1 History of Urology Forum May 23, 2005 “Untreated Syphilis in the Negro Male” A Closure Comes...

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www.usrf.orgwww.usrf.org

History of Urology Forum May 23, 2005

““Untreated Syphilis in the Negro Male”Untreated Syphilis in the Negro Male”A Closure Comes to the Tuskegee StudyA Closure Comes to the Tuskegee Study

Shamim M. Baker Shamim M. Baker Los Angeles Los Angeles

Otis W. Brawley, M.DOtis W. Brawley, M.D.. AtlantaAtlanta

Leonard S. Marks, M.DLeonard S. Marks, M.D.. Los Angeles

Supported in part by GSK educational grant

Tuskegee, Al c1940

Photographs of the staff and participants of the TSUS, reproduced by the National Archives (3.7MB)

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Why The Current Report?Why The Current Report? Death of last survivor in Death of last survivor in

20042004

Story untold in urologyStory untold in urology

Under-representationUnder-representation of African-American men in prostate research trials

Film courtesy of CNN

In the official U.S. governmental apology in 1997, one of the last survivors of the Tuskegee Study is featured (1.9MB)

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Tuskegee Study of Untreated SyphilisTuskegee Study of Untreated Syphilis (TSUS)(TSUS)

Purpose : To define natural history of disease in Purpose : To define natural history of disease in African- American menAfrican- American men

Design: Longitudinal observationDesign: Longitudinal observation

Location: Macon County, Alabama Location: Macon County, Alabama 36% seropositivity36% seropositivity

Sponsor: United States Public Health Service (USPHS)Sponsor: United States Public Health Service (USPHS)

Duration: 1932-1972Duration: 1932-1972

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Study Organization: 1932-1933Study Organization: 1932-1933

4,000 African-American men screened : 399 with 4,000 African-American men screened : 399 with tertiary syphilis and 201 seronegative enrolledtertiary syphilis and 201 seronegative enrolled

Incentives: free medical care, lunches, Incentives: free medical care, lunches, transportations, and burial stipendstransportations, and burial stipends

Time frame: Originally 6-8 months, Time frame: Originally 6-8 months, extended to time of deathextended to time of death

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Eunice Rivers, R.N. Eunice Rivers, R.N. Facilitate recruitmentFacilitate recruitment

Photo courtesy US National Archive

Liaison between doctors Liaison between doctors and communityand community

“ “Miss Rivers’ Study”Miss Rivers’ Study”

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Study Continuation: 1941-1964Study Continuation: 1941-1964

Study continued despite …Study continued despite …

• U.S. entry into WWII (1941)U.S. entry into WWII (1941)

• Penicillin availability (1945)Penicillin availability (1945)

• Nuremberg Code (1947) and Nuremberg Code (1947) and Declaration of Helsinki (1964)Declaration of Helsinki (1964)

Became longest observational study in medical Became longest observational study in medical history, 1932-1972history, 1932-1972

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End of TSUSEnd of TSUS July 26, 1972 story in July 26, 1972 story in

NY times NY times

Article reproduced courtesy of Associated Press

Two main issuesTwo main issues

• Penicillin therapyPenicillin therapy• Informed consentInformed consent

Study halted in 1973Study halted in 1973

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Outcomes of TSUS Outcomes of TSUS Over 100 participants died, including wives and Over 100 participants died, including wives and

children *children *

13 peer-reviewed publications were derived from study13 peer-reviewed publications were derived from study

Eunice Rivers, R.N. , first African-American to Eunice Rivers, R.N. , first African-American to publish a paper in Journal of American Medical publish a paper in Journal of American Medical AssociationAssociation

* Source: La Times Obituary, 1/25/04

$10 million dollar settlement$10 million dollar settlement

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Kennedy Hearings, 1973Kennedy Hearings, 1973

U.S. Subcommittee on U.S. Subcommittee on Health Health

Film Courtesy of HBO, “Miss Evers Boys”, 1997

Nurse Rivers was a Nurse Rivers was a prominent witnessprominent witness Congressional Hearings chaired by

Senator Kennedy (2.0MB)

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Legacy of TSUS Legacy of TSUS

1974: National Research Act 1974: National Research Act

1974-1978: Commission created under National 1974-1978: Commission created under National Research ActResearch Act

1979: Belmont Report for Protection of Human Subjects 1979: Belmont Report for Protection of Human Subjects of Biomedical and Behavioral Researchof Biomedical and Behavioral Research

1983: Title 45, part 46 Code of Federal1983: Title 45, part 46 Code of Federal

Regulations “Protection of Human Subjects”Regulations “Protection of Human Subjects”

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Official ApologyOfficial ApologyThe White House, May 16, 1997The White House, May 16, 1997


President Clinton calls onto the survivors and descendents of the TSUS for an official governmental apology (2.9MB)

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‘‘Tuskegee Effect,’ 2005Tuskegee Effect,’ 2005 Lingering African-Lingering African-

American distrust of American distrust of medical research medical research

Critical under-Critical under- representation of representation of African-American African-American men in prostate trialsmen in prostate trials


President Clinton emphasizes the need for active participation in clinical research. (3.2MB)

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““Untreated Syphilis in the Negro Male”Untreated Syphilis in the Negro Male”A Closure Comes to the Tuskegee StudyA Closure Comes to the Tuskegee Study

Shamim M. Baker Shamim M. Baker Los Angeles Los Angeles

Otis W. Brawley, M.DOtis W. Brawley, M.D.. AtlantaAtlanta

Leonard S. Marks, M.DLeonard S. Marks, M.D.. Los Angeles

Supported in part by GSK educational grant

Tuskegee, Al c1940

Photographs of the staff and participants of the TSUS, reproduced by the National Archives (3.7MB)

1 History of Urology Forum May 23, 2005 “Untreated Syphilis in the Negro Male” A Closure Comes...

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