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In the year 2016, a scandal shook the worlds of experts and the public. At least until into the 1970s, medications were tested on children in the Federal Republic of Germany – children in youth institutions and in psychiatric institutions. The many press reports since February 20161, beginning with a report in the ZDF broadcast Frontal 21 on 2 February 2016 (“Medikamententests in Heimen. Kinder als Versuchskaninchen”) refer to a study by the pharmacologist Sylvia Wagner [9]. As she was looking through the Deutsche Medizinische Wochenschrift, she found around 50 pertinent publications from within the period 1945–1975. The articles freely state what sort of collective was used to test medications or inoculations, for example, “96 children at an infants’ and small children’s home were divided into 2 groups” [9]. The author found no indications of any declaration of consent by the persons responsible. Using these first results and starting with the names of the authors, she consulted further sources. In sum, she found 33 inoculation experiments with small children in homes between 1947 and 1970, and 13 experiments, primarily with neuroleptics and sexual hormones, with older children in homes or psychiatric institutions.

These experiments on minors have an ethical dimension, not difficult to see upon examining the dates involved. The Nuremberg Codex of 1947 does not seem to have stopped any of them, although the first rule there states that research on human beings may be undertaken only on people capable of consent after they have been informed and have agreed. Not a few of the studies belong to the post-1964 period, after the Declaration of Helsinki. These manifests of ethics were not legally binding and the laws concerning medications were still in development. Not until the medications law of 1976 in the Federal Republic (the first was passed in 1961 and amended in 1964) was it required to provide proof of effectivity and innocuousness. § 40 deals in detail with the protection of human beings in clinical assessments, particularly the protection of minors by means of written consent of the legal guardian following elucidation. Here too it is laid down that probands shall not be “kept in an institution on court orders or the orders of a responsible authority” [10]. The approval of innoculations, however, has been legally regulated since 1896 [9].

In any case, the experiments described by Sylvia Wagner took place not only in cooperation with the producing firms but also in agreement with state authorities, for example, the Senator for Health in Berlin, the Robert Koch Institute or Federal Health Office, and some were financed by the German Research Council (DFG) [9]. Whether similar experiments were carried out after the law came into force in 1978 or after the introduction of Ethics Commissions, especially in the 1980s, has not yet been researched.

Besides the experiments using medications on institutionalised children, Sylvia Wagner’s paper and the media echo a further aspect of scandalisation: an assumed connection with National Socialist crimes against humanity, a connection produced by means of personal continuities. For example, Hans Heinze (1895–1983) is mentioned [11]; in the post-war period, he was the director of the Psychiatric Section for Children and Young People in Wunstorf near Hanover, and responsible there for experiments with medications. It is well-known that Heinze, President of the then newly founded Association for the Psychiatry of Children and Young People from 1941, was one of those mainly responsible for the National Socialist movement on “children’s euthanasia.” After the war and a time as a POW, he succeeded in founding a post-war career in the Federal Republic.

Sylvia Wagner, then makes presuppositions in her paper, which were obviously taken up by the press:

1 The Nuremberg Codex and its history – the experiments on human beings in the concentration camps of the Nazis – ought to have exercised influences on research practice in the post-war years, as the Codex is a prominent example of the effect of historical events on ethical debate and practice – even then when it had become clear that the “lesson” had by no means been learnt always and everywhere [12].

2 Research on institutionalised children in the Federal Republic of Germany shows at least continuity in personnel from National Socialist research on human beings, or more generally continuity with National Socialism.

But does the reference to the extremism of deregulated research under National Socialism, together with the focus on the de facto existing continuity of person, not obstruct the view of more complex structural contexts over longer periods of time? The narrative of the criminal research in the concentration camps during the NS period, the Nuremberg Codex as the reaction to that, and as origin of “informed consent” and the protective guidelines in place today for human probands – does all these go deep enough [13]? What about the previous history of the research described by Sylvia Wagner?

