The Pipeline Reading List

The history and social studies of pharmaceutical drug development are flourishing! At the opening conference of the DryAP project in summer 2022, we asked presenters to offer their idiosyncratic suggestions as to which articles or books they thought were important to the field of antibiotic and drug innovation history. Members of the DryAP team also added to this list. We hope that this non-exhaustive bibliography will be of use to others interested in the broader history of antibiotics and pharmaceutical research and development.

Rebecca Glover (London School of Hygiene and Tropical Medicine, LSHTM):

Glover, Rebecca, Andrew Singer, Adam Roberts, and Claas Kirchhelle. “Sale of UK’s Vaccine Manufacturing and Innovation Centre.” BMJ 376 (February 23, 2022): e069999. https://www.bmj.com/content/376/bmj-2022-069999

Comment: Although it does not technically count as original research, this article is important when it comes to “following the money” involved in official R&D decision-making.

Overton, Kristen, Nicolas Fortané, Alex Broom, Stephanie Raymond, Christoph Gradmann, Ebiowei Samuel F Orubu, Scott H Podolsky, Susan Rogers Van Katwyk, Muhammad H Zaman, and Claas Kirchhelle. “Waves of Attention: Patterns and Themes of International Antimicrobial Resistance Reports, 1945–2020.” BMJ Global Health 6, no. 11 (November 1, 2021): e006909. https://doi.org/10.1136/bmjgh-2021-006909

Comment: An important BMJ Global Health article summarising the different waves and themes of attention for AMR at the international level of politics.

Carsten Timmermann (The University of Manchester, Manchester)

Dutfield, Graham. That High Design of Purest Gold: A Critical History of the Pharmaceutical Industry, from 1880 to 2020. Singapore: World Scientific, 2020. https://www.worldscientific.com/worldscibooks/10.1142/11889#t=aboutBook

Comment: An important history of medicines and the commercial actors that make and sell them. This book covers the 140 years since the modern pharmaceutical industry came into being as well as the regulatory frameworks, R&D philosophies, and marketing strategies that have been part and parcel of this process.

Glover, Rebecca and Andrew Singer, Adam Roberts and Claas Kirchhelle. "NIMble innovation-a networked model for public antibiotic trials." The Lancet 2, 11 (2021): E637-E644. https://doi.org/10.1016/S2666-5247(21)00182-8

Comment: This article combines the history of different non-profit modes of pharmaceutical R&D with a social-sciences led analysis of current problems within the antibiotic R&D pipeline to propose a novel non-profit infrastructure of networked R&D and trials institutes for antibiotic innovation.

Hughes, Sally Smith. Genentech: The Beginnings of Biotech. Chicago: University of Chicago Press, 2011.

https://press.uchicago.edu/ucp/books/book/chicago/G/bo8169877.html

Comment: An important history of the origins and take-off of the modern biotech industry with a specific focus on an early international poster-child biotech company..

Timmermann, Carsten. Moonshots at Cancer: The Roche Story. Basel: Editiones Roche, 2019. https://www.research.manchester.ac.uk/portal/files/176797210/Timmermann_Moonshots_At_Cancer_2019.pdf

Comment: A thoroughly researched and important analysis of the shifting R&D and marketing strategies at Swiss pharma giant Roche as well as the growing importance of cancer, biotech, and venture capital within the global pharmaceutical industry.

Robin Wolfe Scheffler (MIT, Boston)

Mikami, Koichi. “Orphans in the Market: The History of Orphan Drug Policy.” Social History of Medicine. Social History of Medicine 32, 3. (August 2019): 609–630, https://doi.org/10.1093/shm/hkx098.

Comment: An important history of the origins and (un)intended consequences of orphan drug policies in pharmaceutical development.

Rasmussen, Nicolas. Gene Jockeys: Life Science and the Rise of Biotech Enterprise. Baltimore: John Hopkins University Press, 2014. https://www.press.jhu.edu/books/title/10825/gene-jockeys

Comment: An important overview of the rise of Biotech Enterprises from the mid-20th century onwards with a strong focus on the USA.

Carpenter, Daniel. Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA. Princeton: Princeton University Press, 2010. https://press.princeton.edu/books/paperback/9780691141800/reputation-and-power

Comment: This book serves as an important guide to US FDA and the major sections of history that were influenced by the FDA since the 1930s.

