"Simple Methods" and "Determined Contraceptors": The Statistical Evaluation of Fertility Control, 1957-1968

Abstract

This paper discusses the use of two US research projects in legitimizing fertility control through the authority of scientific research. The projects included field trials of "simple methods of contraception" and IUDs that were sponsored by the US Population Council and the Planned Parenthood Federation of America (PPFA). Research was used to test whether simple methods and the IUD were safe and effective. In 1957, contraception research did not have the support of the academic medical leadership, and most state health departments did not distribute birth control literature. The clinical field trials were conducted through 95 PPFA-affiliated centers under the direction of PPFA's Medical Director Mary Calderone during 1957-64. The institutional affiliation served to give legitimacy to PPFA and to validate use-effectiveness of creams, jellies, or spermicides with a diaphragm. The Population Council reactivated the National Committee on Maternal Health (NCMH) with Christopher Tietze as head and as a member of the Advisory Committee of the new PPFA Clinical Investigation Program. Clarence Gamble, who believed in the "anything that works approach," severed his relationship with NCMH. Calderone thought that "any method was better than no method, but the most critical factor in effectiveness was availability." What was innovative about these trials was the study of the practice of contraception and the use of a statistical measure. The trials found that the diaphragm was the most effective and acceptable method. The EMKO brand was the most popular foam. Tietze's evaluation of five different IUDs during 1963-68 did not meet the rigorous criteria of Louis Lasagna, but did determine the regularity and continuity of contraceptive practice. Life table methods were used to demonstrate a statistically valid result. By 1964 contraception became recognized in the medical field. By 1968 a statistically valid result among "determined contraceptors" established the medical legitimacy of the IUD, and global distribution ensued.