Ethically Sound: Ethically Impossible

In the 1940s, US researchers in Guatemala exposed prisoners, psychiatric patients, soldiers and sex workers to sexually transmitted diseases, without their consent. Did the researchers intentionally flaunt the ethical standards of the day? In this episode of Ethically Sound, host Hillary Wicai Viers talks with Bioethics Commission member Dr. Anita Allen and Dr. Paul Lombardo, and discusses the Bioethics Commission's report "Ethically Impossible": STD Research in Guatemala from 1946 to 1948.

 

Transcript

Host: 

In the 1940s, US researchers in Guatemala exposed prisoners, psychiatric patients, soldiers and sex workers to sexually transmitted diseases, without their consent. Did the researchers intentionally flaunt the ethical standards of the day? Welcome to Ethically Sound: A podcast of the Presidential Commission for the Study of Bioethical Issues. I’m Hillary Wicai Viers. 

Today we’re speaking with Dr. Anita Allen, professor of Law and Philosophy at University of Pennsylvania and a member of the Bioethics Commission. First, let’s hear from historian Dr. Paul Lombardo from Georgia State University.

Dr. Lombardo:

In 2010, a scholarly article revealed that between 1946 and 1948, officers of the U.S. Public Health Service in collaboration with Guatemalan officials, intentionally infected psychiatric patients, sex workers, prisoners, and soldiers with several sexually transmitted infections, including syphilis. The revelations led to extensive media coverage, and the experiments were widely condemned. President Obama directed the Presidential Commission for the Study of Bioethical Issues to investigate and conduct an ethical analysis in order to determine more completely exactly what had happened and who was responsible.

In May of 2011, I visited Guatemala City with colleagues from the staff of the Bioethics Commission as part of that investigation. We met with then Guatemalan Vice President Espada who led their investigative commission. We saw the buildings where the experiments were done, and then we traveled to the Guatemala National Archives. There we met with historians and archivists who were our Guatemalan counterparts.

It became clear to me that my perspective as an American, focused on the scandalous breach of research ethics that the syphilis studies represented, differed in important ways from the perspective of our Guatemalan colleagues. Though they appreciated the ethical failures that the study entailed, they saw the events in a more expansive light. The victims were poor, often from the Guatemalan highlands, marginalized people even in their own country. To our hosts, coping with the culmination of 20 years of contemporary civil strife, the studies were not just a failure of research ethics, but yet another example—like many of more recent vintage—of researchers’ insensitivity to human rights more generally. 

I returned to the United States with a more complete understanding of the meaning of the stories we tell about research ethics, not merely as a parochial academic concern, but within a larger historical frame where ill treatment of research participants implicate the human rights of all people.

Host:

That was Dr. Paul Lombardo, Professor at Georgia State University. Paul served as a senior advisor to the Bioethics Commission, as it worked to provide an unvarnished ethical analysis of the U.S. research that took place in Guatemala, and to bring this dark chapter of history to light.

As part of its fact-finding mission, staff from the Bioethics Commission sifted through thousands of documents and records, as well as nearly 10,000 pages of research notes left behind by Dr. John Cutler, a physician with the U.S. Public Health Service who led the studies in Guatemala.

The Bioethics Commission discovered that researchers conducted diagnostic tests including blood draws and spinal taps on as many as 5,500 Guatemalan prison inmates, psychiatric patients, soldiers, commercial sex workers, orphans and school children. Researchers deliberately exposed about 1,300 people to syphilis, gonorrhea or chancroid. Eighty-three subjects died, although the exact relationship between the experimental procedures and the subject deaths remains unclear.

The Bioethics Commission also discovered that several of the same researchers had conducted similar experiments that involved intentionally exposing prison inmates to gonorrhea in Terre Haute, Indiana, in 1943. In the Terre Haute experiments, the researchers went to some lengths to obtain consent of their subjects: the researchers fully briefed the prisoners who, in turn, volunteered and gave informed consent. A few years later, the same researchers in Guatemala did not seek their subjects’ consent.

Faced with this evidence, the Bioethics Commission judged that the Guatemala experiments involved unconscionable basic violations of ethics—ethics that the researchers followed in the US prison studies, but did not follow in the Guatemalan studies.

The Bioethics Commission published its analysis in a report titled Ethically Impossible. You can download Ethically Impossible, and all the Bioethics Commission’s reports at www.bioethics.gov. 

Host: 

Here today to talk with us about the Bioethics Commission’s report Ethically Impossible, is Dr. Anita Allen. Dr. Allen is Vice Provost for Faculty at the University of Pennsylvania and Henry R. Silverman Professor of Law and Professor of Philosophy, and a member of the Bioethics Commission.

Welcome Dr. Allen, thank you for being here.

The 2010 revelation of the unethical STD research in Guatemala in the 1940s, led to an apology from President Obama to the President and people of Guatemala, why was it important to carry out a fact finding ethical analysis after that?

Dr. Allen:

Well, the apology was based on the discovery that U.S. doctors, public health service doctors had traveled to a foreign country and engaged in research which was quite unethical on the most vulnerable populations; women, children, prisoners, sex workers, people with disabilities and disorders that require caretaking and not disease-giving. So that was why the apology was given. The need to do fact finding, ethical analysis after that was based on the importance of learning from the past and really understanding what happened. So by going deeper into the history and building on what Professor Susan Reverby had discovered in her research was an important way for us to make sure that we did have a complete historical picture of what had occurred and also to increase our chances for understanding what we need to avoid by way of research practices moving forward.

