The role of the State Security Service (Stasi) in the context of international clinical trials conducted by western pharmaceutical companies in Eastern Germany (1961–1990)

BackgroundAfter 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.MethodsA 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.ResultsAt 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.ConclusionsClinical 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.背景：20世纪60年代柏林墙建成后，诸多西方国际制药厂商曾在东德（German Democratic Republic，GDR）开展药物临床试验。目前，存储于德意志民主共和国国家安全部（史塔西，Stasi，MfS）档案中的该主题大量文献尚未得到系统性分析。迄今为止，史塔西在临床试验监管中所扮演的角色仍不明确。 方法：本研究首先在史塔西档案数据库中开展关键词检索，对所有可获取的档案进行筛查，以识别参与临床试验的机构、企业及人员。在此基础上，进一步申请调取相关档案。最终共有259份档案可供分析，其中160份档案提取得到有效数据。本研究采用情境化研究方法，批判性地探讨了数据的来源、内容与影响；同时辅以遵循文献分析核心步骤的研究框架。 结果：东德时期至少开展了400项临床试验，确切数量仍有待考证。根据史塔西档案中的相关记载，实际数量可能远高于此。试验初期的核心目标是帮助东德当局决策是否进口特定西方药物；至1983年，该目标发生转变，临床试验的首要目的变为获取外汇。史塔西担忧制药企业会对东德医疗体系产生重大影响，因此安插间谍于相关医疗委员会、高校及医院中。史塔西持续开展监控的目的在于监测东西方人员之间的一切接触，西方企业代表亦在毫不知情的情况下遭到史塔西监视。研究文献同时显示，东德时期开展的多项临床试验未符合东德相关法规，因此被史塔西认定为非法。史塔西并未对医学伦理相关问题给予过多关注。 结论：东德时期开展的临床试验均受到史塔西的监视，其核心目标是监控所有参与试验的人员，包括其与西方的联络渠道。患者知情同意、临床试验安全性等相关医学伦理问题并非其关注重点。鉴于东德时期临床试验的总体规模庞大，现有证据仅能证明极少部分医生曾对试验开展批判性讨论，且公众从未被官方告知相关临床试验的存在。