Trials in the German Democratic Republic suggested to be ethically ambiguous

1. Beginning in the 1980’s, the German Democratic Republic (GDR) faced impending bankruptcy and allowed Western pharmaceutical companies to conduct clinical trials in the state in exchange for hard currency.

2. Archival records suggest that clinical trials conducted in the GDR occurred without patient consent and without fully informing patients of the nature of the trials, although there was no evidence to suggest that these trials systematically or intentionally harmed patients.

Study Rundown: During the Cold War, Eastern Bloc states such as the German Democratic Republic (GDR) faced impending bankruptcy. In exchange for payment from Western pharmaceutical companies, the GDR allowed clinical trials to be conducted on patients within the state. There is a lack of reliable, systematically analyzed data regarding study details, legal contracts for the trials, amount of money paid to conduct these trials, and extent to which patients were educated about and informed of their participation. This analysis systematically reviewed clinical studies conducted in the GDR, including their extent, legal basis, and adherence to ethical principles, based on data gathered from archived material in the Federal Archive in Berlin and the archives of the East German Secret Service. The analysis found that at least 220 clinical trials were conducted between 1983-1990 using drugs manufactured by Western companies. The Berliner Import Export GmbH (BIEG), a part of the GDR foreign exports department, kept approximately half of the payments made for the trials, the rest of which was distributed between the other Ministries of the GDR. Overall, the records suggest that the GDR did attempt to follow international ethical standards in conducting these trials. However, there was no record of patient consent forms or documentation of written or oral consent in the national archives, despite provisions requiring written consent.

The most notable limitation is the study’s reliance on information available in historical archives, as there is likely information about the conduct and legal basis of these trials not recorded in the archives. However, the available data allow for an objective, systematic review of the accessible evidence, which is arguably more objective than media accounts of the clinical studies. Overall, media sensationalism regarding these clinical trials is believed to be unjust, and the authors suggest that continued reliable, objective investigation of the GDR health care system is needed to clarify and characterize the historical and contemporary research activities in the GDR state.

Click to read the study in the Journal of Medical Ethics

Relevant Reading: Health-Care Services in the GDR during the 1980s: A Status Report Based on the Files of the State Security Agency

In-Depth [historical analysis]: This study detailed the extent to which clinical trials were conducted in the German Democratic Republic in the 1980s, and their ethical and legal implications. Archived material from the Federal Archive in Berlin and the East German Secret Service were reviewed. The authors found that contracts for the clinical trials were prepared primarily by the BBA, an agency of the GDR Ministry of Healthy, and signed by participating Western pharmaceutical companies that included Hoechst, Sandoz, Boehringer Mannheim, and Bayer. The Berliner Import Export GmbH (BIEG), a division of the GDR foreign exports department, was also a signatory on these contracts and kept half of the financial compensation provided to the GDR by Western pharmaceutical companies to conduct these trials. The other half of the compensation was distributed between the Ministries of Health, Higher Education and Investigation, and the Academy of Sciences. Records indicate that the GDR health system received approximately DM (Deutsche Mark) 16.5 million for the clinical trials. No monetary compensation was provided to patients for their participation in these trials. More than 220 trials were conducted between 1983-1990, for drugs manufactured by 68 Western companies. Tested drugs included chemotherapy agents, anti-depressants, heparin, insulin, and contrast agents. Studies were conducted in more than 90 institutions, although no evidence was found to suggest that trials were conducted at government orphanages, prisons, or military establishments. The review indicates that the GDR attempted to conduct the trials following international ethical standards. There was no evidence to suggest any practices intended to intentionally harm patients. Instead several documents indicated that the supervising health authorities demanded protection of patients in these trials. There was not, however, any indication of written patient education or patient consent forms in the available national archives, despite BBA stipulation that written consent by obtained for all Western studies. A contributing factor to this lack of documentation is suspected to be the GDR ideology that placed the interests of the collective over those of the individual, which would have superseded the traditional ethical principle of patient autonomy.

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