Tuskegee Study of Untreated Syphilis in the Negro Male
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The Tuskegee Study of Untreated Syphilis in the Negro Male (also known as the Tuskegee Syphilis Study, Public Health Service Syphilis Study, or the Tuskegee Experiment) was a clinical study, conducted between 1932 and 1972 in Tuskegee, Alabama by the U.S. Public Health Service. 399 poor — and mostly illiterate — African American sharecroppers were studied to observe the natural progression of the disease if left untreated.
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.
When the study began in 1932, standard medical 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 the Office for Human Research Protections (OHRP) exists within HHS.
 Study clinicians
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. 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 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, Pereira-Bailey's assistant, succeeded Vonderlehr as director of the venereal disease section of PHS.
|“||For the most part, doctors and civil servants simply did their jobs. Some merely followed orders, others worked for the glory of science.||”|
—Dr John Heller, Director of the Public Health Service's Division of Venereal Diseases
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.
 Study details
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 released in 1936. This was not a secret study; several published reports and data sets appeared 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.
 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.
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."
 Ethical implications
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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. Prevailing medical ethics at the time did not have the exacting standards for informed consent currently expected, and doctors routinely withheld information about patients' condition from them.
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, many of the men had died from syphilis, a number 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.
 Cultural adaptations
In 1977 Gil Scott-Heron released a 33 second song "Tuskeegee 626" on the Bridges album with lyrics exposing and detailing the Tuskegee Syphilis Experiments.
Dr. David Feldshuh wrote a stage play in 1992 based on the history of the Tuskegee study, titled Miss Evers' Boys. It was a 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 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.
In the film Half Baked, Dave Chappelle's character Thurgood Jenkins mentions that his grandfather "was in the Tuskegee experiments" when speaking with a doctor about the possibility of submitting himself to clinical testing for marijuana.
- ^ "Tuskegee Study - Timeline". NCHHSTP. CDC (2008-06-25). Retrieved on 2008-12-04.
- ^ "Final Report of the Tuskegee Syphilis Study Legacy Committee". Tuskegee Syphilis Study Legacy Committee (1996-05-20). Retrieved on 2008-12-04.
- ^ Heller J (1972-07-26). "Syphilis Victims in U.S. Study Went Untreated for 40 Years; SYPHILIS VICTIMS GOT NO THERAPY", New York Times, Associated Press. Retrieved on 4 December 2008.
- ^ Thomas A (2008-03-16). "Tuskegee Syphilis Study's impact debated: Blacks still distrust clinical trials, some but not all studies show", San Francisco Chronicle, Associated Press. Retrieved on 4 December 2008.
- ^ Katz RV, Kegeles SS, Kressin NR, et al (November 2006). "The Tuskegee Legacy Project: willingness of minorities to participate in biomedical research". J Health Care Poor Underserved 17 (4): 698–715. doi:10.1353/hpu.2006.0126. PMID 17242525. PMC: 1780164. http://muse.jhu.edu/cgi-bin/resolve_openurl.cgi?issn=1049-2089&volume=17&issue=4&spage=698&aulast=Katz.
- ^ Office for Human Research Protections (OHRP) (2005-06-23). "Protection of Human Subjects". Title 45, Code of Federal Regulations, Part 46. US Department of Health and Human Services. Retrieved on 2008-12-04.
- ^ "Office for Human Research Protections". Department of Health and Human Services (2008-09-28). Retrieved on 2008-12-04.
- ^ DiClemente RJ, Blumenthal DS (2003). Community-based health research: issues and methods. New York: Springer Pub. pp. p. 50. ISBN 0-8261-2025-3. http://www.google.co.in/books?id=KN_-9lwSI5oC.
- ^ Alexander Cockburn; Jeffrey St. Clair (1998). Whiteout: The CIA, Drugs and the Press. London: Verso. pp. p. 67. ISBN 1859841392. http://books.google.co.uk/books?id=s5qIj_h_PtkC&pg=PA67&lpg=PA67&dq=%22some+merely+followed+orders,+others+worked+for+the+glory+of+science+&source=web&ots=zcnx0d0xsd&sig=M-IcQ5KHCBmaEjNgZG1B72FA0aQ&hl=en&sa=X&oi=book_result&resnum=2&ct=result.
- ^ "Research Ethics: The Tuskegee Syphilis Study". Tuskegee University. Retrieved on 2008-12-04.
- ^ a b Parker, Laura (1997-04-28). "'Bad Blood' Still Flows In Tuskegee Study", USA Today. Retrieved on 4 December 2008.
- ^ Jones J (1981). Bad Blood: The Tuskegee Syphilis Experiment. New York: Free Press. ISBN 0029166764.
- ^ a b "Doctor of Public Health Student Handbook" (PDF) 17. University of Kentucky College of Public Health (2004).
- ^ Bill Jenkins left the PHS in the mid-1970s for doctoral studies. In 1980, he joined the CDC Division of Sexually Transmitted Diseases, where he managed the Participants Health Benefits Program that assured health services for survivors of the Tuskegee Study.
