by Elisa A. Hurley, PhD, Education Director
The portrayal of research in popular media can offer considerable insight. To reflect on some of the lessons offered, PRIM&R staff have spent the summer reading and watching books, movies, and television shows that have generated conversation and debate around issues related to research ethics. Over the next several weeks, they will share their reflections here, so join us as we explore popular representations of the research world.
Like its title, Roberto Abadie’s The Professional Guinea Pig: Big Pharma and the Risky World of Research Subjects is a provocative book. Abadie conducted 18 months of ethnographic research in a Philadelphia community of self-defined “professional guinea pigs,” individuals who regularly volunteer for, and in many cases make their livings from, participating in phase I clinical trials, largely sponsored by the pharmaceutical industry. The book draws on that research to argue that the current practice of paying healthy individuals to participate in phase I trials exploits them, commodifies their bodies, and “subverts basic ethical principles and guidelines regulating the participation of human subjects in research” (154).
Abadie points out that the practice of paying people to participate in clinical trials is relatively new, emerging in the 1970s when it was no longer considered ethically defensible to use captive populations such as prisoners, members of the military, or institutionalized persons, as research subjects. He suggests that the ongoing need for healthy subjects for phase I trials in the absence of these ready populations led to the creation of a “trial economy” in which individuals are “recruited on the open market.”
According to Abadie, the prospect of financial gain is most professional guinea pigs’ sole motivation for participating in phase I trials which, after all, offer no prospect of therapeutic benefit to them. This fact is the source of a number of overlapping concerns Abadie outlines. One is that when individuals give their bodies and time to the pharmaceutical industry in exchange for money, they are being commodified and dehumanized. Another is that the compensation offered adversely affects the way subjects perceive and manage risk. More specifically, paid subjects tend to discount or entirely ignore the long-terms risks of participating in trials, such as potentially dangerous drug interactions, because they are so focused on short-term considerations such as what they need to do, and what immediate risks they need to endure, to receive compensation for the trial at hand.
His third concern, and perhaps the most serious, is that “the existence of market-recruited subjects in phase I clinical trials defies the principle of justice.” He explains: “the involvement of professional subjects in trial research is unjust because it burdens a group of poor research subjects without offering them a therapeutic benefit” (154). Social inequalities mean that some individuals are particularly vulnerable to being exploited by the trial economy: their financial need makes them more likely to take on risks, and their dependency on trial income interferes with their ability to freely consent to participate in research.
Abadie’s claims are indeed provocative, and his book sheds important light on a little recognized—and perhaps actively ignored—aspect of the modern clinical trial landscape, namely, the fact that phase I clinical trials depend on a readily available pool of healthy volunteers who have the time and willingness to submit themselves to the often boring, frequently uncomfortable, and sometimes quite risky, work of participating in phase I research.
That said, the strength of Abadie’s case that professional research subjects are exploited and otherwise treated unethically, is undermined by the fact that the professional guinea pig community he studies is a group of white male anarchists whose ideology emphasizes independent, flexible work, and whose participation in phase I trials is, as Abadie himself describes, a lifestyle choice. Of course, the fact that someone appears to choose a form of work does not in itself mean that they are free from exploitation—having severely circumscribed options can, depending on what does the circumscribing, amount to exploitation. But throughout the book, Abadie makes it clear that the anarchist guinea pigs he lives with in West Philadelphia are an unusually well-informed and articulate group characterized by relative stability, low expenses, easy mobility, greater clinical trial opportunities than other subject populations, and ideological opposition to the pharmaceutical industry, which they often act on by trying to sabotage the trials in which they take part. Abadie’s argument that paying phase I subjects is exploitative and unjust would have been more convincing had he explored the lives of phase I trial subjects for whom volunteering is a necessity or best choice given limited options, rather than a lifestyle choice or political statement.
Surprisingly, when it comes time to make recommendations, Abadie does not suggest that we do away with phase I trials—he recognizes how important they are—or with paying people to participate in them. Rather, he suggests that we need to better and more systematically recognize phase I volunteer participation as labor, and to provide better working conditions and proper compensation for that work. Abadie is not alone in this suggestion. Holly Fernandez Lynch, JD, MBE, of the Petrie-Flom Center at Harvard Law School has recently taken this idea to its logical conclusion, arguing in a recent article that human research subjects should be reconceived as human research “workers” and protected by extensions of labor and employment laws.
Thus, though I was unconvinced by many of the book’s central arguments, I acknowledge that Abadie leaves us with some thought-provoking questions about the ethics of phase I clinical trials. For those who will be at the 2013 AER Conference in Boston this November, I hope you’ll join me and your fellow attendees on Thursday, November 7 to further discuss Abadie’s work as part of the research ethics book group lunch!