The United States apologized Friday for a study conducted more than 60 years ago in Guatemala in which US-led researchers infected hundreds of people with syphilis and gonorrhea without their consent.
The study conducted between 1946 and 1948 was “clearly unethical”, Secretary of State Hillary Clinton said in a statement issued jointly with Health Secretary Kathleen Sebelius, in which the two officials extended an apology to “all the individuals who were affected by such abhorrent research practices.”
Clinton told Guatemalan President Alvaro Colom by phone of her “personal outrage and deep regret that such reprehensible research could have occurred,” Assistant Secretary of State Arturo Valenzuela told reporters.
Francis Collins, director of the National Institutes of Health (NIH), the US government body that funded the study, called it “deeply disturbing” and “an appalling example in a dark chapter in the history of medicine.”
Senator Robert Menendez, a member of the congressional Hispanic caucus, called the experiments in Guatemala one of the “darkest moments” in US history.
“No innocent fellow human should be treated as a lab rat, no matter your nationality,” Menendez said.
The study, which was never published, came to light this year after Wellesley College professor Susan Reverby stumbled upon archived documents outlining the experiment led by controversial US public health doctor John Cutler.
Cutler and his fellow researchers enrolled vulnerable populations 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.
“There is no evidence study participants gave informed consent, and in fact… the subjects were often deceived about what was being done to them,” Collins told reporters as he outlined the experiment’s most flagrant ethics violations.
The US surgeon general at the time, Thomas Parran, appeared to have been aware of the Guatemala experiment, said Collins.
Initially, the researchers infected female commercial sex workers with gonorrhea or syphilis, and then allowed them to have unprotected sex with soldiers or prison inmates.
“When few of these men became infected, the research approach changed to direct inoculation of soldiers, prisoners and mental hospital patients,” background documents on the study show.
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.
Collins said there were “no formalized regulations about the protection of human subjects taking part in medical research in the 1940s” but insisted today’s studies are bound by much stricter rules that would prevent a recurrence of such unethical experimentation on human beings.
The United States has called on two high-level organizations to probe the experiment conducted more than 60 years ago and come up with ways of ensuring nothing like it ever happens again.
Independent experts under the umbrella of the Institute of Medicine will conduct a fact-finding probe of the Guatemala study, and the US Presidential Commission for the Study of Bioethical Issues will convene international experts to review the standards surround human medical research around the world, Collins said.
The doctor behind the Guatemala study, 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 given no remedial treatment for 40 years, between 1932 and 1972.