title: Association Between Financial Conflicts of Interests and Supportive Opinions for Erectile Dysfunction Treatment.
abstract: A conflict of interest (COI) is a situation in which a person has competing loyalties or interests that make it difficult to fulfil his or her duties impartially. Conflict of interest is not categorically improper in itself but requires proper management. A SCOPUS literature search was performed for publications on the efficacy/safety of Phospho-Di-Esterase Inhibitors (PDEIs) for treating erectile dysfunction. A categorization tool (CoOpCaT) was used to review and classify the publications as supportive/not-supportive for the discussed active ingredient and reporting or not reporting a COI for that specific drug or for the remaining PDEIs (i.e. competitors). Multivariable binary logistic regression was performed. In the 419 selected records the prevalence of supportive opinions was higher when a COI for the index label was declared. The CoOpCaT showed good internal consistency, discriminative validity and intra/inter-rater agreement. The strongest predictor for a supportive opinion was the total number of financial COIs for the index label. A mild protective effect of the total number of financial COIs for any competitor label was noted. Financial COIs have frequently been associated with bias, and the measures currently adopted to restrain it lack effectiveness. Some evidence for monitoring and/or compensating this bias is reported here, but the ultimate solution remains distant.
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, Section of Legal Medicine, University Hospital of Padova, Via Falloppio 50, Padova, 35121, Italy. boscolorafael@tiscali.it.
authors.forename: Rafael
authors.initials: R
authors.lastname: Boscolo-Berto
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, Section of Legal Medicine, University Hospital of Padova, Via Falloppio 50, Padova, 35121, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Montisci
authors.affiliation: Department of Urology, Ospedale Niguarda Cà Granda, Piazza Ospedale Maggiore 3, Milano, 20162, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Secco
authors.affiliation: Department of Urology, University of Verona, Piazzale Scuro 10, Verona, 37134, Italy.
authors.forename: Carolina
authors.initials: C
authors.lastname: D'Elia
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, Section of Legal Medicine, University Hospital of Padova, Via Falloppio 50, Padova, 35121, Italy.
authors.forename: Rosella
authors.initials: R
authors.lastname: Snenghi
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, Section of Legal Medicine, University Hospital of Padova, Via Falloppio 50, Padova, 35121, Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Viel
authors.affiliation: Department of Cardiac, Thoracic and Vascular Sciences, Section of Legal Medicine, University Hospital of Padova, Via Falloppio 50, Padova, 35121, Italy.
authors.forename: Santo Davide
authors.initials: SD
authors.lastname: Ferrara
mesh_terms: D035843:Biomedical Research / Q000941:ethics*; D016265:Conflict of Interest; D030881:Disclosure; D007172:Erectile Dysfunction / Q000188:drug therapy*; D032984:Ethics, Research; D006801:Humans; D016015:Logistic Models; D008297:Male; D010726:Phosphodiesterase Inhibitors / Q000627:therapeutic use*; D011642:Publications / Q000941:ethics; D011643:Publishing / Q000941:ethics*
chemical_list: D010726:Phosphodiesterase Inhibitors
keywords: Bias; Conflict of interest; Ethics; Financial disclosure; Sponsor