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PROYECTO DE TP


Expediente 7536-D-2010
Sumario: SOLICITAR AL PODER EJECUTIVO DISPONGA EXHORTAR AL GOBIERNO DE LOS ESTADOS UNIDOS DE AMERICA A INFORMAR LOS RESULTADOS DE LA INVESTIGACION SOBRE EL ESTUDIO DE INOCULACION DE ENFERMEDADES DE TRANSMISION SEXUAL EN LA REPUBLICA DE GUATEMALA LLEVADA CABO DESDE 1946 A 1948.
Fecha: 14/10/2010
Publicado en: Trámite Parlamentario N° 154
Proyecto
La Cámara de Diputados de la Nación
DECLARA:


Que vería con agrado que el Poder Ejecutivo -por intermedio del Ministerio de Relaciones Exteriores, Comercio Internacional y Culto- exhorte al Gobierno de los Estados Unidos de América a informar a la comunidad internacional los resultados de la minuciosa investigación prometida sobre el estudio de inoculación de enfermedades de transmisión sexual del Servicio de Salud Pública de ese país en la República de Guatemala, llevada a cabo de 1946 a1948.

FUNDAMENTOS

Proyecto
Señor presidente:


I. Una aclaración
Como médico, no puedo dejar de sentirme horrorizado por los hechos que consigno a continuación. Hermanos latinoamericanos fueron utilizados como "conejillos de Indias", sin su consentimiento, para una experiencia que, desde todo punto de vista, contraría la ética profesional.
Por ello, he ido a las fuentes para buscar toda la documentación original referida a la materia. Por tratarse de una experiencia capitaneada desde los Estados Unidos de América, el material se encuentra en idioma inglés, exceptuando la declaración oficial del Departamento de Estado, cuya traducción al castellano se encuentra en su propia página Web.
Sin embargo, para tener una apreciación general del tema, he comenzado por introducir la temática con la noticia periodística, para luego recurrir a las fuentes.
II. ¿Cuál es la noticia? (1)
Estados Unidos debió pedir disculpas a Guatemala por un estudio que realizó, ocultándolo, con parte de su población, al infectar deliberadamente a cientos de ciudadanos con enfermedades de transmisión sexual. El experimento, calificado de "abominable" por la secretaria de Estado, Hillary Clinton, fue realizado entre 1946 y 1948. El |° de octubre, el presidente norteamericano, Barack Obama, se comunicó con su par de Guatemala, Alvaro Colom, quien luego definió el hecho como un "delito de lesa humanidad", calificó los episodios como "espeluznantes y desagradables", y advirtió que "el gobierno se reserva el derecho de (realizar) una denuncia".
"Lamentamos profundamente que esto haya sucedido y ofrecemos nuestras disculpas a todas las personas que resultaron afectadas por esas abominables prácticas de investigación", declararon Hillary Clinton y la secretaria de Salud, Kathleen Sebelius, en un comunicado que corroboraba la denuncia hecha hace cuatro años por una investigadora universitaria. El responsable del experimento, cuya veracidad había sido puesta en duda hasta ahora, fue el propio Servicio de Salud Pública de Estados Unidos (PHS, por sus siglas en inglés). El estudio fue "claramente antiético", afirmó el comunicado firmado por Clinton y Sebelius. "Aunque estos sucesos ocurrieron hace más de 64 años, estamos indignados de que tal investigación reprochable haya ocurrido bajo el pretexto de la salud pública." Un "profundo pesar", indicó la secretaria de Estado, la embargó por ver que "una investigación tan reprensible pudiera ocurrir". Esto "no representa los valores de Estados Unidos", aseveró.
En improvisada conferencia de prensa, el presidente guatemalteco contó que Clinton le había informado el hallazgo el jueves. "Es un delito de lesa humanidad lo ocurrido en esa época y el gobierno se reserva el derecho de una denuncia", advirtió, al tiempo que dio a conocer que ya ordenó a los ministros de Salud, Defensa y Gobernación (Interior) que localicen los archivos de esa época para "protegerlos y resguardarlos".
Colom también señaló que "los investigadores y expertos conocían del trabajo, reconocían la naturaleza y lo antiético de la investigación".
El experimento se realizó entre 1946 y 1948, a espaldas de cientos de ciudadanos guatemaltecos que fueron inoculados intencionalmente con sífilis y gonorrea. De acuerdo con la cadena estadounidense NBC, los investigadores médicos de Estados Unidos infectaron a "cientos de personas" en Guatemala, incluyendo a pacientes de instituciones mentales. En ninguno de los casos pidieron permiso a esas personas para servirse de ellas como sujetos de prueba.
Liderados por el Servicio de Salud Pública durante la administración de Harry Truman, los estudios observaban el desarrollo de las enfermedades en períodos prolongados de tiempo, sin ofrecer tratamiento alguno a los infectados, aseguró el diario guatemalteco Prensa Libre. Además, informó NBC, "muchos de los infectados fueron alentados a transmitir la infección a otros como parte del estudio", y una tercera parte de los afectados "nunca recibió un tratamiento adecuado".
El caso fue descubierto en 2006 por la investigadora Susan Reverby, de la Universidad Wellesley (Massachusetts), quien reveló que el estudio llevado a cabo por el médico John Cutler buscaba comprobar la efectividad de la penicilina para combatir enfermedades de transmisión sexual. Reverby descubrió que la Salud Pública ya había realizado estudios con "voluntarios" de una cárcel de Indiana, a quienes se infectó con gonorrea. Sin embargo, al encontrarse con que esos prisioneros no querían exhibir ante los investigadores las consecuencias de la enfermedad, el estudio debió replantearse.
"Para seguir adelante con ese trabajo - escribió Reverby- y para extenderlo también a la sífilis, el PHS miró hacia más allá de las fronteras estadounidenses." Eligieron varones en la Penitenciaría Nacional y en bases del ejército, y varones y mujeres en el Hospital Nacional Mental de Guatemala; llegaron a reclutar 696 conejillos de Indias humanos. Cutler y el equipo, descubrió Reverby, primero utilizaron prostitutas ya afectadas con sífilis para infectar a los prisioneros; luego procedieron a la inoculación directa de la bacteria en los penes o brazos de las personas elegidas. Después se les suministraba penicilina. Sin embargo "no está claro" si alguno de ellos pudo curarse, o si se les administró "el tratamiento adecuado".
Luego de conocida la información, Clinton anunció que el Estado norteamericano procedería a otra "minuciosa investigación" y que convocaría a especialistas internacionales "para que revise e informe sobre los métodos más eficaces para asegurar que toda investigación médica en seres humanos que se realice en el mundo en la actualidad cumpla con rigurosas normas éticas".
III. ¿Cuál fue la declaración oficial del Departamento de Estado? (2)
Declaraciones de la secretaria de Estado Hillary Rodham Clinton y la secretaria de Salud y Servicios Sociales Kathleen Sebelius sobre el Estudio de inoculación de enfermedades de transmisión sexual del Servicio de Salud Pública de Estados Unidos de 1946 a 1948:
El estudio de inoculación de enfermedades de transmisión sexual que se llevó a cabo de 1946 a 1948 en Guatemala claramente fue antiético. Aunque estos sucesos ocurrieron hace más de 64 años, estamos indignados de que tal investigación reprochable haya ocurrido bajo el pretexto de la salud pública. Lamentamos profundamente que esto haya sucedido y ofrecemos nuestras disculpas a todas las personas que resultaron afectadas por esas abominables prácticas de investigación. La conducta demostrada durante el estudio no representa los valores de Estados Unidos ni nuestro compromiso con la dignidad humana y el gran respeto hacia el pueblo de Guatemala. El estudio es un triste recordatorio de que las garantías adecuadas para la investigación en seres humanos no existían hace medio siglo.
