Question

People's initial reaction to the Tuskegee experiment is to ask how it could have happened. What do you think? Could it happen again? How can this be avoided in the future?

Answer 1

Tuskegee is a city in Macon County, Alabama, United States. The Tuskegee Study of Untreated Syphilis in the African American was an infamous and unethical clinical study conducted between 1932 and 1972 by the U.S. Public Health Service. The Public Health Service started working on this study in 1932 in collaboration with Tuskegee University, a historically black college in Alabama.

Syphilis is an STD (sexually transmitted disease). It is caused by the bacteria Treponema pallidum. While it is not as common as it used to be, syphilis is still considered a potentially deadly disease.

There are two ways in which syphilis can be contracted.

It can be spread through close sexual contact, usually in the form of oral, vaginal or anal sex.

Pregnant woman women can pass the disease onto their unborn child, resulting in the baby being born with syphilis. This is known as congenital syphilis, and can result in a number of skin and organ problems in the infant. Congenital syphilis can be fatal.

A pregnant woman who has syphilis is also more likely to have a stillborn baby.

There are four stages to this disease. Each stage produces its own set of symptoms.

Primary stage: A painless ulcer called a chancre develops, usually in the genital area. (This indicates where the syphilis-causing bacteria entered the body.) However it may also appear in other areas, such as in the mouth if syphilis is contracted as a result of oral sex. The chancre is firm and oozes fluid that contains the syphilis bacteria.

This stage usually begins around three weeks after a person has been exposed to syphilis (however it can occur anywhere between 10 and 90 days later).

This stage lasts four to six weeks. During this time the chancre may disappear completely, but the infection remains and if left untreated, advances to the next stage.

Secondary stage: The syphilis-causing bacteria now spread to the bloodstream. A number of symptoms develop on the skin. These may include a red rash on the palms of the hands and the soles of the feet, small blisters filled with pus, or thick grey or pink patches.

There may also be symptoms, which are similar to having the flu, such as fever, aches and pains, and headaches.

These symptoms, which can last for up to a year, may eventually disappear. However they may also return.

Latent stage: This is a dormant period. It usually occurs around two years after a person first contracts syphilis. Most people experience no symptoms during this stage, however the infection is still there. This stage can last for years. It is thought that syphilis remains infectious for one or two years into the latent stage.

If syphilis hasn’t been treated up to this point, there is a chance that it will develop into the final stage.

Tertiary stage: During this stage, the syphilis bacteria can cause serious damage to many internal organs, including the brain, spinal cord and heart.

Tumours called gummas may develop in the mouth, nose, bones, or organs such as the liver.

There may be vomiting or abdominal pain.

This stage can end in blindness, dementia, paralysis, and even death. Syphilis is not infectious during this stage. This stage usually occurs within 10 years of a person first contracting syphilis.

Investigators enrolled in the study a total of 600 impoverished, African-American sharecroppers from Macon County, Alabama.The purpose of this study was to observe the natural history of untreated syphilis; the African-American men in the study were told they were receiving free health care from the United States government. From 1932-1972, the U.S. Public Health Service conducted a study of the effects of untreated syphilis in Black men in Macon County, Alabama. The study was conducted in Macon County, Alabama, where Tuskegee is the county seat. Early in the study, 399 men with late latent syphilis, and 201 men without syphilis were initially enrolled. As the study evolved, additional participants were added, so the number of men in the study varies according to the source.

The 399 men in the syphilitic group were initially recruited because they already had late latent syphilis. The 201 men in the control group did not have the disease. Local African American and white physicians were recruited not to treat the men. Autopsy and physician assessments were done at local hospitals. A number of Tuskegee Institute (now known as Tuskegee University) faculty and staff were involved in the study. The study became unethical in the 1940s when penicillin became the recommended drug for treatment of syphilis and researchers did not offer it to the subjects. Federally supported studies using human subjects must be reviewed by Institutional Review Boards. Regulations governing confidentiality were also developed. Researchers now must get voluntary informed consent from all persons taking part in studies changed the way we conduct Public Health Research today. The study was limited to black men 25 years of age or older, however as a result of lack of treatment, some women contracted syphilis from men who participated in the study’s syphilitic group. No women were included in the study.

In July 1972, an Associated Press story about the Tuskegee Study caused a public outcry that led the Assistant Secretary for Health and Scientific Affairs to appoint an Ad Hoc Advisory Panel to review the study. The panel had nine members from the fields of medicine, law, religion, labor, education, health administration, and public affairs. The panel found that the men had agreed freely to be examined and treated. However, there was no evidence that researchers had informed them of the study or its real purpose. In fact, the men had been misled and had not been given all the facts required to provide informed consent. The men were never given adequate treatment for their disease. Even when penicillin became the drug of choice for syphilis in 1947, researchers did not offer it to the subjects. The advisory panel found nothing to show that subjects were ever given the choice of quitting the study, even when this new, highly effective treatment became widely used.

The advisory panel concluded that the Tuskegee Study was “ethically unjustified”–the knowledge gained was sparse when compared with the risks the study posed for its subjects. In October 1972, the panel advised stopping the study at once. A month later, the Assistant Secretary for Health and Scientific Affairs announced the end of the Tuskegee Study. In the summer of 1973, a class-action lawsuit was filed on behalf of the study participants and their families. In 1974, a $10 million out-of-court settlement was reached. As part of the settlement, the U.S. government promised to give lifetime medical benefits and burial services to all living participants. The Tuskegee Health Benefit Program (THBP) was established to provide these services. In 1975, wives, widows and offspring were added to the program. In 1995, the program was expanded to include health as well as medical benefits. The Centers for Disease Control and Prevention was given responsibility for the program, where it remains today in the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention. The last study participant died in January 2004. The last widow receiving THBP benefits died in January 2009. There are 12 offspring currently receiving medical and health benefits.

Though not a clinical trial, the Tuskegee Syphilis Study has put research in a bad light for many Americans, especially minority populations. Conducted by the US Public Health Service (PHS) from 1932 to 1972, the study intentionally withheld treatment for 399 poor African American men suffering from syphilis. The men were sharecroppers and laborers from Macon County, Alabama.

The goal of the comparative study was to observe the long-term effects of syphilis. Penicillin was not in use as a standard treatment for syphilis in the 1930's. However, it became widely available in the 1940's and later became a standard treatment for syphilis. The participants were never made aware of or given the treatment. Over three-fourths of the subjects eventually died from complications of syphilis. Many of those who survived became blind and crippled.

The experiment was conducted without the benefit of patients' informed consent. In exchange for their participation, the men received physical examinations, free rides to and from the clinic, free hot lunches, and free medicine for any disease other than syphilis.

The study was finally terminated only after a former PHS employee leaked information on the study to an Associated Press reporter. The press ran lead stories exposing the study on July 26th, 1972. At the time the story broke, only 74 study participants were alive.

What happened at Tuskegee was terrible, there's no getting away from it. But since then, we have put safeguards in place to prevent this from happening again. Minorities are underrepresented in clinical trials for a number of reasons, one being the mistrust that stems from memories of Tuskegee. But today, complete information on the nature of research studies is available to prospective participants. Other barriers deal with the culture and the language. Many Hispanics, for example, feel more comfortable with Hispanic health care providers and researchers, said Dinora Dominguez, a patient recruitment specialist at NIH. They at least want to work with professionals who have an understanding or appreciation of their culture. NIH conducts research on a cross-section of common and serious diseases, and is interested in developing treatment for them.