Institute for History of Medicine and Medical Ethics at the University of Erlangen-Nuremberg, Erlangen, Germany.
Berlin University of Psychology (PHB), Berlin, Germany.
PLoS One. 2018 Apr 2;13(4):e0195017. doi: 10.1371/journal.pone.0195017. eCollection 2018.
After the building of the Berlin Wall in the 1960s, a number of international pharmaceutical manufacturers from the West had their drugs tested in Eastern Germany (GDR). So far, the extensive collection of documents on the subject stored in the archives of the GDR State Security Service (Stasi, MfS) has not been systematically analysed. Until now, the role of the Stasi with respect to the surveillance of the trials has been unclear.
A keyword search within the database of the Stasi files was conducted. All available files were screened in order to identify institutions, companies and personnel involved in the clinical trials. On this basis, further files were requested. A total of 259 files were available for analysis. Relevant data was derived from 160 of these files. A contextualised approach was applied, which critically explored the origin, content, and impact of the data. In addition, an approach guided by the central steps of document analysis was applied.
At least 400 clinical trials were conducted during the GDR period. The exact number remains speculative. According to references found in the Stasi files, it might have been considerably higher. Initially, the main goal of the trials was for the GDR authorities to decide whether to import certain Western drugs. By 1983, this intention had changed. Now, the primary aim of the trials was the procurement of foreign currency. The Stasi feared that the pharmaceutical companies could have a significant influence on GDR Health System. Stasi spies were holding positions in the responsible medical committees, universities, and hospitals. Constant surveillance by the Stasi served the purpose of monitoring any contact between people from the West and the East. Unknowingly, representatives of Western companies were surveilled by the Stasi. The studied documents also point to the fact that a number of clinical trials conducted during the GDR period did not comply with GDR regulations, and were therefore deemed illegal by the Stasi. The Stasi was not particularly interested in medico-ethical questions.
Clinical trials conducted during the GDR period were surveilled by the Stasi. It was their aim to monitor all people involved in the trials, including their Western contacts. Relevant medico-ethical questions like patient consent and safety with respect to the clinical trials were not the focus. Considering the significant number of conducted trials, only limited evidence exists of doctors having discussed them critically. The public was not officially informed about the trials.
20 世纪 60 年代柏林墙建成后，许多来自西方的国际制药商在东德（DDR）进行了药物测试。迄今为止，存储在东德国家安全局（斯塔西，MfS）档案中的关于这一主题的大量文件尚未得到系统分析。到目前为止，斯塔西在监视试验方面的作用尚不清楚。
在斯塔西文件数据库中进行了关键词搜索。为了确定参与临床试验的机构、公司和人员，对所有可用的文件进行了筛选。在此基础上，又请求了一些其他文件。共有 259 份文件可供分析。从其中 160 份文件中得出了相关数据。采用了一种上下文方法，批判性地探讨了数据的来源、内容和影响。此外，还采用了一种以文件分析的核心步骤为指导的方法。
在东德时期，至少进行了 400 次临床试验。确切的数字仍在推测之中。根据在斯塔西档案中找到的参考文献，这个数字可能要高得多。最初，试验的主要目的是让东德当局决定是否进口某些西方药物。到 1983 年，这种意图发生了变化。现在，试验的主要目的是获取外汇。斯塔西担心制药公司可能对东德卫生系统产生重大影响。斯塔西间谍在负责的医学委员会、大学和医院中担任职务。斯塔西的持续监视旨在监测东西方人员之间的任何联系。不知情的是，西方公司的代表也受到了斯塔西的监视。所研究的文件还指出，东德时期进行的一些临床试验不符合东德的规定，因此被斯塔西视为非法。斯塔西对医学伦理问题并不特别感兴趣。
东德时期进行的临床试验受到斯塔西的监视。他们的目的是监控所有参与试验的人，包括他们与西方的接触。与临床试验相关的重要医学伦理问题，如患者同意和临床试验的安全性，并不是重点。考虑到进行的试验数量众多，只有有限的证据表明医生对这些试验进行了批判性讨论。公众没有被正式告知这些试验。
