“Personal Genome Medicine: The Legal and Regulatory Transformation of US Medicine,” a new book by LSU Law Professor Michael J. Malinowski examining the ethical, legal, and social implications of direct-to-consumer, genetic health risk testing services such as 23andMe’s Personal Genome Health Service, has been published by Cambridge University Press.
“Professor Malinowski’s book is timely and vitally important,” said LSU Law Dean Alena Allen. “The advent of corporations having access to DNA has created a multitude of legal and ethical questions. Professor Malinowski’s book provides a framework with guidance about how to think about these complex issues. He is clearly a leader on these important topics.”
Drawing from the history of U.S. medicine, Professor Malinowski applies law, policy, public and private sector practices, and governing norms to analyze the commercialization of personal genome sequencing and testing sectors, as well as to assess their impact on the future of U.S. medicine.
“In the roughly 30 years that I have been researching and writing about these important topics, I have witnessed an explosion in the use of these emerging technologies far beyond anything I could have imagined when I began my career,” said Professor Malinowski, a Yale Law School alumnus who has been an LSU Law faculty member since 2002. “In 2017, when the U.S. Food and Drug Administration approved direct-to-consumer genetic health risk testing that does not meet evidentiary science clinical standards—with medical professional involvement wholly optional—it was a jolting deviation from the U.S. legacy of protecting and promoting the evidentiary-science base of medicine. ‘Personal Genome Medicine’ represents the culmination of my scholarship on this issue to date, and my hope is that it will elevate and advance the conversation in a meaningful way.”
In “Personal Genome Medicine,” Professor Malinowski proposes regulatory reforms for government and medical professionals that will enable technological advancements while maintaining personal and public health standards.
McGill University Professor Bartha Maria Knoppers, a leading expert in the field of genetics and ethics, described “Personal Genome Medicine” as a “tour de force.”
“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,” said Knoppers, who was made an Officer of the Order of Canada in 2002 in recognition of being “a world authority on the ethical aspects of genetics, genomics, and biotechnology.”
Professor Malinowski holds the Ernest R. and Iris M. Eldred Professorship, and Lawrence B. Sandoz, Jr. Endowed Professorship at LSU Law, where his core courses include Bioethics Law and Policy, Health Law Survey, Disability Law, and Biotechnology: Law, Business, and Policy. He is the author of several academic books (“Handbook on Biotechnology Law, Business, and Policy: Human Health Products from the Laboratory Bench to Market Approvals” [2016], “Biotechnology: Law, Business, and Regulation” [1999]) and more than 50 law review articles, as well as one children’s book (“Why Am I Me?”, 2019).
Prior to his Professor Malinowski earned his B.A. in 1987 from Tufts University and his J.D. in 1991 from Yale Law School, where he served as articles editor of The Yale Law Journal.
Original source can be found here.