Responsible Conduct (MEDI 5070) 4/15/2017 Time Line for Human Subject Research and Protection Tuskegee Study – 1932-72 Declaration of Helsinki - 1964 Nuremberg Code - 1947 WWII – 1939-45 Eugenics Movement 1900 10 20 30 40 50 60 70 80 90 2000 Tuskegee Study

Tuskegee Study of Untreated Syphilis Responsible Conduct (MEDI 5070) 4/15/2017 Tuskegee Study of Untreated Syphilis 1932-1972 Tuskegee Study

Gender and Race Related Manifestations in 6,420 Cases of Late Syphilis Responsible Conduct (MEDI 5070) 4/15/2017 Gender and Race Related Manifestations in 6,420 Cases of Late Syphilis From: Sowder WT. An interpretation of Bruusgaard’s paper on the fate of untreated syphilitics. American Journal of Syphilology 1940; 24:684-691 Tuskegee Study

Tuskegee Study Rationale - 1932 Was there enough information to justify a cohort study of untreated Negro men? Were effective treatments available for managing syphilis?

Tuskegee Study of Untreated Syphilis Negro Men Infected with Syphilis 1932-1972 Macon County, Alabama

Alabama

Cotton Pickers – 1938 - Arkansas Russell Lee – Farm Security Administration Library of Congress - LC-USF33- 011671-M2

Incentives for Participation Burial costs Periodic Examinations

Nurse Eunice Rivers and Unidentified Subject Cotton Field – Macon County, Alabama (Centers for Disease Control, Atlanta, GA)

Field Follow-up: Tuskegee Study - 1952 Mr. David Albritton, Dr. Walter Edmondson, Nurse Eunice Rivers, and Unidentified Subject Macon County, Alabama (Centers for Disease Control, Atlanta, GA)

Tuskegee Study: Press Reaction - 1972

William Osler, M.D. “Believe nothing that you see in the newspapers – they have done more to create dissatisfaction than all other agencies. If you see anything in them that you know is true, begin to doubt it at once.” 1900

Rudolf H. Kampmeier, M.D. Editorials: The Tuskegee Study of Untreated Syphilis. Southern Medical Journal 1972; 65 (10): 1247-1251 Final Report on the “Tuskegee Syphilis Study.” 1974; 67 (11): 1349-1353 Argues that the Tuskegee study should be interpreted in the context of the times in which it was conducted.

The Shibboleth of Informed Consent “…I have no intention of becoming entrapped in this topic since to me the interpretation of customs and mores of a generation or two ago in today’s terms is a tilting at windmills…. In the days of the Tuskegee Study we used to walk into a patient’s room and announce ‘We’re going to take out your gallbladder tomorrow morning,’ the answer commonly was, ‘OK’ and that was it – no ‘informed consent,’no signed paper of permission – ergo, Jenner, the Hunters, Pasteur, and hundreds of thousands of physicians and surgeons of the past have been unethical in terms of ‘informed consent.’” Kampmeier, RH. Southern Medical Journal 1974; 67:1349-1353

Tuskegee Study - 1972 What is the evidence that treatment of tertiary syphilis with penicillin changes outcomes? What proportion of cohort participants received antibiotics over the course of the study? How complete was the cohort follow-up?

White House Apology Ceremony – May 16, 1997 Responsible Conduct (MEDI 5070) 4/15/2017 White House Apology Ceremony – May 16, 1997 Front Row (left to right): Herman Shaw, Fred Simmons, Charles Pollard, Frederick Moss, Carter Howard. Back Row (left to right): Surgeon General David Satcher, President William J. Clinton, Vice-President Albert Gore. Tuskegee Study