May 9, 2023

The FDA Approves the First Birth Control Pill

The FDA Approves the First Birth Control Pill

May 9, 1960. The United States Food and Drug Administration revolutionizes society by approving the first birth control pill.

Transcript

Cold Open


It’s October 26th, 1916.

Inside a shabby, run-down building in the Brownsville neighborhood of Brooklyn, a group of women listen intently as a dark-haired young nurse talks to them about their reproductive health. The speaker is Margaret Sanger, the woman who recently opened a birth control clinic in this building, the first of its kind in the United States.

It’s a daring enterprise; the publication or circulation of information on birth control and abortion is deemed obscene and illegal. Margaret knows that if the authorities learn about the clinic’s existence, she and her colleagues will be arrested. But as she scans the desperate faces of the clinic’s visitors, their eyes imploring her to help them gain control over their bodies, Margaret is reminded that it’s worth the risk. There must be nearly a hundred women in the clinic this morning, all anxious to learn more about how to safely avoid unwanted pregnancies.

Margaret cuts her eyes across to the front door, where a young woman dressed in a fur hat and overcoat has just shuffled in off the street. The woman looks around her with the same lost and frightened expression that Margaret has grown accustomed to.

The young woman approaches Margaret and asks in a timid voice if this is the Brownsville birth control clinic. Margaret nods and smiles reassuringly. But then the young woman’s expression shifts. Her eyes narrow, and a look of indignation spreads across her face.

She reaches into her coat and removes a tin whistle. Margaret realizes with a stab of panic that this young woman is no patient; she’s an agent of the police. 

At the whistle’s blow, the door flies open and a squadron of police officers swarm inside.

Pandemonium breaks out as the officers begin frisking and intimidating the patients. As the officers begin rounding up the patients, amid the chaos, Margaret steps forward and, in a strong unwavering voice, introduces herself as the head nurse and founder of the clinic.

Immediately, the lead officer marches across to Margaret… and places her under arrest, escorting her from the building.

Margaret Sanger will spend thirty days in prison for violating the Comstock Laws, a set of federal acts intended to restrict the spread of materials regarded as “obscene,” including information about birth control. But despite the setback, Margaret will not be silenced. She has witnessed women in the poorest parts of New York struggling to feed all their families and believes wholeheartedly that unwanted pregnancies are both a scourge to society and the main obstacle that women face in becoming equal to men.

Margaret will continue campaigning for women’s reproductive rights for years, envisioning a safe, and affordable medical option that could prevent unplanned pregnancy. But little progress will be made toward discovering such a drug until Margaret meets an eccentric biologist in 1951, sparking a decade-long quest to invent a birth control pill, one that will revolutionize society after it’s approved by the FDA on May 9th, 1960.

Introduction


From Noiser and Airship, I’m Lindsay Graham and this is History Daily.

History is made every day. On this podcast—every day—we tell the true stories of the people and events that shaped our world.

Today is May 9th, 1960: “The FDA Approves the First Birth Control Pill”.

Act One: The Mad Scientist


It’s the winter of 1951; nine years before the FDA will approve the birth control pill.

A dinner party is taking place in Manhattan. Seated around the table are various friends and associates of Abraham Stone, vice president of Planned Parenthood - a non-profit organization that provides reproductive health education across the United States. Cigar smoke and erudite conversation fill the air. But one guest sits away from his peers. In the corner of the room, quietly pushing food around his plate with his fork, is a middle-aged man with jet-black eyebrows and a shock of white hair.

Dr. Gregory Pincus is something of an outcast in the academic community. He began his career as an assistant professor at Harvard, where he made a name for himself in the field of reproductive biology. While experimenting on rabbits, Gregory discovered that a mammal’s egg can be fertilized outside of the womb by injecting them with certain hormones. And by this method, he was able to create a rabbit embryo in a test tube – a breakthrough that shocked the public and triggered a wave of newspaper articles likening Gregory to Dr. Frankenstein. Fearing the negative press, the university board distanced themselves from the eccentric biologist. He was denied tenure and promptly left Harvard to set up his own makeshift laboratory in a converted garage.

Gregory named his facility the Worcester Foundation for Experimental Biology, and, with the help of a few grants, he was able to continue his studies without worrying about university politics. But despite this newfound academic freedom, Gregory still doesn’t feel satisfied. His disgraced departure from Harvard has left him with a chip on his shoulder, and a determination to prove his critics wrong by achieving something truly groundbreaking.

To that end, he has been researching potential treatments for female infertility by conducting experiments with the hormones estrogen and progesterone. But Gregory is yet to make an important breakthrough – something that would cement his legacy. So, even while he attends this dinner party at the home of his old associate, the biologist’s mind is on his experiments.

