Section 4. Readings The Ethical Considerations of Medical Experimentation on

Human Subjects

by Manny Bekier, M.S.

November 18, 2010



A critical examination of the ethics of medical experimentation on human subjects, focusing on the medical experiments conducted on human subjects by the doctors in Nazi Germany, as well as, in post-war U.S. may contribute to a greater effort to curb potential abuse. In this endeavor, it is necessary to understand the prevailing principles that guided the medical profession in Nazi Germany in pursuing their heinous actions.



Why is this so relevant today? After all, this happened in the past, and not even in the U.S., an aberrant culture created by a totalitarian regime over 65 years ago that no longer exists. Will such an examination help in confronting biomedical issues today?



In 2010 United States Secretary of State Hilary Clinton apologized for syphilis and gonorrhea experiments conducted on Guatemalans between 1946-1948 without their knowledge or permission. These experiments involved 696 subjects, male prisoners and female patients in the National Mental Health Hospital of Guatemala. What is especially shocking is the fact that 60 years later the public learned about these unethical experiments co-sponsored by the U.S. Public Health Service, the NIH, the Pan American Health Organization and the Guatemalan government: http://www.commondreams.org/headline/2010/10/01-6 . The fact that these experiments were considered, approved and initiated only a year after the trial of the Nazi doctors and their dreadful experiments on human subjects, makes this subject especially relevant.



Dr. Arthur Caplan, a noted medical ethicist stated at a biomedical ethic conference,” The whole discipline of biomedical ethics rises from the ashes of the Holocaust”. (Robert Leiter, Tainted Science, Jewish World, July 14-20,1989). When we examine these past events, do we have the right to sit in judgment and make moral pronouncements?



The relevance for today cannot be overstated. In looking over the many documents available today, we might want to consider first whether we can make the argument that we are in a position to make retrospective moral judgments. Can we retroactively sit in judgment of the doctors who performed medical experiments on prisoners in the concentration camps? These crimes were so enormous and so grossly immoral that they should not be so casually dismissed by citing some principle reflecting cultural ethical relativism (i.e. “you can’t judge people of that time, in that place, by our standards today”; - “there was a war going on and a suspension of normal rules are to be expected”). Can we simply state that since there was a war putting Germany in danger, extraordinary means were justified? Many people today might agree that extraordinary danger excuses extraordinary means to serve the common good. Despite the fact that such a belief totally rejects human rights, one is prevented from offering any judgment of these actions according to the principles of cultural ethical relativism. The position one takes on retrospective moral judgment has serious implications on what one should be doing today. If one cannot judge that human rights were seriously violated in Nazi Germany, one cannot argue that human rights are being violated today. If morality is to have any validity today, clearly the arguments of cultural ethical relativism should be totally rejected. Alan Buchanan states that there can be no moral progress unless we are able to apply the same moral yardstick to the past and the present. The passage of time does not affect the validity of moral judgment (Ronald Munson, Intervention and Reflection, p. 525). The fact that 65 years have passed does not diminish the evil manner in which the Nazi medical experiments were conducted. The American Nuremberg Military Tribunal judged some of the key doctors. (The Nuremberg Trials). Some may wonder what is one to gain by issuing judgments of culpability? Shouldn’t this energy be focused on the future? Shouldn’t efforts be made to ensure that these wrong doings do not occur again? As Allan Buchanan stated, it would be a serious mistake to assume the choice must be to either make judgments of culpability or to focus on future prevention. (Munson,

p.530).



The Nuremberg Code of 1947 came into being as a result of the heinous human experimentation performed by the Nazi doctors in the many concentration camps throughout the German Third Reich. The judgment by the war crimes tribunal, as a result of the “Doctors Trial” at Nuremberg, established 10 principles to guide physicians in all human experimentation: http://www.cirp.org/library/ethics/nuremberg/ . Prior to the Nazi war crimes tribunal, there was no written international code for doctors. Lawyers defending the Nazi doctors pointed to events in the U.S., attempting to argue, for example, that similar wartime experiments were conducted with prisoners at the Illinois State Penitentiary, who allegedly, deliberately infected prisoners with malaria http://www.whale.to/a/cantwell9.html .



The experience of the Nazi medical experiments performed in the concentration camps has made it painfully aware that medical experiments on human beings need to conform to well-defined ethical standards and should supersede the justification that such experiments may yield results for the “greater good of society” that might not be obtained by other methods or means of study. The first principle of the Nuremberg Code clearly states, “The voluntary consent of the human subject is absolutely essential”. This is followed by an explicit clarification of all the associated requirements, making it extremely difficult for research principle investigators to twist it’s meaning: http://www.ushmm.org/research/doctors/Nuremberg_Code.htm