En la actualidad, los reglamentos que gobiernan la investigación médica en seres humanos financiada por Estados Unidos prohíben este tipo de violaciones atroces. Estados Unidos es inquebrantable en su compromiso de garantizar que todos los estudios médicos en seres humanos que se realizan en la actualidad, cumplan con las rigurosas normas legales y éticas de Estados Unidos e internacionales. Bajo el espíritu de este compromiso con la ética investigativa, estamos iniciando una minuciosa investigación con respecto a los detalles de este caso de 1946. Además, mediante la Comisión Presidencial para el Estudio de Asuntos de Bioética, convocaremos también a un cuerpo de especialistas internacionales para que revise e informe sobre los métodos más eficaces para asegurar que toda investigación médica en seres humanos que se realice en el mundo en la actualidad cumpla con rigurosas normas éticas.
El pueblo de Guatemala es uno de nuestros amigos cercanos y vecinos en las Américas. Nuestros países son socios en una variedad de asuntos y nuestros pueblos están vinculados por valores compartidos, comercio y por los muchos estadounidenses de origen guatemalteco que enriquecen nuestro país. A medida que avanzamos para comprender mejor este atroz suceso, reiteramos la importancia de nuestra relación con Guatemala y nuestro respeto por el pueblo guatemalteco, así como nuestro compromiso con las normas éticas más exigentes en la investigación médica.
IV. ¿Cuáles fueron las declaraciones a la prensa al respecto? (3)
Lo que sigue es la trascripción literal de la teleconferencia que mantuvieran el Secretario de Estado Adjunto para América Latina, Arturo Valenzuela, y el Director del Instituto Nacional de la Salud, Francis Collins, con periodistas de diversos medios nacionales y extranjeros, el 1° de octubre de 2010:
OPERATOR: Welcome and thank you for standing by. At this time, all participants are in a listen-only mode until the question-and-answer session of today's call, and at that time, you may press *1 to ask a question. I'd also like to inform all parties that today's call is being recorded.
Now I'd like to turn the call over to Mr. Michael Ratney. Sir, you may begin.
MR. RATNEY: Okay. Good morning, folks. Thanks for joining us this morning. We have with us Assistant Secretary of State Arturo Valenzuela, Assistant Secretary for Western Hemisphere Affairs, and Dr. Francis Collins, the director of the National Institutes of Health. They're going to be discussing the U.S. Public Health Service's Sexually Transmitted Disease study from the 1940s. You should all have seen already the statement that Secretary Clinton and Secretary Sebelius put out on this, plus other fact sheets that are available on the HHS website.
Just to reiterate, this is the only topic these two gentlemen will be discussing this morning, no questions on any other public health or foreign policy issues. This is going to be on the record. Assistant Secretary Valenzuela and Dr. Collins will make brief opening statements and then will take your questions. We will go for about 45 minutes.
So with that, I'm going to turn it over to Dr. Collins to make a brief statement. Dr. Collins.
DR. COLLINS: Thank you. Today, I will share with you information that has come to light about deeply disturbing research that was conducted over 60 years ago. This case of unethical human subjects research represents an appalling example from a dark chapter in the history of medicine. I would like to briefly summarize what we know about the research project and then describe the protections that are in place today that prohibit such unethical conduct.
While conducting research on the Tuskegee Study, history professor Susan Reverby of Wellesley College discovered the archived papers of the late John Cutler. Dr. John Cutler was a U.S. Public Health Service medical officer. The archived papers include detailed records from a study that was never published conducted by Dr. Cutler in Guatemala from 1946 through 1948. The study appears to have been funded by a grant from NIH to the Pan-American Sanitary Bureau, now the Pan American Health Organization.
In the study, Dr. Cutler and his collaborators intentionally infected vulnerable populations, including prisoners and mentally ill patients, with sexually transmitted diseases, including syphilis, gonorrhea, and chancroid. The purpose of the study was to test the effectiveness of penicillin, which was relatively new at the time. Notably, the intention was to provide treatment, and the evidence supports that the vast majority were adequately treated.
But there were four primary ethical violations in this study. First, all of the study sections were members of one or more vulnerable populations. Second, there is no evidence they gave informed consent. In fact, third, the subjects were often deceived about what was being done to them. And fourth, without their understanding or consent, individuals were intentionally infected with pathogens that could cause serious illness.
When Dr. Cutler and his colleagues were conducting their studies in Guatemala in the 1940s, there were no formalized regulations regarding the protection of human subjects in research. I want to emphasize that today, the regulations that govern research funded by the United States Government, whether conducted domestically or internationally, would absolutely prohibit this type of study. Today, researchers must fully explain the risks associated with their study to all research participants, and participants must indicate their informed consent.
I want to conclude by saying the National Institutes of Health, the Department of Health and Human Services, the entire U.S. Government are committed to protecting and respecting participants in biomedical research. We are all deeply saddened that so many vulnerable individuals were unwitting subjects in this risky and unethical research study. Thank you.
MR. RATNEY: Okay. Thank you. And now, Assistant Secretary Valenzuela will make a brief statement.
ASSISTANT SECRETARY VALENZUELA: Yes, I want to say that Secretary Clinton called President Alvaro Colom of Guatemala last night to express her personal outrage and deep regret that such a reprehensible research could have occurred, making clear that this does not represent the values of the United States. She reaffirmed the importance of our relationship with Guatemala and her respect for the Guatemalan people.
The United States Ambassador to Guatemala Steve McFarland and I have also been in touch with President Colom and Ambassador Francisco Villagran, the Guatemalan Ambassador to the United States, also to express our regret. And as we move forward, we want to try to better understand what happened and how something like this could have transpired. And we've expressed, as the Secretary did also, our commitment to human dignity and to the respect for the people of Guatemala.
Let me just say that our countries partner on a range of issues. I met with President Colom just about a week ago in New York to discuss a broad range, as I say, of matters that we're working on together, both Guatemala and United States. We're bound by shared values, we're bound by commerce, we're bound by the many Guatemalans who live in the United States and enrich our country. And we consider Guatemala to be one of our close friends and neighbors in the Americas.
So I'll leave that statement there and open it up for questions.
MR. RATNEY: Okay. Thanks. We'll go to the first question.
OPERATOR: Thank you. At this time, *1 to ask a question.
MR. RATNEY: And if I could just reiterate, we're going to do question at a time without follow-ups until we've satisfied everybody.
OPERATOR: First question comes from Betsy McKay. Your line is open.
QUESTION: Hi, I have a couple questions, if possible. One is: Has compensation been offered to Guatemala for this? And secondly, Dr. Collins, I'm wondering if you could talk about how revelations of this research might inform discussions that go on today about whether to conduct experiments - scientific or medical experiments among prison communities.
MR. RATNEY: Could you identify your outlet, please?
QUESTION: Oh, I'm sorry. Wall Street Journal.
DR. COLLINS: Well, I can answer the second question, if you'd like. Basically, as a result of this revelation, the United States Government is asking the Institute of Medicine, which is part of the National Academy of Sciences, to convene a committee of independent experts to conduct a fact-finding investigation by reviewing the conduct of the Guatemala experiments. And they will issue a report establishing all the facts of the study. We need to be sure we have all the details.
But separately, and particularly relevant to your question, the Presidential Commission for the Study of Bioethical Issues of the U.S. Government will convene an international group of experts to review and report on the most effective methods to ensure that all human medical research conducted around the globe today meets rigorous ethical standards, and how training of researchers will ensure such abuses do not occur.
With regard to your question about vulnerable subjects, that is an explicit component of the human subjects regulations in the United States and has been so for a couple of decades, that those kinds of experiments deserve a special scrutiny and a special attention to informed consent and whether or not it's even possible in the circumstance of individuals who are incarcerated.
ASSISTANT SECRETARY VALENZUELA: All I would add to what Dr. Collins said is that we will wait for the findings and recommendations of these two efforts before any additional steps might be taken.
MR. RATNEY: Okay. Can we go to the next question, please?
OPERATOR: The next question comes from Kim Ghattas with BBC. Your line is open.
QUESTION: Yes. Hi, good morning. Thank you for the call. Reading the synopsis of the study by Susan Reverby, it looks as though the Guatemalan authorities gave their permission for this experiment. I was wondering whether this was your understanding as well, whether you believe that the Guatemalan Government was aware of all the aspects of the study. Or were they in some way deceived as well by what exactly was going on?
