Every year, as the first flu epidemic erupts, we are warned of the danger of antibiotics misuse. Antibiotics, physicians say, must be taken only in case of bacterial infectious diseases. Otherwise, not only would they be ineffective in healing the common cold and seasonal flu, but they could be ineffective in case we really need them to cure bacterial infections. However, in the 1950s and the 1960s, antibiotics were largely misused. The Food and Drug Administration (FDA) certified products containing antibiotics and antihistamines for cold cures, despite medical publications bringing evidence against their efficacy.

In this book, Scott H. Podolsky, internist at Massachusetts General Hospital, associate professor of global health and social medicine at Harvard Medical School, and the director of the Center for the History of Medicine at the Francis A. Countway Library of Medicine, brilliantly reconstructs the history of how the debate on antibiotics regulation was crucial in the making of drug regulation legislation in the USA. The book is divided into five chapters. The first introduces the main topics of the book, the birth of the expert in infectious diseases and of antibiotic ‘reformers’, medical investigators who aimed at regulating antibiotic use, and the importance of the introduction of broad-spectrum antibiotics in the transformation of the marketing of ‘wonder drugs’. The second chapter stresses how fixed-dose combination antibiotics catalysed the interest of antibiotic reformers. The third chapter reconstructs the importance of the debate on fixed-dose combination antibiotics in Senator Estes Kefauver's hearings on the pharmaceutical industry between 1959 and 1962, which eventually resulted in the Kefauver-Harris amendments to the Federal Food, Drug, and Cosmetic Act of 1938, which regulated the introduction of new drugs in the USA by allowing the marketing of those drugs that were proved safe. After the Thalidomide disaster, a number of amendments to the law were approved. One of these prescribed that manufacturers had also to provide evidence of the efficacy of their drugs. The FDA also became more meticulous and slow in reviewing drug applications. The fourth chapter deals with the misuse of antibiotics, stressing how federal removal of the inappropriate prescription of appropriate drugs (in 1968 the anaesthesiologist and pharmacologist John Adriani referred to drugs misuse as ‘irrational drugs’) turned out to be ineffective. The fifth chapter describes the evolution of policies on antibiotics regulation and prescription in national and international institutions, such as the World Health Organization, somehow complicating the narrative by showing the conflicting efforts and aims of the different actors.

The focus taken by The Antibiotics Era differs from that of Robert Bud's seminal Penicillin (2007). Indeed, the latter reconstructs the history of antibiotics research and mass production worldwide, with a special interest on Britain and on Anglo-American relations, whereas the former deals with the history of drug control and regulation, along the lines of the other important studies on drug regulation in the USA, such as Peter Temin's Taking Your Medicine (1980), John P. Swann's Academic Scientists and Pharmaceutical Industry (1988), Harry Marks's The Progress of Experiment (2000), Daniel Carpenter's Reputation and Power (2010), and Dominique Tobbel's Pills, Power and Policy (2011). The Antibiotics Era adds an element to the above-mentioned studies: it stresses the role that a number of clinical pharmacologists, such as Max Finland, Harry Dowling, Louis Lasagna and Louis Goodman, played in the reform of the US drug regulatory system. Indeed, the author convincingly argues that the introduction of broad-spectrum antibiotics and the debate on fixed-dose combination antibiotics were central to the reform of the drug regulatory system in the US, both in the elevation of randomized control trials to a position of legal and conceptual dominance, and in the introduction of the principle of usefulness for the certification of drugs by the FDA.

Podolsky's focus on clinical pharmacologists contrasts with that of Harry Marks on biostatisticians, who argued that reformers trusted methods rather than men. Clinical pharmacologists, who at that time were not much acquainted with statistical methods and were not very fond of them, such as Finland, were inclined to consider that clinical investigation ultimately relied on investigators and not on formal procedures. The author carefully analyses the positions and the role of all the actors involved in the story, both individuals and institutions, such as pharmaceutical companies, the American Medical Association, the FDA and the Federal Trade Commission (FTC).

In the book's introduction the author warns the reader that his narrative focuses on the US only. The choice can be justified in the light both of the dominant position of US firms in antibiotics and of the importance of the US in post-war medical research. The author recalls that any local story inevitably ends up collapsing in a global story, and in the book's last chapter he seeks to extend his narratives onto a global scale. The reviewer's main concern goes, however, the other way round. As John Krige often reminds us, twentieth-century science and technology in the US were much more connected globally than American historians usually acknowledge. Readers of the BJHS, for instance, could be interested in knowing whether large-scale randomized trials on Patulin (1944) and on antihistamines (1950) in common-cold therapy performed under the direction of the UK Medical Research Council played any role in the discussions between American clinical pharmacologists. With regard to pharmaceutical companies, it would be interesting to extend the analysis to foreign companies operating in the US. The major Swiss pharmaceutical companies set up subsidiaries in the US, but their strategies were decided in Switzerland. For instance, when, in 1950, producers of ethical drugs, such as CIBA, decided to market antihistamines over the counter, which, after the publication of reports suggesting their value as cold cures, had been certified for over-the-counter sale by the FTC, the crucial decisions were taken in Basle (Novartis Firmenarchiv, containing CIBA, Geygy and Sandoz records, are fully accessible to scholars). Nonetheless, despite this concern The Antibiotic Era is an excellent book and it will clearly become a reference for all scholars interested in the history of twentieth-century medicine and drug regulation.