WASHINGTON U.S. government researchers must have known they were violating ethical standards by deliberately infecting Guatemalan prison inmates and mental patients with syphilis for an experiment in the 1940s, according to a presidential commission.
The U.S.-funded research in Guatemala did not treat participants as human beings, failing to even inform them they were taking part in research, as was the case for a similar study in the United States, the commission said on Monday.
The United States apologized last year for the experiment, which was meant to test the drug penicillin, after it was uncovered decades later by a college professor.
President Barack Obama's Commission for the Study of Bioethical Issues investigated the syphilis experiment and discussed its key findings in Washington on Monday. A final report is due in December.
"They should shock the conscience not in spite of their medical context, but precisely because of it," said the commission's chairwoman Amy Gutmann, president of the University of Pennsylvania.
"The people who were in the know, did want to keep it secret because if it would become more widely known, it would become the subject of public criticism," she said.
The commission's conclusions have 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 the tests conducted by the U.S. Public Health Service (PHS) as a crime against humanity and said last year it would consider taking the case to an international court. It is conducting its own investigation. Victims of the study are suing the U.S. government.
In a November 2010 article in the Journal of the American Medical Association, directors of the National Institutes of Health and the Centers for Disease Control and Prevention rejected the possibility that such unethical practices could happen now. But the bioethics community is less convinced.
"Too often people become absorbed with the merit of a scientific question and can lose sight of the ethics in answering it," said Mary Faith Marshall, a professor at the University of Minnesota's Center for Bioethics. "Possibly, if you broaden the scope... to private industry, you'll see things that are even worse."
WAR AGAINST DISEASE
PHS officer Dr. John Cutler, a rather junior scientist at the time, led the Guatemala research from 1946 to 1948 under a grant from the NIH to the Pan American Sanitary Bureau and in collaboration with several Guatemalan agencies.
The commission's investigators said the study of sexually transmitted diseases such as syphilis was an important scientific goal at the time, but they found no reasonable excuse for the way in which the study was conducted, noting that it demonstrated "institutional failure."
The fact that the study was done shortly after the end of World War II, with widespread reporting on the use of prisoners and concentration camp inmates for human experiments should have made the researchers aware of the breach of standards, commission members said.
The investigators plowed through thousands of pages of archives to find that researchers in Guatemala deceived the participants who were members of especially vulnerable groups, kept poor notes, did not try hard to protect the subjects from risks and conducted experiments in illogical order.
"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.
Some 1,300 people were infected with venereal disease, more than half of them with syphilis. They included inmates 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.
The patients were given antibiotic penicillin to test its ability to cure or prevent syphilis, an infection that can cause genital sores and rashes and, if left untreated, damage internal organs and cause paralysis, blindness or death.
In one example of archived records cited at the meeting, Dr. Cutler noted that one of the mentally ill women he had infected with syphilis appeared to be dying. Still, the woman remained a study subject and was further infected with STDs before she developed grueling side effects and died.
"They thought, 'we're in a war against disease and in war soldiers die'... Those who are on the cutting edge of the science are the ones that can easily fall," said Wellesley College professor Susan Reverby, whose research uncovered the records of the Guatemalan experiment.
"It's too easy to say, 'Oh, we'd never do anything like that," she told Reuters. "We really need to think about what we're doing now that's going to look horrible in 20 years."
Reverby uncovered the Guatemala archives after years of research into a medical study in Tuskegee, Alabama where hundreds of black American men were deliberately left untreated for syphilis. The experiment lasted 40 years until 1972.
Dr. Cutler, who went on to take part in the Tuskegee study, also participated in a 1943 gonorrhea experiment in Terre Haute, Indiana. There, prison inmates were deliberately infected with the STD, but were informed of the study and asked to give consent. Until his death in 2003, Cutler remained unapologetic about his research.
Guatemalan Vice President Dr. Rafael Espada planned to speak at Monday's event, but canceled those plans because of Hurricane Irene that hit the U.S. east coast over the weekend.
(Editing by Michele Gershberg and Anthony Boadle)