Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals Jill A. Fisher New York: NYU Press. 2020. 336pp. $89 (cloth) $30 (pbk) $16.50 (ebk) ISBN: 978-1479862160

One topic that has been brought to the forefront of public attention as a result of the COVID-19 crisis is the clinical trials process. Questions are being raised regarding participant recruitment and selection, ensuring adequate numbers of racial and ethnic minority participants, developing best practices for conducting clinical trials, and achieving valid and reliable results under time and resource constraints. These concerns provide the context for Jill Fisher's new book, Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals. Adverse Events focuses on phase I clinical trials, which involves testing drugs on healthy groups of volunteers. The primary goal of Phase I trials is to observe any ‘adverse events’ in order to determine the safety of drugs and set dose levels for Phases II, III and IV research.

In this book, Fisher subverts medicine's conception of the adverse event by applying it to the social situations of Phase I clinical trial participants. She explores six Phase I clinical trial facilities in the East Coast, West Coast and Midwestern regions of the United States. In her investigation, involving interviews with 235 healthy volunteers and 33 research staff as well as approximately 450 hours of participant observation in Phase I clinics, she found that volunteers bring with them experiences that themselves can be characterized as adverse in nature. Fisher uncovers these less-visible adverse events, including socioeconomic disadvantage, racism and anti-immigrant sentiments, and explores how they affected participants’ cultural, social and physiological experiences in the Phase I trial clinic. Fisher richly describes the disadvantaged backgrounds of Phase I volunteers, which allows readers to understand the motivations underlying their clinical trial participation. The dominant drive to participate is short-term financial gain. While working as a full-time clinical trial participant is infeasible and undesirable for most and fails to yield a larger payoff than a minimum wage job, the healthy lump sum payment can provide low-income individuals an emergency safety net or allow them to leverage funds for the future.

At the core of Fisher's thesis lies the argument that social inequalities shape both the experiences of Phase I clinical trial participants and the scientific results of the research. Essentially, the system exploits the adverse social backgrounds of healthy volunteers in order to portray drugs as safe. Fisher proposes two concepts that enable us to understand the experiences of trial participants and their exploitation: imbricated stigma and the healthy volunteer as model organism. Drawing on Goffman’s (2009 [1963]) notions of discredited and discreditable stigmas, Fisher's imbricated stigma draws attention to the multiple layers of disadvantage that most participants bring with them to the clinic as well as the stigma they adopt when they become a clinical trial participant. According to Fisher, the multilayered stigmas that volunteers face cause them to downplay the risks and instead focus on the short-term monetary relief that comes from participation. The healthy volunteer as model organism, which constructs the ideal volunteer as being compliant with study demands and relies on serial participation by volunteers, emerges from and capitalizes on pre-existing social inequalities. A combination of the bodily capital of volunteers and their vulnerable social position makes them amenable to being shaped into an organism that will yield favourable results for pharmaceutical companies. The problem with this is that the adverse backgrounds of Phase I volunteers result in the overrepresentation of disadvantaged populations, which means that study results are not generalizable to the general population and may not be generalizable to potential users of a particular drug. Further, the artificial conditions of the laboratory environment pose problems for obtaining valid results. Thus, social inequalities and the mission of industry to obtain certain outcomes interfere with the ability to come away with valid scientific findings.

While this book succeeds in demystifying Phase I trials, one criticism is that it is not clear what the concepts developed by Fisher do for our understanding of cases outside of the Phase I trials context. What is special about the notion of imbricated stigma that can help us in understanding experiences of multilayered disadvantage that other concepts – namely, intersectionality – cannot? Does the idea of the healthy volunteer as model organism apply to other phases of the clinical trials process, or is this strictly a Phase I phenomenon? These questions are left unexplored in this book. More attention could have been devoted to fleshing out the broader implications of this study's proposed concepts.

All quibbles aside, this book makes public the very private world of the Phase I clinical trial experience. The findings in this book challenge us to consider what equity means in including disadvantaged populations in research. At what point are researchers engaging in the exploitation of study participants, and what are the effects of social inequalities on scientific results? Fisher's book underscores the need to consider social factors in scientific investigations and reveals the equity-related and scientific implications of a failure to do so. These concerns are particularly pressing in the era of COVID-19.