STD's Clinical Research-US apologise

http://www.cnn.com/2010/WORLD/americas/10/01/us.guatemala.apology/index.html?hpt=T2


US apologizes for infecting Guatemalans with STDs in the 1940sBy the CNN Wire Staff
October 1, 2010 10:18 p.m. EDT

President Obama offers "profound apologies" to the Guatemalan president for the tests.STORY HIGHLIGHTS
Obama offers "profound apologies"
Guatemala accepts the apology, the presidential spokesman said
The United States is launching an investigation
The research was "reprehensible," the U.S. statement said
Washington (CNN) -- The United States apologized Friday for a 1946-1948 research study in which people in Guatemala were intentionally infected with sexually transmitted diseases.

A statement by Secretary of State Hillary Clinton and Secretary of Health and Human Services Secretary Kathleen Sebelius called the action "reprehensible."

"We deeply regret that it happened, and we apologize to all the individuals who were affected by such abhorrent research practices," the joint statement said. "The conduct exhibited during the study does not represent the values of the United States, or our commitment to human dignity and great respect for the people of Guatemala."

President Barack Obama called his Guatemalan counterpart Friday "offering profound apologies and asking pardon for the deeds of the 1940s," President Alvaro Colom told CNN en Espanol in a telephone interview from Guatemala City.

"Though it happened 64 years ago, it really is a profound violation of human rights," said Colom, who said the report took him by surprise.

Clinton called him on Thursday, he said. "She too offered her apologies," he said, adding that she told him she was ashamed the United States had been involved in the matter.



Video: U.S. gave STDs to Guatemalans
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Asked whether Guatemala was planning to take legal action, Colom said, "That's part of the work of the commission."

"We reject these types of actions, obviously," said Guatemala presidential spokesman Ronaldo Robles. "We know that this took place some time ago, but this is unacceptable and we recognize the apology from Secretary Clinton."

The scientific investigation, called the U.S. Public Health Service Sexually Transmitted Disease Inoculation Study of 1946-1948, aimed at determining the effectiveness of penicillin in treating or preventing syphilis after subjects were exposed to the disease. Gonorrhea and chancres were also studied. Penicillin was a relatively new drug at the time.

The tests were carried out on female commercial sex workers, prisoners in the national penitentiary, patients in the national mental hospital and soldiers. According to the study, more than 1,600 people were infected: 696 with syphilis, 772 with gonorrhea and 142 with chancres.

The study came to light recently when Wellesley College researcher Susan Reverby found the archived but unpublished notes from the project as she was researching a similar study that was conducted between 1932 and 1972 in Tuskegee, Alabama. That study included nearly 400 poor African-American men with preexisting syphilis whose disease was allowed to progress without treatment. Researchers did not infect the subjects, but they did not tell them they had the disease either.

The Tuskegee study was done under the direction of Dr. John C. Cutler, a U.S. Public Health Service medical officer who died in 2003.

"I was doing what historians do," said Reverby, a professor of the history of ideas and women and gender issues, who has written a book on the Tuskegee study. She went to the University of Pittsburgh, where Cutler had taught, and searched through an archive of his papers.

"There was nothing on Tuskeegee in the papers, but there was this report of the Guatemala study," she told CNN in a telephone interview. "I started to read, and I almost fell off my chair."

She found that Cutler also led the research in Guatemala. It was carried out there, in part, she said, because prostitution was legal and prisoners were allowed to bring prostitutes in for sex.

Dr. Francis Collins, director of the U.S. National Institutes for Health, told reporters that the Guatemala study represented "a dark chapter in the history of medicine."

The study "appears to have been funded" by the U.S. National Institutes of Health, he said, citing four primary ethical violations: 1) study subjects "were members of one or more vulnerable populations;" 2) there is no evidence they gave informed consent; 3) they were often deceived about what was being done to them; 4) they were intentionally infected with pathogens that could cause serious illness without their understanding or consent.

U.S. officials said Friday that ethical safeguards would prevent such abuses from occurring today.

An Institute of Medicine task force will look at what happened in the study, and a group of ethics experts will convene to review the matter and report on how best to ensure such abuses do not recur, Collins said.

"The study is a sad reminder that adequate human subject safeguards did not exist a half-century ago," the U.S. statement said. "Today, the regulations that govern U.S.-funded human medical research prohibit these kinds of appalling violations."

