“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 Through Dr Sencer’s, the -at the time- still unpublished paper made it up the chain of command through CDC to the National Institutes of Health, the Department of Health and Human Services (DHHS), the Department of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.

President Obama calls for a review of human subjects’ protection following the unraveling of the Guatemala STD study.

On October 5, 2010, I reported on this same blog on the recently discovered Tuskegee-like scandal, which took place in Guatemala in the ’40s and saw the purposeful infection of prisoners and other vulnerable populations with the syphilis bacterium (https://humanitiesandhealth.wordpress.com/2010/10/05/clinton-delivers-formal-apology-for-a-newly-discovered-tuskegee-like-study/). The study was only recently brought to light thanks to the studies of Wellesley College history professor Susan Reverby, which resulted in a formal apology delibered by Secretary of State Hillary Clinton on October 1, 2010, much on the footsteps of the apology given by former President Bill Clinton in 1997 to the Tuskegee victims.

More than two months have passed since Hillary Clinton’s public apology, and now President Obama has officially asked the Presidential Commission for the Study of Bioethical Issues to undertake an exhaustive review of human subjects’ protection guidelines. As we can read in the Presidential Memorandum, says Obama:

In light of this revelation [The Guatemalan study], I want to be assured that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally. I ask you, as the Chair of the Presidential Commission for the Study of Bioethical Issues, to convene a panel to conduct, beginning in January 2011, a thorough review of human subjects protection to determine if Federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the Federal Government. I also request that the Commission oversee a thorough fact-finding investigation into the specifics of the U.S. Public Health Service Sexually Transmitted Diseases Inoculation Study”.

The Presidential Commission for the Study of Bioethical Issues was appointed by Barack Obama one year ago to substitute the dismantled “President’s Council of Bioethics” and is chaired by political theorist Amy Gutmann, who symbolizes the greater emphasis put by the President on the policy implications of ethical positions taken by the Commission.

The past few years have witnessed an increasing number of clinical trials being moved offshore, i.e. to low and middle income countries, and as reported by Nellie Briston on the Lancet this week: “A thorough review of the safeguards in place to protect modern human trial participants is appropriate and timely” .

Also on a related topic, the Commission will need to explore the relationship between the FDA and Helsinki Declaration regulating internationally clinical research on human subjects. The Helsinki Declaration was controversially shelved by the FDA in October 2008, which favoured instead the adoption of Good Clinical Practice (GPC) Guidelines, which represent a weaker ethical standard as, for example, they are silent on the use of placebos in clinical trials when there exists an active treatment as an alternative.

The Presidential Commission will start its work on the issue in January and has 9 months to deliver the reports.

Further readings

Bristol, N. US reviews human trial participant protection, The Lancet 2010; 376(9757):1975-6, doi:10.1016/S0140-6736(10)62247-7; http://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2962247-7/fulltext?rss=yes

Camporesi, S. The FDA decision to shelve the Helsinki Declaration: Ethical considerations, ecancermedicalscience, June 10, 2008; doi=10.3332/eCMS.2008.LTR76, http://www.ecancermedicalscience.com/comment-letters-to-the-editor.asp?doi=10.3332/eCMS.2008.LTR76#letter

McNeil, D. U.S. Apologizes for Syphilis Tests in Guatemala, The NewYorkTimes, October 1, 2010, http://www.nytimes.com/2010/10/02/health/research/02infect.html

Presidential Memorandum-Review of Human Subject Protection, November 24, 2010, http://www.whitehouse.gov/the-press-office/2010/11/24/presidential-memorandum-review-human-subjects-protection