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

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.