MR. RATNEY: Dr. Collins.
DR. COLLINS: So it remains, I think, for the investigation to clarify exactly what - the nature of the collaborative effort with the Guatemalan Government. It's clear that some components of the government were aware of the study. But beyond that, it's not entirely clear what the arrangements were.
MR. RATNEY: Okay. We can go to the next question, please.
OPERATOR: And our next question comes from Stephen Smith with the Boston Globe. Your line is open.
QUESTION: Hi. Good morning. Thank you for conducting the briefing. I had several questions. First, I was wondering if you could discuss whether efforts have been made or are going to be made to contact any potential survivors. Obviously, the individuals, many of them I'm surmising are deceased, but are there efforts going to be made to potentially contact any survivors or their family members?
And secondly, could you discuss a little bit further Professor Reverby's role, how she came to contact the various health agencies, and whether there is any indication that anyone in the United States Government before this was cognizant - obviously, U.S. Government officials were participants in the 1940s - but is there evidence that there was knowledge of this at high levels of government either in the 1940s or subsequently?
MR. RATNEY: Dr. Collins, could you answer the first one? The second question, I'd refer any journalist to Dr. Reverby's own study, which is available on the Wellesley College website for all of the information about the modalities of her study at that time.
DR. COLLINS: In terms of an effort to contact survivors, obviously, many of the individuals involved in this study would no longer be alive since this is more than 60 years ago. And yet, there are in the records addresses, so it may be possible if there is a desire to do that to search for names and addresses. But that will have to be a component of the follow-up study, which is to be conducted by the taskforce. And let me correct myself. There are names. I'm not sure, in many instances, whether there are addresses. After all, some of these were patients in a mental hospital, about which there may not have been much information.
MR. RATNEY: Okay. Could we go to the next question, please?
OPERATOR: Our next question is from Juan Lopez with CNN Español. Your line is open.
QUESTION: Yes, hi. I wanted to follow up on the second question. When you look at Dr. Reverby's study, it says that not only the Guatemalan Government, according to her report, co-sponsored, but it also mentions the National Institutes of Health, the now Pan American Health Organization. So the question is: Why are you apologizing? And was there - did this study result in the treatment - in any new treatment, in any developments? Are you aware of any significant developments on the treatment of STDs?
DR. COLLINS: This is Dr. Collins. The results of this work were never published, so it would be difficult to ascertain whether they had any effect on medical practice.
ASSISTANT SECRETARY VALENZUELA: Well, the reason why we're taking this up is because this was funded by the U.S. Government at the time. And I think that we recognize that that was an egregious mistake and that's why we're bringing it to the attention of everyone. And this is why we are taking this as serious as we are and why we're proposing further studies to, in fact, find out exactly what transpired beyond the research that we have available at this particular point.
MR. RATNEY: Okay. We can go to the next question, please.
OPERATOR: And our next question is from Mr. Jeff Custer with the Voice of America. Your line is open.
QUESTION: Hi. Thanks so much. I just wanted to clarify just a couple of quick things. Dr. John Cutler helped to carry out this study, as I understand it, and he also was an investigator in the Tuskegee STD study. Also, was it only Guatemalans that were involved in this research?
DR. COLLINS: You are correct that Dr. Cutler was a participant in the Tuskegee study and in a variety of other studies done in the United States. But what we're talking about today are the experiments that were carried out by Dr. Cutler and other colleagues in 1946 to 1948 in Guatemala.
MR. RATNEY: Okay. Can we go to the next question, please?
OPERATOR: Lori Montenegro from the Telemundo network. Your line is open.
QUESTION: Yes. Thank you for taking the question. This is for Mr. Collins. I understand that you say that in the '40s there were really no regulations that would have prohibited what you call as unethical practices. But my question is: You being from the medical field, wasn't - wouldn't there have been a common sense knowledge that this was unethical? How would you do this to people without telling them and not knowing what the results could have been with - by later treating them with penicillin that, at that time, was not known? It was new. We didn't know what the side effects could be, et cetera.
DR. COLLINS: I find it very difficult, as a physician-researcher today, to imagine how these studies could have been conducted in a way that individuals participating in them could have considered ethical. Clearly, though, there were at that time inadequate norms that governed this kind of research activity. Fortunately, over the course of the last 60 years, we have now in place very effective oversight mechanisms to keep this kind of research from happening today.
MR. RATNEY: Okay. Thank you. We'll go to the next question.
OPERATOR: Mr. Arthur Brice from CNN, your line is open.
QUESTION: Thank you. Mr. Valenzuela, could you characterize the response from the Guatemalan Government, please?
ASSISTANT SECRETARY VALENZUELA: Well, yeah. They were obviously extremely concerned about this information. They were saddened by it. They agreed with our characterization that this is an extremely unfortunate incident in the past.
But both the president, the ambassador, and others that we've talked to expressed to us that this is something that happened 64 years ago and that - reiterated the strong relationship that Guatemala has with the United States and the strong cooperation they have with the United States. And they were, in that sense, appreciative that we expressed to them not only information about this matter, but also our deep regret at what happened.
MR. RATNEY: Can we go to the next question, please?
OPERATOR: And our next question comes from Karen Zeitvogel. Your line is open.
QUESTION: Hi. I'm Karen Zeitvogel from AFP, Agence France-Presse. I have two questions. Secretaries Clinton and Sebelius said that there's going to be a thorough investigation. Is that the same or in addition to the two investigations that you just told us about by the IOM (Institute of Medicine) and the Presidential Bioethics Committee? And the other question is: Is there any evidence maybe in, like, NIH grant funding trails that this might not be a one-off?
MR. RATNEY: Dr. Collins?
DR. COLLINS: So, yeah - the first question, yes. The two (inaudible) follow-up studies in - by the U.S. Government, as mentioned in the statement from the secretaries, are the ones that I also mentioned. One of them being an Institute of Medicine taskforce committee to look at the details of what happened in the Guatemalan study; the other being asking the President's commission to look more broadly across the world at the way in which human subjects research is overseen to ensure that the highest rigorous ethical standards are now being maintained and that researchers are being appropriately trained.
With regard to your second question, there is no evidence of grants being received by Dr. Cutler after Guatemala until the 1960s, and those studies do not involve intentional infection of patients.
MR. RATNEY: Okay. The next question, please.
OPERATOR: Comes from Andrew Jack, Financial Times. Your line is open.
QUESTION: Yes, thanks. Yes, I have two questions. First of all, just following up on that one, but whether or not Cutler himself received more funding, I'm just wondering how many other horrendous ethical abuses like this might be out there from the past few decades, whether you've got any sense from other research; and secondly on the international ethical review going forwards, what issues you think potentially could be of concern, which, at least in a few decades time, we might look on today's medical practice and say how could we have allowed that to happen.
DR. COLLINS: Well, in fact, when one considers that the ethical standards back in the '40s and even earlier and a little after that were inadequately in place, one can identify, and this is in the published literature, more than 40 other studies where intentional infection was carried out with what we would now consider to be completely inadequate consent in the United States. So these were done domestically.
In terms of trying to guess what we might in the future look back on and say, well, how could we have done that now, that is obviously something that bioethicists worry about a lot, and I don't have an easy answer for you. But I am sure that we should all be cautious about trying to argue that we have somehow arrived at the final end point of understanding what is completely ethical and what is not.
MR. RATNEY: The next question, please.
OPERATOR: The next question is from Kristen Minogue with the Science magazine. Your line is open.
QUESTION: Hello, thank you for talking to us this morning. I was wondering with the investigations, what is the timeline for them.
DR. COLLINS: Since this is just now coming to the fore, and certainly the IOM has been asked to look into this and the President's bioethics commission has as well, I don't think, as yet, a timeline has been set.
MR. RATNEY: Okay, thanks. Next question, please.
OPERATOR: Lauran Neergaard, your line is open, with Associated Press.
