Revisiting the Syphilis Study: What Really Happened at Tuskegee? Quincy J. Byrdsong, Ed.D., CIP, CCRP Vice President for Academic Planning and Strategic Initiatives Augusta University Information for this presentation has been retrieved from “The Tuskegee Syphilis Study” by Fred. D. Gray, attorney for the human subjects involved

Learning Objectives Analyze myths and assumptions regarding the Syphilis Study Describe the scientific rationale for conducting the Syphilis Study Chronologize the Syphilis Study with responses to ethical dilemmas Identify lessons learned and impact of human subjects research today

True or False?

Address the following statements: The human subjects in the Syphilis Study knew they were in a research study but just did not know what the study was about. The human subjects in the Syphilis Study were injected with the syphilis bacteria. The Syphilis Study was conducted on the Tuskegee Airmen. The Syphilis Study is an example of inequitable subject selection. The researchers tricked the human subjects into participating in the Syphilis Study by calling the disease “bad blood” instead of “syphilis.”

Myth #1: The human subjects in the Syphilis Study knew they were in a research study but just did not know what the study was about.

Myth #2: The human subjects in the Syphilis Study were injected with the syphilis bacteria. Between 1929 and 1931, the Public Health Services surveyed six rural areas in the South. The highest prevalence of syphilis was found in Macon County, Alabama. A more focused program in Macon County (36% of the population had syphilis) found that virtually none of the cases had been treated. Eligibility criteria (1932-33): black male with syphilis for at least five years*; had not received treatment *in 1933, a control group of non-syphilitic men were added

Myth #3: The Syphilis Study was conducted on the Tuskegee Airmen. Although the antibiotic, penicillin, was discovered around 1928, it was not considered to be an effective treatment for syphilis until around 1945. A Lieutenant Colonel in the United States Army was one of the first to introduce a higher dose therapy for neurosyphilis. This work became instrumental in establishing the standard practice for treatment of syphilis and was eventually widely used in military populations contracting STDs. However, the Public Health Service rigorously discouraged enlistment of the subjects into the military as well as denied them participation in treatment programs sponsored by the health department.

Myth #4: The Syphilis Study is an example of inequitable subject selection. According to the Belmont Report, the third ethical principle, justice, is most readily manifested by ensuring that there be equitable procedures and outcomes in the selection of research subjects. The social level of subject selection requires a distinction be drawn between those benefitting and those burdened. The individual level of subject selection requires fairness; not offering pleasant research to just those found in favor of the investigators but also not offering risky research just to subjects considered to be undesirable. In the case of the Syphilis Study, the research questions could only be answered through collecting data from Black males with syphilis. Since both this location and this population had the highest incidence, subject selection was reasonable.

Myth #5: The researchers tricked the human subjects into participating in the Syphilis Study by calling the disease “bad blood” instead of “syphilis.” During the era in which the Syphilis Study began, the general topic of venereal or sexually-transmitted disease (STD) was considered taboo. To discuss a sexually-transmitted disease, a discussion regarding sexual activity, sexual intercourse, and the cleanliness and function of sexual organs would also have to take place. Society was uncomfortable with these conversations and since it disproportionately affected the poor, even doctors were disinterested in acknowledging the damage it could potentially do to a population. Since syphilis was not openly discussed and consequently not well understood, it was also not used with the human subjects in the Syphilis Study. The terminology “bad blood” was used instead since it was a common local term used for illnesses ranging from STD’s to anemia to fatigue.

Did a study of untreated syphilis in the Negro male in Macon County, Alabama have any scientific merit?

Scientific rationale for the Syphilis Study: Although studies by American’s syphilologists showed that 80 percent would suffer active lesions, a study of untreated syphilis in Oslo, Norway showed only 37 percent developed active lesions. More research was needed to address this marked disparity. Syphilis had become an epidemic for Macon County but, very few researchers were willing to do research in this area or any other STD. Considering this indifference, the Syphilis Study would serve as the counter more responsible approach from the public health standpoint. Poorly designed studies of syphilis showed complications of heart disease in Blacks but, neurological complications in Whites. Since the study in Oslo was on White Norwegians only, there was a need for comparative data. Males were chosen because of their external sex organs which increased their likelihood of noticing lesions and determining time of infection.

Macon County, Alabama - 1932 Deep South – Top of the “Black Belt” Conveniences Technology Center of the cotton culture Of the 27,000 population, 22,000 were Black. Rigorously segregated Only two incorporated towns: Notasulga and Tuskegee Some educated at the Tuskegee Institute Attributed much of its fame to George Washington Carver Friendship formed between Institute Founder Booker T. Washington and philanthropist Julius Rosenwald

The Rosenwald Fund Julius Rosenwald(1862 – 1932) Jewish-American businessman and philanthropist Co-owned Sears, Roebuck, and Company President and and Founder of the Museum of Science and Industry Established the Rosenwald Fund The Rosenwald Fund Patron of Booker T. Washington and the Tuskegee Institute Financed the construction of many schools for Black students Partnered with the Public Health Service to expand medical services to poor Black areas in the South

Timeline of Events 1930 – Spends $50K for syphilis treatment demonstrations in six states (Alabama: Macon County) 1931 – Rosenwald funding is cut for treatment programs; physicians decide to follow the men diagnosed untreated 1932-33 – Follow up becomes a study of 399 syphilitic and 201 controls. 1945 – Penicillin accepted as the preferred treatment for syphilis 1947 – PHS establishes treatment centers, penicillin widely used in military operations 1968 – Concerns raised about the study 1969 – CDC reaffirms the need for the study 1972 – Study condemned in major news outlets; study ends

What did we learn from “The untreated syphilis in the Negro male” Study?

Lessons Learned Anyone could potentially be vulnerable as a subject of research Location Environment Status Respect for persons is much more than obtaining informed consent Trust Communication Compassion The good of science can never be considered over the importance of human life Accountability Responsibility Judgment

Questions to consider Why was the Syphilis Study allowed to go so long? Why was the PHS so interested in answering this research question? Is deception research ever appropriate? Considering how epidemics can wipe out a population, could this Study have been done if it were designed differently? Describe. How has your knowledge of the Syphilis Study impacted how you approach your work in clinical research?

Discussion