 Good afternoon and welcome to the afternoon session which is on the past and future of ethics. Our first speaker is Dr. Daniel Slamacy and Dan is the Kilbride Clinton Professor of Medicine and Ethics at the University of Chicago, both in the Department of Medicine and the Divinity School. He's also Associate Director of the McLean Center for Clinical and Medical Ethics as well as the Director of the Program on Medicine and Religion. Dan has previously held faculty positions at New York Medical College and Georgetown University and he has served on numerous government advisory commissions. He was appointed to the Presidential Commission for the Study of Bioethical Issues by President Obama in 2010 and his research interests encompass both theoretical and empirical investigations of the ethics of end-of-life decision-making, ethics education, and spirituality in medicine. He is the author or editor of six books including The Healer's Calling, Methods of Medical Ethics, The Rebirth of a Clinic, and Safe Passage, a Global Spiritual Source Book for Care at the End of Life. Dan also serves as the Editor-in-Chief of the Journal of Theoretical Medicine and Bioethics and today Dan will speak to us on a topic the history and ethics of U.S. STD experiments in Guatemala 1946-1948. Thanks to those of you who took a shorter lunch break and got here. When I was asked to speak for this session, Mark gave me a somewhat directed assignment in that he wanted me to say something from our experience on the Presidential Commission for the Study of Bioethical Issues and I chose this topic partly because while many people have heard about these experiments I still find there are huge numbers of people who really don't have never heard about this work that the U.S. government did and secondly those who have don't really know the details and I thought it would be valuable even though it's not sort of late-breaking news to go through this. The story I'm going to tell you really is credited to the historian at Wellesley College, Susan Reverby, who spent her entire career studying the Tuskegee experiments and decided that she was going to ask the question what were these guys and in those days they were all guys doing before they were in Tuskegee and she began to investigate the work done by one investigator John Cutler. She published some preliminary or made some preliminary reports in October 2010 on his work in Guatemala after the Second World War and first published it in the Journal of Political History in 2011 and the details that I'll get into in a few minutes were, here's Dr. Cutler, were so great that actually President Obama decided he would ask the Commission to do two projects, one which was to investigate the history of what actually happened in Guatemala and the second to give a contemporary assessment of what research protections are currently in place and it's really the first of these that I'm going to talk to you about this afternoon. To understand this I think we have to go back to a little bit in time and try to understand the late 1940s medical milieu. There was a war on venereal disease. It was a scourge that we now reserve for diseases like cancer, perhaps like HIV, but the war on syphilis was in full gear and this had occurred just after the Second World War. Penicillin had only been had been discovered in 1928 but had not shown to be effective for syphilis until 1943 and had mostly been used for soldiers. And there was a great deal of scientific work going on, some of it getting into the newspapers and in 1947 and New York Times correspondent Waldenmark Kempford reported on some syphilis experiments that had occurred in rabbits which seemed to be promising and he said it would be ethically impossible to undertake such research and to shoot living syphilis germs into human bodies unquote in that article. Little did Mr. Kempford know. The United States government in cooperation with the Guatemalan government undertook a series of studies in Guatemala. One set were serological, better understanding, the cerebral spinal fluid tests and blood tests for syphilis and to better understand what happened over time with or without treatment, sort of what was already beginning to happen in Tuskegee. But then secondly to conduct exposure studies. Originally trying to say how could we prophylax against people getting venereal disease with either a topical solution or with giving penicillin before contact and then it later shifted to treatment experiments. The serologic studies work went on for quite some time, began in 1946. The purpose was to develop better tests for syphilis, blood draws, lumbar punctures, external punctures and the populations studied were orphans, leprosarium patients and some US Air Force personnel who were stationed in Guatemala. But the intentional exposure studies were short lived, 46 to 48. They involved commercial sex workers, prisoners, Guatemalan soldiers and hospitalized psychiatric patients. And here's basically what they did. They first tried to induce, transmit the infection by having people engage in intercourse with infected prostitutes to try to get experimental models in human beings for syphilis and gonorrhea. When that was proved not efficient enough, quote unquote, they then made direct genital skin contact with solutions of these