Editing Tuskegee Syphilis Study (section)

==History==

===Study details===
[[File:Tuskegee study.jpg|thumb|Subject blood draw, c. 1953]]

In 1928, the "[[The Oslo Study|Oslo Study of Untreated Syphilis]]" had reported on the [[Pathology|pathologic]] manifestations of untreated syphilis in several hundred white males. This study was a [[retrospective study]] since investigators pieced together information from the histories of patients who had already contracted syphilis but remained untreated for some time.<ref name="Whorley-2006" />

The U.S. Public Health Service Syphilis Study at Tuskegee group decided to build on the Oslo work and perform a [[prospective study]] to complement it.<ref name="Brandt-1978" /> The U.S. Public Health Service Syphilis Study at Tuskegee began as a 6-month descriptive epidemiological study of the range of pathology associated with syphilis in the population of Macon County. The researchers involved with the study reasoned that they were not harming the men involved in the study, under the presumption that they were unlikely to ever receive treatment.<ref name="Reverby-2009" /> At that time, it was believed that the effects of syphilis depended on the race of those affected. Physicians believed that syphilis had a more pronounced effect on African-Americans' [[cardiovascular system]]s than on their [[central nervous system]]s.<ref name="HHS-2008" />

Investigators enrolled in the study a total of 600 impoverished, African-American [[sharecropper]]s.<ref name="Reverby-2009" /> Of these men, 399 had latent syphilis, with a control group of 201 men who were not infected.<ref name="CDC-2020" /> As an incentive for participation in the study, the men were promised free medical care, but were deceived by the PHS, who never informed subjects of their diagnosis, despite the risk of infecting others, and the fact that the disease could lead to blindness, deafness, mental illness, heart disease, bone deterioration, the collapse of the central nervous system, and death.<ref name="Brown-2017"/><ref name="Associated Press-2017"/><ref name="Heller-1972"/><ref name="AP News-2017"/> Instead, the men were told that they were being treated for "bad blood", a colloquialism that described various conditions such as syphilis, [[anemia]], and fatigue. The collection of illnesses the term included was a leading cause of death within the southern African-American community.<ref name="CDC-2020" />

At the study's commencement, major medical textbooks had recommended that all syphilis be treated, as the consequences were quite severe. At that time, treatment included [[arsenic]]-based compounds such as [[arsphenamine]] (branded as the "606" formula).<ref name="Brandt-1978" /> Initially, subjects were studied for six to eight months and then treated with contemporary methods, including [[Arsphenamine|Salvarsan]] ("606"), [[Mercury (element)|mercurial]] ointments, and [[bismuth]], which were mildly effective and highly toxic.<ref name="Reverby-2009" /> Additionally, men in the study were administered disguised placebos, ineffective methods, and diagnostic procedures, which were misrepresented as treatments.<ref name="Gray-1998"/>

Throughout, participants remained ignorant of the study clinicians' true purpose, which was to observe the natural course of untreated syphilis.<ref name="Reverby-2009" /> Study clinicians could have chosen to treat all syphilitic subjects and close the study, or split off a [[control group]] for testing with penicillin. Instead, they continued the study without treating any participants; they withheld treatment and information about penicillin from the subjects. In addition, scientists prevented participants from accessing syphilis treatment programs available to other residents in the area.<ref>{{Cite book|last=Jones|first=James H.|url=https://archive.org/details/badbloodtuskegee00jone/page/161/|title=Bad Blood: The Tuskegee Syphilis Experiment|publisher=[[Free Press (publisher)|The Free Press]]|year=1981|isbn=978-0029166703|location=New York City|page=[https://archive.org/details/badbloodtuskegee00jone/page/161/ 161–62]}}</ref> The researchers reasoned that the knowledge gained would benefit humankind; however, it was determined afterward that the doctors did harm their subjects by depriving them of appropriate treatment once it had been discovered. The study was characterized as "the longest non-therapeutic experiment on human beings in medical history."<ref name="Jones-1981" />

To ensure that the men would show up for the possibly dangerous, painful, diagnostic, and non-therapeutic [[Lumbar puncture|spinal taps]], doctors sent participants a misleading letter titled "Last Chance for Special Free Treatment".<ref name="Brandt-1978" />