Nadya Wells (Geneva Graduate School, Geneva)

Roy, V., “Crisis for Cures? Tracing Assetization and Value in Biomedical Innovation.”In Assetization: Turning Things into Assets in Technospecific Capitalism, edited by Karen, Birch and Fabian Muniesa, chapter 4. Cambridge: MIT Press, 2020, https://doi.org/10.7551/mitpress/12075.001.0001

Comment: This chapter analyzes processes of ‘assetization’ to reveal the ways in which structures and practices of valuation in modern finance have become entabled with the valuation of health by patients, physicians, and policy makers as well as resulting impacts on pharmaceutical R&D strategies.

Mazzucato M and HL Li. “A market shaping approach for the biopharmaceutical industry: governing innovation towards the public interest.” Journal of Law, Medicine & Ethics. 49,1 (2021): 39-49. https://doi.org/10.1017/jme.2021.8

Comment: This article analyses current biopharmaceutical markets and diagnoses a lack of directionality to meet key public needs, inefficient collaboration, high prices that fail to reflect the public contribution, and an overly-financialized business model. It proposes a novel ‘market shaping’ approach to overcome challenges.

Dumit J. “Prescription Maximization and the Accumulation of Surplus Health in the Pharmaceutical Industry.” In Lively Capital, edited by Kaushik Sunder Rajan, 45-92. Durham: Duke University Press, 2012, https://www.jstor.org/stable/j.ctv1131900?turn_away=true

Comment: This article introduces the concept of ‘surplus health’, which is defined as ‘the capacity to add medications to our life through lowering the level of risk required to be “at risk.”’

Claas Kirchhelle (University College Dublin, Dublin):

Bud, Robert. Penicillin: Triumph and Tragedy. Oxford: Oxford University Press, 2007, https://global.oup.com/academic/product/penicillin-9780199541614?cc=us&lang=en&

Comment: A brilliant guide through the origins and challenges of the antibiotic era through the biography of the most iconic of all antibiotics - penicillin. In his book, Bud masterfully weaves together the scientific backdrop of the discovery of penicillin and its subsequent development in Oxford with a socio-cultural history of the emergence of the global brand of penicillin, its’ uses, production, and modifications around the world, and the ultimately incomplete responses to antimicrobial resistance (AMR).

Lesch, John, The First Miracle Drugs: How the Sulfa Drugs Transformed Medicine. Oxford: Oxford University Press, 2007, https://global.oup.com/academic/product/the-first-miracle-drugs-9780195187755?cc=us&lang=en&

Comment: This magisterial history of the sulfonamides takes readers on a grand tour spanning from the birth of modern chemotherapy around 1900 to the rise of modern systematized antimicrobial screening in the Bayer laboratories, and the legacies of these first generation antimicrobials for the subsequent boom of biological antibiotics. Lesch is not only adept at picking apart the different disciplinary and industrial traditions that gave rise to the ‘golden era’ of antimicrobial drug development, but also casts important light on the biographies and personal rivalries of key people involved in this story.

Landecker, Hannah. "Antibiotic resistance and the biology of history." Body & Society 22, no. 4 (2016): 19-52, https://doi.org/10.1177/1357034X14561341

Comment: Although technically not about drug development, this article by Hannah Landecker takes readers on a mind-bending journey through the biological consequences of the antibiotic era, the genetic legacies we inhabit, and how taking this biology of history seriously might engender new ways of writing history.

Greene, Jeremy A. Generic: The unbranding of modern medicine. JHU Press, 2014, https://www.press.jhu.edu/books/title/10620/generic

Comment: This fascinating book takes readers on a journey through the history of the modern generics industry as well as wider 20th and 21st century debates about questions of generalizable medical knowledge, bioequivalence, the different values encoded in innovation, and the changing logics of industry and health care systems.

Bjerke, Lise. "Antibiotic geographies and access to medicines: Tracing the role of India's pharmaceutical industry in global trade." Social Science & Medicine 312 (2022): 115386, https://pubmed.ncbi.nlm.nih.gov/36182675/

Comment: This insightful article on antibiotic manufacturing in India uses international trade data to map India's rising importance within the global pharmaceutical indsutry as well as the importance of south-to-south politics for the future of pharmaceutical manufacturing.

Jørgen Leisner (University of Copenhagen, Copenhagen):

Sams-Dodd, Frank. "Target-based drug discovery: Is Something Wrong?" Drug Discovery Today 10, 2 (15 January 2005): 139-147. https://doi.org/10.1016/S1359-6446(04)03316-1

Sams-Dodd, Frank. "Is Poor Research the Cause of the Declining Productivity of the Pharmaceutical Industry? An Industry in Need of a Paradigm Shift." Drug Discovery Today 18, 5-6 (March 2013): 211-217. https://doi.org/10.1016/j.drudis.2012.10.010

Comment: These two papers by Sams-Dodd explore the world behind the scenes of compound screening and executive boardrooms of companies. They explain how superficial ideas may present an easy sell, but may also take you in the wrong direction, screening wise:

Wright, P. M., I. B. Seiple, and A. G. Myers. “The evolving role of chemical synthesis in antibacterial drug discovery.” Angewandte Chemie International Edition England 53, 34 (2014): 8840–8869. https://doi.org/10.1002/anie.201310843

Comment: This article contains an excellent review on synthetic antimicrobials. It puts them on the landscape as opposed to the natural reservoir of natural antimicrobials for which a coherent framework for understanding their distribution and variety, including target spectrum, still to a large extent is lacking.

