Tuskegee study

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  • 1. The Tuskegee Syphilis Study (1932-1972)Benhur Pradeephttp://www.myclinicalresearchbook.blogspot.com

2. In late July of 1972, Jean Heller of the Associated Pressbroke the story: for forty years the United States PublicHealth Service had been conducting a study of the effects of untreated syphilis on black men in Macon County, Alabama Bad Blood http://www.myclinicalresearchbook.blogspot.com 3. Background In exchange for their participation, the men were promised treatment,along with free meals, medical examinations, and burial insurance, but inreality received no substantial treatment - For example, the patients were misled into accepting mercury bands as a treatment when in fact these bands only acted as a screen for the physicians from the disease Additionally, doctors administered painful and potentially life crippling spinal taps not as a treatment or to improve their survival chances, but only as a method to collect data http://www.myclinicalresearchbook.blogspot.com 4. Background cont.. Instead of informing patients they had syphilis and were contagious,doctors told patients they had "bad blood, meaning several differentillnesses, such as syphilis, anemia and fatigue - Thus, uninformed patients proceeded to spread the disease to their wives and children Although they later performed autopsies to examine the diseaseseffects initially poor protocol was included - Study to last 6 12 months A shift of focus to examine the aging process of the syphilis patients led to the longevity of the study lasting 40 yearshttp://www.myclinicalresearchbook.blogspot.com 5. Penicillin TIn 1943 penicillin became a viable treatment for Syphilis Patients of the study did not receive penicillin treatment because doctorsargued that it was a new development that had potential negativeeffects Despite the Henderson Act of 1943 and Alabamas public health statutes,which was a public health law mandating the testing and treatment ofindividuals with tuberculosis and venereal diseases, penicillin was stillnot given to the patientshttp://www.myclinicalresearchbook.blogspot.com 6. Syphilis: Overview Syphilis the AIDS of an earlier time. Syphilis is a sexually transmitted disease (STD) and Congenital. If its nottreated, it can get worse over time and cause serious health problems. Syphilis is a sexually transmitted infection caused by Treponemapallidum. The problem was.., until 1907, no one could treat it. Nobel Prize winning-microbiologist. Paul Ehrlich discovered Salvarsan. An Arsenic based compound, and was the first chemotherapy.http://www.myclinicalresearchbook.blogspot.com 7. The 1920s Progressive era in medicine. Armed with confidence and the scientific methods. U.S. Public Health Service officials were determined to control syphilis intheir time. They set up free treatment clinics throughout the south, including Maconcounty, Alabama, home to the Tuskegee Institute.http://www.myclinicalresearchbook.blogspot.com 8. The 1932 The funding for treatment ran out. While writing the final report, Dr. Taliaferro Clark, head of the PHSVenereal Disease Division conceived an idea to salvage the study Macon county offered an unparalleled opportunity for the study of theeffect of untreated syphilis in the Negro male. http://www.myclinicalresearchbook.blogspot.com 9. The Study of Untreated Syphilis in the Negro Male Was only supposed to last a year but then Dr. Raymond Vondelehr advocated continuing the study to getautopsies. Autopsies would confirm clinical observation and therefore greatlycontribute to the studys scientific reliability. http://www.myclinicalresearchbook.blogspot.com 10. Bringing them to Autospy By the time the story finally hit the newspapers in 1972, The experiment had gone on for 40 years. During all this time, it was no secret to the wider medical community. Results of the study had been published in well known medical journals.http://www.myclinicalresearchbook.blogspot.com 11. Tuskegee Syphilis Study (1932 1972) July 25, 1972: story broke in Washington Star. 600 low income African-American males from rural Alabama with a highincidence of syphilis infection were monitored for 40 years to observecourse of disease. Given free medical exams but they were not told that they had syphilis. Cure (penicillin) became available in 1950s. Participants and families denied treatment. http://www.myclinicalresearchbook.blogspot.com 12. Newspaper Headlines A Violation of Human Dignity (Houston Chronicle, Aug. 5, 1972) An Immoral Study (St. Louis Post-Dispatch, July 30, 1972) Inhuman Experiment (Oregonian, July 31, 1972) Blot on Humanity (Chatanooga Times, July 28, 1972) Cruel Experiment (South Bend Tribune, July 29, 1972) A Shocking Medical Experiment (New Haven Register, July 29, 1972) Humans as Guinea Pigs (Richmond Times Dispatch, Aug. 6, 1972) Official Inhumanity (LA Times, July 27, 1972) Horror Story (Providence Sunday Journal, July 30, 1972) Nightmare