For an informed consent to be considered ethically valid, there must be full disclosure. This entails that the potential participant must be thoroughly informed as to the purpose of the research, the procedures to be used, the benefits to the participant, if any, and the potential risks and discomforts of participating in the research. Any deception jeopardizes the integrity of the informed consent process. There should also be assurances of confidentiality or anonymity of the participant. The participant's consent to participate in the research must also be voluntary and free of any coercion. It is vital that the participant understand what has been explained and be given the opportunity to ask questions. It is also necessary that the participant be competent to give consent. In the absence of competency, a legally approved advocate may provide consent. Participation in the research study should be authorized, preferably in writing. Everything should be clearly stated in an informed consent document, written in an easily understood format that avoids or explains technical terms, and whom to contact with further questions: http://depts.washington.edu/bioethx/topics/resrch.html#ques1 . The principles established by the Nuremberg Code for medical practice were modified and somewhat weakened in less than a year by the Declaration of Geneva, by modifying consent from "absolutely essential” to "if at all possible." Now doctors were given the latitude to obtain consent “if at all possible” and research was allowed without consent where proxy consent was given (Article II.1) Over the years the regulation of medical research continued to evolve. The World Medical Association adopted the Declaration of Helsinki in June 1964. Since then it has undergone various revisions, the last one, sixth revision, in October 2008. No doubt there will be a further evolution of ethical guidelines as new issues in research develop:

http://en.wikipedia.org/wiki/Declaration_of_Helsinki .



Looking at the medical experimentation performed on human beings under the Nazi regime, one will begin to understand why the effort was made to develop the Nuremberg Code, and the rationale for holding the participating doctors accountable for their actions. In reality the medical experiments conducted by the Nazi doctors were only a small part of the grand scale of systematic medical killing of the Third Reich. (Robert J. Lifton, The Nazi Doctors, New York: Basic Books, 1986, p. 269).



The Subjects

All records indicate that the subjects (prisoners) did not consent to any of the experiments. In many cases, experiments were performed by unqualified persons and under the most horrendous physical conditions. All of the experiments were conducted with no thought or precautions to the wellbeing of the subject from the possibilities of injury, disability, or death. In virtually all the experiments the subjects experienced extreme pain, resulting in permanent injury, mutilation, or death: http://www.ushmm.org/research/doctors/Nuremberg_Code.htm .



The Doctors

The Medical Case, the first of twelve Nuremberg proceedings, began on October 25, 1946. Twenty-three physicians, scientists, and other senior officials in the Nazi medical administration were put on trial. Seven of the accused were sentenced to death and executed; nine were given prison sentences; and seven were acquitted. Several major perpetrators were able to evade prosecution:

http://www.ushmm.org/research/library/bibliography/?lang=en&content=medical_experiments .



These twenty-three physicians hardly reflect the many medical participants conducting unethical medical experiments during the Third Reich. The majorities of the doctors were able to evade punishment and simply vanished, or, as in most cases, were reabsorbed into the medical community to continue their practice. The trial documents and evidence related to this case amount to approximately 2800 documents and 13,000 pages of material:

http://nuremberg.law.harvard.edu/php/docs_swi.php?DI=1&text=medical .



The prosecuting attorney at the Nuremberg Trials, General Telford Taylor expressed it succinctly, “This policy of mass extermination could not have been so effectively carried out without the active participation of German medical scientists.”

http://www.law.umkc.edu/faculty/projects/ftrials/nuremberg/doctoropen.html .



Who were these doctors, what influenced their thinking and how did they justify their actions in which they turned themselves from healers into murderers? When one considers Nazi medical experimentation, the name of Dr. Mengele is the name that most often comes up. Although he performed ghastly experiments on nearly 1,500 sets of imprisoned twins at Auschwitz and is considered by many, the most notorious of the Nazi doctors, he was hardly alone. He was not even the highest-ranking physician at Aushwitz (SS captain Dr. Eduard Wirths was the physician in charge at Auschwitz): http://www.ushmm.org/wlc/en/article.php?ModuleId=10007060 . Dr. Mengele M.D., PhD was hardly the crazed mad scientist portrayed in the motion picture The Boys From Brazil.



The medical profession in Germany, until several decades ago, attempted to cover-up the role played by the Nazi doctors rather than trying to understand what had happened and how it was allowed to happen, and the subject has remained taboo.



Attempts were made in the post war years to characterize these doctors, as a lunatic fringe, on the fringe of the medical profession. We were presented with myths of incompetence, madness on the part of a few, and coercion. William Shirer (author of The Rise & Fall of the Third Reich) described the Nazi doctors as “irrational psychopathic butchers” on the fringes of professional medicine (W.L. Shirer, The Rise and Fall of the Third Reich, Greenwich, Conn: Fawcett, 1962). In reality, these doctors were not madmen, nor insane and this is why it requires critical examination of the medical profession to understand their behavior. It would be irresponsible to simply caricaturize the Nazis doctors and scientists as mad, irrational or devoid of conscience. These doctors, many of whom, were the leading professionals in their fields, were highly regarded by their peers throughout the world. It was some of these internationally recognized doctors who were in the forefront of giving credibility to Nazi racist theories.



The Thinking

How does one explain the attraction to National Socialism? 45% of the physicians in Germany became members of the Nazi Party. This was the highest ratio of Nazi party membership of any profession. By 1942, more than 38,000 doctors joined Nazi Party (almost 50%). The attraction was the biomedical vision with its emphasis on biology, research support, as well as, career opportunities.



