One of the published books about the study written by Fred D. Gray
The Tuskegee Syphilis Study from 1932 to 1972, also known as the Public Health Service Syphilis Study was a clinical study, conducted around Tuskegee, Alabama, where 399 (plus 200 control group without syphilis) poor and mostly illiterate African-American sharecroppers became part of a study on the treatment and natural history of syphilis. This study became notorious because it was conducted without due care to its subjects, and led to major changes in how patients are protected in clinical studies. Individuals enrolled in the Tuskegee Syphilis Study did not give informed consent and were not informed of their diagnosis; instead they were told they had "bad blood" and could receive free treatment, a free ride to clinic, one hot meal per day and in case of dying: $50 for the funeral.
The study was originally started as a study on the incidence of syphilis in the Macon County population. The subject would be studied for six to eight months, then treated with contemporary treatments (including Salvarsan, mercurial ointments and bismuth) which were somewhat effective, but quite toxic. The initial intentions of the study were to benefit public health in this poor population as evidenced by participation from the Tuskegee Institute, the Black university founded by Booker T. Washington. Its affiliated hospital lent the PHS its medical facilities for the study, and other predominantly black institutions as well as local black doctors also participated. The philanthropic Rosenwald Fund was to provide monies to pay for the eventual treatment. The study recruited 400 syphilitic Black men and 200 healthy Black men as controls.
STUDY TERMINATION AND AFTERMATH
In 1966, Peter Buxtun, a PHS venereal disease investigator in San Francisco, sent a letter to the director of the Division of Venereal Diseases to express his concerns about the morality of the experiment. The Center for Disease Control (CDC) reaffirmed the need to continue the study until completion (until all subjects had died and had been autopsied). To bolster its position, the CDC sought and gained support for the continuation of the study from the local chapters of the National Medical Association (representing African-American physicians) and the American Medical Association.
With his concerns rebuked, Peter Buxtun went to the press. The story broke first in the Washington Star on 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 ordered the termination of the study. As part of a settlement of a class action lawsuit subsequently filed by NAACP, 9 million dollars and the promise of free medical treatment was given to surviving participants and surviving family members who had been infected as a consequence of the study.
In 1974 the National Research Act became law, creating a commission to study and write 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: "What was done cannot be undone, but we can end the silence...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."
The early ethics of the Tuskegee Syphilis Study may be considered in isolation at study inception. In 1932, treatments for syphilis were relatively ineffective and had 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 evaluate the effectiveness of treatment of this then terrible disease was not inherently wrong. However, this study exploited a vulnerable sub-population to answer a question which would have been of benefit to the whole population. This was, some argue, a manifestation of racism on the part of the study organizers.
However, with the development of an effective, simple treatment for syphilis (i.e. penicillin), and changing ethical standards, the ethical and moral judgements became absolutely indefensible. By the time the study had closed, hundreds 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 synonymous with exploitation in clinical studies, and has been compared with the experimentation of the Nazi physician Josef Mengele.
Sociological studies have shown 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 to seek routine preventive care.
The aftershocks of this study led directly to the establishment of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the National Research Act. This act requires the establishment of Institutional Review Boards (IRBs) at institutions receiving federal grants. Special consideration must be given to ethnic minorities and vulnerable groups in the design of clinical studies.
This post is an original composition of this blog's author and contains factual accounts taken from the following manuscripts and online sources: Wikipedia, Ethical Spurs in Medicine, The Tuskegee Tragedy, The American Journal of Medicine Review on Syphillis 2006, The Tuskegee Syphilis Study