Review of Adverse Events: Race, Inequality, and the Testing of New Pharmaceuticals. Jill A. Fisher, New York: NYU Press, 2020, 336 pp.

Laura A. Meek

University of Hong Kong

Adverse Events is an impeccably researched and empirically rich depiction of the Phase I clinical trial industry in the United States. These Phase I trials offer substantial financial compensation to healthy volunteers for consuming experimental drugs, typically while also remaining overnight in facilities, undergoing daily medical procedures, and eating exactly as instructed for days or weeks at a time. Fisher’s text invites us into this world, bringing it to life through detailed descriptions of everyday interactions, the materiality and space of study facilities, the tempo and rhythm of scheduled routines, and in-depth accounts from both volunteers and staff.

More than this, though, Adverse Events reveals the many and varied ways in which social inequalities—particularly class and race—compel individuals to become healthy volunteers for Phase I trials, despite the risks involved. While women are frequently excluded from studies as part of safety protocols, Fisher reveals that the overrepresentation of Black and Latino men—who comprise around 60% of healthy volunteers and many of whom participate serially as their primary source of income—is a result of socioeconomic inequality. Not only are the clinic staff aware of this issue, they have a vested financial interest in maintaining it. In fact, “everyone involved … is incentivized to game the system” (p. 10), with frightening implications for the safety of the pharmaceuticals we all consume.

The book’s title cleverly encapsulates its central argument: Adverse (life) events structure who ends up routinely exposed to adverse (clinical trial) events. During clinical trials, the term “adverse events” refers to the embodied effects of experimental drugs. In fact, the purpose of Phase I trials “truly is to produce adverse events” (p. 139); studies are designed to increase the dosage of investigational drugs—until the side effects are too severe—as a method for determining tolerability and establishing a drug’s therapeutic dose. Fisher shows how the industry exploits socioeconomic inequalities that provide a steady stream of volunteers who will undergo this process for the financial compensation. Meanwhile, the adverse life events, which compel individuals to risk their health, include circumstances such as unemployment, criminal records, immigration status, and consumer debt.

Adverse Events also presents fascinating insights into how serial healthy volunteers labor to become “model organisms” for clinical trials. By regulating their diet and exercise, sleep and stress levels, limiting their use of drugs and alcohol, detoxing after studies and avoiding any studies that might disqualify them from future ones, serial volunteers work to ensure they will continue to qualify for clinical trials. In this way, they become adept at cultivating particular kinds of bodies: “ones that can produce data to make [trial] drugs appear as safe as possible” (p. 142). Fisher brilliantly highlights the contradictions and tensions inherent in maximizing one’s health to be able to undergo the health risks of adverse events.

One of the crucial contributions of this scholarship lies in the frightening implications it has for the validity of safety data on pharmaceuticals. Since trials rely on serial volunteers who have modeled their bodies in such ways, these individuals are far from representative of the general population who will later consume these drugs. Further, volunteers are incentivized to report fewer adverse events to ensure they complete the study (and receive full compensation) and so that they appear as desirable candidates for the future trials. Meanwhile, clinical staff prefer such cultivated and docile bodies, likely to produce favorable data, leading them to frequently turn a blind eye to various forms of rule-breaking, such as when volunteers ignore the mandatory break (called a “wash out period”) between studies.

The book’s analysis could have been strengthened by deeper attention to structural inequalities, including the ways in which the drug development industry profits from the prison–industrial complex, xenophobic immigration policies, the precarity of informal labor regimes, and neoliberal state withdrawal. The decision to analyze these factors solely in terms of stigma felt insufficient as this largely elided discussion of how the pharmaceutical industry benefits from and contributes to the inequality of lives under racial capitalism (Bhattacharyya 2018; Leroy and Jenkins 2021). Thus, while the emphasis on identity is insightful, greater critical attention to broader political and economic processes would have advanced the book’s arguments even further. For instance, what additional frameworks or concepts (beyond “imbricated stigma”) help conceptualize why many low-income minority men have no better options for earning an income than to become model organisms for clinical trials? How does this relate to the longer durée of scientific racism, anti-blackness, and health inequities in (and beyond) American society? And what does this teach us about race and biomedical epistemology, bioethics, and/or for-profit health care?

This limitation aside, one of the book’s laudable strengths is Fisher’s refusal to paint any group of actors as unidimensional. The detailed narratives of recruiters, nurses, physician–investigators, administrators, managers, and healthy volunteers convey how everyone is constrained within the for-profit pharmaceutical industry as well as larger racializing capitalist structures that delimit life choices. The richness of these interviews is at times quite powerful, leaving the reader with stories that resonate in their candor, nuance, and ambivalence. The interviews and observations recounted in the book are drawn from six Phase I research facilities in the United States. Chapters offer comparative insights into the differing priorities and conditions both regionally (West Coast, Midwest, East Coast) and across type of facility (e.g., pharmaceutical company, academic medical center, contract research organization).

Adverse Events is eminently readable and accessible, making it a perfect addition to undergraduate courses. It could be read alongside scholarship on pharmaceuticals and capitalism, race and biomedicine, and STS seminars addressing themes of validity and strategic ignorance, ethics and risk, experimentation and model organisms, or clinical trials and labor. I assigned Chapter 6, “The Dark Side of the Model,” alongside Adams (2002) in my introductory-level STS course. This material initiated a robust discussion around how inequalities and profit motives alter the very design of scientific studies. Teaching this work in Hong Kong also brought to the fore the extent to which this book is about American society in particular. Fisher notes some contrasts with clinical trials in other places—such as the use of “sentinel dosing” in Europe and requirements for ethnically Japanese volunteers in Japan (p. 274, notes 4 and 7)—but future research could productively delve into how inequality, ethics, and study design intersect in different contexts.

Finally, this is a text that can—and should—reach audiences beyond academia. Adverse Events concludes with a call to make visible both the validity issues and the socioeconomic exploitation inherent in the Phase I clinical trial industry. The book stands as an open invitation for greater dialogue, awareness, and redress of these issues within the pharmaceutical industry, through public health policy, and among the public. We will all live in a more just and healthy world if we join in realizing these aims.

References Cited

Adams, V. 2002. Randomized Controlled Crime: Postcolonial Sciences in Alternative Medicine Research. Social Studies of Science 32: 659–90.

Bhattacharyya, G. 2018. Rethinking Racial Capitalism: Questions of Reproduction and Survival. New York: Rowman & Littlefield.

Leroy, J., and D. Jenkins, eds. 2021. Histories of Racial Capitalism. New York: Columbia University Press.