The Nazi biomedical vision included the belief that certain “races” are superior to others; that scientific management could solve social problems (preventing the propagation of the “unfit”); the conviction that mental illness justified compulsory sterilization, and the measure of individual worth be in economic terms (reduce the cost of the defective or non-productive population). The overall vision was a lofty one: to improve the genetic composition of their citizenry in hope of creating a society in which individuals would be economically useful. These beliefs reflected basic utilitarian moral principles.



The rationale of these utilitarian principles can best be illustrated by examining the text of a speech by Dr. Walter Groß, the head of the Nazi Party’s Office of Racial Policy (October 13, 1934). “A single mentally ill Negro of English citizenship lived for 16 years in an institution in Berlin, costing 26,000 Marks. 26,000 Marks were thrown away on a life that had no meaning. 26,000 Marks that could have been used to prepare a dozen strong, healthy, and gifted children for life and a job. We went so far as to put the sick and the dying before the young, strong, healthy and promising. That is against nature and life. A nation going this way is heading for the abyss.” http://www.calvin.edu/academic/cas/gpa/gross.htm . With these utilitarian principles, the Nazi government was able, through their T4 program, to euthanize (a euphemistic term meaning “good death”) at least 5,000 physically and mentally disabled German children. These children were categorized as “life unworthy of life” (one of many Nazi euphemisms justifying murder): http://www.ushmm.org/wlc/en/article.php?ModuleId=10005200 . The Office of Racial Policy was also prepared to rebut any arguments postulating divine law or natural law. In the same speech Dr. Groß, delivered the Nazi perverted perspective of natural law,“It is true that we are subject to a higher power. We humans may never interfere with the great laws of the Creator. But you are wrong. See the laws the Creator has established for his world and your life. The great law is that life must be able to preserve itself, and that if it cannot, it will collapse. It is the hard, brutal law of the struggle for existence and of selection and extinction.” http://www.calvin.edu/academic/cas/gpa/gross.htm .



To gain insight into the ethical issues that prevailed, it is necessary to understand the evolutionary ethics that prevailed in Nazi thought. Rudolf Hess, the Deputy Führer, came right to the point when he described National Socialism as “nothing but applied biology” (Lifton, p.129). This kind of thinking did not originate with the Nazis. This “biomedical vision” has a long history: http://www.trufax.org/avoid/nazi.html . This can best be understood by reading this medical interpretation of the Nazi ideology in which Germany was viewed as being ill and Hitler was sent as the doctor. (Please note the euphemism of the enemies within as “bacteria”). “When the Führer took power in 1933, the German people’s body was severely ill. The poison of foreign worldviews ran through the veins of all the people’s organisms. Hardly anyone was immune. Then Providence sent the German people a doctor, the Führer. He knew the disease; he knows the German people suffered from a corruption of its racial strength. Using every possible medication, including if necessary the most radical, the bacterium was removed from the people’s body. Our people are becoming racially healthy once more.” http://www.calvin.edu/academic/cas/gpa/erblehre.htm .



It is interesting to note that natural law was considered central to the legal theory for the prosecution of these Nazi doctors during the Nuremberg trials. Natural law is a view that certain rights or values are inherent in, or universally recognized, by virtue of human reason or human nature. Since natural law, whose guiding principles are set by nature, are considered self-evident and have validity everywhere, the prosecution felt that it could serve as the standard to criticize the laws established by the Nazi regime. The prosecution had to rely on natural law theory because most of the actions of the Nazi doctors were recognized as being legal under the judicial system of the Third Reich. In fact, the Nazi defendants claimed they were merely following the established laws of the nation. They were not killing by their own authority, but obeying the laws of the state, which can determine the method of death. Even if a law is viewed as repulsive, one cannot deny legality. The law is no less legitimate as law merely because people find it morally reprehensible: http://bad.eserver.org/issues/2004/69/swartz.html .



In addition to claiming they were acting within the law, the Nazi doctors justified their actions by what they considered to be moral reasons. To mention a few: law takes precedence over ethics; the good of the many is more important than the good of the few; national emergencies supersede ethics; to improve society by social engineering based on eugenic theories; some groups can lose their claim to humanity; some people were sub-humans (racially inferior) and were equated with vermin; Jews were a threat to society and the family.



The Ethics

All medical research had a purpose and ultimately was designed to help the German military effort, such as developing new weapons, testing pharmaceuticals and aiding in the medical treatment of military personnel who had been injured, as well as advancing the racial ideology of the Nazi regime: http://www.ushmm.org/wlc/en/article.php?ModuleId=10005168 . Consequently, the doctors during the Nazi regime felt that they were doing wonderful work for humanity. This raises a critical issue. The doctors in Germany took the Hippocratic Oath, yet they knowingly violated the Hippocratic principle of “do no harm”. How were they able to reconcile this glaring contradiction? To begin to address this contradiction, an examination must be made of some of the moral premises utilized. One of the premises already cited was the exclusion of some ethnic groups’ claim to humanity. In Nazi Germany, Jews were, through a series of laws known as the Nuremberg Laws, methodically excluded from society, becoming non-persons.



