Syphilis Experiments Shock, But So Do Third World Drug Trials

Aug. 30, 2011— -- A commission set up last year by President Barack Obama has revealed that 83 Guatemalans died in U.S. government research that infected hundreds of prisoners, prostitutes and mental patients with the syphilis bacteria to study the drug penicillin -- a project that the group called "a shameful piece of medical history."

"The report is good and I applaud the Obama administration for giving it some sunshine," said Dr. Howard Markel, a pediatrician and medical historian from the University of Michigan. "Internationally, what we do as a human society is to make sure that these things never happen again."

But medical ethicists say that even if today's research is not as egregious as the Guatemala experiment, American companies are still testing drugs on poor, sometimes unknowing populations in the developing world.

Many, like Markel, note that experimenting with AIDS drugs in Africa and other pharmaceutical trials in Third World countries, "goes on every day."

"It's not good enough, in my opinion, to protect only people who live in the developed world -- but all human beings," he said.

The U.S. Public Health Service and the Pan American Sanitary Bureau worked with several Guatemalan government agencies from 1946 to 1948, exposing about 1,300 people to the sexually transmitted diseases syphilis, gonorrhea or chancroid.

They infected soldiers, prostitutes, prisoners and mental patients. More than 5,500 people in all were part of the medical experimentation.

And the presidential panel said government scientists knew they were violating ethical rules.

Scientists wanted to see if penicillin, which was a relatively new drug, could prevent infections. The research was paid for with U.S. tax dollars and culled no useful medical information.

This week the Obama commission revealed that only 700 of them received treatment and 83 died by 1953. The commission could not confirm whether the deaths were a direct cause of those infections.

In the 1940s, syphilis was a major health threat, causing blindness, insanity and even death.

Many of the same researchers had carried out studies on prisoners in Terre Haute, Indiana, but unlike the Guatemalan patients, the Americans gave consent.

For years, the experiments were secret, until a medical historian at Wellesley College in Massachusetts found the records among the papers of Dr. John Cutler, who led the experiments. A federal commission to learn more was set up last year.

According to Markel, ethical considerations in science began to emerge after World War II, and further enlightenment followed after the American civil rights movement.

"This was far too common a phenomenon until our recent history -- in the prison population and homes for the mentally retarded," he said. "Part of the reason we did this research is we didn't think of them as humans."

The discovery of the Holocaust and the murder of 6 million people -- Jews, the disabled, homosexuals and gypsies, as well as bad experimentation by Nazi doctors, opened the world's eyes.

The founding of the United Nations and the World Health Organization also brought attention to human rights.

"Each new discovery and advance in social rights, we had to learn the lesson over and over again," he said. "For a long time, blacks were second or third class citizens."

Tuskegee Project Continued Until 1972

One government project that infected black men in Tuskegee, Ala., continued up until 1972 when an Associated Press story on the project caused public outrage.

In 1932, the Public Health Service, working with the Tuskegee Institute, began a study to record the natural history of syphilis in hopes of justifying treatment programs for blacks.

The study initially involved 600 black men -- 399 with syphilis, 201 who did not have the disease. The study was conducted without the benefit of patients' informed consent.

Like the Guatemalans under experimentation, they never received any treatment to cure their illness.

"Some people ask if what went on in Guatemala could go on today, and I say I don't think so," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. "I don't think the pharmaceutical companies are running around giving people diseases or operating in prisons or mental asylums."

But today, drug companies hoping to speed up their Phase 3 clinical trials and get Food and Drug Administration (FDA) approval go to developing countries to find an abundance of poor patients will to try new drugs.

"Giving people a fatal disease is the worst thing you can do," according to Caplan, who said ethical questions are also raised when "we give poor people medicine for a disease they might have, and leave and sell [the drugs] in the U.S."

He said there are also no internationally enforceable standards for such research. "The world doesn't have any rules," said Caplan.

About a decade ago when the human genome was being mapped, companies were excited about exploring new drug options, and private funding expanded.

