Producing Standards, Producing the Nordic Region: Antibiotic Susceptibility Testing, from 1950–1970

Lie, Anne Kveim

doi:10.1017/s0269889714000052

Cited by 12 publications

(7 citation statements)

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“…1 In the case of Europe and North America, historians have shown that distinct national antibiotic usage patterns have become socially entrenched over decades. [77][78][79][80][81] To this day, antibiotic usage patterns vary across Europe and North America despite both regions' close economic, political and cultural ties. 82 83 Differences of usage are even more substantial between HICs and LMICs with patients in the latter countries often depending to a much stronger degree on the efficacy BMJ Global Health of a limited number of locally available, affordable and easily administrable drugs-particularly in areas where there is no access to professional healthcare facilities.…”

Section: Prioritisationmentioning

confidence: 99%

Setting the standard: multidisciplinary hallmarks for structural, equitable and tracked antibiotic policy

et al. 2020

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There is increasing concern globally about the enormity of the threats posed by antimicrobial resistance (AMR) to human, animal, plant and environmental health. A proliferation of international, national and institutional reports on the problems posed by AMR and the need for antibiotic stewardship have galvanised attention on the global stage. However, the AMR community increasingly laments a lack of action, often identified as an ‘implementation gap’. At a policy level, the design of internationally salient solutions that are able to address AMR’s interconnected biological and social (historical, political, economic and cultural) dimensions is not straightforward. This multidisciplinary paper responds by asking two basic questions: (A) Is a universal approach to AMR policy and antibiotic stewardship possible? (B) If yes, what hallmarks characterise ‘good’ antibiotic policy? Our multistage analysis revealed four central challenges facing current international antibiotic policy: metrics, prioritisation, implementation and inequality. In response to this diagnosis, we propose three hallmarks that can support robust international antibiotic policy. Emerging hallmarks for good antibiotic policies are: Structural, Equitable and Tracked. We describe these hallmarks and propose their consideration should aid the design and evaluation of international antibiotic policies with maximal benefit at both local and international scales.

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Section: Prioritisationmentioning

confidence: 99%

Setting the standard: multidisciplinary hallmarks for structural, equitable and tracked antibiotic policy

et al. 2020

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“…The main framework of this system was established already in 1928. Key features of the system were shared with the other Nordic countries, whose drug laws are routinely cited as the earliest of their kind . It established the principle that a drug had to be approved of before it could be legally sold—that is, preapproval, also referred to as registration, market authorization, or licensing.…”

Section: Context Of Origin: Containing “A Flood Of Drugs”mentioning

confidence: 99%

Less Is More: Norwegian Drug Regulation, Antibiotic Policy, and the “Need Clause”

Hobæk

Lie

2019

Milbank Quarterly

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The current crisis of antibiotic resistance calls for policy reforms locally and globally. Historical insight in different regulatory systems can inform current decision making. A strong regulatory control implementing antimicrobial resistance concerns can ensure the combined objective of promoting access and limiting excess use by letting only certain drugs onto the market in compliance with public health needs. Regulation at this level also has powerful effects on consumption and needs to be considered as a tool for curbing antibiotic resistance. The Norwegian drug regulatory procedures was an example of how national drug regulatory authorities can promote innovation of new drugs that meet public health needs indirectly by accepting only drugs of added therapeutic value. Context Antibiotic resistance is an increasingly serious threat to global health that requires coordinated action. Most current policy efforts address the lack of medicines. There is also a need for new thinking on promoting access to all who are in need of antibiotics, while simultaneously curbing inappropriate use. As the situation calls for new approaches, we examined one drug regulatory system in which antimicrobial resistance (AMR) has been on the agenda for a long time. The Norwegian drug regulatory system, and particularly its “need clause,” has been invoked in international debates but not previously studied in detail. Methods We conducted a historical review of the Norwegian drug regulatory system by examining the archives of the Norwegian health authorities, the Norwegian Medicines Agency, and policy debates in the period. Findings The Norwegian drug regulatory system focused on the rational use of drugs, tied closely to public health needs. It was originally written to address unnecessary consumption of drugs, not consumer protection and safety. The most flexible element within this system stated that a drug must be “needed” in order to be registered. When antibiotic resistance became a concern, it limited the market entry of drugs considered to promote resistance, such as combination and broad‐spectrum products. This was a powerful and flexible regulatory device that also influenced drug consumption. Conclusions The need clause has lately been promoted as an alternative to address the current situation. The solutions to the problem of antibiotic resistance cannot be the same everywhere, and we do not argue that this drug regulatory system should be adopted globally. However, the current situation calls for consideration of many different aspects. This historical case demonstrates how regulatory procedures can be used to limit market entrance and promote appropriate use simultaneously.