The racial policies developed had a strong grounding in genetics and evolutionary biology. One need only look at some of the many written explanations by the Nazi government to prevent offspring with hereditary illnesses.“In the case of plants and animals cultivated by humans, care is taken to weed out the less valuable. Only the useful and valuable genetic material is preserved. That is also what nature wants through the law of selection. Should not we do the same with people? Or shall the lines of our people with hereditary illnesses overcome the healthy? That would mean the self-dissolution and destruction of the whole people, for a people that suffers from hereditary illnesses is not able to maintain itself in the great battle of selection between the peoples!

To protect the healthy population from the dangers of hereditary illness and dissolution, the National Socialist State created the “Law for the Prevention of Offspring with Hereditary Illnesses “ of 14 July 1933. Under this law, the genetically burdened are sterilized for the following diseases…” http://www.calvin.edu/academic/cas/gpa/erblehre.htm .



In line with this thinking, prisoners were not viewed as individuals, but rather as “living culture” or rats, to be used with no consideration for wellbeing. In most cases, rats were treated far better than Jewish concentration camp inmates. In equating Jews with rats, a propaganda film by Fritz Hippler, The Eternal Jew, was made to show Jews as a dangerous parasitic race spreading disease. In this film, images of rats are juxtaposed over derogatory images of Jews. The narrator explains the Jews' rat-like behavior, while showing footage of rats squirming from sewers: http://www.holocaust-history.org/der-ewige-jude/ .



Since the doctors in Nazi Germany were guided by utilitarian moral principles, they did not need to consider informed consent. The utilitarian moral code has no need to consider informed consent. If more social good was to be gained without securing agreement, that was all that matters and was viewed as morally legitimate (Munson p.492). Utilizing utilitarian principles, Nazi Germany had no difficulty designating the mentally retarded, habitual criminals, the physically handicapped, patients with chronic diseases, as those less valuable members of society, referred to as “life unworthy of life”, and they could be legitimately sacrificed to improve life for the majority of the population. It is interesting to note that the definition of mentally retarded and undesirable was expanded over time to include anyone opposed to the Nazi regime.



According to Kantian principles (the categorical imperative), people cannot be forced to accept treatment or be subject to medical experimentation for “the good of the majority”. The Kantian view states that people should always be treated as “ends”, and never as “means” only. Therefore it is implicit with Kantian principles that a society cannot use a part of the population as slaves, as this treats them merely as means. By exploiting a part of the population for the gain of the rest, or even to exploit a single individual would reflect utilitarian principles. The medical experiments performed by the doctors in the concentration camps were predominantly utilitarian in nature. It should be noted that not one of the prisoners voluntarily waived their rights as human beings in order to sacrifice themselves for the alleged greater good of German society. That option was never a consideration, as the prisoners were considered “less than human”.



The Experiments

Between 1939 and 1945, at least seventy medical research projects involving cruel and, often, lethal experimentation on human subjects were conducted in Nazi concentration camps:

http://www.ushmm.org/research/library/bibliography/?lang=en&content=medical_experiments . There were a great many doctors at so many concentration camps performing a wide range of medical experimentation. For a brief description of these doctors and the medical crimes they committed, see: http://www.webster.edu/~woolflm/nazidocsandothers.html .





In addition to the infamous Mengele’s medical experiments on twins, there were freezing experiments, high altitude experiments, malaria experiments at Dachau and Aushwitz; muscle and nerve regeneration, bone transplantation experiments, and sulfonamide experiments at Ravensbrück concentration camp; mustard gas experiments at Sachsenhausen, Natzweiler; sea water experiments at Dachau; sterilization experiments at Auschwitz, Ravensbrück and other places; and experiments with poison and phosphorus burn experiments at Buchenwald. For a comprehensive list of the medical experiments and other medical crimes, see the indictments (Oct. 25, 1946) of the Nuremberg Military Trial Case 1: http://nuremberg.law.harvard.edu/php/docs_swi.php?DI=1&text=medical

Also see: http://www.law.umkc.edu/faculty/projects/ftrials/nuremberg/nurembergdoctortrial.html .



The Nazis’ experiments on human subjects are well documented. There were so many doctors, at so many camps doing a wide range of cruel, unethical experiments. Even medical students were afforded the opportunity to practice and operate on people, regarding their specialty. One can imagine, for the research scientists and sponsoring pharmaceutical companies, this was paradise. Imagine having an endless supply of “live human materials” on which to test any medical hypothesis.



The results of many of these experiments were not exactly a secret. Findings were regularly published and distributed to the German medical profession and in a number of postwar scientific publications. In fact there is an abundance of documentation on these experiments. This paper will only focus on two types of experiments, as they are examples of ethical issues related to post-war experiments conducted in the U.S. and ethical issues we are still confronting today.