bacteria. And then when that wasn't efficient enough, went to direct injection of suspensions of the bacteria into the urethra of the subjects, quote unquote, of these studies. And when that wasn't efficient enough, engaged in what they called gentle scarification and abrasion to increase the efficiency of the infection rate, thinking that would more mimic actual intercourse. And then they moved to something called cisternal punctures, which was actually not something that our researchers who were not physicians actually understood, but they actually injected spirochetes directly into the cisterna magna as a model for neuro syphilis because it would take too long to wait 10 or 15 years for the natural course of things to develop it. And they also thought it might be an experimental shock therapy for the psychiatric patients into whom they were doing it. And again, for those of you who don't know what this is, this is a cisterna magna puncture. Emulsions of spirochetes directly injected into this cerebrospinal fluid. There is no record of any of these subjects giving consent. Some subjects, including those with mental illness and children, didn't have the capacity to give consent. Evidence shows that researchers intentionally deceived some subjects about the nature of the study and what was being done to them. There's one quote relating to the Native Central Americans as being only confused by explanations and knowing what's happening so it's better not to engage in informed consent. These were not rogue experiments done by people who had no backing. The Public Health Services Venereal Disease Division, now the Centers for Disease Control, was very much involved and provided a large amount of the funding. The National Institutes of Health, which had only recently been founded, was very much involved in this. And study sections approved this research. The Pan American Sanitary Bureau and the Guatemalan government were all involved in these projects. And it went pretty far up the chain of command. The Meeting 1 of the NIH Syphilis study section, when it was first founded, approved these studies. The National Advisory Health Council approved the studies and Surgeon General at the time, Thomas Parent, approved these studies. There were site visits, like any other experiment, from the PHS Venereal Disease Research Lab and from the NIH Chief Division of Research grants to see how the project was progressing. Staffing came directly from the Public Health Service of the United States as well as from the government of Guatemala. Some idea of the magnitude of this, 5,500 persons were enrolled in these projects. The intentional exposure studies involved 1,300 patients. Only in 678 of these cases was there any evidence of any attempt to treatment and usually that would be inadequate by current standards. And then in diagnostic testing there were 5,000 subjects, only 820 of whom show any record of any sort of treatment. The age range was pretty great. An intentional exposure includes a 10-year-old Guatemalan soldier who was part of the intentional exposure studies up to the age of 72 and a psychiatric patient. And the mean age was 25. Diagnostic testing was largely done in children. To give you an idea of how detailed the records were and what sorts of things happened, we'll give you a profile that we called from the records of a patient simply named Bertha, who was in February of 1948 involved first in intentional exposure to syphilis experiments. And then if you move to the right hand column, on August 23rd, Dr. Cutler wrote that Bertha appeared as if she was going to die, but it didn't specify why. That same day he put gonorrheal pus from a male subject into both of Bertha's eyes as well as into her urethra and rectum. He also reinfected her with syphilis. Several days later Bertha's eyes were filled with pus from the gonorrhea. She was bleeding from the urethra and four days later she died. Now let's try to even step back a little bit from that story to show that there have been other intentional exposure experiments. In fact, Albert Neiser, a Prussian physician at the late 19th into the early 20th century, had worked with prostitutes trying to treat syphilis, taking serum from prostitutes and trying to treat them. He did that and was actually prosecuted by the Prussian government in 1898. And as far as I know, actually it was not, as we sometimes think in the United States, the Benjamin Cardoza in the famous New York hospital court decision that thought up the idea of informed consent. It was actually the Prussian government in prosecuting Albert Neiser who said that you didn't ask any of these people their permission before you injected them with syphilis and injected them with serum from prostitutes who were infected with it. But of course, one of the things that was most shocking to me is that the experiments that were going on in Guatemala were happening roughly contemporaneously with the trial of the Nazi physicians. And while I had been aware, as many of you may have been aware of the experiments that were done, horrific experiments in high altitude exposure and in cold exposure, the indictment against these physicians also included experiments that were done by Nazi physicians on concentration camp victims, where they inoculated their muscles with