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Streptomycin, 1946 Streptomycin, 1946: British central administration of supplies of a new drug of American origin with special reference to clinical trials in tuberculosis Alan Yorke Yoshioka Thesis submitted for the degree of Doctor of Philosophy, Imperial College of Science, Technology and Medicine University of London 1998 Abstract This thesis is the first detailed and integrated account of the introduction of the antibiotic drug streptomycin to Britain shortly after the Second World War. Based largely on archives of the Medical Research Council (MRC) and other Departments, it describes how the central government handled imports, production, distribution and clinical research. It provides an alternative to a literature focusing narrowly on the research methods used in the MRC's clinical trials. Streptomycin, isolated in the USA in 1943, was developed commercially under government control, following the model of penicillin. Laboratory results suggested that streptomycin was potentially useful in treatment of several diseases, including tuberculosis, which was then a major public health problem in many countries. The Ministry of Health anticipated a surge of public demand for this drug, that was then extremely expensive in its country of origin and not yet available in the UK, while there was still little sound evidence of its effect in human disease. The Ministry of Supply agreed to allow industrial firms to develop facilities to produce enough streptomycin for the MRC to ascertain its clinical value; however, domestic production was continually delayed. Following months of frustration of British attempts to procure even small quantities of streptomycin from the USA, finally, in November 1946, American export control authorities released a huge quota of the drug at a cost of £80,000. The Treasury approved the purchase, which was earmarked for research. Drawing attention to the management of material resources through selective framing of knowledge, this thesis provides a portrait of the work of technical experts within a bureaucratic system, and it reveals how the shortage of streptomycin shaped the existence and form of an important research programme. 2 Table of Contents Acknowledgements 4 1. Introduction 6 2. The research background: chemotherapy of tuberculosis 18 3. Demand and distribution 36 4. Production policy 94 5. Imports 128 6. Clinical trials 154 7. Purchase of streptomycin 187 8. Conclusion 215 Appendices A. Dramatis personae 225 B. The MRC's standard statement, sent during Autumn 1946, in response to requests for streptomycin for treatment of tuberculosis 232 C. Attendance at streptomycin clinical trials (tuberculosis) planning meetings 233 D. Appeal to Hale, 11 Nov 1946 234 Bibliography 238 3 Acknowledgements Over my time in London I have accumulated many debts. It is a pleasure here to thank all those who helped me, even if it is not possible to name every one. The longer the list, the more invidious the omissions may appear, but no slight is intended. I offer my thanks to the following: For encouragement, insightful reading and knowing when to let me get on with it: my supervisors, Andy Warwick and Chris Lawrence. For fmancial assistance: the Welicome Trust, the Committee of Vice- Chancellors and Principals, Peter Bartlett, Alan O'Connor and my mother. For arranging part-time work: Bill Bynum and David Edgerton. For logistical support: Ainslee Rutledge, Sally Bragg, Sarah Sullivan, and the rest of the staff of the Welicome Institute for the History of Medicine. For generous assistance with last- minute preparation of the thesis: Henriette Bruun. For research assistance: the staff of the libraries of the Weilcome Institute, Imperial College and Science Museum, St Mary's Hospital, University of London, University College London, London School of Hygiene and Tropical Medicine, and Medical Research Council; the staff of the Public Record Office; Janice Goldbloom of the National Academy of Sciences-- National Research Council; Majorie Ciarlante and other staff of the United States National Archives; staff of Rutgers University special collections; the staff of the National Archives of Canada; Gail Pietrzyk of the University of Pennsylvania special collections; Elizabeth Grout, Jeffrey Sturchio and others of Merck & Co. For access to archival material: Merck & Company. Crown copyright material in the Public Record Office is reproduced by permission of the Controller of Her Majesty's Stationery Office. For orienting me in the field of tuberculosis research: Prof Denis Mitchison, Prof Wallace Fox, Prof Sir John Crofton, Prof Guy Scadding, Dr Noel Snell, the late Dr Trevor Mann, and especially Dr Philip Hart. For help with sources on streptomycin: Prof Albert Schatz and Prof Doug Eveleigh. For assistance at an early stage of the project: Dr Raymond Wrighton, Sir Richard Doll, Prof Peter Armitage, Sir Christopher Booth, Dr Stephen Lock, Prof Peter 4 Elwood and the staff of the MRC Epidemiology Unit (South Wales). For access to unpublished material: Robert Bud, Desirée Cox, Steve Epstein, Ilana Lowy, Donald McGraw, Harry Marks, J. Rosser Matthews, Marcia