The Dark Side of the Model

The clinic practices that make healthy volunteers into model organisms also raise important validity concerns about Phase I trials. Chapter 6 concentrates particularly on the ways in which healthy volunteers, clinics, and the pharmaceutical industry all have incentives to make investigational drugs appear safer than they really might be. The chapter considers intrinsic validity concerns, extrinsic validity concerns, and adverse event reporting as a validity calamity. Intrinsic concerns have to do with the sex, race/ethnicity, age, and seriality of healthy volunteers and raise the question of whether and to what extent healthy volunteers can be considered representative of the general population. Extrinsic concerns include staff and healthy volunteer practices, such as treating the inclusion-exclusion criteria for studies as more malleable than intended or failing to adhere to or enforce the waiting period before healthy volunteers can enroll in their next study. The chapter concludes with a treatment of adverse event reporting as an in-depth case of validity problems that emerge in clinical trials when all the actors have an economic interest in underreporting any symptoms that occur in healthy volunteers during these studies.