QUESTION: Hi, Dr. Collins. A couple quick questions for you. Do you know what exactly the NIH approved in that grant? Did it specifically say that there was going to be intentional infection?
And you said that it looked like there was generally adequate treatment afterwards, but I wonder, given the iffiness of the serology then, what in these papers leads you to believe that.
DR. COLLINS: Well, the grant support, because of the fact this is more than 60 years old, all that remains in terms of documentation is the name of the grant, which was Investigation of Venereal Diseases in Guatemala. It was actually the grant issued to a Dr. J.P. Mahoney[1]. So we are unaware of what the grant itself might have proposed.
In terms of the documentation of adequate treatment, again, that's what the task force should be looking at. And Professor Reverby's paper as well covers that. The documentation was largely based on whether the standard therapy of penicillin was given in the accepted dose.
MR. RATNEY: Okay, next question, please.
OPERATOR: Mike Stobbe, your line is open, with Associated Press.
QUESTION: Hi, sorry just wanted to shoot a question. Doctor, to your knowledge what's the highest sign-off that took place on this? Did it go to the NIH director, the surgeon general, the FSA administrator? And also, you made a comment a minute ago about there have been 40 other studies where intentional infection was carried out in the United States. Was that all done under the purview of the Public Health Service?
DR. COLLINS: The Surgeon General of the United States, Dr. John Curran, was aware of the study in the 1940s. In terms of the 40 studies done that also involved intentional infection, I don't know whether all of those were, in fact, supported by the Public Health Service, but certainly many of them were.
MR. RATNEY: Okay, next question, please.
OPERATOR: And our next question comes from Teo Rodrigues. Your line is open.
QUESTION: I'm from Guatemala. I work at a Guatemalan newspaper. I just want to know, do you think that after the U.S. Government paying for this monstrosity and then eight years later overthrowing a democratically elected president in Guatemala, are we going to get some sort of compensation? I'm not talking about economic or something, but is "sorry" enough for this?
DR. COLLINS: Thanks. Sorry, what newspaper are you with?
QUESTION: Diario des America.
ASSISTANT SECRETARY VALENZUELA: Well, I would just reiterate what I said earlier, and that is that with these two studies that are being commissioned now, we will await the findings and recommendations of those studies before we move forward. And I would caution you not to link the two events that you're talking about. The one that we're discussing now occurred in '46, '48, and the other one that you just mentioned occurred in '54, and they're not linked.
MR. RATNEY: Okay, next question, please.
OPERATOR: Jeannie Baumann with the BNA Medical Research and Law Report, your line is open.
QUESTION: Hi, thanks for taking my question. Dr. Collins, with minority participation in clinical research already a concern, I was wondering if there's a concern that this - that these findings will further - be a further detriment in terms of recruiting minorities into clinical studies or if you think that since it happened 60 years it might now have an impact.
DR. COLLINS: Well, of course, we're concerned about the way in which this horrendous experiment, even though 60 years ago, may appear to people hearing about it today as indicative of research studies that are not conducted in ethical fashion. I think the track record in the last 20 or 30 years has been really quite remarkable in terms of providing the framework to assure people who are considering participation in clinical research that ethical standards of the highest sort are going to be maintained.
But we all recognize that the Tuskegee study, which involved the same Dr. Cutler, did great damage to the confidence and the trust that individuals, particularly from the African American community, had in medical research. So it can't be a good thing that we have now unearthed by Professor Reverby's study through these archives of an example again of medical research being conducted on vulnerable populations in a way that is reprehensible.
At the same time, I want to make my personal commitment that we are doing everything we can at NIH, and the government now will be extending that in terms of making sure across the world that these standards are being adhered to reassure people that medical research is being conducted with the highest standards. That is our goal. We will not be satisfied with less.
QUESTION: Thank you.
MR. RATNEY: Next question, please.
OPERATOR: Cristina Fernandez with the El Pais newspaper, your line is open.
QUESTION: Hi, thank you so much. I wanted to ask if you know if there's any data available regarding any victims because of the infections that any of the members that participated in the study actually died from the disease.
DR. COLLINS: I believe in Professor Reverby's paper there is an indication that one person of the hundreds who were involved in this, who had an epileptic condition, died in the course of penicillin treatment from what's called status epilepticus which is a seizure that simply can't be stopped. There would be considerable question, of course, about whether that was related to the penicillin treatment or whether that was a consequence of that person's underlying condition.
MR. RATNEY: Next question, please.
OPERATOR: Stephen Smith from the Boston Globe.
QUESTION: Thank you. A couple of further questions. One, I'm wondering if you could discuss your sentiments about Dr. Reverby and her discovery of this and reflect upon the importance of researchers such as herself who scour the historical record. And second, I'm wondering, as a result of these findings, whether it is vivifying any sort of effort or whether this might be part of the IOM work to see if globally during this period there were similar experiments being conducted.
DR. COLLINS: Personally, I think Professor Reverby, who is a very capable medical historian, has done a good thing here by uncovering aspects of a study that was previously unknown, not published, but hidden away in the archives at the University of Pittsburg. And by uncovering it and bringing it to the attention of officials in the Public Health Service, giving us all a chance to look at this, and even as we are appalled at what was done, to try to redouble our efforts to make sure that nothing of this sort could ever happen again. And that's very much what's happening now.
Professor Reverby's paper, which I really encourage everybody to read closely, I think is very clearly written in a fashion that doesn't overstate or understate the nature of what was done here. In terms of the further investigation of the circumstances of the 1940s in this study, that will be up to the IOM panel to investigate.
MR. RATNEY: Thanks. Next question, please.
OPERATOR: And I'm showing no further questions.
MR. RATNEY: Okay, thank you, ladies and gentlemen, and thank you to our participants.
__________________
[1] Dr. J.F. Mahoney
V. ¿Cuál es la denuncia concreta?
Reproducimos, a continuación, la versión que será publicada en la edición de Enero 2011 del Journal of Policy History, y que puede ser bajado de la págin Web de Wellesley College (4) :
Policy is often made based on historical understandings of particular events, and the story of the "Tuskegee" Syphilis Study (the Study) has, more than any other medical research experiment, shaped policy surrounding human subjects. (5) The forty-year study of "untreated syphilis in the male Negro" sparked outrage in 1972 after it became widely known, and inspired requirements for informed consent, the protection of vulnerable subjects, and oversight by institutional review boards. (6)
When the story of the Study circulates, however, it often becomes mythical. In truth the United States Public Health Service (PHS) doctors who ran the Study observed the course of the already acquired and untreated late latent disease in hundreds of African American men in Macon County, Alabama. They provided a little treatment in the first few months in 1932 and then neither extensive heavy metals treatment nor penicillin after it proved a cure for the late latent stage of the disease in the 1950s. (7) Yet much folklore asserts that the doctors went beyond this neglect, and that they secretly infected the men by injecting them with the bacteria that causes syphilis. This virally spread belief about the PHS's intentional infecting appears almost daily in books, articles, talks, letters, websites, tweets, news broadcasts, political rhetoric, and above all in whispers and conversations. It is reinforced when photographs of the Study's blood draws circulate, especially when they are cropped to show prominently a black arm and a white hand on a syringe that could, to an unknowing eye, be seen as an injection.
Historians of the Study have spent decades now trying to correct the misunderstandings in the public and the academy, and to make the facts as knowable as possible. (8) The story is horrific enough, it is argued, without perpetuating misunderstanding over what really did happen and how many knew about it. (9) What if, however, the PHS did conduct a somewhat secret study whose subjects were infected with syphilis by one of the PHS doctors who also worked in "Tuskegee?" How should this be acknowledged and affect how we discuss historical understandings that drive the need for human subject protection?
Rumors and Realities
Scholars who wish to debunk the myth of deliberate infection in the Study can acknowledge that myths do express some basic realities. As the oral historian Alessandro Portelli argues, "The wrong tales allow us to recognize the interests of the tellers and the dreams and desires beneath them" (10) "A rumor," other folklorists suggest, "is a 'form of communication though which men [and women] caught together in an ambiguous situation attempt to construct a meaningful interpretation of it by pooling their intellectual resources.'" (11) In a highly racialized and racist country, the idea that government scientists-drunk on their power over trusting sharecroppers in need of care-would deliberately and secretly infect black men with a debilitating and sometimes deadly disease seems possible.