Clostridia and Streptococci. And then when that wasn't efficient enough in language that eerily parallels the language in Guatemala, they actually purposefully abraded the wounds and inserted glass to simulate shrapnel, which might make the infection more like the battlefield infection they thought they were going to treat. And again, I want to suggest that this had approval from the highest levels of the government. Thomas Perrin, the U.S. Surgeon General, is quoted in a letter. It's having said to one of the site visitors, you know, we couldn't do such an experiment in this country, unquote, in congratulating them on the work that they were doing. Cutler, after his work in Guatemala, went on to Tuskegee and then went on to the University of Pittsburgh, where he became Dean of the School of Public Health. Now, in our report, we made these conclusions at least. In my view, and I'll get to this in a minute, I think they're at least minimal comments that we could make. This, certainly from a scientific point of view, could be criticized. And several scientists told us that they basically didn't have very good information in these studies. Second, you can certainly criticize them for a failure to obtain informed consent, which was known about at least since the time of Albert Neiser. Also was done in experiments that were done in the Terre Haute Prison by the Public Health Service, even before they went to Guatemala. At least American prisoners were being asked to obtain informed consent before engaging in experiments, which were not even anywhere near as horrendous as the ones that were done in Guatemala. And we thought that the individual investigators, not just what they did, but the individual investigators themselves, could be held morally culpable, that these failures were not just wrong now, but that they were wrong then, and they should have known they were wrong. And in fact, many of their efforts to cover it up, and for instance, keeping this secret and never publishing it, gave some credence to the belief that they actually had some inkling that others would think that what they were doing was wrong. And that much you can find anytime you would like at www.bioethics.gov slash studies. We have our report available for you there online. You can also order them from the government. But I'd like to take us for a few moments a little bit into ethical analysis beyond the report itself, which I think even as a member of the commission was somewhat minimal. We didn't really raise questions of justice in terms of what went on there. And quotes like, you know we couldn't do such an experiment in this country, and Indians are only confused by explanations in knowing what is happening, suggests that the U.S. government and its investigators were holding a different standard in Guatemala than they would use in the United States. And similars were not being treated similarly. In addition, I would go further, from our report, and say that these were gross violations of human dignity for the subjects. Particularly disturbing for me were the really dispassionate discussions of the need to increase the efficiency of the infection that led to the pre-inoculation genital abrasion. It was almost as if one was reading about laboratory animals, this sort of dispassionate tone of the primary sources. And prostitutes were not treated and were used as reservoirs, I mean sort of like animal reservoirs for other kinds of diseases. They were simply continually used as sources for fresh, infective material, which again seems to be a gross violation of the dignity of the persons who were involved in these experiments. The question is always raised and I think we need to continually raise it for ourselves, whether a beneficent social end justifies any and every scientific means. Certainly it seems to me that if you are at least in any way inclined to think that Kant had something to say that was reasonable when he said that act in such a way that you treat humanity whether in your own person or in the person of another always and at the same time as an end and never simply as a means would cast a severe judgment on these sorts of experiments, despite how the investigators themselves thought they were doing something very noble, which was continuing the war on syphilis and gonorrhea, the war on venereal disease. I wonder whether our report went far enough in declaring that these actions were unconscionable. Could we have used the phrase crimes against humanity or a phrase like atrocities? There was some discussion of this within the commission. We decided in the end on saying unconscionable, but maybe there were those at least who sided with me that felt that that didn't go far enough. There were others and maybe some of you in the room who think it goes too far. Particularly the question of whether one can assign retrospective individual blame to Dr. Cutler and his colleagues. The question arises of whether we're holding them to a standard that we now have but didn't really exist for them at the time. I can tell you that for instance the American Sexually Transmitted Disease Association removed Thomas Perrin's name from its career development award for his endorsement of these experiments and Pitt took Cutler's name off a lecture series even from their knowledge of Tuskegee before