I recommend The Birth of the Pill for your summer reading list. This story of the scientific development of the birth control pill from 1950 to 1960 is engagingly written and easy to read. It is also an important history to remember as women continue to fight for their reproductive freedom while religious groups drag their implacable opposition to contraception through the courts.
As the subtitle suggests, author Jonathan Eig tells the story of four crazy characters who worked together to develop the pill. Each had life experiences that, by keeping him or her out of the mainstream, facilitated an eventual involvement with the pill.
Four Crazy Characters
Margaret Sanger, the preeminent birth control crusader, wanted a pill that women could easily take to control their own reproduction and therefore their lives. Her nondiplomatic personality, however, frequently left other birth control movement leaders “frustrated” with her.
Katharine McCormick inherited an enormous fortune from her husband, whom she discovered to be schizophrenic soon after she married him. Because of her experience of encouraging research into his mental illness and her own devotion to women’s rights, McCormick volunteered the funding that sustained scientist Gregory Pincus’s research for ten years.
Although he was a promising young scientist, Pincus was dismissed from a research position at Harvard after giving a 1937 interview to Collier’s Magazine about successful in vitro fertilization of rabbits. At the time, that science was too threatening because it suggested the possibility that women could bear children without the aid of men. As Collier’s described Pincus:
In the huge Biological Laboratory —a building which represents several of Harvard’s fifty-two million dollars’ worth of real estate—a 33-year-old scientist leaned over a microscope. His name might have been borrowed from a cop in a detective novel: Gregory Pincus. But what he saw has possibilities more thrilling than anything a detective-story writer ever imagined: a world in which women would be a dominant, self-sufficient entity, able to produce young without the aid of a man.
Moreover, the article warned, “The mythical land of the Amazons would then come to life. A world where women could be self-sufficient; a man’s value precisely zero.” That world was too much for Harvard to consider; Pincus was left to found and run his own lab.
Harvard Medical School did employ Dr. John Rock, the talented and poised doctor with his “dignified air and impressive credentials” who ran numerous fertility clinics for patients and appears as the movie-star-like figure who gave a positive public image to the other three. Rock, however, had his own struggles; he was a devout Catholic who opened a rhythm clinic and eventually learned that women should have access to birth control because “compassion for his patients overwhelmed his compulsion to toe the Church’s line.” Rock spent years writing books and giving numerous press interviews trying to persuade his church that the pill (which mimicked women’s reproductive cycles) was just as natural as the rhythm method and should be accepted.
After reading the book, the reader shares Eig’s conclusion:
looking back from a distance of more than half a century, it seems unbelievable that a group of brave, rebellious misfits— Sanger, Pincus, McCormick, and Rock— made such a radical breakthrough, and did it with no government funds and comparatively little corporate money. Indeed, there are countless ways that they might have failed.
The Dark Side
The scientific tale has a dark side, however. Because they were desperate to test their product in human beings, the scientists violated most of our current notions about informed consent and clinical trials. Over the years, patients, nurses and office staff took versions of the pill and informally reported its effects. Pincus experimented on patients at the local asylum without consent because the director:
was simply pleased to have a few more physicians on hand in his enormous hospital. It helped, too, that McCormick offered money to paint and refurbish some of the asylum’s wards in exchange for cooperation in the progesterone study. And so they began administering progesterone and estrogen in varying doses to women diagnosed with paranoia, schizophrenia, melancholia, manic depression, chronic alcoholism, Alzheimer’s disease, Pick’s disease, and more.
Much of the research was conducted under questionable conditions in Puerto Rico, where birth control had been legal since 1937. One of Pincus’s associates there “told his female students they were required as part of their coursework to enroll in the clinical trial and if any of them stopped taking the pills and submitting to the urine tests, temperature readings, and Pap smears, he would ‘hold it against her when considering grades.’” G.D. Searle, the company that manufactured the drugs, sent them to Pincus unlabeled so the company wouldn’t be too closely connected to his research.
