Pharmaceuticals and modern statecraft in South Africa: the cases of opium, thalidomide and contraception.

This article provides a history of three pharmaceuticals in the making of modern South Africa. Borrowing and adapting Arthur Daemmrich's term 'pharmacopolitics', we examine how forms of pharmaceutical governance became integral to the creation and institutional practices of this state. Through case studies of three medicaments: opium (late 19th to early 20th century), thalidomide (late 1950s to early 1960s) and contraception (1970s to 2010s), we explore the intertwining of pharmaceutical regulation, provision and consumption. Our focus is on the modernist imperative towards the rationalisation of pharmaceutical oversight, as an extension of the state's bureaucratic and ideological objectives, and, importantly, as its obligation. We also explore adaptive and illicit uses of medicines, both by purveyors of pharmaceuticals, and among consumers. The historical sweep of our study allows for an analysis of continuities and changes in pharmaceutical governance. The focus on South Africa highlights how the concept of pharmacopolitics can usefully be extended to transnational-as well as local-medical histories. Through the diversity of our sources, and the breadth of their chronology, we aim to historicise modern pharmaceutical practices in South Africa, from the late colonial era to the Post-Apartheid present.

Changing patterns of asthma medication use related to US Food and Drug Administration long-acting ß2-agonist regulation from 2005-2011.

BACKGROUND: Safety concerns associated with long-acting ß2-agonists (LABAs) have led to many US Food and Drug Administration (FDA) regulatory activities for this class of drugs. Little is known about the effect of these regulatory activities on use of LABA-containing agents or other asthma medications. METHODS: We created rolling cohorts of pediatric and adult asthmatic patients in the Mini-Sentinel Distributed Database between January 2005 and June 2011. The proportions of asthmatic patients using LABA-containing products, inhaled corticosteroids (ICSs), leukotriene modifiers, short-acting ß2-agonists, oral corticosteroids, other bronchodilators, and no medications were measured on a monthly basis, and the changes were evaluated by using interrupted time series with segmented regression analysis. RESULTS: When the 2005 regulatory activity was announced, there were statistically significant decreases in the use of fixed-dose ICS-LABA agents in children (-0.98 percentage points) and adults (-1.24 percentage points). Increased use of ICSs and leukotriene modifiers was observed just after the regulatory activities were announced in both children and adults. Although of smaller magnitude, continued favorable changes in the use of LABA agents were observed after the 2010 FDA regulatory activity. CONCLUSION: The 2005 and 2010 FDA regulatory activities might have contributed to reduced use of LABA agents, as intended; however, their effect, independent of other factors, cannot be determined. Use of other classes of asthma medications was similarly affected.

Entitled to Addiction?: Pharmaceuticals, Race, and America's First Drug War.

This article rethinks the formative decades of American drug wars through a social history of addiction to pharmaceutical narcotics, sedatives, and stimulants in the first half of the twentieth century. It argues, first, that addiction to pharmaceutical drugs is no recent aberration; it has historically been more extensive than "street" or illicit drug use. Second, it argues that access to psychoactive pharmaceuticals was a problematic social entitlement constructed as distinctively medical amid the racialized reforms of the Progressive Era. The resulting drug control regime provided inadequate consumer protection for some (through the FDA), and overly punitive policing for others (through the FBN). Instead of seeing these as two separate stories-one a liberal triumph and the other a repressive scourge-both should be understood as part of the broader establishment of a consumer market for drugs segregated by class and race like other consumer markets developed in the era of Progressivism and Jim Crow.

Early Developments in the Regulation of Biologics.

This article is a history of the policy positions and legal interpretations adopted by the Public Health Service (PHS) under the 1902 Biologics Control Act. PHS generally interpreted the scope of the Act narrowly because it lacked authority to deny marketing licenses for ineffective biologics and wanted to minimize the number of worthless drugs with the imprimatur of a governmental license. In addition, PHS implemented important regulatory strategies not expressly authorized by the Act.

Prohibited or regulated? LSD psychotherapy and the United States Food and Drug Administration.