Yet those scholars may also argue that people who believe in such deliberate infection are confusing the Study with other American 1960s and 1970s horror tales about overzealous medical researchers who injected cancer cells into elderly Jewish patients and provided live hepatitis cells through oral and injecting means to young children with mental retardation. The conflating also comes when the Study is referred to as "America's Nuremberg" (to equate its affect on ethics) and to link it to the horrors of the monstrous Nazi medical experiments. In addition, to think the men were infected taps deep into our cultural collective consciences' fears of experimentation. It avoids considering the Study's unwitting participants' sexual activities, or those of their parents, since syphilis is primarily, of course, a sexually transmitted disease. To assume the men in the Study were infected, rather than watched for decades, appears to make the racism worse, although it is the very ordinariness of the withholding of treatment that ought to frighten us more. (12)
Historians and other scholars have also argued that there were debates over whether the heavy metals treatments were appropriate for those in the late latent stage of the disease and that public health's mission was to stop contagion, not focus on chronic illness. Others have claimed, too, that the concern with the dangers of penicillin limited some of its usefulness, especially for patients who were at least two decades out from initial syphilitic infection. (13)
Historians may also emphasize medical understandings of syphilis's stages and transmission. These explanations require discussing the multiple stages of the disease and when and how decisions about treating those in latency were made. More importantly, even if the government doctors had wanted to give the men syphilis, it is very difficult to pass on syphilis outside of sexual contact, breast-feeding, or congenitally from a still infectious mother to her newborn. To explain this is also to confront pre-20th century understandings of the disease as hereditary, not just congenital, since syphilis cannot be just passed down in genes or somehow through a bloodline. It demands explaining the doctors could not just inject the spirochetal bacteria that causes syphilis easily from the blood of one person to another, and that centuries of research efforts had demonstrated the difficulties of finding ways experimentally to recreate the disease in the healthy. (14) The Treponema pallidum, the spirochete-shaped bacteria that causes syphilis, cannot be cultured and grown in vitro in a laboratory (unlike N. gonorrhoea, which can be cultured).
In sum, it takes time and a commitment to learning the medical science, understanding standard public health practices, and considering cultural beliefs in both the public and health care communities to explain why the men in Alabama were not, and could not easily have been, infected by the PHS, and yet why this is believed. Telling a quick black and white story makes for a better rhetorical media or political sound bite, or a brief historical introduction in a glossed over bioethics lesson.
Ironically, though, the mythic version of the "Tuskegee" Study may offer a better picture of mid-century PHS ethics than the seemingly more informed accounts. For Public Health Service researchers did, in fact, deliberately infect poor and vulnerable men and women with syphilis in order to study the disease.
The mistake of the myth is to set that story in Alabama, when it took place further south, in Guatemala.
The Guatemala story emerges from the records of work done by the PHS's Dr. John C. Cutler between 1946 and 1948, now in the University of Pittsburgh archives. An internationally known public health researcher-administrator and expert on sexually transmitted diseases and reproductive health, Cutler had been an assistant surgeon general in the PHS and the deputy director of the Pan American Sanitary Bureau (a precursor to the Pan American Health Organization). (15) He worked in Guatemala, India and West Africa and ended his career as, his obituary in 2003 read, "a much beloved professor both at the graduate school of Public Health and the Graduate School of Public and International Affairs" at Pitt. (16)
Cutler was dedicated to researching and conquering sexually transmitted (then known as venereal) diseases and providing usable and effective contraception to women. He published more than fifty articles on varying venereal diseases, the prophylaxis of disease with chemical contraceptives, and the lessons for ending the AIDS epidemic. (17) Those who know about the "Tuskegee" Study will recognize his name as a key researcher of that work during the 1960s and one of its staunchest defenders on PBS's 1993 Nova film about it called "The Deadly Deception," produced more than twenty years after the Study closed. (18)
Almost two decades before his involvement with the Study in Alabama, the PHS put Cutler in charge of a two-year research project in Guatemala. This experiment in the global, rather than the American South, differed from the Study in Alabama in two major ways: government doctors did infect people with syphilis and then did treat them with penicillin. In this research program of a series of carefully delineated experiments, PHS doctors exposed their subjects to syphilis or gonorrhea through the use of infectious prostitutes or directly through inoculum made from tissue from human and animal syphilitic gummas and chancres, or pus of gonorrhea filed sores. After learning what they wished from each exposure, they used penicillin presumably to cure the infection.
Exploring why these experiments in Guatemala were so different from those in Alabama provides insight into the ethical concerns of the PHS researchers, the powerful pull of the need for scientific knowledge, and the difficulty of analyzing the inter-relationship and movement of research between what has been called the "imperial periphery" and "metropolitan transformations." (19)
Penicillin Cure or Chemical Prophylaxis?
By the end of World War II, penicillin became more widely available and had begun to demonstrate its effectiveness as a cure with early and secondary syphilis and numerous other diseases. (20) Much of the drug's doses and limitations still remained to be tested. Looking out at the future, 1940s syphilologists began to realize, however, as Johns Hopkins's Joseph Earle Moore would lament a decade later, "the biologically minded clinician regrets... that syphilis seems to be vanishing with most of its fascinating and more fundamental riddles still unsolved." (21)
One of these remaining questions had to do with if, in addition to condoms, there was a need for a better chemical prophylaxis against the disease that a man could apply directly to his penis right after possible exposure, or whether just relying upon penicillin as cure from a health professional after the syphilis was diagnosed would be sufficient. (22) Syphilologists were well aware of the problems with many of the serologies done to determine syphilis, the inability to translate animal research studies (primarily done with rabbits and sometimes with chimpanzees) to humans, the complicated chronicity of the disease, and the wiliness of the syphilitic spirochete that had fascinated them for decades.
In 1944 the PHS had done experiments on prophylaxis in gonorrhea at the Terre Haute Federal Penitentiary in the United States. In this prison, the "volunteers" were deliberately injected with gonorrhea, but the PHS had found it difficult to get the men to exhibit infection and the study was abandoned. (23) To continue that work, and to extend it to syphilis, the PHS looked south beyond American borders.
The PHS had a long history of international work going back to its 19th century participation in foreign quarantines and sanitary conferences with a focus on infectious diseases, and then its 1945 establishment of an Office of International Relations to formalize these efforts. (24) To coordinate disease control in the Americas, the PHS had led the organizing in 1901 of the Pan American Sanitary Bureau (the precursor to the Pan American Health Organization) and the American Surgeon Generals, official heads of the PHS, served as directors of the Bureau between 1902 until 1936. (25) Indeed, one historian has argued the Pan American Sanitary Bureau "functioned until the late 1930s...as a virtual branch of the [PHS]." (26) In turn many Central American and Latin American countries sought assistance from the PHS and the Rockefeller Foundation as their funds and surveys assisted in the creation of federal control over health in regional and indigenous areas through the development of a public health infrastructure.
The United Fruit Company owned and controlled much of Guatemala, the quintessential "banana republic," in the first half of the 20th century. When the PHS looked to Guatemala for its research in the immediate post-World War II years, it came into the country during the period known for its relative freedoms; between 1944 and the U.S. led CIA coup of the elected government in 1954, there were efforts made at labor protection laws, land reform, and democratic elections. The PHS was part of the effort to use Guatemala for scientific research as they presumed to transfer laboratory materials, skills, and knowledge to a Guatemalan public health elite. (27)
Guatemala appeared to be a possibility as an excellent site for study for several reasons. The PHS training of Juan Funes, Guatemala's leading venereal disease public health official, made the forging of close cooperation easier and the building of a public health infrastructure important. Unlike Alabama, where the PHS expected to find a large number of subjects with the
late latent stage of the disease already, Guatemala offered subjects who did not yet have syphilis. For in his somewhat haphazard surveys in the 1930s, the Harvard Medical School Tropical Medicine professor George Cheever Shattuck found little syphilis in the Guatemalan highlands and reported little in the army as well. Shattuck shared the belief of Guatemalan health officials that "syphilis is more frequent in Latins [especially in Guatemala City] than in Indians and that, when manifested in an Indian, it appears in mild form." (28) Racialized assumptions about the disease, central to the project in Alabama, also followed it to Guatemala.
