Abstract
Abstract This paper discusses several ethical issues related to clinical trials within the Soviet system of drug development and testing, which reflected larger ideological principles of healthcare organization in the ussr, with its focus on eradicating market elements from drug development. The centralized state-controlled system was thought to combat such drawbacks of free-market drug development as high prices and aggressive advertising; also to discourage the duplication of research by numerous independent actors that was perceived to be common in capitalist countries. Another significant ethical issue was the Soviet emphasis on the unity of scientific research and clinical treatment. Their strict separation, introduced to support normative standards defined by the U.S. pharmaceutical drug testing system, was rejected in the ussr where knowledge of new treatment options came from treatment practice, not laboratory-like experimental conditions of randomized controlled double-blind trials. The Soviet design was closer to so-called ‘pragmatic trials’ that focus on solving ‘real-life’ problems in clinical practice. Not all ethical problems were successfully addressed in the Soviet model, where there were always significant gaps between neatly postulated theory and messy clinical practice. The unity of scientific research and clinical practice was difficult to achieve. Archival research shows potential ethical issues related to geographic disparities in carrying out clinical trials, and the importance of personal and informal connections in the Soviet model.
Highlights
The ongoing covid-19 pandemic has revived discussions related to ethical issues in the organization of healthcare in general, and in clinical trials
This paper discusses several ethical issues related to clinical trials within the Soviet system of drug development and testing, which reflected larger ideological principles of healthcare organization in the ussr, with its focus on eradicating market elements from drug development
In the context described above, the present paper discusses several ethical issues and concerns related to clinical trials within the Soviet system of drug development and testing
Summary
The Soviet system of drug development and testing reflected larger ideological principles of healthcare organization that were adopted in the ussr.[12]. Review in 1958–1963 (as part of larger policy experiments tried out during the ‘Thaw’ under Nikita Khrushchev) centered around the fact that it allowed the unwarranted duplication of research on similar drugs to be carried out simultaneously at multiple sites across the Soviet Union.[30] The system of central planning, executed by the Ministry of Health and the Pharmacological Committee in coordination with the Ministry of Medical Industry and other healthcare institutions, was thought to streamline the process of drug development and to make it more efficient and economical.[31] Another significant ethical issue was the Soviets’ emphasis on the unity of scientific research and clinical treatment. Tests on healthy volunteers were generally not allowed in the ussr (with some exceptions made for vaccines and preventive medications).[37]
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