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Professional Frank Snowden:
This morning I want in a way to circle back in time to cover an issue that's been lurking in the background but we've never faced directly. You will remember that when we talked about the Paris School of Medicine, there was the ethical issue raised of the relationship of the patients to the physicians who were using them for medical studies, and we've talked about this as well in a variety of other contexts. For example, in the breakthrough of the mosquito theory of transmission of malaria, we've seen that there were human experiments involved in that. But there wasn't really an ethical framework of a formal kind until well into the twentieth century, and it's that development that I want to look at this morning--the development of a framework of bioethical experimentation for human studies--and to do that, I'd like to look at the Tuskegee syphilis study from 1932 to 1972,whichwas, if we like, the catalyst around which a framework of biomedical ethics was developed. Now, the Tuskegee study was a complex story. It captured the national imagination, because it seemed to embody everybody's fears as a worst-case scenario in medical ethics. Tuskegee as a study embodied a number of features that contributed to that. Clearly it demonstrates, as I think we'll see, the corrupting influence of commercial considerations on medicine and medical research. It demonstrates the negative impacts of scientific arrogance. It brings out the dangers of a military chain of command model of public health, in which no one questions or resists decisions from higher authority. It shows the exploitation of the poor and disadvantaged by powerful interests and the government, and it also clearly embodies racism. This is an experiment that began with an idea that racial groups are a serious biological category, not just a social one, but that races are biological entities, and that the differences from one
group to another are so significant that diseases themselves follow different paths in the bodies of different racial groups. Well, the place where this unfolded was in Macon County, Alabama in the 1930s, and Tuskegee is here in Alabama. Let me look a little more closely. That's Macon County inthestate of Alabama. There are a number of features we need to think about when we remember Macon County, and we need to take off our twenty-first century spectacles and think back to a different world in the 1930s, when this experiment got underway. And at that time, Macon County was one of the most disadvantaged places in the whole of the United States. It had a large population of poor and illiterate African-American sharecroppers, and this was the time of apartheid in our country. Studies had revealed in connection with the social conditions of the sharecroppers in Macon County an overwhelming burden of disease and suffering. In a rigidly segregated environment, the African-American population was also overwhelmingly illiterate. In fact, the state of Alabama spent sixty-five dollars a year on each white student in the county, but less than seven dollars for every African-American student. Venereal diseases, and especially syphilis, were also rampant in Macon County. Well, the story that unfolds is a pretty awful one, but paradoxically, it begins with good intentions. The good intentions were those of a philanthropic program established by an organization--I guess we would call it an NGO--the Julius Rosenwald Fund. Rosenwald at the time was the president of the Sears & Roebuck Company, and under these auspices, Dr. Thomas Parran conducted a study of syphilis in the south in 1929 and '30, and this study had a clear moral purpose. The idea was that it was to begin by demonstrating the burden of syphilis, and that this would be a first step that would pave the way for the federal government subsequently to step in and establish a national syphilis eradication program. The vision was this: in year one, there would be a Wasserman test survey of six states in the south of this country; that is, establishing the extent, the prevalence, of syphilis. In the second year, there would begin a program of treatment and of education. Let's look at what was found in the beginning of the study year one was actually completed, and it found that the United States had a national rate for syphilis of 4 for every 1,000 of population. On the other
hand, for African-Americans, the rate was 7.2 for every 1,000 of population were syphilitic. But if we come now to Macon County, Alabama, and that's the point, the statistics were absolutely staggering. Fully 360--and no, I'm not making a mistake-- 360 per 1,000 of population of the African-American population of Macon County, Alabama was found to be afflicted with syphilis. So, Macon County--and this is the point-- was clearly placed on the map as the very ideal place if you were interested in how syphilis affected the bodies of African-Americans, and particular, African-American males. Well, the year two of the philanthropic program never got under way. The reason was simple: it was the Great Depression, and funding for the program vanished. The phase that had been intended of education, of treatment, and hopefullyoferadication, never materialized. What remained was only the initial study. At this point in the wake of the activity of the Rosenwald Fund, United States Public Health Service intervened, and it had, as we'll see, two very different objectives. The first was associated with this man, and the idea of the syphilis study was his brainchild. This is Tagliaferro Clark, and his idea was to have a scientific and racial curiosity. There had been at the turn of the century a Scandinavian study on the course of untreated syphilis in the human body. That was conducted in Scandinavia, and Dr. Clark thought that since the early study had involved a Nordic people, it would be really intriguing, really neat, to do a companion study to show the natural history of syphilis untreated in the body of the African-American male. And if you wanted to do that kind of study in this country, what place could possibly be better than Macon County, which offered unlimited material for just