Citing first, the Freezing / Hypothermia experiments done at Dachau, as society was presented with the ethical issue of utilizing the medical data from these experiments in 1989: http://www.nytimes.com/1989/05/21/us/nazi-scientists-and-ethics-of-today.html?pagewanted=all . Citing second, the radiation experiments done at Aushwitz (objective to mass sterilize unsuspecting prisoners), as the U.S. government sponsored radiation experiments on some of the most vulnerable members of our society, long after the verdicts for this crime was handed down at the Nuremberg Tribunal.



The freezing / hypothermia experiments were conducted on men to simulate the conditions suffered by many of the soldiers of the German armies on the Eastern Front. The objective of the researchers was to find the best medical response for the thousands of German soldiers who were freezing to death and those soldiers debilitated by the cold. The experiments were designed to find the most effective way of rewarming German aviators who were forced to parachute into the North Sea. The experiments were conducted primarily at Dachau, under the supervision of Dr. Weltz and his assistant, Dr. Sigmund Rascher. The results of Dr. Rascher’s freezing experiments were publicized at the 1942 medical conference entitled "Medical Problems Arising from Sea and Winter": http://remember.org/educate/medexp.html . Dr. Weltz also spoke on the subject "Warming up after Freezing to the Danger Point." http://www.ess.uwe.ac.uk/genocide/Medical%20Case%20Trial%20Prosecution2.htm . The freezing experiments were divided into two parts. First, to establish how long it would take to lower the body temperature to the point of death, and second how to best resuscitate the frozen victim. The subjects of these experiments were young healthy Jews or Russian prisoners of war. The two main methods used to freeze the victim were to put the person in an icy vat of water (the fastest way to drop the body temperature) for up to eight hours at a time, or to put the victim outside naked, strapped to a stretcher, in sub-zero temperatures for 9 to 14 hours, as the victims screamed with pain as their bodies froze. The resuscitation or warming experiments by various means were equally as cruel and painful to the subjects as the freezing experiments, and resulted in horrible deaths: http://remember.org/educate/medexp.html . The results, or “data” from these experiments has raised serious medical ethical issues today. Is it ever appropriate to use data as morally repugnant as that, which was extracted from victims of the Nazi medical experiments conducted in the concentration camps? Simply put, is it ethical to use data gathered unethically? And if we're faced with this kind of situation again, how are we to respond? Furthermore, are there any circumstances where using such data is ethically permissible? It was these questions that brought together approximately 200 scholars for a conference in Minnesota in 1989: http://www.nytimes.com/1989/05/21/us/nazi-scientists-and-ethics-of-today.html?pagewanted=all . Behind the discussions was the fear that without ethical guidelines there could be future scientific abuses like those committed under the Nazi regime. The participants spent much of their time debating how the data from the Nazi experiments should be used, if at all.



The Use of Medical Data

The results of those studies have been available to medical researchers since the end of World War II. But in recent years several scientists who have sought to use the Nazi research have stimulated public controversy by raising the issue of social responsibility and potential abuses of science. It was not until Dr. Robert Pozos, a researcher on hypothermia, raised the ethical issue of whether he should utilize Nazi data collected on hypothermia, was there so much public attention drawn to this issue. Pozos’ research focused on the methods of rewarming frozen victims of cold. Pozos had to speculate what the effects would be on a human being at freezing temperatures. The only ones that put humans through extensive hypothermia research were the Nazis: http://www.jlaw.com/Articles/NaziMedEx.html . Pozos had simply been the first scientist to raise the question publicly whether all this was ethically acceptable. However, he was hardly the first to use Nazi research data. The Journal of the American Medical Association (JAMA) published an article (July 1946) by Dr. Molnar, a University of Rochester physiologist, who expressed no sense of any ethical ambiguity while writing about hypothermia survival based on Nazi data. In 1983, John S. Hayward at the University of Victoria used the Nazi hypothermia data to test survival suits carried in fishing boats in the freezing Canadian Arctic: http://articles.latimes.com/1988-10-30/news/mn-958_1_nazi-data-issue/6 . According to the Hastings Center Report, there were at least 45 research articles published since the end of World War II that cited data from Nazi experiments: http://articles.latimes.com/1988-10-30/news/mn-958_1_nazi-data-issue/6 .



The bioethical conference, initiated by Dr. Pozos’ questions was never satisfactorily resolved. "Ethicists never answer a question," Pozos said. "They raise one question, which raises another question and another. I want guidelines. I want to know if the data is good, should we use it? Or should the data forever be banned?" http://articles.latimes.com/1988-10-30/news/mn-958_1_nazi-data-issue/6 . A significant number of scholars who attended felt that they should apply a moral judgment, but let the data be used.



