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Gatekeeping and trailblazing: The role of biomarkers in novel guidelines for diagnosing Alzheimer’s disease

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Abstract

In innovation policy discourse, clinical practice guidelines are often viewed as gatekeepers: they select which novel technologies may enter clinical practice. Earlier research has pointed out, however, that in biomedical innovation a ‘regime of hope’ and a ‘regime of truth’ interact. High expectations of future developments can feed into clinical guidelines by changing assessment criteria, thus co-shaping the ‘gate’ innovations have to pass. This paper shows how diagnostic guidelines can embody hope in yet another way, by introducing a novel disease vocabulary that paves the way for emerging diagnostic technologies. I discuss two sets of guidelines for diagnosing Alzheimer’s disease: the guidelines issued by the American National Institute on Aging and the Alzheimer’s Association (2011), and the parts of the DSM-5 related to diagnosing AD (2013). Both function as gatekeepers in that they explicitly discourage the use of biomarker testing in clinical practice. However, they also act as ‘trailblazers’, transforming the conceptualization of Alzheimer’s disease in such a way that biomarker tests can be easily fitted in later on. The paper ends with some reflections on the potential presence of such ‘trailblazing’ in other diagnostic guidelines, and its acceptability from an ethical and societal point of view.

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Notes

  1. The term ‘short-cut’ was suggested first by Annette Leibing, University of Montreal (personal communication).

  2. Both sets of guidelines were actually preceded by a largely European initiative to reformulate the NINCDS/ARDRA guidelines for diagnosing AD (Dubois et al, 2007, 2010, 2014). I have not included these because they are explicitly intended for use in research settings only. The so-called ‘Dubois-criteria’ actually propose categories that are more or less in line with the NIA-AA categorisation, even though the labels used are often slightly different (Visser et al, 2012)

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Acknowledgements

The research for this paper was enabled by a grant from the Dutch Organization for Scientific Research (NWO) under its program Responsible Innovation, for which my sincere thanks. Many thanks also to my colleagues in the project: Yvonne Cuijpers, Anna Laura van der Laan, Harro van Lente, and Ellen Moors, to Peter Whitehouse, to the participants in the Technology & Values seminar of the Department of Philosophy, University of Twente, and to the anonymous reviewers, who all gave constructive feedback on earlier versions of this paper. I also declare that I have no competing interests – intellectual or financial – in the research detailed in the manuscript.

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Boenink, M. Gatekeeping and trailblazing: The role of biomarkers in novel guidelines for diagnosing Alzheimer’s disease. BioSocieties 13, 213–231 (2018). https://doi.org/10.1057/s41292-017-0065-0

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