such observations. Clark started with a profoundly racist hypothesis that he wished to demonstrate, and that is the simple one that the African-American male was racially distinct from the white male, and was so in ways that could be demonstrated by studying the natural history of syphilis in their bodies. It was thought, or at least he thought, that African-American men had such a high incidence of syphilis because of their irresistible furor sexualis, and their deficient cranial capacity that didn't really leave enough room for gray matter to control it. Secondly, once established in the body of the African-American man, syphilis, Dr. Clark believed, ran a different course than it would in the body of the white man, and he had an idea of what he expected that difference to be. In the body of white males, the damage was overwhelmingly to their more highly evolved--and therefore more vulnerable--neurologic systems. He expected that the result in African-American males would be very different, being less neurologically sophisticated, their bodies would experience damage instead primarily to their cardiovascular systems, and proof was to be gained by studying the natural course of the disease in a group of males--African-American males--who were systematically untreated. So, let's keep this in mind: it's to be in the bodies of African males that are systematically not treated. Let's remember that this is a study that was based not on any therapeutic objective. On the contrary, the main interest of the syphilis study conducted at Tuskegee was to examine syphilitic black male bodies postmortem. For this reason, as the biomedical ethicist, Susan Lederer, explains, the real purpose of the study was not to treat the African-American men involved as subjects, or even as bodies, but rather as cadavers that had not yet died. Let me quote the words of one of the physicians involved in the study, who wrote the following: "The most important phase of the study was to follow as many patients as possible to postmortem examination in order to determine the prevalence and severity of the syphilitic disease process." One physician of the U.S. Public Health Service expressed the thought very succinctly and with chilling candor. He said, "Once the study was established, the subjects had no more interest for us until they were dead." Well, what's the second objective of the study? The second aim of the study is often not remembered so clearly. It was more commercially driven and less well known. Remember--cast your mind back to the 1930s--and worldwide at that time, there was a vast and stable demand for a reliable diagnostic test for syphilis. The demand was created, first of all, by law--laws that required, for example, testing for syphilis before marriage, testing for syphilis before induction into the army. And still at this time, at the start of the 1930s, there was no absolutely reliable diagnostic test for the disease. Furthermore, developing such a test was scientifically challenging because of a feature of Treponema pallidum, the spirochete that, as you know, that's the pathogen responsible for syphilis. The Treponema pallidum, as one of its features, has extreme fragility. It could not really be cultivated in the laboratory at this time. So, there was an alternative, the experimenters thought, and that was a simple one: to keep a ready supply of serum available through regular blood samples from untreated syphilitic subjects. I started to say patients, but the point is they aren't patients. They weren't to be treated, they were subjects. And indeed, in the course of the Tuskegee study itself, two new reliable tests were developed using Tuskegee blood, and they were successfully marketed. These two tests were the venereal disease research laboratory test--was one--and the other was called "the fluorescent treponemal antibody absorption test." And needless to say, the subjects of this experiment were never paid for this particular service that they rendered to science. Well, a problem faced Tagliaferro Clark and his experimenters. The problem was to recruit volunteers, volunteers to take part in a study that had no therapeutic purpose. Why would you volunteer, you might ask, to take part in a study that has no benefit for you, but whose purpose, in fact, was to use your living body as a natural history exhibit, to observe pathology while the subjects received no treatment, and while their blood serum was used as a culture medium? Well, they thought of a solution, and that was to make use of the ample availability of African-American males in Macon County who were vulnerable to manipulation because they were desperately poor, because they were illiterate, because they had almost no access to medical care and the medical profession, and because, at this very moment, they had a substantial and as yet unfulfilled expectation--the expectation created unknowingly by the Rosenwald study-- that there would soon be a therapeutic intervention of the United States government. What the United States Public Health Service did was to send out mass postings to black churches in Macon County, and these letters and placards let it be known that the government was embarking on the long-awaited treatment program. Let me be clear again about that: the announcement by the Public Health Service was that the second phase was underway, and that what was coming was a program of treatment--treatment for anyone who thought that he or she-- well, in this case, he--had what was called "bad blood." Now, "bad blood" in Macon County, Alabama, was not a scientific term, but a really elastic term, local term, borrowed from popular culture that had a number of inconsistent meanings. Bad blood might mean anemia. It might mean simple indigestion. It might mean venereal disease. So, if you had bad blood, whatever that was, treatment is on the way. And in addition to treatment, volunteers, if you volunteered, were promised that in due course, they would be provided will all funeral expertise courtesy of the U.S. government, provided they allowed their bodies to be subjected to autopsy--the famous postmortem examination that Tagliaferro Clark was so enthusiastic about. They would also be provided with free meals occasionally, and free
