A presidential commission investigating how United States researchers deliberately infected prison inmates and mental patients in Guatemala with syphilis in the 1940s is expected this morning to issue new guidelines on ethical testing of new drugs.
The recommendations, which aim to establish more stringent guidelines for protecting patients used as guinea pigs in new drugs testing, will come as the Commission for the Study of Bioethical Issues takes the wraps off its own investigation specifically into the case of the Guatemala scandal.
That American researchers travelled to Guatemala and used vulnerable patients as they attempted to gauge the usefulness of penicillin – then a newly discovered medicine – was a secret for decades before it was uncovered and made public by the Wellesley College professor Susan Reverby.
The Guatemala government threatened to take the US to the international court for crimes against humanity. It led to the empanelling of the commission by President Barack Obama, to find out as much as possible about the experiments.
Professor Reverby told Reuters: "It's too easy to say, 'Oh, we'd never do anything like that'. 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."
The scandal was reminiscent of the uproar that surrounded the case of hundreds of black American men who were similarly exposed by doctors to syphilis in Tuskegee, Alabama. Those experiments lasted 40 years, until 1972. It was while researching that case that Professor Reverby discovered records about the exercise in Guatemala.
While most in the medical research profession will assert that nothing of this kind could happen again, concerns linger about pharmaceutical companies attempting to test products in foreign countries where protections for patients may be lacking.
Much briefer than the Tuskegee experiments, those in Guatemala were conducted between 1946 and 1948 during the presidency of Harry Truman. Soldiers and prostitutes were also among those chosen to be infected with syphilis. President Obama formally apologised in October last year. It's not clear, however, that some of the Guatemala ministries may not have known what was going on.
The experiments in Guatemala were led by a US government physician, John Charles Cutler, who was later to take part in the Tuskegee research project. The studies, which would not have been permissible on US soil, were funded by the US government. And while in the case of Tuskegee, syphilis was tracked in people who were already infected, in Guatemala the disease was introduced deliberately into the systems of otherwise healthy people.
The US Centers for Disease Control and Prevention later acknowledged that that "the design and conduct of the studies was unethical in many respects, including deliberate exposure of subjects to known serious health threats, lack of knowledge of and consent for experimental procedures by study subjects, and the use of highly vulnerable populations".