The U.S. presidential commission has found that U.S. government researchers violated ethical standards by deliberately infecting Guatemalan prison inmates and mental patients with syphilis for an experiment in the 1940s. This research did not treat Guatemalan participants as human beings and failed to inform them they were taking part in research study, calling into question the bioethics behind the study design.
Wellesley College historian Susan M. Reverby uncovered the disturbing experiments while reading papers from John C. Cutler, a doctor with the federal government’s Public Health Service. Cutler participated in the Tuskegee experiment, in which hundreds of African American men with syphilis in Alabama were left untreated to study the disease between 1932 and 1972. Cutler died in 2003. The commission concluded there will be consequences for U.S. diplomacy and will impact the ethical discussion surrounding how new drugs are tested on patients, as manufacturers increasingly conduct clinical trials abroad.
Guatemala condemned this study by the U.S. Public Health Service (PHS), calling it a crime against humanity and will potentially pursue this case in international court. Victims of the study plan to sue the U.S. government.
The Guatemala research from 1946 to 1948 was led by Dr. John Cutler under a NIH grant and in collaboration with several Guatemalan agencies. In addition, with the study conducted shortly after World War II, which reported use of prisoners and concentration camp inmates for human experiments, these researchers should have been aware of the breach of ethical standards. The commission’s investigators referred to this study as an “institutional failure.”
The researchers in Guatemala deceived the participants, who commonly were from vulnerable social groups. The participants included inmates who were exposed to infected prostitutes brought into jails, and male and female patients in a mental hospital. Some subjects had bacteria poured on scrapes made on their genitals, arms or faces. Additionally, the researchers kept poor notes, did not try hard to protect the subjects from risks, and conducted experiments in illogical order.
As a result, about 1,300 people were infected with venereal disease, and more than half of them with syphilis, a sexually transmitted disease. The patients were given antibiotic penicillin to test its ability to cure or prevent syphilis. Syphilis is an infection that can cause genital sores and rashes, and when left untreated, it can cause damage to internal organs and cause paralysis, blindness or death.
“It was bad science. Regardless of the ethical issues ... from a purely scientific standpoint, I found this body of science bereft of any point,” said commission member Dr. Nelson Michael of the Walter Reed Army Institute of Research.
Thus, this study calls into question the bioethical violations involved in the study design and the potential compensation to the research victims. This commission committee will set a precedent for future clinical trials in other countries for drugs and vaccines. The United States should create a system to compensate people who are harmed by participating in scientific research, a panel of federal advisers recommended Tuesday.
Many other countries require sponsors of studies and researchers to carry insurance for research-related injuries or have other ways to compensate volunteers who are harmed, making the United States an “outlier,” the subcommittee of the Presidential Commission for the Study of Bioethical Issues concluded.
“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,’” said Amy Gutmann of the University of Pennsylvania, who chairs the commission and served on the subcommittee.
On Tuesday, the 13-member commission discussed the 48-page report outlining the findings of a 14-member international subcommittee investigating whether current rules adequately protect people in medical studies from physical harm or unethical treatment internationally.
The experts in bioethics and biomedical research from India, Uganda, China, Russia, Brazil, Argentina, Belgium Guatemala, Egypt and the United States met in London, Washington and Philadelphia and made five broad recommendations.
“The United States should implement a system to compensate research subjects for research related injuries,” said Christine Grady of the National Institutes of Health, who helped present the findings of the subcommittee. “Many countries around the world and some U.S. research institutions have actually moved forward and developed compensation systems.”