Dominique Tobbell's contribution to the expanding corpus of drug studies, Pills, Power, and Policy, is a thoughtful, well researched, and refreshingly well-written study of how a variety of interests shaped drug regulation during the crucial period from the 1950s through the 1970s. Relying on an array of primary source material, trade literature, massive Congressional hearings, and most of the relevant secondary sources, the author carefully crafts the story of how the pharmaceutical industry cultivated scientific and professional alliances that it later used to resist and modify efforts by Congress, the Food and Drug Administration (FDA), and therapeutic reformers to impose stricter controls on drugs. This book is a model of how to capture the intricacies and broad impact of those who have tried to influence policy from outside the government. Tobbell begins by focusing on Merck and Company as a case study of how the pharmaceutical industry developed knowledge networks with the academic research community. Merck was one of the most well-regarded, research pharmaceutical firms since the 1930s, supporting and collaborating with outside researchers, sponsoring postdoctoral fellowships, and offering a working environment for its own scientists that resembled academe. Tobbell demonstrates how these connections developed by Merck and other companies would figure prominently in battles with the federal government over drug bills and regulations in the coming decades. Tobbell also describes how these crucial alliances were extended to health professionals, principally physicians and pharmacists. Here, for example, we learn about the industry's efforts to create state-by-state antisubstitution laws, a response to pharmacists who, swimming in a morass of postwar molecularly modified therapeutic also-rans, started to fill prescriptions for the latest branded drugs with generics. According to Tobbell, by 1959, forty-four states had laws on the books prohibiting such practices. Not wanting to completely alienate pharmacists, however, the industry created the National Pharmaceutical Council to help enhance pharmacy's public image as an important member of the healthcare team. Tobbell relates several public relations efforts by the pharmaceutical industry in the 1950s to help “educate” the public about the good work of the industry. The book's last three chapters analyze how this foundation of networks and public relations efforts figured in the response to regulate pharmaceuticals. Legislators such as Estes Kefauver and Gaylord Nelson began taking a closer look at various industries and the commodities they brokered in the 1950s; drugs in this sense were no different than the steel monopolies. Tobbell documents the industry's three-pronged response to Kefauver and his 1959 efforts to rein in drug pricing, tinker with drug patents, and impose other controls on drug commerce and research. In addition to calling in its extensive network of like-minded researchers and professional organizations like the American Medical Association that railed against perceived threats on their autonomy, the pharmaceutical industry invoked its status as a successful standard bearer of free market competition. The industry also highlighted its efforts to resist the spread of communism by providing life-saving drugs to developing nations, thus anticipating and undercutting Russia's similar efforts to court ideological favor. In the end, Kefauver's principal interests in cost controls failed to shape the 1962 Drug Amendments, but the drug industry's well-orchestrated resistance to reform did not prevent many other provisions that changed the face of drug regulation. Tobbell subsequently explains how the drug industry's trade association attempted to influence policy through its Commission on Drug Safety, which consisted of industry and academic representatives. Little appeared to develop from their recommendations, which had little to do with drug safety and much to do with giving companies and the people who conducted drug research a greater say in how they would be regulated. On the other hand, the Drug Research Board, affiliated with the National Academy of Sciences and lasting from the mid-1960s to the mid-1970s, had some limited success in focusing on the need for more clinical pharmacologists, negotiating some changes in the informed consent regulations, working with the FDA to appoint experts to review thousands of pre-1938 drugs under the drug efficacy study, and homing in on concerns with the therapeutic equivalence of generic drugs. The latter is the focus of the last chapter, and serves as yet another battleground between reformers interested in seeing mandatory use of generics to help control drug costs and those who had both commercial and scientific concerns with a broader place for generics in the therapeutic armamentarium. Here the reformers failed, as Tobbell argues, both because of worries that generic drugs might be chemically but not therapeutically equivalent, and because prescription drug costs in the 1970s were still a small fraction of overall health costs. Tobbell also explains other failed efforts to reform pharmaceutical policies in this decade as largely a matter of bad timing. But by the end of the 1970s, things began to change. Forty states revised their antisubstitution laws by 1979, and in 1984, Congress passed the Hatch–Waxman Act that facilitated expansion of generics in the drug marketplace. Tobbell covers many complex issues in Pills, Power, and Politics astutely and clearly. That so few errors creep in—such as confusing new drug applications with new molecular entities (167 and 184) and the suggestion that advisory committees make the actual decisions about drug approvals (6)—is a credit to her exhaustive research and obvious contemplation of this subject over many years. Some readers might be disappointed that the thrust of this book is on the response to drug policy proposals rather than their creation, particularly within the federal government. Tobbell's focus, however, builds on rich extant work while carving out a new and intellectually significant niche. In sum, anyone interested in how health policy has been shaped will profit from this most enjoyable book.
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Joslyn Swann (2013) studied this question.