title: Patient involvement in drug licensing: a case study.
abstract: Embodied health movements work on the boundary between lay and expert knowledge. Consumer groups, depending on their goals, may increase or decrease pharmaceuticalization. This paper reports a small case study about the retrospective evaluation of a specific second line treatment for type 2 diabetes by an existing patient involvement group. The group is part of a research collaboration between academia and the health service in England, and shares some characteristics of embodied health movements. We used the case study to explore whether an institutionally funded non activist patient group can make a more balanced contribution to drug licensing decisions than that made by either access-oriented or injury-oriented consumer groups, without being co-opted by an institutional agenda. The questions we wished to address were how this group evaluated existing mechanisms for licensing drugs; how they balanced scientific and lay knowledge; how they made their decisions; and how they viewed their experiences as panel members. The five panel members were interviewed before and after the panel discussion in July 2013. They were critical of current licensing processes, and used their own embodied experiences of medicines to evaluate expert knowledge. Their decisions on the panel were informed either by a balancing of benefits and harms, or by trust in experts. The case study suggests that such a group may have the potential both to balance the pro-pharmaceuticalization impact of access-oriented groups and to influence forms of pharmaceutical governance.
authors.affiliation: Institute of Health Research, University of Exeter Medical School, Veysey Building, Salmon Pool Lane, Exeter EX2 4SG, UK. Electronic address: n.britten@exeter.ac.uk.
authors.forename: Nicky
authors.initials: N
authors.lastname: Britten
authors.affiliation: Institute of Health Research, University of Exeter Medical School, Veysey Building, Salmon Pool Lane, Exeter EX2 4SG, UK. Electronic address: S.Denford@exeter.ac.uk.
authors.forename: Sarah
authors.initials: S
authors.lastname: Denford
authors.affiliation: Peninsula Patient Involvement Group, University of Exeter Medical School, Veysey Building, Salmon Pool Lane, Exeter EX2 4SG, UK. Electronic address: fhgdowndevonway@yahoo.co.uk.
authors.forename: Faith
authors.initials: F
authors.lastname: Harris-Golesworthy
authors.affiliation: Peninsula Patient Involvement Group, University of Exeter Medical School, Veysey Building, Salmon Pool Lane, Exeter EX2 4SG, UK. Electronic address: stephaniejibson@blueyonder.co.uk.
authors.forename: Steph
authors.initials: S
authors.lastname: Jibson
authors.affiliation: Peninsula Patient Involvement Group, University of Exeter Medical School, Veysey Building, Salmon Pool Lane, Exeter EX2 4SG, UK. Electronic address: nigelpyart101@googlemail.com.
authors.forename: Nigel
authors.initials: N
authors.lastname: Pyart
authors.affiliation: Institute of Health Research, University of Exeter Medical School, Veysey Building, Salmon Pool Lane, Exeter EX2 4SG, UK. Electronic address: Ken.Stein@exeter.ac.uk.
authors.forename: Ken
authors.initials: K
authors.lastname: Stein
mesh_terms: D003255:Consumer Organizations; D003657:Decision Making; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy; D004335:Drug and Narcotic Control; D004739:England; D017144:Focus Groups; D006297:Health Services Accessibility; D006801:Humans; D008004:Licensure; D000069450:Liraglutide / Q000009:adverse effects / Q000627:therapeutic use; D008119:Lobbying; D019982:Organizational Case Studies; D010344:Patient Advocacy; D010358:Patient Participation; D000067490:Prescription Drug Overuse; D055553:Prescription Drugs; D011361:Professional Competence; D018570:Risk Assessment
chemical_list: D055553:Prescription Drugs; D000069450:Liraglutide
keywords: Drug licensing; Health social movements; Patient groups; Pharmaceuticals; Public involvement; UK