Overview and History
In order for new pharmaceutical products and medical strategies to be approved and marketed for the general public, they must first be tested on human subjects. ‘Clinical trial’ is the term given to a research study that explores the safety and efficiency of new treatment options (“What Are Clinical Trials?”). When a new pharmaceutical is being tested, the new drug compound is first tested in animals. If the substance shows low levels of toxicity, it is then “tested in Phase I trials involving a small group of thirty to a hundred healthy human subjects” (Abadie 3). A drug that has proved to be safe in Phase I trials then moves to Phases II and III where it is tested in larger groups of humans, typically those who have the specific condition that the drug and treatment plans are supposed to improve (Abadie 3).
Over the last three decades, research using human subjects has developed in importance, scale, and enforced safety protocol (Fisher 195). Before the 1970s, most clinical trials were conducted on prisoners; as “captive, compliant, and readily available” subjects in a controlled environment, prisoners seemed to be the ideal research subject (Abadie 4). As the public became aware of the widespread use of these vulnerable prisoner populations, ethical concerns were raised and human subject regulations intensified (Abadie 4).
The shift from self-regulation to institutionalized, formal regulations of human research subjects can be explained by the context of the social movements in the 1960s and 1970s that supported civil and human rights and the ethical treatment of humans (Abadie 125). Contemporary human subject protections began with the Nuremberg Code in 1947, although this Code is simply a list of standards that should be followed, rather than a legally binding document (Freyhofer 166). It was not until 1974 that the United States Congress passed the National Research Act, establishing a National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission published its recommendations in the 1979 Belmont Report. One year later, the Food and Drug Administration banned the use of prisoners in research clinical trials (Abadie 125).
In the United States, industry-sponsored pharmaceutical testing began after World War II (Abadie 125). Because of increased pharmaceuticalization, or the use of pharmaceuticals to treat conditions, the pharmaceutical industry had a growing demand for human bodies to study and needed a non-prisoner population (Abadie 125). To meet this demand, a new industry of companies was created; these companies are called Contract Research Organizations (CROs), and they specialize in finding the right types of bodies for the clinical trials (Fisher 195). CROs work to connect human subjects with the clinical trials that need them (Fisher 195). CROs refer to these human subjects as “volunteers” (Abadie 3; Fisher 195). Healthy “volunteers” that could be enticed with financial incentives became the new pool of research subjects (Abadie 123). In recent years, the use of financial incentives to appeal to potential human subjects has extended beyond Phase I trials and into later phases of drug development (Abadie 2).
Although this entry focuses on clinical trials in the United States, it is important to note that increased regulations of clinical trials are not just occurring here. After a healthy volunteer participating in a trial in France had to be hospitalized, France’s government began working with European Medicines Agency and the European Commission “to strengthen regulations” for healthy research subjects (Bichell, “Botched French Drug Trial”).
Perspective: An Individual Choice, Benefiting the Public Good
In the United States, national organizations and smaller research institutions like universities use language that suggests that clinical trials benefit the public good (Dickersin and Rennie). For example, Vanderbilt University Medical Center’s page on Clinical Trials states that the trials “help advance science and health care for the public good” (“Vanderbilt Clinical Trials”). Additionally, the National Library of Medicine states that clinical trials are “designed to add to medical knowledge.” (“Learn About Clinical Studies”).
The human subjects in clinical trials are sometimes referred to as “professional guinea pigs,” both by the human subjects themselves and those studying and writing about them (Bichell, “Professional ‘Guinea Pigs’”). Click on the link for a brief podcast overview of professional guinea pigs. This new term labels participation in a research trial as a profession, adding to the notion that being a human research subject is something a volunteer chooses to become involved in, much like everyone else seems to choose their career path. The pharmaceutical industry promotes this professionalization amongst human subjects by having databases of human subjects and trials as well as recruiters that work with them to coordinate schedules (Abadie 24). Human subjects can receive “invitations” for trial screenings that might appeal to them as well as financial incentives for any referrals they may make (Abadie 26). Having “professionals” that understand the “typical volunteer protocol” of clinical trials results in studies that run smoothly and, according to the pharmaceutical companies, produce the best knowledge (Abadie 24; Petryna, “The Right of Recovery” S70).
A number of research subjects use clinical trials to get regular medical checkups, with the belief that if they did not participate in a trial, they would have no access to care (Abadie 114; Petryna, “The Right of Recovery” S71). In addition to receiving medical care and regular check-ups, the human subjects receive financial compensations that “help to make ends meet”; they see this as a win-win for the medical community and for themselves (Abadie 114). Abadie, an anthropologist whose research is centered on the ethics of clinical trials, even found that the patients enrolled in Phase II and III clinical trials have an improvement in quality of life than those patients who do not, reinforcing the idea that clinical trials are good for patients (118). Many human research subjects believe what they are doing benefits the public good through the production of medial knowledge, and they also see it as a choice that has immense personal benefits.
