“Ethically impossiblE” STD Research in Guatemala from 1946 to 1948 september 2011 About the cover: Detail taken from historical map Complete map shown above Author: Schrader; vivien St Martin, L. Date: 1937 Short title: Mexique Publisher: Librairie hachette, Paris type: Atlas Map Images copyright © 2000 by cartography Associates David rumsey historical Map collection www.davidrumsey.com “Ethically impossiblE” STD Research in Guatemala from 1946 to 1948 Presidential Commission for the Study of Bioethical Issues Washington, D.C. September 2011 www.bioethics.gov “EThically impossiblE” STD Research in Guatemala from 1946-1948 abouT ThE PresidenTial commission foR ThE STuDy of BIOETHICAL Issues Thep residential commission for the Study of bioethical issues (the commission) is an advisory panel of the nation’s leaders in medicine, science, ethics, religion, law, and engineering. Thec ommission advises the president on bioethical issues arising from advances in biomedicine and related areas of science and technology. The commission seeks to identify and promote policies and practices that ensure scientific research, health care delivery, and technological innovation are conducted in a socially and ethically responsible manner. for more information about the commission, please see www.bioethics.gov. ii contents pREFACE ........................................................................................................ 1 BACKGROUND .............................................................................................. 9 Terre haute prison Experiments, 1943-1944 ................................................ 13 Implementing the Experiments .................................................................. 20 Developments in the Science and prevention of Sexually Transmitted Diseases ... 23 GUATEMALA EXpERIMEnTS 1946-1948 .................................................... 27 initial Experiment Design ........................................................................... 28 Treatment programs and Goodwill Efforts ................................................... 32 Serological Experiments .............................................................................. 36 Penitentiary ............................................................................................ 37 Children ................................................................................................. 38 Leprosarium ............................................................................................ 40 Psychiatric Hospital ................................................................................. 41 intentional Exposure Experiments ............................................................... 41 Overview ................................................................................................ 41 Gonorrhea Experiments ............................................................................ 43 Syphilis Experiments ................................................................................ 52 Chancroid Experiments ............................................................................ 69 Winding Down the Guatemala Experiments ................................................ 70 Extension of the Grant ............................................................................ 70 Disposition of the Laboratory .................................................................... 71 Race and Secrecy during the Guatemala Experiments ................................... 72 Issues of Race ........................................................................................... 72 Concerns about Secrecy ............................................................................. 74 ThE POST-CUTlER CONTINUATION OF ThE GUATEMALA EXpERIMEnTS AND FINAL REPORTS 1948-1955 ....................................... 81 Serology Experiments .................................................................................. 82 continuing observations ............................................................................ 83 PUBLICATION OF ThE GUATEMALA DaTa ............................................. 85 AFTERWoRD ............................................................................................... 87 REViEWING ETHICAL STANDaRDS IN CONTEXT ................................. 91 current human Research protections and Ethical Requirements of our own Time .......................................................................................................... 92 longstanding Ethical principles .................................................................. 93 contemporaneous Standards for Ethical Research in 1946-1948 .................. 97 Evaluating General mitigating arguments ..................................................101 Evaluating historically Specific mitigating arguments ............................... 104 iii “EThically impossiblE” STD Research in Guatemala from 1946-1948 The Guatemala Experiments—looking back, looking ahead, and apportioning blame ..................................................................................107 TABLES AND FIGuRES ..............................................................................109 Table 1: The cutler Documents .................................................................. 110 Table 2: individuals involved in the STD Experiments in Guatemala ...........112 Table 3: Timeline of all Guatemala Experiments ......................................... 116 Table 4: Subject and population Specific Data ............................................. 118 figure 1: organizational chart of the office of Scientific Research and Development ............................................................................................ 120 figure 2: organizational chart of the national Research council ...............121 figure 3: organizational chart for the u.S. public health Service, 1946 ....... 122 figure 4: organizational chart for the national advisory health council, December 1946 ........................................................................................ 123 figure 5: organizational chart for the Syphilis Study Section .................... 124 figure 6: intentional Exposure Experiments Goals over Time ......................125 figure 7: intentional Exposure Experiments over Time ............................... 126 figure 8: methods of Exposure over Time .................................................. 127 GLOSSaRy OF KEy TERmS........................................................................ 129 APPEnDICES ................................................................................................137 appendix i: Waiver form proposed in preparation for the Terre haute Experiments ............................................................................................. 138 appendix II: chancroid Experiment Report Excerpt ...................................141 appendix III: investigation methods ..........................................................142 Research in Guatemala ............................................................................146 Advisors to the Investigation .....................................................................146 Targeted Interviews .................................................................................148 Staff Delegation to Guatemala ................................................................148 Translation ............................................................................................148 appendix iV: Subject Database methods ..................................................... 149 Creation of Subject Database ...................................................................149 Subject Database Quality Control ............................................................ 151 Limitations ............................................................................................ 153 Figures 6, 7, and 8..................................................................................154 appendix V: Suggestions for further Reading ............................................. 155 EnDNOTES .................................................................................................. 159 INDEX ..........................................................................................................201 iv presidential commission for the Study of bioethical issues President Barack Obama The White House 1600 Pennsylvania Avenue, NW Washington, DC 20500 Dear Mr. President: On behalf of the Presidential Commission for the Study of Bioethical Issues, we present to you this report, “Ethically Impossible”: STD Research in Guatemala from 1946 to 1948. In response to your request of November 24, 2010, the Commission oversaw a thorough fact-finding investigation into the specifics of the U.S. Public Health Service-led studies in Guatemala involving the intentional exposure and infection of vulnerable populations. Following a nine-month intensive investigation, the Commission has concluded that the Guatemala experiments involved gross violations of ethics as judged against both the standards of today and the researchers’ own understanding of applicable contemporaneous practices. It is the Commission’s firm belief that many of the actions undertaken in Guatemala were especially egregious moral wrongs because many of the individuals involved held positions of public institutional responsibility. The best thing we can do as a country when faced with a dark chapter