Tuskegee Syphilis Study
The Tuskegee Study of Untreated Syphilis in the Negro Male was a study conducted between 1932 and 1972 by the United States Public Health Service and the Centers for Disease Control and Prevention on a group of nearly 400 African American men with syphilis as well as a control group without. The purpose of the study was to observe the effects of the disease when untreated, to the point of death and autopsy. Although there had been effective treatments to reduce the severity of the disease since the 1920s, the use of penicillin for the treatment of syphilis was widespread as of 1945. The men were not informed of the nature of the study, proper treatment was withheld, and more than 100 died as a result.
The Public Health Service started the study in 1932 in collaboration with Tuskegee University, a historically Black college in Alabama. In the study, investigators enrolled 600 impoverished African American sharecroppers from Macon County, Alabama. Of these men, 399 had latent syphilis, with a control group of 201 men who were not infected. As an incentive for participation in the study, the men were promised free medical care and promised funeral expenses. While the men were provided with both medical and mental care that they otherwise would not have received, they were deceived by the PHS, who never informed them of their syphilis diagnosis and who provided disguised placebos, ineffective treatments, and diagnostic procedures, such as lumbar punctures, as treatment for "bad blood".
The men were initially told that the experiment was only going to last six months, but it was extended to 40 years. After funding for treatment was lost, the study was continued without informing the men that they would never be treated. None of the infected men were treated with penicillin despite the fact that, by 1947, the antibiotic was widely available and had become the standard treatment for syphilis.
The study continued, under numerous Public Health Service supervisors, until 1972, when a leak to the press resulted in its termination on November 16 of that year. By then, 28 patients had died directly from syphilis, 100 died from complications related to syphilis, 40 of the patients' wives were infected with syphilis, and 19 children were born with congenital syphilis.
The 40-year Tuskegee Study was a major violation of ethical standards and has been cited as "arguably the most infamous biomedical research study in U.S. history." Its revelation led to the 1979 Belmont Report and to the establishment of the Office for Human Research Protections and federal laws and regulations requiring institutional review boards for the protection of human subjects in studies. The OHRP manages this responsibility within the United States Department of Health and Human Services. Its revelation has also been an important cause of distrust in medical science and the US government amongst African Americans.
In 1997, President Bill Clinton formally apologized on behalf of the United States to victims of the study, calling it shameful and racist. "What was done cannot be undone, but we can end the silence," he said. "We can stop turning our heads away. We can look at you in the eye, and finally say, on behalf of the American people, what the United States government did was shameful, and I am sorry."
History
Study details
In 1928, the "Oslo Study of Untreated Syphilis" had reported on the pathologic manifestations of untreated syphilis in several hundred white males. This study was a retrospective study since investigators pieced together information from the histories of patients who had already contracted syphilis but remained untreated for some time.The U.S. Public Health Service Syphilis Study at Tuskegee group decided to build on the Oslo work and perform a prospective study to complement it. The U.S. Public Health Service Syphilis Study at Tuskegee began as a 6-month descriptive epidemiological study of the range of pathology associated with syphilis in the population of Macon County. The researchers involved with the study reasoned that they were not harming the men involved in the study, under the presumption that they were unlikely to ever receive treatment. At that time, it was believed that the effects of syphilis depended on the race of those affected. Physicians believed that syphilis had a more pronounced effect on African-Americans' cardiovascular systems than on their central nervous systems.
Investigators enrolled in the study a total of 600 impoverished, African-American sharecroppers. Of these men, 399 had latent syphilis, with a control group of 201 men who were not infected. As an incentive for participation in the study, the men were promised free medical care, but were deceived by the PHS, who never informed subjects of their diagnosis, despite the risk of infecting others, and the fact that the disease could lead to blindness, deafness, mental illness, heart disease, bone deterioration, the collapse of the central nervous system, and death. Instead, the men were told that they were being treated for "bad blood", a colloquialism that described various conditions such as syphilis, anemia, and fatigue. The collection of illnesses the term included was a leading cause of death within the southern African-American community.
At the study's commencement, major medical textbooks had recommended that all syphilis be treated, as the consequences were quite severe. At that time, treatment included arsenic-based compounds such as arsphenamine. Initially, subjects were studied for six to eight months and then treated with contemporary methods, including Salvarsan, mercurial ointments, and bismuth, which were mildly effective and highly toxic. Additionally, men in the study were administered disguised placebos, ineffective methods, and diagnostic procedures, which were misrepresented as treatments.
Throughout, participants remained ignorant of the study clinicians' true purpose, which was to observe the natural course of untreated syphilis. Study clinicians could have chosen to treat all syphilitic subjects and close the study, or split off a control group for testing with penicillin. Instead, they continued the study without treating any participants; they withheld treatment and information about penicillin from the subjects. In addition, scientists prevented participants from accessing syphilis treatment programs available to other residents in the area. The researchers reasoned that the knowledge gained would benefit humankind; however, it was determined afterward that the doctors did harm their subjects by depriving them of appropriate treatment once it had been discovered. The study was characterized as "the longest non-therapeutic experiment on human beings in medical history."
To ensure that the men would show up for the possibly dangerous, painful, diagnostic, and non-therapeutic spinal taps, doctors sent participants a misleading letter titled "Last Chance for Special Free Treatment".
