Harvard Civil Rights Civil Liberties Law Review
November 14, 2018
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This article grossly under communicates the realities of human experimentation on prisoners from Guantanamo Bay to the shores of our very own United States including experimentation for COVID 19 vaccines on prisoners and other marginalized populations often out of the sight of the main stream public -- as evident by the consistent fines leveraged against Big Pharma such as in the case of Purdue Pharmaceuticals an the opioid epidemic lodge against the American people: please see the other below articles for more information.
For decades, there has been an ongoing debate in the scientific community about the appropriate recommended daily sodium intake. The American Heart Association currently recommends 2,300 milligrams of sodium a day for healthy people, and 1,500 milligrams for those with high blood pressure. Some scientists argue that Americans eat too much sodium, but others point to the lack of conclusive evidence. They argue that very low sodium levels may actually lead to higher rates of death, heart attacks, and strokes, and without conclusive studies, “it is prudent not to advocate for extreme reduction of salt intakes in the diets of most Western populations.”
In June 2018, the New York Times reported on a proposal in the journal Hypertension by researchers, including the former head of the Food and Drug Administration, that would end this frustrating debate with a scientist’s dream – a large-scale randomized clinical trial measuring the effects (i.e. death and strokes) of different salt intake levels on a diverse population whose diet could be tightly controlled.
The proposed test subjects would be prisoners. The vision is to conduct a study on 10,000 to 20,000 prisoners over the course of 5 years, funded by the National Institute of Health. Participating prisons would feed inmates the current diet or a low-sodium diet, but individuals prisoners would not be able to choose which group to join. They can choose whether to release their health data to the study. Scientists would then be able to track over time the health effects of the varied sodium intake levels. The scientists recognized important ethical issues, but this perfect test population was too good to ignore.
There are many reasons to be wary of this proposal, not least of which is the horrific history of scientific studies using prisoners as test subjects. From 1946 to 1948, the US purposely infected Guatemalan prisoners with syphilis for public health studies. Until the early 1970s, a wide variety of pharmaceutical research was conducted on prisoners, and by 1972, “more than 90% of investigational drug toxicity testing was conducted on prisoners.” In the 1950s through the 1970s, biomedical experiments were conducted at Holmesburg Prison in Philadelphia, and some resulting in permanent injuries.
Specifically in light of this history, regulations were adopted to protect human subjects and particularly vulnerable populations, including prisoners. U.S. regulations limit studies involving prisoners to those that examine conditions causing incarceration or that specifically affect prisoners as a group. There is a general prohibition on studies that are meant to solely benefit the general U.S. population. The NIH explains: “Because prisoners may not be free to make a truly voluntary and uncoerced decision whether or not to participate as subjects in research, the regulations require additional safeguards for the protection of prisoners in research. These safeguards are found in 45 CFR 46, Subpart C. Subpart C applies to all research that includes any individual who is or becomes a prisoner while participating in a research study.” The Code of Federal Regulations (45 CFR 46, Subpart C) allows prisoners to be included as subjects only when the research falls into the following four categories: 1) a study of criminal behavior; 2) a study of prisons as institutional structures or prisoners as incarcerated persons; 3) research on conditions particularly affecting prisoners as a class; and 4) research on practices which have the intent and reasonable probability of improving the health or well-being of the subject. An HHS Secretarial waiver to Subpart C for certain epidemiological research essentially creates a fifth category of permissible research: when epidemiological research has the sole purpose either to describe the prevalence of a disease or to study potential risk factor associations.
But now, some scientists, including authors of an article in the Journal of Law and the Biosciences, are calling for reduced restrictions on studies involving prisoners. They say the stringent barriers and daunting regulatory requirements are an overcorrection of historical practices and that those transgressions would never happen today. The regulations effectively exclude prisoners from participating in scientific discovery and today, “prisoners-participants” would be partners, not subjects.
This reveals a cognitive mistake. We tend to look at historical practices and take comfort in the fact that we are more advanced and developed now and would not make the same mistakes. But what exactly has changed? The prison population has increased, and conditions in prisons remain highly restrictive and oppressive. There is little reason to think that prisoners today would be partners instead of subjects in scientific studies.
