A Striking Look into the Invisible World of Phase 1 Clinical Trials: A Book Review of Jill Fisher's Adverse Events

“Your health is your wealth.” This quote succinctly encapsulates the argument laid out in Jill A. Fisher’s “Adverse Events”: the Phase 1 clinical trial industry in the US not only relies upon but also exploits the social inequalities of the society in which it operates. Phase 1 clinical trials are those conducted to establish the safety profiles of drugs by monitoring the adverse health events (from which the book takes its name) that its human participants experience. In her book, Fisher - Professor of Social Medicine at UNC Chapel Hill - gives readers a vivid look into this “Invisible Industry” by skilfully weaving together narrative accounts gathered from interviews with over 200 research participants and staff members, empirical data, and theoretical analysis of stigma and the standardization of research participants.

As Fisher explains, Phase 1 clinical trials are usually the first medical research trials involving humans and are predominantly conducted with healthy volunteers. Participants are confined to a controlled research setting where, for example, they are told when to eat, sleep, and shower, where their luggage is searched for contraband items upon arrival, and they must consume every item of food presented to them. They are furthermore monitored and tested through procedures such as blood draws, urine collection, and ECGs in an effort to measure and document bodily changes; or, more officially, adverse events. Adverse events can range from headaches and diarrhoea to hallucinations and - in rare cases- death. Such incidents are referred to as events (not effects) until they can definitely be said to be caused by the intervention under investigation - the threshold for establishing causation, unsurprisingly, is rather high and even so, often contested by the Pharmaceutical industry. As volunteers do not participate in clinical trials (especially Phase 1 trials) for any benefits to their own health, Fisher explores the reason why people risk experiencing such adverse events: the financial compensation they receive for participating in medical research.

With her work, Fisher aims to shed light not only on the experiences of research participants, but also on the social contexts that underpin their involvement. Volunteers’ narratives of life in a Phase 1 clinic take readers from the check-in and consent processes (Chapters 1 and 7) to spinal taps gone wrong and participants’ construction of risk (Chapter 8). While Chapters 2 and 5 unpack the stigmatizing and dehumanizing language around viewing participants as “lab rats,” Chapter 6 goes on to show this characterization and its practical consequences undermine the accuracy and validity of the trials’ results. Though every chapter addresses a different aspect of the participants’ experiential journey through Phase 1 trials, they are all framed by Fisher’s ongoing discussion of the racial and social inequalities that are reflected in the industry.

Given that participation is almost exclusively motivated by financial need, Fisher connects the over-representation of African Americans and other ethnic minorities to the widespread and disproportional economic insecurity, lack of educational and employment opportunities, and high levels of stigma that ethnic minority groups face within the US. However, in contrast to what the sub-title of the book suggests, this discussion around race per se is not where the conceptual depth or the novel contribution of Fisher’s work lie. Though certainly important and timely, her commentary on racial disparities in Phase 1 clinical trials and their relationship to social inequalities adds little to what we do not already know, or at least, could not logically extrapolate ourselves. The emphasis in the title of the book is therefore somewhat misleading in terms of where the bulk of her original theoretical and analytical work is centred.

The more interesting and original aspect of Fisher’s conceptual frame-work is instead found in her exploration around the role of stigma and the idea that participants are shaped to become “model organisms” for research, both physically and behaviorally. It is her analysis of how the latter process is instrumental in not only providing the Phase 1 industry with ready access to a pool of dedicated volunteers but also serves to generate data that presents pharmaceutical products in the best and safest way, that demonstrates how social inequalities are exploited for systematic profiteering by the pharmaceutical sector. It is this discussion that leaves a striking impression on the reader and though Fisher states at the outset that this is not a book about “Big Pharma,” “Adverse Events” certainly raises many serious questions about the lack of transparency, manipulation of research, and exploitation in an industry whose purported aim is to help people.

Given the ongoing struggle against structural inequality and for racial equality as well as the surging spotlight that the search for a Covid-19 vaccine throws on the pharmaceutical industry, “Adverse Events” is likely to be of interest to a broad audience. It is suitable for lay people who have an interest in exploring a largely unseen side of the pharmaceutical industry, people working in pharmaceuticals who wish to scrutinize the ins-and-outs of their industry, as well as students and academics such as bioethicists, sociologists, and those studying race and ethnicity.