The aforementioned instances of research misconduct did not lead to any significant changes in policy or procedure for “human subjects”. It took a forty year longitudinal study conducted on 400 black sharecroppers in Macon, Alabama to shame the science community into change.
In 1932 the United States Public Health Service (USPHS) began its study to better understand the natural course of untreated latent syphilis. 400 hundred African American men with the disease and a control group of 200 men without were recruited. The subjects were misleadingly promised “special free treatment”. This included but was not limited to spinal taps (done without anesthesia) to study the neurological effects of syphilis and baths in mercury which was standard for 1932. Most concerning was ,when penicillin began to emerge as a safe and effective treatment for the disease, the men were denied access to these treatments. Even when penicillin became widely available by the early 1950s as the preferred treatment for syphilis, this therapy was withheld. On several occasions, the USPHS sought to prevent treatment.
Essentially the men became part of a placebo study. A placebo is a substance or an intervention of some other type that is not known to affect the underlying problem. In this case, by the 1940s the heavy metals therapy became an inert treatment when compared to antibiotic therapy. Placebos are most often used to determine if reports of pain are effects of physiological conditions instead of psychological processes. If participants receiving the placebo report that feel “better”, it is said that their condition/ and or pain is the result psychological issues. They have proven to be useful in many cases; however, these men were never made aware of any other treatment options. The USPHS took measures to prevent them from gaining access to proven methods of intervention.
At least 28 men died of advanced stage syphilis. Some estimate that more than 100 men would ultimately succumb to ‘bad blood’ as the men would call it. In 1972, when accounts of the study first appeared in the national press, the Department of Health, Education and Welfare (HEW) stopped the experiment. HEW brought in a panel to evaluate the ethics and usefulness of the study. The panel decided that penicillin should have been offered to the men when the treatment became available. Ultimately the men and/or their families would win a class action suit that afforded them and their descendants access to real medical care for the rest of their lives.
In 1976, historian James Jones interviewed John Heller, director of the Venereal Diseases unit of the PHS from 1943 to 1948. Among Heller's remarks were the following: "The men's status did not warrant ethical debate. They were subjects, not patients; clinical material, not sick people". Issues of informed consent were common before and during this 40 year period. The Institutional Review Board was formed to regulate procedures and protocol for research involving human subjects.
In 1974 the National Research Act was signed into law. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research currently works ensure basic principles of ethics are followed in research.
The Tuskegee study is one of the most famous instances of government being directly involved in the mistreatment of human test subjects. It serves as a current place of contention between scientists and African American communities. (Tuskegee Legacy Project)
Do you think these events would occur if there was a black scientist involved? Comment Below.
Allan M. Brandt. 1978. Racism and research: The case of the
Tuskegee Syphilis study. The Hastings Center Report 8(6): 21-29.
Protection from Harm: The Tuskegee Syphilis Study
Is It Always Unethical to Use a Placebo in a Clinical Trial?
The Tuskegee Timeline
FINAL REPORT of the Tuskegee Syphilis Study Ad Hoc Advisory Panel
The Tuskegee Legacy Project: Willingness of Minorities to Participate in Biomedical Research