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

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Testing ground GDR: Western pharmaceutical firms conducting clinical trials behind the Iron Curtain. / Erices, Rainer; Frewer, Andreas; Gumz, Antje.

in: J MED ETHICS, Jahrgang 41, Nr. 7, 2015, S. 529-533.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Erices, R, Frewer, A & Gumz, A 2015, 'Testing ground GDR: Western pharmaceutical firms conducting clinical trials behind the Iron Curtain', J MED ETHICS, Jg. 41, Nr. 7, S. 529-533. https://doi.org/10.1136/medethics-2013-101925

APA

Erices, R., Frewer, A., & Gumz, A. (2015). Testing ground GDR: Western pharmaceutical firms conducting clinical trials behind the Iron Curtain. J MED ETHICS, 41(7), 529-533. https://doi.org/10.1136/medethics-2013-101925

Vancouver

Erices R, Frewer A, Gumz A. Testing ground GDR: Western pharmaceutical firms conducting clinical trials behind the Iron Curtain. J MED ETHICS. 2015;41(7):529-533. https://doi.org/10.1136/medethics-2013-101925

Bibtex

@article{8a6028a02a434a4a878493732f430d8d,
title = "Testing ground GDR: Western pharmaceutical firms conducting clinical trials behind the Iron Curtain",
abstract = "Western pharmaceutical companies conducted clinicaltrials in the Eastern Bloc during the Cold War. Recently,media reports about alleged human experimentationprovoked a wave of indignation. However, a scientificand objective account of these trials is lacking. The aimof this study was to describe and evaluate the clinicaltrials performed in the German Democratic Republic(GDR) based on archival material from the health systemand the secret service. We found documents relating to220 trials involving more than 14 000 patients and 68Western companies. However, no record of patientinformation forms or systematic documentation regardingthe provision of patient consent was discovered. Therewas no evidence to suggest that the trials systematicallyand intentionally damaged patients. The trials wereconducted without the knowledge of the public. GDRlegislation stipulated that patients must consent to thetrials, but no evidence was found to suggest thatpatients were systematically informed. Documentssuggest that at least some of the trials were carried outwithout patients having a comprehensive understandingof what the trial involved. The GDR agreed to the trialsdue to impending bankruptcy and Westernpharmaceutical companies capitalised on this situation.",
author = "Rainer Erices and Andreas Frewer and Antje Gumz",
year = "2015",
doi = "10.1136/medethics-2013-101925",
language = "English",
volume = "41",
pages = "529--533",
journal = "J MED ETHICS",
issn = "0306-6800",
publisher = "BMJ PUBLISHING GROUP",
number = "7",

}

RIS

TY - JOUR

T1 - Testing ground GDR: Western pharmaceutical firms conducting clinical trials behind the Iron Curtain

AU - Erices, Rainer

AU - Frewer, Andreas

AU - Gumz, Antje

PY - 2015

Y1 - 2015

N2 - Western pharmaceutical companies conducted clinicaltrials in the Eastern Bloc during the Cold War. Recently,media reports about alleged human experimentationprovoked a wave of indignation. However, a scientificand objective account of these trials is lacking. The aimof this study was to describe and evaluate the clinicaltrials performed in the German Democratic Republic(GDR) based on archival material from the health systemand the secret service. We found documents relating to220 trials involving more than 14 000 patients and 68Western companies. However, no record of patientinformation forms or systematic documentation regardingthe provision of patient consent was discovered. Therewas no evidence to suggest that the trials systematicallyand intentionally damaged patients. The trials wereconducted without the knowledge of the public. GDRlegislation stipulated that patients must consent to thetrials, but no evidence was found to suggest thatpatients were systematically informed. Documentssuggest that at least some of the trials were carried outwithout patients having a comprehensive understandingof what the trial involved. The GDR agreed to the trialsdue to impending bankruptcy and Westernpharmaceutical companies capitalised on this situation.

AB - Western pharmaceutical companies conducted clinicaltrials in the Eastern Bloc during the Cold War. Recently,media reports about alleged human experimentationprovoked a wave of indignation. However, a scientificand objective account of these trials is lacking. The aimof this study was to describe and evaluate the clinicaltrials performed in the German Democratic Republic(GDR) based on archival material from the health systemand the secret service. We found documents relating to220 trials involving more than 14 000 patients and 68Western companies. However, no record of patientinformation forms or systematic documentation regardingthe provision of patient consent was discovered. Therewas no evidence to suggest that the trials systematicallyand intentionally damaged patients. The trials wereconducted without the knowledge of the public. GDRlegislation stipulated that patients must consent to thetrials, but no evidence was found to suggest thatpatients were systematically informed. Documentssuggest that at least some of the trials were carried outwithout patients having a comprehensive understandingof what the trial involved. The GDR agreed to the trialsdue to impending bankruptcy and Westernpharmaceutical companies capitalised on this situation.

U2 - 10.1136/medethics-2013-101925

DO - 10.1136/medethics-2013-101925

M3 - SCORING: Journal article

VL - 41

SP - 529

EP - 533

JO - J MED ETHICS

JF - J MED ETHICS

SN - 0306-6800

IS - 7

ER -