Host:

So what did the investigation entail?

Dr. Allen:

Well the investigation entailed members of the Commission traveling to Guatemala, and by Commission, I mean Commission members and Commission staff members, going to Guatemala to look at records there and to continue on the investigation. It meant the Commission reviewing thousands of pages, over 125,000 pages of original research records tied to the experiments conducted in Guatemala. And by the way, these records have been provided to the National Archives for retention. It entailed several public meetings—three public meetings—to address the President’s request to conduct the fact finding mission, and these public meetings involved inviting learned scholars of health research from all over the world to come and speak to us as well as other experts in the area. And then to really reflect with all this documentation in hand, and all these experts’ opinions in hand, reflect on what was the cause of the unethical behavior, and what we could do to prevent it happening again.

Host:

And why was it important to look at the U.S. Terre Haute Prison Studies?

Dr. Allen:

So before our U.S. Health Service conducted STD research in Guatemala, there were experiments in the United States at Terre Haute Prison that were related. They didn’t involve giving people STDs, but it involved looking at some of the treatments that might be effective. But it was like a line, an ethical line that was observed in the United States whereby it was just considered, as our report title reflects, ethically impossible to give someone an STD in order to see what treatments would be effective or to see what treatments would not be effective. You couldn’t do that. You couldn’t just make people sick in order to look for cures and solutions and treatments. So going to Guatemala and looking at Terre Haute background was a way of understanding what was considered ethically permissible at the time in our own country, and to consider why therefore it was especially unethical to take activities which could not happen on our own soil to another country and then let them happen there. Unfortunately, our doctors were working in collaboration with Guatemalan doctors who themselves were parties to this unethical conduct. But all of that compares then “what could not be done here” to “what was done there.” [It] is a way of helping to figure out “what was the moral compass?” and “how was that moral compass ignored?” in this really shameful episode in U.S. public health history.

Host:

Was it appropriate to use contemporary values to criticize researchers in the past? 

Dr. Allen:

Let me start by saying that everybody would agree that it’s important to address the problem of sexually transmitted infections. And at the time that the experiments in Guatemala took place and the Terre Haute experiments took place, it was in the great interest of our country to figure out whether or not there were treatments which could be a prophylaxis against STDs. And so the underlying goal was a very noble one. But I think that one of the reasons why it’s appropriate to use contemporary value to criticize past researchers is that, in this case especially, we’re talking about not 300 years ago, or 1,000 years ago, but we’re talking about something that’s happened within the last 100 years, and I don’t think anyone would want to say that right and wrong has dramatically changed in the last 100 years. But I do think that everyone would agree that researchers and doctors had a bit more flexibility… we had a bit fewer explicit black letter ethical rules and black letter laws then than we have now. But in the absence of those same black letter laws and black letter rules there was still, I think, a common sense between then and now, that it’s always wrong to make people sick on purpose. Especially when they don’t have the education and awareness and knowledge and haven’t given the informed consent that would conceivably justify such a thing.

Host:

And so could something like this happen today?

Dr. Allen:

Well, I think not. I don’t think this exact kind of thing could happen today. First of all, the Nuremberg Code which was actually a product of this Guatemala scandal era—but it represented many U.S. and European experts agreeing upon some baseline ethical principles to govern human subject research—those are now very much embodied in our culture. The Belmont Principles, which were developed a few decades later, are now very much embedded in our ethical culture and in our research culture. The human subject research rules, the Common Rule, is now embedded in our practices as both law and ethics, and there are much more stringent rules around informed consent for medical research. So I think that it’s just not likely that such a thing could happen again today. But we were very careful as a commission not to reach that conclusion too readily, because we do know that horrors happen. We’ve seen horrible things happen in our own time that suggest a lack of respect for individuals who are different from ourselves. So we have to be really careful about the conclusion that this couldn’t happen again. So the commission made a very good effort to encourage us to look carefully as a nation at our research practices, to better document the kinds of federally funded research that are going on in foreign countries.

The commission’s report Moral Science indicates a number of important areas where research protections could be improved or refined.

Host:

Dr. Allen, we’re delighted to have you with us today. Thank you so much.

Dr. Allen:

Thank you. I think that nothing had the emotional impact on me that the Guatemalan experiment disclosures did, and I am proud to have been a part of bringing more understanding and a spotlight to this important set of concerns and this important piece of history. Thank you.

Host:

You’ve been listening to Ethically Sound: A podcast of the Presidential Commission for the Study of Bioethical Issues. Thanks for joining us. You can check out our full series online at bioethics.gov.

 

 


Ethically Sound Episodes

The Bioethics Commission has launched a new podcast series entitled Ethically Sound.  

Each podcast is playable direct online from the link(s) below or from SoundCloud, iTunes or the Ethically Sound Playlist on Youtube.  Follow the hashtag #EthicallySound for launch announcements.

Safeguarding Children

Ethics and Ebola

Anticipate and Communicate

Privacy & Progress

Gray Matters

New Directions

Moral Science

Ethically Impossible

Bioethics for Every Generation

Charting a Path Forward

This is a work of the U.S. Government and is not subject to copyright protection in the United States. Foreign copyrights may apply.