transport to the treatment center. So, what was on offer might not seem enormously expansive, and I think it's a reflection of the dramatic conditions, social conditions, of people at the time that large numbers of people came forward. And approximately 600 were selected, and they were regarded by those who were rejected as the fortunate ones. They were lucky. They'd been taken into a treatment program of the U.S. government. And after selection, the 600 were divided into two groups: 399 were found to have syphilis, and they formed the study group, 200 without syphilis served as controls. Now, this raises an ethical issue immediately. Were these volunteers? I would argue that these 600 African-American males can only by some stretch of the imagination be called volunteers for a really simple reason: you can't be a volunteer if you're lied to about that for which you're volunteering. In other words, they volunteered for one thing, and what was put in place was something radically different. They were promised treatment, but treatment was precisely what they were to be denied systematically for the remainder of their lives. Let me quote Tagliaferro Clark, who presided over the first year of the study, and directly approved the use of this deception. He wrote this to a colleague: "These negroes are very, very ignorant, and easily influenced by things that would be of minor significance to a more intelligent group." Now, what was the site of the study? This is a picture of one of the buildings of Tuskegee Institute, now known as Tuskegee University. It had a very honorable history. It was founded by Booker T. Washington for the education of freed men after the civil war, and it was induced to cooperate by the idea that such cooperation with the study would enhance its prestige and would gain access for it to government funding. And there was an African-American nurse--we see here her with a doctor--a Eunice Rivers, who was the local African-American nurse who served as the intermediary between the physicians of the Public Health Service and the subjects of the experiment. A lot's been written about Nurse Rivers and her role in the experiment. I think that we ought to remember the context of the time and the training in which nurses were trained not to question, but to do as they were told. Now, at the outset, something also paradoxical happened, and I would argue that it in fact, even if you wanted to have an entirely cold-blooded look at scientific validity for such a study, this particular study was made scientifically invalid from the outset. At the beginning, the experimenters ruined any possibility that the study could ever produce valid scientific results because the government doctors began the study by administering a small dose of the accepted therapy of the day. In other words, the experiment is to begin to have a study of untreated syphilis, and they begin by administering a small dose of the established therapeutic medication of the day, which is a combination of arsenic and mercury compounds plus bismuth. So, this ruined the premise of observing purely untreated syphilitics. Then further weakening the scientific--if we call it that--validity of this study was the fact that some members of the control group contracted venereal disease, and they were simply transferred to the test group. They shuffled the deck between the study group and a control group. Well, thereafter nonetheless, this particular study continued for forty years, down until 1972, and the volunteers thereafter received no further treatment. They were subject to regular annual physical examination and blood tests, and to spinal taps, and they were given something that they thought was medicine. It was called "pink medicine," and they took it regularly, and actually what it was is aspirin. Let me give you a primary source. This is the Macon County Health Department, and this is the notice that was given to those who were experimenting. It says, "Dear Sir, some time ago, you were given a thorough examination, and since that time we hope you've gotten a great deal of treatment for bad blood. You will now be given your last chance to get a second examination. This examination is a very special one, and after it is finished, you will be given a special treatment (I underline that word) if it is believed you are in a condition to stand it." And let me just look at the very bottom, in case you missed anything along the way. At the bottom you could read, "Remember this is your last chance for special free treatment. Be sure to meet the nurse." So, the deception in this study was systematic and extended. In fact, there was a time when there was a great threat to this Tuskegee study, and that was when America entered the Second World War, because at that time there was the danger that the members of the study group risked being drafted into the Army, and that would entail blood tests. Their syphilis would be discovered, and the Army would provide treatment, ending the experiment. So, the assistant surgeon general of the United States intervened on behalf of the study and provided the Selective Service Board of Macon County with the list of all those men included in the study, and they were exempted from the military draft. Now, at the outset of this experiment, what was the therapy for syphilis? What is the treatment that these men were being deprived of? And we have to say that by contemporary standards, the treatment at the time was not highly effective, and the most that we can say is that the members of the study at the outset were being denied the best available care of the standards of the time. This was the metal therapy, as it was called, that I mentioned before. But what about later on? This study continues from '32 to '72. By later in the 1940s, penicillin, a highly efficacious remedy for syphilis, was developed, and it was determined that the members of the study would be systematically denied the antibiotic as well. Local doctors in Macon County were all provided with the names of the members of the study, and they were instructed by the Public Health Service that those men were not to be given penicillin. So, the study