How evidence-based are the pharmaceutical industryás printed promotional material presented to physicians in three Latin American countries

Article type
Authors
Ciapponi A1, Reveiz L2, Glujovsky D1, García Martí S1, Rey Ares L1, Bardach A1, Ramírez Moreno L3, Ferreira A3, Rubinstein F1, Rada G4
1IECS - Institute for Clinical Effectiveness and Health Policy. Argentina
2Andean Cochrane Branch of the Ibero-American Cochrane Center
3Clínica Reina Sofía, Bogotó Colombia
4Department of Internal Medicine. Faculty of Medicine, Pontificia Universidad Católica de Chile
Abstract
Background: A major marketing technique used by pharmaceutical companies is direct-to-physician marketing. Of these, one of the most used is the printed promotional material (PPM).

Objectives: To determine if the references provided by printed promotional material (PPM) presented to physicians by pharmaceutical representatives support its statements and to assess the validity of the PPM against the best available evidence.

Methods: A consecutive sample of all the PPM distributed by pharmaceutical representatives was collected from January 2010 to March 2011, in a family medicine practice in Buenos Aires, Argentina; in a general medicine practice in Bogotó, Colombia; and in an internal medicine ambulatory practice in a public hospital in Santiago de Chile, Chile. Reprints and monographs were excluded. The number and accuracy of PPMás statements supported by cited references; and the correctness of references cited in PPM according to the International Committee of Medical Journal Editors guidelines was evaluated. The retrievability of the references was also assessed. Adverse reactions/warnings about drug interactions and contraindications were collected. Relevant clinical information of the material was translated to PICO format questions to systematically search the best related evidence (systematic reviews [SR] or RCTs) in: 1) The Cochrane library 2) MEDLINE. We assessed the risk of bias (ROB) of identified SRs and RCTs using the AMSTAR instrument and the Cochrane Handbook respectively. PPM agreement with citation/best evidence was classified as 'concordantá, 'partially concordantá or 'discordantá. Pairs of independent reviewers graded the citationsá ROB and the quality of the evidence using the GRADE system.

Results: See Table 1.

Conclusions: 2/3 PPMs citations have serious flaws (High ROB, discordant or reference unavailable); 50% of statements are supported by the citation, and 30% are concordant with the best available evidence; Cochrane SR are rarely cited by PPMs. Physicians should not trust in PPM and should demand they be regulated.