Surrogate markers emboldened and boxed warnings and an expanding culture of misinformation: evidence-based clinical science should guide FDA decision making about product labeling.

As health care providers, we are committed to the bestpossible patient care. The ability to provide that level of careto our patients is based in no small part on the availability ofaccurate clinical information about drug and device usagethat reflects actual clinical issues of importance to theclinical decision-making process. The dissemination ofinaccurate, misleading or nonclinically relevant information,regardless of the intentions or reasons, can lead to innuendo,presumption and conjecture concerning clinical outcomesand do harm to the very patients such information is meantto protect.The development of safe and effective contraceptiveoptions for women is the direct result of advances inlaboratory-based research, which has provided an importantfoundation for the development of an evidence-basedapproach to contraceptive management. This marriage oflaboratory and clinical investigation has not only served tobetter delineate pathophysiological processes but also hasexpanded our understanding of the mechanisms of thera-peutic actions. However, when laboratory-based studiesalone are used to explain clinical outcomes, prediction ofclinical outcomes can be corrupted by a lack of clinicalinformation and replaced by a process replete withunsupported assumptions, premature declarations and un-founded concern about the safety and effectiveness oftherapeutic interventions. Such a disingenuous applicationof high-quality laboratory investigation is unfortunately nowmore commonly used to predict clinical risks of contracep-tive use. In several instances, warnings and specificlanguage have been included in the package inserts ofcontraceptives based on nonclinical studies.Nonclinically based outcome variables, or surrogatemarkers, are studied to ostensibly better understand thepathophysiological basis of clinical outcomes associatedwith the use of particular drugs or therapeutic interventions.However, when such surrogate markers are studied to