MBBS Curriculum 2020

Manufactured Values: Industry Front Groups, Looping Effects, and Regulatory Decisions

13 February 2018 - 17:00-18:30

LectureBennett Holman, University of Yonsei.

Classroom 6, Hodgkin Building, Guy’s Campus

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Evaluating a case to determine whether it is an example of overtreatment frequently
trades on values: “Which side effects are important enough to include in any measurement of
harm? Are some side effects more important than others? Who should decide—patients,
clinicians, or researchers? And what if they disagree?” (Carter et al. 2015). In an effort to deal
with just this issue, the FDA created the patient focus drug program. Combining philosophy
with qualitative methods from the social sciences, our research first examines the October
2014 patient meeting for Flibanserin and female sexual dysfunction. We show that industry-
funded participants presented a unified message that was almost completely distinct from
other participants. We argue that this process can be understood as an example of a “looping
effect” (i.e. women have internalized the industry’s narrative which now genuinely structures
their experience). Setting this case in context of broader efforts by industry to shape the
experience of patient groups, we argue that: At best this significantly complicates efforts to
incorporate patient values into risk/benefit judgments, and at worst, it belies the
presupposition that patient interests are an objective, immutable, and knowable factor to be
incorporated into medical decision making and regulatory decisions.

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