Collins said the published literature contains more than 40 other U.S.-based studies "where intentional infection was carried out with what we could now consider to be completely inadequate consent in the United States."

Many of those studies were funded by the Public Health Service, he said.

But at least some people believed at the time that the experiment was flawed, according to Wellesley's Reverby, who cited this reaction to Cutler's work from his supervisor, PHS physician R.C. Arnold: "I am a bit, in fact more than a bit, leery of the experiment with insane people," Arnold said. "They can not give consent, do not know what is going on, and if some good organization got wind of the work, they would raise a lot of smoke. I think the soldiers would be best or the prisoners for they can give consent. Maybe I'm too conservative ... In the report, I see no reason to say where the work was done and the type of volunteer."

"The vast majority" of study subjects were adequately treated for their illness, Collins said. One subject died during an epileptic seizure, though it was not clear that the death was related to the study, he added.

Cutler's work helped refine testing procedures and suggested a better means of prevention, but "made little impact on syphilis research," Reverby concluded.

Clinton and Sebelius said the United States is launching an investigation and also convening a group of international experts to review and report on the most effective methods to make sure all human medical research worldwide meets rigorous ethical standards.

"As we move forward to better understand this appalling event, we reaffirm the importance of our relationship with Guatemala, and our respect for the Guatemalan people, as well as our commitment to the highest standards of ethics in medical research," the U.S. statement said.

CNN's Arthur Brice, Nick Valencia and Tom Watkins and CNNRadio's Shelby Lin Erdman contributed to this report.

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Studies show 'dark chapter' of medical researchBy Elizabeth Landau, CNN
October 1, 2010 6:08 p.m. EDT
The Public Health Service took photographs during the Tuskegee syphilis study, but no captions remain. This is one of them.STORY HIGHLIGHTS
The Tuskegee study, which began in the early 1930s, consisted of 399 African-American men
The Guatemala-based research involved 696 subjects
Both studies were sponsored by U.S. government health agencies
(CNN) -- The Tuskegee syphilis experiment of the 20th century is often cited as the most famous example of unethical medical research. Now, evidence has emerged that it overlapped with a shorter study, also sponsored by U.S. government health agencies, in which human subjects were unknowingly being harmed by participating in an experiment.

Research from Wellesley College professor Susan Reverby has uncovered evidence of an experiment in Guatemala that infected people with sexually transmitted diseases in an effort to explore treatments.

The U.S. government apologized for the research project on Friday, more than 60 years after the experiments ended. Officials said an investigation will be launched into the matter.

The Tuskegee and the Guatemala studies show what National Institutes of Health Director Francis Collins called a "a dark chapter in the history of medicine."

As unethical as the methods were, the basic research questions behind both studies were highly relevant at the time, said Peter Brown, medical anthropologist at Emory University. Research in Guatemala focused on the powers of penicillin; in Tuskegee, researchers wanted to know the natural history of syphilis.

"In a racist context, they thought [syphilis] might be different in African-Americans; the real unethical part in my mind had to do with denial of treatment and, most importantly, the denial of information about the study to the men involved," he said.

In 1926, syphilis was seen as a major health problem, according to the Centers for Disease Control and Prevention; in 1928, about 25 percent of black employees at the Delta Pine and Land Company of Mississippi had tested positive for syphilis, according to Tuskegee University. A charity called the Julius Rosenwald Fund came to the U.S. Public Health Service to start a project to improve the health of African-Americans in the South.

But in 1929, the Great Depression began, and the Rosenwald Fund had to cut its funds for the treatment program.

The director of the U.S. Public Health Service, Dr. Taliaferro Clark, proposed salvaging the project by investigating the course of untreated syphilis.

Getting African-Americans to participate was not a challenge; most African-Americans did not have access to medical care at that time and the study provided free health exams, food and transportation, according to Tuskegee University.



Video: U.S. gave STDs to Guatemalans
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But none of the patients who had syphilis was told that he carried the condition, and doctors did not give the patients sufficient treatment. Instead they were told they would get treatment for "bad blood," a phrase that connoted a variety of illnesses including syphilis, anemia and fatigue, the CDC said.

