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7 results

  • 6 - A Warning Label for Direct-to-Consumer/DTC Genetics and Genomics

  • Michael J. Malinowski, Louisiana State University
  • Book:
    Personal Genome Medicine
    Published online:
    30 August 2023
    Print publication:
    31 August 2023, pp 299-364

  • 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.

  • 2 - US Integration of Government, Academia, and Industry

  • Michael J. Malinowski, Louisiana State University
  • Book:
    Personal Genome Medicine
    Published online:
    30 August 2023
    Print publication:
    31 August 2023, pp 73-123

  • 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.

  • 5 - Vulnerability of the Science and Evidence Base of US Medicine

  • Michael J. Malinowski, Louisiana State University
  • Book:
    Personal Genome Medicine
    Published online:
    30 August 2023
    Print publication:
    31 August 2023, pp 202-298

  • 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.

  • 3 - Direct-to-Consumer/DTC and Direct-to-Physician/DTP Biopharma Marketing in the US

  • Michael J. Malinowski, Louisiana State University
  • Book:
    Personal Genome Medicine
    Published online:
    30 August 2023
    Print publication:
    31 August 2023, pp 124-157

  • 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.

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

  • Michael J. Malinowski, Louisiana State University
  • Book:
    Personal Genome Medicine
    Published online:
    30 August 2023
    Print publication:
    31 August 2023, pp 27-72

  • 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.

  • Appropriateness of psychotropic medication use in a cohort of adolescents with intellectual disability in Queensland, Australia

  • Menghuan Song, Robert S. Ware, Tan N. Doan, Lyn McPherson, Julian N. Trollor, David Harley
  • Journal:
    BJPsych Open / Volume 6 / Issue 6 / November 2020
    Published online by Cambridge University Press:
    17 November 2020, e142
    • Article
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      • Open access
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  • Background

    Psychotropic medications are sometimes used off-label and inappropriately. This may cause harm to adolescents with intellectual disability. However, few studies have analysed off-label or inappropriate prescribing to this group.

    Aims

    To examine the appropriateness of psychotropic prescribing to adolescents with intellectual disability living in the community in south-east Queensland, Australia.

    Method

    Off-label medication use was determined based on whether the recorded medical condition treated was approved by the Australian Therapeutic Goods Administration. Clinical appropriateness of medication use was determined based on published guidelines and clinical opinion of two authors who specialise in developmental disability medicine (J.N.T. and D.H.).

    Results

    We followed 429 adolescents for a median of 4.2 years. A total of 107 participants (24.9%) were prescribed psychotropic medications on at least one occasion. Of these, 88 (82.2%) were prescribed their medication off-label or inappropriately at least once. Off-label or inappropriate use were most commonly associated with challenging behaviours.

    Conclusions

    Off-label or inappropriate use of psychotropic medications was common, especially for the management of challenging behaviours. Clinical decision-making accounts for individual patient factors and is made based on clinical experience as well as scientific evidence, whereas label indications are developed for regulatory purposes and, although appropriate at a population level, cannot encompass the foregoing considerations. Education for clinicians and other staff caring for people with intellectual disability, and a patient-centred approach to prescribing with involvement of families should encourage appropriate prescribing. The effect of the National Disability Insurance Scheme on the appropriateness of psychotropic medication prescribing should be investigated.

  • Patient Requests for Off-Label Bioprediction of Dementia

  • MATTHEW L. BAUM
  • Journal:
    Cambridge Quarterly of Healthcare Ethics / Volume 25 / Issue 4 / October 2016
    Published online by Cambridge University Press:
    16 September 2016, pp. 686-690

  • In 2012, the FDA approved for the differential diagnosis of Alzheimer’s disease a brain-imaging technology, Amyvid-PET (aka florbetapir-PET), capable of non-invasively estimating the burden of amyloid plaques; this approval for one indication renders the technology a candidate for off-label use for another indication according to a physician’s judgment. What should a physician do if an educated, pro-active, and concerned patient requests off-label use of Amyvid-PET to help her estimate the likelihood that her mild memory complaints are “just normal aging” or are likely to profoundly worsen? I consider reasons that a physician might justify denial of such a request, including concerns of safety, uncertain benefit, and fair resource allocation, but cautiously conclude that there may be certain cases where off-label bioprediction would be permissible.