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Tuskegee study Tuskegee study Presentation Transcript

  • The Tuskegee Syphilis Study (1932-1972) Benhur Pradeep http://www.myclinicalresearchbook.blogspot.com
  • “In late July of 1972, Jean Heller of the Associated Press broke 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
  • Background In exchange for their participation, the men were promised treatment, along with free meals, medical examinations, and burial insurance, but in reality 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
  • Background cont.. Instead of informing patients they had syphilis and were contagious, doctors told patients they had "bad blood,” meaning several different illnesses, 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 disease’s effects 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 years http://www.myclinicalresearchbook.blogspot.com
  • Penicillin TIn 1943 penicillin became a viable treatment for Syphilis Patients of the study did not receive penicillin treatment because doctors argued that it was a new development that had potential negative effects Despite the Henderson Act of 1943 and Alabama’s public health statutes, which was a public health law mandating the testing and treatment of individuals with tuberculosis and venereal diseases, penicillin was still not given to the patients http://www.myclinicalresearchbook.blogspot.com
  • Syphilis: Overview Syphilis the AIDS of an earlier time. Syphilis is a sexually transmitted disease (STD) and Congenital. If it’s not treated, it can get worse over time and cause serious health problems. Syphilis is a sexually transmitted infection caused by Treponema pallidum. 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
  • The 1920‘s Progressive era in medicine. Armed with confidence and the scientific methods. U.S. Public Health Service officials were determined to control syphilis in their time. They set up free treatment clinics throughout the south, including Macon county, Alabama, home to the Tuskegee Institute. http://www.myclinicalresearchbook.blogspot.com
  • The 1932 The funding for treatment ran out. While writing the final report, Dr. Taliaferro Clark, head of the PHS Venereal Disease Division conceived an idea to salvage the study … Macon county “offered an unparalleled opportunity for the study of the effect of untreated syphilis” in the Negro male. http://www.myclinicalresearchbook.blogspot.com
  • 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 get autopsies. Autopsies would confirm clinical observation and therefore greatly contribute to the study’s scientific reliability. http://www.myclinicalresearchbook.blogspot.com
  • “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
  • Tuskegee Syphilis Study (1932 – 1972) July 25, 1972: story broke in Washington Star. 600 low income African-American males from rural Alabama with a high incidence of syphilis infection were monitored for 40 years to observe course 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
  • “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
  • 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
  • Q: How could it have happened? That as late as 1972 four hunered blacks were part of a government-run experiment, part of which was withhold treatment of syphilis. http://www.myclinicalresearchbook.blogspot.com
  • Q: How did it get started? Like most research, for noble reasons. It followed studies in late 1920s to test & 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
  • Q: When, Who, Why and Goal? Tuskegee study of untreated syphilis in Negro male began between 1931 and 1934. Taliferro Clark, a PHS worker who came to Alabama during Rosenwald study. Preferred to treat but no funding for it. Clark noted that of initial 1400 admitted for treatment, only 33 had undergone any previous treatment. To learn about effects of syphilis on blacks; to see if it was different than on whites (racist assumption?) http://www.myclinicalresearchbook.blogspot.com
  • 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 a Norwegian study of several hundred untreated patients between 1891- 1910. Of note were great frequency in cardiovascular damage, and only rare neurological damage. Common assumptions was that in blacks there was higher frequency of neurological damage. (NOTE: Norwegian study was done before even salvarsan, let alone penicillin was available.) http://www.myclinicalresearchbook.blogspot.com
  • 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 to participate Tuskegee hospital medical director agreed to be local medical participant. Protocol submitted to Johns Hopkins Medical School doctors, who suggested study of males, over 25, 2-300 size of sample, insure no previous treatment. http://www.myclinicalresearchbook.blogspot.com
