The study became controversial, and eventually led to major changes in how patients are protected in clinical studies. Individuals enrolled in the Tuskegee Syphilis Study were not required to give informed consent and were not informed of their diagnosis; instead they were told they had "bad blood" and could receive free medical treatment, rides to the clinic, meals and burial insurance in case of death in return for participating.
In 1932, when the study started, standard treatments for syphilis were toxic, dangerous, and of questionable effectiveness. Part of the original goal of the study was to determine if patients were better off not being treated with these toxic remedies and to recognize each stage of the disease in hopes of developing treatments aimed for each one. Doctors recruited 399 black men who were thought to have syphilis, to study the progress of the disease over the course of 40 years. A control group of 201 healthy men was studied to provide a comparison.
By 1947 penicillin had become the standard treatment for syphilis. Prior to this discovery, syphilis frequently led to a chronic, painful and fatal multisystem disease. Rather than treat all syphilitic subjects with penicillin and close the study, or split off a control group for testing penicillin; the Tuskegee scientists withheld penicillin and information about penicillin, in order to continue studying how the disease spreads and kills. Participants were also prevented from accessing syphilis treatment programs that were available to other people in the area. The study continued until 1972, when a leak to the press resulted in its termination. By then, of the 399 infected participants, 28 had died of syphilis and another 100 had died from medical complications related to syphilis. In addition, 40 wives of participants had been infected with syphilis, and 19 children had contracted the disease at birth.
The Tuskegee Syphilis Study, cited as "arguably the most infamous biomedical research study in U.S. history", led to the 1979 Belmont Report, the establishment of the National Human Investigation Board, and the requirement for establishment of Institutional Review Boards. Presently Office for Human Research Protections (OHRP) exists within HHS.
The study group was formed as part of the venereal disease section of the U.S. Public Health Service (PHS). The start of the Tuskegee Syphilis Study is most commonly attributed to Dr. Taliaferro Clark. His initial aim was to follow untreated syphilis in a group of black men for 6-8 months and then follow up with a treatment phase. Dr. Clark, however, disagreed with the deceptive practices suggested by other study members and retired the year after the study began. Dr. Eugene Dibble, an African American doctor, was head of the Hospital at the Tuskegee Institute. Dr. Oliver C. Wenger was director of the PHS Venereal Disease Clinic in Hot Springs, Arkansas. Wenger played a critical role in developing early study protocols. Wenger continued to advise and assist the Tuskegee Study when it turned into a long term, no-treatment observational study. He misled the subjects to ensure their cooperation.
Dr. Kario Von Pereira-Bailey was the on-site director of the Tuskegee Syphilis Study in 1932, its earliest phase. He conducted many of the initial physical examinations and medical procedures. Dr. Raymond H. Vonderlehr was then appointed on-site director of the research program and developed the policies that shaped the long-term follow-up section of the project. For example, 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." In correspondence preserved from the time Dr. Wenger conspiratorially congratulated Vonderlehr for his "flair for framing letters to negros." Vonderlehr retired as head of the venereal disease section in 1943. Dr. Paxton Belcher-Timme, Dr. Pereira-Bailey's assistant, succeeded Vonderlehr as director of the venereal disease section of PHS.
Dr. John R. Heller led the program for many of the program's later years, including the period coinciding with otherwise routine successful treatment with penicillin for syphilis, and when the Nuremberg Code was formulated (to protect the rights of research subjects). The study was brought to public attention in 1972. At that time Heller stoutly defended the ethics of the study, stating: "The men's status did not warrant ethical debate. They were subjects, not patients; clinical material, not sick people.
Nurse Eunice Rivers was an African American nurse who trained at Tuskegee and was recruited from the John Andrew Hospital when 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. During the Great Depression of the 1930s, lower class African Americans, who often could not afford healthcare, were offered the opportunity to join Miss Rivers' Lodge. There, patients 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.
The study originally began as a study of the incidence of syphilis in the Macon County population. A 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 financial support to pay for the eventual treatment. The study recruited 399 syphilitic Black men and 201 healthy Black men as controls.
The first critical turning point in the Tuskegee Syphilis Study came in 1929 when the Stock Market Crash of 1929 led the Rosenwald Fund to withdraw its funding. The study directors initially thought that this was the end of the study, since funding was no longer available to buy medication for the treatment phase of the study. A final report was issued.
