The subjects in the study did not give informed consent. In fact, they didn’t even know they were being infected.

When the Guatemalan study came to light last year, President Obama apologized on behalf of the United States. He also asked a Presidential Commission to investigate if safeguards are in place to make sure such unethical experiments could not be repeated.

On Thursday the Presidential Commission for the Study of Bioethical Issues released its findings.

“It was bad science, and it was bad ethics,” says Amy Gutmann, president of the University of Pennsylvania and chair of the commission. “The commission is confident that what happened in Guatemala in the 1940s could not happen today.”

Gutmann says that today there are measures in place to protect human subjects from unethical treatment. For example, volunteers must give informed consent, and institutional review boards oversee the ethics of research projects.

But the commission couldn’t tell how well these rules were followed in every study. Gutmann says when it comes to federally funded research, there needs to be more transparency and accountability.

When the bioethics commission asked the government to submit information on studies it had funded last year, some departments struggled.

“The Pentagon for example required more than seven months to prepare information on specific studies supported by the Department of Defense,” says Gutmann. “They did not have a central database to which they could refer, and they told us that it was very difficult for them to gather all the information that we requested.”

In its new report, the presidential commission recommends the government set up a website with information about the human subject studies it funds.

Another issue raised in the report is what to do when volunteers are injured or otherwise harmed in the course of research.

Larry Gostin is a bioethicist at Georgetown University who was not on the commission. He says compensation is a real issue.

“You have to remember that human subject research is just that – it’s a medical experiment,” he says.

The commission recommends that the federal government develop a clear policy to compensate participants who are harmed.

Gostin supports that recommendation. He points out that most developed countries have such policies.

“The United States is behind the curve on compensation,” he says.

The Guatemalan citizens who were experimented on without their knowledge never received compensation. Five of those Guatemalans who are still alive are suing the U.S. government.

Their lawyer, Terry Collingsworth, says that before filing the lawsuit in March he reached out to the government and asked for a compensation for his clients. He says he has yet to receive a response.

The presidential commission did not address the issue of whether the Guatemalans who were experimented on in the 1940s should be compensated.

Renee Krueger (Photo: Eric Niiler)

By Eric Niiler

Early on a cold fall morning, a dozen volunteers gathered in a waiting room at the Walter Reed Army Institute of Research outside Washington, D.C. They had come to test an experimental malaria vaccine.

The volunteers included college students, Walter Reed employees, and a 41- year-old single mother from Baltimore named Renee Krueger.

Krueger said she had volunteered because she wanted to help people at risk for malaria, including U.S. troops serving overseas.

“Every medicine that we have, whether it’s over the counter or prescription, somebody had to be willing to try it,” Krueger said.

Right now, there is no clinically available vaccine for malaria, although there are some experimental ones in the works. Walter Reed researchers wanted to test a new vaccine they hoped would protect against Plasmodium vivax, one of the four major strains of malaria parasite.

Col. Chris Ockenhouse, director of Walter Reed’s malaria vaccine research program, said the volunteers would permit a quick test of whether the vaccine had promise.

“If you had to do this same process out in the field,” he said, “you may have to vaccinate tens of thousands of individuals and wait a year or two to determine whether your vaccine worked or not.”

Here, the research would take just two weeks. The scientists would vaccinate these volunteers and then intentionally infect them with the malaria parasite to see if they got sick.

The stakes were high. It had taken six years of lab work just to get to this stage of vaccine development. Col. Ockenhouse said he was “cautiously optimistic” that the vaccine would fully protect at least some of the volunteers from malaria.

The Test Begins

“I hate mosquitoes,” said Renee Krueger as she rolled up her sleeve.

Krueger had already received the experimental vaccine. Now she was about to become infected.

She joined the other volunteers around a table and placed her bare arm over a small screen-covered canister. It held five mosquitoes that carried the malaria parasite.

Krueger couldn’t leave until she had been bitten by all five. That took close to an hour.

“They’re starting to itch a little bit where the mosquitoes bit me,” she said. “But other than that, I’m fine.”

With the protection of the experimental vaccine, Krueger hoped she would stay fine. But some of the other volunteers knew that they would not stay healthy.

Army First Sergeant Joe Civitello was in the “control arm” of the study – a comparison group of volunteers that would not receive the vaccine.

