“Promotion Bias” in Medical Product Research

A substantial body of medical literature raises concerns about integrity of the clinical research enterprise in which biostatisticians fill central roles. Such concerns have led to escalating disclosure requirements for publication, including requests for data from biopharmaceutical companies for replication of statistical analyses or for independent pre-publication reanalyses. The accumulating critique of clinical research has two distinguishable themes that, if valid, warrant close attention by biostatisticians. One is incomplete reporting of research results, through failure to publish on entire studies, or selective omission of patients and/or relevant endpoints. The other is co-opting of scientific processes and studies for marketing ends through i) programs of intensive production of work designed to mold opinion favoring one or a class of products, ii) seeding studies, which may emphasize introducing new products into physician practices over science, iii) ghost management of research programs by public relations firms, and iv) ghost authorships of research reports and reviews for medical opinion leaders. We define bias produced by such practices, in principle, as “promotion bias.” While their extent is unclear, the existence of these practices is undisputed. This paper and handout will introduce the biostatistician to the medical literature noted above, and to the medical profession's responses. The hope is that biostatisticians will become knowledgeable about this debate on clinical research practices. To the extent that promotion bias exists and is tacitly accepted, the public credibility of Biostatistics as a profession is threatened, and a public stance against the contributing practices seems warranted.