How evidence-based are the pharmaceutical industry’s printed promotional material presented to physicians: a multinational study

Article type
Authors
Ciapponi A1, Reveiz L2, Rada G3, Glujovsky D1, García-Martí S1, Rubinstein F1, Rey Ares L1, Bardach A1, Valderrama S3
1Argentine Cochrane Centre, Institute for Clinical Effectiveness and Health Policy-IECS, Buenos Aires, Argentina
2Instituto de Investigaciones, Fundación Universitaria Sánitas
3Evidence Based Medicine Unit and Department of Internal Medicine, Pontificia Universidad Católica de Chile, Santiago de Chile, Chile
Abstract
Background: A major marketing technique used by pharmaceutical companies is direct-to-physician marketing. The physician-industry interaction affects prescribing and professional behavior. Pharmaceutical sales representatives frequently visit 70% to 90% of physicians during their daily practice. Promotional Material is considered useful (58% of residents), influential (22% of physicians) or inappropriate (12–60% of physicians). Objectives: To determine if references provided by printed promotional material (PPM) presented to physicians by pharmaceutical representatives support its statements. We will also assess the validity of PPM against the best available evidence. Methods: A consecutive sample of all PPM distributed in a family medicine practice (Hospital Italiano de Buenos Aires, Argentina), a general medicine practices (Consultorios de la Cl´ınica Reina Sof´ıa, Bogota´ Colombia) and an internal medicine practice (Centro Me´ dico San Joaqu´ın, Santiago de Chile, Chile) was collected between January 1 and March 30, 2010. Reprints and monographs were excluded. We will evaluate the number and accuracy of PPM’s statements supported by cited references; and the correctness of references cited in PPM according to the International Committee of Medical Journal Editors as well as the availability of those references in area libraries. Adverse reactions, warnings about drug interactions and contraindications will also be collected. Relevant clinical information of thematerial will be translated to PICO format question to systematically search in TRIP Database (first step) and/or MEDLINE (PUBMED). We will assess the quality/risk of bias of identified systematic reviews and randomized controlled trials using the AMSTAR instrument and the Cochrane Handbook respectively. PPM will be classified as ‘‘adequately’’, ‘‘insufficiently’’ or ‘‘inadequately’’ supported and cited. Two independent reviewers will grade the quality of PPM’s evidence using the GRADE system, and will contrast the strength of its statements against the best available evidence to classify them as correct, incorrect or misleading. Results will be presented at the Colloquium