Researchers knowingly violated ethical boundaries when they intentionally infected Guatamalan prisoners, mental health patients, and prostitutes with sexually transmitted diseases in a 1940s research project, a presidential commission concluded yesterday.
When the harrowing experiments came to light (see ‘A shocking discovery’), President Barack Obama charged the President’s Commission for the Study of Bioethical Issues with investigating the matter. After picking through 125,000 pages of historical documents, the committee determined that the experiments were unethical even by the prevailing norms of the era, and that those who conducted the research actively sought to keep experiments out of the public eye.
It was also no accident that the research was performed in Guatemala, argued Amy Gutmann, chairwoman of the commission and president of the University of Pennsylvania. “Some of the people who were involved in this experiment explicitly said, ‘We could not do this in our own country’,” she said. “It was a foreign population that was seen as ethnically, racially, nationally different.”
“The only way you could continue doing this is to think of what you were working on as material as opposed to human subjects,” Gutmann added.
The work was also in clear opposition to ethical standards of the time, argued Nelson Michael, director of the US Military HIV Research Program. “I’m not aware of any standards that would have said, ‘it’s ok to go offshore to do this kind of research’,” he said. “They did it because they found a doorway that they found darkened and they went through it.”
Sexually transmitted diseases, including gonorrhea and syphilis, were among the biggest threats to public health at the time. It was estimated that 20% of the people living in psychiatric institutions were there because of the neurological effects of advanced syphilis. The researchers in the Guatemalan study, which included John Cutler, an architect of the Tuskegee syphilis experiments, were looking for a way to prevent the spread of such diseases. But despite that sense of urgency, the studies carried out in Guatemala were poorly designed, poorly executed, and entirely unethical, the commission concluded.
All told, the commission found that more than 5,000 people were enrolled in either or both of the programme’s two research arms: one in which prisoners, the mentally ill, and prostitutes were intentionally infected with disease, and another in which blood and spinal fluid was tested for background levels of the infectious agents. The latter studies were also conducted in young Guatemalan orphans. All of the experiments were performed without consent of the subjects.
The commission found evidence of 83 deaths, but could not determine to what extent the deaths were likely to be related to the experiments.
The committee is still writing up its conclusions, and plans to submit a report on the historical study to Obama in September. It will also prepare a second report – following a probe into the adequacy of current policies to protect human research subjects – by the end of the year.
John Arras, a philosopher at the University of Virginia, said that he initially struggled with the decision over whether the researchers deserved blame for the ethical transgression. But the details of the experiments wiped away any doubt, he added.
Arras then detailed the stomach-churning case of Berta, a patient in a psychiatric ward who was injected with syphilis and not given treatment until three months after her infection. Soon after, Cutler wrote that Berta seemed about to die. That same day, he put gonorrheal pus from another patient into both of her eyes, her urethra, and her rectum. He also re-infected her with syphilis. Several days later, her eyes were filled with pus from the gonorrhea and she was bleeding from her urethra.
Six months later, Berta was dead.
“I would submit that this kind of case cannot be waved away by even the most acute awareness of fluctuation in medical ethics standards of the time,” Arras said.