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Journal of the History of Medicine and Allied Sciences 57.2 (2002) 117-160



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Women’s Trials:
The Approval of the First Oral Contraceptive Pill in the United States and Great Britain

Suzanne White Junod and Lara Marks

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On 23 June 2000 the United States celebrated the fortieth anniversary of the approval of Enovid, the first oral contraceptive. 1 From the time of the first clinical trials to the present, nearly 200 million women have swallowed various formulations of the contraceptive pill, making it one of the most widely consumed class of drugs in the world. By the end of the twentieth century oral contraceptives had become a feature of everyday life, with more than 70 million women reaching for their pill packet on a daily basis around the globe. 2 Widely regarded as a revolutionary drug in its early years, the pill might retrospectively be considered the first “designer” or “lifestyle” drug of the twentieth century. As with many drug firsts, many lessons can be learned from its development and use. Indeed, as we argue in this essay, the pill played a significant role in reshaping pharmacology, social perceptions of [End Page 117] medication, and the regulatory process for new drugs during the second half of the twentieth century.

Developed in the 1950s, the pill was once optimistically hailed as a scientific cure for the world’s rising population and its consequent social and political ills (Fig. 1). Historians, however, have begun to show that the oral contraceptive did not prove to be the social panacea envisioned by its inventors, and that its history is more complex. Much of its history cannot be disentangled from the wider political, economic, and social issues of the day. Watkins, for instance, has shown that the availability of the pill in the United States had a major impact on the relationship between doctors and female patients in the 1960s. 3 Similarly, Critchlow has illustrated how the contraceptive controversy in American politics started with the appearance of the pill and continued with the debates surrounding RU-486, the abortion pill. 4 More recently, Marks has challenged previous histories, which have championed the pill as a North American product that fuelled the sexual revolution, suggesting that its roots and subsequent adoption were much more diverse in origin and can only be understood within a wider international framework. 5

Adding to the growing knowledge about the pill and its widespread influence on twentieth-century history, we offer a detailed cross-cultural (or at least transatlantic) history of the actual processes by which the first pill formulation, Enovid (U.S.) and Enavid (U.K.) came onto the market. Such a detailed account of the marketing of the pill emphasizes that the birth control pill was introduced in various stages, rather than simply approved at a single point in time. The drug was first marketed in 1957 for treating gynecological disorders. Only in 1960 was it allowed to carry a contraceptive claim, and only after 1961 did reports begin to appear that the drug could cause serious, albeit rare, thrombotic complications (blood clots). Between the time that Enovid was approved as a menstrual regulator and then as a contraceptive, attitudes regarding the perception of safety changed greatly, as did the evaluations carried out to assess risk and efficacy.

The pill redefined the very conception of contraception. In contrast [End Page 118] [Begin Page 120] to previous methods of contraception, which often presented innumerable messy problems, from leaky condoms to poorly fitting diaphragms and rhythm miscalculations, the pill transformed contraception into something seen as simple, straightforward, and very reliable. In contrast to short-acting barrier contraceptives, however, the pill posed significant safety concerns for regulators. The very fact that it could be taken for such extended periods of time and by healthy women raised some anxiety. 6 Such fears seem to have diminished quickly among the regulators between 1959 and 1960, the very time that the drug was...

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