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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.

The relatively short period from 1914 to 1932 witnessed a radical change in the attitudes of both governmental authorities and professional communities towards drugs and addiction. Before the First World War, Russians could easily buy cocaine or heroin at a pharmacy, medical science did not view addiction as a serious social problem. There was practically no government regulation or legislation concerning recreational drugs. By the early 1930s, however, the market of recreational drugs had been heavily regulated, drug sale had been criminalized, and physicians and criminologists had begun to label drug addicts as bourgeois, degenerate, or otherwise socially anomalous people who should be sent to special camps. An important turning point occurred in late 1924, when Soviet authorities issued two decrees that provided a legal definition of criminal drug sales, signaling the start of a more intensive struggle against drug abuse. This paper examines the social practice of late Imperial and early Soviet public health in order to evaluate the evolution of "in-the-field" medical approaches towards opiate, cocaine and cannabis addiction. It focuses on the period when drug use was first constructed as a delinquency, and thus as a social problem requiring immediate intervention. It examines attempts of physicians and pharmacists to restrict and control drug production, distribution and sale; sanitary propaganda and other prophylactic measures; and the establishment of special institutions for the treatment of addicts. It is concerned only peripherally with the judicial prosecution of drug dealers and drug addicts.

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