Signals and noise in drug safety analyses: the incretin therapy debate provides the rationale for revamping epidemiologic pharmacovigilance.

摘要

In this issue of Diabetes Care, our editorial team has decided to "push the envelope" by openly addressing a safety issue in drug development and monitoring that is gaining interest and provoking controversy. Traditionally, we have not felt it was our charge to comment on moral issues or political decisions related to aspects of medical care or delivery. Rather, it has been our goal and privilege to "survey the current landscape of clinical, research, and health care changes" and "to provide the most up-to-date information for our readers" (1). On one previous occasion we felt it was necessary to voice our opinion as an editorial on academic freedom (2), which we considered critical for the sake of scientific dialogue and collaboration across national borders. At present, we feel it is our charge to bring to the forefront another contentious topic that directly concerns the care of people with diabetes: the ongoing debate on the risks versus benefits of incretin-based therapies. Thus, in this issue we present four articles providing background material and specific arguments on this controversy.