The Tuskegee Study and Ethical Violations
The Tuskegee study of untreated syphilis in the African-American male is deemed to be the longest recorded non-therapeutic experiment on humans in medical history. The study began in 1932, initiated by the United States Public Health Service (USPHS), and was concluded in 1972 only after ethical violations surrounding the conduct of the study were made aware to the American public. The study gets its name from its study site—Tuskegee Institute (currently Tuskegee University) in Mason County, Alabama.
Designed to determine the natural progression of syphilis, the study used 400 African-American males, all of whom had advanced syphilis at the time of recruitment, and a control group of 200 men. The men were largely left untreated and only had periodic blood tests and routine autopsies that provided more information on the disease course in addition to the clinical presentations.
In 1969, the study got a green light from the US federal government to continue despite unethical concerns raised by one of the principal investigator. Seeing as his concerned had been ignored, the investigator leaked the study details to a reporter friend who then passed it on to Jean Heller, a reported for the Associated Press. The public outrage following the breaking news in July 1972 forced the study to shut down.
At the time of the study going public, an estimated 28 to 101 study participants had died from syphilis and related complications. Further, it is estimated that at least 40 spouses of the participants had been infected and 19 children had congenital syphilis as a result.
A class lawsuit was filed in 1973 and the surviving study participants and heirs of the deceased received an out-of-court settlement totalling to 10 million dollars. Additionally, new guidelines were developed as a response, in order to protect human study participants, most notably the Ethical Principles and Guidelines for the Protection of Human Subjects of Research, commonly referred to as the Belmont Report of 1979.
Let us now highlight some of the major ethical concerns surrounding the Tuskegee Study:
- Informed consent: information about the disease was not fully disclosed to the participants. The term “bad blood”, which at the time could mean any illness from anaemia to HIV/AIDS, was used by the doctors, and so the participants did not know they were suffering from syphilis.
- Even after penicillin became available for syphilis treatment in the 1940s, participants were never given the choice. Researchers judged that the benefits of non-treatment far outweighed those of treatment in latent syphilis. While this may have been true, given no available data on efficiency of penicillin treatment at the time, participants were not given the option to opt out of the study once treatment became available.
- The impact of syphilis on the participants’ spouses and children was not taken into account despite the existence of a state law (1927) that required the reporting and treatment of several venereal diseases, including syphilis. As a result, at least 40 wives were infected and 19 children born with congenital syphilis.
- The beliefs within the medical profession regarding the socio-economic state and sexual behaviour clouded the conduct of the study thus ignoring the chain effect of a treatable infection to an entire community. In the Tuskegee study, racism was largely a factor that led to the biased recruitment of black participants. It was believed that syphilis was more prevalent in the black community due to their perceived promiscuous nature.
Syphilis, the Infection
Treponema pallidum pallidum, a small cork-screw-shaped bacterium (spirochetes), is the causative agent for syphilis, a highly contagious bacterial infection. Syphilis may be acquired or congenital.
Acquired Syphilis
In acquired syphilis, the bacteria enter the body through skin and mucous membranes during sexual intercourse or other bodily interactions such as kissing. Once the spirochetes “drill” their way through the mucous membrane, they are carried to the nearest lymph gland via lymph capillaries. Here, they rapidly multiply then make their way to the blood stream and eventually throughout the body.
There are three stages of acquired syphilis: primary, secondary and tertiary (latent) syphilis.
Primary syphilis: About 2-4 weeks post infection, an ulcer (chancre), usually hard and painless, develops around the genital area (at the point of contact). This chancre is filled with fluid rich in treponemes (syphilis-causing bacterium). The regional lymph nodes are usually enlarged as bacteria are multiplying. The ulcer may heal spontaneously in about 6 weeks without treatment, leaving a scar that may last for months. Primary syphilis is very infectious.
Secondary syphilis: The second stage of syphilis begins as the scar is healing, with a rash occurring within 2-8 weeks after the lesion has healed. The rashes are as a result of the now widespread bacterial multiplication and their dissemination in the blood. At this point, the patient experiences pain in the bones and joints, cardiac symptoms and non-specific symptoms like fever, headache, swollen lymph nodes that accompany the rash. Skin lesions (condylomata) develop in some cases.
The secondary stage gives way to a period of latency where the disease is silent, not gone. While the manifestations of the disease diminish or disappear on the outside, the spirochetes work their way into the lymph organs, bone marrow, central nervous system and other vital organs. If you are luck, you can live in peaceful co-existence with the infection to your death. In many cases however, after about 2-3 years, the disease enters its final and most fatal stage—the tertiary (late stage) syphilis.
Late (tertiary) syphilis: At this stage, the disease is a merciless killer. Gummas, lesions characteristic of late syphilis, appear on the skin, filled with a concentration of spirochetes. Damage to the bones by spirochetes resemble osteomylitis. Damages to the cardiovascular and central nervous system are often permanent and fatal. Some of these include aneurysm in blood vessels, paralysis, insanity (‘general paralysis of the insane’), blindness and deafness.
Congenital Syphilis
A pregnant mother with untreated syphilis via placental transmission, resulting in foetal death or abortion (in early pregnancy stages). In children that live, symptoms of congenital syphilis may appear about a year after birth with rashes, painful limbs, jaundice, and anaemia among others.
References
- Emanuel, E. J., Grady, C. C., Crouch, R. A., Lie, R. K., Miller, F. G., & Wendler, D. D. (Eds.). (2008). The Oxford textbook of clinical research ethics. Oxford University Press.
- Thomas, S. B., & Quinn, S. C. (1991). The Tuskegee Syphilis Study, 1932 to 1972: implications for HIV education and AIDS risk education programs in the black community. American journal of public health, 81(11), 1498-1505
- Ogungbure, A. A. (2011). The Tuskegee Syphilis study: some ethical reflections. Thought and Practice, 3(2), 75-92.
- Heintzelman, C. A. (2003). The Tuskegee syphilis study and its implications for the 21st century. The New Social Worker, 10(4), 4-5. https://www.socialworker.com/feature-articles/ethics-articles/The_Tuskegee_Syphilis_Study_and_Its_Implications_for_the_21st_Century/
- Nix, E. (2017). Tuskegee experiment: The infamous syphilis study. History, 16. https://www.history.com/news/the-infamous-40-year-tuskegee-study