“I’m going to get malaria,” he said with a nervous laugh. “Somebody’s got to do that part too, right?”

After being infected, the volunteers headed home. They went back to work and to their families.
Meanwhile, the malaria parasites were moving through their bodies. The parasites infect the liver then reproduce and move to the bloodstream, where they attack red blood cells.

It takes at least ten days before any symptoms set in. So, on the ninth day, the volunteers returned.
This time, they checked into a hotel, where Walter Reed doctors would monitor their health.

Waiting for Symptoms

It was a Friday night, and Renee Krueger felt great. In fact, she had brought her two daughters for the weekend.
“They’re excited,” she said. “When they go to the hotel, they think we’re on vacation.”

On Saturday, Krueger took the girls shopping and to the hotel’s indoor swimming pool. That same day, Sergeant Civitello got sick, just as expected.

It started with achy muscles. “Then the headache and the fever and the diarrhea started to kick in,” he said, “and you’re like, uh, this is not fun.”

Doctors immediately treated him with two kinds of anti-malaria medicine.

Meanwhile, on Sunday morning, Renee Krueger still felt pretty good. Then, that afternoon, she got a call from the doctors. They had been testing her blood, and they found malaria parasites multiplying in her body. She needed to go on medication.

“I was a little surprised when I got the call,” said Krueger. “I was a little tired but I just thought that was from being lazy today. But I guess maybe that’s why I’m tired.”

Over the next several days, Krueger developed the typical symptoms of malaria – achy muscles, nausea, and fever.
The fact that she and others who were vaccinated got sick suggested the vaccine was not working. But Major Jason Bennett, who was running the clinical trial, tried to remain optimistic.

“The main goal of this trial was to test the safety of the vaccine,” he said, “[and] we know that the vaccine is safe.” He said it would take more analysis to determine how effective the vaccine was. Even if vaccinated people got sick, Bennett said the vaccine might have delayed symptoms.

Four days later, on Thursday, the trial was done. By now, Renee Krueger had recovered from malaria, but she looked exhausted. And she was disappointed.

“We wanted it to work,” she said. “It would have been nice to be part of something that could have been life-changing for a lot of people. It could have saved a lot of lives.”

Failure is the norm in early vaccine trials, which is why researchers are working on other approaches to immunizing people against malaria.

Those experimental vaccines will also need to be tested on humans. Walter Reed’s doctors say they will be looking for new groups of volunteers later this year.

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This text below is a phonetic transcript of a radio story broadcast by PRI’s THE WORLD. It has been created on deadline by a contractor for PRI. The transcript is included here to facilitate internet searches for audio content. Please report any transcribing errors to theworld@pri.org. This transcript may not be in its final form, and it may be updated. Please be aware that the authoritative record of material distributed by PRI’s THE WORLD is the program audio.

MARCO WERMAN: The high cost of healthcare in America was addressed at length by the president last night. Mr. Obama argued there’s so much waste and abuse in the current health care system that making more efficient would provide a way to expand coverage to the nation’s uninsured. That’s a message Boston University professor, Eugene Litvak, has been promoting for years. Litvak is a Soviet-trained management consultant who now advises US hospitals on better ways to manage the flow of patients. The World’s Katy Clark has more.

KATY CLARK: Eugene Litvak is an unlikely prophet. He learned the art of efficient business operations in the notoriously inefficient Soviet Union. But Litvak says his outsider status helps him when it comes to addressing the inherent waste in America’s healthcare system.

EUGENE LITVAK: Many people who were born in this country believe the healthcare delivery system should not be even touched because it just was this way forever. I don’t have this baggage and many people just forgive me because believe that this guy is Russian, crazy; he just doesn’t know what he is doing.

CLARK: But Litvak does know what he’s doing. It’s called operations management or the art of meeting customer’s needs as efficiently as possible. Operations management is common in other industries – making cars for instance or making donuts – but it’s relatively new in hospitals. Litvak says running a hospital is a lot like running a restaurant.

LITVAK: If you want to increase customer throughput through the restaurant we have only three means to do that. The first one you would ask your diners to eat quickly and you would ask your waiter to serve them quickly. That’s the first option. Second option you build more restaurant tables so you make sure you accommodate more people. That’s how you improve access to your restaurant. And finally the third option that you make sure that your tables are not staying idle.

