IDEAS home Printed from https://ideas.repec.org/a/eee/socmed/v304y2022ics027795362030143x.html
   My bibliography  Save this article

Framing utility: Regulatory reform and genetic tests in the USA, 1989–2000

Author

Listed:
  • Sturdy, Steve

Abstract

Before about 1990, insofar as diagnostic and other medical tests were subject to regulatory oversight, it was chiefly to ensure that they met appropriate standards of analytic and clinical validity. Over the course of the 1990s, however, regulatory reformers in the United States began to argue that genetic tests, specifically, should also be assessed to determine whether or not they actually benefit those undergoing testing—whether they possess “clinical utility”, as they put it. The present paper asks why this shift in regulatory focus occurred specifically in relation to genetic tests, and why clinical utility became a key object of assessment. It answers these questions by situating concerns about genetic tests in the longer history of medical genetics. Looking back to the 1970s and medical geneticists' efforts to distance themselves from their earlier association with eugenics, it shows that they adopted a particular framing of the dangers of genetic testing which would inform their response to the proliferation of new genetic tests and the growth of commercial testing in the 1990s. In a series of policy committees convened over the course of that decade, medical geneticists called for regulatory measures to be implemented to ensure that genetic tests were only introduced into medical practice if they had been shown to be beneficial to those tested. The paper follows the deliberations of those committees to show in detail how geneticists worked within this framing to accommodate new technical capacities and regulatory opportunities. In the course of these deliberations, they adopted the idea of clinical utility to signify the need for evidence of benefit specifically to those tested. The paper concludes with some observations regarding how this framing of genetic tests relates to current understandings of “genetic exceptionalism” and to more recent articulations of clinical utility.

Suggested Citation

  • Sturdy, Steve, 2022. "Framing utility: Regulatory reform and genetic tests in the USA, 1989–2000," Social Science & Medicine, Elsevier, vol. 304(C).
  • Handle: RePEc:eee:socmed:v:304:y:2022:i:c:s027795362030143x
    DOI: 10.1016/j.socscimed.2020.112924
    as

    Download full text from publisher

    File URL: http://www.sciencedirect.com/science/article/pii/S027795362030143X
    Download Restriction: Full text for ScienceDirect subscribers only

    File URL: https://libkey.io/10.1016/j.socscimed.2020.112924?utm_source=ideas
    LibKey link: if access is restricted and if your library uses this service, LibKey will redirect you to where you can use your library subscription to access this item
    ---><---

    As the access to this document is restricted, you may want to search for a different version of it.

    References listed on IDEAS

    as
    1. Hogarth, Stuart, 2015. "Neoliberal technocracy: Explaining how and why the US Food and Drug Administration has championed pharmacogenomics," Social Science & Medicine, Elsevier, vol. 131(C), pages 255-262.
    2. Shobita Parthasarathy, 2007. "Building Genetic Medicine: Breast Cancer, Technology, and the Comparative Politics of Health Care," MIT Press Books, The MIT Press, edition 1, volume 1, number 0262162423, April.
    3. Bourret, Pascale & Keating, Peter & Cambrosio, Alberto, 2011. "Regulating diagnosis in post-genomic medicine: Re-aligning clinical judgment?," Social Science & Medicine, Elsevier, vol. 73(6), pages 816-824, September.
    Full references (including those not matched with items on IDEAS)

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Cambrosio, Alberto & Campbell, Jonah & Keating, Peter & Polk, Jessica B. & Aguilar-Mahecha, Adriana & Basik, Mark, 2022. "Healthcare policy by other means: Cancer clinical research as “oncopolicy”," Social Science & Medicine, Elsevier, vol. 292(C).
    2. Löwy, Ilana, 2022. "Non-invasive prenatal testing: A diagnostic innovation shaped by commercial interests and the regulation conundrum," Social Science & Medicine, Elsevier, vol. 304(C).
    3. Armstrong, David, 2019. "Diagnosis: From classification to prediction," Social Science & Medicine, Elsevier, vol. 237(C), pages 1-1.
    4. Stuart Hogarth & Paul Martin, 2021. "The ratio of vision to data: Promoting emergent science and technologies through promissory regulation, the case of the FDA and personalised medicine," Regulation & Governance, John Wiley & Sons, vol. 15(3), pages 969-986, July.
    5. Shobita Parthasarathy, 2011. "Whose knowledge? What values? The comparative politics of patenting life forms in the United States and Europe," Policy Sciences, Springer;Society of Policy Sciences, vol. 44(3), pages 267-288, September.
    6. Bourgain, Catherine & Pourtau, Lionel & Mazouni, Chafika & Bungener, Martine & Bonastre, et Julia, 2020. "Imperfect biomarkers for adjuvant chemotherapy in early stage breast cancer with good prognosis," Social Science & Medicine, Elsevier, vol. 246(C).
    7. Boenink, Marianne, 2011. "Unambiguous test results or individual independence? The role of clients and families in predictive BRCA-testing in the Netherlands compared to the USA," Social Science & Medicine, Elsevier, vol. 72(11), pages 1793-1801, June.
    8. Aarden, Erik & Van Hoyweghen, Ine & Horstman, Klasien, 2011. "Constructing access in predictive medicine. Comparing classification for hereditary breast cancer risks in England, Germany and the Netherlands," Social Science & Medicine, Elsevier, vol. 72(4), pages 553-559, February.
    9. Swallow, Julia & Kerr, Anne & Chekar, Choon Key & Cunningham-Burley, Sarah, 2020. "Accomplishing an adaptive clinical trial for cancer: Valuation practices and care work across the laboratory and the clinic," Social Science & Medicine, Elsevier, vol. 252(C).
    10. Gisler, Monika & Sornette, Didier & Woodard, Ryan, 2011. "Innovation as a social bubble: The example of the Human Genome Project," Research Policy, Elsevier, vol. 40(10), pages 1412-1425.
    11. Tyskbo, Daniel & Sergeeva, Anastasia, 2022. "Brains exposed: How new imaging technology reconfigures expertise coordination in neurosurgery," Social Science & Medicine, Elsevier, vol. 292(C).
    12. Ross, Emily & Swallow, Julia & Kerr, Anne & Chekar, Choon Key & Cunningham-Burley, Sarah, 2021. "Diagnostic layering: Patient accounts of breast cancer classification in the molecular era," Social Science & Medicine, Elsevier, vol. 278(C).
    13. Erik Aarden & Luca Marelli & Alessandro Blasimme, 2021. "The translational lag narrative in policy discourse in the United States and the European Union: a comparative study," Palgrave Communications, Palgrave Macmillan, vol. 8(1), pages 1-9, December.
    14. Gardner, John & Webster, Andrew, 2016. "The social management of biomedical novelty: Facilitating translation in regenerative medicine," Social Science & Medicine, Elsevier, vol. 156(C), pages 90-97.
    15. Cambrosio, Alberto & Campbell, Jonah & Keating, Peter & Bourret, Pascale, 2022. "Multi-polar scripts: Techno-regulatory environments and the rise of precision oncology diagnostic tests," Social Science & Medicine, Elsevier, vol. 304(C).

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:eee:socmed:v:304:y:2022:i:c:s027795362030143x. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: Catherine Liu (email available below). General contact details of provider: http://www.elsevier.com/wps/find/journaldescription.cws_home/315/description#description .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.