Georgia State University College of Law Professor Paul A. Lombardo serves as a senior advisor to the Presidential Commission for the Study of Bioethical Issues.
September 14, 2011
ATLANTA – U.S. researchers who knowingly breached medical ethics by infecting Guatemalans with sexually transmitted diseases in the 1940s without informing them of the risks preyed upon the country’s vulnerable populations, said a Georgia State University law professor who’s a senior advisor to the presidential commission investigating the study.
“I think this is going to be a study that takes its place alongside some of the most notorious research of the 20th century,” said Georgia State University College of Law Professor Paul A. Lombardo, who served as a senior advisor to the Presidential Commission for the Study of Bioethical Issues. “The researchers in Guatemala with the Public Health Service managed to break every modern rule of research ethics. They chose the poorest, least educated and most vulnerable subjects in prisons, hospitals, orphanages and mental asylums. They infected them with a variety of different diseases, and in many instances they gave them no treatment at all.”
About 5,500 Guatemalans were enrolled in the study conducted by the Public Health Service. Roughly 1,300 of them were deliberately infected with STDs such as syphilis, gonorrhea, or chancroid. At least 83 died, but it was not clear if the experiments killed them. Though the original stated aim of the experiments was to see if penicillin could prevent infection after exposure, the study’s leaders changed explanations several times.
Lombardo was asked to be a senior advisor for the bioethics commission primarily because of his previous work on research ethics. Lombardo has written on other studies that involved people in institutions, including an article on a study that was carried out during the Second World War in a mental hospital in Virginia, as well as the infamous U.S. Public Health Service Study of Untreated Syphilis, also known as the Tuskegee study, which bears striking similarities to the experiments in Guatemala.
Both the Guatemala experiments and the Tuskegee study focused on syphilis in vulnerable populations. Both were also managed from the same U.S. Public Health Service laboratory and featured some of the same researchers, including Dr. John Cutler, who was a scientist at Tuskegee after leading the Guatemala experiments.
Part of the commission’s work involved going through a large number of documents that had been generated by Dr. Cutler, Lombardo explained, but perhaps just as important, included looking at the historical record and determining who Dr. Cutler worked with and what might have been his motivation in carrying out these studies.
Lombardo traveled to Guatemala with three other members of the commission staff to visit with researchers in that country who are looking at this same episode and compiling a report for the government of Guatemala. They met with Vice President Dr. Jose Rafael Espada, a physician who is coordinating and directing that effort for the Guatemalans. They also visited sites where some of the research had taken place, including a clinic and a prison.
“We also visited the archives of Central Americain Guatemala City in an attempt to see if we could review documents left there by researchers,” Lombardo said. “That trip was an extraordinary look at not only what happened 60 years ago, but the current state of affairs both politically and socially in Guatemala itself.”
The title of the commission’s report, “Ethically Impossible,” is a quotation from a brief article in The New York Times on April 27, 1947 that Dr. Cutler read. Amy Gutmann, the chair of the bioethics panel and the president of the University of Pennsylvania, said Dr. Cutler read the article about other syphilis researchers — one of them from his own agency — doing tests like his on rabbits. The article stated that it was “ethically impossible” for scientists to “shoot living syphilis germs into human bodies.” Dr. Cutler’s response, Dr. Gutmann said, was to order stricter secrecy about his work.
“The researchers in Guatemala felt they had an opportunity to do work that would not have been possible in America,” Lombardo explained. ”They were experienced and very aware that any research similar to this in the United States, some of which they had just participated in, had to be done with detailed disclosures, informed consent and legal waivers signed by all the people who were participating. So they knew how to do it right, they simply did not do it right in Guatemala because they didn’t feel they had to, and they kept it a secret for their whole lives.”
Documentation on the Guatemala experiments was recently discovered by Susan Reverby, Ph.D., a professor of women's studies at Wellesley College in Massachusetts, whose revelation prompted President Barack Obama to issue a national apology to Guatemala last October. Obama also requested that the commission issue a report on the extent of the study and the likelihood for similar abuses to occur today.
As a result of the commission conducting a complete investigation, there is now a factual and historical base for any other kind of ethical or historical investigation people may want to do, Lombardo said, including thousands of unpublished documents and many other published works that can be used as reference point to look into this further. The report also points out in very clear terms that what happened in Guatemala was terribly wrong, Lombardo said, and deserved condemnation.
In all, more than a dozen people were involved in the experiments and their cover-up, reached all the way from Dr. Cutler, who was in charge of work in Guatemala City, to his superiors who worked for the Venereal Disease Research Laboratory and their superiors, which included people all the way up to the Surgeon General of the United States Public Health Service. Actually, several surgeons general knew about the work in Guatemala, Lombardo said.
“I think the thing that is most surprising to people about this study is that it could have been kept a secret for so long, but also that there could easily be other studies like it that we’ve never learned about,” Lombardo said. “This is a study that was done under cover of secrecy but also under cover of war. Even though it began after World War II had ended, the argument in favor of it was there was still a need to find out how effective penicillin was to use as a preventative medication for soldiers on their way to battle. The search for a prophylactic medication that would prevent STDs like syphilis had gone on more than 30 years, and the men and women who were involved in this study were certainly part of that search, even though the war had already stopped.”
The report points forward to the need to review how international research is regulated and monitored today and make sure that the protections that are in place on paper are in fact followed in practice.
“There will be another report from the commission on international research ethics, which will come out sometime around the end of the year,” Lombardo said.
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