Combating corruption in the pharmaceutical arena

Corruption in healthcare generally and specifically in the pharmaceutical arena has recently been highlighted in reports by Transparency International. This article focuses on four areas of corruption: legislative/regulatory, financial, ideological/ethical, and communications. The problems identified and the solutions considered focus on structural considerations affecting how pharmaceuticals are discovered, developed, distributed, and ultimately used in clinical settings. These include recourse to user fees in the regulatory sphere, application of intellectual property rights to medical contexts (patents and access to research data), commercial sponsorship of ghost writing and guest authors, linkage/delinkage of the funding of research and overall health objectives to/from drug pricing and sales, transparency of payments to healthcare professionals and institutions, and credible regulatory sanctions. In general, financial and other incentives for all actors in the system should be structured to align with desired social outcomes — and to minimise conflicts of interest among researchers and clinicians.

Los que tienen el dinero hacen las reglas: auspicios y resultados en la investigación médica / Those who have the gold make the rules: funding and outcomes in medicines research

Last year, three coauthors and I published a systematic review and meta-analysis showing that the outcome of medicines research of all types is dependent on the source of funding. We showed that when pharmaceutical companies sponsor research it is much more likely to have a positive outcome than when funding comes from other sources. We postulated two possible reasons for our findings: publication bias and the use of inappropriate comparators. Since our article appeared, four similar papers have been published with three of these supporting our findings. The one dissenting paper may have suffered from a Type II error. Other explanations advanced to account for this bias and included a biased interpretation of the overall trial results. As the pharmaceutical industry expands its role in funding medicines research the bias in outcomes threatens the entire scientific endeavour.

El año pasado, tres coautores y yo publicamos una revisión sistemática y un metaanálisis que mostraban que los resultados de la investigación médica de cualquier tipo dependen de la fuente de recursos económicos. Mostramos que cuando las compañías farmacéuticas auspician los trabajos de investigación, éstos son mucho más proclives a tener un resultado positivo que cuando los fondos provienen de otras fuentes. Postulamos dos posibles explicaciones para nuestros hallazgos: sesgo de publicación y el uso de comparaciones inapropiadas. Desde que apareció nuestro artículo se publicaron cuatro estudios similares, de los cuales tres respaldan nuestros hallazgos. El único estudio que disentía con ellos podría haber sufrido un error de tipo II. Otra explicación posible que da cuenta de esta distorsión es una interpretación tendenciosa de los resultados generales de los ensayos. Dado que la industria farmacéutica está expandiendo su papel como auspiciante de las tareas de investigación médica, las distorsiones en los resultados amenazan todo el esfuerzo científico.