Experiment (Raleigh News and Observer, July 28, 1972) They Helped Men Die (Milwaukee Journal, July 27, 1972) http://www.myclinicalresearchbook.blogspot.com 13. Tuskegee Syphilis Study Overall question: HOW COULD IT HAVE HAPPENED? - How did it get started? - When did study actually begin? - Who proposed it? - Why? - What was goal of study? - Were there precedents? - Did anyone else approve the study? - Any difficulty securing subjects? - When was one-time study extended? - How was time extension possible? - How could treatment of subjects be prevented? - How did study continue after 1945 and discovery of penicillin? - How was the project finally ended?http://www.myclinicalresearchbook.blogspot.com 14. Q: How could it have happened? That as late as 1972 four hunered blacks were part of a government-runexperiment, part of which was withhold treatment of syphilis. http://www.myclinicalresearchbook.blogspot.com 15. Q: How did it get started? Like most research, for noble reasons. It followed studies in late 1920s totest & treat those least able to get diagnosis and treatment for syphilis:rural blacks. - pilot program in Miss. run by federal Public Health Service and Rosenwald Fund (foundation created explicitly to help blacks, later changed its focus to concentrate on health) - expanded in 1930 to other locations, including Macon Cty. Ala. (30 mi. east of Montgomery, 80% black). Tuskegee Inst. there, plus a veterans hospital. All black with 22 doctors. - 1st stage: 7,000- 10,000 people tested; 36% tested positive (very high) - 2nd stage was treatment with Salvarsan and mercury; 1200 treated by fall of 1930. After another year, high cost and limited effect made Rosenwald announce end of program. State of Ala. could not pick up cost; nor could PHS (until 1934).http://www.myclinicalresearchbook.blogspot.com 16. Q: When, Who, Why and Goal? Tuskegee study of untreated syphilis in Negro male began between 1931and 1934. Taliferro Clark, a PHS worker who came to Alabama during Rosenwaldstudy. Preferred to treat but no funding for it. Clark noted that of initial 1400admitted for treatment, only 33 had undergone any previous treatment. To learn about effects of syphilis on blacks; to see if it was different thanon whites (racist assumption?) http://www.myclinicalresearchbook.blogspot.com 17. Q: Were there precedents? Only anecdotal observations of blacks. Nothing systematic or large scale.But in 1928 an article in a German journal was published with results of aNorwegian study of several hundred untreated patients between 1891-1910. Of note were great frequency in cardiovascular damage, and onlyrare neurological damage. Common assumptions was that in blacks therewas higher frequency of neurological damage. (NOTE: Norwegian studywas done before even salvarsan, let alone penicillin was available.)http://www.myclinicalresearchbook.blogspot.com 18. Q: Did anyone else approve the study? Yes Discussed with PHS colleagues, all approved Ala. State Board of Health approved, on condition that all were treated.No problem since Clark initially proposed a 6-8 month study; treatment,when funds available, took a year. Ala. also wanted local doctors toparticipate Tuskegee hospital medical director agreed to be local medicalparticipant. Protocol submitted to Johns Hopkins Medical School doctors, whosuggested study of males, over 25, 2-300 size of sample, insure noprevious treatment.http://www.myclinicalresearchbook.blogspot.com 19. Q: Any diffulty securing subjects? No, because it was deliberately confused with earlier testing andtreatment.Q: When was time of study extended? By April 1933 results showed little neurological damage. Idea was firstsuggested that for little expense, subjects could be observed for 5-10years to produce more information. Subjects already identified andparticipating. June 1933 Clark retired and was succeeded by new PHS doctor, RaymondVonderlehr. He proposed to follow subjects to autopsy, because so muchmore info could be learned. http://www.myclinicalresearchbook.blogspot.com 20. Q: How was time extension possible? Little question about it. Most important was agreement of local doctors,because they would not provide treatment. Most subjects were indigent. Nurse Eunice Rivers hired, crucial to keeping men in program. She assured themand suggested burial stipend as incentive. (funded by Milbank MemorialFund). http://www.myclinicalresearchbook.blogspot.com 21. Q: How could treatment be prevented? TIn 1937 Rosenwald finally renewed funding of treatment program; in1939 a mobile PHS treatment program was assigned to Macon Cty. Nurse Rivers screened men, saying they were under study; several menprevented from treatment 1939-41. Her justification: doctors orders andtreatment had side effects. After 1942 draft physicals given (pos. testsrequired treatment; Vonderlehr got exemptions).Q: How did study continue after 1945 and Penicillin? As new officials came across the study and raised questions (1948, 1951,1952),