Ways of Regulating Drugs in the 19th and 20th Centuries eds. by Jean-Paul Gaudillière and Volker Hess (review)

Ways of Regulating Drugs is a collection of essays on pharmaceutical history knitted together by an unusually well-developed theoretical framework. “Regulation” typically refers to rule making or enforcement by a state; Gaudillière and Hess argue that historians need to recognize a much broader range of interacting drug regulators, each with their own “internal logic, . . . practices and procedures . . . [and] rationalities underpinning the management of therapeutic agents” (p. 7). In addition to “administrative” (state) regulation, the editors propose four other types: professional (by physicians and pharmacists), industrial (by drug companies), public (by the media, patients, and NGOs), and finally juridical (by courts). To understand pharmaceuticals, all of these must be taken seriously as distinct if tightly connected actors. Toward this goal, Ways of Regulating Drugs presents twelve very wide-ranging, generally excellent, and often quite specialized chapters.

Many chapters emphasize that drug trajectories are shaped by the (often fractious) interaction of multiple regulators. Volker Hess’s opening chapter on the regulation of “secret remedies” in nineteenth-century Prussia, for example, uses public controversies to explore a surprisingly modern effort to harness medical expertise to state regulation while preventing a “capture” of one by the other. Harry Marks (posthumously, in a volume dedicated to his memory) investigates the troubles of a modern effort to accomplish a similar feat: the seeming inescapability of drug controversies in the twentieth-century United States, he argues, is a structural consequence of a hybrid state-professional system designed to protect physician autonomy. Jean-Paul Gaudillière sees connections between industrial and state regulation in the fate of herbalists in the modernizing drug regimes of mid-twentieth-century Germany and France. Industrialized German herbalists, he notes, were able to secure licensure in a new system whose epistemology they shared; French herbalists, who had not industrialized, lost their official status. Alberto Cambrosio, Peter Keating, and Andrei Mogoutov use a case study of cancer trials in the 1970s and 1980s to argue that regulation is a recursive process, one of many “informational enhancements” that transform drugs from stable chemicals into evolving “drug regimens.” And Toine Pieters and Stephen Snelders find that the rise and fall of best-selling sleep drug Halcion in the 1970s and 1980s was powered by dynamic interactions among marketing, research, lawsuits, media, and the state regulators trying to navigate them all.

Other chapters use the “regulating” framework to bring new perspectives to players not always understood as agents of drug control. Christian Bonah’s chapter on Stalinon in postwar France, for example, points out that courts served as regulators in a drug controversy where the state response was hobbled by its own previous approval of the drug. In a case study of the British firm Imperial Chemical Industries (ICI), Vivian Quirke argues that drug companies themselves should be understood as regulators; ICI, she notes, had long implemented a drug safety regime, and in the post–World War II era this regime evolved (most importantly by integrating biomedical disciplines) in response to state demands. Axel Huntelmann’s chapter on Paul Ehrlich shows that researchers, too, can be regulators. Ehrlich’s methodical approach to developing, testing, and circulating information about Salvarsan enabled the drug to survive a round of bad publicity and a potentially damning lawsuit.

Many chapters wrestle intelligently with one of the most difficult challenges of pharmaceutical history: reckoning meaningfully with the role of drug users and their communities in a story often dominated by experts and authorities. Some confront the thorny issue quite directly. In examining American controversies over the diabetes drug Orinase in the 1970s, for example, Jeremy Greene uncovers how state, industrial, and professional regulators all sought to influence the public by circulating competing information about the drug’s safety; consumers thus played a real role in the regulatory drama. Ilana Löwy explains that...