CLARK: The healthcare system has already implemented the first two options, reducing the length of a typical hospital stay for instance and adding more beds. Litvak says the third option, managing the flow of patients more efficiently, is the least tried. But he maintains it holds the most promise. Take what happened at Cincinnati Children’s Hospital. CEO Jim Anderson brought Litvak on as a consultant four years ago. Anderson was concerned about chronic delays and patient overcrowding.

JIM ANDERSON: He helped us understand the importance of surgical scheduling so that in our elective surgeries we schedule those in a much more even way throughout the week rather than have them peak at any particular time of the week in a very unregulated way.

CLARK: Litvak also suggested that Cincinnati Children set aside two operating rooms strictly for emergencies in order to minimize disruptions to scheduled surgeries. These days Cincinnati Children’s Hospital is doing more surgeries with the same resources and pulling in an additional $137 million in revenue. Jim Anderson is thrilled with the results but he says it wasn’t a simple process.

ANDERSON: Well it is hard work and it does go against the cultural norms of healthcare.

CLARK: Translation: Doctors don’t like to change their schedules around and administrators are loathed to antagonize doctors. That’s meant an uphill battle for Eugene Litvak. In 12 years of preaching efficiency Litvak and his colleagues have managed to get only a half dozen in the US to implement their ideas. Fighting an entrenched system though is nothing new to him. America’s healthcare bureaucracy reminds him of his life back in the Soviet Union.

LITVAK: Frequently having some conversations with decision makers I feel that if I can only replace English with Russian I would feel like I’m back home.

CLARK: But Litvak remains hopeful that hospitals will come around to his way of thinking especially if President Obama’s healthcare reform efforts succeed. Litvak believes if America is ever going to provide high quality healthcare to all its citizens, hospital administrators have to start thinking more like modern factory bosses and less like Soviet-era bureaucrats. For The World this is Katy Clark.

Copyright ©2009 PRI’s THE WORLD. All rights reserved. No quotes from the materials contained herein may be used in any media without attribution to PRI’s THE WORLD. This transcript may not be reproduced, in whole or in part, without prior written permission. For further information, please email The World’s Permissions Coordinator at theworld@pri.org.

• BBC coverage of the health care debate
• The Guardian newspaper: Is public healthcare in the UK as sick as rightwing America claims?
• Zack Cooper’s LSE profile

Karadzic as "Dragan Dabic" (left) and in court

New York Times gallery

Read the Transcript
This text below is a phonetic transcript of a radio story broadcast by PRI’s THE WORLD. It has been created on deadline by a contractor for PRI. The transcript is included here to facilitate internet searches for audio content. Please report any transcribing errors to theworld@pri.org. This transcript may not be in its final form, and it may be updated. Please be aware that the authoritative record of material distributed by PRI’s THE WORLD is the program audio.

KATY CLARK: I’m Katy Clark, and this is The World, a co-production of the BBC World Service, PRI, and WGBH Boston.  The war crimes trial of former Bosnian Serb leader Radovan Karadzic hasn’t started yet, but Karadzic is already challenging some of the evidence against him.  Prosecutors have charged Karadzic with masterminding the 1995 massacre of some 8,000 Muslim men and boys in Srebrenica.  Karadzic wants access to DNA evidence from mass graves, because, he claims, the death toll has been exaggerated.  The former Bosnian Serb leader was in hiding for years before his arrest last year in Belgrade.  Karadzic had been living a relatively public life there, practicing alternative medicine under the name Dragan Dabic.  Jack Hitt’s story about Karadzic’s new-age adventure will appear in this Sunday’s New York Times magazine.  Jack Hitt, it’s a strange story indeed.  I mean, tell us exactly how did the most hunted war criminal on the planet manage to spend 3 years becoming, as you explain in your piece, something of a minor celebrity in Belgrade, without anyone realizing who he was?

JACK HITT:  Well, you know, I think a lot of people expected him to hide out in the sort of heroic way that you expect war criminals to.

CLARK:  In the mountains?

HITT:  Go into the jungle and you know, eat squirrel and live with his men.  But Radovan Karadzic was a psychiatrist before he was a politician.  He was a member of the traditional medicine community, and I think he understood the sort of – the psychological politics of how to hide at an age when everything is watched and seen. So rather than hide out as a traditional doctor, he sort of moved one discipline over, to alternative medicine where, let’s just say that because of some of the dodgy practices, a lot of odd behavior is excused.

