A review of human protection in medical research in the wake of a polemic over a newly revealed US study that infected hundreds Guatemalans with sexually transmitted diseases from 1946-1948 has been ordered by President Barack Obama.
Obama sent a letter to Amy Gutmann, director of the Presidential Commission for the Study of Bioethical Issues, asking her to convene a panel in January to determine "if federal regulations and international standards adequately guard the health and well-being of participants in scientific studies supported by the federal government."
AdvertisementObama also asked the panel to look at the study done on Guatemalans in the 1940s, now with input from "international experts, including from Guatemala; consult... and convene at least one meeting outside the United States."
The commission should wrap up its work in nine months and then deliver a report to Obama, he said.
"While I believe the research community has made tremendous progress in the area of human subjects protection, what took place in Guatemala is a sobering reminder of past abuses," Obama wrote.
The Guatemalan study, which was never published, came to light this year after Wellesley College professor Susan Reverby stumbled upon archived documents outlining the 1940s experiment led by controversial US public health doctor John Cutler.
Cutler and his fellow researchers enrolled people in Guatemala, including mental patients, for the study, which aimed to find out if penicillin, relatively new in the 1940s, could be used to prevent sexually transmitted diseases.
Cutler, was also involved in a highly controversial study known as the Tuskegee Experiment in which hundreds of African American men with late-stage syphilis were observed but given no treatment for 40 years, between 1932 and 1972.
Initially, the researchers infected female Guatemalan commercial sex workers with gonorrhea or syphilis, and then allowed them to have unprotected sex with soldiers or prison inmates.
A total of some 1,500 people took part in the study. At least one patient died during the experiments, although it is not clear whether the death was from the tests or from an underlying medical problem.