even this was discovered. But there are those persons who might suggest and I'd be glad to talk about this whether this is historical anachronism. The doctrine of informed consent as we now have it had not fully been formulated. The Nuremberg Code had not actually been written although it is odd that we at least thought it existed enough that we were able to try Nazi physicians for not having behaved in a way that was consistent with those sorts of principles. And then persons suggested it maybe wasn't fair to in essence try these persons without giving them a chance to defend themselves since they were all deceased. Another issue that comes up and continues to come up is whether there should be compensation for these experiments or if not compensation at least reparations. Compensation being to individual victims, reparations perhaps to the nation. The U.S. government did give $1.8 million for public health in Guatemala along with an apology from the president. Does that go far enough given the extent of what went on? The alleged surviving victims and it's not clear whether they are or not but to the extent that we can believe that they are surviving victims tried to sue the U.S. government but it is actually unconstitutional for foreigners to sue the U.S. government so they were blocked in district court in 2012. You may be aware this is still going on. They have now launched a lawsuit against Johns Hopkins because Hopkins was so involved in the NIH and the war on syphilis and the funding and the approval for these studies. I think it's a $400 million lawsuit that is being heard now. Then lastly, mostly for me, I began this project thinking raise your hands if you think this was the right legitimate thing to do. It seemed like an ethical no-brainer that this was horrific and should never have been done but I began to really become interested in the question of how things like this happen. I mean these men actually thought themselves heroes. This is not the Aristotelian problem of a crazier where one knows what the right thing is to do and can't bring oneself to do it. Perhaps it's explained by Hannah Arendt's idea of the banality of evil but I'm not even sure that properly captures what went on. Maybe in fact what's going on and sometimes goes on for any of us is a problem of self-deception. For instance, the terrorists who carried out the atrocities yesterday in France probably thought that they were doing something noble and good. How does one come to think that? The Arendt experimenter, I think, believes that the exploitation, what we come to think of as the exploitation of innocence is actually justified by the nobility of the end. There are some implications for the present. What is the sort of balance between social good and the good of individuals and the biomedical research that we conduct? I think we need to continually ask ourselves those questions so that this historical example is not something that is simply dead and in the past. We certainly need moral formation and ethical education for scientists. I think we need to be a bit more transparent about our research and I think some of us worry about the current offshoring of research, particularly pharmaceutical research in a globalized world and what we don't know is happening in the developing world now. With that, I'll end my presentation. It gives me two or three minutes, I guess, for questions, so thanks. Question or comment? Sorry to put that on you after lunch. Pretty gruesome stuff. Okay, well maybe. Yes. Go. Marshall's question, if you didn't hear it in the back, is why the commission didn't come out more strongly. I think there were some philosophical questions raised about whether we could legitimately hold persons to standards that didn't exist at the time. I think there may also have been fear about what kind of liability the United States might be put at in even international courts by having the commission come out with a stronger kind of condemnation. There were actually legitimate philosophical differences about that question of whether we can hold persons to standards that didn't exist at the time. I kept trying to insist that Hippocrates would have thought that putting a needle into somebody's brain and injecting spirochetes into it was something a doctor shouldn't do and that anybody who is a physician would know that this was something that was morally wrong even if we didn't have a doctrine of informed consent. But it was not ultimately the persuasive view. Yes. Well I told you it goes back into the late 19th century with Nizer who was purposefully infecting prostitutes with syphilis and then trying to treat them with the serum of prostitutes who were also infected. So this has happened and there were other ones here. I mean there have been experiments. There's a lot of certainly of research that's done even to this day with actual induction of infections. I mean how do you study malaria except by having people bitten by malaria mosquitoes and try to see whether or not the latest attempt you have at a vaccine is actually effective or the treatment is effective. Great volunteers who are trying to do these sorts of things. They're usually attenuated so that they're not going to get sick from it but still those kinds of things do go on. So yes time. Thank you. Thank you.