The Dry Antibiotic Pipeline and the Global Policy Laboratory (1980-2010) [DryAp Project]

For decades after 1945, antibiotics were a powerful symbol of medical technology and progress. But why are there no new classes of antibiotics anymore?

Our project asks how the antibiotic drug pipeline ran dry and it starts from a few hypotheses: In the 1980s, disenchantment with costly screening programs, the customary way to find antibiotics, gained ground. In the 1990s, technology seemed to offer a way out. Synthesizing compounds became automated and so-called targeted drug development, using genomic tools, offered an alternative path to screening. At the same time, a sense of crisis grew with problems of antibiotic innovation and increasing antibiotic resistance becoming part of political debates. By the early 2000s, Big pharma increasingly abandoned antibiotic innovation ­ leaving the field to venture capital-funded, small and medium enterprises. This approach had proven successful for profitable chronic diseases and cancer, but it did not work for antibiotics.

The question of how to re-start antibiotic drug development is high on the agenda of current health politics.

Our project will inform such debates by (1) transforming the notion of the empty pipeline from an often self-serving slogan to a historical concept; (2) providing a complex picture of the generational and gendered dimensions of antibiotic innovation, (3) highlighting the dramatic transformations of pharmaceutical research and development brought about by genomics and venture capital.

At UNISTRA, the Dry Pipeline and Global Policy cluster of the DRYAP Poject analyzes the historical evolution of regulations, legalities, and policies suggested and enforced by countries, pharmaceutical corporations, and non-government organizations relating to antibiotic development and antimicrobial resistance. Particular attention is paid to political entanglements that impacted the development of antibiotics between 1980-2010. 

Erin Paterson is the PhD researcher on this cluster. 

Abstract:

This thesis is a study on the history of antibiotic regulation at the international level between circa 1980 and 2010. The aim is to understand how the narrative of a decline in innovation, research and development of new antibiotics, along with a growing concern about antimicrobial resistance, has arisen internationally. How has this narrative been played out by the many actors involved in the international regulation of medicines? How did it contribute to the adoption of industry-friendly policies from the 2000s onwards, through various incentive mechanisms facilitating the discovery of new molecules and their marketing?

Key focus will be applied to how the actors involved in the field of international drug development and regulation produced a process of 'cognitive alignment' between the 1980s and the late 2000s, where experts ended up adopting the Dry Pipeline narrative and agreeing on solutions to resolve it. Regulations here broadly meaning the setting of international requirements for production, registration, quality control, etc., and the multiple international expert bodies working to facilitate the production, marketing and circulation of antibiotics on a global scale.

Direct focus will be applied to how how pharmaceutical companies have invested in the international arena of antibiotic regulation, by participating in knowledge production activities on an international scale about antibiotic resistance, by defending certain uses (in human and veterinary medicine in particular), or by providing expertise for production requirements. Additional areas of inquiry include international antimicrobial resistance surveillance networks; policies to combat fake antibiotics; the production of codes and guidelines for prudent use, or the standardization of marketing procedures, etc.

Frédéric Vagneron is the PI.