- ^ Thomas SB, Quinn SC (November 1991). "The Tuskegee Syphilis Study, 1932 to 1972: implications for HIV education and AIDS risk education programs in the black community". Am J Public Health 81 (11): 1498–505. PMID 1951814. PMC: 1405662. http://www.ajph.org/cgi/pmidlookup?view=long&pmid=1951814.
- ^ "Rev. Wright Delivers Remarks at National Press Club (transcript)". Washington Post (2008-04-28). Retrieved on 2008-12-04.
- ^ a b Chadwick A (2002-07-25). "Remembering the Tuskegee Experiment", NPR. Retrieved on 4 December 2008.
- ^ a b Merril RM, Timmreck TC (2006). "Experimental Studies in Epidemiology - Ethics in Experimental Research". Introduction to Epidemiology. pp. p. 195. ISBN 0763735825.
- ^ Cohen E (2007-02-26). "Tuskegee's ghosts: Fear hinders black marrow donation", CNN. Retrieved on 4 December 2008.
- ^ "Did Tuskegee damage trust on clinical trials?". CNN (2008-03-17). Retrieved on 2008-12-04.
- ^ "The Pulitzer Prizes : Drama". The Pulitzer Prizes -- Columbia University.
- ^ Geddes, Darryl (1997-09-11). "HBO's adaptation of Feldshuh's play Miss Evers' Boys is up for 12 Emmys". Cornell Chronicle.
- ^ "Awards for Miss Evers' Boys". IMDb.
 Original Tuskegee Study papers
- Caldwell, J. G; E. V. Price, et al. (1973). "Aortic regurgitation in the Tuskegee study of untreated syphilis". J Chronic Dis 26 (3): 187-94.
- Hiltner, S. (1973). "The Tuskegee Syphilis Study under review". Christ Century 90 (43): 1174-6.
- Kampmeier, R. H. (1972). "The Tuskegee study of untreated syphilis". South Med J 65 (10): 1247-51.
- Kampmeier, R. H. (1974). "Final report on the "Tuskegee syphilis study". South Med J 67 (11): 1349-53.
- Olansky, S.; L. Simpson, et al. (1954). "Environmental factors in the Tuskegee study of untreated syphilis". Public Health Rep 69 (7): 691-8.
- Rockwell, D. H.; A. R. Yobs, et al. (1964). "The Tuskegee Study of Untreated Syphilis; the 30th Year of Observation". Arch Intern Med 114: 792-8.
- Schuman, S. H.; S. Olansky, et al. (1955). "Untreated syphilis in the male negro; background and current status of patients in the Tuskegee study.". J Chronic Dis 2 (5): 543-58.
 Further reading
- Gjestland T. "The Oslo study of untreated syphilis: an epidemiologic investigation of the natural course of the syphilitic infection based upon a re-study of the Boeck-Bruusgaard material," Acta Derm Venereol (1955) 35(Suppl 34):3-368.
- Gray, Fred D. (1998). The Tuskegee Syphilis Study: The Real Story and Beyond. Montgomery, Alabama: NewSouth Books.
- Jones, James H. (1981). Bad Blood: The Tuskegee Syphilis Experiment. New York: Free Press.
- The Deadly Deception, by Denisce DiAnni, PBS/WGBH NOVA documentary video, 1993.
- Reverby, Susan M. (1998). "History of an Apology: From Tuskegee to the White House". Research Nurse. http://www.researchpractice.com/archive/apology.shtml.
- Reverby, Susan M. (2000). Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study. University of North Carolina Press.
- Jean Heller (Associated Press), "Syphilis Victims in the U.S. Study Went Untreated for 40 Years" New York Times, July 26, 1972: 1, 8.
- Thomas, Stephen B; Sandra Crouse Quinn (1991). "The Tuskegee Syphilis Study, 1932-1972: Implications for HIV Education and AIDS Risk Programs in the Black Community". American Journal of Public Health 81 (1503).
- Carlson, Elof Axel (2006). Times of triumph, times of doubt : science and the battle for the public trust. Cold Spring Harbor Press. ISBN 0-87969-805-5.
- Washington, Harriet A. (2007). Medical Apartheid: The Dark History of Medical Experimentation on Black Americans From Colonial Times to the Present.
 See also
- World Medical Association
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
- Declaration of Geneva
- Declaration of Helsinki
- Operation Whitecoat
 External links
- CDC Tuskegee Syphilis Study Page
- Excellent review of the TSS
- Patient medical files held at National Archives and Records Administration Southeast Region, Morrow, GA
- Mary Harper; Leader in Minority Health
- Interview at Democracy Now!: Ogg Vorbis recording, interview transcript
- Interview at NPR: 'Medical Apartheid' Tracks History of Abuses
- IHT book review: Book Review: Medical Apartheid
- Racism and Research: The Case of the Tuskegee Syphilis Study. Allen M. Brandt. 
- Tuskegee Syphilis Study article, Encyclopedia of Alabama
- New York Times reviewof HBO movie "Miss Evers' Boys".