The Debate on Medical Ethics and Research in Germany 50 Years after Nuremberg
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By Michael Wunder, Zentrum dür Beratung, Diagnostk und Psychotherapie, Germany
“The question is whether we will ever be able to learn from history”, Alexander Mitscherlich said in 1947. He was a member of the German Medical Commission, who by order of the German General Medical Council witnessed the Nuremberg Trial. “I believe, Mitscherlich continued, “that we won’t master it by just keeping our distance morally. This is doubtless easy to achieve. However, it is useless for us as soon as we think of the dark future of this century, in which situations might occur leading to a similar coldness and ignorance towards the right to live of people more defenseless and disregarded.”
In Germany over decades neither physicians nor the public faced the tiring process of reviewing and questioning history. Even the reports of the German Medical Commission met with a growing disinterest and disapproval of the physicians in post-war Germany. Almost 50% of the German physicians were members of the NSDAP and resumed their work after a brief interruption after 1945.
Thus it is understandable that it was not the physicians’ organizations nor the medical historical departments of the universities that did turn towards history at the beginning of the eighties. It was rather the children and grand children working in the hospitals, the psychiatric institutions and homes for persons with disabilities. They began to ask what here, where they were working did happen 40 or 50 years ago. They were not involved personally nor did they blame father and mother. This is the generation I also belong to.
Discussion about medical ethics and about the future of medicine are nowadays after Auschwitz and Hadamar particularly in Germany impossible without the reference to history.
This idea was the basis of the International Congress “Medicine and Conscience” of the German Section of International Physicians for the Prevention of Nuclear War in the city of Nuremberg in October 1996. As result of this congress, in the following year, on the 50th anniversary of the pronouncement of judgment in the Nuremberg Trial, the 20th August 1997, the Nuremberg Code 1997 was presented. It is based on the historical experiences and the fundamental ideas of the Code 1947 in order to answer the current questions of medicine to the application of bio-sciences to human beings. Ten topics such as medical experiments, reproductive medicine, genetic diagnostics and therapy, transplantation, euthanasia, and distribution of resources are dealt with. The Nuremberg Code thus follows the widespread practice of considering the informed consent to be the principal idea in all fields of public health care service. However, in the following I will focus, due to the time limit and the theme of this symposium, only on the topic of medical research.
The critical-historical link to the Nuremberg Code 1947, that we attempted with the Code 1997, is faced with two fundamental questions.
1. The Code’s significance, is it only historical or even universally valid? Or to put it differently: Is the Code of 1947 only to be understood from the historical context? Does it only aim at the judgment of the practices of the NS-physicians? Or does it at all imply a universal validity for medical research and medicine in a civilized world?
Historical evidences as well as a look at the text of the Code clearly speak for a universal validity.
Telford Taylor, the chief prosecutor of Nuremberg stated in his introduction that the trial was no mere murder trial, since the defendants were physicians having sworn the Hippocratic oath, and thus having become murderers in the execution of their profession. Logically, the judges created with the Nuremberg Code a basis of judgment of crimes which became possible within the bounds of medicine. The judges described the statements of the Code as basic principles “which must be followed so that human experiments comply with moral, ethical and legal principles”.
Moreover, the famous first sentence of the Code and well as its detailed explanations as to voluntariness, the test person and the researcher, and to the quality of the information in view of the Auschwitz and Hadamar-medicine, would have been meaningless, even almost absurd, had they not been seen as general rules.
2. Here, a further basic question arises: Does the Code have a purely legal character rendering only the protection of human rights reclaimable, or does it have the character of an ethical code for a humane medicine in the first place?
It is obvious that the informed consent is the core of the Nuremberg Code. “The Principles of Ethics Concerning Experimentation with Human Beings” presented at court in December 1946 by Andrew Ivy were based on the Hippocratic ethics of the responsible Physicians’ behavior. To these principles the judges of Nuremberg deliberately added the irrevocable human rights of the test person: the absolute necessity of the informed consent in point 1 and the right to withdraw from the experiment in point 9. By doing this, however, they did not replace the statements as to the responsible physicians’ behavior, which will be described in point 2-8 as well as in point 10.
The Nuremberg Code of 1947 thus is a really brilliant link between the Hippocratic ethics of physicians’ responsibility and human rights. The answer to the raised question can only be ‘yes’: the Code is characterized by human rights and lawfulness, and it is an ethical code for a human medical research.