Greenwood, David. Antimicrobial Drugs: Chronicle of a Twentieth Century Medical Triumph. Oxford: Oxford University Press, 2008, https://global.oup.com/academic/product/antimicrobial-drugs-9780199534845?cc=us&lang=en&

Comment: A very inspiring and useful book, especially because of its mixture of scientific descriptions and historical content.

Laura Martinenghi (University of Copenhagen, Copenhagen)

Drews, Jürgen. “Drug Discovery: A Historical Perspective.” Drug Discovery 287. (2000): 1960-1964. DOI: 10.1126/science.287.5460.1960

Comment: As Jürgen Drews says in this article, “History does not repeat itself—at least not simply and linearly.” Here, the former chair of Roche’s research board depicts a historical journey merged with pharmaceutical and biotechnology perspectives, filled with interesting points of view that are applicable even 20 years later. This article expands on his book: Drews, Jürgen. In Search of Tomorrow's Medicines. New York: Springer, 1999.

Chandler, Clare. Addressing Antimicrobial Resistance through Social Theory: An Anthropologically Oriented Report. London: London School of Hygiene & Tropical Medicine, 2016, https://antimicrobialsinsociety.org/essential-reading/chandler-et-al-2016/

Comment: This work defines the antimicrobial resistance issue from a social science perspective. It is a thorough review of antibiotics that follows the point of view of development through the applications and mapping of different solutions. It is very inspiring.

María J Santesmases (Institute of Philosophy at the Consejo Superior de Investigaciones Cientificas (CSIC), Madrid).

Bud, Robert F. "Strategy in American cancer research after World War II: A case study." Social studies of science 8, 4 (1978): 425-459, https://journals.sagepub.com/doi/abs/10.1177/030631277800800402?journalCode=sssb

Comment: This early essay by Robert Bud is an important survey of early drug screening efforts in the United States.

Gaudillière, Jean-Paul. "The living scientist syndrome: memory and history of molecular regulation." In The historiography of contemporary science and technology, edited by Thomas Söderquist, 109-128. London: Routledge, 2013, https://www.taylorfrancis.com/chapters/edit/10.4324/9780203726914-7/living-scientist-syndrome-jean-paul-gaudilli%C3%A8re

Comment: Gaudillière’s essay is an insightful reflection on methods for approaching the historical study of living scientists.

Serrano, Elena, Joris Mercelis, and Annette Lykknes. "“I am not a Lady, I am a Scientist.” Chemistry, Women, and Gender in the Enlightenment and the Era of Professional Science." Ambix 69, 3 (2022): 203-220, https://www.tandfonline.com/doi/pdf/10.1080/00026980.2022.2100954

Comment: This article is a very clear, useful and brief introduction to the issue of women in the sciences and knowledge production.

Kirchhelle, Claas. Pyrrhic progress: the history of antibiotics in Anglo-American food production. New Brunswick: Rutgers University Press, 2020, https://www.ncbi.nlm.nih.gov/books/NBK554200/

Comment: Kirchhelle’s open access monograph is the first comprehensive overview of antibiotic use, resistance, and regulation in food production on both sides of the Atlantic.

Ortiz-Gómez, Teresa, and María Jesús Santesmases. “Introduction” in Gendered drugs and medicine: historical and socio-cultural perspectives, edited by Teresa Ortiz-Gómez, Teresa, and María Jesús Santesmases, 1-22. London: Routledge, 2016, https://books.google.fr/books?hl=en&lr=&id=Q_AGDAAAQBAJ&oi=fnd&pg=PP1&dq=Ortiz-G%C3%B3mez,+Teresa,+and+Mar%C3%ADa+Jes%C3%BAs+Santesmases.+%E2%80%9CIntroduction%E2%80%9D+in+Gendered+drugs+and+medicine:+historical+and+socio-cultural+perspectives,+edited+by+Teresa+Ortiz-G%C3%B3mez,+Teresa,+and+Mar%C3%ADa+Jes%C3%BAs+Santesmases,+1-22.+London:+Routledge,+2016.&ots=I3D8OwFHfw&sig=T8BJm4qUe82j3NsTA8g-uhciy5g&redir_esc=y#v=onepage&q&f=false

Comment: The authors provide a concise introduction to the gendered histories encoded in modern drug research and development.

