US researchers intentionally infected about 1,300 Guatemalan prisoners, soldiers, and mental patients with syphilis, gonorrhea, or chancroid during the late 1940s, reports The New York Times. The studies were unearthed by Wellesley College's Susan Reverby, write Thomas Frieden, director of the Centers for Disease Control and Prevention, and Francis Collins, the director of the National Institutes of Health, in the Journal of the American Medical Association. As Reverby researched the Tuskegee syphilis study, she found papers from the Public Health Service's John Cutler that describe the Guatemalan study. (Cutler was later a Tuskegee investigator.)
"[The US] paid for syphilis-infected Guatemalan prostitutes to have sex with prisoners. When some of the men failed to become infected through sex, the bacteria were poured into scrapes made on the penises or faces, or even injected by spinal puncture," the Times says, adding that "the stated aim of the study was to see if penicillin could prevent infection after exposure. But the study's leaders changed explanations several times."
In their commentary, Frieden and Collins list the major ethical lapses of the study: a lack of valid informed consent, intentionally giving people a dangerous pathogen, and deception. They also note that the researchers recognized these ethical lapses. "I am a bit, in fact more than a bit, leery of the experiment with the insane people. They can not give consent, do not know what is going on, and if some goody organization got wind of the work, they would raise a lot of smoke," wrote Cutler's supervisor RC Arnold in a letter. The bioethics panel found during its investigation that the researchers conducted similar experiments on inmates in the US, but had used volunteers and obtained informed consent for that work, The Washington Post adds.
In JAMA, Frieden and Collins say that safeguards have been put into place to protect research participants, notably the Numerberg Code and the Declaration of Helsinki. However, the Times notes that Cutler "must have known from the Nuremberg doctors' trials under way by 1946 that his work was unethical."
"The NIH and CDC are committed to ensuring that lessons drawn from the past help shape actions to protect all future research participants, no matter where studies are conducted. The 1946-1948 inoculation study should never have happened, and nothing like it should ever happen again," Frieden and Collins write.
A subcommittee of the bioethics panel recommended that the US create a system to compensate people injured by scientific research trials, says the Post, adding that many other countries have such systems. "The panel felt strongly that it was wrong and a mistake that the United States was an outlier in not specifying any system for compensation for research subjects other than, 'You get a lawyer and sue,'" says Amy Gutmann, the chair of the panel.
The US government has formally apologized to the Guatemalan government. The Guatemalan government is conducting its own review of the experiments, but those results have not yet been released.