Tuskegee Study of Untreated Syphilis in the Negro Male

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Depression-era U.S. poster advocating early syphilis treatment. Although treatments were available, participants in the study did not receive them.

The Tuskegee Study of Untreated Syphilis in the Negro Male^[1] (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. They recruited 399 poor, mostly illiterate,^{[citation needed]} African American sharecroppers with syphilis to study for research related to the natural progression of the disease if left untreated.

The 40-year study was controversial for numerous reasons related to ethical standards, most notably because researchers had failed to treat patients appropriately after the 1940s validation of penicillin as an effective cure of the disease. Revelation of study failures in this and other respects led to major changes in US law and federal regulation on how participants are protected in clinical studies, including the necessity for informed consent, communication of diagnosis, and accurate communication about tests.^[2]

When the study began in 1932, standard medical treatments for syphilis were toxic, dangerous, and of questionable effectiveness. Part of the original study goal was to determine if patients were better off not being treated with such toxic remedies. Additionally, researchers wanted to understand each stage of the disease in hopes of developing suitable treatments for each.

By 1947 penicillin had become the standard treatment for syphilis. Rather than treat all syphilitic subjects and close the study, or split off a control group for testing penicillin, the Tuskegee scientists withheld penicillin and information about it, to continue the study. Participants were prevented from accessing syphilis treatment programs available to other people in the area. The study continued until 1972, when a leak to the press resulted in its termination. Victims included numerous men who died of syphilis, wives who contracted the disease from them, and children born with transmitted congenital syphilis.^[3]

The Tuskegee Syphilis Study, cited as "arguably the most infamous biomedical research study in U.S. history,"^[4] led to the 1979 Belmont Report and the establishment of the National Human Investigation Board.^[5] It also led to federal regulation requiring Institutional Review Boards for protection of human subjects in medical studies. Presently the Office for Human Research Protections (OHRP) manages this responsibility within the US Department of Health and Human Services (HHS).^[6]

[edit] History

[edit] Study clinicians

Some of the Tuskegee Study Group clinicians. Dr. Reginald D. James (third to right), a black physician involved with public health work in Macon County, was not directly involved in the study. Nurse Rivers is on the left.

The study group was formed by the venereal disease section of the U.S. Public Health Service (PHS) at its national headquarters. Dr. Taliaferro Clark was credited with its origin. His initial goal 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 disagreed with the plan of other study members to conduct an extended study when he understood their intention to use deceptive practices. He retired the year after the study began.

Representing the PHS, Clark had solicited the participation of Tuskegee Institute, the historically black college (HBCU) which was well-known in Georgia, and a regional office of PHS in Arkansas. Dr. Eugene Dibble, an African-American doctor, was head of the John Andrew Hospital at the Tuskegee Institute. Dr. Oliver C. Wenger was director of the regional PHS Venereal Disease Clinic in Hot Springs, Arkansas. He and his staff took a lead in developing study procedures.

Wenger and his staff 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. To ensure cooperation of the subjects, he did not give them accurate information. ^[7]

Dr. Raymond H. 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. 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 from the time, Wenger congratulated Vonderlehr for his "flair for framing letters to negros." Vonderlehr retired as head of the venereal disease section in 1943, shortly after penicillin had first been confirmed as a valid cure for syphilis.

Nurse Eunice Rivers was an African-American woman trained at Tuskegee Institute who worked at its affiliated John Andrew Hospital. She was recruited to the study at its start. Dr. Vonderlehr was a strong advocate for her role, as she was the direct link to the community. During the Great Depression of the 1930s, the Tuskegee Study began by offering lower class African Americans, who often could not afford healthcare, the chance to join "Miss Rivers' Lodge". Patients were to 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.

As the study continued long-term, Nurse Rivers became the chief person who had continuity. Unlike the changing slate of national, regional and on-site PHS administrators, doctors, and researchers, Rivers stayed at Tuskegee University. She was the only study staff person to work with participants for the full 40 years. By the 1950s, Nurse Rivers had become pivotal to the study—her personal knowledge of the subjects enabled maintenance of long-term follow up.

Dr. Paxton Belcher-Timme, (Pereira-Bailey's assistant?), succeeded Vonderlehr as the on-site director in Tuskegee.