  • Q: Any diffulty securing subjects? No, because it was deliberately confused with earlier testing and treatment.Q: When was time of study extended? By April 1933 results showed little neurological damage. Idea was first suggested that for little expense, subjects could be observed for 5-10 years to produce more information. Subjects already identified and participating. June 1933 Clark retired and was succeeded by new PHS doctor, Raymond Vonderlehr. He proposed to follow subjects to autopsy, because so much more info could be learned. http://www.myclinicalresearchbook.blogspot.com
  • 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 them and suggested “burial stipend” as incentive. (funded by Milbank Memorial Fund). http://www.myclinicalresearchbook.blogspot.com
  • Q: How could treatment be prevented? TIn 1937 Rosenwald finally renewed funding of treatment program; in 1939 a mobile PHS treatment program was assigned to Macon Cty. Nurse Rivers screened men, saying they were under study; several men prevented from treatment 1939-41. Her justification: doctor’s orders and treatment had side effects. After 1942 draft physicals given (pos. tests required 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), other PHS officials regarded it as a “never to be repeated opportunity”; 20 years invested in experiment. http://www.myclinicalresearchbook.blogspot.com
  • Q: How was the project finally ended? TAll along articles were published on results. As late as June 1965 a doctor in Detroit hospital (Irwin Schatz) read a 1964 article and sent a letter to PHS (“I am utterly astounded by the fact that physicians allow patients with a potentially fatal disease to remain untreated when effective therapy is available.”) It was filed in CDC with note it was first such letter. No reply written. Peter Buxtun first heard of Tuskegee when hired at SF VD clinic in Dec. 1965. Curiosity and required paper made him research Tuskegee articles (sent by CDC). Based on his reading Buxtun sent a letter in Nov. 1966 questioning the study. No reply, but a CDC official visited him over Christmas to talk to Buxtun, and he was invited to Atlanta for a meeting a few months later. But no change in CDC policy. http://www.myclinicalresearchbook.blogspot.com
  • Q: How was the project finally ended? Nov. 1967 Buxtun resigned from VD clinic; fall 1968 he entered law school in SF; Nov. 1968 he wrote another letter to CDC. Now (post MLK assassination riots) it got attention. Feb. 1969 an ad hoc committee met at CDC, serious debate about ending experiment, but in the end it decided to continue. Also, consent to continue was asked from Macon Cty. Medical Society (now mostly black). The men still alive (56 with syphilis and 36 control) would be monitored until their death. CDC wrote this back to Buxtun who was still in law school. He talked to a few colleagues (one suggested the ACLU file a suit), but Buxtun left it until he mentioned it to a friend who was a reporter for the AP, who became very interested. It was Feb. 1972. Another reporter, Jean Heller, in Washington got the assignment and the story broke on July 25, 1972. An assistant secretary of HEW responded he was “shocked and horrified” at the report. Another ad hoc panel was immediately created (Aug. 24, 1972); Feb. 1973 Sen. Kennedy began hearings. http://www.myclinicalresearchbook.blogspot.com
  • Tuskegee Syphilis Study: In short July 25, • Story breaks in Washington Star 1972 Aug. 24, • Ad hoc panel created at PHS to review experiment 1972 • Panel recommends ending the study Oct. 1972 Feb.-Mar. • Edward Kennedy begins Senate hearings 1973 • HEW Secretary (Weinberger) orders treatment for subjects in Mar. 3, study 1973 http://www.myclinicalresearchbook.blogspot.com
  • Tuskegee Syphilis Study: In short • $1.8 billion lawsuit filed by patients and families July 1973 • New guidelines for human subject experiments 1974 • Govt. settles lawsuit ($37,500 to each living survivor Dec. and $15,000 to heirs) 1974 • Govt. extended treatment to wives and children who 1975 had contracted syphilis • Clinton apologizes in person to 4 of the 8 survivors 1997 http://www.myclinicalresearchbook.blogspot.com
  • Tuskegee Syphilis Study -  Became a major factor in the writing of the 1979 Belmont Report which guides human subject research today in the U.S and others. http://www.myclinicalresearchbook.blogspot.com
  • Basic Principles of Belmont Report The 3 basic ethical principles of Belmont report are - Autonomy - Beneficence - Justice http://www.myclinicalresearchbook.blogspot.com
  • Thank You Benhur Pradeep pradeep.ben84@gmail.comwww.presentationpoint.com http://www.myclinicalresearchbook.blogspot.com