"We began to see big money come from pharma, intended to sell in the developing world but trying it out in poor nations because it could be done cheaply and faster. They face less vigorous regulatory oversight," he said.

The key to protection is informed consent. If a patient is in a placebo group and not getting the drug, they need to know that, he said.

"If they have no education and they are bedazzled to see a doctor for the first time, they may not be listening," said Caplan. "Informed consent at its best is dubious in poor countries."

Existing treatment that works on a disease should never be held back, he said. "If you come to test a diabetes drug among poor people in India and given them a placebo and not insulin, you are exploiting them, especially if you are going to sell the drug only in Europe and Canada and they get to use it for a while and then you leave."

Drugs should also be made available once the study concludes, according to Caplan.

"And if the country is so corrupt the drugs get stolen on the black market, we should commit building a water treatment plant or a clinic or make a road," he said.

And those who don't think about where their drugs are tested should think twice, he said.

"It's the same phenomenon: 'I can get really cheap clothes made by sweat shop in labor in China. I am not asking how it's made, I just like the low price,'" said Caplan. "The stance we take toward the poor is they matter less."

Prisoners, like those infected with syphilis in Guatemala are often poorly education and "easily coerced," said Caplan.

Meanwhile, Guatemala's Vice President Rafael Espada said his government would make a formal apology to his people because local doctors had also been involved in the U.S.-funded program.

President Obama has also apologized to Guatemalan President Alvaro Colom. A final report is due in December.

One government project that infected black men in Tuskegee, Ala., continued up until 1972 when an Associated Press story on the project caused public outrage.

In 1932, the Public Health Service, working with the Tuskegee Institute, began a study to record the natural history of syphilis in hopes of justifying treatment programs for blacks.

The study initially involved 600 black men -- 399 with syphilis, 201 who did not have the disease. The study was conducted without the benefit of patients' informed consent.

Like the Guatemalans under experimentation, they never received any treatment to cure their illness.

"Some people ask if what went on in Guatemala could go on today, and I say I don't think so," said Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania. "I don't think the pharmaceutical companies are running around giving people diseases or operating in prisons or mental asylums."

But today, drug companies hoping to speed up their Phase 3 clinical trials and get Food and Drug Administration (FDA) approval go to developing countries to find an abundance of poor patients will to try new drugs.

"Giving people a fatal disease is the worst thing you can do," according to Caplan, who said ethical questions are also raised when "we give poor people medicine for a disease they might have, and leave and sell [the drugs] in the U.S."

He said there are also no internationally enforceable standards for such research. "The world doesn't have any rules," said Caplan.

About a decade ago when the human genome was being mapped, companies were excited about exploring new drug options, and private funding expanded.

"We began to see big money come from pharma, intended to sell in the developing world but trying it out in poor nations because it could be done cheaply and faster. They face less vigorous regulatory oversight," he said.

The key to protection is informed consent. If a patient is in a placebo group and not getting the drug, they need to know that, he said.

"If they have no education and they are bedazzled to see a doctor for the first time, they may not be listening," said Caplan. "Informed consent at its best is dubious in poor countries."

Existing treatment that works on a disease should never be held back, he said. "If you come to test a diabetes drug among poor people in India and given them a placebo and not insulin, you are exploiting them, especially if you are going to sell the drug only in Europe and Canada and they get to use it for a while and then you leave."

Drugs should also be made available once the study concludes, according to Caplan.

"And if the country is so corrupt the drugs get stolen on the black market, we should commit building a water treatment plant or a clinic or make a road," he said.

And those who don't think about where their drugs are tested should think twice, he said.

"It's the same phenomenon: 'I can get really cheap clothes made by sweat shop in labor in China. I am not asking how it's made, I just like the low price,'" said Caplan. "The stance we take toward the poor is they matter less."

Prisoners, like those infected with syphilis in Guatemala are often poorly education and "easily coerced," said Caplan.

Meanwhile, Guatemala's Vice President Rafael Espada said his government would make a formal apology to his people because local doctors had also been involved in the U.S.-funded program.

President Obama has also apologized to Guatemalan President Alvaro Colom. A final report is due in December.