Analysis
← vista completaPublished on May 30, 2013 | http://doi.org/10.5867/medwave.2013.04.5671
A tale of harm, waste and deception: how big pharma has undermined public faith in trial data disclosure and what we can do about it
Una historia de perjuicio, desperdicio y engaño: cómo la gran industria farmacéutica ha socavado la fe pública en los datos de sus ensayos clínicos y qué podemos hacer al respecto
Abstract
The article addresses the issue of data stemming from interventional studies in humans conducted by the pharmaceutical industry and how lack of data, or data distortion, can impact on clinical decision making and systematic reviews. The cases of rosiglitazone (Avandia ™, GlaxoSmithKline), rofecoxib (Vioxx ™, Merck), and oseltamivir (Tamiflu ™, Roche), are discussed as examples of harm (morbidity and mortality were higher in the treatment groups), waste (government spending in public health programs was not based on evidence), and deception (non-reporting of adverse events in fase III trials). The consequences of this behavior on scientific production are manifold. Most importantly, evidence that is used to inform clinical decisions is reduced and distorted, which also includes publication bias. The article mentions several solutions that have appeared in international literature, such as registration of clinical trials prior to implementation, the use of guidelines to improve the quality of reports, encouraging the publication of all research results and safeguarding autonomy of academy and investigators. Registration of clinical trials has not been effective in preventing the opacity surrounding phase III intervention trials funded by industry. Editors of biomedical journals, health authorities in charge of approving drugs before marketing, ethics committees that authorize the conduct of trials in their facilities, researchers, academics and patient organizations, are all major stakeholders. The pharmaceutical industry is called upon to respond to these proposals that promote transparency. If they do so, public trust in research conducted by them may be recovered.