Over the 1950s and early 1960s, the use of the hallucinogenic drug lysergic acid diethylamide (LSD) to facilitate psychotherapy was a promising field of psychiatric research in the USA. However, during the 1960s, research began to decline, before coming to a complete halt in the mid-1970s. This has commonly been explained through the increase in prohibitive federal regulations during the 1960s that aimed to curb the growing recreational use of the drug. However, closely examining the Food and Drug Administration's regulation of LSD research in the 1960s will reveal that not only was LSD research never prohibited, but that the administration supported research to a greater degree than has been recognized. Instead, the decline in research reflected more complex changes in the regulation of pharmaceutical research and development.

Neoliberal pharmaceutical science and the Chicago School of Economics.

In recent years, science studies scholars have critically examined several methods used by the pharmaceutical industry to exert control over knowledge about drugs. Complementary literatures on 'medical neoliberalism' and 'neoliberal science' draw attention to the economic ideas justifying such methods of organizing knowledge, and in so doing suggest that neoliberal thinkers may play an important role in developing them. As yet, the nature of this role remains unexplored. Relying on heretofore-unexamined archival evidence, this article establishes a direct link between the Chicago School of Economics and the mobilization of the pharmaceutical industry in the 1970s. It argues that economists affiliated with the Chicago School of Economics sought to influence pharmaceutical policy and science and constructed institutions to do so. These institutions--most notably the Center for the Study of Drug Development--remain highly influential. This article contributes to a historical understanding of how neoliberal ideas came to assume prominence in pharmaceutical policy, the management of science, and scientific practice.

The shipwreck of the singular.

In 1962, Louis Lasagna was one of the central figures in the creation of our current drug regulation systems. His influence on the practice of modern medicine, through a series of unanticipated consequences of these systems, has been profound. In the 1960s, he was one of the most progressive thinkers in medicine. By the 1980s, he had apparently become one of the most reactionary. This article attempts to delineate the dilemmas he believed he was dealing with, dilemmas that stemmed from a system he had helped create, that produced this apparent change in orientation. The problems with which he grappled are ones that remain unresolved and indeed, have become more acute. The example of how he attempted to remedy what had gone wrong may provide pointers as to how to solve or how not to solve current difficulties.

'Power to the people': a reply to Healy, Mangin and Applbaum.

In challenging one portion of the history presented in my article, Healy et al. argue that Louis Lasagna was a 'classical liberal' who sought only to increase the scientific stature of the physician--patient encounter. They advance this interpretation to encourage science and technology studies scholars to heed Lasagna's ideas about how to organize the medical marketplace. I argue that Healy et al. mischaracterize Lasagna's ideas. I conclude with an example of these ideas being put into practice, Lasagna's efforts on behalf of Wyeth in the approval and marketing of Redux and Fen-Phen.

[Briefly analysis on academic origins of traditional Chinese medicine dispensing].

Through collecting and collating the development process of traditional Chinese medicine dispensing, the development of modern Chinese medicine dispensing on the basis of experience could be promoted. "Heyaofenji", "Hehe", " Heji" in ancient Chinese medicine, herbal medicine literature and law were collected, and then things were sorted out according to traditional Chinese medicine dispensing theory, skills and legal norms. Firstly, "Tang Ye Jing Fa" is the earliest book which marks the rudiment of traditional Chinese medicine dispensing. Secondly, traditional Chinese medicine dispensing theory formed in "Shen Nong's herbal classic". Thirdly, Zhang Zhongjing's "Treatise on Febrile Diseases" marked the formation of Chinese medicine dispensing skills. Lastly, Provisions in Tang Dynasty law marks the development of traditional Chinese medicine dispensing.

The regulation of nicotine in the United Kingdom: how nicotine gum came to be a medicine, but not a drug.

This article explores the utility of actor-network theory (ANT) as a tool for socio-legal research. ANT is deployed in a study of the evolution of divided regulatory responsibility for tobacco and medicinal nicotine (MN) products in the United Kingdom, with a particular focus on how the latter came to be regulated as a medicine. We examine the regulatory decisions taken in the United Kingdom in respect of the first MN product: a nicotine-containing gum developed in Sweden, which became available in the United Kingdom in 1980 as a prescription-only medicine under the Medicines Act 1968. We propose that utilizing ANT to explore the development of nicotine gum and the regulatory decisions taken about it places these decisions into the wider context of ideas about tobacco control and addiction, and helps us to understand better how different material actors acted in different networks, leading to very different systems of regulation.