With a grant from the National Institute of Health to the Pan American Sanitary Bureau under the direction of the PHS's Venereal Disease Research Laboratory (VDRL), the PHS cooperated with officials at the Guatemala's Ministry of Health, the National Army of the Revolution, the National Mental Health Hospital and Ministry of Justice on what was benignly called "a series of experimental studies on syphilis in man." The focus of the experiments was to understand whether various chemicals, other than the ones then available, could be used as a prophylaxis against syphilis after sexual exposure to the disease, to try and see what caused false positive serologic tests for the disease, and to demonstrate more fully when and how differing dosages of penicillin actually cured infection. (29)
The PHS and the Pan American Sanitary Bureau assigned Cutler, who had been working at the VDRL and on the Terre Haute prison gonorrhea project, to lead this research in Guatemala with the assistance of the PHS-trained Funes.
Cutler and Funes had two goals. One was to use what was called "syphilization" to test the human response to "fresh infective material to enhance body response to disease...[to understand] superinfection and reinfection." (30) The second goal was to find ways to prevent the disease immediately after exposure. (31) During World War II, the United States had provided its troops calomel-sulpha-thiazole ointment in "pro kits." (prophylaxis kits). But these were painful to use, so the PHS wondered if less noxious chemicals or penicillin could be used instead. (32)
"Normal Exposure" and Normal Science Animal experimentation, especially with rabbits, was long a mainstay in 20th century syphilis research, but it could not answer these pressing research questions. The PHS researchers wanted to do an experiment where they knew there would be a good deal of what they politely called "normal exposure" to the disease in humans. As subjects, they chose the usual quartet of the available and contained: prisoners in a national penitentiary, inmates in Guatemala's only mental hospital, children in the national orphanage, and soldiers in a barracks in the capital.
Guatemala had legalized prostitution and "allowed prostitutes to pay regular visits to men in penal institutions," they explained in their reports. (33)
With the cooperation of officials at the Ministry of Justice and the warden of Guatemala City's Central Penitentiary, which housed nearly 1500 inmates, prostitutes who tested positive for either syphilis or gonorrhea were allowed to offer their services to prison inmates, paid for by U.S. taxpayers through the funds of the PHS. In yet another set of experiments, uninfected prostitutes had inoculum of the diseases placed on their cervixes before the sexual visits began.
Serological tests were done on the inmates before the prostitutes were invited to the prison and then afterwards to see if infection had occurred. The men were divided into groups and various chemical and biological prophylaxis techniques were tested after presumed infection. If positive, the men were then provided with enough penicillin to produce a cure.
Rabbits, of course, were much easier to manage and manipulate than human beings, as the doctors soon discovered. Not enough of the sexually well-serviced men (the researchers actually timed how long they spent with the prostitutes and thought they acted "like rabbits"), even when plied with alcohol, seemed to getting syphilis. (34) The prostitutes were not easily controlled either, and one researcher lamented, "unfortunately our female donor is leaving her profession for marriage and is no longer available." (35) The next problem the researchers ran into regarded the blood tests: too many positives even before more "normal exposure" occurred. Since they needed men who either had never had the disease or had already been cured of the disease for their studies, they discovered their pool was too small for statistical significance to be possible.
Their first answer then became, not abandoning the research, but rather questioning the tests.
The serology (blood tests) for syphilis had always been a problem, as the balance between sensitivity and specificity created many false positives and false negatives. And as the researchers wrote, "the impression is widespread that in certain tropical and subtropical areas there is a high degree of seropositivity which may not be truly indicative of the prevalence of syphilis." (36) There had long been an understanding that the presence of yaws (another treponemal disease) and malaria could affect positive blood tests for syphilis. In Guatemala, while they were getting positive reactions on the tests, they could find no clinical signs or spinal fluid evidence of the disease in the men's bodies. (37) To deal with this the researchers had to do repeat and differing blood tests (drawing 10 cc of blood every week or biweekly) to see if there had spontaneous cure of the disease, or the complex pattern on the blood tests (sometimes negative even when the patient still had the disease) often seen in longstanding syphilis cases.
Even though the inmates were in a prison and there was no mention of any kind of informed consent, the researchers met resistance. As they reported, "the inmates were for the most part uneducated and superstitious. Most of them believed they were being weakened" by the frequent blood withdrawals. Even though penicillin and iron pills were promised, "in their minds there was no connection between the loss of a 'large tube of blood' and possible benefits of a small pill." (38) This resistance and the difficulty of managing the prisoners suggested perhaps the studies on the serologies could be better done elsewhere.
With the cooperation of the Guatemalan government, the researchers turned to 438 children between the ages of 6 and 16 in the National Orphanage to study the blood tests, not to give the children syphilis. (39) Three children who appeared to have signs of congenital syphilis after repeat testing and examination were given penicillin. Yet another 89 gave positive results on their tests but showed no signs of the disease clinically. Finding the problem was not with the antigens used in the tests, the research physicians argued for the use of specific kinds of blood tests with this kind of population to rule out confounding factors they could not identify. (40)
They still, however, had not answered the question of whether penicillin could be used for prophylaxis, not just cure after a definitive positive blood test, in comparison to other chemicals applied directly to the genitalia. Faced with this and continued concerns with the serologies and reinfection after treatment, they turned to experiments with the inmates in the country's only asylum. Here it was not possible to introduce prostitutes, follow the inmates around to watch and time their sexual encounters, or gain acceptance by the female patients for physical examinations. So the researchers planned an inoculation, rather than "sexual exposure," study, though most of the asylum officials at first thought the inoculation was just another kind of drug. (41)
As in Tuskegee and throughout the global South in these years, the cooperation was sought with the institution, not the subject- inmates or their families. And the best way to gain that cooperation was by offering supplies. In a severely under-funded and overcrowded institution, the PHS supplied "much needed anti-convulsant drugs, particularly Dilantin, for the large part of the population which were epileptic." They also "bought a refrigerator for biologicals, a motion picture projector that supplied the sole recreation for the inmates, metal cups, plates and forks to supplement the completely inadequate supply available." (42) Individual subjects were offered cigarettes: an entire packet for inoculation, blood draws or spinal taps and a single cigarette for "clinical observation." (43)
Creating and Introducing the Inoculum
Making the syphilis inoculum was not easy. One method was to grind up gummas (syphilitic growth) in the testes of rabbits infected with the Nichols and Frew strains of the bacteria. This proved extremely difficult as rabbits had to be flown in from the VDRL in Staten Island to Cutler in Guatemala City; many neither survived the trip nor developed enough of an infection. In addition, the researchers tried to make inoculum from scrapings of the chancres on the bodies
of already infected asylum inmates, or men from the army that had a "street strain," picked up by local prostitutes not involved in the study itself. (44) Once the sample was obtained (by either killing the rabbits to scraping the men's penile chancres), the live inoculum had to be made quickly since the spirochetes could not last more than 45 to 90 minutes outside a body. This left very little time to remove the materials, centrifuge it with fresh homemade beef heart broth, and
prepare to deliver it to the subjects. Some inoculum was created with heat-killed bacteria and others with the living spirochetes.
Then the inoculum had to be introduced in the bodies of the subjects. On the women inmates, because of what was called "local prejudices against male viewing of the body, even by physicians," the inoculum was inserted after needles were used to abrade the women's forearms, face or mouth. With the men, the inoculation was often much more direct after what soldiers for
generations had called the "short arm" inspection. They chose men with "at least moderately long foreskins [to keep the mucus membranes moist]" and who could "sit or stand calmly in one spot for several hours." In the experiments, a doctor held the subject's penis, pulled back the foreskin, abraded the penis slightly just short of drawing blood by scraping the skin with a hypodermic needle, introduced a cotton pledget (or small dressing) and dripped drops of the syphilitic emulsion onto the pad and through it to the roughed skin on the man's penis for at least an hour, sometimes two.
