Adverse Events

As COVID-19 vaccine trials ramp up around the world, let's take a look at clinical trials for US pharmaceuticals. Who ends up as the participants, and as a result, who faces the possible adverse events?

Adverse events: race, inequality, and the testing of new pharmaceuticals

Fisher, Jill A. New York University, 2020
336p index, 9781479877997 $89.00, 9781479862160 $30.00, 978147986143

Adverse Events is a rigorous text that examines how Phase I clinical trials on new pharmaceuticals (drug candidates) are carried out in the US. Human participants in these trials are selected from a pool of healthy volunteers, with the intent to control potential “adverse effects” that could result from taking the medications. In this study, Fisher (Univ. of North Carolina, Chapel Hill) documents how such trials are actually conducted through interviews with volunteers and participating staff. The economic, corporate, and administrative context of clinical trial facilities is examined, along with the priorities of pharmaceutical companies involved. This book presents weighty implications relative to current US economic and employment arrangements, since in practice most healthy volunteers are men drawn from socially disadvantaged groups (the unemployed, immigrants, racial/ethnic minorities) and/or who live in economically disadvantaged communities. The high rate of compensation is attractive to volunteers, despite the health risks involved and a highly controlled clinical setting that resembles incarceration. Risk assessment, informed consent, and social interaction among volunteers and with clinical staff are among the topics discussed. The volunteer selection processes are also scrutinized. This text could be a helpful reference in courses on bioethics, biomedical research methods, social justice, gender and race/ethnicity, intersectionality studies, and the sociology of science.

Summing Up: Highly recommended. Lower- and upper-division undergraduates. Graduate students, faculty, and professionals.
S. M. Weiss, Secular, Eclectic, Academic Homeschoolers
Subject: Science & Technology – Health Sciences
Choice Issue: Jan 2021