The U.S. Public Health Service Syphilis Study at Tuskegee published its first clinical data in 1934 and issued its first major report in 1936. This was before the discovery of penicillin as a safe and effective treatment for syphilis. The study was not secret, since reports and data sets were published to the medical community throughout its duration.<ref name="Reverby-2009" />

During World War II, 256 of the infected subjects registered for the draft and were consequently diagnosed as having syphilis at military induction centers and ordered to obtain treatment for syphilis before they could be taken into the armed services.<ref name="CPH-2004">{{Cite book|title=Doctor of Public Health Student Handbook|publisher=University of Kentucky College of Public Health|location=Lexington, Kentucky|year=2004|page=17}}</ref><ref name="Reverby-2012">{{cite book |editor1-last=Reverby |editor1-first=Susan M. |title=Tuskegee's Truths: Rethinking the Tuskegee Syphilis Study |year=2012 |publisher=[[UNC Press Books]] |location=Chapel Hill, North Carolina|isbn=978-1469608723 |pages=226–28 |url=https://books.google.com/books?id=f3q0CgAAQBAJ&pg=PA226 |access-date=December 22, 2020 |archive-date=January 18, 2021 |archive-url=https://web.archive.org/web/20210118011338/https://books.google.com/books?id=f3q0CgAAQBAJ&pg=PA226 |url-status=live }}</ref> PHS researchers prevented these men from getting treatment, thus depriving them of chances for a cure. Vonderlehr argued, "this study is of great importance from a scientific standpoint. It represents one of the last opportunities which the science of medicine will have to conduct an investigation of this kind. ... [Study] Doctor [Murray] Smith ... asked that these men be excluded from the list of draftees needing treatment. ... in order to make it possible to continue this study on an effective basis."<ref name="Reverby-2012"/>

Later, Smith, a local PHS representative involved in the study, wrote to Vonderlehr to ask what should be done with patients who had tested negative for syphilis at the time of enrollment in the study and were being used as control subjects but had later tested positive when registering for the draft: "So far, we are keeping the known positive patients from getting treatment. Is a control case of any value to the study, if he has contracted syphilis? Shall we withhold treatment from the control case who has developed syphilis?"<ref name="Reverby-2012"/> Vonderlehr replied that such cases "have lost their value to the study. There is no reason why these patients should not be given appropriate treatment unless you hear from Doctor Austin V. Deibert who is in direct charge of the study".<ref name="Reverby-2012"/>

By 1947, penicillin had become standard therapy for syphilis. The U.S. government sponsored several public health programs to form "rapid treatment centers" to eradicate the disease. When campaigns to eradicate [[venereal disease]] came to Macon County, study researchers prevented their subjects from participating.<ref name="CPH-2004" /> Although some of the men in the study received arsenical or penicillin treatments elsewhere, for most of them this did not amount to "adequate therapy".<ref>{{Cite journal|last1=Benedek|first1=Thomas G.|journal=[[Perspectives in Biology and Medicine]]|last2=Erlen|first2=Jonathon|pages=24–25|title=The Scientific Environment of the Tuskegee Study of Syphilis, 1920–1960|year=1999|volume=43|issue=1|publisher=[[Johns Hopkins University Press]]|location=Baltimore, Maryland|doi=10.1353/pbm.1999.0034|pmid=10701219|s2cid=34614156}}</ref> [[File:Tuskegee-syphilis-study subjects-talking-to-nurse-eunice-rivers.jpg|thumb|Subjects talking with study coordinator, Nurse Eunice Rivers, c. 1970|alt=]]By the end of the study in 1972, only 74 of the test subjects were still alive.<ref name="AP News-2017" /> Of the original 399 men, 28 had died of syphilis, 100 died of related complications, 40 of their wives had been infected, and 19 of their children were born with [[congenital syphilis]].<ref name="Kim-2018" />[[File:Tuskegee-syphilis-study doctor injects subject with placebo.gif|thumb|Researcher collecting a blood sample as part of the Tuskegee Syphilis Study|alt=]]

