Tuskegee Study of Untreated Syphilis in the Negro Male

The Tuskegee Study of Untreated Syphilis in the Black Man [ [http://www.cdc.gov/nchstp/od/tuskegee/time.htm U.S. Public Health Service Syphilis Study at Tuskegee] ] (also known as the Tuskegee Syphilis Study, Pelkola 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. [cite web | title = Final Report of the Tuskegee Syphilis Study Legacy Committee | publisher = University of Virginia Health Sciences Library | date = May 20, 1996 | url = http://www.healthsystem.virginia.edu/internet/library/historical/medical_history/bad_blood/report.cfm
accessdate = 2007-05-08 ]

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. [ [http://select.nytimes.com/gst/abstract.html?res=F40616F6345A137B93C4AB178CD85F468785F9&scp=1&sq=Syphillis%20vicitims%20in%20u.s.%20study%20went%20untreated&st=cse "Syphilis victims in U.S. study went untreated for 40 years"] , "Associated Press", July 26, 1972] 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. [ [http://www.sfgate.com/cgi-bin/article.cgi?f=/c/a/2008/03/16/MNOUVHQVB.DTL "Tuskegee Syphilis Study's impact debated"] , Associated Press, March 16, 2008]

The Tuskegee Syphilis Study, cited as "arguably the most infamous biomedical research study in U.S. history", [cite journal | last = Katz | first = Ralph V. | authorlink = | coauthors = Stefanie L. Russell, S. Steven Kegeles, Nancy R. Kressin | title = The Tuskegee Legacy Project: Willingness of Minorities to Participate in Biomedical Research | journal = J Health Care Poor Underserved | volume = 17 | issue = 4 | pages = 698–715 | publisher = Johns Hopkins University Press | month = November | year = 2006 | url = http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=1780164
id = PMCID 1780164 | accessdate = 2007-05-07 | doi = 10.1353/hpu.2006.0126 | pmid = 17242525] led to the 1979 Belmont Report, the establishment of the National Human Investigation Board [ [http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm Basic HHS Policy for Protection of Human Research Subjects] ] , and the requirement for establishment of Institutional Review Boards. Presently "Office for Human Research Protections (OHRP)" exists within HHS [ [http://www.hhs.gov/ohrp/ Office for Human Research Protections (OHRP)] ] .

tudy 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. [Citation | last = Blumenthal | first = Daniel S. | last2 = Diclemente | first2 = Ralph J. | title = Community-Based Health Research: Issues and Methods | publisher = Springer Publishing | year = 2003 | pages = 50 | url = http://www.google.co.in/books?id=KN_-9lwSI5oC | isbn = 0826120253 ]

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." [http://www.tuskegee.edu/Global/Story.asp?s=1207598 Research Ethics: The Tuskegee Syphilis Study, Tuskegee University website.]

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.

tudy 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, [cite news | last = Parker | first = Laura | title = 'Bad Blood' Still Flows In Tuskegee Study | publisher = USA Today | date = April 28, 1997 | url = http://www.tuskegee.edu/global/Story.asp?s=1209852] 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".Citation | title = Bad Blood: The Tuskegee Syphilis Experiment | publisher = New York: Free Press | year = 1981 | author = James Jones]

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. [cite web |url=http://www.tuskegee.edu/global/Story.asp?s=1209852 |title='Bad Blood' Still Flows in Tuskegee Study |accessdate=2007-07-24 |format= |work=] 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."Citation | title = Doctor of Public Health Student Handbook | publisher = University of Kentucky College of Public Health | year = 2004 | pages = 17 | url = http://www.ukcph.org/Portals/0/DoctorofPublicHealth/Dr.P.HStudentHandbook.pdf]

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.

tudy 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. [ 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. ]

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. ["The Tuskegee Syphilis Study, 1932 to 1972: implications for HIV education and AIDS risk education programs in the black community." Am J Public Health. 1991 November; 81(11): 1498–1505.] 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." [ [http://www.washingtonpost.com/wp-dyn/content/article/2008/04/28/AR2008042801511_5.html?sid=ST2008042801405 "Rev. Wright Delivers Remarks at National Press Club", p.5] , Washington Post]