''The question is not whether we should use the data, but how,'' said Dr. Robert Proctor, chair of the Science, Technology and Power at the New School for Social Research. According to Dr. Proctor, ''It should be used if the circumstances under which it was conducted are acknowledged and could be dedicated to the memory of the victims”. Others, such as Dr. Arthur Caplan, a bioethicist and an organizer of this conference, stated ''I don't think lives hang in the balance, I think we can find out what we need to know from other sources”: http://www.nytimes.com/1989/05/21/us/nazi-scientists-and-ethics-of-today.html?pagewanted=all . But what if lives hang in the balance? If the intended benefit were to save lives, wouldn’t most agree that the data should be used? There are many who would agree that the data should be used when lives are at stake. This is an especially strong argument when there is no other alternative source from which to gain that information, and the capacity to save lives is clearly evident. Some scholars suggest a compromise solution, in which researchers be allowed to make full use of the Nazi data and simultaneously denounce and condemn the Nazi doctors and their experiments. With this concept, the researchers using the Nazi data must be prepared to expose the Nazi doctors' immoral experiments as medical evil, never to be repeated. "If Pozos dedicated his study to the memory of those victims of the Nazis, it would serve as a nice way of reminding people about the horrible experiments," said the Israeli director of The Simon Wiesenthal Center, Dr. Ephraim Zuroff: http://articles.latimes.com/1988-10-30/news/mn-958_1_nazi-data-issue/6 . This convenient solution bears some moral hypocrisy. When researchers use Nazi data, legitimacy is indirectly conferred on the data used. The ethical guidelines condemning the means used in acquiring the data would be severely undercut: http://www.jlaw.com/Articles/NaziMedEx.html .



Professor Henry K. Beecher of Harvard Medical School, said that even though suppression of the data would constitute a loss to medicine: "this loss, it seems, would be less important than the far reaching moral loss to medicine if the data were to be published." Beecher feels that, even though Nazi data might benefit some lives, greater ethical issues arise: http://www.jlaw.com/Articles/NaziMedEx.html . Dr. Howard Spiro, Chairman Emeritus of the Department of Internal Medicine at the Yale School of Medicine, expressed the ethical issue succinctly in a Letter to the Editor of the New York Times (4/19/88) “No one honors the memory of the dead victims by ''learning'' from experiments carried out on them. Instead, we make them our retrospective guinea pigs. Any data obtained in the Nazi concentration camps seems unlikely to be irreplaceable except in their horror.” He also stated that this will “put us at risk of retrospectively participating in their torture and death.” “If expressing revulsion means losing something of value, then we should continue to express our revulsion, particularly if we want to teach our children, and our students, what they should not do”.



Radiation Exposure Experimentation

Having mentioned the Nazi experiments of hypothermia and their ethical implications today, attention is directed to the Nazi sterilization experiments using radiation. The example of radiation exposure experiments has been specifically chosen for discussion, among the many categories of Nazi medical experimentation, because scientists in the U.S., having the knowledge of the verdicts of the medical crimes (Nuremberg Trials), conducted radiation exposure experiments on our citizens. There are a number of cases illustrating our use of radiation exposure experiments:

http://www2.sunysuffolk.edu/pecorip/SCCCWEB/ETEXTS/MEDICAL_ETHICS_TEXT/Chapter_7_Human_Experimentation/Case_Presentation.htm .



Sterilization experiments were conducted at Auschwitz, Ravensbrück, and other camps from March 1941 to January 1945. The purpose of these experiments, conducted by Dr. Carl Clauberg, was to develop a method of sterilization that would be capable of sterilizing millions of people with a minimum of time and effort.



Carl Clauberg was a highly respected professor and gynecological researcher. He was regarded as one of the most respected individuals in German medical society. In December 1942, Carl Clauberg came to Auschwitz and was given Block 10 for his medical experimental activities. Several hundred Jewish women from various countries were placed in Block 10. The experiments performed on these women were conducted by means of radiation, surgery and the use of drugs. Clauberg developed a method of non-surgical mass sterilization that consisted of injecting into the female reproductive organs a specially prepared caustic substance that produced severe inflammation:

http://www.shoah.dk/doctors/clauberg.htm . The women were coerced to submit to this experimentation with the implied threat from Clauberg that he would send them back to Birkenau (which meant the gas chamber). Those women who refused, or who were considered unsuitable or debilitated, were sent to Birkenau, where they were usually gassed (Lifton, p.272). In his correspondence with Himmler, Clauberg refers to the women for his experiments as “the human material to be provided” (Lifton, p.275).



Thousands of victims were sterilized. Radiation treatment, however, became the favored method of sterilization. The radiation was administered through an established procedure based on deceit. Prisoners were brought into a room and asked to complete forms, which took several minutes. During this time, the radiation treatment was administered and unknown to the prisoners, they were rendered completely sterile. As a result many suffered severe radiation burns. The consequences were that many victims became unfit for work and were gassed in the gas chambers, or died as a result of the burns: http://en.wikipedia.org/wiki/Nazi_human_experimentation .

The objectives of Dr. Clauberg’s experiments are clearly expressed in his letter to Himmler of June 1943, “I shall be able to report in the foreseeable future that one experienced physician, with an appropriately equipped office and the aid of ten auxiliary personnel, will be able to carry out in the course of a single day the sterilization of hundreds, or even 1,000 women.” (Lifton p. 276).



