By Gary Evans, Medical Writer
Among the most outrageous transgressions in research ethics were the U.S. Public Health Service’s (PHS) sexually transmitted disease (STD) experiments in Guatemala beginning in the 1940s.
Bioethicists recently published a case study1 of this horrific chapter in human research history after comprehensively reviewing all the records of the Guatemala experiments. The most egregious aspect was that some participants were intentionally infected with syphilis and other STDs.
“It is critical that people like IRB professionals and those of us in research ethics are continually reminded of the reason that we have the regulatory structures and institutional approvals that we do today. I think often people don’t quite realize how bad it got,” says Kayte Spector-Bagdady, JD, MBioethics, chief of research ethics at the Center for Bioethics and Social Sciences in Medicine at the University of Michigan.
Incredibly, after more than a half-century, the books have not been closed on this research debacle. Earlier this year, a federal judge allowed a $1 billion lawsuit to proceed against several groups allegedly involved in the experiments.
“The Guatemala STD experiments still represent an ongoing saga,” she says.
On Jan. 3, 2019, a federal judge in Maryland ruled the lawsuit could proceed, denying an appeal by the defendants that a prior Supreme Court ruling protected them against international claims in such cases.
According to the complaint, which U.S. District Judge Theodore Chuang allowed to proceed, “Plaintiffs estate of Arturo Giron Alvarez and 773 other Guatemalan nationals have filed a civil action against the Johns Hopkins University and four affiliated entities, the Rockefeller Foundation, and Bristol-Myers Squibb Company. Plaintiffs allege that defendants subjected them or their family members to medical experiments in Guatemala without their knowledge or consent during the 1940s and 1950s, in violation of the law of nations.”2
Johns Hopkins and others named in the suit denied the allegations and will continue to contest the claim.
Military Readiness
STD research in the 1940s was considered critical because the infections sidelined many military personnel during WWII. With the 1943 discovery of penicillin, the PHS wanted to take a preventive step and develop an STD prophylaxis. Preventing STDs would ensure military readiness and prevent the expense and delays of penicillin treatment. Among the first iterations of this research was a post-exposure wash that could be applied after sexual contact to theoretically prevent STD infections.
“John C. Cutler, a senior surgeon at PHS who later was the lead investigator in Guatemala, believed that before the wash would be ready for widespread use in the U.S. Armed Services, it should be tested via controlled experiments on subjects at high risk for infection,” the authors of the case study report.
However, the experiments conducted in 1946-1948 included highly vulnerable populations without informed consent. Disturbingly, these included Guatemalan children, prisoners, and psychiatric and leprosy patients. The experiments with children were apparently to distinguish between congenital syphilis from sexually acquired disease, and the records did not show any children were intentionally infected.
Unfortunately, others were. Here we have the most unconscionable aspect of the experiments, which was apparently done in the name of expediency. Instead of the long-term commitment and ethical standards of a randomized clinical trial, the PHS researchers tested the wash intervention by intentionally exposing some 1,300 prostitutes, soldiers, prisoners, and psychiatric patients to STDs, the authors report.
Many that developed subsequent infections did not receive treatment. Not only are there no records of informed consent, there is evidence that participants were deceived, the authors determined. At least 83 people died during the experiments, but there is little data establishing a direct link to the research. PHS supervisors expressed concern to the principal investigator about the research, but apparently made no attempt to stop it. Although research standards were less stringent, the PHS knew the research was unethical and decided to bury it from the public record, the case study authors concluded.
Decades later, Cutler donated the Guatemala research record to the University of Pittsburgh School of Public Health, where he had been a faculty member, before his death in 2003. The act of voluntarily donating this material speaks volumes to the ethical blind spot with which the PHS researcher viewed this work.
“He didn’t think what he did was wrong, and in fact, wanted people to know,” Spector-Bagdady says.
On the other hand, the data had been hidden in the first place because the PHS knew it was unethical, she adds.
“He had supervisors at that time who said, ‘No, what you did was wrong, and you need to hide it,’” she says. “This indicates to us that this [case study] is not a retrospective moral judgment, where we say by the standards of today we are judging what people did in the 1940s. Actually, they knew that what they were doing was wrong at the time.”
The documents were subsequently discovered by a historian and turned over to the CDC in 2010. Then-President Barack Obama apologized to the people of Guatemala and ordered a fact-finding commission, which in 2011 published a report of the atrocities.3
“The passage of more than 60 years between this research and its public revelation not only denied study subjects a remedy for the harms they endured, but also erased any opportunity to modify the research ethics regime as it formed in response to this historical failure,” the case study authors concluded.
