Medical trials on children, young people and adults in the care homes for the disabled and psychiatric wards in Schleswig-Holstein were common practice until 1975. Kiel University is now preparing a legal analysis of these procedures.
Between 1949 and 1975, disabled or mentally ill people in Schleswig-Holstein who were placed in institutions for the disabled and in adult, child and youth psychiatric units were systematically treated and sedated with pharmaceuticals that had neither been tested nor licensed. These are the facts compiled by the research team from the universities in Lübeck and Kiel headed by Professor Cornelius Borck of the Institute for Medical History and Science Research at the University of Lübeck. The research was commissioned by the Ministry of Social Affairs, Health, Youth, Family and Senior Citizens and was initiated in October 2019.
One reason for the medical trials was cost-related: psychotropic drugs were expensive, while the budgets of the institutions were often restricted. Therefore, free “doctors’ samples” and new pharmaceutical products such as anti-epileptic drugs, psychotropic drugs, anti-depressants and tranquillisers were used with the knowledge of the Schleswig-Holstein Ministry of the Interior, which was responsible for the regional health care system until 1971. Institutions entered into cooperation agreements with the pharmaceutical industry to test new substances in clinical trials – and were paid for these trials and for the publication of their findings. Apparently, the patients concerned were not previously informed about the trials or had given their consent, as is customary and legally stipulated nowadays, or at least no such confirmation can be found in the files of the respective institutions or in the archives of the pharmaceutical companies.
“The people subjected to these trials suffered a great deal,” Dr Sebastian Graf von Kielmansegg from the Faculty of Law at Kiel University explained. In the three-year research project, the medical law professor and the prospective lawyer Tjorben Studt, student assistant at the faculty in Kiel, are concerned with the legal aspects from a historical vantage point. For this purpose, Studt studied scientific papers, court decisions and other publications in detail.
“The retroactive legal assessment of historical events will always be hypothetical, as you never know how the courts would have decided at that time,” von Kielmansegg explained. Especially as the legal parameters were different then. Before 1976, there was no binding legal regulation in place for testing and licensing new medicines in Germany. This regulation was only introduced when a new pharmaceutical law came into force in 1976. “We therefore focused on evaluating whether other legal regulations and ethical or professional standards were applied at the time.” After all, those certainly existed. In its ruling in the Nuremberg Doctors’ Trial in 1947 (which was later referred to as the Nuremberg Code), the US military tribunal determined that from then on, persons participating in clinical trials had to voluntarily give their consent. In addition, patients participating in clinical trials also had to be legally competent to give their consent. “This excludes people who, due to disability or illness, are not able to express their wishes clearly.” Furthermore, the World Medical Association formulated ethical guidelines in 1964. “Although these were not legally binding,” von Kielmansegg added.
Nevertheless, such trials were apparently common practice – even though under criminal law they could certainly be regarded as bodily harm. But there was no outcry or scandal among the people. In order to understand why, we have to put ourselves back in the position of people in the 1950s and 1960s, according to the legal scholar. Doctors were held in extremely high regard. They had the final say in a society in which the prevailing structures were clearly authoritarian and hierarchical. “If the doctor prescribed tablets, they were taken or administered as a matter of course. And that applied especially to institutions such as psychiatric wards.” On top of that, many of those affected had no family at all or parents who showed little interest in their children. What is more is that the doctors did not necessarily see the people as subjects of clinical trials, but genuinely wanted to help them. “However, it’s a fine line between research and treatment – treatments of an experimental nature, mind you – and in many cases this line became blurred,” according to the legal expert. While this was not considered to be objectionable at the time, von Kielmannsegg’s conclusion is clear: “The conditions under which the trials were held were not proper.” At the same time, von Kielmannsegg does not want to judge this. “The purpose of our research is not to pass judgement, but merely to provide facts.” The research will be completed in autumn 2020, when the final report produced by the universities in Lübeck and Kiel with the findings will be submitted to the ministry. After that, the next important project will be initiated: the work on “Forms of suffering and injustice during inpatient treatment in Schleswig-Holstein’s institutions for the disabled and psychiatric wards for children and young people from 1949 to 1975”.
Author: Jennifer Ruske