In the study's later years, Dr. John R. Heller led the national division. (Need years). By the late 1940s outside the study, doctors, hospitals and public health centers routinely treated diagnosed syphilis with penicillin. This was also the period following World War II, in which the revelation of the Holocaust and related Nazi medical abuses brought about changes in international law. Western allies formulated the Nuremberg Code to protect the rights of research subjects. No one appeared to have reevaluated the protocols of the Tuskegee Study according to the new standards.

In 1972 the Tuskegee Study was brought to public and national attention by internal staff members who gave information to the Washington Star and the New York Times. Heller still 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."^[9]

Dr. Taliaferro Clark	Dr. Oliver Wenger	Dr. Raymond Vonderlehr	Dr. John Heller
Dr. Eugene Dibble	Eunice Rivers, nurse and study co-ordinator	Charlie Pollard, survivor	Herman Shaw, survivor

[edit] Study details

Subject blood draw, circa 1953

This is a fact! 100%

The Tuskegee Study Group Letter inviting subjects to receive "special treatment", actually a diagnostic lumbar puncture.

The study 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 methods. (These included Salvarsan, mercurial ointments and bismuth which were somewhat effective, but quite toxic. They were all that was available.) Tuskegee Institute participated, as its representatives understood the intent of the study was to benefit public health in this poor population.^[10] The Tuskegee University-affiliated hospital effectively loaned the PHS its medical facilities. Other predominantly black institutions as well as local black doctors also participated. The Rosenwald Fund, a major Chicago-based philanthropy devoted to black education and community development in the South, provided financial support to pay for the eventual treatment of the patients. Initially, study researchers recruited 399 syphilitic Black men and 201 healthy Black men as controls.

Continuing effects of the Stock Market Crash of 1929 and beginning of the Great Depression led the Rosenwald Fund to withdraw its offer of funding. Study directors initially thought this event might mean the end of the study, as there was no funding to buy medication for the treatment phase of the study. They issued a final report.

In 1928 the Oslo Study in Norway 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 work and perform a prospective study equivalent to the Oslo Study. This was not inherently wrong; since there was nothing the investigators could do therapeutically at the time, they could study the natural progression of the disease as long as they did not harm their subjects. They reasoned that the knowledge gained would benefit humankind. The investigators became fixated on this scientific goal to the exclusion of reasonable judgment. In the end, they did harm their subjects, by depriving them of appropriate treatment when it was discovered. The study was characterized as "the longest non-therapeutic experiment on human beings in medical history."^[11]

Current standards hold that Ethical considerations were limited from the start, and rapidly deteriorated. For example, to ensure that the men would show up for the possibly dangerous, painful, diagnostic and 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. After penicillin was discovered as a cure, researchers continued to deny such treatment to many study participants. Many patients were lied to and given placebo treatments— so that researchers could observe the progression of the fatal disease.^[10] In 1934, the Tuskegee Study published their first clinical data, and issued their first major report in 1936. This was still prior to the discovery of penicillin as treatment for syphilis. This was not a secret study; several published reports and data sets appeared throughout the study.

By 1947 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, however, study researchers prevented their patients from participating.^[12] During World War II, 250 of the subject men registered for the draft and were consequently diagnosed and ordered to obtain treatment for syphilis before they could be taken into the armed services. PHS researchers prevented them from getting treatment, thus also depriving them of being cured, serving the country, and gaining the benefit of the GI Bill passed after the war. The PHS representative at the time was quoted as saying: "So far, we are keeping the known positive patients from getting treatment."^[12]

By the end of the study in 1972, only 74 of the test subjects were alive. Twenty-eight of the original 399 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 Tuskegee Study is an important topic on how not to conduct research and treat patients. It is covered in most medical schools and in public health graduate courses.

[edit] Study termination and aftermath

Peter Buxtun, a PHS venereal disease investigator, the "whistle-blower".

In 1966 Peter Buxtun, a PHS venereal-disease investigator in San Francisco, sent a letter to the national director of the Division of Venereal Diseases to express his concerns about the ethics and morality of the extended Tuskegee Study. The Center for Disease Control (CDC) (which by then controlled it) 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 local chapters of the National Medical Association (representing African-American physicians) and the American Medical Association (AMA).