Perspective: A Constrained Choice, Benefiting Big Pharma
Although some “professional” human subject “volunteers” state they have chosen to earn a living in this manner, Dr. Jill Fisher, a medical social scientist who focuses on the pharmaceutical industry, and Dr. Roberto Abadie worry that the commodification of clinical trial research has led to unprecedented coercion and increased risks. Fisher argues that this occurs with both early-stage Phase I trials as well as later evaluations done in Phase II and III trials (201). Fisher found that Phase I studies are “overwhelmingly filled by low-income, minority men” in need of the financial compensation, while Phase II and III trials are filled by volunteers that do not have health insurance (201). Although these populations are not vulnerable in the way that imprisoned human subjects were in the early 20th century, Abadie believes they are being wrongly coerced by pharmaceutical companies with benefits that they cannot say no to (91). These new populations found in a large number of clinical trials have been labeled “ready-to-recruit” by both scholars like Dr. Fisher and CROs (Fisher 196). This terminology is used by the pharmaceutical industry, suggesting that they recognize the “political and economic conditions that disadvantage populations around the world” (Fisher 196). Disadvantaged communities with large bodies of potential volunteers are “very appealing for the pharmaceutical companies” and can be disproportionately advertised to (Abadie 91).
Promotional materials used by the NIH to advertise clinical trials (“Help Get the Word Out!”). These materials demonstrate how organizations like the NIH frame clinical trials to potential human subjects.
With this frame of mind, human subjects are still seen as making a choice, but it is a choice that they make under very particular circumstances that leave them with few options (Abadie 90). It benefits the pharmaceutical company to have these volunteers become “professionals” who know what typical protocol of these studies (Abadie 91); this results in easier recruitment and trials that run efficiently and smoothly at a lower cost to the industry (Petryna, “Ethical Variability” 187).
Connection to Politics of Health
Clinical trials can be linked to the politics of health most clearly through the concept of ethical variability. Dr. Adriana Petryna, a professor, author, and research whose studies focus on medical anthropology and politics of pharmaceutical globalization, defines ethical variability as “a tactic informing the regulation and organization of commercial clinical trials” (“Ethical Variability” 184). This tactic “takes the specifics of local context and lived experience” as a basis for changing ethical standards in order to save costs in human research (Petryna, “Ethical Variability” 184). Some CROs have turned from recruiting American volunteers to recruiting volunteers from eastern European and the Global South (Petryna, “Ethical Variability” 185; Petryna, “The Right of Recovery” S68). There is an ethical acceptability based on the population chosen for the research, and levels of ethical standards have been shown to be lowered for more vulnerable populations such as those found in eastern Europe and the Global South (Petryna, “Ethical Variability” 185).
Sile Lane, director of policy at Sense about Science (a charity concerned with the abuse of scientific evidence in public life), voices the concerns of one side of this argument. Despite the legal protocol and protections that have been established, Lane argues that doctors and pharmaceutical companies have “betray[ed] the trust” of those who volunteer for trials by not acting ethically and by not publishing all of their data. For more information on ethical variability and the perspective that there are “hidden” sides to clinical trials, Lane’s TEDxTalk can be watched here.
Works Cited
Abadie, Roberto. The Professional Guinea Pig. Duke University Press, 2002.
Bichell, Rae Ellen. “Botched French Drug Trial Followed Rules But Lacked ‘Common Sense.’” NPR, 3 May 2016, www.npr.org/sections/health-shots/2016/05/03/475867184/botched-french-drug-trial-followed-rules-but-lacked-common-sense.
—. “Professional ‘Guinea Pigs’ Can Make a Living Testing Drugs.” NPR, 8 May 2016, www.npr.org/sections/health-shots/2016/05/08/476797735/professional-guinea-pigs-can-make-a-living-testing-drugs.
Dickersin, Kay, and Drummon Rennie. “Registering Clinical Trials.” The Journal of the American Medical Association, vol. 290, 2003, pp. 516-523.
Fisher, Jill A. “‘Ready-to-Recruit’ or ‘Reading-to-Consent’ Populations? Informed Consent and the Limits of Autonomy.” The Pharmaceutical Studies Reader. Eds. Sergio Sismondo and Jeremy A. Greene, vol. 1, Wiley-Blackwell, 2015, pp. 195-207.
Freyhofer, Horst H. Nuremberg Medical Trial. Peter Lang Publishing, Incorporated, 2004.
“Help Get the Word Out!” NIH, www.nih.gov/health-information/nih-clinical-research-trials-you/. Accessed 22 September 2017.
Lane, Sile. “The Hidden Side of Clinical Trials.” TEDxMadrid, 28 September 2016. TED Talk.
“Learn About Clinical Studies.” National Library of Medicine, January 2017, https://clinicaltrials.gov/ct2/about-studies/learn.
Petryna, Adriana. “Ethical Variability: Drug Development and Globalizing Clinical Trials.” American Ethnologist, vol. 32, no. 2, 2005, pp. 183-197.
—. “The Right of Recovery.” Current Anthropology, vol. 54, no. 7, 2013, pp. S67-S76.
“Vanderbilt Clinical Trials.” Vanderbilt Health, https://www.vanderbilthealth.com/clinicaltrials/.
“What Are Clinical Trials?” National Heart, Lung, and Blood Institute, https://www.nhlbi.nih.gov/studies/clinicaltrials.
Glossary Entry Author and Editor: Jordan Moody
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