The Tuskegee Study: Ethics in Clinical Research.

If today a scientific experiment on human was to be carried out, an institute has to abide by a list of rules and regulations. The human subjects have to be handle with utmost care and dignity.

Fig 1: Representation of a Clinical Trial.

During the clinical trials (that is study involving human subjects), human rights should be not be hindered and no human should be harmed unnecessarily. The clinical experiments involving human subject, have to comply with four main priniciples:

1. AUTONOMY:

The principle of Autonomy demands the subjects to be treated as autonomous individuals, whose welfare and rights need to be respected. The subjects can make their own decision as per their convenience.

2. NON-MALEFICENCE:

The principles of non–maleficence (do not harm) compels investigators to minimize the harm to the study population.

3. BENEFICENCE:

The principles of beneficence (do good) emphasises on enhancing benefits to the study population.

4. JUSTICE:

The principle of justice demands priority to be given to the interests of each and every person in society.

Various stringent terms and conditions, strict rules and regulations have to be followed during the execution of these experiments, to be acceptable by the science community. The experiments which harm humans in any way can land the experimenters in trouble. However, it was not the same way around hundreds of years ago. There have been few black pages in the history of science, one such episode is of Tuskegee Syphilis Study.

• Tuskegee Syphilis Study (1932-1972):

In the beginning of the 20th century, Syphilis was seen as a major health issue. It is a sexually transmitted infection caused by a bacteria called Treponema pallidum.

Fig 2: Rashes in patients of Syphilis (Image Source: Cruz et al, 2010).

This disease had a social stigma attached to it. The symptoms of Syphilis includes development of sores and skin rashes (see fig 2). If untreated other symptoms like fever, swollen lymph glands, sore throat, patchy hair loss, headaches, weight loss, muscle aches and fatigue may develop. Finally , different organ systems are affected, including the circulatory system, nervous system and so on. The infection eventually leads to paralysis, dementia, blindness or even death.

Around a century back, health workers were not well versed with this disease and in 1932 the US Public Health Service working with the Tuskegee Institute, Alabama, US, began a study syphilis. This experiment is also infamously called the “Tuskegee Study of Untreated Syphilis in the Negro Male.” The purpose of this study was to observe the natural history of untreated syphilis.

This study involved all African-American men (*Rascism). They were told by the health workers that they were receiving free health care from the United States government (*Misinformation). It started with a group of 600 black men, all from poor background. Out of these 600 subjects, 399 were having syphilis while 201 who did not have the disease. The men were lured with a promise of free medical care, meals, and free burial insurance for participating in the study.

(Just: Have a look at the Tuskegee Patient Medical Files.)

Fig 3: The health worker with the volunteers of Tuskegee Syphilis Study (Image Source: Britannica).

According to the Centers for Disease Control, the men were told that they were being treated for “bad blood“, a term referring to a group of ailments including syphilis, anaemia, and fatigue, but were not told that they had syphilis specifically (*Misinformation). The participants were also not aware that, it could be transmitted to spouses and the future babies (*Misinformation). In name of treatment they were only given a placebo or aspirin (*Harm). Spinal taps were performed to test syphilis, which were misled to be believed as a ‘new special treatment’ (*Misinformation).

Initially, the subjects were informed that the study would be conducted for six months, however it continued for the next 40 years till 1972. Even when penicillin was found to cure the disease in 1953, the subjects were not treated and were allowed to suffer and even die (*Harm).

Fig 4: The Descendants of untreated participants of Tuskegee Syphilis study (Image Source)

In 1966, a venereal disease investigator for the U.S. Public Health Service (USPHS) named Peter Buxton, found the study disturbing and wrote to them. However, USPHS did not take any action. In 1968, Buxton questioned the study again, which went unheeded again.

Finally, in July 25, 1972, Buxton met a reporter who printed the details of the study in Washington Star newspaper in Washington D.C., leading to a public outcry. This shocked and horrified the Federal Director of Health, Education and Welfare.

The Assistant Secretary for Health and Scientific Affairs appointed an Ad Hoc Advisory Panel to review the study. This panel found that the Tuskegee Study was “ethically unjustified” and thus, ended the Tuskegee Study in 1972. The USPHS still justified their act by stating that “…doctors and civil servants simply did their job, for the glory of science.”

Ultimately, penicillin was given to the survivors, 50 wives and 20 children who had contracted syphilis.

No compensation was offered until, a class-action lawsuit was filed on behalf of the study participants and their families, in 1973. The case was finally settled for $10 million in 1974 and the U.S. government assured lifetime medical benefits and burial services to all living participants.

In 1997, the then US President Bill Clinton apologized, saying “The United States government did something that was morally wrong and racist.”