As COVID-19 continues to claim lives and devastate economies, experts have been contemplating strategies for accelerating the development of a vaccine. A paper published in March in the Journal of Infectious Disease advocates the use of human challenge trials—which involve vaccinating a small number of volunteers and “challenging” them with a deliberate infection of the virus—in order to bypass the lengthy efficacy and safety controls of typical vaccine development. While some virologists and bioethicists have expressed concerns about both the ethics and efficacy of human challenge trials, a general consensus seems to be emerging in favor of their use to evaluate candidate vaccines. The World Health Organization issued criteria for ethical acceptability of COVID-related human challenge studies, while 35 Congressmembers have written a letter to the FDA urging regulators to embrace the controversial strategy. The advocacy group 1Day Sooner has recruited thousands of volunteers to participate in such trials if they are to occur. These efforts to push forward with challenge studies reflect the belief that, as a recent paper in Vaccine puts it, “desperate diseases by desperate measures are relieved.”
As scientists and lawmakers deliberate over whether or not to expose human subjects to the virus, it is worth searching through the history of human challenge trials for lessons that might inform our current moment. Challenge trials are as old as modern vaccinology itself, dating back to Edward Jenner’s studies of smallpox inoculation in the 18th century. While they have since been applied towards understanding disease pathogenesis and measuring vaccine efficacy, the use of challenge trials have historically also raised questions about the slippery boundary between the coercion and the consent of volunteers in medical experiments. Such questioning provoked an ethical crisis within the medical community in the 1970s, after researchers, journalists and activists drew public attention towards the use of imprisoned populations in challenge trials in the United States. These contestations reveal the ways in which prisons functioned—and continue to function—as “zones of exception,” in which imprisoned bodies are enrolled into biopolitical experimental orders characterized by the suspension of normal ethical and protective mechanisms of research. This history, then, opens up avenues for reflecting on the politics of life and of prisons during the COVID-19 pandemic—a politics characterized by the bifurcation between, on the one hand, lives that may be volunteered in the service of public health (such as those who have signed up to participate in challenge trials) and, on the other, the incarcerated lives that are rendered available for sacrifice.
A necessary starting point for understanding the relationship between prisons and human challenge trials in the United States is the Maryland House of Correction, a notoriously violent maximum security prison in Jessup. Researchers associated with the University of Maryland School of Medicine first began recruiting male inmates to participate in challenge trials evaluating potential typhoid fever vaccines in 1952 (Waddington et al. 2014). This university-prison collaboration would be expanded through the efforts of the Theodore Woodward, Chair of Medicine at the university and a giant of twentieth century vaccinology. While serving in the U.S. Army Typhus Commission during and after WWII, Woodward had performed scrub typhus challenge trials with prisoner volunteers in Morocco. This work inspired him to find prison populations to enroll into experimental vaccine research upon his return stateside (Hornick et al. 2007). Woodward was, in fact, falling in line with broader trends emerging within the medical community at the time: journalists and scholars have recorded numerous instances of medical researchers construing prisons and imprisoned populations as cheaply available “acres of skin” for experimentation (Hornblum 2013).
In 1962, Woodward and colleagues at the University of Maryland oversaw the building of a dedicated research ward at the House of Correction, designed for use in human challenge trials for typhoid, malaria and other infectious illnesses. The Prison Volunteer Research Unit (PRVU) was staffed full time by male nurses and physicians from the University’s medical school, and held 24 beds for inmates participating in human challenge trials. Over the next twelve years, the PRVU recruited 1886 imprisoned men to participate in trial experiments, and drawing researchers from all over the country as it became one of the nation’s premier sites for studying infectious disease. These investigations resulted in hundreds of publications and yielded several important breakthroughs in vaccinology, including the first recorded successful protective immunization against malaria in 1973 (Clyde et al. 1973; Vanderberg 2009).
Scientists at all stages of their careers were drawn to Woodward’s work in Maryland. The PRVU launched several research careers, and many who worked there have in recent years taken to the pages of research journals to reflect on the value of the program to the field of vaccinology (Hornick et al. 2007; Vanderberg 2009). They especially emphasize the PRVU’s handling of ethical considerations relating to medical research involving prisoners. Prisoners participating in clinical trials were paid two dollars per day and lived full-time in the medical ward, which had hot water, color TV, and private bathroom facilities, unlike the rest of the prison. Proponents of the PRVU insisted that participation in human challenge trials provided inmates with a “beneficial and unusual punishment,” sparing them from the inhumane conditions prevalent in the rest of the Maryland House of Correction—conditions that lead inmates to organize riots in 1964 and 1972 (Hoffman 2000). Before the advent of the institutional review board (IRB), Woodward and colleagues had established vetting protocols for research involving prison volunteers, which involved first briefing participants on a summary of the research, and providing interested individuals with a second, more detailed explanation of the study’s procedures, side effects and risks (Waddington et al. 2014). Thus, PRVU researchers argued that prisoners were fully cognizant of the risks they faced when participating in trials. Furthermore, they claimed that inmates appreciated the opportunity to contribute to public health efforts by assisting in the development of medical knowledge that might help eradicate infectious diseases (McDonald 1967).
