By Rob Stein
Washington Post Staff Writer
Saturday, October 2, 2010; A1
The United States revealed on Friday that the government conducted medical experiments in the 1940s in which doctors infected soldiers, prisoners and mental patients in Guatemala with syphilis and other sexually transmitted diseases.
The experiments, led by a federal doctor who helped conduct the famous Tuskegee syphilis study in Alabama, involved about 1,500 men and women who were unwittingly drafted into studies aimed at determining the effectiveness of penicillin.
The tests, which were carried out between 1946 and 1948, infected subjects by bringing them prostitutes who were either already infected or purposefully infected by the researchers and by using needles to open wounds that could be contaminated.
"Although these events occurred more than 64 years ago, we are outraged that such reprehensible research could have occurred under the guise of public health," Secretary of State Hillary Rodham Clinton and Health and Human Services Secretary Kathleen Sebelius said in a joint statement apologizing for the experiments. "We deeply regret that it happened, and we apologize to all the individuals who were affected by such abhorrent research practices."
President Obama had been briefed about the revelations and called Guatemalan President Alvaro Colom to "personally express that apology," White House spokesman Robert Gibbs said."Obviously, this is shocking. It's tragic. It's reprehensible," Gibbs said.
The Guatemalan government planned to investigate, saying it "deeply deplores that these experiments affected innocent people," according to a statement issued late in the day.
In addition to exposing another episode of unethical medical experimentation, officials said the revelations were concerning because they could further discourage already often-suspicious minorities and others from participating in medical research. They also come as U.S. drug companies are increasingly going to poor, less-educated countries to test new drugs and other therapies.
"At a time when so much medical research is global, it behooves us to take account of what has been done in the past by American researchers in other countries," said Susan M. Reverby, a professor in the history of ideas and professor of women's and gender studies at Wellesley College in Massachusetts who discovered the experiments while investigating Tuskegee for a book.
In Tuskegee, perhaps the most notorious medical experiment in U.S. history, hundreds of African American men with late-stage syphilis were left untreated to study the disease between 1932 and 1972. In the Guatemala case, the subjects were treated, but it remains unclear whether they were treated adequately or what became of them.
Reverby discovered the experiments while reading papers in the University of Pittsburgh's archives from John C. Cutler, a doctor with the federal government's Public Health Service who later participated in Tuskegee. He died in 2003.
"I almost fell out of my chair when I started reading this," Reverby said in a telephone interview. "Can you imagine? I couldn't believe it."
The studies were sponsored by the Public Health Service, the National Institutes of Health and the Pan American Health Sanitary Bureau (now the World Health Organization's Pan American Health Organization) and the Guatemalan government. The goal was to assess whether taking penicillin right after sex would prevent sexually transmitted infections.
Cutler, Guatemalan health official Juan Funes and colleagues decided to study men in Guatemala City's Central Penitentiary because its prisoners were allowed to have sex with prostitutes. Some of the prostitutes tested positive for syphilis; in other cases, doctors put infectious material on the cervixes of uninfected prostitutes before they had sex with prisoners.
But because so few men were getting infected, the researchers then attempted "direct inoculations made from syphilis bacteria poured into the men's penises and on forearms and faces that were slightly abraded . . . or in a few cases through spinal punctures," Reverby wrote in a synopsis of the experiments.
They conducted similar experiments involving gonorrhea and chancroid and on soldiers in an army barracks and on men and women in the National Mental Health Hospital. In some cases, the subjects drank "syphilitic tissue mixed with distilled water," Reverby wrote in a synopsis of the testing. Doctors used needles to scrape the arms, faces or mouths of the women to try to infect them.
A number of high-ranking U.S. government officials knew about the research, including Thomas Parran Jr., who was then U.S. surgeon general, the documents show. "You know, we couldn't do such an experiment in this country," Parran said, according to Cutler. Parran died in 1968.
The gonorrhea studies involved 772 subjects, 234 of whom became infected and 233 of whom received treatment, according to an investigation by the federal Centers for Disease Control and Prevention. The chancroid studies involve 142 subjects, including 138 who became infected and 129 who received treatment. The syphilis experiments involved 497 subjects who were exposed to the bacteria that causes the disease, 427 of whom became infected and 332 of whom received treatment. A total of 443 of the subjects actually developed syphilis; 331 received treatment, although only 85 could be documented to have received full treatment, the CDC found.
Gonorrhea can cause a variety of complications, including infertility. Chancroid can cause painful ulcers. Syphilis can cause blindness, major organ damage, paralysis, dementia and death.
Seventy-one of the syphilis subjects died during the study, including one from a fatal epileptic seizure, but it was unclear whether any were caused by the studies. The fates of the other subjects will be investigated, officials said.
The researchers also took blood samples from 438 children at the National Orphanage, but in that case, they did not purposefully infect anyone, Reverby said.
Cutler discontinued the experiments "when it proved difficult to transfer the disease and other priorities at home seemed more important," she wrote. The results were never published. Cutler died in 2003.
Reverby shared her discovery last spring with David Sencer, a retired director of the CDC, who notified current CDC officials, leading to Friday's public disclosure. Reverby describes the tests in a 29-page paper that will be published in January in the Journal of Policy History.
NIH Director Francis S. Collins condemned the experiment and said strict prohibitions are in place to prevent such abuses from happening today.
"This case of unethical human subject research represents an appalling example from a dark chapter in the history of medicine," Collins told reporters during a telephone briefing Friday.
Although Collins said it was important that the experiments had been made public, he acknowledged that the revelation could deepen entrenched suspicions about scientists and doctors. The Tuskegee experiment continues to be blamed for making many minorities reluctant to participate in medical studies or even seek medical care.
"We are concerned about the way in which this horrendous experiment, even though it was 60 years ago, may appear to people hearing about it today as indicative of research studies that are not conducted in an ethical fashion," Collins said. "Today, the regulations that govern research funded by the United States government, whether conducted domestically or internationally, would absolutely prohibit this type of study."
The National Academy of Sciences' Institute of Medicine will also investigate the experiment and the Presidential Commission for the Study of Bioethical Issues will form a panel of international experts to "ensure that all human medical research conducted around the globe today meets rigorous ethical standards," officials said.