CLARK:  What kind of odd behavior are you talking about?  Give us an example of some of his stuff that you experienced or encountered.

HITT:  Well, one of the people that he fell in with was Savo Bojovic, who is a fairly well known sexologist, who has invented a number of different machines. He had a solution for men who womanized a lot and worried about getting women pregnant, so he had invented a small metal cup he would cradle their testicles in and then pass a small amount of electricity through that, and his machine would put all the sperm to sleep for awhile, and it would allow a man to go out and heroically exercise his – his manhood.  Radovan Karadzic and the persona of Dragan Dabic had settled on just the fact that his hands could radiate this bioenergy warmth, and he could detect illness and correct it with his hands.  I had many people describe for me how he had healed certain people.  The one thing about that world, though, is that they’re all aware of the fact that many people don’t believe that their methods work.  And so when you hang out with these people, they spend a lot of time talking to you about their method, trying to convince you of its efficacy.  They don’t really listen to what you have to say.  So if you are hiding out, it’s a great world if you want to just sort of sit quietly in a place and not have a lot of people bother you with questions.

CLARK:  But are these people who live in the real world?  I mean, I’m wondering if they knew what Radovan Karadzic looked like, and if they actually took a good look at Dragan Dabic, they would have seen some similarities and might have suspected something more?

HITT:  You know, I went over there thinking that they must have known, or that some of them did, because that was sort of the word on the street. I’m not convinced that they did.  I’m now convinced that they did not know.  If you look at the photographs of him as the alternative healer, he has grown this enormous mass of gray hair and he’s bundled it up on the top of his head in this big knot right at his forehead.  It’s very noticeable and odd, so you have to look at it.  You

don’t look at his eyes, for example.  He lost some weight, so it sort of pulled down his face a little bit and changed his eye shape.  He grew an enormous bushranger beard.  He looked different in every possible respect.  There was nothing about him that looked like Radovan Karadzic.

CLARK:  In fact, as you write, there was a woman who lived across the street from him in Belgrade and said “Good morning” to him every morning, I think, and she worked for Interpol.  When she logged on to her computer, there was a picture of “Wanted:  Radovan Karadzic” right up there, and she never even noticed.

HITT:  Her screensaver was a picture of Osama Bin Laden and Radovan Karadzic, and little did she know she was saying “Good morning” to him.

CLARK:  While reading your story, I found myself wondering about the idea of redemption and if Karadzic might have actually repented for his alleged war crimes?

HITT:  There’s been no repentance and there’s no – so far, he does not acknowledge he’s committed these crimes.  I will say that when I talked to all of the people who were duped by him, they don’t feel they’ve been duped at all.  I would say to them, “So, you know, this man, his name is not really Dragan Dabic.  He was not really a healer.  He was Radovan Karadzic.”   And they would say, “I don’t know Radovan Karadzic.  I know Dragan Dabic, and he’s a good man.”   And many of them said, “I believe that Dragan Dabic is the real person and that Radovan Karadzic is the fake, invented persona.”

CLARK:  Jack Hitt is a contributing writer for the New York Times magazine.  His story about Radovan Karadzic appears this Sunday.  Thanks for speaking with us.

HITT:  Thank you.

Copyright ©2009 PRI’s THE WORLD. All rights reserved. No quotes from the materials contained herein may be used in any media without attribution to PRI’s THE WORLD. This transcript may not be reproduced, in whole or in part, without prior written permission. For further information, please email The World’s Permissions Coordinator at theworld@pri.org.

Read the Transcript
This text below is a phonetic transcript of a radio story broadcast by PRI’s THE WORLD. It has been created on deadline by a contractor for PRI. The transcript is included here to facilitate internet searches for audio content. Please report any transcribing errors to theworld@pri.org. This transcript may not be in its final form, and it may be updated. Please be aware that the authoritative record of material distributed by PRI’s THE WORLD is the program audio.

KATY CLARK: In many parts of Africa, when people get sick, there’s a good chance that they won’t go to the doctor for a visit or the pharmacist for a prescription.  They’ll go to a traditional healer for some herbs or some prayers or a ceremony or two.  They do it for lots of reasons:  limited access to medical care, the prohibitive costs of Western medicines or because their spiritual beliefs tell them to.  Jori Lewis reports from the West African nation Senegal where traditional medicine is big business.