Ethical implications

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. [http://www.npr.org/programs/morning/features/2002/jul/tuskegee/ NPR : Remembering the Tuskegee Experiment ] ] It was known that syphilis was particularly prevalent in poor, black communities.Merril, Ray M. and Timmreck, Thomas C. "Introduction to Epidemiology". 2006, page 195] 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.Fact|date=April 2008

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.cite video |people = Alex Chadwick (Host, Day to Day) |date2 = 2002-07-22 |month2 = 07 |year2 = 2002 |title = Alex Chadwick report |url = http://www.npr.org/ramfiles/me/20020725.me.14.ram |format = RAM |medium = Radio |publisher = NPR |location = |accessdate = 2008-08-14 |accessmonth= 08 |accessyear = 2008 |time = 3:37 |id = |isbn = |oclc = |quote = "...the Tuskegee story exploded like a bomb, in one day the notorious syphilis experiment was closed down."] 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. [cite news | last = Elizabeth | first = Cohen | title = Tuskegee's ghosts: Fear hinders black marrow donation | language = en | publisher = CNN | date = February 26, 2007 | url = http://www.cnn.com/2007/HEALTH/02/07/bone.marrow/index.html | accessdate = 2007-05-08 ] 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. [cite news | title = Did Tuskegee damage trust on clinical trials? | language = en | publisher = CNN | year = 2008 | url = http://www.cnn.com/2008/HEALTH/03/17/clinical.trials.ap/index.html| accessdate = 2008-04-08 ]

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 the runner-up for the 1992 Pulitzer Prize in dramaFact|date=April 2008 and was adapted into an HBO made-for-TV movie in 1997. The adaptation was nominated for twelve Emmy Awards, [cite web
url = http://www.news.cornell.edu/Chronicle/97/9.11.97/Emmys.html
title = HBO's adaptation of Feldshuh's play Miss Evers' Boys is up for 12 Emmys
first = Darryl | last = Geddes | date = 1997-09-11 | publisher = Cornell Chronicle] winning in five categories. [cite web
url = http://www.imdb.com/title/tt0119679/awards
title = Awards for Miss Evers' Boys | publisher = IMDb] 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 "" 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.

References

Footnotes

Original Tuskegee Study papers

* cite journal
last = Caldwell | first = J. G | coauthors = E. V. Price, et al. | year = 1973
title = Aortic regurgitation in the Tuskegee study of untreated syphilis
journal = J Chronic Dis | volume = 26 | issue = 3 | pages = 187-94
* cite journal
last = Hiltner | first = S. | year = 1973
title = The Tuskegee Syphilis Study under review
journal = Christ Century | volume = 90 | issue = 43 | pages = 1174-6
* cite journal
last = Kampmeier | first = R. H. | year = 1972
title = The Tuskegee study of untreated syphilis
journal = South Med J | volume = 65 | issue = 10 | pages = 1247-51
* cite journal
last = Kampmeier | first = R. H. | year = 1974
title = Final report on the "Tuskegee syphilis study
journal = South Med J | volume = 67 | issue = 11 | pages = 1349-53
* cite journal
last = Olansky | first = S. | coauthors = L. Simpson, et al. | year =1954
title = Environmental factors in the Tuskegee study of untreated syphilis
journal = Public Health Rep | volume = 69 | issue = 7 | pages = 691-8
* cite journal
last = Rockwell | first = D. H. | coauthors = A. R. Yobs, et al. | year = 1964
title = The Tuskegee Study of Untreated Syphilis; the 30th Year of Observation
journal = Arch Intern Med | volume = 114 | pages = 792-8
* cite journal
last = Schuman | first = S. H. | coauthors = S. Olansky, et al. | year = 1955
title = Untreated syphilis in the male negro; background and current status of patients in the Tuskegee study.
journal = J Chronic Dis | volume = 2 | issue = 5 | pages = 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.
* cite book
first = Fred D. | last = Gray
title = The Tuskegee Syphilis Study: The Real Story and Beyond
location = Montgomery, Alabama | publisher = NewSouth Books | year = 1998
* cite book
first = James H. | last = Jones
title = Bad Blood: The Tuskegee Syphilis Experiment
location = New York | publisher = Free Press | year = 1981
* [http://www.lib.unc.edu/house/mrc/films/full.php?film_id=6341 "The Deadly Deception", by Denisce DiAnni, PBS/WGBH NOVA documentary video, 1993.]
* cite journal
first = Susan M. | last = Reverby
url = http://www.researchpractice.com/archive/apology.shtml
title = History of an Apology: From Tuskegee to the White House | journal = Research Nurse | year = 1998
* cite book
first = Susan M. | last = Reverby
title = Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study
publisher = University of North Carolina Press | year = 2000
* Jean Heller (Associated Press), "Syphilis Victims in the U.S. Study Went Untreated for 40 Years" "New York Times", July 26, 1972: 1, 8.
* cite journal
last = Thomas | first = Stephen B | coauthors = Sandra Crouse Quinn
title = The Tuskegee Syphilis Study, 1932-1972: Implications for HIV Education and AIDS Risk Programs in the Black Community
journal = American Journal of Public Health | year = 1991 | volume = 81 | issue = 1503
* cite book
first = Elof Axel | last = Carlson
title = Times of triumph, times of doubt : science and the battle for the public trust
publisher = Cold Spring Harbor Press | year = 2006 | isbn = 0-87969-805-5
* cite book
first = Harriet A. | last = Washington | year = 2007
title = Medical Apartheid. The Dark History of Medical Experimentation on Black Americans From Colonial Times to the Present

