and bioethics.