Critics of the PRVU, however, charged that the coercive environment of prison precluded any possibility for true informed consent. They argued that when forced to choose between the brutal conditions of the cell block or a comparatively comfortable bed in the medical ward, most prisoners would choose the latter, no matter the risks presented by participation in challenge trials. Coercion, they claimed, was the essence of imprisonment. In such a situation, it was simply not possible for inmates to offer true voluntary consent. In 1974 the American Civil Liberties Union (ACLU) filed a lawsuit to end volunteer studies in all the nation’s prisons. During the trial, Woodward stressed the value of vaccine research to improving the nation’s health, telling the judge that “those vaccines were of little more value than water” (Hornick et al. 2007). The case was eventually dismissed, with the judge ruling that the ACLU was unable to prove that the volunteers had been coerced, while also praising the contributions to medical knowledge and public health made by the PRVU and other prison research facilities.
Despite this victory in court, overwhelming public opposition to medical experimentation on prisoners lead to the closing of the PRVU in 1974. Two years later, the U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research published a report on experimentation with prisoners, concluding that most prisons did not meet conditions in which prisoners, in the words of the Nuremberg Code, were “so situated as to be able to exercise free power of choice.” The report’s authors recommended cessation of all medical experimentation in which a high degree of voluntariness could not be proven, effectively bringing an end to human challenge trials with prison volunteers. Barring a suspension of these norms, this means that any COVID-19 human challenge trials in the U.S will likely not include imprisoned volunteers.
The pandemic, however, has exposed the multitude of ways through which the lives of incarcerated persons are still rendered as available to be freely sacrificed. While the rest of the nation isolates in an effort to curb the spread of the virus, prison factories have kept running. Politicians have instrumentalized the language of crisis as justification, claiming that only through using cheap prison labor can states address shortages in facemasks, hand sanitizer and other personal protective equipment (PPE) needed by the general public. This continuance of prison manufacturing during the pandemic and the lack of effort to protect incarcerated populations have seen prisons become infection hotspots. In such a situation, New York State’s “NYS Clean” hand sanitizer, produced by incarcerated labor at a cost of just $6 per gallon and made available to state residents free of charge, stands as an artifact of a politics of life that in the name of public health places inmates into an enforced intimacy with illness and death.
We would be remiss, however, to mistake this situation as one brought on by the exigencies of the COVID-19 crisis, and not instead as the logical consequence of a system of imprisonment in which the state robs individuals of complete custody of their bodies. As the history of human challenge trials shows, prisons have functioned and continue to function as exceptional spaces for the extraction of various forms of biological labor from vulnerable populations. Linking the use of imprisoned people in human challenge trials to the continuation of prison labor during the pandemic is a moral economy based upon the unequal valuation of lives, which renders imprisoned bodies as available for taking on a disproportionate share of risk without receiving a commensurate share of benefits. The ongoing critique of the contemporary politics of imprisoned life, then, must challenge the notion that the exposure of prisoners to biological hazard is a desperate measure taken to alleviate desperate conditions and not instead the result of the very moralities woven into the fabric of the American prison-industrial complex.
Jason Ludwig is a PhD student in the Department of Science and Technology Studies at Cornell University. His research interests include race, disaster and the politics of life and health.
Clyde, D. F., H. Most, V. C. McCarthy, and J. P. Vanderberg. “Immunization of Man against Sporozite-Induced Falciparum Malaria.” The American Journal of the Medical Sciences 266, no. 3 (September 1973): 169–77. https://doi.org/10.1097/00000441-197309000-00002.
Hoffman, S. “Beneficial and Unusual Punishment: An Argument in Support of Prisoner Participation in Clinical Trials.” Indiana Law Review 33, no. 2 (2000): 475–515.
Hornblum, Allen M. Acres of Skin: Human Experiments at Holmesburg Prison. Routledge, 2013.
Hornick, Richard B., William E. Woodward, and Sheldon E. Greisman. “Doctor T. E. Woodward’s Legacy: From Typhus to Typhoid Fever.” Clinical Infectious Diseases 45 (2007): S6–8.
McDonald, John C. “Why Prisoners Volunteer to Be Experimental Subjects.” JAMA 202, no. 6 (November 6, 1967): 511–12. https://doi.org/10.1001/jama.1967.03130190117017.
Vanderberg, Jerome P. “Reflections on Early Malaria Vaccine Studies, the First Successful Human Malaria Vaccination, and Beyond.” Vaccine 27, no. 1 (January 1, 2009): 2–9. https://doi.org/10.1016/j.vaccine.2008.10.028.
Waddington, Claire S., Thomas C. Darton, William E. Woodward, Brian Angus, Myron M. Levine, and Andrew J. Pollard. “Advancing the Management and Control of Typhoid Fever: A Review of the Historical Role of Human Challenge Studies.” The Journal of Infection 68, no. 5 (May 2014): 405–18. https://doi.org/10.1016/j.jinf.2014.01.006.