Welcome to the fifth installment of our series chronicling the history of the birth control pill. In the previous installment, Margaret Sanger and Katharine McCormick envisioned and bankrolled the development of the birth control pill. Now it had to be tested in large-scale trials.
John Rock, Gregory Pincus, and Min-Chueh Chang had collaborated in the Pill’s development; now it was time to conduct clinical trials. The first study observed 60 women, some of whom were infertility patients while others were nurses. These small trials involved daily temperature readings, vaginal smears, and urine samples, as well as monthly endometrial biopsies. Although the initial results seemed promising, the sample size was small and few of the subjects complied with the protocol.
The approval of the Pill in 1960 marked a turning point in our history.
More test subjects were needed. At this point, historians’ accounts differ. Elaine Tyler May claims that, unable to locate an acceptable pool of volunteers, the researchers tested the Pill on subjects who could not give their consent, such as psychiatric patients. According to Bernard Asbell, however, Rock was scrupulous when it came to informed consent, despite it not being a legal requirement — or even much of a concept at all at this time in history.
Willing participants notwithstanding, conducting such trials in the United States posed a challenge, due to laws against contraception. So the first large-scale clinical trials were conducted in Puerto Rico in 1956. Puerto Rico was densely populated and there was a high demand for alternatives to permanent sterilization, which was widespread on the island due to funding from a wealthy eugenicist named Clarence Gamble, who advocated sterilization for the world’s poor. The clinical trials in Puerto Rico were conducted by Drs. Edris Rice-Wray and Adaline Sattherthwaite; the brand of birth control pill tested was named Enovid. Volunteers were so easy to come by that some clinics had waiting lists. Continue reading