Acknowledge the Past
IRB Advisor asked Spector-Bagdady to comment further on the Guatemala STD experiments in the following interview, which has been edited for length and clarity.
IRB Advisor: For medical purposes, the National Institutes of Health is conducting the All of Us initiative to obtain DNA of a diverse group of 1 million people. Do you think such efforts can be successful, considering ethical failures like the Guatemala STD exposures?
Spector-Bagdady: It is very valid that members, particularly of minority communities, are suspicious of the harms that have been levied upon them by the medical and research profession. Tuskegee, Guatemala — there are hundreds of examples of the medical and research profession victimizing people. I understand why they would be hesitant to engage. That said, I think the programs like All of Us are doing the right thing by not just saying “how can we recruit more people,” but saying “how can we reconceptualize what it is to be a research participant? How can we provide full transparency and engagement to research participants, such that we change the entire system and people feel in control and more comfortable?”
IRB Advisor: So, revisiting and discussing transgressions like this can actually contribute to more representative research?
Spector-Bagdady: I think it is really important to be honest and transparent about the harms that were done in the past so that we can move forward from a place of mutual understanding. We can’t go forward unless we admit what we have done already that put people in the position of being rightfully suspicious. And it is important that we have a diverse group of participants to work with for research. If we don’t have diverse communities represented, it means that our research might not be as useful, relatable, or applicable to a diverse set of communities.
This is particularly true for things like genetics research or precision medical work that is so closely tailored to small variations in people’s genes. If we don’t have a large population from which we can pull the data to do this kind of research, we worry that our findings will be more applicable to certain portions of the community than others.
IRB Advisor: The initial push for this was to protect WWII soldiers, but the intentional exposures to vulnerable populations did not occur until after the war. What drove this unethical research forward in the absence of a wartime imperative?
Spector-Bagdady: Yes, the research was actually started in earnest after the war was over. It wasn’t quite as urgent because the U.S. Armed Forces weren’t at risk of STDs with the same regularity that they had been during the war. But we prepare for military medicine in times of peace just as in times of war. Because this had been such an incredible problem in WWII, and it was the obvious next step of their work, I think that really drove this research.
IRB Advisor: How would you compare this historical travesty to others like Tuskegee and the “Unfortunate Experiment” of leaving cervical cancer untreated in women in New Zealand?
Spector-Bagdady: Comparing research ethics scandals is a zero-sum game. One doesn’t need to be worse than the others for us to learn from them all.
IRB Advisor: When you look into this case, do you consider that this is maybe as much evidence of evil people as unethical science?
Spector-Bagdady: That is a good question. I think it would be too dismissive to just say that these things occurred because of an evil person or a couple of evil people. Because many men — white men at the highest echelons of science — knew what was going on. They knew exactly what was happening, and no one stopped it. This was much broader. Yes, I do think John Cutler was an incredibly immoral and hurtful person. However, there was a system that allowed him to victimize thousands of people. It takes a system. This was sponsored by the Public Health Service. It was funded by the National Institutes of Health. The most important men in syphilisology and infectious diseases knew that this was happening.
IRB Advisor: You mention in the paper an undercurrent of racism that may have contributed to the research mindset.
Spector-Bagdady: All of the experiments involved vulnerable populations including women, children, minorities, and people with mental disabilities. It involved psychiatric patients and prisoners, and the people who populated those institutions were largely from the indigenous communities in Guatemala. They were sort of doubly vulnerable. They did not speak the English the Americans were speaking, but they also did not speak the Spanish that the Guatemalans spoke.
REFERENCES
1. Spector-Bagdady K, Lombardo PA. Case Study: U.S. Public Health Service STD Experiments in Guatemala (1946-1948) and Their Aftermath. Ethics and Human Research; 20 March 2019, 41: 29-34.doi:10.1002/eahr.500010.
2. Estate of Arturo Giron Alvarez et al v. The Johns Hopkins University et al. U.S. District Court of Maryland. No. 1:2015cv00950 - Document 204 (D. Md. 2019) Civil Action No. TDC-15-0950. Jan. 3, 2019.
3. Presidential Commission for the Study of Bioethical Issues. “Ethically Impossible”: STD Research in Guatemala from 1946 to 1948. Washington, DC: Government Printing Office, 2011.
Bioethicists recently published a case study of this horrific chapter in human research history after comprehensively reviewing all the records of the Guatemala experiments. The most egregious aspect was that some participants were intentionally infected with syphilis and other STDs.
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