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“…Drug resistance had become a significant issue by that time, at least among some biomedical researchers in the US, Norway and Japan, and would continue to increase in significance, intensifying warnings, research interest and funding to combat resistance as a phenomena produced by drug use both in the microbiological laboratory and the clinic (Creager, 2007;Gradmann, 2011;Lie, 2014;Podolsky, 2010Podolsky, , 2014. But according to Lederberg's interpretation, presented in Stockholm in May 1959, the cell was killed by these substances before they accessed chromosomes and become mutagenic.…”

Section: Transits Of the Bacterial Cell Wallmentioning

confidence: 99%

“…On the history of drug patenting seeGaudillie`re (2008),Romero de Pablos (2011, 2014 andHu¨ntelmann (2012).2 A staining technique designed by H.C. Gram in the late 1880s, combined crystal violet dye and an iodine salt as a mordant to fix the dye. The technique divided cells into those that were tainted by this combination and those that were not.…”

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confidence: 99%

The Bacterial Cell Wall in the Antibiotic Era: An Ontology in Transit Between Morphology and Metabolism, 1940s–1960s

Santesmases

2015

J Hist Biol

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This essay details a historical crossroad in biochemistry and microbiology in which penicillin was a co-agent. I narrate the trajectory of the bacterial cell wall as the precise target for antibiotic action. As a strategic object of research, the bacterial cell wall remained at the core of experimental practices, scientific narratives and research funding appeals throughout the antibiotic era. The research laboratory was dedicated to the search for new antibiotics while remaining the site at which the mode of action of this new substance was investigated. This combination of circumstances made the bacterial wall an ontology in transit. As invisible as the bacterial wall was for clinical purposes, in the biological laboratory, cellular meaning in regard to the action of penicillin made the bacterial wall visible within both microbiology and biochemistry. As a border to be crossed, some components of the bacterial cell wall and the biochemical destruction produced by penicillin became known during the 1950s and 1960s. The cell wall was constructed piece by piece in a transatlantic circulation of methods, names, and images of the shape of the wall itself. From 1955 onwards, microbiologists and biochemists mobilized new names and associated conceptual meanings. The composition of this thin and rigid layer would account for its shape, growth and destruction. This paper presents a history of biochemical morphology: a chemistry of shape - the shape of bacteria, as provided by its wall - that accounted for biology, for life itself. While penicillin was being established as an industrially-manufactured object, it remained a scientific tool within the research laboratory, contributing to the circulation of further scientific objects.

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Producing Standards, Producing the Nordic Region: Antibiotic Susceptibility Testing, from 1950–1970

Cited by 12 publications

References 40 publications

Setting the standard: multidisciplinary hallmarks for structural, equitable and tracked antibiotic policy

Setting the standard: multidisciplinary hallmarks for structural, equitable and tracked antibiotic policy

Less Is More: Norwegian Drug Regulation, Antibiotic Policy, and the “Need Clause”

The Bacterial Cell Wall in the Antibiotic Era: An Ontology in Transit Between Morphology and Metabolism, 1940s–1960s

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