Tuskegee Syphilis Study

History

The study built on the 1928 Oslo Study of Untreated Syphilis, which had examined untreated syphilis in white males retrospectively. The U.S. Public Health Service Syphilis Study at Tuskegee was designed as a prospective study to complement the Oslo work, beginning as a six-month descriptive epidemiological study of syphilis pathology in Macon County. Researchers believed they were not harming participants, assuming the men would never receive treatment anyway, and held racialized views that syphilis affected African Americans' cardiovascular systems more than their central nervous systems. Investigators enrolled 600 impoverished African American sharecroppers, 399 with latent syphilis and 201 uninfected controls.

Participants were promised free medical care but were deceived about their diagnosis; they were told they had "bad blood," a term covering syphilis, anemia, and fatigue. At the study's start, medical textbooks recommended treating all syphilis with arsenic-based compounds like arsphenamine ("606"). Subjects were initially studied for six to eight months and given contemporary treatments including Salvarsan, mercurial ointments, and bismuth, which were mildly effective and highly toxic. They also received disguised placebos and diagnostic procedures misrepresented as treatment.

Study termination

Several PHS employees, including Austin V. Deibert and Albert P. Iskrant, criticized the study on scientific grounds. The first external dissenter was Count Gibson, an associate professor at the Medical College of Virginia, who raised ethical concerns to PHS's Sidney Olansky in 1955. In 1965, Chicago doctor Irwin Schatz wrote to the study's authors denouncing its unethical practice; his letter was ignored and filed with a memo that no reply would be sent. In 1966, PHS venereal-disease investigator Peter Buxtun wrote to the national director of the Division of Venereal Diseases about the study's ethics.

The CDC, which then controlled the study, reaffirmed its continuation until all subjects had died and been autopsied, receiving support from local chapters of the National Medical Association and the American Medical Association. In 1968, PHS statistician William Carter Jenkins called for an end to the study in his newsletter The Drum, but it is unclear who read his work. Buxtun went to the press in the early 1970s; the story broke in the Washington Star on July 25, 1972, reported by Jean Heller of the Associated Press, and became front-page news in the New York Times the next day. Senator Edward Kennedy held congressional hearings, and an ad hoc advisory panel found the study medically unjustified and ordered its termination on November 16, 1972.

Aftermath

In 1974, Congress passed the National Research Act and created a commission to study and write regulations for human participant research. The Office for Human Research Protections was established within the Department of Health and Human Services to oversee clinical trials. New requirements included informed consent, communication of diagnosis, accurate reporting of test results, and institutional review boards with laypeople to review study protocols. In 1994, a symposium titled "Doing Bad in the Name of Good?: The Tuskegee Syphilis Study and Its Legacy" was held at the University of Virginia.

Following this, the Tuskegee Syphilis Study Legacy Committee was formed, chaired by Vanessa Northington Gamble, and issued its final report in May 1996. The committee had two goals: that President Bill Clinton publicly apologize for the government's wrongdoing, and that a strategy be developed to redress damages, including a center at Tuskegee University for public education and ethics training. On May 16, 1997, Clinton formally apologized at a White House ceremony for surviving study participants. The federal government then contributed to establishing the National Center for Bioethics in Research and Health Care at Tuskegee, which opened in 1999.

Legacy

One of the study's main goals was to determine the necessity and timing of treatment for syphilis, focusing on late latent syphilis. However, the study was not scientifically viable because participants received treatments such as mercury rubs, injections of neoarsphenamine, protiodide, Salvarsan, and bismuth, meaning the subjects were not truly untreated. PHS's Austin V. Deibert recognized that this compromised the study's main goal, making results meaningless and impossible to manipulate statistically.

He noted that even the toxic pre-penicillin treatments could greatly lower late syphilitic cardiovascular disease, though they were never prescribed to participants. The study's conception reflected racial attitudes of the time: clinicians assumed African Americans were particularly susceptible to venereal diseases due to race and were not interested in treatment. Taliaferro Clark cited the "rather low intelligence of the Negro population" and promiscuous sex relations as contributing to syphilis spread, but in reality, the promise of medical treatment secured subjects' cooperation.

Did You Know?

• The study was originally planned to last only six months but was extended to 40 years.
• By 1947, penicillin was widely available and the standard treatment for syphilis, but none of the infected men were treated with it.
• During World War II, PHS researchers prevented 256 infected subjects from getting treatment after they were diagnosed at military induction centers.
• The study was not secret—reports and data sets were published to the medical community throughout its duration.