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Exploring the Tuskegee Syphilis Study

The Tuskegee Study was intended to examine the long-term side effects of untreated syphilis. It tracked a group of 600 poor African-American men in Alabama, 399 who had syphilis and the rest who did not, for over 40 years. During the course of the study, scientists actively denied treatment to these men, which had devastating effects on the health of not only the men but their families. This is why the study is best known as "The Tuskegee Incident," and as one of the most deliberate examples of violation of scientific ethics seen in the United States in the last 50 years (Boskey, 2007).

From 1932 to 1972, there were 399 African-American males that were denied treatment for syphilis and mislead by officials of the United States Public Health Service. As part of a study carried out in Macon County, Alabama, poor sharecroppers were told they were being treated for bad blood, when in reality the physicians in charge of the study made sure that these men went untreated. In the years since its details first were exposed, the Tuskegee Syphilis study has become a powerful symbol of racism in medicine, ethical misconduct in human research, and government abuse of the defenseless (Bad Blood: The Tuskegee Syphilis Study, 2009).

During the 1990's there was a time of reflection upon the Tuskegee Study and its troubling implications. In 1994, the issue was tackled in a symposium entitled, "Doing Bad in the Name of Good?: The Tuskegee Syphilis Study and Its Legacy," assembled at the Claude Moore Health Sciences Library. The debate at the symposium led to the creation of the Tuskegee Syphilis Study Legacy Committee. In 1996, this Committee met at Tuskegee University to explore how the government and the nation could publicly address the Tuskegee Syphilis Study and its impact (Bad Blood: The Tuskegee Syphilis Study, 2009).

In its final report the Committee recommended that President Clinton to apologize for the wrongs of the Tuskegee Study. The Committee's work was recognized on May 16, 1997 when the President apologized on behalf of the United States government to the surviving participants of the study. These men along with members of the Legacy Committee were invited to the White House to witness the apology. Although the President's words formally closed this chapter in the history of American public health, the Study's consequences are still felt in African-American communities and the biomedical professions (Bad Blood: The Tuskegee Syphilis Study, 2009).

The notorious Tuskegee Syphilis Study (TSS), conducted by the U.S. Public Health Service (USPHS) from 1932-1972, is widely recognized to have imposed research abuses on 399 African-American sharecroppers in Macon Country, Alabama, who were the subjects of this study on the effects of untreated syphilis in the Negro male. Today there is extensive belief that a major legacy of that unethical research study is a strong unwillingness among many African-Americans to participate in clinical research studies as a result of the abuses for fear of further abuses. In 1994 the National Institutes of Health Guidelines were created for the Inclusion of Women and Minorities in epidemiologic and clinical studies. This established a national mandate to include diverse populations in all epidemiologic and clinical studies. The ultimate objective of mandating the inclusion of diverse populations in these studies was to set a national agenda to reduce health disparities (Katz, Green, Kressin, James, Wang, Claudio and Russell, 2009).

It was thought that the true nature of the Tuskegee experiment had to be kept from the subjects to ensure their cooperation. Because of the fact that the sharecroppers were at a gross disadvantage in their lives made them easy to manipulate. The participants were pleased at the prospect of free medical care since almost none of them had ever seen a doctor before. The study was intended to discover how syphilis affected blacks as opposed to whites. The theory was that whites experienced more neurological complications from syphilis, whereas blacks were more susceptible to cardiovascular damage. How this information would have changed clinical treatment of syphilis is uncertain. Although the study was touted as one of great scientific merit, from the outset its actual benefits were not very clear. It took roughly forty years before someone involved in the study took a hard and honest look at the end results and reported that nothing learned in the study would prevent, find, or cure a single case of infectious syphilis or bring us closer to our basic mission of controlling venereal disease in the United States (Brunner, 2009).

By the end of the experiment, 28 of the men had died of syphilis, 100 were dead of related complications, 40 of their wives had been infected, and 19 of their children had been born with congenital syphilis. In order to convince the community to support the experiment, one of the original doctors admitted it was necessary to carry on this study under the appearance of a demonstration and provide treatment. In the beginning, the men were prescribed the syphilis remedies of the day, bismuth, neoarsphenamine, and mercury, but in such small amounts that only 3% showed any improvement. These doses of medicine were good public relations and did not interfere with the true aims of the study. Ultimately, all syphilis treatment was replaced with a pink medicine which was nothing other than aspirin (Brunner, 2009).

Although the study had reasonable goals which were to understand the effects of untreated syphilis on whole body health, it was performed in an ethically unjustifiable way. For almost 30 years following penicillin becoming the accepted treatment for syphilis in, the men in the Tuskegee study were actively denied treatment by not only the study doctors, but by physicians in their own communities who had been requested to withhold treatment from the study participants so that scientists could continue to follow the course of the disease (Boskey, 2007).