The Tuskegee study, which began in the early 1930s, consisted of 399 African-American men with syphilis and 201 without, according to the CDC. The Tuskegee Institute partnered with the Public Health Service for an experiment that was supposed to last 6 months. Instead it lasted about 40 years.

While the Tuskegee study was still going in the 1940s, other efforts that would never meet today's medical ethics standards were going on elsewhere. The Public Health Service did research at a U.S. prison in 1944 that involved injecting inmates with gonorrhea, Reverby said. That project was abandoned, and the Public Health Service turned to Guatemala to more closely examine syphilis and in what ways penicillin could treat or prevent it, Reverby said in documents posted on her website.

"The whole fact that the Public Health Service was very aware about the ethical problems is very characteristic of American international health policy at the time, which was very condescending to other countries," Brown said.

It turns out that a physician at the Public Health Service, Dr. John C. Cutler, participated in both the Guatemala and the Tuskegee experiments. Cutler came to the Tuskegee project in the 1960s, according to Reverby, and continued to defend it even in the 1990s, long after it ended. Cutler died in 2003 at age 87.

The Guatemala syphilis research involved 696 subjects who came from the Guatemala National Penitentiary, army barracks and the National Mental Health Hospital, according to Reverby's research. These subjects did not give direct permission to participate. Instead, the authorities signed them up. There were also 772 patients exposed to gonorrhea and 142 subjects exposed to chancres, according to a CDC report.

Unlike the Tuskegee project, these participants were given the diseases as part of the experiment.

"The doctors used prostitutes with the disease to pass it to the prisoners (sexual visits were allowed by law in Guatemalan prisons) and then did direct inoculations made from syphilis bacteria poured onto the men's penises or on forearms and faces that were slightly abraded when the 'normal exposure' produced little disease, or in a few cases through spinal punctures," Reverby wrote.

Many people wrongly believe that the Tuskegee study involved injecting subjects with syphilis, according to a 2008 study led by Ralph Katz of the NYU College of Dentistry. His survey found that more than 60 percent of both whites and blacks said they believed study subjects were injected with syphilis.

Another important difference between the studies is that the subjects in Guatemala received penicillin after getting the sexually transmitted disease, Reverby wrote, although it's not clear whether everyone was cured.

In Tuskegee, on the other hand, the Public Health Service made sure that the subjects with syphilis did not get treatment from elsewhere. During World War II, draft boards agreed to lift the requirement of syphilis treatment for study participants, according to Tuskegee University.

Tuskegee study subjects continued to be excluded when the Public Health Service began giving other patients penicillin to treat syphilis in 1943. The agency set up Rapid Treatment Centers to treat the disease in 1947, helping to lower the overall syphilis rate; study subjects were still not treated, according to the CDC.

The Guatemalan study ended when "it proved difficult to transfer the disease and other priorities at home seemed more important," according to Reverby's paper. Cutler was told go back to the United States, she said. There he went on to work on an inoculation study at Sing Sing Prison in Ossining, New York, from 1953 to 1956, and later to Tuskegee. As for the participants in the Guatemalan study, there was some follow-up laboratory testing and observation until the early 1950s, the CDC said.

Tuskegee experiments stopped on a more dramatic note: in 1972 when Peter Buxton, who also worked for the Public Health Service, relayed information about the experiment to a reporter. By that time, 28 men had died of syphilis and 100 others had died of related complications. As a result of the experiment, at least 40 wives contracted syphilis and 19 children had it from birth.

The exposure of the study sparked congressional hearings in 1973 that led to a total overhaul of the Health, Education and Welfare rules concerning work with human subjects. A class-action lawsuit resulted in an out-of-court settlement of $10 million, with the U.S. government promising lifetime medical benefits and burial services to all study subjects still living. This program later expanded to include wives, widows and children.

President Bill Clinton publicly apologized to the victims of the Tuskegee experiments in an emotional speech in 1997, in which he said the study was shameful and racist.

"The people who ran the study at Tuskegee diminished the stature of man by abandoning the most basic ethical precepts. They forgot their pledge to heal and repair. They had the power to heal the survivors and all the others and they did not. Today, all we can do is apologize," he said at a ceremony at the White House.

Because of the ethical guidelines that all research institutions must follow, these kinds of studies would not happen in the United States today, Brown said.

http://www.cnn.com/2010/HEALTH/10/01/guatemala.syphilis.tuskegee/index.html?hpt=Sbin