“Ethically impossible”, report of US Presidential Bioethics Commission on STD Guatemala Study. An instance of history of medicine shaping the bioethics agenda.

“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.”

These words open the 1st report of the US Presidential Commission on the Study of Bioethical Issues (the Commission) on the STD Guatemala Study, whose investigation was triggered by the historical analysis of Susan Reverby, Professor in the History of Ideas and Professor of Women’s and Gender Studies at Wellesley College, published in the Journal of Policy History in 2011. Professor Reverby gave a draft of her JPH paper in late June 2010 to Dr. David Sencer, former director of the Centers for Disease Control and Prevention (CDC) and who recently passed away in May 2011. Through Dr Sencer’s, the -at the time- still unpublished paper made it up the chain of command through CDC to the National Institutes of Health, the Department of Health and Human Services (DHHS), the Department of State, and the White House.

On October 1, 2010, Secretary of State Hillary Rodham Clinton and Secretary of DHHS Kathleen Sebelius offered a formal apology to Guatemala for this research, which they called “abhorrent,” “unethical,” and “reprehensible”, as you can read on an older post on this same blog. On November 24, 2010, President Obama charged the Commission with a 9-month task to undertake both a forward-looking assessment of research ethics and an historical review of events that occurred in Guatemala between 1946 and 1948.

During the nine months from January 2011 to September of the same year, the Commission held three public meetings addressing the President’s requests, and heard from experts in law, history, medicine, and ethics, and received testimony from members of the public.

Susan Reverby

With dual responsibilities to give a full and fair accounting of events largely hidden from history for nearly 65 years, and also to provide an assessment of the current system of protection of human subjects, the Commission decided to publish two reports. The first report, that aims to “uncover and contextualize as much as can be known at this time about the experiments that took place nearly 65 years ago”, while also aiming to inform current and continuing efforts to protect the rights and welfare of the subjects of US- sponsored or -conducted research, can be found here.

The “Ethically Impossible” report concludes, unsurprisingly, that many of the actions of the investigators of the study “disregarded principles widely accepted as applicable across time, as well as the standards of our own time that are embodied in the ethics and regulation of biomedical research today”. The Report also aims to reassure insofar as “the Guatemala experiments could not be approved under the current system for protecting human subjects in US-funded research”.

This story can be read as a contemporary instance of the history of medicine shaping and informing the current bioethics agenda at the highest level. While the ethical conclusions of the report are, perhaps necessarily, neither surprising nor particularly original, the work of the Commission was the necessary corollary of the public apology delivered by both Secretary of State Hillary Rodham Clinton, and represents an extremely valuable and extensive historical assessment of the ‘research study’.

Further readings

Susan Reverby’s article that triggered the Presidential Commission for the Study of Bioethical Issues’ investigation, titled “Normal Exposure” and Inoculation
Syphilis: A PHS “Tuskegee” Doctor in
Guatemala, 1946–1948, and published in the Journal of Policy History in 2011, can be dowloaded here.

“Ethically Impossible”, the full report of the US Presidential Commission for the Study of Bioethical Issues on the STD Research in Guatemala from 1946 to 1948, published in September 2011, can be downloaded from this page.

Secretary of State Hillary Rodham Clinton delivers formal apology for a newly discovered Tuskegee-like study, October 5, 2010, CHH Blog.

President Obama calls for a review of human subjects’ protection following the unraveling of the Guatemala STD study, December 10, 2010, CHH blog.

US Secretary of State Hillary Rodham Clinton delivers formal apology for a newly discovered Tuskegee-like study

Back in 1997 Bill Clinton delivered a public apology to the victims of the infamous Tuskegee study, where about 400 people infected with syphilis among the black sharecroppers in Alabama had been left deliberately without the existing cure, penicillin, so that doctors could follow the “natural course” of the disease. Together with the public apology delivered by former US president, a large financial aid (about $200,000) was offered to the people of Tuskegee and Macon Countee to set up the Tuskegee Bioethics Center, which was inaugurated in 1999.

Almost 15 years later, it is now the turn of another Clinton, namely Bill’s wife and current US secretary of State, Hillary Rodham Clinton, to give another formal apology for a study which shares many striking and scary similarities with the Tuskegee study.

Between 1946 and 1948, almost 700 Guatemalan prison inmates, mental patients and soldiers – categories which in medical ethics we would surely refer to as “vulnerable”- were deliberately infected by US doctors with the Treponema pallidum (the bacterium responsible for syphilis), with the aim of studying the effectiveness of penicillin as a treatment.

Infection modalities were to be chosen among the following three: a) infected prostitutes paid to infect their clients; b) Treponema pallidum bacteria poured directly onto the genital organs, face or arms of other individuals (for which apparently option a) was not available; or c) bacteria were injected directly by spinal puncture.
Apart from scenario a) then,  it is quite difficult to imagine that individuals were not realizing that something odd was going on!

The Guatemalan experiment was brought up by Susan M. Reverby, professor at Wellesley College, who had initially presented her research on the trial at a conference last January, though without eliciting any out-of-the ordinary attention. The deserved attention arrived a few months later, when in June 2010 Reverby sent a draft of the manuscript she was working on for the Journal of Policy History to Dr David J. Sencer, former Director of the US Center for Disease Control. It was then up to Dr Spencer – apparently a person of stronger political power than Dr Reverby – to push the US government to commence a deeper investigation on the case.

Susan Reverby had already found some documents about the Guatemalan case back in 1985, when she was working at the University of Pittsburgh. The documents were signed by Dr Cutler, “principal investigator” of the trial, and also later involved in – guess what?- the Tuskegee study (to note, esteemed professor Cutler kept defending the soundness of the Tuskegee trial in terms of science and ethics until his death-bed).

Among public reactions to Clinton’s (Hillary) apology, it seems to me interesting to report here the one by professor Mark Siegler, Director of the Maclean Center for Medical Ethics at the University of Chicago. According to Siegler, the Guatemalan study is much worse from an ethical point of view than the Tuskegee study. His rationale is the following: in the Tuskegee study, the black sharecroppers in Alabama were already infected with the venereal disease, and not given the existing treatment, whereas in the Guatemalan study men were being deliberately infected with the disease (the full comment by Professor Siegler can be read on the New York Times)

Which do you think is better (or less ethically blamable, I should maybe say): to deliberately infect individuals with various -more or less pleasurable- ways, and then cure them and try to save their lives; or deliberately not curing already infected and socially disadvantaged people?