President Barack Obama today asked his bioethics commission to dig into the recent discovery that US government-funded scientists intentionally infected subjects with syphilis in a study in Guatemala in the 1940s.
“The research was clearly unethical,” Obama wrote in a memorandum to Amy Gutmann, the chair of the Presidential Commission for the Study of Bioethical Issues. “In light of this revelation, I want to be assured that current rules for research participants protect people from harm or unethical treatment, domestically as well as internationally.”
While the Guatemala experiment is six decades old, the shift of many pharamceutical companies’ clinical trials overseas in recent years has brought under scrutiny the protection of human subjects in clinical trials outside of developed nations.
Obama asked the commission, which is just concluding a report on synthetic biology, to launch a panel in January charged with examining if federal regulations and international standards “adequately guard the health and well-being of participants in scientific studies supported by the Federal Government.”
He also asked the commission to “oversee a thorough fact-finding investigation into the specifics of the U.S. Public Health Service Sexually Transmitted Diseases Inoculation Study.”
That study first came to public attention last month when the US government apologized to the government of Guatemala, and the survivors and descendants of those infected in a National Institutes of Health-sponsored set of experiments conducted between 1946 and 1948. In that study, nearly 700 Guatemalan prisoners, soldiers and mental patients were intentionally infected with syphilis without their knowledge or consent, in an effort to test penicillin’s effectiveness against the disease. Additional experiments involved other sexually transmitted diseases.
The experiment was uncovered by Susan Reverby, a medical historian at Wellesley College in Massachusetts, who discovered records of it in the archives of the University of Pittsburgh. (Read Nature’s interview with Reverby). Her findings are to be published in the Journal of Policy History in January.
Obama instructed the commission to complete its work within nine months. He added that it should hold “at least one meeting” outside the country, enlist international experts, including experts from Guatemala, and report back to him with its findings and recommendations.