continued for twenty-five more years, when a therapy actually existed. Well, by 1972, at the conclusion, twenty-eight of the men in the study died directly from syphilis. A hundred others died of complications related to syphilis. Forty wives of members of the study were infected with syphilis, and nineteen children fathered by members of the study were more with congenital syphilis. There was, however, no intention in the Public Health Service to terminate the study, and this was not, strictly speaking, a secret study. There were published reports on a regular basis. This is really one of the more disconcerting parts of this study. What does it say about our society at the time? The first report--in other words, this is a study and a kind of study that was published, that was written about publicly in scholarly articles, and people thought this was okay. The first published report was in 1936, and papers were later written every four to six years or so, until 1970. And strikingly, there was never a protest within the medical community about reports on this type of study that appeared in medical journals for forty years. In 1969, a committee of the Centers for Disease Control determined that the study should continue, and this conclusion was backed by local chapters of the American Medical Association. The end came only in 1972, when a former employee of the Public Health Service, named Peter Buxton, reported this story to the Associated Press. An article appeared in the Washington Star in July 1972, and this caused a national scandal, with charges against the government of having carried out the immoral equivalent of Nazi medicine, of abuse of state power, of racism and many other things. A famous book appeared by James Jones called Bad Blood. Bad blood--you now know what that means. There was a play, Miss Rivers' Boys, by David Feldshuh. There was a movie, Miss Evers' Boys, in 1997. The attorney Fred Gray initiated a lawsuit on behalf of the patients, and there was an out of court settlement that gave surviving patients medical treatment--at last, at last--and 40,000 dollars in compensation. So, let's think about the ethics of this experiment, what was learned, and what ethical framework was established to prevent a recurrence of something of the kind. We need to remember, in judging the ethics of those who initiated and continued the study, that at the time it started, there were no clearly spelled out guidelines for biomedical research on human beings, and it would be unfair and anachronistic to hold researchers retrospectively accountable for the standards of 2010. But I think we need to look at the concerns that were raised by medical ethicists in a variety of forums with regard to this experiment--remembering of course some of the considerations were retrospective--but I'm going to argue that many ethical bases made this unethical even by the standards of 1932. Well, places where this was raised: there was a congressional investigation led by Senator Edward Kennedy, that took place in 1973. The National Medical Association produced a report in the same year. There was a National Research Act in 1974 that created what was called the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, which came to be known popularly as the Belmont Report. There was the class action suit on behalf of the survivors and their relatives that I mentioned, and in 1997, there was an official presidential apology by President Bill Clinton, of which more in just a minute. The standard that the medical ethicists applied was Immanuel Kant's notion of a categorical imperative. And that is that ethical problems--and here I'm oversimplifying Kant definitely--but the general idea, which is what is important to us, and the context of the conclusions of the Belmont Report, was that ethical problems arise whenever a human being is not used as an end for his or her own benefit, but is used only as the means to some further ulterior objective. And to give teeth and specific content to that idea, a number of corollaries were said to flow, to make that meaningful. The first was--and we live with this, and you will know the phrase--the doctrine of informed consent. Now, remember the letter to the volunteers that I showed you, saying, "Remember, this is your last chance for free treatment. Be sure to meet the nurse." That was hardly informed consent. We know about the hoax of the pink medicine; the ethically obtuse use of that term "bad blood," which wasn't a medically valid concept; the fact that the volunteers were never informed of the availability and utility of penicillin; and you can't really have informed consent if you don't know what you're consenting to. The subjects were never specifically told that they had syphilis, about the course of the disease. They were never consulted about what possible treatment options were available. And spinal taps were presented to them as what were called "spinal shots"--once again, a slightly and deceptive play on words which suggested that the spinal taps had some therapeutic purpose. Isn't that what you understand when you go to the doctors and you get a shot? The second thing that was thought to be an ethical response that's necessary in biomedical research is the idea, the principle of beneficence. That is, the subjects of a scientific and medical experiment should be entitled to the expectation that some benefit will ensue for their suffering and their participation. And the point about this study in Tuskegee was that it was entirely designed to be non-therapeutic. There would never be a benefit to those who took part. A third major principle outlined is that biomedical research should be governed by what was called justice, and by that was meant the principle that the most vulnerable members of a society should not be chosen as experimental subjects to the maximum extent possible. In other words, biomedical research should refrain from doing its experiments on prisoners, on the mentally deficient, on children, the poor, and members of disadvantaged minorities--people who can be easily misled, coerced or intimidated--and the point about this experiment was that the subjects at Tuskegee were targeted precisely because they were