A Note on Birth Control Development
As with all historical scientific research that used human subjects for trials, the first birth control pill was tested using methods that would not pass the Institutional Review Boards of today and would, in fact, violate all legal and ethical standards currently in place. The Common Rule (or Federal Policy for the Protection of Human Subjects) which provides the standards for current biomedical research wasn't established until 1991. At the time of the trials, only basic toxicity tests were required for human testing, and there were very few informed consent rules for research.
Research leads Gregory Pincus and John Rock first trialed Enovid on groups of women held at the Worcester State Hospital, previously known as the Worcester Lunatic Asylum and the Worcester Insane Asylum, women who were unable to give informed consent for participation in the trials.
After a discussion that included Pincus, Rock, Margaret Sanger, and Katharine Dexter McCormick, they moved the trials to Puerto Rico where Enovid was tested on a group of mostly indigent women - a demographic of women who were regularly involuntarily sterilized through hysterectomies after their second child. These women were not given the full details of the health risks they took as trial participants, and were in many cases not told they were even taking a drug that was not yet approved for use.
Patients underwent painful and potentially dangerous endometrial biopsies, and their side effects were almost universally dismissed as psychosomatic. Enovid was a high estrogen pill, and the side effects experience by some test subjects included life threatening blood clots and increased risk of stroke and heart attack - resulting in at least one death of a test subject.
To read more about the development and testing of Enovid, we recommend:
'A Cage of Ovulating Females,' the development and testing of the oral birth control pill
Drucker, Donna J. Contraception: a Concise History. Cambridge, Massachusetts: MIT Press, 2020.
