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Tue August 30, 2011
Commission: Researchers Knew Of Ethical Problems In Guatemala STD Study
U.S. researchers knowingly breached medical ethics by infecting Guatemalans with venereal diseases in the 1940s without informing them of the risks, a presidential commission has found.
The Presidential Commission for the Study of Bioethical Issues, which was asked by President Barack Obama to investigate the Guatemalan study in October 2010, came to the conclusion after learning that the researchers had conducted similar research with American prisoners in 1943 but had given them the chance to make informed consent.
The U.S. government formally apologized for the "reprehensible research" last year.
Medical ethics have come a long way in the last few decades, but many are still worried about how U.S. research is conducted overseas. In the wake of revelations of the Guatemala study in 2010, the president asked the panel to review the rules that ensure that people who participate in research are protected from harm or unethical treatment. On Tuesday, the panel released recommendations for how to improve the rules, including a suggestion that the U.S. compensate research subjects if they are injured in a study.
For the Guatemalan research between 1946-1948, scientists sought out people in mental institutions, prisoners, commercial sex workers, and members of the Guatemala army and intentionally infected 1,300 of them with venereal diseases.
The study in Guatemala was undertaken to investigate the use of penicillin to treat and prevent infection, but the results were never published. Only 700 people received some kind of treatment.
"I kept asking the question, 'How could they do this?' ... My conclusion is, and it has to be a reluctant one: ... the doctors did not treat these human beings as if they were worthy of respect or consideration," said Amy Gutmann, chairwoman of the Presidential Commission for the Study of Bioethical Issues, which was asked by the president to investigate the Guatemalan study in October 2010.
This came after Susan Reverby, a professor of women's studies at Wellesley College, uncovered documents detailing the study. Reverby was interviewed by NPR's Robert Siegel last year.
The commission said Monday in a briefing that the researchers, including John Cutler, a physician who was also involved with the notorious Tuskegee syphilis experiments, apprised Indiana prisoners involved in a 1943 STD study of the risks. Those who volunteered to paticipate gave informed consent. But the Guatemalans were not given the same chance. Some 83 of the Guatemalan study participants had died by 1953, the panel said, but it's not clear if those deaths were from the STDs or other causes.
The Guatemalan government is also doing its own review of the research project, but hasn't released its findings.
Commission members said Monday that the scientists may have realized the study was unethical, which could explain why they never published any results.
"What stings the most in terms of bad science is that it never passed peer review and was never published," said Commission member Dr. Nelson L. Michael at the Walter Reed Army Institute of Research and Director of the U.S. Military HIV Research Program.
A full report of the commission's findings on the Guatemala experiment is due to President Obama in September.