Editing Tuskegee Syphilis Study (section)

===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>