ee 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

* [http://www.cdc.gov/nchstp/od/tuskegee/time.htm CDC Tuskegee Syphilis Study timeline]
* [http://www.cdc.gov/nchstp/od/tuskegee/ CDC Tuskegee Syphilis Study Page]
* [http://www.msu.edu/course/hm/546/tuskegee.htm Excellent review of the TSS]
* [http://hsc.virginia.edu/hs-library/historical/apology/ University of Virginia: The Troubling Legacy Of The Tuskegee Syphilis Study]
* [http://www.npr.org/programs/morning/features/2002/jul/tuskegee/index.html NPR: Remembering Tuskegee: Syphilis Study Still Provokes Disbelief, Sadness]
* [http://www.gpc.edu/~shale/humanities/composition/assignments/experiment/tuskegee.html Internet Resources on the Tuskeegee Study]
* [http://www.imdb.com/title/tt0119679/ IMDB page] for "Miss Evers' Boys"
* [http://movies2.nytimes.com/gst/movies/movie.html?v_id=161965 New York Times review] of HBO movie "Miss Evers' Boys".
* Patient medical files held at [http://www.archives.gov/southeast/finding-aids/tuskegee.html National Archives and Records Administration Southeast Region, Morrow, GA]
* [http://www.washingtonpost.com/wp-dyn/content/article/2006/08/04/AR2006080401492.html Mary Harper; Leader in Minority Health]
* [http://www.tuskegee.edu/Global/Story.asp?s=1207598 Research Ethics: The Tuskegee Syphilis Study. Tuskegee University]
* Harriet Washington, author of "Medical Apartheid: The Dark History of Medical Experimentation on Black Americans from Colonial Times to the Present"
* Interview at Democracy Now!: [http://www.archive.org/download/dn2007-0119/dn2007-0119-1.ogg Ogg Vorbis recording] , [http://www.democracynow.org/article.pl?sid=07/01/19/1432231 interview transcript]
* Interview at NPR: [http://www.npr.org/templates/story/story.php?storyId=7046077 'Medical Apartheid' Tracks History of Abuses]
* IHT book review: [http://www.iht.com/articles/2007/01/24/features/bookjeu.php Book Review: Medical Apartheid] by Denise Grady. January 24, 2007
* Racism and Research: The Case of the Tuskegee Syphilis Study. Allen M. Brandt. [http://www.jstor.org/view/00930334/ap060046/06a00160/2?frame=noframe&userID=[e-mail]/01c0a8486a0050b6e5a&dpi=3&config=jstor]