Tuskegee syphilis study

Study Clinicians

Dr. Raymond H. Vonderlehr was the on-site director of the Tuskegee Syphilis Study in 1932. He conducted many of the initial physical exams and medical procedures. Vonderlehr developed the policies that shaped the next stage of the project, He decided to gain the "consent" of the subjects for spinal taps (to look for signs of neurosyphilis) by depicting the diagnostic tests as a "special free treatment." Dr. Wenger subsequently congratulated him later for his "flair for framing letters to negroes." Vonderlehr retired as head of the venereal disease section in 1943. Dr. John R. Heller, Dr. Vonderlehr's assistant then succeeded Vonderlehr as director of the venereal disease section of PHS. Notably, Heller's leadership coincides with the years when penicillin was introduced as routine treatment for syphilis in other PHS clinics, and when the Nuremberg Code to protect the rights of research subjects was formulated. Heller was alive when the study was brought to public attention in 1972, and defended the ethics of the study.

Nurse Eunice Rivers was an African American nurse initially trained at Tuskegee and was recruited from the John Andrew Hospital at the time the study began. Dr. Vonderlehr became a strong advocate for her role. As the study became a constant fixture within the PHS, Nurse Rivers became the chief continuity person and was the only staff person to work with the study for all 40 years of its existence. By the 1950s, Nurse Rivers' had become pivotal to the study - her personal knowledge of all the subjects allowed the very long follow up to be maintained.

Study Details

The first critical turing point in the Tuskegee Syphilis Study was the withdrawl of funding from the Rosenwald Fund due to the Wall Street crash. The study directors initially thought that this was the end of the study and a final report was even issued. Somehow, the study was continued and evolved into a new study whose aim appeared to be to study the natural history of syphilis. Notably, in 1928, Sweden's Oslo Study reported on the pathologic manifestations of untreated syphilis in several hundred white males. This study was a retrospective study, with investigators piecing together information from patients that had already contracted syphilis and had remained untreated for some time. The Tuskegee study group decided to perform a prospective study equivalent to the Oslo Study.

Ethical consideration, poor from the start, rapidly deteriorated. For example, in the middle of the study, to ensure that the men would show up for a possibly dangerous spinal tap, the doctors sent the 400 Africans a misleading letter titled, “Last Chance for Special Free Treatment.” The letters did not mention that an autopsy would be eventually required. The study had started with 400 infected black men and 200 healthy black men as controls. By 1972, only 74 of the test subjects were still alive. For many participants, treatment was intentionally denied - while patients were lied to and given placebo treatments - in order to 'observe' the fatal progression of the disease.

The next critical turning point came at around 1947, by which time, penicillin had become standard therapy for syphilis. Several government sponsored public health programs were implemented to form "rapid treatment centers" to eradicate the disease. Nonetheless, experimenters on the study obsessively kept the study subjects from receiving penicillin. When several nationwide campaigns to eradicate venereal disease came to Macon County, the men were prevented from participating. During World War II, 250 of the men registered for the draft and were consequently ordered to get treatment for syphilis The PHS exempted them. The PHS representative at the time is quoted: “So far, we are keeping the known positive patients from getting treatment.”

By the end of the study, 28 of the men had died directly 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.

Study Termination and Aftermath

venereal disease investigator, the "whistle-blower"
In 1966, Peter Buxtun, a PHS venereal disease investigator in San Francisco, sent a letter to the director of the Division of Venereal Diseases which expressed concerns about the morality of the experiment.

When his concerns were ignored, in 1970, he went to the press. The story broke first in the Washington Star July 25, 1972, then became front page news in the New York Times the following day. As a result of public outcry, in 1972, an ad hoc advisory panel was appointed which determined the study was medically unjustified, and terminated the study. As part of a settlement of a class action lawsuit subsequently filed by the NAACP, $9 million was given to the study participants and free medical treatment was promised to the survivors and the surviving family members infected as a consequence of the study.

In 1974, the National Research Act became law, which created a commission to study and create regulations governing studies involving human participants.

On May 16, 1997, with five of the eight remaining survivors of the study attending the White House ceremony, President Bill Clinton formally apologized to Tuskegee study participants.

Ethical implications

The early ethics of the Tuskegee Syphilis Study may be considered in isolation before the widespread use of penicillin. In 1932, treatments for syphilis were relatively ineffective and had very severe side effects. It was known that syphilis was particularly prevalent in poor, black communities. The intention of the Study was in part to measure the prevalence of the disease, to study its natural history and the real effectiveness of treatment. Prevailing medical ethics at the time did not have the exacting standards for informed consent currently expected; doctors routinely withheld information about patients' condition from them. A clinical study to try find the effectiveness of treatment of this then terrible disease was not inheritently wrong. However, this study exploited a vulnerable sub-population to answer this question which would have been of benefit to the whole population. This was, some argue, a manifestation of racism and on the part of the study organizers. There was no question that a literate white syphilitic would not have been given the best treatment at the time (arsenic and mercury).

However, with the development of an effective, simple treatment for syphilis (i.e. penicillin), and the changing ethical standards as time went on, the ethical and moral judgements were became absolutely indefensible. By the time the study had closed, dozens of men had died from syphilis and many of their wives had become infected and their children born with congenital syphilis. This study has become synonomous with exploitation in clinical studies, and has been compared with the experimentation of the Nazi physician Josef Mengele.

It is believed that the Tuskegee Syphilis Study has predisposed many African Americans to distrust medical and public health authorities. The Study is likely a significant factor in the low participation of African Americans in clinical trials and organ donation efforts and in the reluctance of many black people in seeking routine preventive care.

The aftershocks of this study led directly to the establishment of the National Human Investigation Board in the US, the establishment of Institutional Review Boards (IRBs) and the Belmont Report. Special consideration must be given to ethnic minorities and vulnerable groups in the design of clinical studies.

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