title: Public voices in pharmaceutical deliberations: negotiating "clinical benefit" in the FDA's Avastin Hearing.
abstract: This article offers a hybrid rhetorical-qualitative discourse analysis of the FDA's 2011 Avastin Hearing, which considered the revocation of the breast cancer indication for the popular cancer drug Avastin. We explore the multiplicity of stakeholders, the questions that motivated deliberations, and the kinds of evidence presented during the hearing. Pairing our findings with contemporary scholarship in rhetorical stasis theory, Mol's (2002) construct of multiple ontologies, and Callon, Lascoumes, and Barthe's (2011) "hybrid forums," we demonstrate that the FDA's deliberative procedures elides various sources of evidence and the potential multiplicity of definitions for "clinical benefit." Our findings suggest that while the FDA invited multiple stakeholders to offer testimony, there are ways that the FDA might have more meaningfully incorporated public voices in the deliberative process. We conclude with suggestions for how a true hybrid forum might be deployed.
authors.affiliation: The Ohio State University, Columbus, OH, USA, teston.2@osu.edu.
authors.forename: Christa B
authors.initials: CB
authors.lastname: Teston
authors.forename: S Scott
authors.initials: SS
authors.lastname: Graham
authors.forename: Raquel
authors.initials: R
authors.lastname: Baldwinson
authors.forename: Andria
authors.initials: A
authors.lastname: Li
authors.forename: Jessamyn
authors.initials: J
authors.lastname: Swift
mesh_terms: D061067:Antibodies, Monoclonal, Humanized / Q000009:adverse effects* / Q000627:therapeutic use*; D000068258:Bevacizumab; D001943:Breast Neoplasms / Q000188:drug therapy*; D017277:Drug Approval; D004345:Drug Industry; D006809:Humanities; D006801:Humans; D017008:Negotiating; D011639:Public Opinion; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab