Sixty-three years ago today the U.S. Food and Drug Administration (FDA) approved the world’s first birth control pill forever changing America’s cultural landscape. While conflicting ideologies about sex and reproductive health remain, the drug’s creation and dark road to approval through highly questionable clinical trials conducted by doctors with unethical methods, at the expense of the women in those trials, has not yet had its full reckoning.
On May 9, 1960, the FDA approved the hormonal, oral contraceptive pill Enovid, a 10-milligram dose of estrogen and progesterone, which prevented ovulation and pregnancy in women. The pill combined synthetic versions of those hormones that occur naturally in a woman’s fertility cycle.
The pill’s approval marked the first time the FDA had approved a drug that was not designed to treat a medical problem. Instead, the pill’s purpose was social in nature intended for healthy women to take over a long period of time. It was this “social” use, and a potential link between the pill to cancer, that gave the FDA initial pause in approving the pill. The pill’s creators, biochemist Dr. Gregory Pincus and obstetrician and gynecologist Dr. John Rock, dismissed the concerns and pressed the FDA to approve the pill, which the FDA did five months later. The FDA avoided long-term safety concerns by approving the pill for use no longer than two years at a time.
The idea for developing a birth control pill belongs to Margaret Sanger. Sanger, a nurse and activist, who in 1916 established the Brownsville Clinic in Brooklyn, New York, which later evolved into Planned Parenthood, saw the idea of a “simple, cheap, contraceptive” as the greatest need of her Planned Parenthood movement. The movement itself is built on eugenics and population reduction. Sanger shared the same worldview of eugenics as Charles Darwin and Adolf Hitler, and she saw birth control along with abortion as a tool to help accomplish population control and to weed out the “undesirable” races and people to evolve a better human race.
Sanger stated, “More children from the fit and less from the unfit. That is the chief aim of birth control.”
In 1951, Sanger met Dr. Pincus, an expert in reproductive biology. Driven by the mysteries of reproduction, he had successfully created rabbit embryos in test tubes. He was labeledas “Dr. Frankenstein” in The New York Times for this research prompting Harvard University to dismiss him. He then converted his garage into a makeshift laboratory and called it the Worcester Institute for Experimental Biology. Sanger approached Dr. Pincus at a dinner party and asked him if it was possible to develop a contraceptive pill. He not only believed it was possible, but he took on the challenge of making it a reality. Sanger secured a large grant from wealthy heiress Katherine McCormick, and Dr. Pincus began work on the birth control pill.
Since Dr. Pincus was not a clinical physician, federal law prohibited him from taking any drug into human trials. He needed a willing physician. He found one in Dr. Rock, another Harvard professor, who wasn’t necessarily interested in the scientific implications of the project, but rather the social implications. Dr. Rock was interested in curbing overpopulation, especially in the groups he saw as inferior. He stated 10 years after the pill’s FDA approval, “People like to have babies. And this is particularly so among primitive peoples.”
In 1952, the two researchers began testing their first version of their birth control pill at Boston’s Free Hospital for Women. To bypass state law prohibiting unmarried women from taking birth control, they claimed they were testing an infertility drug. They administered it to about 60 volunteers, many of whom quickly dropped out of the study due to side effects. Wanting more compliant subjects akin to the rabbits in a cage Dr. Pincus used before, they moved the research to Worcester State Hospital and began testing the drug on psychiatric patients. Again, the pair made an erroneous claim that they were testing a tranquilizer. They recruited 16 female patients and gave them prototype birth control pills, and then surgically examined their ovaries to understand the drug’s effect on their ovulation.
Upon realizing the patient pool at the hospital was too small to get FDA approval for the pill, they moved the trials to Puerto Rico due to its relaxed birth control laws and state-sponsored sterilization program to control population growth. They selected 265 women from the poorest areas of San Juan where poverty and immobility allowed for easy control of the trial. Even with a significant number of dropouts due to side effects, they gathered sufficient findings to petition the FDA to approve their drug.
According to a History Daily video, the side effects for the women in these trials included blood clots, bleeding, depression, and nausea. After the pill was approved and on the market for a year, historians have noted that up to one million women used the pill, and subsequently, reports of blocked arteries, strokes, and other cardiovascular issues among women soon began to rise. Later research would show the hormonal dose in the original pill was 10 times too high.
Dr. Pincus was unfazed by any negative criticism about the methods they employed. He told The New York Times years later, “These side-effects are largely psychogenic. Most of them happen because women expect them.” According to Harvard University, Dr. Pincus partnered with a pharmaceutical company escalating his research into synthetic hormones all while purchasing shares in the company to foster incentive to find the “next wonder drug.” Yet, the women in Worcester State Hospital and in Puerto Rico did not receive any compensation for the pill created at their expense.
Liberty Counsel Founder and Chairman Mat Stater said, “Margaret Sanger deserves no honors for her devastating work in birth control, eugenics and abortion. Her life’s work, and the work of these so-called doctors, have used and discarded women, targeted minorities, and killed innocent babies under the guise of population control, but with the sole purpose of eliminating people. They are a dark stain on the history of America. The FDA’s sordid history is nothing new. This agency needs a complete overhaul.”