This was compared to other forms of introducing the syphilis to the body, including scraping the forearm before providing the inoculum, or ingestion of syphilitic tissue mixed with distilled water, the removal of spinal fluid that was then infused with the syphilitic mixture and reintroduced into the body, and venipunctures of the mixtures into the medial cubital vein of the forearm. (45) In other studies of prophylaxis at an army barracks, the men were allowed to have sex with uninfected prostitutes, then had the syphilitic inoculum put into the meatus of their penis, told to urinate an hour later and apply differing kinds of chemical prophylaxis. (46) In still other studies, the inoculum was placed on the cervix of prostitutes before they were allowed to have sex with the prisoners.
Cutler's scientific fervor was impressive, for his sense of the dangers of syphilis was acute. The experiments varied the ways the inoculations were done, whether the syphilitic mixture came from a single chancre, a combination of "donors," or from the rabbits or the bodies of infected prostitutes and inmates and soldiers. The researchers gave out differing kinds of chemical prophylaxis to some of their subjects, or set up other men as controls who had no prophylaxis.
They made sure no one had the disease, or had taken anything for it, before they began the experimentation. Anyone infected was given penicillin and presumed to be cured, although there appears to have been no real follow up to determine this. The studies involved hundreds of men and women, many of whom had their photographs taken and left in the files.
Deception
Deception was central here, as in Tuskegee. Cutler, writing to famed penicillin researcher and PHS physician R.C. Arnold in 1947, admitted they were not really telling very many people that the inoculum contained the syphilis bacteria. "As you can imagine," Cutler reported to his colleague, "we are holding our breaths, and we are explaining to the patients and others concerned with but a few key exceptions, that the treatment is a new one utilizing serum followed by penicillin. This double talk keeps me hopping at time." (47) In a second letter he repeated his concerns that "a few words to the wrong person here, or even at home, might wreck it or parts of it...." (48)
Leading scientists knew that secrecy, and even law breaking was sometimes necessary to further research. Thomas Rivers, the famed virologist who led the Rockefeller Institute for Medical Research Hospital in New York, made this clear in his 1967 memoir when he recalled: Well, all I can say is, it's against the law to do many things, but the law winks when a reputable man wants to do a scientific experiment. For example, the criminal code of the City of New York holds that is a felony to inject a person with infectious material. Well, I tested out live yellow fever vaccine right on my ward in the Rockefeller Hospital. It was no secret, and I assure you that the people in the New York City Department of Health knew it was being done....Unless the law winks occasionally, you have no progress in medicine. (49)
Rather than law breaking, in Guatemala the secrecy added to the difficulties of an already challenging project. Experiments on prophylaxis needed to determine how much inoculum to give, the time it was allowed to enter the body and the kinds of "antiseptic agents" and "spirocheticidal" therapy to provide. (50) Keeping track of the hundreds of subjects proved complicated, especially in the asylum when patient's names were forgotten, or the staff called them, for example, "The mute of St. Marcos." Eliese Cutler, a Wellesley College alumna and. Cutler's wife, helped because she "got to know the patients and helped keep things straight," while also photographing them and the inoculations for the record. Some of the inmates were given the syphilis emulsions numerous times and another, they lamented, "after scarification, and the first application of emulsion...fled the room and was not found until 2 hours later with the pledget still in place." (51) Once it became clear that some of the inoculum took, researchers were "scrupulous" they asserted in making sure the penicillin was given to cure anyone who became infected, and the blood testing continued. (52)
The Guatemalan officials had their own demands. They asked Cutler to test and treat men in army barracks, to do surveys of disease in the lowlands, and to provide more penicillin for the country as part of the price for cooperation. He traded off drugs for malaria at the orphanage for the right to continue blood testing. His bosses in the PHS worried, however, that Cutler might be making too many promises of supplies and developing too ambitious a program. The PHS was already fighting a battle at home to continue its work in venereal disease in the face of the seemingly easy penicillin cure, so the project in Guatemala became difficult to justify. (53) After multiple letters Cutler promised to be careful and promised, "we shall use our supply sparingly so as to have it available at all times for use in demonstration programs and to build good will." (54)
Cutler remained confident that he had a gold mine for the research. While he was getting pressure from home to justify the abrading and inoculations, he reminded his supervisors "normal sex leads to this kind of trauma and minute lacerations." Writing to his director supervisor (the famed PHS researcher John F. Mahoney, who had first demonstrated penicillin's power over syphilis in 1943), Cutler noted "with the opportunity offered here to study syphilis from the standpoint of pure science just as Chesney studies it in the rabbit it should be possible to justify the projects in the event of the impossibility of resolution of the prophylactic program." (55)
Back in the United States, leading scientists were also hopeful, at first. Inoculation studies earlier in the century had caused much controversy, and after the 1910s most of it proceeded on animals, not humans. (56) Mahoney told Cutler in October 1946 "your show is already attracting rather wide and favorable attention up here. We are frequently asked as to the progress of the work. Doctor T. B. Turner at Johns Hopkins wants us to check on the pathogenicity in man of the rabbit spirochete; Doctor Neurath of Duke would like to have us follow patients with his verification procedures; Doctor Parran [the Surgeon General] and probably Doctor Moore [the leading syphilologist at Hopkins] might drop in for a visit after the first of the year." (57) Harry Eagle of the National Cancer Institute, who had created one of the serology tests for syphilis and did major work on penicillin, wanted in on the studies as well, since his theory that penicillin could be used as a prophylaxis had only been tested in animals, not humans. He was so angry he was not allowed in on the data that he went to the Surgeon General over it. (58)
The studies in Guatemala proved problematic, however, both for scientific and political reasons. Mahoney admitted that Cutler's data were not showing enough infection could be transferred and that "the circumstance confirms the conclusion drawn from the Terre Haute study that a very important factor other than the presence of the organism must be operative in the transmission of the disease." (59) By the fall of 1947, interest in prophylaxis was waning at home, and Mahoney told Cutler that there would be very little money if the study were just for serologies and penicillin therapy. Yet assumed racial and climatic differences would require a broader sweep. "A comprehensive study of the reliability of serology as a diagnostic instrument among aboriginal peoples in tropical America would require a different approach being used at present.," Mahoney argued. "We would be obliged to canvas the South and Central American nations, the Mexican Indians, the Indian tribes in the United States, and finally, the southern negro." (60)
Should They Do This?
There was also what bioethicists would later call the "yuck factor" of all the work. (61) PHS physician R.C. Arnold, who supervised Cutler from afar, was more troubled than was Cutler about the ethics of the project. Eight months after the "Doctors' Trials" at Nuremberg had ended, he confided to Cutler, "I am a bit, in fact more than a bit, leery of the experiment with the insane people. They can not give consent, do not know what is going on, and if some goody 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....Also, how many knew what was going on. I realize that a pt [patient] or a dozen could be infected, develop the disease and be cured before anything could be suspected...In the report, I see no reason to say where they work was done and the type of volunteer." (62)
Everyone involved with these studies seemed to know they were treading on complicated ethical grounds. There had been debates within the National Research Council in the early 1940s over the ethics of the Terre Haute prison study on gonorrhea. The PHS knew that such studies had to be methodologically sound and scientifically fruitful, historian Harry Marks has argued, to justify the risks to prisoners. (63) Yet the PHS knew there were very few other ways to get at this information and to find a way to stop syphilis' spread through prophylaxis before the disease was established, not just cure afterward. While the gonorrhea studies had failed in Terre Haute, they still hoped the new trials on gonorrhea and syphilis in Guatemala would prove so successful that the risks would have been worth it. Malaria specialist G. Robert Coatney, who had done prison malaria studies, visited the project in February 1947. In reporting to Cutler after
he returned to the States, he explained that he had brought Surgeon General Thomas Parran up to date and that with a "merry twinkle [that] came into his eye...[he] said 'You know, we couldn't do such an experiment in this country.'" (64)
Cutler, too, acknowledged that other syphilogists thought human experimentation on penicillin as prevention for syphilis that required inoculation with the disease "could not be ethically carried out." Concerned that discussion of this ethical problem was taking place in the United States just as information on their grant in Guatemala was published in Journal of the American
Medical Association, Cutler told Mahoney, "it is becoming just as clear to us as it appears to be to you that it would not be advisable to have too many people concerned with this work in order to keep down talk and premature writing....
