A Review of The Tuskegee Syphilis Study
By: Nathaniel Zona
The Tuskegee Syphilis Study was a biomedical research project of great infamy. Such fame is not the product of medical breakthroughs regarding syphilis. Rather, the study is a pillar of biomedical research due to its bioethical injustices, mistreatment of subjects, and institutionalized racism.
In 1932, the Public Health Service (PHS), working with the Tuskegee Institute, began research with the intention of studying the natural course of syphilis while justifying treatment programs for the black community [1]. The research program initially involved 600 African American men. Of the 600 chosen for the study, all from Macon County, Alabama, 399 had syphilis and 201 did not have the bacterial disease [1]. The Tuskegee Syphilis Study initially had a timeline of six months; however, the study was continued and the men involved suffered through forty years of unethical treatment inflicted by the study.
When the research began, the prospective subjects were told that they were being treated for “bad blood,” a term that was used to vaguely describe ailments such as anemia, fatigue, and syphilis [1]. This was the only diagnosis that was provided to the participants. There was a lack, and often a complete absence, of communication to the men about the disease they had and what it entailed. The subjects all came from an impoverished socio-economic background, and likely did not have the resources to gain insight into their condition.
As the study progressed, the subjects were told that they would receive treatment for the aforementioned bad blood that they possessed. Additionally, they would receive medical exams, meals, and proper burial insurance for their cooperation [1]. While they may have received some of these so-called benefits, the study did not provide the only true necessity which was treatment for their latent syphilis. The men involved in the study did not have any knowledge of the true intent of the research -- to observe the natural progression of syphilis, rather than to intervene and provide care. The basis of observation rather than intervention necessitated that the subjects would not actually receive any treatment for their syphilitic symptoms. This neglected the majority of medical textbooks and physician advice of the time that suggested bismuth injections and arsenic compounds should be administered to treat latent syphilis [2]. Although the suggested treatments proposed risks of their own, the option was never offered to the subjects. Despite knowing the availability of treatment, and the immorality of allowing the disease to advance, those in charge of the study continued observation without treatment.
Once the infection becomes tertiary syphilis, it attacks the neurological and cardiovascular systems, and can lead to permanent disability or death [3]. All the while, the subjects believed they were being treated. The experiment carried on until 1972. For forty years, the study was conducted without the patient’s informed consent [1]. Outside of Tuskegee, the PHS was establishing and promoting “Rapid Treatment Centers” for those with symptomatic and latent syphilis [3]; however, test subjects in the study were unaware of, and did not have access to these centers. Furthermore, the local physicians in the county were made aware of the participants in the study and asked to avoid providing syphilis-related care for the subjects [3].
During and and after the Second World War, penicillin became more widely recognized as an antibacterial treatment and proved to be much more effective and much less dangerous than previous treatments. Penicillin became the drug of choice in treating patients with syphilis. The study subjects were not informed of the new penicillin treatment. In fact, as the Center for Disease Control (CDC) gained relevance and became associated with the study, it endorsed the continuation of the experiment without the use of penicillin [3].
From 1932-1972 many physicians, nurses, researchers, and medical students had been involved in or became aware of the study; yet, there was little examination of the morality of the study over its forty years, even with the release of regular publications. The 1954 Public Health Report, “Untreated Syphilis in the Male Negro” reported that in the first twenty years of the study, over 40% of the syphilitic patients had died [4]. Even with multiple publications discussing these methods and results, the study stayed relatively unknown to the general public. Eventually, those involved started to come to the realization that the study was ethically flawed, yet made attempts to conceal this. In a 1969 ad hoc committee meeting, held to review data and give advice for the continuation of the study, panel members discussed the anticipated criticism for a lack of patient treatment. One doctor concluded the discussion by stating that by building rapport with local physicians, making their goals transparent, there would be no need to treat the subjects because there would be no harsh criticism from the medical society [5]. Another panel member even noted that there was no need to improve patient care, for when he was at the study location, they had identified two cases of glaucoma and treated both. He believed the gesture was much appreciated, as if the glaucoma treatment was compensation for intentional withholding of life-saving treatment [5].
From the inception of the study, the intentions and methodology were flawed. The Tuskegee Syphilis Study used a “study in nature” approach which the researchers justified because the affected subjects did not seek treatment to begin with [2]. Dr. Taliaferro Clark, chief of the PHS Venereal Disease Division, labeled the study as an “unparalleled opportunity” in which providing no treatment would create a “ready-made situation valuable for observing consequences” [2]. Because this particular community in Tuskegee was geographically and economically isolated from medical and educational assistance, the researchers were aware of the easily exploitable situation, and took advantage of it. Alan Brandt, in a review of the study, writes, “In retrospect, the Tuskegee Study revealed more about the pathology of racism than the pathology of syphilis” [2].