Christoph Gradmann (University of Oslo, Oslo)

Hillier, K. "Babies and Bacteria: Phage Typing, Bacteriologists, and the Birth of Infection Control." Bulletin of the History of Medicine 80. (2006): 733-761, https://www.jstor.org/stable/44449593

Comment: This paper brilliantly tells the story of how laboratory diagnostics that used phages and epidemiology defined drug resistance in the 1950s.

Tansey, E. M., Ed. “Post penicillin antibiotics: from acceptance to resistance. A Witness Seminar.” London: Wellcome Institute for the History of Medicine. (12 May 1998), https://archive.org/details/postpenicillinan00witn

Comment: In this most interesting oral history witness seminar, witnesses discuss how the antibiotic utopia eroded.

Gradmann, C. "Re-Inventing Infectious Disease: Antibiotic Resistance and Drug Development at the Bayer Company 1945-1980." Medical History 59. (2016): 155-180, https://www.cambridge.org/core/journals/medical-history/article/reinventing-infectious-disease-antibiotic-resistance-and-drug-development-at-the-bayer-company-194580/18346FF43B01B112D1A5256829F50B53

Comment: The paper draws a line from studying drug resistance to pharmaceutical marketing. It’s about how a company used resistance to imagine future markets. It is perhaps the most important source for DryAP’s research question.

Isabel Gómez (Institute of Philosophy at the Consejo Superior de Investigaciones Cientificas (CSIC), Madrid).

Silver, L. L. “Challenges of antibacterial discovery.” Clinical microbiology reviews, 24, 1. (2011): 71–109. https://doi.org/10.1128/CMR.00030-10

Comment: This exhaustive review offers a comprehensive landscape of the process, actors and approaches to antibacterial discovery. It not only allows for an insightful understanding of antibiotic research, but this article also highlights the discovery void from a historical and experimental perspective.

Hinchliffe, Steve. “Postcolonial Global Health, Post-Colony Microbes and Antimicrobial Resistance.” Theory, Culture & Society 39, 3. (2022): 145–168. https://doi.org/10.1177/0263276420981606

Comment: Throughout this provocative article, microbes and, more specifically, antimicrobial resistant bacteria, are presented as agents and social actors of power hierarchies and dominance relations. This perspective inspires innovative and more critical approaches to AMR, avoiding dichotomies while also paying attention to the cultural and economic differences within this global concern.

Hardon, A. and E. Sanabria. “Fluid Drugs: Revisiting the Anthropology of Pharmaceuticals.” Annual Review of Anthropology 46, 1. (2017): 117-132. https://doi.org/10.1146/annurev-anthro-102116-041539

Comment: This review questions the interpretation of drugs and how they are reflected by the sociocultural factors that contribute to their construction. It examines different aspects of clinical and pharmaceutical research, and it shows how medicines can’t be considered as (nor reduced to) pure chemical components. Instead, medicines are constantly made, adapted, and appropriated in changing social milieus.

Erin Paterson (University of Strasbourg, Strasbourg)

Podolsky, Scott. The Antibiotic Era: Reform, Resistance, and the Pursuit of a Rational Therapeutics. Baltimore: John Hopkins University Press, 2015. https://www.press.jhu.edu/books/title/11299/antibiotic-era

Comment: Podolsky’s book offers an in depth look at the history of antibiotic development and the timeline of key events along the process specifically within the United States. It reviews discussion of reform, and the various political and regulatory machinations that have influenced antibiotics since their inception.

Baxerres, Carine and Maurice Cassier, eds. Understanding Drugs Markets: An Analysis of Medicines, Regulations, and Pharmaceutical Systems in the Global South. New York: Taylor & Francis Group, 2022. https://www.routledge.com/Understanding-Drugs-Markets-An-Analysis-of-Medicines-Regulations-and-Pharmaceutical/Baxerres-Cassier/p/book/9780367350673

Comment: Although not primarily focused on Antibiotics, Understand Drug Markets highlights Benin, Ghana, Côte d’Ivoire, and Cambodia’s drug markets and how the structures and systems are put into place. When mentioned, and when put into extenuating context, this book is invaluable for setting the scene as to why certain polemics occur within the “Global South” that are not as evident in the “Global North” context. By looking at how and why these pharmaceutical systems and methods of disbursement are arranged, the factors that led to common issues leading to AMR, such as the overuse/misuse of antibiotics or poor quality of drugs, become more evident.