In 1968 William (Bill) Carter Jenkins, an African-American statistician in the U.S. Public Health Service (PHS), (part of the Department of Health, Education, and Welfare, known as HEW), founded and edited The Drum. The newsletter was devoted to ending racial discrimination in HEW. The cabinet-level department included the CDC. In The Drum, Jenkins called for an end to the Tuskegee Study. He did not have success and it is not clear who read his work.^[13]

Buxtun finally went to the press in the early 1970s. The story broke first in the Washington Star on July 25, 1972. It became front-page news in the New York Times the following day. Senator Ted Kennedy called Congressional hearings, at which Buxtun and HEW officials testified. As a result of public outcry, in 1972, the CDC and PHS appointed an ad hoc advisory panel to review the study. It determined the study was medically unjustified and ordered its termination. As part of a settlement of a class action lawsuit subsequently filed by NAACP, the US government (through HEW) paid $9 million and promised to provide free medical treatment to surviving participants, as well as to surviving family members infected as a consequence of the study.

In 1974 Congress passed the National Research Act and created a commission to study and write regulations governing studies involving human participants. On May 16, 1997, President Bill Clinton formally apologized and held a ceremony for the 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. To our African American citizens, I am sorry that your federal government orchestrated a study so clearly racist" Five of the eight remaining study survivors attended the White House ceremony.

The Tuskegee Syphilis Study significantly damaged the trust of the black community toward public health efforts in the United States ^[14] and likely contributed to continuing rumors in the black community that the government was responsible for the HIV/AIDS crisis by introducing the virus to the black community. "In 1990, the Southern Christian Leadership Conference conducted a survey among 1056 African American Church members in five cities. They found that 34% of the respondents believed that AIDS was an artificial virus, 35% believed that AIDS is a form of genocide, and 44% believed that the government is not telling the truth about AIDS."^[15]

[edit] Ethical implications

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The ethics of the early stages of the Tuskegee Syphilis Study may be considered in contrast to developments after the use of penicillin was verified as valid treatment. In 1932 treatments for syphilis were relatively ineffective and had severe side effects.^[16] Researchers knew that syphilis was particularly prevalent in poor, black communities.^[17] Prevailing medical ethics at the time did not have the exacting standards for informed consent which we now expect. Doctors routinely withheld information about patients' condition from them.^{[citation needed]}

After penicillin was found to be an effective treatment for syphilis, the study continued for another 25 years without treating the men suffering from the disease. After the study and its consequences became front-page news, it was ended in a day.^[16] By the time the study had closed, many of the men had died from syphilis, a number of their wives had become infected, and numerous children were born with congenital syphilis transmitted in utero.

The Tuskegee Study has led blacks to mistrust medical care, such as organ donation, as well as perhaps contributed to reluctance of many poor black people to seek routine preventive care.^[18] Two groups of researchers at Johns Hopkins debated the effects that the Tuskegee Study has had on blacks and their willingness to participate in medical trials.^[19] Distrust of the government because of the study has contributed to beliefs in persistent rumors in the black community that the government was responsible for the HIV/AIDS crisis.

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.

[edit] Cultural response

• 1977 Gil Scott-Heron released a 33-second song "Tuskeegee 626" on the Bridges album.

• 1992, 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,^[20] In 1997 it was adapted for an HBO made-for-TV movie. The HBO adaptation was nominated for twelve Emmy Awards,^[21] and won in five categories.^[22]

• Frank Zappa's musical Thing-Fish was loosely inspired by the events.

• 1992, musician Don Byron released his debut album, Tuskegee Experiments, inspired by the study.

• 1996, the television series New York Undercover used the study as the subject of a second-season episode titled "Bad Blood."

• 2003, Marvel Comics limited series Truth: Red, White & Black reinterpreted the Tuskegee Experiment as part of the Weapon Plus program.

• In the stoner comedy Half Baked (1998), Dave Chappelle's character Thurgood Jenkins stated that his grandfather "was in the Tuskegee experiments."

• The study has been referred to numerous times in the Fox television series House throughout the seasons.

[edit] References

[edit] Footnotes

[edit] 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. 

[edit] 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. 

[edit] 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

[edit] 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
• Tuskegee Syphilis Study article, Encyclopedia of Alabama
• New York Times review of HBO movie "Miss Evers' Boys"