There were other radiation experiments in the camps, aside from Dr. Clauberg’s. Dr. Horst Schumann was also searching for a practical means of mass sterilization. Schumann was one of the leading figures in the Nazi Euthanasia program (code name T4). He was director of the killing center at Grafeneck and later a member of project 14f13, medically sanctioned killing in the concentration camps (Lifton, p.278). The objective of Schumann’s medical experiments was to develop assembly-line sterilization in which the ignorant victims would not be aware of what was happening to them (Lifton, p. 279)."X-ray sterilization" equipment was set up for Schumann at Birkenau. He was provided with a large room containing two extensive X-ray machines and a booth protected by lead plates to protect him from radiation (Lifton, p. 281). The sterilization experiments consisted of exposing the women's ovaries and the men's testes to radiation. The exposure to high intensity radiation produced severe burns on the victims that would not heal. It is estimated that approximately 1,000 prisoners, male and female underwent radiation sterilization or castration, and about 200 of these were subjected to surgical removal of testicles or ovaries. This data is based on relatively accurate surgical records of these experiments conducted at Auschwitz (Lifton, p. 283).



General Telford Taylor, the prosecutor at the Nuremberg Trials, summed up for the prosecution the true intent of these sterilization experiments, “We will show that in some instances the true object of these experiments was not how to rescue or to cure, but how to destroy and kill. The sterilization experiments were it is clear, purely destructive in purpose.”

http://www.ess.uwe.ac.uk/genocide/Medical%20Case%20Trial%20Prosecution1.htm



Post War U.S. Radiation Exposure Experimentation

Hardly several years passed since the Nuremberg Trials and U.S. scientists were already actively engaged in secret radiation exposure experiments. Were these scientists oblivious to the medical crimes prosecuted at Nuremberg? Were they oblivious to the Nuremberg Code with its first principle of “informed consent” that was adopted to prevent such abuse? Or was the utilitarian argument of the “Cold War” or bending other ethical theories holding greater sway?



There were a number of cases in the post war years illustrating our use of radiation exposure experiments: http://www2.sunysuffolk.edu/pecorip/SCCCWEB/ETEXTS/MEDICAL_ETHICS_TEXT/Chapter_7_Human_Experimentation/Case_Presentation.htm . The experiment that took place at a state residential school in Fernald, Massachusetts, is one of many radiation experiments. Knowledge of this and other radiation testing experiments resulted from the declassified government documents made available in 1993. In this experiment, which was conducted from 1946 - 1953, Professor of Nutrition, Robert Harris studied the absorption of calcium and iron by feeding 125 mentally challenged children of the Fernald School, milk and cereal that contained radioactive tracers. This was a joint experiment by Harvard and MIT, which included a research fellow sponsored by the Quaker Oats Company, in addition to working in cooperation with senior members of the Fernald staff. Young male children were exposed to tracer doses of radioisotopes. These non-therapeutic nutritional studies with radioisotopes were accomplished by deceiving the parents of the boys by having the boys join a "Science Club", and further enticing them with larger portions of food, parties, and trips to Boston Red Sox baseball games: http://en.wikipedia.org/wiki/Walter_E._Fernald_State_School .



In one study, the fifty-seven club members were fed cereal along with radioactive tracers. In another study seventeen children were exposed to radioactive iron via injection. The doses involved were low and the researchers felt that it would be extremely unlikely that any of the children who were used as subjects would be harmed: http://www.hss.energy.gov/HealthSafety/ohre/roadmap/achre/chap7_5.html . When news of these experiments reached the public, MIT issued the following news release “At a news conference on May 9, the Task Force on Human Subject Research announced its conclusion that the subjects in the radiation experiments done by MIT and Harvard University researchers in the early 1950s were not exposed to dangerous levels of radiation.” The Vice President and Dean for Research J. David Litster of MIT tried to focus public attention to the fact that no harm was done to the “participants”. He stated, "I am pleased that the task force has confirmed MIT's initial impression that no harm was done to the participants in the cereal nutrition studies that were the initial focus of publicity”. http://tech.mit.edu/V114/N28/fernald.28n.html (an MIT newspaper).



Utilitarian principles were convincingly argued to justify these experiments. The purpose of these studies was to “improve understanding of nutritional processes in order to promote health in young people and the children used were protected and compensated”. Hans Jonas, an influential German philosopher, argued the implications of such experiments that expose individuals to dangers for the common good.

“We should not feel the need to participate in any medical experiment for the sake of progress”. http://www2.sunysuffolk.edu/pecorip/SCCCWEB/ETEXTS/MEDICAL_ETHICS_TEXT/Chapter_7_Human_Experimentation/Readings.htm .



Although John Rawls did not develop the theory of distributive justice until much later, these experiments showed a total lack of concern for individuals viewed as “least advantaged in our society”. How was it that the Fernald School was chosen for these experiments? Why wasn’t one of the many elite private schools in Massachusetts chosen, one were the wealthy send their children? At least in one of those schools, the children might have a better understanding as to what they were participating in, and certainly the parents would also be less likely to be unduly persuaded. The fact that a school for mentally challenged children was chosen among all the possible schools makes this immediately ethically suspect. Any volunteer should have had complete freedom and knowledge about an experiment before deciding to participate. Hans Jonas makes his point by suggesting that medical professionals who wish to become subjects should be considered first, followed by the highly motivated, educated, and least dependent individuals: http://www2.sunysuffolk.edu/pecorip/SCCCWEB/ETEXTS/MEDICAL_ETHICS_TEXT/Chapter_7_Human_Experimentation/Readings.htm .