In addition to the argument against outdated regulation, scientists also make several affirmative arguments for conducting this study in prisons. First, they emphasize the enormity of the potential findings and the benefit to society as a whole. Categorically excluding prisoners from scientific studies would be detrimental for the public benefit of comprehensive scientific studies, and since exploitation can be avoided, “prisoners should be afforded the opportunity to contribute to this [public] good.” The optimistic language that these proponents use is unnerving.
They seem to be minimizing the risk in view of the personal and public glory of scientific discovery. Minimal risk of exploitation is hardly a fair trade-off, particularly given that the historical and current realities of exploitation are far from minimal. As Celia B. Fisher, University Chair in Ethics and Director of the Center for Ethics Education at Fordham University writes, “Privileging the potential public health benefits of a study over protections for vulnerable persons, even when risks are judged as minimal, is a gateway to future decisions prioritizing majority health over individual rights.” And as a technical matter, prisoners may not actually be an ideal test population because they are
disproportionately male and black, and have higher rates of drug use, HIV, and hepatitis C. Thus, results may not be instructive for the general population.
Second, some scientists argue for the benefit that prisoners themselves would receive. The benefit is two-fold: the health benefit of participating in experimental studies and the more philosophical benefit of having agency and representation.
The argument for individual health benefit is straightforward to understand. Prisoners have a personal interest in contributing to scientific studies that would improve their own health. A finding about appropriate sodium levels would lead to healthier diets for prisoners whose diets are dictated by choices of the prison industry. Beyond the salt study, prisoners may also seek to participate in experimental treatment when alternatives have been exhausted. This is cast as part of a prisoner’s right to healthcare.
The reality of prisoners’ access to healthcare and healthy diets reveals the weakness of this line of argumentation. The dependency of prisoners on the outcome of a salt study is not an argument for their participation in studies that contribute to societal knowledge and may influence prison leaders. It is an indictment of the oppressive state in which prisoners live. That prisoners’ basic health is wholly dependent on choices made for them by enlightened officials and not on their own choice is a strikingly callous way to justify participation in studies. While prisoners may indeed benefit from experimental treatment, the inadequacy of basic healthcare is the more pressing issue. Problems with the prison food system include “inadequate portions, rotten food, and food labeled “not for human consumption.” Using the rhetoric of “basic human right to healthcare” to argue for prisoners’ rights to experimental, “cutting-edge” healthcare is devastatingly tone-deaf. The opportunism and selective scope displayed by scientists pushing for experimentation on prisoners is a strong argument in itself for maintaining stringent regulations.
The argument for the personal satisfaction and agency of prisoners is a more complicated one. Some argue that due to the overrepresentation of minorities in the prison population, prisoners will be eager to contribute to improved demographic representation in scientific studies. 12 percent of the U.S. population is black, but only 5 percent of clinical trial participants are black. 16 percent of the population is Hispanic, but only 1 percent of clinical trial participants are. While the research on prisoners’ perspectives is scarce and it is plausible that prisoners would like to see diversification of trial participants, this desire seems more aligned with objectives of scientists than of prisoners. Further, the opportunism of using the disproportionate oppression of minorities as a selling point for further use of their minority identity should be a cautionary point.
Others take a different approach and urge the consideration of individual agency. Despite being in coercive and oppressive environments, prisoners should be afforded the opportunity to participate in a study. Their motives may include contributing to society, repenting for past behavior, or simply introducing variation into their routine. Here, the concept of prisoner as partner instead of subject resurfaces, and the argument is that “vulnerable populations [should not be] unnecessarily excluded simply because of their vulnerable status, which could only widen the divide between those privileged to enjoy in the benefits of science…We cannot allow the mere possibility of exploitation be indisputable grounds for exclusion of the individuals from research.”
