Human Testing
4:30 am
Fri March 8, 2013

Would You Want An Award With A Tainted Name?

Leonardo da Vinci's "Vitruvian Man."
Credit Commons/Leonardo da Vinci, Galleria dell' Accademia, Venice (1485-90)

Last summer, St. Louis Public Radio’s Véronique LaCapra began a conversation about some of the ethical issues involved when people are used as the subjects of scientific research.

Now a Washington University professor is drawing attention to an example of unethical human testing — funded by the U.S. government. It happened more than 60 years ago, in Central America. Bradley Stoner sat down with Véronique to explain why he’s raising the issue again now.

What happened in the 1940s in Guatemala?

STONER: Well, the American government sponsored studies to determine the effectiveness of penicillin for preventing infection with various sexually transmitted diseases.

And in 2010, it was revealed that in fact the U.S. government had indeed been involved in intentional infection studies of individuals in Guatemala from 1946 to 1948. More than 1,300 people were exposed to syphilis, gonorrhea, and chancroid, intentionally, but there’s no evidence that they provided consent, and in fact many of these people really couldn’t provide consent because they were residents of insane asylums and some children were involved as well.

Were those the only populations, or were there other people as well?

STONER: There were orphans, there were soldiers, there were prostitutes, and there were people in a mental institution in Guatemala.

"More than 1,300 people were exposed to syphilis, gonorrhea, and chancroid, intentionally, but there's no evidence that they provided consent."

The study was actually conducted by American and Guatemalan physicians with funding from the U.S. government. So the concern here is that the U.S. government sanctioned a study that skirted evolving codes of ethics and understandings of what was required to do a study like this in the United States.

So why are you bringing up these issues again now?

STONER: Well, this is a big concern for us in the American STD association, because we give an award every year called the Thomas Parran award.

Most people today haven’t heard of Dr. Thomas Parran, but he was the surgeon general in the 1930s and worked tirelessly to bring STDs out of a veil secrecy and into the public conversation. He worked to destigmatize sexually transmitted diseases and turn them into medical conditions, and really set the stage for the way we deal with STD control today.

"Most people today haven't heard of Dr. Thomas Parran, but...he's a real hero to those of us in the field who are working on STD control and prevention as a medical issue."

So he’s a real hero to those of us in the field who are working on STD control and prevention as a medical issue. He really stood by his principles and argued very forcefully that we should talk about these conditions in public. He was actually Time “man of the year” in 1938, I think.

But his fingerprints are all over the background of these Guatemala studies, which were discovered by a historian going through the files of one of the research physicians who had conducted the study. So these were secret studies that never came to light until they were found in the archives of the researcher who was actually mostly involved in the study.

Now Dr. Parran — just to be clear — was not that researcher, so what was his involvement in these studies?

STONER: Dr. Parran, as the head of the U.S. Public Health Service was responsible for signing off on all funding proposals that came before his department. And so the scientific study section that reviewed the proposal for the Guatemala studies ultimately made its way up to his office for his final signature.

"[Dr. Parran's] fingerprints are all over the background of these Guatemala studies..."

So funding would not have been given if Dr. Parran had not agreed to support these studies, and there’s some evidence that he was aware of what was going on and that he knew that doing studies like this would be difficult to do in the U.S. because active consent was not obtained from the research subjects.

What is your organization doing about all this?

STONER: The American STD Association is undergoing some public airing of this controversy and some soul-searching, and we’re asking our members to weigh in on what to do about the Thomas Parran award.

Because this is an award that we give for high achievement in the field of STD research and prevention, and if Dr. Parran was implicated in funding and approving unethical research, is it appropriate for us to continue to give an award in his name?

Online extras: More From Our Conversation With Bradley Stoner

Why would the U.S. government have funded these kinds of studies?

STONER: The U.S. government sponsored STD research primarily for military preparedness. There was a tremendous military imperative to make sure that our fighting forces were prepared for any future conflict. In those days, treatment of STDs was not as effective and much more prolonged, and so prior to penicillin, it really took soldiers out of the field when they acquired an STD.

So when penicillin was discovered, it opened up a whole avenue of need, if you will, to determine whether treatments could prevent infection or prophylactic treatment before exposure, immediately after exposure, could prevent particularly soldiers from acquiring these diseases.

So these were really military experiments but they were conducted primarily under the auspices of the U.S. Public Health Service.

What about the syphilis study that the U.S. government health service carried out involving African American men in Tuskegee Alabama? How do these Guatemalan studies compare to that?

STONER: The Tuskegee study is a really — it’s a difficult time in the field of STD.

When the study was started in the 1930s, you could argue that the treatments for syphilis were probably as bad or worse than the disease itself. They were using arsenic, mercury, and other types of long-term therapies which had their own toxicities.

So the Tuskegee study actually started as a non-treatment study, to see if not treating syphilis was as bad as using some of the treatments available of the day. No one was ever intentionally infected in Tuskegee, these were men that had naturally acquired syphilis.

But when penicillin was discovered it was withheld from them intentionally for the next 20 years. And they were told that they were getting medical treatment, but they really weren’t. So that’s really a violation of human rights, and really violated the dignity of these individuals.

But the Guatemala studies were different in the sense that these individuals who were intentionally exposed.

Is it possible that governments or private industry are still conducting unethical medical testing today? I’m thinking for example of pharmaceutical testing that’s sometimes carried out in developing countries, where maybe requirements for informed consent are not what they are here in the U.S.?

STONER: We like to think that today we have ethical codes that would prevent something like this from happening, that there is a lot of scrutiny and external observation. You never really know behind the scenes what’s going on, on the ground, but certainly for federally sponsored research, and research that is conducted by university researchers and with money coming from the U.S. government, there are a number of checks in place to prevent something like this from happening.

The establishment of Institutional Review Boards that scrutinize protocols and procedures would not allow something like this to have happened today, and researchers would have been held to a much higher standard.

But even in those days I think there was a sense that consent for medical testing and experimentation is implicit in doing any sort of study, so I think these researchers knew they were skirting some sort of scrutiny that they would have been under in the U.S.

Could it be happening today in other parts of the world? It’s possible, but we would like to think that it’s not.

Check out a timeline related to research ethics, here.

Follow Véronique LaCapra on Twitter: @KWMUScience