The figure of a skandalon in connection with research on human beings, on minors, too, and a resulting need for ethical rules is by no means limited to the period following the Second World War – it can be found, together with ethical discussions, in the late 19th century. A prominent example is the “Neisser case.” The dermatologist Albert Neisser (1855–1916) had “inoculated” patients with a new type of syphilis serum in 1892. Among the patients, of whom some later developed syphilis, were some prostitutes, some of whom were underage, thus belonging to a socially marginalised and vulnerable group of people [14]. Additionally, they had been involved in the research without being told and without getting their consent. Shortly after the scandal, the trial, and the public reaction to the event, the Prussian Ministry for Education and Medical Matters issued a directive permitting experimentation on humans only after detailed explanation to and after receiving consent from the probands [14]. Important effects of this directive are not known – the public debate, however, continued.

A further influential scandal was the so-called Lübecker Totentanz (Lübeck Dance of the Dead), which involved non-institutionalised children. The whole matter was actually an accident in the course of inoculation owing to impure material, using a method that had in principle already been introduced, the BCG inoculation against tuberculosis, with which, outside Germany, some 150,000 children had been inoculated by 1928 [15]. In Lübeck too, the parents had consented. Nevertheless, the accident, connected with a method of inoculation still seen as new, influenced the debate on research on human beings [16].

A little later, 1931, the Reich Ministry of the Interior issued remarkable guidelines that may be seen as the first document with such far-reaching requirements, nationally and internationally. The guidelines were published on the broadest basis, so that the expert public must have known of them [17]. Following a fundamental commitment to the need for experiments on human beings (“medical science needs the experiments on humans”), the guidelines point out the particular “obligations of the physician towards probands.” They then distinguish – as far as is known, for the first time – between the attempt at a cure with (potential) benefits for the proband and the scientific experiment in the narrower sense, in which such benefits are not in the foreground [17]. For experiments focusing on cures, it is established that a particularly careful assessment should be carried out in the case of children that a social position of neediness should not be exploited, that special care must be taken with living infectious agents – the rules clearly show the influence of the previous scandals. Perhaps the most important rule to distinguish between the 2 types of experiments is this: the attempted cure requires only the informed consent of the person involved or their representative; the scientific experiment requires the consent from the proband him- or herself without fail.

The guidelines of 1931 were not legally binding, and no punishment was threatened [17]. Little is known of their effects – but one cannot say that they remained unnoticed under National Socialism. Two cases of their application by a high-ranking NS functionary are documented. Hans Reiter (1881–1969), after 1933 President of the Imperial Ministry of Health, gave his opinion in 1937 on the planned experiment with a new measles serum by the Robert Koch Institute, which was to be tested on convalescent children. Experiments on healthy children, thus Reiter, were unacceptable “under all circumstances.” “Why no self-test?,” he noted sarcastically in the margin. Again in 1937, Reiter expressed his opinion on an experiment planned by a physician at the Women’s Clinic in Halle, Hamann, to be carried out on pregnant women with eclampsia. This was permitted only after the subsequent agreement of the director had been filed – as in prescribed in the guidelines [18, 17]. Further mention, for example, in publications on experiments on humans, is not currently known, but this point needs further research.

Quite clearly the guidelines had no influence on the extreme form of deregulated research in the concentration camps. This ought not to be surprising, for the researchers used this ”historical chance” precisely because of the “unlimited possibilities” – Hans Reiter too obviously had no compunctions about participating in research on Buchenwald prisoners in 1941 [19]. The protection of probands was clearly only meant for parts of the population now. Other groups were ascribed more the status of experimental animals, whose welfare, however, played no role, while dealing with experimental animals was regulated in the new animal welfare laws [20, 19]. This extreme research in National Socialism and its influences on the ethical debate are relatively well investigated [21, 22]. The “guidelines” were known at the Nuremberg trials; they were used as an exculpating argument for the German medical professionals. They appeared to document the ethical standards of this profession, in contrast to the 23 defendants. This helped to shape an image of a small number of criminal perpetrators versus a large number of physicians who acted ethically. Andrew Ivy, the expert for the prosecution, emphasised the supposedly legally binding character of the “guidelines,” with regard to the negative evaluation of experiments on humans worldwide in the public eye [17].

