National Academy of Medicine

FDA and the Media: Lessons from Tysabri about Communicating Uncertainty

September 11, 2015 | Discussion Paper

Despite a rigorous approval process, there is always uncertainty about newly approved drugs: will the benefits observed in initial approval studies hold up over time?  Will side effects emerge? Uncertainty is amplified when drugs receive accelerated approval based on preliminary evidence or surrogate outcomes. Communicating uncertainty about new drugs is an important challenge facing FDA but opportunities exist to create realistic expectations and highlight the inherent uncertainty associated with accelerated approval.

In this paper we examine how uncertainty was communicated by major media and FDA in the case of Tysabri, a multiple sclerosis drug, in order to draw lessons on how to improve the communication of uncertainty about new drugs.


Note

Disclaimer: The views expressed in this paper are those of the authors and not necessarily of the authors’ organizations, the National Academy of Medicine (NAM), or the National Academies of Sciences, Engineering, and Medicine (the National Academies). The paper is intended to help inform and stimulate discussion. It is not a report of the NAM or the National Academies. Copyright by the National Academy of Sciences. All rights reserved.