This is perhaps the strongest argument for prisoner participation because limited agency is a problematic aspect of prison yet is difficult to address because of its elusive nature. However, the answer lies in reducing the systemic oppression of the prison structure, not in abrogating requirements for informed consent. While it is unfortunate to sacrifice potentially agentic behavior for strict adherence to the requirement of informed consent, this sacrifice is necessary for the protection of vulnerable populations. Prisoners exist such highly coercive environments that consent is almost unrecognizable and certainly should not be imputed where it does not exist. Free choice is severely compromised when choosing to participate in a study implicates access to health care, anticipating the preferences of correctional officers, or outcomes in disciplinary or parole hearings.
But in the proposed salt study, prisoners are not even afforded the opportunity to opt out. And complex issues arise because food in prison holds great significance. Bland food is sometimes used as a form of punishment, and participation in the study becomes akin to punishment. Prisoners also supplement meals with high-sodium snack foods purchased from the commissary. Cutting off access to foods like ramen, Doritos, and beef sticks leaves prisoners without any variation from prison food like unappetizing nutraloaves (loaves formed by pulverizing and baking the contents of a normal meal). The logistics of tracking those purchases are difficult and implicates the machinations of the prison service industry. Ramen is also sometimes used as currency in prison, and banning these purchases could be highly disruptive to the social order in prison.
The food dynamics and power dynamics in prison are particularly complex, and true informed consent is exceedingly difficult to obtain. The entire salt debate begs the question of what other influences are at work. One strong candidate is the salt industry. Studies in favor of maintaining current levels of salt intake would benefit vast swaths of the food industry. Decisions by funders, including the NIH, may be influenced by lobbyists from these industries. The salt debate itself may have arisen from food industry actors “manufacturing doubt” and demanding a “conclusive study” to hold a lower sodium intake recommendation at bay.
One final caution against experimentation on prisoners is the lack of legal remedy. Prisoners generally have a difficult time vindicating their legal rights due to the qualified immunity that prison officials enjoy under 42 U.S.C § 1983. But in the context of food, the legal options are particularly bleak. A challenge based on involuntary consent does not seem viable because the proposed salt study takes advantage of the very fact that prisoners cannot make choices about their daily meals to sidestep the issue of voluntary participation. Allowing scientists to experiment on prisoners will give scientists free reign in areas where prisoners already have restricted choice, such as diet.
The other possibility for legal challenge would to make an argument for an 8th Amendment violation due to the inadequacy of the food as a result of the experiment.
In Wilson v. Seider, the Supreme Court held that prison officials must exhibit at least “deliberate indifference” to the prisoner’s conditions in order to be unconstitutionally inflicting cruel and unusual punishment. However, litigation regarding the quality of prison food has been largely unsuccessful. The 7th Circuit held that denial of food as a form of punishment was not cruel and unusual punishment. The 4th Circuit held that providing three meals on weekdays but only two meals on weekends was constitutional. Various courts have found that serving undercooked chicken, the occasional maggot-infested meal, or nutraloaves are not violations of a prisoner’s 8th Amendment rights. Given the food quality that courts are willing to accept, it seems unlikely that a court would find reduced sodium to be an 8th Amendment violation.
And something like a salt study could actually cause prison food to significantly deteriorate in quality and in quantity. Currently, prisons try to cut costs by serving small quantities of food, possibly less than what they report and driving prisoners to lick condiment packages or drink excessive water. Much of the food is high in sodium due to the efficiency of serving non-perishable foods. To decrease sodium levels, a prison could either find a source of low-sodium, non-perishable food, or simply reduce the quantity of food even further. The second option seems easiest, and given the tendency of courts to find nothing wrong with prisons providing serving small portions, this potential result would also be very difficult to legally challenge.
The eagerness of the scientists is entirely understandable. The promise of resolving a consequential debate affecting the lives of millions and achieving academic glory is a powerful force. Current regulations were implemented in recognition of these overwhelming forces and the atrocities that have resulted. Close scrutiny is imperative when society suddenly turns to those it had previously cast away.
Should people be used for medical experimentation without their permission or knowledge? Why? Why not?
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