Ethical Aspects of Clinical Trials Outsourced by Western Pharmaceutical Companies to the GDR

Abstract

Between 1983 and 1990, at least 163 Western drugs were tested in the GDR. On the basis of archival documentation, relevant literature, and interviews we examined the clinical trials of five drugs more thoroughly; two of these individual case studies are introduced in this article. In the case of the clinical trials of the synthetic human growth hormone Saizen we found extensive trial and patient documentation, which allows for a detailed analysis of ethical aspects  such as parent information and informed patient consent. In the case of the clinical trials of the „abortion pill“ Mifepristone (RU-486) for the World Health Organization we uncovered irregularities with regard to the ethical evaluation. However, taken together, we could not find any serious violation of ethical norms in connection with our cases studies.

Download