America and the Pill: A History of Promise, Peril, and Liberation Read Online Free PDF Page B

were certainly some clear cases of abuse and unethical practices, such as the coercive studies using psychiatric patients, the testing of the pill largely conformed to the standards of the day and often exceeded them. At the time there were few regulations in place for the testing of drugs. Compared to other countries, the United States had relatively stringent requirements for gaining govern- ment approval because of FDA regulations. But it was not until 1962 that doctors were required to inform patients if the drugs they prescribed were experimental. Standards of informed con- sent for the testing of drugs were in the distant future. 29
    Although progesterone and estrogen had been administered to women for decades to treat gynecological disorders and pre- vent miscarriages, finding a large enough volunteer group to test the contraceptive effectiveness of these hormones presented a major challenge. The laws against contraception in Massachu-

    setts, where small initial trials had been conducted, ruled out that state as a site for a large study. John Rock had previously studied the pill for its “rebound effect” to encourage fertility, with the hope that after an infertile woman stopped taking the pill, she would then start ovulating and become pregnant. That research did not violate any laws. But Rock knew that if he tried to test the drug as a contraceptive, he could face criminal charges resulting in steep fines and imprisonment.
    So the researchers considered several other possible sites for a study, within the United States as well as outside the country. Katharine McCormick worried about finding a stable popula- tion of willing and cooperative volunteers. “Human females are not easy to investigate as are rabbits in cages,” she noted. She was concerned that if the women did not stay in one place to allow for adequate follow-up exams, or if they did not take the pills consistently, “the whole experiment has to begin over again—for scientific accuracy must be maintained or the re- sulting data are worthless.” 30
    In 1956, Rock and Pincus finally decided to conduct the first large-scale clinical trials in Puerto Rico. The island ap- peared to be an ideal setting for several reasons: No laws pro- hibited contraception, and in fact, there was already an established network of sixty-seven birth control clinics on the island. With more than six hundred people per square mile, Puerto Rico was one of the most densely populated areas of the world. Impoverished women living in crowded, disease- ridden conditions were desperate for birth control. At the time, the only option available to them for reliable contraception was sterilization, which had been vigorously promoted and was

    widespread on the island, due in large measure to funding from the wealthy eugenicist Clarence Gamble, a longtime advocate of sterilization of the poor. Puerto Rican women wanted a nonsurgical, reversible, and effective means of preventing preg- nancy. Women who volunteered for the studies were given pills containing 10 milligrams of progesterone and small amounts of estrogen, many times greater than the pills on the market today. But at the time researchers were uncertain whether lower doses of hormones would be effective, and they wanted to be sure that the pill they tested would prevent pregnancy. 31
    In Puerto Rico, two women conducted the on-site trials, Dr. Edris Rice-Wray and Dr. Adaline Satterthwaite. Rice-Wray, a faculty member at the Puerto Rico Medical School and direc- tor of the Public Health Department’s Field Training Center for nurses, was medical director of the Puerto Rican Family Planning Association. Working with Pincus and Rock, she set up a research site in a suburb of San Juan. Satterthwaite, who like Rice-Wray was born and trained in the United States, es- tablished a trial site in Humacao, a rural area. The women they recruited were eager to participate. Already saddled with large families, many were in poor health