Tuskegee Syphilis Study in the United States

Trial Practices

After the Tuskegee Study, the United States government changed its research practices to prevent a repeat of the mistakes made in Tuskegee.

In 1974, the National Research Act was signed into law, creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research now, one of the former U.S. national bioethics commissions. The group identified basic principles of research conduct and suggested ways to ensure those principles were followed.

In addition to the panel’s recommendations, regulations were passed in 1974 that required researchers to get voluntary informed consent from all persons taking part in studies done or funded by the Department of Health, Education, and Welfare (DHEW). They also required that all DHEW-supported studies using human subjects be reviewed by Institutional Review Boards, which read study protocols and decide whether they meet ethical standards.

The rules and policies for human subjects research have been reviewed and revised many times since they were first approved. From 1980-1983, the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research (it is also one of the former U.S. national bioethics commissions currently) looked at federal rules for doing research on human subjects to see how well those rules were being followed. An Ethics Advisory Board was formed in the late 1970s to review ethical issues of biomedical research. In 1991, federal departments and agencies (16 total) adopted the Federal Policy for the Protection of Human Subjects.

Efforts to promote the highest ethical standards in research are still going on today. In October 1995, President Bill Clinton created a National Bioethics Advisory Commission, funded and led by the Department of Health and Human Services. The commission’s task was to review current regulations, policies, and procedures to ensure all possible safeguards are in place to protect research volunteers. It was succeeded by the President’s Council on Bioethics, which was established in 2001, and then the Presidential Commission for the Study of Bioethical Issues established in 2009.

The Legally Mandated Medical Experiment at Tuskegee

Prior to the well-known and now infamous US Public Health Service (PHS) Syphilis Study at Tuskegee (1932-1972), social experimenters in the Southern US had developed a complex intervention embodied in a codification of, “Laws and policies systematically disadvantaging African Americans during and long after their 246-year enslavement.”6 While slavery was abolished in 1865, there was no immediate organized effort to correct its abuses. Whites continued to regard former slaves as intellectually, morally, and physically inferior.6,7 It was not until passage of the Civil Rights Act in 1964 that rights originally promised with the 1868 passage of the 14th amendment were reaffirmed,6 meaning that throughout the 400 years blacks and whites have lived together in the US, the basic citizenship of African Americans has been specifically affirmed for less than 50 of those years.6,7

In Alabama, the state where the PHS Syphilis study occurred, the State Constitutional Convention of 1901 specifically codified white supremacy: Sections 178 and 180 through 182 included provisions specifically designed to disenfranchise black voters. Section 256 established an entirely segregated school system. Section 102 prevented the legislature from ever allowing interracial marriages. “Custom, backed up by the threat of violence from the police or lynch mobs, enforced forms of residential, economic, and social segregation encompassing banking (separate banks), medicine (separate medical practices and hospitals), law (informal exclusion of blacks on juries), religion (separate churches), and daily life (encompassing separate residential areas, schools, and even cemeteries). If these measures failed to enforce whites’ preferences to avoid associating with blacks, the state stood ready to step in.”8

Racially segregated medical care available to Alabama residents in the 1930’s adversely affected African American access to health care in general9,10 and to services for the treatment of syphilis in particular.11,12 In general, health care in the Jim Crow South degraded black patients and black physicians alike, dispensing services through a complex maze of separated and unequal care.9,10 More specific to syphilis, in 1926, Moore and Keidel11,12 reported that continuous treatment of early syphilis, including 21 injections of an arsphenamine, reduced clinical or serological relapse to 21% as against 89.2% in patients receiving one to eight injections. In Macon County, Alabama the initial peer reviewed paper from the PHS Syphilis study confirmed that, “‘Adequate treatment has not been freely available to most indigent citizens for a period longer than a decade.’”12,13 Indigence, in turn, was more common among African Americans,14 and poor blacks, knowing they could not pay for proper health care, often declined to seek it. Patent medicine, folk healing, and/or unlicensed practitioners were substituted.9 By 1954, care had not substantially improved, and PHS researchers commented that even though medical facilities were available in the county, “Costs are prohibitive or patients are unaware of them.”12 Alabama laws and policies operant at the start of the PHS Syphilis study therefore constituted the protocols for a legally mandated social experiment that subjected African Americans to health care that was inconsistent with recommendations prescribed by the best available medical evidence even if and when they approached the health care system.

Application of benchmarks such as respect for persons, justice, beneficence, nonmaleficence, caring and solidarity15 would have made it clear that the only ethical avenue for federal PHS physicians working in Alabama was advocacy for change consistent with the best available medical evidence. In particular, the principle of respect for persons establishes that provision of unequal healthcare on the basis of race is unjust. Moreover, while justice may encompass, “aridity, impersonality, disconnectedness, and emotional neutrality”,16 caring compensates by requiring, an empathic attunement to patient needs.15 Additionally, solidarity, includes concern for the oppressed, thereby reinforcing, “The egalitarian perspective that addressing the needs of the worst off should prima facae be the first priority of justice.”17 The PHS physicians who designed the Syphilis study might have fought to provide a model for excellence in health care. Instead, their study not only embraced Alabama’s unjust social protocols, but distilled them to the point that inadequate care became no care – simultaneously cloaked in a web of lies to make participants believe they had been freed from unjust treatment. Moreover, this unethical medical experiment was entirely legal according to federal statute – one reason that no one involved was either indicted or charged with a legal violation.18 The consequences of this multifaceted betrayal are still being felt.19

Corrective federal laws and policies following exposure of the PHS Syphilis study outlawed medical research, but lawmakers and bioethicists alike failed to address ethical issues relating to other mechanisms for legal suspension of medical evidence. We next describe two examples in which this may have occurred, both to the disadvantage of African American women and their families.

