By Alina Selyukh
WASHINGTON (Reuters) - A U.S. presidential commission will release on Monday its findings on a government research project that deliberately infected Guatemalan prison inmates and mental patients with syphilis in the 1940s.
The 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.
The United States formally apologized last year for the experiment, which was meant to test the drug penicillin, after it was uncovered decades later by a college professor.
Guatemala condemned it as a crime against humanity and said last year it would consider taking the case to an international court. Victims of the study are suing the U.S. government.
President Barack Obama's Commission for the Study of Bioethical Issues has conducted its own investigation and will release its findings at 1 p.m. (1700 GMT) in Washington on Monday, followed by recommendations on Tuesday on protecting research participants from unethical treatment.
"They will have a chance to do a richer investigation and we'll have a richer picture of what happened," said Wellesley College professor Susan Reverby, whose research revealed the previously unpublished records of the Guatemalan experiment.
"It's too easy to say, 'Oh, we'd never do anything like that,'" she told Reuters. "(At the time,) they thought they were doing good science, these were decent people, not monsters, and therefore we really need to think about what we're doing now that's going to look horrible in 20 years."
In a November 2010 article in the Journal of the American Medical Association, the 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, at least for government-affiliated studies.
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," she said.
Protections for research participants may not work in some foreign countries where subjects are poor and illiterate, making their informed consent hard to trust, said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania.
"Peer review in corrupt countries doesn't mean very much," he added.
In a more recent incident, Pfizer Inc's 200-patient trial of antibiotic Trovan during a 1996 meningitis outbreak in Kano, Nigeria, triggered a decade-long legal battle after 11 children died and the company was accused of not obtaining adequate prior consent. Pfizer settled all outstanding lawsuits from the case in February.
Even before Reverby's discovery, the U.S. Department of Health and Human Services was working on proposed changes, released in July, to its 1991 rules protecting human research subjects, which have been criticized for being too stifling for low-risk studies and too loose for high-risk research.
Reverby uncovered the Guatemala experiment 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.
While studying the archives of Dr. John Cutler, a Public Health Service officer and a Tuskegee researcher, Reverby found boxes of medical records and notes from another, previously unknown study conducted between 1946 and 1948 in Guatemala.
Later confirmed by federal health agencies, her findings showed that the PHS, under a grant from the NIH to the Pan American Sanitary Bureau and in collaboration with several Guatemalan agencies, deliberately infected hundreds of people with the sexually transmitted diseases syphilis, gonorrhea and chancroid.
The patients were given antibiotic penicillin to determine its effectiveness in curing or preventing syphilis, an infection that can cause genital sores and rashes and, if left untreated, damage internal organs and cause paralysis, blindness or even death.
"They thought, 'we're in a war against disease and in war soldiers die,'" Reverby said. "Those who are on the cutting edge of the science are the ones that can easily fall."
Some 700 people were infected with syphilis. These included inmates exposed to infected prostitutes brought into prisons and male and female patients in a mental hospital. Some subjects had bacteria poured on scrapes made on their genitals, arms or faces.
Records show no documentation that syphilis study subjects gave informed consent or understood they were participating in research, according to a September 2010 report by the CDC.
Until his death in 2003, Cutler remained unapologetic about his research. The bioethics commission's findings are expected to put his work in historical context.
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.
"There is a great deal of skepticism and cynicism with which the U.S. is greeted in (Latin America)," said Larry Birns, director of the non-profit Council on Hemispheric Affairs. "This will reaffirm in the minds of average Latin Americans how dirty and loathe the United States is."
(Editing by Michele Gershberg and Eric Beech)