Unearthed Syphilis Study Demonstrates the Purpose of Ethical Regulations in Human Clinical Trials

Robert Enneser by Robert Ennesser

In 1946, American researchers went to Guatemala and infected 1500 prisoners, orphans, and patients in mental institutions with syphilis and gonorrhea under a U.S.-Guatemalan government partnership.  Today, such experimentation would not occur because of strict research requirements including documenting details of human research and obtaining approval from Institutional Review Boards to move forward with human research.  While ensuring research requirements are met can seem tedious for researchers, Professor Susan Reverby of Wellesley College recently provided a reminder of why those regulations are in place – to ensure the safety of human participants in clinical studies.

On Friday, October 1, 2010, Secretary of State Hillary Clinton and Secretary of the Department of Health and Human Services Kathleen Sebelius apologized to Guatemalans affected by a U.S. Public Health Service syphilis study take took place from 1946 to 1948.  In an abhorrent experiment, researchers infected more than 1500 individuals with syphilis or gonorrhea-causing bacteria by either causing abrasions or encouraging visits with prostitutes known to be infected.  Most of the experimental cohort, made up primarily of prisoners, soldiers, and inmates at a mental institution, were treated with antibiotics, but up to one-third did not have received any treatment.

The Guatemalan syphilis study, unearthed by Professor Reverby, was headed by Dr. John Cutler – a researcher later involved in the infamous Tuskegee syphilis study  as well as a similar experiment at the Sing Sing Penitentiary in New York.  The Tuskegee study ran from 1932 to 1972 and exploited untreated syphilis in African-American men in Macon, Alabama in the name of research.  The Sing Sing study involved an attempt to produce a vaccination against syphilis by using dead syphilis bacteria.

There are two main differences between the Tuskegee and Guatemalan studies.  In the Tuskegee study, the researchers (1) did not infect the participants and (2) failed to treat the participants.  The researchers purposely did not treat the participants who were suffering in order to determine the progression of disease.  In the Guatemalan study, researchers (1) infected test subjects – with the blessing of the Guatemalan government – to test the effectiveness of antibiotics and (2) treated most of the subjects.  As many as one-third of participants infected in the study did not receive treatment.

It is easy to condemn the research of Dr. Cutler – his actions put people at risk of serious diseases and jeopardized the health of hundreds of people.  It is more difficult to overcome the apparent public acceptance of these events.  Although our modern media condemns these syphilis studies as a dark chapter in U.S. medical history, media in the era of these experiments was much more accepting. For example, newspapers reported favorably on the results from Dr. Cutler’s Sing Sing Penitentiary syphilis experiments.  On December 8, 1954, the Tusculoosa News reported “[a]n injection of killed syphilis organisms apparently protected part of the volunteers who previously had syphilis from being infected a second time when inoculated with live organisms.”  The Tusculoosa News did not report Dr. Cutler’s dangerous research methods.

The U.S. has changed its stance to promote ethical treatment of research subjects. Modern ethical tenets have produced stringent human research requirements of informed consent, patient risk-benefit analysis by an Institutional Review Boards, and awareness of special protections needed for vulnerable populations such as prisoners and mentally disabled persons.  Dr. Cutler’s atrocious experiments and his attitudes toward human research are a period in our history we would like to forget.  But we shouldn’t forget completely.  Because Dr. Cutler and the syphilis experiments remind us of the dangers of unchecked ethical behavior in the name of science and remind modern researchers of the purpose of ethical restraints on human research.