In Germany an important objection against the informed consent is raised: In view of the threatening genetic screening and manipulation of human beings by bio-medicine it is foolish to still rely on the free consent as instrument of correction. Neither are individuals free, they who are supposed to make decisions, nor are they able to really understand the things they should decide on. Rather is there the “legitimization by procedure” in the sense of Theordor Adorno, that is the approval of an unstoppable inhuman technique by the informed consent developed into its pure form.
I don’t share this criticism. It is obvious that the principle of informed consent must fail if celebrated as the only moral-ethical authority. Inhuman practices, such as the active euthanasia or interventions in the germ-line, affecting the lives of future individuals, cannot not be justified by the informed consent of individuals of today.
The principle of informed consent does not mean what is practicable should be practiced, only if a person agrees to it. The principle of informed consent is an absolutely necessary prerequisite, but no sufficient predicament for a humane medicine. Thus, the presented Nuremberg Code 1997 contains apart from the personal consent of the test person, naturally further prerequisites, such as the expected benefit for the health of concrete persons or groups, the prevention of unnecessary experiments by applying already existing knowledge and the avoidance of unnecessary pressure of the test person, the publication of the results, the observing of the ethics-commission’s decisions and many more.
However, it is alarming that almost all following revisions of the Nuremberg Code did not further describe the additional prerequisites of a socially responsible medicine, but relativize and degrade the principle of informed consent.
The impetus for revisions to the original Nuremberg code, in my opinion, was the Declaration of Helsinki of the World Medical Association of 1964. Here, the scientific progress was the primary agenda, whereas the rights of the patient were only considered in relation to it. For the clinical research in the sense of an individual healing attempt the informed consent should only be procured if this is possible and consistent with patient psychology. In case of incapacity the consent should be given by a legal guardian. The explanations of the non-therapeutic clinical research are ambiguous. On the one hand it is said that it “cannot be undertaken without his free consent”. On the other hand it is said: “if he is legally incompetent the consent of the legal guardian should be procured.” And further: “The subject of clinical research should be in such a mental, physical, and legal state as to be able to exercise fully his power of choice.” Instead of the fundamental statement of the Nuremberg Code there appears unclearness and the tendency towards dissolving the principle of informed consent in the regulations of the design of systematic studies.
Since Helsinki it becomes more and more clear: the dealing with persons not able to consent is the touchstone of how seriously medicine takes the informed consent.
In this context Jay Katz refers to the draft texts of Helsinki of 1962. Here, it is clearly said that the following groups of people should never be used as subject of experiments: prisoners of war, civilians detained as a result of military occupation, persons retained in prison and “ persons incapable of giving consent because (of) age, mental incapacity, or being in a position in which they are incapable of exercising the power of free choice.”
This clarity directly corresponds to the Nuremberg Code of 1947, but it is diminished in Helsinki 1964. Nevertheless, we referred to it when we started to work on the re-formulation of the Nuremberg Code in 1997. The Nuremberg Code 1947 clearly states that the person concerned must have the capacity of giving his informed consent. This means in our opinion that the person not being able to consent must be protected from research interventions. A consent in a healing attempt supposed to benefit the person concerned can be replaced by the informed consent of a legal guardian. The consent to research for the benefit of others and not for the person concerned must not be given by others. “Medical experimentation is subject to personal and non-substitutable consent” says the New Nuremberg Code of 1997 - which, by the way - complies with the existing legal situation in Germany.
This issue in particular led to a highly controversial public debate in Germany. In April 1997 the Council of Europe passed the “Convention on Human Rights on Biomedicine”, formerly “Bioethics Convention”. 22 out of 40 governments have signed it. Up to now, Germany has not done so.
The controversial convention says instead of persons not able to consent to research the representative may give authorization, in case it is for the benefit of “persons in the same age category or afflicted with the same disease or disorder or having the same condition” and if “the research entails only minimal risk and minimal burden for the individual concerned”.
In fact, the convention contains controversial issues such as the legalization of embryo research , the permission to intervene on the human genome for preventive, diagnostic or therapeutic purposes. The public discussion, however, was roused by the issue of the legalization of research on persons not able to consent for the benefit of others, that means persons with intellectual disabilities, mental illnesses, children, dementia and brain damage patients. 1.5 million signatures have been gathered against this. Thus, quite unexpectedly this issue has become a main conflict in the Public Health Service. Adherents as well as critics are not at all restricted to specific parties, churches and associations. Several debates and hearings have taken place in Bonn.
