Date of this Version
Published in Anthropology Now 3:3 (December 2011), pp 29-35.
On June 16, 2001, the national press first reported the death of Ellen Roche, a healthy 24-year-old who volunteered for an asthma study at Johns Hopkins University. The story revealed that a few days into the trial she felt very sick, was discharged, and sent home. Within some hours she checked into the emergency room at a local hospital and fell into a coma. Ellen remained in this state until her death a month later. She had received $375 for participating in seven to nine sessions as an outpatient in the clinical drug study that resulted in her death.
This tragedy exposed real gaps in our understanding of human subjects in medical research. Although bioethicists have focused on the ethics of paying subjects to test drug safety, less attention has been paid to who the healthy paid subjects are, what motivates them, how they make decisions about joining a trial, or the effects money has in the way they perceive and deal with risk. The pharmaceutical industry is one of the most globalized and profitable businesses in the United States. Anthropologists have been exploring—particularly in this last decade—different aspects of the industry, from the influence of drug reps on medical prescription practices, to the globalization of clinical trials. Yet the participation of healthy paid subjects selling their bodies in the first phase of drug development has remained all but invisible.
The lack of control and oversight of Phase I Trials and in subsequent phases of drug development might not only endanger professional research subjects and trial participants, but might also compromise the public health and well-being of us all.