Medical historian Susan M. Reverby was researching syphilis in 2010 when she unearthed a cache of shocking documents from the U.S. Public Health Service (USPHS). These unpublished papers, dating from 1946 to 1948, revealed that the U.S. government funded a study in Guatemala to test the effectiveness of penicillin in treating STDs such as gonorrhea, chancroid (which causes genital sores) and syphilis.
Why? Franklin Delano Roosevelt was determined to find cures for the sexually transmitted diseases (STDs) that plagued U.S. soldiers during World War II. He charged the top brass in military medicine with this mission. Some researchers thought penicillin could prevent infection after exposure to the venereal diseases, and the Guatemalan study was set up to test this theory.
The U.S. Department of Health and Human Services estimates that 1,300 were involved in the study. The New York Times' overview of the subsequent White House bioethics panel investigation numbers the subjects at 5,500, with 1,300 infected as a result of the experimentation.
The leader of the experiment was Dr. John C. Cutler, a dean of the University of Pittsburgh, who'd investigated the spread of STDs at a prison in Terre Haute, Indiana, in the early 1940s and who would go on to supervise the Tuskegee experiments in Alabama. In the Terre Haute experiments, prisoners were asked for their consent to be infected with gonorrhea and awarded commuted sentences for participation in the study. In Tuskegee, African-American sharecroppers who had syphilis were told they were being treated for the disease but were, in fact, simply being observed without medical treatment.
Between the Terre Haute and Tuskegee experiments, Cutler spent 1946-1948 in Guatemala, studying prisoners, prostitutes and patients with mental retardation. In Reverby's report, she explains that infecting subjects with syphilis — "syphilization" — was a method used to monitor the body's response to "fresh infective material," observations from which could empower scientists to better understand "superinfection and reinfection."
That was just part of Cutler's objective. The other part was to find a preventive measure to combat the disease directly after exposure. In military medicine, the go-to preventative was calomel sulphathiazole ointment, which reportedly caused major discomfort. Could penicillin be a less painful, more effective alternative?
Cutler's team infected prostitutes with syphilis, then ushered them into prisons to have sexual intercourse with prisoners and spread the disease. For those who didn't contract the disease through intercourse, Cutler directed his team to abrade their faces or genitals, then directly transfer the bacteria into open wounds. Some prisoners had the bacteria injected into their spines. The same methodology was used in mental hospitals, and documentation shows that patients were injected with syphilitic bacteria in their spines, base of their skulls or in moist, open points of entry, such as the eyes and rectum.
It probably goes without saying that the subjects of the experiment did not give their consent for participation and weren't aware they were being given syphilis. Of those infected, an estimated 700 were treated — and not all of them were given appropriate doses of penicillin. At least 83 died, though there is no proven correlation between death and syphilitic infection.
As he conducted his research, officials back in Washington grew uneasy about Cutler's work. The USPHS physician R.C. Arnold, one of Cutler's supervisors, thought the experiment was ethically dubious. "I am a bit, in fact more than a bit, leery of the experiment with the insane people," Arnold said. "They cannot 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. I think the soldiers would be best or the prisoners for they can give consent. Maybe I'm too conservative."
What was Cutler's response to this kind of criticism?
Reverby found letters that reflected Cutler's anxious state of mind, well aware he was pushing the boundaries of ethical conduct. Her report includes this excerpt from Cutler's collected correspondence: "As you can imagine ... we are holding our breaths, and we are explaining to the patients and others concerned with but a few key exceptions, that the treatment is a new one utilizing serum followed by penicillin. This double talk keeps me hopping at time."
Cutler also wrote that he was worried his experiment might be shut down with "a few words to the wrong person here, or even at home" that "might wreck it or parts of it."
His fears were justified. In 1948, Reverby reports that Cutler was summoned home and reassigned to a new project. He was directed to leave behind his "laboratory materials," and he never published his findings in medical journals (although a colleague did publish some details).
Decades Later, a Discovery
Cutler went on with his career, and the dark secrets of his experimentation lay mostly buried until Reverby's research uncovered them in 2010. The White House assembled a bioethics panel to investigate the case, and as a result of their findings, President Obama issued a formal apology to the president of Guatemala, and Secretary of State Hillary Clinton and Health and Human Services Secretary Kathleen Sebelius also issued a statement and apology. The five remaining survivors, all aged 80 or older, were located and given medical tests and treatment.
Addressing the scope and structure of Cutler's experiment, Reverby remarks that the researcher drew from "the usual quartet of the available and contained," that is, prisoners, mental hospital patients, children and soldiers. These are parties who are less empowered or powerless to give consent.
Dr. Catharine Young, who works in biomedical sciences and is currently serving as Senior Science and Innovation Policy Advisor for the British Embassy, says, "If you speak to scientists who are involved in human research, you will find that the culture is one of: 'If you are not willing to test it on yourself, don't do it to others.'" Young adds, "It is also important to realize that research follows the same principles as medicine, in that even if one is conducting research for the benefit of the society as a whole, you first do no harm to the individual (the subject)."
She explains that the 1960s saw the implementation of institutional review boards (IRBs) "in part because of cases like Cutler. Thankfully, because of these regulations and the many safeguards in place, the culture simply does not allow for these types of practices to occur."
So, is this to say that there's no longer experimentation performed on anyone who can't give consent? The answer is complicated.
"Take children, for example," Young says. "Children are unable to consent legally because they do not understand what they are volunteering for. Their guardians may consent on their behalf." This doesn't mean that scientific research shouldn't be conducted with children.
"Often the most critical research populations that require the most attention are those who cannot consent for themselves — consider Alzheimer's patients, for another example." Young clarifies, "While the benefit of research on these individuals could ultimately lead to enhancing lives in the future, it should never be at the psychological or physical risk of the subject."
Cutler might have had aspirations of eradicating syphilis or finding a more soldier-friendly treatment for infection, but he endangered thousands of lives and double-talked to make progress in his living Guatemalan laboratory.
"As scientists, we have a duty to ensure that we contribute to the progression of our respective fields; however, our work should never place us in a position whereby our lives become more important than the lives of our subjects," Young says. That is where Cutler failed and why the United States apologized on behalf of him decades after his files were buried and lost to time.