Pills, Power, and Policy: The Struggle for Drug Reform in Cold War America and Its Consequences (review)

Today, concerns regarding the incentivizing of the pharmaceutical industry, the affordability of medicines, and the “capture” of the medical profession by industry reverberate throughout both academic and congressional debate. Yet as Dominique Tobbell relates, these are not new concerns. Daniel Carpenter has recently analyzed in detail the means by which the FDA enlarged its scope of regulation throughout the latter half of the twentieth century to become arguably the most important regulatory agency in the world. Yet the federal government could have gone still further. And Tobbell, in this well-researched and skillfully argued volume, explores how the pharmaceutical industry and its allies in the medical profession forestalled still more aggressive reform in the second half of the twentieth century, setting the stage for the ongoing debate and reform efforts of the twenty-first century.

The 1938 Federal Food, Drug and Cosmetic Act, as Carpenter has written, mandated that drugs be determined safe prior to their release for interstate sale, necessitating increased investment in the testing of drugs. Expanding upon the work of John Swann and Nicolas Rasmussen, Tobbell begins by examining how the drug industry and academic medicine expanded their mutually beneficial relationships in the post–World War II era partly to meet this need. For an increasingly research-oriented drug industry, relationships with medical schools and their faculty not only provided access to leading scientists but also helped to enable the training of the emerging cadre of “clinical pharmacologists” who could evaluate their products. For academia, industry funding provided the support required by their faculty, independent of government direction or oversight.

Such relationships would be put to the test by the end of the 1950s. As concerns regarding the prices of the wonder drugs escalated, the leading research-oriented pharmaceutical firms banded together. They could not, however, fend off Senator Estes Kefauver’s muckraking investigation and congressional hearings into the drug industry beginning in 1959, as lines were drawn between reformers in Congress and academic medicine on the one hand, and the pharmaceutical industry, the American Medical Association, and cultivated allies from academic medicine on the other. Industry and its allies invoked Cold War rhetoric regarding the need for an unshackled wonder-drug-producing industry both for the health of the American people and for a potential worldwide battle against communist pharmaceutical purveyors. And while the Kefauver–Harris Amendments of 1962 mandated the formal proof of drug efficacy and introduced the phased system of drug review existing today, more radical measures attending to patents were successfully kept out of the final bill.

The 1962 amendments still entailed a significant expansion of FDA oversight. Yet as Tobbell explains, industry and its academic allies, recognizing the degree to which the FDA’s increased powers seemingly outstripped its personnel, formed a Commission on Drug Safety as an advisory body to the FDA. The commission evolved into the Drug Research Board (DRB), under the auspices of the National Academy of Sciences–National Research Council, but still well represented by industry representatives and their academic allies. The DRB, from the mid-1960s through the mid-1970s, would serve to counter FDA attempts to control a national drug compendium and blocked federal efforts to mandate the substitution of generic for brand-name drugs (which would instead occur in piecemeal fashion at the state level). Years of alliance building had apparently borne fruit and would again in the Hatch–Waxman Act in 1984 (which extended patent durations even as it supported the expansion of the generic drug industry), the Medicare Prescription Drug Improvement and Modernization Act in 2003, and even the Patient Protection and Affordable Care Act in 2010.

My only quibble with Tobbell’s analysis is that notions of medical “capture” by industry run the risk of being overly simplistic (as Tobbell...