Significance

Legal protocols deviate from medical experiments, however, in that there are no requirements to provide medical evidence that the likely benefits of an intervention outweigh the risks. On the contrary, US lawmakers are free to mandate human exposures to interventions which are harmful according to the best available medical evidence. For example, US lawmakers have sorted the nation into a social experiment based on primary and secondary automobile seat belt laws. According to the best available medical evidence, primary laws (which allow police citations solely on the basis of failure to wear a seat belt) save more lives than secondary laws (which allow police citations for seat belts only after a driver has been stopped for some other reason).2 Moreover, additional medical evidence shows that secondary seat belt laws may be especially harmful to racial and ethnic minorities.3,4 At present, however, 17 US states have secondary laws, 32 have primary laws, and one has no law.5 Clearly, evidence from political science, business analyses, and other disciplines has been given primacy over medical evidence. This is an important freedom, and is founded, in part, on the ethical principle of autonomy. It is analogous to an individual’s right to reject medical recommendations for a particular procedure. While individuals may make such decisions on their own, however, we argue that the ethical principles of beneficence, non-maleficence, justice, caring, and solidarity require continued medical surveillance, reporting, and advocacy regarding the outcomes of population-based, legally mandated, human experimentation.

Authors: Robert S. Levine, Jamila C. Williams, Barbara A. Kilbourne, and Paul D. Juarez

Resources

Notes

1. Amdur R, Bankert EA. Institutional Review Board: Member Handbook. Third Edition Jones and Bartlett Publishers; Sudbury, MA: 2011. p. 47.
2. Guide to Community Preventive Services . Use of Safety Belts: Primary (vs. Secondary) Enforcement. Centers for Disease Control and Prevention;
3. Briggs NC, Schlundt DG, Levine RS, Goldzweig IA, Stinson N, Jr., Warren RC. Seat belt law enforcement and racial disparities in seat belt use. Am J Prev Med. 2006;31(2):135–141.
4. Briggs NC, Schlundt DG, Levine RS, Goldzweig IA, Stinson N, Jr, Warren RC. Seatbelt use among Hispanic ethnic subgroups of National origin. Inj Prev. 2006;12:421–6.
5. Anonymous [Accessed July 19, 2012];Safety belt and child restraint laws. 2012 Jul;
6. Moseley KL, Kershaw DB. African American and white disparities in pediatric kidney transplantation in the United States – unfortunate or unjust? Camb Q Healthc Ethics. 2012 Jul;21(3):353–65.
7. Byrd WM, Clayton LA. Race, medicine and health care in the United States: A historical survey. JNMA. 2001;93(3 Suppl):11S–34S.
8. Novkov J. [Accessed July 23, 2012];Segregation (Jim Crow) Encyclopedia of Alabama.
9. Ward TJ., Jr. [Accessed July 29, 2012];Health care. The Jim Crow Encyclopedia. Available at URL: http://testaae.greenwood.com/doc_print.aspx?fileID=GR4181&chapterID=GR4181-3616&path=encyclopedias/greenwood.
10. Ward TJ., Jr. ;Black hospital movement in Alabama. Encyclopedia of Alabama.
11. Moore JE, Keidel A. The treatment of early syphilis. I. A plan of treatment for routine use. Bull Johns Hopkins Hosp. 1926;39:1–55.
12. Kampmeier RH. The Tuskegee study of untreated syphilis. In: Reverby SM, editor. Tuskegee’s Truths: Rethinking the Tuskegee syphilis study. University of North Carolina Press; Chapel Hill: 2000. pp. 193–201.
13. Vonderlehr RA, Clark T, Wenger OC, Heller JR., Jr. Untreated syphilis in the male Negro: A comparative study of treated and untreated cases. JAMA. 1936;107
14. Flynt W. [Accessed July 23, 2012];Poverty in Alabama. Encyclopedia of Alabama.
15. Stone JR. Elderly and older racial/ethnic minority healthcare inequalities: Care, solidarity and action. Cambr Quart Healthc Ethics. 2012;21:342–52.
16. Stone JR. Elderly and older racial/ethnic minority healthcare inequalities: Care, solidarity and action. Cambr Quart Healthc Ethics. 2012;21:344.
17. Stone JR. Elderly and older racial/ethnic minority healthcare inequalities: Care, solidarity and action. Cambr Quart Healthc Ethics. 2012;21:346.
18. Roy B. The Tuskegee syphilis experiment: Biotechnology and the administrative state. JNMA. 1995;87:56–67. Reprinted in Reverby SM, Editor. Tuskegee’s truths: Rethinking the Tuskegee syphilis study. Chapel Hill: University of North Carolina Press. 2000. Pp.299-317.

Tuskegee Syphilis Study

Tuskegee Syphilis Study in the United States

Trial Practices

The Legally Mandated Medical Experiment at Tuskegee

Significance

Resources

Notes

See Also

Further Reading (Books)

Further Reading (Articles)