JORI LEWIS:  Rokhaya Pouye had been suffering from years.  She couldn’t eat.  She couldn’t walk.  She couldn’t sleep.  When her family took her to the hospital, the doctors couldn’t find anything wrong with her.  So her family decided if it wasn’t the body, it had to be the spirit – or spirits, to be precise.  Madame Pouye says she turned to traditional medicine.  The spirits, she says, asked her to kill three oxen in a ten-day ceremony to protect herself from the sorcerers.  She says she was healed by an ndeup ceremony.  It’s a ritual that involves prayer, animal sacrifice and dance.  And now she helps out at local ndeup ceremonies, like this one in a suburb of Dakar.   The women of this extended family whirl, jump and fling themselves around a courtyard.  They move to the drums until they feel the spirits taking over their bodies.  One woman falls to the ground, tears running down her face.  Another picks up a drummer and carries him around.  He doesn’t miss a beat.  It’s beautiful to watch.  But is this medicine?  Mamadou Ngom oversees the traditional medicine sector for the World Health Organization in Dakar.  His answer is an emphatic yes.

NGOM:  Yes, that’s traditional medicine.  The problem that we have as scientists is that we are grounded in reason and scientific criteria.  We say, “What are they doing?”  But it’s something that they have done many times over many years, and they know they will get the same results.

LEWIS:  Ngom says that in Africa, about 80 percent of people use or have used traditional medicine.  That’s a big umbrella term that encompasses everything from an ndeup ceremony to incantations to healing with herbs and powders.  Many like Madame Pouye turn to traditional medicine after going to a medical doctor.  But others go because it’s cheaper, more convenient or it’s all they know.  Sometimes they regret it.  Across the border in the Gambian capital of Banjul, I met the Saho family.  They were gathered on the hospital bed of 1-year-old Ibrahima.  When Ibramhima got sick with a bad fever, his father Ousmane took him to a marabout, a spiritual leader and healer.  And then he went to another and another.

OUSMANE:  Some were telling me his private parts got problems, that’s why he is sick.  Some were telling me he lacks water, you know, he don’t have enough water.  You know, they were giving me conflicting information about my child’s sickness.  But later on when I come with my senses based on the advice of my wife, I have to come to the hospital.  Thank God, he’s recovering.

LEWIS:  Little Ibrahima had pneumonia.  At the hospital they gave him antibiotics and attached him to an IV.  When I met them, Ibrahima had been in the hospital for about 10 days, but was finally getting better.  Charles Katy is the cultural director for the International Association for the Promotion of Traditional Medicine, known as PROMETRA.  He says fakes and charlatans are a problem.

KATY:  We have many charlatans here.  They say marabout but when somebody says, “I’m a marabout.  I can do this and this.  Come and see me.  My house is there.  This is my number.  Call me and so on.”  It’s not because he’s able to treat but he wants money.

LEWIS:  In an attempt to address this problem, Prometra has established a clinic in the Senegalese town of Fatick, where the healers police each other; they have organized hundreds of them:  priests, fortune tellers, bonesetters, and herbal specialists.  Healers at the clinic meet once a month to discuss clinic business.  Diene Ndiaye is the current chairman.  Ndiaye harvests certain herbs and plants to help people with respiratory diseases, gastrointestinal problems and STD’s.  He says the wisest healers know their own limits, and that there is a role for both types of medicine.

NDIAYE:  The medical doctor and traditional healer, it’s like the right hand and the left hand.  If they join, they can more effectively help people.  Medical doctors are doing a very good job but sometimes they fail in treating diseases where traditional medicine works.  At other times, it’s the other way around.  I think we have to work together.

LEWIS:  The WHO says it wants to help African countries register and regulate traditional healers.  The scientists can identify plants and herbs and their uses.  What they can’t do is regulate the spiritual aspects at the heart of so many traditional practices.  But most people here would say even though those practices aren’t science, they’re still medicine.  For The World, I’m Jori Lewis, in Fatick, Senegal.

Copyright ©2009 PRI’s THE WORLD. All rights reserved. No quotes from the materials contained herein may be used in any media without attribution to PRI’s THE WORLD. This transcript may not be reproduced, in whole or in part, without prior written permission. For further information, please email The World’s Permissions Coordinator at theworld@pri.org.