◆Part 1: The Study
In 1932 the United States Public Health Service began a study of untreated syphilis in Macon County, Alabama. The subjects were Black men. The stated purpose was to observe the natural course of the disease.
A Background Paper prepared by the Venereal Disease Branch of the Center for Disease Control, dated 27 June 1972, and quoted by the Ad Hoc Advisory Panel, described the original groups. The syphilitic group held 399 men who had received no therapy and who gave historical and laboratory evidence of syphilis that had progressed beyond the infectious stages. A control group of 201 men was selected as free of syphilis by serology, history, and physical examination.
The study ran for 40 years. It ended in 1972.
◆Part 2: No Consent
The Panel reported that there is no evidence that informed consent was gained from the human participants. Submitting voluntarily to examination is not informed consent.
The Panel stated a fundamental ethical rule. A person should not be subjected to avoidable risk of death or physical harm unless he freely and intelligently consents. There was no evidence that such consent was obtained from the participants in this study.
CDC later recorded that Tuskegee community members were aware of a study but thought it was a special government health care program. The Panel recorded that the Macon County Health Department and Tuskegee Institute were cognizant of the study.
No women were enrolled as subjects. CDC recorded that as a result of lack of treatment, some women contracted syphilis from men in the syphilitic group.
◆Part 3: Penicillin
Penicillin became the treatment of record for syphilis. The Panel found that penicillin therapy should have been made available to the participants not later than 1953, when penicillin became generally available.
Withholding of penicillin after it became generally available amplified the injustice already imposed on this group. The Panel judged that the scientific merits of the study were vastly overshadowed by the violation of basic ethical principles pertaining to human dignity and human life.
The study continued. In 1970 Drs Anne Yobs and Arnold L Schroeter recommended procedures for orderly termination. The study still did not end then.
◆Part 4: The Panel
The Assistant Secretary for Health and Scientific Affairs convened the Tuskegee Syphilis Study Ad Hoc Advisory Panel. Broadus N Butler, PhD, President of Dillard University, chaired it.
On 25 October 1972 the Panel issued its initial recommendation on Charge II. The study of untreated syphilis in Black males in Macon County, Alabama, then known as the Tuskegee Syphilis Study, should be terminated immediately. The Panel estimated that approximately 125 of the participants, including 50 of the controls, were still alive. The current health status of the participants was not known to the Panel at that time.
The Final Report was transmitted on 28 April 1973 to Dr Charles C Edwards, Assistant Secretary for Health, United States Department of Health, Education, and Welfare. The Panel concluded that in retrospect the Public Health Service Study of Untreated Syphilis in the Male Negro in Macon County, Alabama was ethically unjustified in 1932.
The Panel also judged the longitudinal study as initially reported in 1936 and through the years to be scientifically unsound. Its results were disproportionately meager compared with known risks to the human subjects involved.
◆Part 5: Settlement And Apology
CDC records a 10 million dollar out of court settlement after the study. Living men from the syphilitic group received 37500 dollars. Heirs of deceased men from that group received 15000 dollars. Living control group participants received 16000 dollars. Heirs of deceased control group participants received 5000 dollars.
On 16 May 1997 President Clinton spoke in the East Room of the White House. He said the United States government did something that was wrong, deeply, profoundly, morally wrong. He said the men believed they had found hope when they were offered free medical care by the United States Public Health Service. He said they were betrayed. He said even once a cure was discovered they were denied help and they were lied to by their government.
He said on behalf of the American people what the United States government did was shameful, and he was sorry.
◆Part 6: The Record
The documents show a federal study of untreated disease. They show no informed consent. They show penicillin withheld after it was generally available. They show a government panel that called the study ethically unjustified and ordered it ended. They show a presidential apology 25 years after the study stopped.
The National Archives holds patient medical files and photographs from the study. CDC publishes an official account of the Untreated Syphilis Study at Tuskegee. The Ad Hoc Advisory Panel Final Report remains the federal judgment on the record.
Final Report of the Tuskegee Syphilis Study Ad Hoc Advisory Panel. United States Department of Health, Education, and Welfare. Public Health Service. Transmitted 28 April 1973. CDC About The Untreated Syphilis Study at Tuskegee. Clinton White House. Remarks by the President in Apology for Study Done in Tuskegee. 16 May 1997.