The revelation in 1972 of study failures by [[whistleblower]] [[Peter Buxtun]] led to major changes in U.S. law and regulation concerning the protection of participants in clinical studies. Studies since then require [[informed consent]],<ref name="HHS-2009">{{Cite web|title=Code of Federal Regulations Title 45 Part 46 Protections of Human Subjects 46.1.1 (i)|url=https://www.hhs.gov/ohrp/sites/default/files/ohrp/policy/ohrpregulations.pdf|date=January 15, 2009|website=[[U.S. Department of Health and Human Services]]|access-date=May 14, 2020|archive-date=March 28, 2016|archive-url=https://web.archive.org/web/20160328191725/http://www.hhs.gov/ohrp/policy/ohrpregulations.pdf|url-status=live}}</ref> communication of [[diagnosis]] and accurate reporting of test results.<ref name="UVA-1996a">{{Cite web|title=Final Report of the Tuskegee Syphilis Study Legacy Committee|url=http://www.hsl.viriginia.edu/historical/medical_history/bad_blood/report.cfm|date=May 20, 1996|website=Tuskegee Syphilis Study Legacy Committee|access-date=May 14, 2020}}{{Dead link|date=November 2023 |bot=InternetArchiveBot |fix-attempted=yes }}</ref>

===Study clinicians===
The [[venereal disease]] section of the [[U.S. Public Health Service]] (PHS) formed a study group in 1932 at its national headquarters in Washington, D.C. [[Taliaferro Clark]], head of the USPHS, is credited with founding it. His initial goal was to follow untreated syphilis in a group of African-American men for six months to one year, and then follow up with a treatment phase.<ref name="Reverby-2009" /><ref name="Jones-1981">{{cite book|first=James H.|last=Jones|url=https://archive.org/details/badbloodtuskegee00jone_0|title=Bad Blood: The Tuskegee Syphilis Experiment|publisher=[[Free Press (publisher)|Free Press]]|year=1981|isbn=978-0-02-916676-5|location=New York City|page=91}}</ref> When the [[Rosenwald Fund]] withdrew its financial support, a treatment program was deemed too expensive.<ref name="Whorley-2006">{{Cite thesis|last=Whorley|first=Tywanna Marie|date=2006|title=The Tuskegee Syphilis Study: Access and Control over Controversial Records|url=http://d-scholarship.pitt.edu/9244/1/Dissertation_Whorley_2006.pdf|publisher=[[University of Pittsburgh]]|journal=|access-date=May 14, 2020|archive-date=August 9, 2020|archive-url=https://web.archive.org/web/20200809113148/http://d-scholarship.pitt.edu/9244/1/Dissertation_Whorley_2006.pdf|url-status=live}}</ref> Clark, however, decided to continue the study, interested in determining whether syphilis had a different effect on African-Americans than it did on Caucasians. A regressive study of untreated syphilis in white males had been conducted in Oslo, Norway, and could provide the basis for comparison.<ref name="Whorley-2006" /><ref>{{Cite book|last=Jones|first=James H.|title=Bad Blood: The Tuskegee Syphilis Experiment|publisher=The Free Press|year=1981|isbn=978-0029166703|location=New York|pages=17–19}}</ref> The prevailing belief at the time was white people were more likely to develop neurosyphilis and that black people were more likely to sustain cardiovascular damage. Clark resigned before the study was extended beyond its original length.<ref>{{Cite book|last1=Fregni|first1=Felipe|title=Critical Thinking in Clinical Research: Applied Theory and Practice Using Case Studies|last2=Illigens|first2=Ben M.W.|publisher=Oxford University Press|location=Oxford, England|isbn=9780199324507 |date=2018|page=11}}</ref>

Although Clark is usually assigned blame for conceiving the U.S. Public Health Service Syphilis Study at Tuskegee, [[Thomas Parran Jr.]] also helped develop a non-treatment study in Macon County, Alabama. As the Health Commissioner of New York State (and former head of the PHS Venereal Disease Division), Parran was asked by the Rosenwald Fund to assess their serological survey of syphilis and demonstration projects in five Southern states.<ref>Jones (1981), pp.52–90</ref> Among his conclusions was the recommendation that: "If one wished to study the natural history of syphilis in the African American race uninfluenced by treatment, this county (Macon) would be an ideal location for such a study."<ref>{{Cite web|title=Did a U.S. surgeon general come up with the idea of the notorious Tuskegee syphilis experiment?|url=https://www.inquirer.com/philly/news/thomas-parran-tuskegee-syphilis-hornblum-experiment-20170720.html|last=Bender|first=William|website=www.inquirer.com|date=July 20, 2017 |language=en-US|access-date=May 14, 2020|archive-date=June 18, 2020|archive-url=https://web.archive.org/web/20200618114758/https://www.inquirer.com/philly/news/thomas-parran-tuskegee-syphilis-hornblum-experiment-20170720.html|url-status=live}}</ref>