Nevertheless, these experiments cannot be cavalierly ethically dismissed because no harm was done to the “participants”. Did the “participants” or their legal guardians really know that they were participating? Was informed consent properly utilized? Available evidence suggests that the information provided to the parents of the children was, at best, incomplete. The letter to the parents seeking permission makes no mention of any risks or the use of a radioisotope and there was no basis to inform the parents that the project was intended for the children's improvement. The researchers also offered inducements, as well as, subtle coercion to secure cooperation: http://www.hss.energy.gov/HealthSafety/ohre/roadmap/achre/chap7_5.html . Although these experiment, by no means can be morally compared to the Nazi experiments, the relevant issue is that this research project, one of many, knowingly violated the principles laid down by the Nuremberg Code. The critical question must be asked: Are there adequate safeguards today to protect people from secret government experimentation? For the last several decades we have witnessed the meteoric rise of genetic research and genetic engineering. Will these advances in medical research re-awaken our eugenic impulse to “play God”? (See the eugenics movement in the U.S. in the 1920’s and ‘30’s). Writing in the Columbia Journalism Review, Geoffrey Sea states: “A startling fact about the experiments is that, despite the documentation of hundreds of cases of unethical conduct resulting in lasting damage to thousands of people, not a single physician or nurse, scientist or technician, policy maker or administrator has yet come forward to admit wrongdoing.” http://www.whale.to/a/cantwell9.html .

Regardless of how medical researchers are able to reconcile their wrongdoings, there is the need for an increase in scrutiny by ethical review boards. It should be clear that medical researchers need comprehensive codes of ethics in this age of technology and terror. The regulations governing human experimentation are very important and require continuing attention to ensure the ethical aspects of all human experimentation. It is incumbent that medical researchers be made aware of their ethical obligations, including the obligation to abide by government regulations and to “blow the whistle” on unethical research. The Current Situation

Due to the growing public concern for adequate protection of human subjects in research, there are today many federal, state and institutional policies, procedures and regulations. On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The guidelines established by this commission after nearly four years of deliberation, clearly defined the basic ethical principles that should underlie the conduct of all biomedical research on human subjects. These guidelines, referred to, as “The Belmont Report” will hopefully assist in resolving the ethical problems that surround the conduct of research with human subjects: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm . These guidelines stress three ethical principles:



1. Respect for persons (autonomy of the individual and individuals with diminished autonomy are entitled to protection).

2. Beneficence (the obligation to do no harm and to maximize possible benefits).

3. Justice (fairness).



This last principle can best be illustrated by the experience of the Fernald School, in which the subjects chosen were mentally challenged boys that could easily be manipulated and taken advantage of. In addition, the National Bioethics Advisory Commission (NBAC) was established by Executive Order and signed by President Clinton on October 3, 1995.

NBAC identified and laid down broad principles to govern the ethical conduct of research. To read their report, see:

http://bioethics.georgetown.edu/pcbe/reports/past_commissions/nbac_human_part.pdf .



Today, there are Institutional Review Boards (IRB), which are responsible for the review and approval of all research involving human subjects and are guided by the ethical principles as set forth in the "Belmont Report". The standard IRB policy explicitly states that the use of human subjects in research is not permitted until the IRB has reviewed and approved the research protocol, and informed consent has been obtained from the subject or the subject's legal representative: http://research.downstate.edu/ethics/ethics.htm . At Downstate Medical Center (where the author of this paper has a faculty appointment), all regulations are stated in a highly comprehensive IRB Investigator’s Procedure Manual for the Protection of Human Subjects, which is available online: http://research.downstate.edu/irb/irb_piguide.pdf . In addition to making the “Belmont Report” mandatory reading, there is a comprehensive training program and IRB certification is a requirement for approval for all research at Downstate involving human subjects: http://research.downstate.edu/irb/irb.htm .



Conclusion

In this age of so many medical advances, a humanistic perspective is hoped for. It is important for us to bear in mind that medical progress is not an unconditional commitment. A slower course of progress in the eradication of disease will in no way threaten society, however an erosion of our moral values does pose such a threat. We must bear in mind that it was the ruthless pursuit of scientific progress and “applied biology” to improve the overall health of German society, at the expense of those most vulnerable and those denied recognition as human beings, that greatly contributed to the moral decay of Germany.



The process of critically examining past history will hopefully prompt a greater effort to curb potential abuse. As a result of retrospective moral judgment ethical principles and resulting guidelines have evolved and coupled with serious efforts to hold government officials and medical researchers personally accountable for any wrongdoings will provide better protection for human subjects.





Copyright © 2010, Manny Bekier. All rights reserved.