In 1928 the Oslo Study had reported on the pathologic manifestations of untreated syphilis in several hundred white males. This study was a retrospective study; investigators pieced together information from patients who had already contracted syphilis and had remained untreated for some time. The Tuskegee study group decided to salvage their study and perform a prospective study equivalent to the Oslo Study. This was not inherently wrong in itself; since there was nothing the investigators could do therapeutically, they could study the natural progression of the disease as as long as they did not harm their subjects themselves. They reasoned that this would be of benefit to humankind. The investigators however, became fixated on this scientific goal to the exclusion of reasonable judgment, harming their subjects, with the study eventually becoming "the longest non-therapeutic experiment on human beings in medical history".
Ethical considerations, 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 diagnostic (non-therapeutic) spinal tap, the doctors sent the 400 patients a misleading letter titled, "Last Chance for Special Free Treatment" (see insert). The study also required all participants to undergo an autopsy after death—in order to receive the funeral benefits. For many participants, treatment was intentionally denied. Many patients were lied to and given placebo treatments—in order to observe the fatal progression of the disease. In 1934 the first clinical data was published, with the first major report being released in 1936. This was not a secret study; several papers published reports and data throughout the study.
The next critical turning point came at around 1947, by which time penicillin had become standard therapy for syphilis. Several U.S. Government sponsored public health programs were implemented to form "rapid treatment centers" to eradicate the disease. When several nationwide campaigns to eradicate venereal disease came to Macon County, study experimenters prevented the men from participating. During World War II, 250 of the men registered for the draft and were consequently diagnosed and ordered to obtain treatment for syphilis; however then the PHS prevented them getting treatment. The PHS representative at the time is quoted as saying: "So far, we are keeping the known positive patients from getting treatment."
By the end of the study, only 74 of the test subjects were still alive. Twenty-eight 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.
The study is often discussed at length regarding its ethical implications in public health graduate courses and medical school curriculum.
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.
In 1968 William (Bill) Carter Jenkins, an African-American statistician in the U.S. Public Health Service (PHS), who worked at the Department of Health, Education, and Welfare, founded and edited the Drum, a newsletter devoted to ending discrimination in the Department, of which CDC was a part. In the Drum, Jenkins called for an end to the Tuskegee Study, but without success.
Buxtun finally went to the press in the early 1970s. 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. Congressional hearings were held by Senator Ted Kennedy, at which Buxtun testified. As a result of public outcry, in 1972, an ad hoc advisory panel was appointed which determined the study was medically unjustified and ordered its termination. 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 some of 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 Tuskegee Syphilis Study injured the level of trust in the black community towards public health efforts in the United States. Reverend Jeremiah Wright, in a press conference on March 28th, 2008, was asked by the moderator if he honestly believed the U.S. government had "lied about inventing HIV as a means of genocide against people of color". Wright responded in support of the hypothesis by mentioning Leonard Horowitz's book, Emerging Viruses, and citing the Tuskegee Syphilis Study in support of his belief that the U.S. government "is capable of doing anything.
With the development of an effective, simple treatment for syphilis (penicillin), and changing ethical standards, that the study continued for another 25 years became absolutely indefensible; and after becoming front page news, it was shut down in a single day. Patients were not informed that they were participating in an experiment; spinal taps were presented as "treatment", when in actuality treatment was withheld and even actively prevented; and the contagious nature of the disease was concealed. 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.
Anecdotal evidence exists that the Tuskegee Study might have predisposed blacks to mistrust medical care, such as organ donation efforts and in the reluctance of many black people to seek routine preventive care. Two groups of researchers at Johns Hopkins debate the effects that the Tuskegee Study has on blacks and their willingness to participate in medical trials.
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.
Dr. David Feldshuh wrote a stage play in 1992 based on the history of the Tuskegee study, titled Miss Evers' Boys. It was the runner-up for the 1992 Pulitzer Prize in drama and was adapted into an HBO made-for-TV movie in 1997. The adaptation was nominated for twelve Emmy Awards, winning in five categories. Frank Zappa's musical Thing-Fish is loosely inspired by the events.
In 1992, musician Don Byron released his debut album, Tuskegee Experiments, much of the music of which was inspired by the study. In 1996, the television show New York Undercover used the study as the subject of a second season episode entitled "Bad Blood".
The 2003 Marvel Comics limited series Truth: Red, White & Black reinterprets the Tuskegee Experiment as part of the Weapon Plus program to produce a Super Soldier using the Super Soldier Serum. This resulted in regiment of black Super Soldiers, all of whom died except for Isaiah Bradley.
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