U.S. injected black men with Syphilis without them knowing - Tuskegee experiment

 

The Tuskegee Study of Untreated Syphilis in the African American Male is the longest nontherapeutic experiment on human beings in medical history, as noted by Arthur L. Caplan (1992). Begun in 1932 by the United States Public Health Service (USPHS), the study was purportedly designed to determine the natural course of untreated latent syphilis in some 400 African American men in Tuskegee, Macon County, Alabama. The research subjects, all of whom had syphilis when they were enrolled in the study-contrary to the “urban myth” that holds “black men in Alabama were injected with the virus that causes syphilis” (Walker, 1992)-were matched against 200 uninfected subjects who served as a control group.

The subjects were recruited with misleading promises of “special free treatment,” which were actually spinal taps done without anesthesia to study the neurological effects of syphilis, and they were enrolled without their informed consent.

The subjects received heavy metals therapy, standard treatment in 1932, but were denied antibiotic therapy when it became clear in the 1940s that penicillin was a safe and effective treatment for the disease. When penicillin became widely available by the early 1950s as the preferred treatment for syphilis, this therapy was again withheld. On several occasions, the USPHS actually sought to prevent treatment.

The first published report of the study appeared in 1936, with subsequent papers issued every four to six years until the early 1970s. In l969, a committee at the federally operated Center for Disease Control decided the study should continue. Only in 1972, when accounts of the study first appeared in the national press, did the Department of Health, Education and Welfare (HEW) halt the experiment.

At that time, 74 of the test subjects were still alive; at least 28, but perhaps more than 100, had died directly from advanced syphilis. An investigatory panel appointed by HEW in August 1972 found the study “ethically unjustified” and argued that penicillin should have been provided to the men. As a result, the National Research Act, passed in 1974, mandated that all federally funded proposed research with human subjects be approved by an institutional review board (IRB). By 1992, final payments of approximately $40,000 were made to survivors under an agreement settling the class action lawsuit brought on behalf of the Tuskegee Study subjects. President Clinton publicly apologized on behalf of the federal government to the handful of study survivors in April 1997.

Several major ethical issues involving human research subjects need to be studied further. The first major ethical issue to be considered is informed consent, which refers to telling potential research participants about all aspects of the research that might reasonably influence their decision to participate. A major unresolved concern is exactly how far researchers’ obligations extend to research subjects. Another concern has to do with the possibility that a person might feel pressured to agree or might not understand precisely what he or she is agreeing to. The investigators took advantage of a deprived socioeconomic situation in which the participants had experienced low levels of care. The contacts were with doctors and nurses who were seen as authority figures.

The USPHS practiced deception in recruiting subjects for the study. It was never explained to the subjects that the survey was designed to detect syphilis. The term “bad blood,” which was a local colloquialism for everything from anemia to leukemia, was used by the doctors and never defined for the subjects. Subjects were never told they had syphilis, the course of the disease, or treatment. The treatment presented consisted of spinal taps, which were described as “spinal shots” (Heintzelman, 1995).

The second major ethical issue is the withholding of treatment for research purposes. This is the gravest charge against the study. Patient welfare was consistently overlooked, although there have been multiple attempts to justify why penicillin treatment was withheld. Some physicians felt that repair of existing damage would be minimal, and others felt that the damage that could result from reactions to the penicillin therapy, including fever, angina, and ruptured blood vessels, would outweigh its benefits. At the time of the Tuskegee Study, no data was available on the efficiency of penicillin treatment in late syphilis, and short- and long-term toxic effects of drugs had not been well documented. In short, when the study was evaluated periodically, researchers judged that the benefits of nontreatment outweighed the benefits of treatment. Moreover, the subjects were never given a choice about continuing in the study once penicillin had become available; in fact, they were prevented from getting treatment.

 

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