Meidrum, Guy Scadding, Ben Toth, and Lise Wilkinson. For opportunities to present my work: the American Association for the History of Medicine, Mark Jackson, Roy Porter, Tilli Tansey, and others. For critical feedback and stimulating discussions: Geoffrey Asherson, Peter Bartlett, Roberta Bivins, Tim Boon, John Carson, Arthur Daemmrich, David Edgerton, Steve Epstein, Gina Feldberg, Elsbeth Heaman, Sarah Hodges, Rob Iliffe, Kate Krug, Vaida Leighteizer, Harry Marks, Lara Marks, Marcia Meidrum, Boris Morrice, Paulo Palladino, Russel Potts, Lois Reynolds, Tilli Tansey, Ben Toth and many others. For much more than a roof over my head: David Cook, Kan-Wen Ma, Biranj Pate! and Josh Ruxin. For hospitality during research trips: Lisa Davis, Robert Davis, Doug Green, Neal Loevinger, Arwen Mohun, Mark Pakianathan, James Preston, Erik Rau, Ted Yoshioka. For "space": Mike Fielder. And for just helping me to get through it: Bill Alexander, Peter Bartlett, Roberta Bivins, Sally Bragg, Jackie Britton, Steve Browning, Henriette Bruun, Chris Cavanagh, Barb Cook, Ann Daily, Sunny Delaney, Ian Digby, Michael Edwards, Sue Ferry, Philip Gatter, Julie George, Naim Hans, Leif Harmsen, Natsu Hattori, Elsbeth Heaman, Nick 44ner, Glen Holman, Dominic Janes, Carla Keirns, Kamil Keliner, Geoffrey Kibby, Rob Lamb, Shang-Jen Li, Jeff Lindstrom, Eileen Magnello, Greg Mann, Jarlath O'Connell, Graham Parker, Kim Pelis, Bob Perks, Robert Pritchard, Doug Robinson, Helen Rozwadowski, Aram Rudenski, Liz Russel, Norris Saakwa-Mante, Sonu Shamdasani, Jim Strick, Cassie Watson, Neil Watson, Sigrid Werner, Jonathan Whiteland, Dorothy Winsor, Andrew Yoshioka, Ted Yoshioka, and many others, especially Tim Boon, Kate Krug, Valda Leighteizer, and Anja Rutten. 5 Chapter 1. Introduction 1.1 Overview In January 1947, the first patients were enrolled in an experiment that would become a landmark in medical history, the clinical trial of the antibiotic streptomycin in pulmonary tuberculosis. Although no one knew for sure whether this substance, discovered in 1943, would turn out to be another 'miracle drug' like insulin or penicillin, many scientists and members of the British public had high hopes. Tuberculosis, the countly's leading killer of young adults, might finally be treated more effectively than with months of rest in a sanatorium. Doctors and patients by the hundreds were trying in vain to obtain streptomycin from the Medical Research Council (MRC), which held almost the whole supply in the country. The government had just imported from the USA a massive stock of the product, 50 kilograms, and decided to sponsor domestic manufacture. The Treasury was preparing to spend £140,000 on streptomycin clinical trials, more than on all of the MRC's other clinical research projects combined. But a year earlier, at the start of 1946, the situation had been very different. Hardly any members of the public had heard of streptomycin. The MRC was unable to procure so much as 500 grams of the substance. And the question of British government subsidies for production was not even on the agenda. How could the position change so drastically in such a short time? Why did the British government purchase such a huge quantity of the drug? Why did it conduct its own clinical trials at all? The existing historical literature, consisting of brief and fragmentary accounts, does not answer such questions. This thesis provides the first detailed and integrated account of the introduction of streptomycin to Britain. It brings together aspects of the streptomycin story that have been discussed in isolation: imports, production, distribution and research. We shall see that once all these pieces are in place, this will lead to a revision of each of the partial stories that have been written. I place supplies of streptomycin at the very heart of my account. Hundreds of letters and memos dealt with issues of supply: attempts to import the drug from 6 the USA, attempts to ensure that stocks of it did not go to waste, uncertainty about whether to boost domestic production. These were among the British Government's primary concerns around streptomycin; by contrast, during the whole of 1946 the now well-known scheme of random allocation of patients in one of the clinical trials was mentioned in a single letter. In the course of providing an account of the introduction streptomycin, I will thus also provide an alternative account of the streptomycin clinical trials, correcting the emphasis in existing literature on that sub-topic. Streptomycin deserves historical attention for many reasons. It was the second antibiotic to come into widespread use, after penicillin. It was phenomenally expensive at first, coming onto a restricted market early in 1946 at a cost of $16 per gram, worth more than its weight in gold. Its commercial success helped create a boom in the pharmaceutical industry. Along with insulin, penicillin and suiphonamides before it, and cortisone afterwards, it belonged to a relatively small class of substances that were hailed by the general public as 'miracle drugs' and helped to tranform doctor-patient relationships.
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