The historical research has hitherto concentrated primarily on the extreme, but much less so the daily practice of medical research, for example, in the university clinics, which could be more essential in answering the question of whether, and how, ethical standards were taken into consideration in everyday research, whether they were discussed, and what lessons could be learnt from all these for today’s research. The historical research is, at the moment, changing the direction of its view from event to routine. An example of this is the book by the British historian Paul Weindling, which has the programmatic title “From Clinic to Concentration Camp” [23]. A bridge between the human experiments in the concentration camps and the research in the everyday clinic is formed by a contribution contained in the book, and dealing with the research department at Heidelberg, by Carl Schneider (1891–1946), one of the leading Nazi psychiatrists, who documented the then current research practice on the basis of psychiatric patient files of children [24]. The goal of the research department, established at the Heidelberg Psychiatric Clinic in the middle of a small university town, was to scientifically distinguish inherited and acquired “imbecility.” In the years 1943 and 1944, 52 children and young people were taken to the adult station for about 6 weeks. These underage probands were subjected to a comprehensive programme of investigation according to the then-current research. Twenty One of the children were subsequently taken to the Eichberg Institution near Eltvile/Wiesbaden and there murdered. In nearly all files, a table of contents of the file shows not only the comprehensive research programme at the cutting edge of contemporary science, but also that the murder of the children was conceptually included in the plan (point 16) [25, 26].

This research was by no means “pseudo-science.” On the contrary, the programme was designed according to the newest developments [27]. In the post-war period, the argument of “pseudo-science” was often used to draw a line between the criminal research of the NS period and the “good science” thereafter, as though this “good science” could be a guarantee for the ethical attitude of scientists [13]. When the research in Heidelberg (just as in Görden) made use of the ethically unlimited possibilities of a specific historical situation with regard to the life of the probands, and this during war and in connection with the NS murders of patients, it nonetheless represented, at the one and the same time, “normal” research on a good scientific level in the everyday clinic. The Reich guidelines were clearly ignored here. A structural momentum involving the probands becomes visible too: most of the children involved were from a home and thus belonged to a particularly vulnerable patient group – the group of institutionalised children, which was obviously frequently used for human experiments still in the post-war period.

The Nuremberg Codex served as a delimitation to the criminal research of the NS period but was also regarded by researchers as a “hindrance” to necessary research on human beings – not only in the Federal Republic of Germany (as were considered the Reich guidelines of 1931, see [17], pp 42–45). Following the Declaration of Geneva by the General Assembly of the World Medical Association in 1948, from 1953 discussions within this Association about their own ethical manifesto were taking place; a year-long intensive debate on 2 groups of probands was provoked, prisoners and institutionalised children. In 1962, a draught for the Ethical Manifesto was published in the British Medical Journal, where it was stated that no experiments on institutionalised children not in the care of their parents should be carried out. In the concluding discussions, the reservations of American scientists played a particular role. They had carried out numerous inoculation experiments in the 1950s, and they thought that experiments on institutionalised children were indispensable because of the standardised conditions – thus they themselves had not held to the central point of the Nuremberg Codex [28].

The research in the United States and the fact that the “guidelines” in Germany had already been formulated in 1931 went to show that research on home children in the Federal Republic of Germany in the 1970s cannot be explained only with continuities from the NS period – a structural ethical problem of science itself is the case here. In the final redaction of the Declaration of Helsinki in 1964, children in institutions are no longer mentioned; research on those unable to give consent, including children with the consent of their guardians, is possible.