Testing ground GDR: Western pharmaceutical firms conducting clinical trials behind the Iron Curtain

  • Rainer Erices
  • Andreas Frewer
  • Antje Gumz

Abstract

Western pharmaceutical companies conducted clinical
trials in the Eastern Bloc during the Cold War. Recently,
media reports about alleged human experimentation
provoked a wave of indignation. However, a scientific
and objective account of these trials is lacking. The aim
of this study was to describe and evaluate the clinical
trials performed in the German Democratic Republic
(GDR) based on archival material from the health system
and the secret service. We found documents relating to
220 trials involving more than 14 000 patients and 68
Western companies. However, no record of patient
information forms or systematic documentation regarding
the provision of patient consent was discovered. There
was no evidence to suggest that the trials systematically
and intentionally damaged patients. The trials were
conducted without the knowledge of the public. GDR
legislation stipulated that patients must consent to the
trials, but no evidence was found to suggest that
patients were systematically informed. Documents
suggest that at least some of the trials were carried out
without patients having a comprehensive understanding
of what the trial involved. The GDR agreed to the trials
due to impending bankruptcy and Western
pharmaceutical companies capitalised on this situation.

Bibliografische Daten

OriginalspracheEnglisch
ISSN0306-6800
DOIs
StatusVeröffentlicht - 2015