The U.S. Public Health Service Syphilis Study at Tuskegee published its first clinical data in 1934 and issued its first major report in 1936. This was before the discovery of penicillin as a safe and effective treatment for syphilis. The study was not secret, since reports and data sets were published to the medical community throughout its duration.
During World War II, 256 of the infected subjects registered for the draft and were consequently diagnosed as having syphilis at military induction centers and ordered to obtain treatment for syphilis before they could be taken into the armed services. PHS researchers prevented these men from getting treatment, thus depriving them of chances for a cure. Vonderlehr argued, "this study is of great importance from a scientific standpoint. It represents one of the last opportunities which the science of medicine will have to conduct an investigation of this kind.... Doctor Smith... asked that these men be excluded from the list of draftees needing treatment.... in order to make it possible to continue this study on an effective basis."
Later, Smith, a local PHS representative involved in the study, wrote to Vonderlehr to ask what should be done with patients who had tested negative for syphilis at the time of enrollment in the study and were being used as control subjects but had later tested positive when registering for the draft: "So far, we are keeping the known positive patients from getting treatment. Is a control case of any value to the study, if he has contracted syphilis? Shall we withhold treatment from the control case who has developed syphilis?" Vonderlehr replied that such cases "have lost their value to the study. There is no reason why these patients should not be given appropriate treatment unless you hear from Doctor Austin V. Deibert who is in direct charge of the study".
By 1947, penicillin had become standard therapy for syphilis. The U.S. government sponsored several public health programs to form "rapid treatment centers" to eradicate the disease. When campaigns to eradicate venereal disease came to Macon County, study researchers prevented their subjects from participating. Although some of the men in the study received arsenical or penicillin treatments elsewhere, for most of them this did not amount to "adequate therapy". By the end of the study in 1972, only 74 of the test subjects were still alive. Of the original 399 men, 28 had died of syphilis, 100 died of related complications, 40 of their wives had been infected, and 19 of their children were born with congenital syphilis.
The revelation in 1972 of study failures by 29-year-old whistleblower Peter Buxtun led to major changes in U.S. law and regulation concerning the protection of participants in clinical studies. Studies since then require informed consent, communication of diagnosis and accurate reporting of test results.
Study clinicians
The venereal disease section of the U.S. Public Health Service formed a study group in 1932 at its national headquarters in Washington, D.C. Taliaferro Clark, head of the USPHS, is credited with founding it. His initial goal was to follow untreated syphilis in a group of African-American men for six months to one year, and then follow up with a treatment phase. When the Rosenwald Fund withdrew its financial support, a treatment program was deemed too expensive. Clark, however, decided to continue the study, interested in determining whether syphilis had a different effect on African-Americans than it did on whites. A retrospective study of untreated syphilis in white males had been conducted in Oslo, Norway, and could provide the basis for comparison. The prevailing belief at the time was white people were more likely to develop neurosyphilis and that Black people were more likely to sustain cardiovascular damage. Clark resigned before the study was extended beyond its original length.Although Clark is usually assigned blame for conceiving the U.S. Public Health Service Syphilis Study at Tuskegee, Thomas Parran Jr. also helped develop a non-treatment study in Macon County, Alabama. As the Health Commissioner of New York State, Parran was asked by the Rosenwald Fund to assess their serological survey of syphilis and demonstration projects in five Southern states. Among his conclusions was the recommendation that: "If one wished to study the natural history of syphilis in the African American race uninfluenced by treatment, this county would be an ideal location for such a study."
Oliver C. Wenger was the director of the regional PHS Venereal Disease Clinic in Hot Springs, Arkansas. He and his staff took the lead in developing study procedures. Wenger continued to advise and assist the study when it was adapted as a long-term, no-treatment observational study after funding for treatment was lost.
Raymond A. Vonderlehr was appointed on-site director of the research program and developed the policies that shaped the long-term follow-up section of the project. His method of gaining the "consent" of the subjects for spinal taps was by advertising this diagnostic test as a "special free treatment". He also met with local black doctors and asked them to deny treatment to participants in the Tuskegee Study. Vonderlehr retired as head of the venereal disease section in 1943, shortly after penicillin was proven to cure syphilis. After Vonderlehr's retirement, John R. Heller Jr., his mentee, succeeded him as head of the venereal disease section. Even with the discovery that penicillin served as an effective treatment for syphilis, Heller did not provide the drug to the participants of the study.
Several African-American health workers and educators associated with the Tuskegee Institute played a critical role in the study's progress. The extent to which they knew about the full scope of the study is not clear in all cases. Robert Russa Moton, then president of Tuskegee Institute, and Eugene Dibble, head of the Institute's John A. Andrew Memorial Hospital, both lent their endorsement and institutional resources to the government study.
Nurse Eunice Rivers, who had trained at Tuskegee Institute and worked at its hospital, was recruited at the start of the study to be the main point of contact with the participants. Rivers played a crucial role in the study because she served as the direct link to the regional African-American community. Vonderlehr considered her participation to be the key to gaining the trust of the subjects and promoting their participation. As a part of "Miss Rivers' Lodge", participants would receive free physical examinations at Tuskegee University, free rides to and from the clinic, hot meals on examination days, and free treatment for minor ailments. Rivers was also key in convincing families to sign autopsy agreements in return for funeral benefits. As the study became long-term, Rivers became the chief person who provided continuity to the participants. She was the only study staff person to work with participants for the full 40 years.