We are just a little bit concerned about the possibility of having anything said about our program that would adversely affect its continuation." (65)
Mahoney continued to worry. There is a good deal of "gossip" in high places about what was going on in Guatemala, he warned Cutler. "I hope you will not hesitate to stop the experimental work in the event of there being an undue amount of interest in that phase of the study." Mahoney, as with Arnold, seemed less concerned with the prostitute transmission studies taking place in the prison, but seemed more squeamish about the politics and morality of the inoculation studies taking place in the asylum. (66)
There was also the problem that such studies, requiring such effort to induce infection, could not be duplicated elsewhere. Mahoney told Cutler about a year and half in to the project, "in syphilis, unless we can transmit the infection readily and without recourse to scarification or direct implantation, the possibilities of studying the subject are not bright." The procedures were, he noted "drastic...[and] beyond the range of natural transmission and will not serve as a basis for the study of a locally applied prophylactic agent." (67) Cutler did his best to try the studies in multiple ways, to use differing strains of the bacteria, to move between animal and human donors, and to emphasize the repeatability. (68)
Even as Cutler continued a number of differing studies, his PHS supervisors were acutely aware this had to stop. Supplies were limited, and the growing use of penicillin diminished political support for this kind of research.
By 1948 Cutler was told to finish up his work, leave the laboratory materials for the Guatemalan venereal disease control effort, and to come home to be assigned elsewhere. Eventually, Cutler and his colleagues would write up the serology findings, and a colleague would publish some details in a Spanish-language public health journal. (69) Cutler put the final report and the hundreds of photographs his wife had taken in his papers, the only record of his decades long research career left behind. (70) The extraordinary efforts he had made to produce disease and understand various kinds of prophylaxis were buried in the files.
Does this Matter?
Moore had been right that the penicillin cure for syphilis left many unanswered questions about the disease. Although Cutler's work helped refine serological testing, and suggested a better chemical prophylaxis, it made little impact on syphilis research. Cutler would go on to do another inoculation study five years later in 1953 with the PHS's Harold Magnuson at New York's Sing Sing Prison with sixty-two "human volunteers, " using as he had in Guatemala both heat- killed and virulent organisms made from ground up rabbit testes.
These inoculations, however, were done intra-cutaneously and subcutaneously. No one was abrading the penises of these American men, even in a prison.
Anyone positive was treated, too, with penicillin. These prison studies were done to answer some questions about re-infection and whether having treated syphilis and then being provided with the "booster" of new disease created immunity to further infection. The extensively quoted and published report on this Sing Sing work covered much of the history of inoculation syphilis, but it made no mention of the studies in Guatemala. (71)
Why then does any of this work in Guatemala matter, besides the arcane history of Cutler's links to Terre Haute, Guatemala, Sing Sing and then Tuskegee, and our prurient and horrified sense of what they did without any individual permission? Do we need to have yet another awful story of the "bad old days" of medical research before the creation of institutional review boards that are presumed to protect human subjects? Does this suggest ways those who are concerned with policy toward subjects should rethink what happened in Tuskegee?
The Guatemala study matters for two reasons. First, it demonstrates the links between periphery and metropole in public health. There was traffic in ideas, in practices, in justifications, and in the bodies of researchers that moved across borders. (72) Ways of treating subjects in one place, deceptions allowed in another, moved around and through the creation of a culture of research. It is not just public health practices, but also public health research, that crossed over from country to country.
Only by understanding this context can we understand the decisions made by the Public Health Service. While they had their qualms about what was being done in Guatemala, they allowed that work to continue for two years.
Having made that decision, they might well have regarded the project in Alabama-which did not infect anyone-as relatively benign.
The story of the work in Guatemala also confirms that fact about noninfecting in the "Tuskegee" Study, since it shows the difficulty of infecting individuals with syphilis in a scientific project. The lengths that Cutler and his colleagues had to go to give the disease to the inmates of the asylum, prison and army barracks in Guatemala, and then later in less atrocious ways at Sing Sing, provides us with a way to say this is not what happened in Tuskegee. Surely, the survivors of the Study in Alabama would remember that this happened to them if there had been such injecting and abrading? In all the records (either in the federal archives or those at Tuskegee University) of aspirins, iron tonics, and pill jars shipped to Tuskegee there is no mention of money spent for rabbits, for laboratories to create the inoculums, or efforts to do this.
At the same time, the Guatemala story may make it even easier to imagine that the government doctors did infect men in Alabama. PHS researchers of the period were technically capable of infecting people with syphilis, even if doing so was more burdensome than the researchers wished. And they were morally capable of infecting people with syphilis, for their faith in their cause allowed them to infect people with this dreadful disease without their consent or even knowledge-at least when those people lacked power and white skin. These facts so complicate the Tuskegee story that I deliberately omitted the Guatemala studies from my book Examining Tuskegee, lest they make it too hard to explain that the men in Alabama were not infected.
Policy makers often pick and choose differing historical accountings to justify the decisions they make. Historians have the luxury to wallow in context and knowable facts, while others make meaning, law and regulations from our work. The Study in Tuskegee is often told in a simple manner and frequently mis-remembered. The inoculation studies in Guatemala put the effort in Tuskegee in context but can also increase fear of medical research. For if the hue and cry has been to "remember Tuskegee" to justify control over medical research, we can only imagine what the sounds might be if these experiments in Guatemala are also in the portrait. As much as we can be squeamish and angry over what was being done in these studies, it forces us to consider how we tell these stories and the policy we make now. (73)
Acknowledgments: I am grateful to Marianne Kasica at the University of Pittsburgh Archives for making the materials available. Thank you to Zachary Schrag for his edits, encouragement and questions as well as those of my colleagues when I gave this first as a paper at the 2010 annual meeting of the American Association for the History of Medicine. I also appreciate the comments of former CDC director David Sencer who did not know the details of this study that did not take place on his watch.
VI. ¿A qué conclusiones podemos arribar?
Un aspecto interesante -y preocupante- a destacar de la teleconferencia transcripta más arriba, es la pregunta efectuada por el periodista del Financial Times, Andrew Jack, sobre cuántos otros experimentos antiéticos de esta naturaleza pueden haber por ahí que todavía no han sido revelados.
El Dr. Collins responde que hubo más de 40 involucrando la infección deliberada de personas, sin su debido consentimiento, en los Estados Unidos. Lo cual nos abre los siguientes interrogantes: si solamente en los Estados Unidos, este tipo de experimentos antiéticos sumaron más de 40, ¿es el caso de Guatemala el único en el exterior? Si no tuvieron reparos en inocular a sus propios nacionales, ¿habrán sido más cautos con los extranjeros?
Esta pregunta es, hoy en día, muy relevante. Porque, como afirma Susan M. Reverby, los medicamentos producidos en los Estados Unidos son testeados ahora con mucho más frecuencia en el exterior que en ese entonces.
Si bien se asegura que ahora no es posible que una experiencia como la reseñada aquí sea llevada a cabo, por los controles éticos actuales, nos queda la pregunta: ¿desde cuándo?
Por lo tanto, consideramos que sólo con la plena dilucidación de este caso, a través de las investigaciones prometidas al más alto nivel de Gobierno, podrá calmarse la comprensible alarma que ha causado esta revelación en la comunidad internacional.
Proyecto
Firmantes
Firmante Distrito Bloque
MORANTE, ANTONIO ARNALDO MARIA CHACO FRENTE PARA LA VICTORIA - PJ
Giro a comisiones en Diputados
Comisión
RELACIONES EXTERIORES Y CULTO (Primera Competencia)