When it was time for the scientists to seek approval of their product, which was called Enovid, they benefitted from certain features of the FDA’s process. First, Enovid was not approved as a contraceptive:
Searle’s application to the FDA in 1957 made no mention of contraception. Amenorrhea, dysmenorrhea, and menorrhagia: these were the menstrual problems Enovid was said to combat. The company also claimed that its new drug would be used to treat infertility because, even though the number of cases was small, tests showed that women resting their ovaries for several months were more likely to become pregnant when they stopped taking the drug.
Nonetheless, second, doctors were (and still are) allowed to prescribe drugs off-label for medical indications not approved by the FDA. So smart doctors could read news stories about Pincus’s contraceptive research and prescribe Enovid as a contraceptive for their customers even though the drug’s label said it was approved for infertility.
Third, the FDA, “overwhelmed at the time by requests for new drug approvals and badly understaffed,” monitored effectiveness more than safety. Thus when Pincus and Searle filed their supplemental request for Enovid to be approved for contraception, the FDA surveyed the doctors who had already prescribed Enovid to get their reaction:
In an internal FDA memo, the agency’s medical director, William H. Kessenich, acknowledged that the evidence on safety was thin. Most women had used the drug for no more than three or four months, and none of the women had used it for more than three years. “Only 66 patients have continued medication for 24 cycles or more,” he wrote.
But he also had to consider the agency’s mandate. The FDA’s job was to establish whether a drug worked. If it worked and there were no obvious indications that it caused harm, the agency had to approve. Even the doctors who urged the FDA to reject Enovid as contraception admitted that there were no signs of serious side effects “as far as they could tell.”
Just when the reader might be wondering if the end (the pill) justified the means (inadequate research design, failures of informed consent, and minimal safety oversight), Eig mentions thalidomide, which went on the market in Europe a few months after Enovid became available in the United States. Many of the pregnant women who took thalidomide to reduce morning sickness bore children with physical disabilities. That is another part of the improbable story; if thalidomide had come first, there would likely have been no pill.
On the brighter side, in this era when we debate whether patents for medical technology block patients from needed tests, Pincus himself never gained a patent for his research. Although the pill was “enormously profitable” for Searle, Pincus suggested “there had really been nothing for him to patent. ‘Do not forget that we have never even made a pill at the foundation,’ he said. ‘All we did was to perfect the formula.’”
The Catholic Church
Unsurprisingly, the Catholic Church’s hierarchy makes a constant appearance as the biggest opponent of contraception, with the archbishop of New York making the argument that “birth control was a more serious sin than abortion. ‘To take life after its inception is a horrible crime,’ he said, ‘but to prevent human life that the Creator is about to bring into being is Satanic. . . . in the latter not only a body but an immortal soul is denied existence in time and in eternity.’”
Individual Catholics, however, are stars of the story, including not only Dr. John Rock, but also Dr. Pasquale DeFelice, an obstetrician-gynecologist completing his residency at Georgetown University Medical Center, later father of ten children, who was tasked with approving the Enovid supplemental application for the FDA. Like Rock, DeFelice must have known that “religion is a very poor scientist”; he ignored the religious opposition to the contraceptive Enovid and approved it when the physician surveys showed it was effective.
The devout Rock was early to the contraceptive cause. “In 1931, he was one of fifteen Boston doctors (and the only Catholic) to sign a petition calling for the repeal of the state’s ban on contraception.” “I don’t think that Roman Catholicism forces a man to interfere with other people’s freedom of conscience and action within their own moral principles,” he told Time magazine in 1948.
Although Rock hoped all his life that a pope would change the teaching, unfortunately, the same split between hierarchy and laity continues today, as Catholic institutions fight the contraceptive mandate of the Affordable Care Act while individual Catholics practice birth control in the same numbers as other Americans.
Sanger wanted a birth control pill—not other forms of contraception—so that “[s]cience would do what the law so far had not; it would give women the chance to become equal partners with men.” It is nice to see Sanger (at age 80) and McCormick (at age 84) vindicated at the end of the book, yet disconcerting to know that their battle for equality continues today.