In 1974 the men that were part of the study succeeded in a class-action lawsuit against the government that gave them lifetime health care benefits. Yet, it wasn't until 1997 that these men and their families received a formal apology from now former President Clinton on behalf of the nation. One of the consequences of the Tuskegee incident is that many African-Americans are now understandably reluctant to participate in research studies, and there is still a great deal of remaining mistrust of the scientific and medical communities (Boskey, 2007).

After the exposure of the Tuskegee study, Congressional intervention eventually led to the publication of the Belmont Report in 1979. The Belmont Report identified three basic ethical principles regarding all human subject research: respect for persons, beneficence, and justice.

Respect for persons necessitates medical researchers to obtain informed consent from their study participants, which means those participants must be given accurate information about their circumstances and treatment options so that they can decide if they want to participate or not depending on what will happen to them.

Beneficence means the all test subjects must be informed of all possible risks as well as benefits of the treatment they agree to go through.

The principle of justice has two parts. Individual justice says that a doctor or researcher cannot administer potentially helpful treatment to some favored class of participants while offering riskier treatments to anyone else. And societal justice upholds the concept that research participants must be selected fairly and randomly, without consideration of any economic, social, and gender class (What principles of the Belmont Report were violated in the Tuskegee Syphilis Study, 2010).

The Tuskegee study is also often cited as a compelling example of why there is a need for the Institutional Review Board (IRB) system of ethical surveillance and control for research that involves human subjects. This system is now applied by most U.S. universities to all research with human beings, regardless of funding source and research topic. It was a New York Times article written by Jean Heller in 1972, entitled "Syphilis Victims in U.S. Study Went Untreated for 40 Years," along with subsequent Congressional hearings held in the post-1968 civil rights era that resulted in the legislation that first mandated IRB review for all government-funded research (Shweder, 2004).

The Tuskegee Syphilis Study is one of the most awful examples of research that was ever carried out in complete disregard of basic ethical principles of conduct. The publicity surrounding the study was one of the major pressures leading to the codification of protection for human research subjects. The project was finally ended in 1972 when Peter Buxton told the story of the Tuskegee Study to an Associated Press reporter. Buxton was an interviewer and investigator for the PHS. He had been trying to raise the issue within the PHS since 1966, but with no success. In spite of his protestations, the experiment was still being carried out when the story appeared on the front pages of newspapers around the country. Congressional subcommittee meetings were called in early 1973 by Senator Edward Kennedy. These resulted in a complete rework of the Health, Education, and Welfare regulations on working with human subjects (Research Ethics: The Tuskegee Syphilis Study, 2010).

The Tuskegee Syphilis Study still remains as one of the most outrageous examples of disregard of basic ethical principles of conduct not to mention violation of standards for ethical research. The suspicion and fear produced by the Tuskegee Syphilis Study are still evident today. Community workers often report mistrust of public health institutions within the African-American community. Recently Alpha Thomas of the Dallas Urban League testified before the National Commission on AIDS saying that many African-American people do not trust hospitals or any of the other community health care service providers because of that Tuskegee Experiment (Research Ethics: The Tuskegee Syphilis Study, 2010).

In 1990, the Southern Christian Leadership Conference (SCLC), which is one of the country's major civil rights organizations, conducted a survey among 1056 African-American Church members in five cities. They found that 34% of the respondents believed that AIDS was an artificial virus, 35% believed that AIDS is a form of genocide, and 44% believed that the government is not telling the truth about AIDS or its research (Research Ethics: The Tuskegee Syphilis Study, 2010).

Following the Tuskegee Study, the government changed its research practices to prevent a repeat of the mistakes made in Tuskegee. In 1974, the National Research Act was signed into law. This shaped the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The group recognized the basic principles of research conduct and suggested ways to ensure those principles were followed. In addition to the panel's advice, regulations were passed in 1974 that required researchers to get voluntary informed consent from all persons taking part in studies done or funded by the Department of Health, Education, and Welfare (DHEW). It was also requires that all DHEW-supported studies using human subjects are reviewed by Institutional Review Boards, which examined study protocols and decided whether they meet ethical standards (U.S. Public Health Service Syphilis Study at Tuskegee, n.d.).

The Tuskegee Health Benefit Program (THBP) is a mandated Congressional program that supplies comprehensive lifetime medical and health benefits to the affected widows and offspring of study participants. There are currently 14 children and two grandchildren that receive medical and health benefits. The greater part of the participants reside in the Georgia; while others live in the Southeastern and Midwestern parts of the United States. Yearly visits are made to the clients to ensure that they are receiving medical services and to resolve any health-related problems they may be experiencing. The visits also permit the program staff and health care representatives the opportunity to interact on a personal basis about the clients' health care needs (Boskey, 2007).

The rules and policies for human subject's research have been reviewed and revised many times since they were first approved. During 1980-1983, the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research looked at federal rules for doing research on human subjects to see how well those rules were being followed. An Ethics Advisory Board was created in the late 1970s to review ethical issues of biomedical research. In 1991, federal departments and agencies adopted the Federal Policy for the Protection of Human Subjects (U.S. Public Health Service Syphilis Study at Tuskegee, n.d.).