One of the ugliest and unethical human studies in the history, Tuskegee Study raised a host of ethical issues such as informed consent, racism, paternalism, unfair subject selection in research, maleficence, truth telling and justice, among others. It is really unbelievable to understand the heinous nature of the Tuskegee study.
The Public Health Service started the study in 1932 in collaboration with Tuskegee University (then the Tuskegee Institute), a historically Black college in Alabama. In the study, investigators enrolled a total of 600 impoverished African-American sharecroppers from Macon County, Alabama.
The goal was to “observe the natural history of untreated syphilis” in black populations. But the subjects were unaware of this and were simply told they were receiving treatment for bad blood. Actually, they received no treatment at all. Even after penicillin was discovered as a safe and reliable cure for syphilis, the majority of men did not receive it.
In 1932, the USPHS, working with the Tuskegee Institute, began a study to record the natural history of syphilis. It was originally called the “Tuskegee Study of Untreated Syphilis in the Negro Male” (now referred to as the “USPHS Syphilis Study at Tuskegee”).
The study initially involved 600 Black men – 399 with syphilis, 201 who did not have the disease. Participants’ informed consent was not collected. Researchers told the men they were being treated for “bad blood,” a local term used to describe several ailments, including syphilis, anemia, and fatigue. In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance.
By 1943, penicillin was the treatment of choice for syphilis and becoming widely available, but the participants in the study were not offered treatment.
The purpose of the study was to observe the effects of the disease when untreated, though by the end of the study medical advancements meant it was entirely treatable. The men were not informed of the nature of the experiment, and more than 100 died as a result.
None of the infected men were treated with penicillin despite the fact that, by 1947, the antibiotic was widely available and had become the standard treatment for syphilis.
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Of these men, 399 had latent syphilis, with a control group of 201 men who were not infected. As an incentive for participation in the study, the men were promised free medical care. While the men were provided with both medical and mental care that they otherwise would not have received, they were deceived by the PHS, who never informed them of their syphilis diagnosis and provided disguised placebos, ineffective methods, and diagnostic procedures as treatment for “bad blood”.
The men were initially told that the experiment was only going to last six months, but it was extended to 40 years. After funding for treatment was lost, the study was continued without informing the men that they would never be treated.
The study continued, under numerous Public Health Service supervisors, until 1972, when a leak to the press resulted in its termination on November 16 of that year. By then, 28 patients had died directly from syphilis, 100 died from complications related to syphilis, 40 of the patients’ wives were infected with syphilis, and 19 children were born with congenital syphilis.
The 40-year Tuskegee Study was a major violation of ethical standards, and has been cited as “arguably the most infamous biomedical research study in U.S. history.” Its revelation has also been an important cause of distrust in medical science and the US government amongst African Americans.
Later in 1973, a class-action lawsuit was filed on behalf of the study participants and their families, resulting in a $10 million, out-of-court settlement in 1974.
On May 16, 1997, President Bill Clinton issued a formal Presidential Apology for the study.
On May 16, 1997, President Bill Clinton formally apologized on behalf of the United States to victims of the study, calling it shameful and racist. “What was done cannot be undone, but we can end the silence,” he said. “We can stop turning our heads away. We can look at you in the eye, and finally say, on behalf of the American people, what the United States government did was shameful and I am sorry.”
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