Oliver C. Wenger was the director of the regional PHS Venereal Disease Clinic in [[Hot Springs, Arkansas]]. He and his staff took the lead in developing study procedures. Wenger continued to advise and assist the study when it was adapted as a long-term, no-treatment observational study after funding for treatment was lost.<ref>{{Cite book|last1=Blumenthal|first1=Daniel S.|title=Community-Based Health Research: Issues and Methods|last2=DiClemente|first2=Ralph J.|publisher=[[Springer Publishing]]|date=2003|isbn=978-0-8261-2025-0|location=New York City|page=50}}</ref>

[[Raymond A. 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. His method of gaining the "[[Informed consent|consent]]" of the subjects for [[Lumbar puncture|spinal taps]] (to look for signs of [[neurosyphilis]]) was by advertising this diagnostic test as a "special free treatment".<ref name="Reverby-2009" />  He also met with local black doctors and asked them to deny treatment to participants in the Tuskegee Study. Vonderlehr retired as head of the venereal disease section in 1943, shortly after [[penicillin]] was proven to cure syphilis.<ref name="Brandt-1978" /> After Vonderlehr's retirement, [[John R. Heller Jr.]], his mentee, succeeded him as head of the venereal disease section. Even with the discovery that penicillin served as an effective treatment for syphilis, Heller did not provide the drug to the participants of the study.<ref>{{cite web |title=Faces of Tuskegee |url=https://msu.edu/course/hm/546/tuskegee.htm |accessdate=December 5, 2015 |publisher=[[Michigan State University]]}}</ref> 

Several African-American health workers and educators associated with the [[Tuskegee Institute]] played a critical role in the study's progress. The extent to which they knew about the full scope of the study is not clear in all cases.<ref name="Reverby-2009" /> [[Robert Russa Moton]], then president of Tuskegee Institute, and [[Eugene Dibble]], head of the Institute's [[John A. Andrew Memorial Hospital]], both lent their endorsement and institutional resources to the government study.<ref>{{Cite book|last=Kaplan|first=Mary|title=The Tuskegee Veterans Hospital and Its Black Physicians: The Early Years|publisher=[[McFarland (publisher)|McFarland]]|location=Jefferson, North Carolina|date=2016|pages=90–91, 104|isbn=9781476662985}}</ref>

Nurse [[Eunice Rivers]], who had trained at Tuskegee Institute and worked at its hospital, was recruited at the start of the study to be the main point of contact with the participants.<ref name="Reverby-2009" /> Rivers played a crucial role in the study because she served as the direct link to the regional African-American community. Vonderlehr considered her participation to be the key to gaining the trust of the subjects and promoting their participation.<ref name="Thomas-2000">
{{cite journal|last1=Thomas|first1=Stephen B.|last2=Crouse Quinn|first2=Sandra|s2cid=68358316|year=2000|title=Light on the Shadow of the Syphilis Study at Tuskegee|url=http://health-equity.pitt.edu/658/1/Light_on_the_Shadow_of_the_Syphilis_Study_at_Tuskegee.pdf|url-status=dead|journal=[[Health Promotion Practice]]|publisher=[[SAGE Publications]]|location=Thousand Oaks, California|volume=1|issue=3|pages=234–37|doi=10.1177/152483990000100306|hdl=1903/22693|archive-url=https://web.archive.org/web/20160616213555/http://health-equity.pitt.edu/658/1/Light_on_the_Shadow_of_the_Syphilis_Study_at_Tuskegee.pdf|archive-date=June 16, 2016|access-date=December 12, 2014|hdl-access=free}}
</ref> As a part of "Miss Rivers' Lodge", participants 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. Rivers was also key in convincing families to sign autopsy agreements in return for funeral benefits. As the study became long-term, Rivers became the chief person who provided continuity to the participants. She was the only study staff person to work with participants for the full 40 years.<ref name="Reverby-2009" />

<gallery>
File:vonderle.gif|[[Raymond A. Vonderlehr]] (medical doctor)
File:Eugene Dibble.jpg|[[Eugene Dibble]] (medical doctor)
File:Eunice Rivers.jpg|[[Eunice Rivers Laurie|Eunice Rivers]] (nurse)
File:Oliver Wenger.jpg|Oliver Wenger
</gallery>
{{clear}}