Mossialos, Elias, Chantal M. Morel, Suzanne Edwards, Julia Berenson, Marin Gemmill-Toyama, David Brogan. Policies and Incentives for Promoting Innovation in Antibiotic Research. Copenhagen: World Health Organization, 2010. https://apps.who.int/iris/bitstream/handle/10665/326376/9789289042130-eng.pdf

Comment: This book breaks down AMR into several different digestible categories for consideration: the background on antibiotics on their own, the background on AMR, the causes of AMR, the reasons for limited innovation, health system responses, and an analysis on opportunities to stimulate research and development. Though relatively short, it covers a broad spectrum of the issues faced within the AMR crisis and offers perspectives, suggestions, and input on how to circumvent various challenges.

Mirza Alas Portillo (University College Dublin, Dublin)

Glover, Rebecca E., Mark P. Petticrew, Nicholas B. Mays, and Claire Thompson. “How Pharmaceutical and Diagnostic Stakeholders Construct Policy Solutions to a Public Health ‘Crisis’: An Analysis of Submissions to a United Kingdom House of Commons Inquiry into Antimicrobial Resistance.” Critical Public Health, January 24, 2022, 1–10. https://doi.org/10.1080/09581596.2022.2026296.

Comment: This article analyzes how solutions to crises such as antimicrobial resistance are framed at the policy level by commercial interests, and this shapes particular narratives on possible solutions.

Denyer Willis, Laurie, and Clare Chandler. “Quick Fix for Care, Productivity, Hygiene and Inequality: Reframing the Entrenched Problem of Antibiotic Overuse.” BMJ Global Health 4, no. 4 (August 1, 2019): e001590. https://doi.org/10.1136/bmjgh-2019-001590

Comment: This article analyzes how antibiotics play a critical role in society beyond their essential role in medicine. Antibiotics are also considered a critical infrastructure and have become essential ‘quick fixes’ for many complex issues. As Laurie Denyer Willis and Clare Chandler state: Antibiotics “are a quick fix for care in fractured health systems; a quick fix for productivity at local and global scales, for humans, animals and crops; a quick fix for hygiene in settings of minimised resources; and a quick fix for inequality in landscapes scarred by political and economic violence.”

Belma Skender (University of Oslo, Oslo)

Aníbal de J. Sosa, Denis K. Byarugaba, Carlos F. Amábile-Cuevas, Po-Ren Hsueh, Samuel Kariuki, Iruka N. Okeke (eds.). Antimicrobial resistance in Developing Countries, Springer-Verlag New York. 2010. ISBN 978-0-387-89369-3. https://link.springer.com/book/10.1007/978-0-387-89370-9#bibliographic-information

Comment: As the title suggests, the book provides a comprehensive overview of antibiotic resistance in developing countries. It is organized into four big parts starting from resistance in general and then moving into more complex chapters of use and misuse, cost, policy, and regulations around antimicrobials.

Stuart B. Levy. The Antibiotic Paradox: How Miracle Drugs Are Destroying the Miracle, by. Second Edition. Perseus Publishing. 2002. ISBN 0-306-44331-7. https://link.springer.com/book/10.1007/978-1-4899-6042-9

Comment: This ‘classic antibiotic bestseller’ is divided into 11 chapters discussing antibiotics from the science point towards more social topics related to antibiotic use, emergence of resistance and its impact. It tells us a fascinating story about the world of bacteria and the human nature of controlling it by looking for a ‘miracle drug’. The ‘antibiotic paradox’ describes how the best agents of treating bacterial infections are also the best agents for propagating resistance when misused or overused.

Jeremy A. Greene, Flurin Condrau, and Elizabeth Siegel Watkins (eds.). Therapeutic Revolutions: Pharmaceuticals and Social Change in the Twentieth Century, Chicago: University of Chicago Press, 2016. ISBN: 978-0226390871. https://press.uchicago.edu/ucp/books/book/chicago/T/bo24313074.html

Comment: The book examines the notion of therapeutic revolution (C. E. Rosenberg from 1977) in the series of articles across history of medicine, medical anthropology, and social studies on medicine. The arguments are built around the question ‘What is revolutionary about therapeutics?’ positioning the notion as a narrative of the past and not an event in itself. Although the book is not focused primarily on the antibiotics, it does provide a chapter from Scott H. Podolsky and Anne K. Lie on the idea of past futures in the context of the so-called antibiotic revolution. Podolsky and Lie argue that examining these forgotten events can provide us with a comprehensive information about scientific and cultural context at the time.