Just against this background of the new sensibility towards history the following arguments must be strongly supported:
1. The legal guardian must always decide for the benefit of the person he cares for, not for the benefit of other patients of the same age group or with the same diagnosis. This, however, he should do according to the latest Euro-norm. The legal guardian may thus give his consent to a healing attempt, but not to research for the benefit of others. The argumentation that the person concerned does benefit from this kind of research by doing something good for the general public, is strongly objected to by the critics. It is too clearly in the shadow of a medicine believed to be long overcome, in which the individual was nothing, the well-being of the people everything, which is why the rights of the individual were not taken seriously.
2. The concepts ‘minimal risk’ or ‘minimal burden’ are vague and open to interpretation. A brochure of the German Department of Justice mentions that it is just a matter of weighing, measuring and observing as well as the use of blood, urine and saliva samples. . On the other hand, in the Explanatory Report of the Convention does already mention replacing X-ray examinations and psychological tests as well as for prolonged coma patients attempts to improve intensive medicine. Thus, it is not a matter of ‘soft’ medicine, but of invasive research methods. Researchers as for example the in Germany well-known prolonged coma specialist Karl Max Einhäupl carelessly permits: “Of course, it is not a matter of taking a blood sample from a vegetative state patient - that’s indeed not the way we see it - but it is a matter of conducting clinical studies with coma patients , which theoretically can shorten the life of a coma patient and harm him.” The new Euro-regulation might be the door-opener of an aggressive research practice with people not able to consent in the name of progress.
3. Dementia researchers in particular maintain that the progress is in danger unless research on people not able to consent is legitimized. However, critics point out that as to the here discussed pharmacological experiments there are no principal biological differences between slight and severe dementia. Thus, according to the president of the German Alzheimer Association, Jens Bruder, “all useful pharmacological research approaches can be conducted on patients with slight dementia being able to consent.” Long-term studies could also work with patients who gave their consent in advance. Adherents of the modification of the law should put up with the question of whether they avoid the dialogue with patients still able to consent so much that they prefer this intervention in the basic rights. Very interesting is a series of studies on the compliance of patients in the field of age dementia. The need for personal dignity and respect followed by the need for social contact and protection from isolation significantly rank before the need for medical treatment. The justification of particular pharmacological studies will therefore be tiring, but all the more necessary.
4. Here the important objection must be raised: the concept of informed consent of the Nuremberg Code means a dialogue between two individuals. On the one hand the researcher who has to explain each step of the experiment so that the test persons are able to understand it. On the other hand the test person asking question, tiring but necessary questions, who can withdraw from the experiment any time. The concept of informed consent does in any case include the rights to full treatment information, confidentiality, dignity and respect, mentioned in the US-debate on the Bill of Patients’ Rights. I believe that more than any ethics commission the informed consent aims at control and the guarantee of the necessity to prove the usefulness of research. If research on people not able to consent was allowed, it would mean a further step towards research without dialogue.
The background of this hot debate in Germany is the question of the protection of human dignity in the biomedical upheaval of medicine. The Nuremberg Code stands for the historical experience of the absolute necessity of the protection of human rights of the individual. Human rights apply to all people, not only independent from color or race, but also independent from efficiency, state of health or capacity to communicate. Bioethical views according to which persons will become human beings with protection, dignity and value only through so-called indicators of personhood such as self-consciousness, self-control, capacity to communicate, memory and a sense for the future are not compatible with human rights. Human rights are universal, they don’t have to be acquired by efficiency, nor do they expire after a brain damage. Human rights must not be weighed against values such as social progress, medical knowledge or freedom of research.
I summarize my position these point:
1. The legacy of Nuremberg is the urgently demanded commitment of medicine to individual ethics and the denial of any orientation towards collective ethics. A humane medical research is always bound to benefit concrete persons. “Higher interests”, the “well-being of future generations” or of the “human species” do not in any case justify evading the protection of human rights of the individual nor the principle of informed consent, whether or not these consideration slow down research.
2. The publicly accepted and protected reliability of human rights in medicine and medical research can be measured by the dealing with people not able to consent. Their protection from being subjected to research for the benefit of others without personal consent therefore most had top priority.
3. Megalomaniacal ideas about health during the Nazi era led to disrespect for the rights and the life of the individual in order to heal the “Volkskörper”. As Jay Katz noted if the necessity of a guaranteed human rights’ protection for the individual had been established well in the professional thinking and practicing of the physicians during the Hitler era, they could never have followed the illusions and criminal consequences of the “Magna Therapia” at the expense of the individual. Should we ever be threatened - as it is sometimes maintained - by a medical system which wants to realize the improvement of the human genome, a modern “Magna Therapia” of the human being by his auto-evolution, only by absolutely insisting on the inviolability of human dignity and everybody’s right to live such a repetition of the third Reich’s history could be prevented.