Background/aims Current research largely tends to ignore the drug-testing model that was developed in the “Second World” as an explicit alternative to the randomized controlled trial. This system can be described as “socialist pharmapolitics,” accounting for the specific features of state socialism that influenced the development and testing of experimental drugs. The clinical trials model employed in the “Second World” was heavily influenced by the Soviet Union, which was by far the most influential player in the socialist bloc during the Cold War. Based on extensive archival research, this article presents an empirical case of a late Soviet clinical trial as a pragmatic alternative to the randomized controlled trial model. It accounts for the divergences between the official model prescribed by the Soviet authorities and the messy realities of healthcare practice. It further outlines different factors that ultimately shaped how clinical trials were organized in Soviet institutions “on the ground.” Accordingly, this article presents a “real-life” history of “socialist pharmapolitics” and outlines the problems that this system faced in practice. Methods Archival research was conducted at the Russian State Archive of Scientific and Technical Documentation in Moscow. Archival files include scientific, technical, and registration documentation such as biochemical, pharmacological, and clinical descriptions of the experimental drug Meldonium, letters between various hospitals, research institutes and the Soviet regulatory body, as well as 26 reports of completed clinical trials. Manual content analysis was used for the interpretation of results. Results This article presents an empirical case of a late Soviet clinical trial as a pragmatic alternative to the randomized controlled trial model. It demonstrates some key differences from the randomized controlled trial model. This article also highlights some of the discrepancies between the model that was officially prescribed by the Soviet authorities and the realities of experimental drug testing in the Soviet Union in the late 1980s and early 1990s. In particular, it notes some elements of randomization, double-blinding, and the use of placebo that were present in Meldonium trials despite being formally denounced by Soviet bioethics. Conclusion The Soviet model for testing experimental drugs differed from the Western one substantially in a number of respects. This difference was not only proclaimed officially by the Soviet authorities, but was for the most part enforced in clinical trials in practice. At the same time, our research demonstrates that there were important differences between the official model and the clinical realities on the ground.

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.

По мере усложнения общественного устройства и способов коммуникации, роста темпов научно-технического и социального прогресса все большую актуальность приобретает проблема самоопределения человека. Исследование данной проблемы связано с анализом понятий тождества личности, кризиса идентичности и стратегий социального взаимодействия. В статье рассматривается проблема эгоидентичности и приводятся аргументы о парадоксальности ее природы, дается описание сущности кризиса самоопределения и его исторического генезиса с позиций современной философии. Тематизируются направления перспективных исследований проблемы самоопределения человека и кризиса идентичности.

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