Danilo Valladares and Amanda Wilson*
GUATEMALA CITY/WASHINGTON DC, Sept 9 (IPS) – The appalling experiments carried out by U.S. doctors in Guatemala from 1946 to 1948 using 1,300 human subjects who were infected with sexually transmitted diseases highlighted the inadequacy of controls and safeguards in clinical testing in this Central American country – still a major problem today, according to experts.
“The trained human resources are not in place for oversight of research, and the standards and regulations are either flawed or are not met,” Dr. Luis López, a member of the Presidential Commission for the Study of Bioethical Issues set up by President Barack Obama to investigate the case, told IPS.
In Guatemala, medical research is regulated by a 2007 Health Ministry agreement on “standards for the regulation of clinical trials”, which is “very weak because it does not have the strength of legislation and fails to outline the intersectoral aspects that could be in play when it comes to experimentation with human subjects,” the expert added.
No such regulations existed in this country in the 1940s, when prisoners, military conscripts, sex workers, mental patients and orphans were deliberately infected with syphilis, gonorrhoea and chancroid purportedly to test penicillin in the shocking U.S.-run experiments.
But more than six decades later, controls “are still so weak that not all studies using human subjects in Guatemala reach the hands of the Health Ministry,” López said.
Various clinical ethics committees operate in universities, hospitals and other institutions in Guatemala. But it is the Health Ministry, through the Commission for the Evaluation of Clinical Trials, that ultimately grants permission for such testing.
The experiments in Guatemala came to light in October 2010, when Susan Reverby, a professor at Wellesley College in the U.S. state of Massachusetts, revealed the research carried out by the U.S. Public Health Service with funding from the U.S. National Institutes of Health (NIH) and led by U.S. Dr. John Cutler in complicity with Guatemalan doctors.
In late August, the presidential bioethics commission established by Obama revealed new details and reported its finding that the experiments in Guatemala were bad even by the standards of the time.
The panel said a total of 5,500 Guatemalans were involved in the research, 1,300 of whom were unknowingly infected with STDs, and only 700 of whom received treatment of any kind.
At least 83 of the 5,500 subjects died by late 1953, although the bioethics commission said it was not clear whether they died as a direct result of the experiments.
Obama apologized to Guatemala in October 2010 and set up the panel to investigate what happened, and to review standards for protecting human subjects in on-going U.S.-funded medical trials, both domestically and internationally. The Guatemalan government also established a commission of enquiry, which has not yet released its report.
Authorities in Guatemala have located five survivors of the experiments, who are to receive compensation from the government.
The public health system is precarious in this country, where half of the population of 14 million lives in poverty and 17 percent in extreme poverty.
With respect to the weak controls in such cases in Guatemala, López said training was needed in oversight of research, and that the Health Ministry standards on the regulation of clinical trials should be made into law, following the example of other Latin American countries like Brazil, Chile, Colombia, Mexico and Peru.
The expert also said clinical trials should focus on illnesses like Chagas disease, tuberculosis, leishmaniasis and malaria, which are common in poor countries like Guatemala, “but are ignored by the pharmaceutical industry, whose interests have never revolved around solving the problems of local populations.”
Dr. Carlos Mejía, the president of the Guatemalan medical association and a member of the Guatemala commission tasked with investigating the experiments led by Cutler, told IPS that in Guatemala, “all kinds of medical research is carried out, but oversight must be strengthened.”
The physician acknowledged that there is insufficient staff monitoring medical trials, especially in remote regions in the country. He also concurred with López that the Health Ministry standards and regulations should be given the force of law.
He said that above and beyond the question of research, the public health system “has not been a priority” in this country, “as demonstrated by the total neglect of the system resulting from a lack of budget funds.”
Mejía said it is “very unlikely, but not impossible” for a repeat of the deplorable 1940s experiments to happen in Guatemala today.
He added, however, that “there are rumors that people were sterilized, but we have to investigate that.”
Continued shock wave in U.S.
Reverby told IPS that the scenario necessitated a deeper analysis than the standard ‘good guys versus bad guys’ approach, which has hitherto been the predominant media angle.
“The story gets covered as if this was Saturday afternoon at the movies – innocent victims, bad doctors. That makes it too easy to think that because we have regulations in place this can’t happen. It’s not a melodrama. What is important to take away here is that they thought what they were doing was right, not that they were monsters.”
The U.S. presidential bioethics commission, made up of 14 members from 10 countries, made five clear recommendations for how to better protect human subjects involved in international research, including: better community involvement and representation, ethics training for researchers, a more comprehensive trials registry, compensation for research-related injuries, and rule harmonization across borders.
The panel also recommended that the United States adopt a system to compensate research participants who are injured as a result of their participation.
Amy Gutmann, the commission chair, pointed out that while many European countries, as well as India and Brazil, have such a system, the United States does not. “The U.S. is an outlier here and the panel felt very strongly it was an outlier on the wrong side,” she said.
In addition, the commission recommended expanding an official U.S. registry for research on human subjects to include studies not specifically involving clinical medical intervention. Panelists noted that currently, U.S. law requires only clinical experiments involving “intervention” to be registered, but there is no similar requirement for non-clinical public health or epidemiological studies.
The panel’s full investigation is due for release later this month.
The debate has just begun
Carla Saenz, regional bioethics advisor for the Pan American Health Organization, attended the Aug. 29 meeting in Washington where bioethics commission members discussed some of the findings. She told IPS that while she agreed with more wide-reaching registries for public health and epidemiological studies, she questioned how standards for “community representation” would be implemented.
“The majority of research takes place in cities of eight million people in huge hospitals,” Saenz told IPS. “So who is a ‘community’? We have to specify what the recommendations need to do.”
With discussions touching on such weighty subjects as the meaning of community and disparities in power and interests, the commission appeared poised to confront at least some of the major bioethics issues today. But there was clear tension in the room when guest speakers discussed one of those questions: the nature of consent.
While Gutmann emphasized the importance of the first principle of the Nuremberg Code for experiments on humans which lists “voluntary consent” as a primary standard for any research involving human subjects, guest speakers disagreed about what, exactly, consent means.
Ezekiel Emanuel, former chief of NIH’s Clinical Centre Department of Bioethics, said he supported allowing research participants to give their “blanket consent,” essentially, one signature that would allow their information or biological materials to be used in any subsequent studies without further permission from participants.
Emanuel said researchers had a market-based incentive to make sure that studies went well and that this would serve as a natural form of checks and balances ensuring participants would be protected. He said surveys show most people in the U.S. don’t care what their data and materials are being used for, as long as they know they are being used.
“If they don’t want that research done, they don’t sign the consent form,” he told the commission.
But another guest speaker, Carletta Tilousi of the Havasupai American Indian Tribe, said she disagreed with blanket consent. She, along with other tribe members, gave her blood to a 1990s study, which Arizona State University said would be dedicated to Alzheimer’s research.
However, tribe members, who live on a territory to the southeast of the Grand Canyon in Arizona, say their blood was used for other research not related to diabetes, including research offensive to the tribe. The university agreed on a settlement with the tribe for 700,000 dollars in 2010.
“I still wonder where it went,” Tilousi said, adding that she wanted to know whether her blood was being used for something good, where and how it was used, and who used it. “That is a question I am going to have to live with.”
*Danilo Valladares reported from Guatemala City and Amanda Wilson from Washington DC.