Human experiments: First, do harm : Nature

The injections came without warning or explanation. As a low-ranking soldier in the Guatemalan army in 1948, Federico Ramos was preparing for weekend leave one Friday when he was ordered to report to a clinic run by US doctors.

Ramos walked to the medical station, where he was given an injection in his right arm and told to return for another after his leave. As compensation, Ramos's commanding officer gave him a few coins to spend on prostitutes. The same thing happened several times during the early months of Ramos's two years of military service. He believes that the doctors were deliberately infecting him with venereal disease.

Now 87 years old, Ramos says that he has suffered for most of his life from the effects of those injections. After leaving the army, he returned to his family's remote village, on a steep mountain slope northeast of Guatemala City. Even today, Las Escaleras has no electricity or easy access to medical attention. It wasn't until he was 40, nearly two decades after the injections, that Ramos saw a doctor and was diagnosed with syphilis and gonorrhoea. He couldn't pay for medication.

"For a lack of resources, I was here, trying to cure myself," says Ramos. "Thanks to God, I would feel some relief one year, but it would come back." Over the decades, he has endured bouts of pain and bleeding while urinating, and he passed the infection onto his wife and his children, he told Nature last month in an interview at his home.

Ramos's son, Benjamin, says that he has endured lifelong symptoms, such as irritation in his genitals, and that his sister was born with cankers on her head, which led to hair loss. Ramos and his children blame the United States for their decades of suffering from venereal disease. "This was an American experiment to see if it caused harm to human beings," says Benjamin.

Ramos is one of a handful of survivors from US experiments on ways to control sexually transmitted diseases (STDs) that ran in semi-secrecy in Guatemala from July 1946 to December 1948. US government researchers and their Guatemalan colleagues experimented without consent on more than 5,000 Guatemalan soldiers, prisoners, people with psychiatric disorders, orphans and prostitutes. The investigators exposed 1,308 adults to syphilis, gonorrhoea or chancroid, in some cases using prostitutes to infect prisoners and soldiers. After the experiments were uncovered in 2010, Ramos and others sued the US government, and US President Barack Obama issued a formal apology. Obama also asked a panel of bioethics advisers to investigate, and to determine whether current standards adequately protect participants in clinical research supported by the US government.

When details of the Guatemalan experiments came to light, US health officials condemned them as 'repugnant' and 'abhorrent'. Last September, the Presidential Commission for the Study of Bioethical Issues went further, concluding in its report1, that "the Guatemala experiments involved unconscionable violations of ethics, even as judged against the researchers' own understanding of the practices and requirements of medical ethics of the day" (see 'Evolving ethics').

Yet that report and documents written by the researchers involved in the Guatemalan work paint a more complex picture. John Cutler, the young investigator who led the Guatemalan experiments, had the full backing of US health officials, including the surgeon general.

"Cutler thought that what he was doing was really important, and he wasn't some lone gunman," says Susan Reverby, a historian at Wellesley College in Massachusetts, whose discovery of Cutler's unpublished reports on the experiments led to the public disclosure of the research2.

Cutler and his superiors knew that some parts of society would not approve. But they viewed the studies as ethically defensible because they believed that the results would have widespread benefits and help Guatemala to improve its public-health system. Those rationalizations serve as a warning about the potential for medical abuses today, as Western clinical trials increasingly move to developing countries to take advantage of lower costs and large populations of people with untreated disease. Bioethicists worry that laxer regulations and looser ethical standards in some countries allow researchers to conduct trials that would not be allowed at home. "The strongest lesson should be that the same rules, same principles, same ethics should apply no matter where you are," says Christine Grady, acting chief of the Department of Bioethics at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland, and a member of the bioethics commission.

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http://www.nature.com/news/human-experiments-first-do-harm-1.9980