maximally vulnerable. A fourth notion that should govern biomedical research is that of a well-designed experiment. Now, you ask: how come that becomes an ethical category, that an experiment should be well-designed; the protocols should be so drafted that the anticipated results have a reasonable chance of resulting from the procedures adopted. In other words, if you take part in a biomedical experiment, there should be the expectation that the experiment is so designed that any risk that you take, such as it is, should not be entirely in vain. So, an ethical principle, it was said, was violated when the Tuskegee experiment began with a dose of therapy, and then began by mixing the test and control groups, so whatever suffering was undergone by the subjects of the experiment would never have any scientific standing. In other words, their suffering would be entirely without benefit to anyone. A fifth thing is that an ethical experiment should not violate the law and the existing ethical guidelines of the government, professional, and international authorities. Well, this study in Alabama violated the law of 1927, which mandated treatment for syphilis. There was also, during the course of the experiment--there was also the idea in 1946--there was an American Medical Association judiciary counsel that issued a report establishing the principle of voluntary consent. In other words, ethical standards emerged during the course of the experiment that weren't there at the outset, but the experiment continued to violate ethical standards that were established after it began. And in 1964, the World Health Organization issues a Helsinki Declaration that said that informed consent should lie at the basis of biomedical research. Two other things were mentioned as ethically very important. One was that in future, the assessment of the ethics of medical research should not be by a closed medical caste. In other words, doctors shouldn't establish themselves that what they're doing is ethical. There should be independent review boards to establish that. And then this experiment was said to violate also the civil rights enshrined in the American constitution: the Thirteenth Amendment against involuntary servitude, and the Fourteenth Amendment against trespass. Now, the question is: what can we say about those who embarked in 1932? They didn't have the framework of the Belmont Report, the Helsinki Declaration, the judicial counsel report of the American Medical Association, but I would argue that a judgment on this isn't all retrospective. I'd remind you that already at the start of the experiment in 1932 it was unethical for physicians to lie to their patients and research subjects, and that it was unethical for a research program to violate the law of Alabama of 1927 that mandated treatment for anyone known to have syphilis. What's the legacy of the Tuskegee experiment? Well, there are positives and negatives. On the positive side, this established a legally binding ethical framework for biomedical research. The universe of conducting biomedical research is now entirely different from that in 1932, and that's entirely a positive gain. This study then did produce something really positive, which is an ethical framework. There's also the fact--and this is positive too--there was a wide debate of all of these issues through the press, through plays, congressional debates, scholarly literature, television broadcasts, President Clinton's public apology and the coverage it received, and all of you well know that phrase about informed consent. On the negative side, there were the sufferings of the study members, their wives, their children born with congenital syphilis. There was harm done to a great university--Tuskegee University--and its reputation. There was harm in terms of a breakdown in trust between African-Americans on the one hand and the medical profession and the government on the other, and one can see the legacy of this is the HIV/AIDS pandemic that we're coming to. In 1990, when asked if HIV/AIDS as an epidemic was a genocidal plot, an opinion poll of African-Americans revealed that ten percent responded yes, and twenty percent that they were not sure. So, at that time in the 1990s, thirty percent of African-Americans thought that perhaps HIV/AIDS was not a disease but a genocidal plot. And this had consequences--consequences in terms of the failure of people to seek medical and public health education and treatment. If your level of distrust is pitched that high, you can understand that, and one of the reasons was the Tuskegee experiment. So, then I'd like to close by remembering Clinton's apology in the White House on May 16, 1997. There were at that time eight experiment survivors, including this man, Howard Shaw, plus representatives of three others. And I can't compete with Bill Clinton in eloquence, so I'd rather simply end by quoting him. What he said was, "The United States government did something that was wrong, deeply, profoundly, morally wrong. It was an outrage to our commitment to integrity and equality for all our citizens. To the survivors, to the wives and family members, the children and grandchildren, I say what you know. No power on earth can give you back the lives lost, the pain suffered, the years of internal torment and anguish. What was done cannot be undone. But we can end the silence. We can stop turning our heads away. We can look you in the eye and finally say, on behalf of the American people, what the United States government did was shameful, and I am sorry. The people who ran the study at Tuskegee diminished the stature of man by abandoning the most basic ethical precepts. They forgot their pledge to heal and repair. They had the power to heal the survivors and all the others, but they did not. Today, all we can do is apologize. But you have the power, for only you (that is, Mr. Shaw) and the others who are here, the family members who are with us in Tuskegee, only you have the power to forgive. Your presence shows that you've chosen a better path than our government did so long ago. You have not withheld the power to forgive. I hope that today and tomorrow that every American will remember this lesson and live by it."
