Drug Tests
Comissioned by the Ministry of Social Affairs, Health, Youth, Family and Senior Citizens of Schleswig-Holstein, the Institute for the History of Medicine and Science Studies investigated drug tests in asylums, psychiatric clinics and institutions for the disabled between 1949 and 1975. To this end, the project team screened contemporary publications in medical journals and evaluated archival sources of the responsible administrations as well as patient files of the state hospitals, the university clinics and other institutions. In addition, archives of pharmaceutical companies were consulted for their records of drug trials and drug application studies (Bayer, Merck, Novartis, Schering).
A total of 43 pre-marketing drug trials and 37 post-marketing drug application studies were identified, which had been conducted at the state hospitals in Schleswig, Neustadt and Heiligenhafen, at the church-run institutions in Rickling and Kropp, at Kiel University Hospital and Lübeck Municipal Hospital. Especially for the LKH Schleswig and the University Psychiatry Kiel, a large number of drug trials and application observations could be documented. In the department of child and adolescent psychiatry at LKH Schleswig-Hesterberg, a total of 17 drug trials and application observations were detectable, compared to 63 drug trials and application observations at the department for adult patients at LH Schleswig.
The contemporary publications reporting on the results of the testing of new drugs demonstrate that these trials were not clandestine, but a publicly known and widespread practice. Ethical or legal concerns were not demonstrable on the part of either the manufacturer or the clinicians and regulators. Until the adoption of the Medicines Act of 1976, the testing of medicines was not subject to detailed legal regulations. Even at that time, however, informed consent by the patient or her legal representative was ethically and legally required. Despite the formulation of fundamental ethical principles already in the Nuremberg Code from 1947 or the Declaration of Helsinki in 1964, no references to ethical evaluation and informed consent could be found in the sources. Adverse effects, on the other hand, were observed, documented, and condoned. In addition, it was also known already at that time that the medication could have long-term negative consequences for the patient.
The research team reconstructed the complex historical context of this drug testing, including the legal framework, the lack of supervision by the authorities, the poor and only slowly changing conditions in the institutional setting and the belated development of a professional ethos by the psychiatrists. The juridical expert and legal historian Prof. Sebastian von Kielmansegg from Christian Albrechts Universität Kiel was recruited specifically to reconstruct the development of the legal framework during the period under investigation.
Overall, it became apparent that drug testing and the administration of psychotropic drugs in general was a widespread and largely unquestioned practice in child, adolescent and adult psychiatry as well as in disability care.
The drugs were given indiscriminately and often for the purpose to facilitate the care rather than for treating the patients, although this practice was already dubious from the perspective of the time.
And interim report was presented to the provincial parliament in the year 2020 and stirred great public interest. The conclusion was drawn that the drug tests should not be investigated in isolation but is part of the problematic psychiatric series of the time. Therefore, a follow-up project was launched in November 2019, to research the conditions of psychiatric practice and to document the suffering and the experiences of injustice by children and adolescents in psychiatric facilities and institutions for the disabled in Schleswig-Holstein in the period from 1949 to 1990.
Project team:
Prof. Cornelius Borck (PI), Prof. Gabriele Lingelbach (CoPI), Jonathan Holst, Dr. Christof Beyer (project team), Prof. Sebastian von Kielmansegg (for the legal-historical contribution)
The comprehensive reports on this projects are available here.