Eventually, in the early 1970s, news of the malpractice occurring in the Tuskegee Study began to develop. In July of 1972, the Associated Press became aware of the situation and incited a public outcry [1]. Another ad hoc review panel was formulated, composed of nine members from law, medicine, labor, education, public affairs, and health administration. Five of these panel members were African American. The panel found that despite the men’s willingness to participate, the research did not inform the participants about the details of the study, and even misled them in their involvement [1]. The panel identified that the men were given no choice to quit the study, or given the information about possible penicillin treatment [1]. The study was deemed ethically unjustified and in October of 1972, the review board recommended that the study should be ended immediately. One month later the Assistant Secretary for Health and Scientific Affairs announced the termination of the Tuskegee Syphilis Study [1]. When the study was finally ended, only 74 of the original 600 test subjects were still alive. At least 28 men had died from the lesions caused by syphilis alone, but it is estimated that over 100 men died due to direct complications of the disease [2].
The legacy of the Tuskegee Syphilis Study has had lasting repercussions on the African American community. There has been an increase in distrust between older black patients and medical care providers when compared to other demographics. After the study was ended, there was a decrease in both outpatient and inpatient medical interactions for black men [6]. Because of the injustice of the Tuskegee Study, there have been mandated changes to the manner in which human subject research can be performed. In 1974, the National Research Act was signed into law, creating a national commission for the protection of human subjects and biomedical research [1]. This Act required an Institutional Review Board (IRB) to be appointed to each federally funded research project. These IRBs regularly review the methods used in the study and ensure the projects are ethically sound, consistent in minimal subject risk, reasonable in subject risk to benefit anticipation, and appropriately make provisions for subject safety and privacy [1]. There have since been many regulations put in place ensuring that voluntary informed consent is given from the participants of the study. An ethical research code and ruleset, known as The Common Rule has been implemented for all government-funded research as well [7]. This provides ethical protection of human subjects through all federal departments and agencies. Additional provisions are included in The Common Rule that guarantee that study subjects must be aware of all courses of action, risks, and benefits from participation in a study. This baseline standard for research creates transparency between those conducting the research and the subjects. In 1995 President Bill Clinton created the National Bioethics Advisory Commission [1]. This commission has been reformed many times so that it adhered to new safety precautions and sound ethical standards. It was most recently revised in 2009 and rebranded as the Presidential Commission for the Study of Bioethical Issues [1]. The project was archived in 2017, but continual measures are taken to review bioethics and prevent any repeat of studies like the Tuskegee Syphilis Study.
The Tuskegee Syphilis Study represents a disappointing and unethical blunder in the field of medicine. As one of the most egregious research studies in American history, it is proof that biased beliefs, practices, and policies are a threat to the good of the healthcare system. Researchers and clinicians continue to learn from these past mistakes and try to improve medical care to make it equivalent and available for all regardless of race, gender, religion, or sexual orientation.
References
Centers for Disease Control and Prevention. U.S. Public Health Service Syphilis Study at Tuskegee. Published online March 2, 2020. Accessed June 23, 2020. https://www.cdc.gov/tuskegee/timeline.htm
Brandt AM. Racism and Research: The Case of the Tuskegee Syphilis Study. The Hastings Center Report. 1978;8(6):21-29. doi:10.2307/3561468
Benedk TG, Erlen J. The Scientific Environment Of the Tuskegee Study of Syphilis, 1920-1960. Perspectives in Biology and Medicine. 1999;43(1):1-30. doi:10.1353/pbm.1999.0034
SHAFER JK, USILTON LJ, GLEESON GA. Untreated syphilis in the male Negro; a prospective study of the effect on life expectancy. Public Health Rep. 1954;69(7):684-690.
Ad Hoc committee meeting to examine data from the Tuskegee Syphilis Study and offer advice on continuance of this study, File No. 281641; Department of Health, Education, and Welfare. Public Health Service. Health Services and Mental Health Administration. Center for Disease Control. Venereal Disease Branch; February 6, 1969. Record Group 442; National Archive at Atlanta.
Alsan M, Wanamaker M. TUSKEGEE AND THE HEALTH OF BLACK MEN. Q J Econ. 2018;133(1):407-455. doi:10.1093/qje/qjx029
Breault JL. Protecting human research subjects: the past defines the future. Ochsner J. 2006;6(1):15-20. doi:10.1043/1524-5012(2006)006[0015:PHRSTP]2.0.CO;2