ABSTRACT

This chapter describes unique challenges confronted by medical writers (MWs). It reviews principles of ethical medical communications. Physicians, their patients, and patient advocacy groups eagerly await the full report of the findings concerning what may prove to be a "best-in-class" medication. Construed broadly, the term "medical writer" is something of a misnomer: it only begins to capture our many professional roles. MWs light potentially divergent paths, elucidating benefit: risk profiles of different diagnostic and treatment modalities. Most reports on a medication's effects on surrogate efficacy endpoints should include any off-target or countervailing pharmacodynamic data such as untoward effects or safety signals. MWs and editors should be "steeped in the science" and focus on drawing inferences from study findings in a statistically and logically sound manner. To achieve fair balance in communications, MWs need to contemplate, learn, and "own" the potentially disparate perspectives and agendas of different authors.