Following last year's revelations that U.S. researchers had conducted macabre human experiments on Guatemalan prison and mental hospital inmates between 1946 and 1948, a presidential Bioethics Commission has said it could not unequivocally say all federally funded research provided human subjects with “optimal protections against avoidable harms and unethical treatment”.
After issuing a public apology to Guatemala, President Barack Obama urged the bipartisan presidential Commission to oversee a thorough review of regulations and international standards to assess whether they adequately protected human participants in federally funded research, no matter where such research occurred.
The Commission recommended several areas where immediate changes could be made to current rules and procedures, which could increase accountability and thereby reduce the likelihood of harm or unethical treatment.
In returning the results of its extensive review, the Bioethics Commission said a key reason why it still could not conclude that adequate protections were in place was the limited ability of some governmental agencies to identify basic information about current human subjects research.
In its study, the Commission considered a broad swath of global research operations, incorporating within its scope foreign sites and partners in biomedical research from 10 countries including India. Other nations from which experts were drawn into the Commission were Argentina, Belgium, Brazil, China, Egypt, Guatemala, Russia, and Uganda.
In comments following the release of the Commission's report, its Chair, Amy Gutmann, said, “The Commission is confident that what happened in Guatemala in the 1940s could not happen today.” However, she added, “It is also clear that improvements can be made to protect human subjects going forward.”
Ms. Gutmann criticised federal agencies for lacking the internal mechanisms to provide needed data about research that they funded. She noted that while Guatemala-style experimentation would not be permitted under today's robust system for human subjects' protection, “There still is a need for more transparency and public access to information about federally supported human-subjects research.”
Last December archival research by Professor Susan Reverby of Wellesley College revealed that vulnerable Guatemalans were clandestinely infected with sexually transmitted diseases such as syphilis, gonorrhoea and chancroid. The study, funded by a Department of State grant to the U.S. National Institute of Health, was purportedly aimed at testing the effectiveness of penicillin, which was relatively new at the time.
The experiments, acknowledged by officials to be a gross violation of modern-day bioethics standards, were led by the late John Cutler, a U.S. Public Health Service medical officer.
Earlier this year, Stephen Hauser, a member of the Commission, said with at least 5,500 prisoners, mental patients, soldiers and children being drafted into the experiments, around 1300 individuals were exposed to venereal diseases by human contact or inoculations in research meant to test the drug penicillin and within that group “we believe that there were 83 deaths”.
Particularly chilling were the cases of a terminally-ill woman who had gonorrhoea-infected pus poured into her eyes. She died six months later. The Commission also commented on another documented case of seven women with epilepsy who were injected with syphilis below the back of the skull, said to be a risky procedure. Ultimately each of the women contracted bacterial meningitis.