But Gregory is not the only party guest lost in their thoughts. Across the room, a wizened old woman watches Gregory. Though she is now seventy-one years old, Margaret Sanger has not stopped campaigning for women’s reproductive rights ever since she established the nation’s first birth control clinic over thirty years ago. In 1936, largely thanks to Margaret’s lobbying efforts, Congress amended the Comstock Act that banned contraception, making it legal for doctors to procure contraceptive methods for patients. It was a significant victory for the birth control movement. But Margaret knows there’s still a long way to go.

Though most states still ban birth control, contraceptive tools are available – either through doctors or on the black market. The most common forms of contraception are condoms and diaphragms, neither of which are one hundred percent reliable. Margaret has long dreamt of a “magic pill”, one a woman could take to prevent fertilization. But she faces several obstacles. First, the development of such a pill would be expensive; she would need millions of dollars to fund the project. Then there is the problem of who would carry out the experiments. Contraception has been such a contentious subject, Margaret suspects it will be hard to find a scientist willing to risk their reputation over something as polarizing as birth control.

But recently, Margaret became aware of Dr. Gregory Pincus. The more she learned about his research into hormones and reproduction, the more confident she felt that he might be the man for the job. When she found out that Gregory would be a guest at tonight’s soiree, she knew she had to attend.

Once the plates have been cleared and the dinner guests are being served brandy in the drawing room, Margaret makes a beeline for Gregory. She introduces herself to the biologist, then proceeds to outline her vision for a cheap and reliable contraceptive pill. She asks whether he thinks it would be possible. Gregory ponders this for a moment. And then it dawns on him that this could be the challenge he’s been looking for – a potentially revolutionary scientific breakthrough, one that would carve his name into history. So Gregory looks at Margaret and says: “Yes, I think it might very well be possible.”

Gregory and Margaret get to work immediately.

Margaret secures funding from Katharine McCormick, a millionaire philanthropist, and women’s rights campaigner. Like Margaret, Katharine believes that an oral contraceptive will allow women to live without the fear of unwanted pregnancy, and therefore step closer toward equality. She agrees to bankroll the research providing up to $100,000 annually until they succeed in creating the revolutionary drug.

Meanwhile, Gregory continues experimenting with hormones. By conducting tests on rabbits, he confirms that progesterone suppresses ovulation – the process in which eggs are released from the ovaries. If they can safely prescribe a large enough dose of progesterone, it could be the key ingredient in a contraceptive pill for women.

The discovery will feel groundbreaking. But to prove this hypothesis, Gregory and his team will have to experiment on something larger than a rabbit. They will have to begin carrying out tests on human beings.

Act Two: The Good Doctor


It’s 1952; one year after Margaret Sanger met Dr. Gregory Pincus.

Within the lecture halls of a medical conference, Gregory struggles to focus on the speaker before him. The 49-year-old looks exhausted. His white hair is even more unkempt than unusual, and dark rings circle his bloodshot eyes.

Since meeting Margaret last year, Gregory has been working long hours in his laboratory in Massachusetts, testing the effects of various hormones on rabbits to see how they affect the ovulation process. He and his team have now developed a birth control pill containing progesterone and estrogen and they’re finally ready to test the drug on humans. But there’s a problem. Gregory is a scientist, not a clinical physician. Federal law prohibits him from conducting human trials. What Gregory needs is a doctor willing to join his team, so they can start carrying out tests on human beings. But with most self-respecting medical professionals either morally opposed to birth control or hesitant to associate themselves with Gregory’s controversial experiments, the biologist has found himself in a bind.

So as he trudges down the hallway of the convention center toward the next lecture, Gregory spots an acquaintance. Dr. John Rock is a 60-year-old gynecologist who runs an infertility clinic in Boston. John is well-known for his support of birth control and has long been an advocate of planned parenthood — a stance all the more surprising given that John is a devout Roman Catholic.

Spotting him now at the conference, Gregory gets an idea. John is a licensed physician, permitted by law to conduct human trials. He could be just the man Gregory needs. So skipping over pleasantries, Gregory pulls John aside and tells him all about his research into the effects of progesterone on the ovulation cycle. John fiddles with his bow tie as he listens. He’s been experimenting with progesterone as a potential cure for infertility. But what Gregory is saying – that the hormone could be synthesized in pill form and administered as birth control – is brilliant. John extends his hand for Gregory to shake; he'd be delighted to join the team.

The biologist and the doctor spend the following year preparing for clinical trials. To bypass Massachusetts state law, which still prohibits unmarried women from taking birth control, John and Gregory claim they are testing a new infertility drug. In the beginning of 1953, at Boston’s Free Hospital for Women, they gather sixty volunteers and administer an early version of the contraceptive pill. The trial gets off to a promising start, with the pill suppressing the women’s ovulation as predicted. But then the participants start dropping out, complaining about side effects like nausea and blood clots. Eventually, so many volunteers drop out that John and Gregory are forced to abandon the trial.

John remains optimistic despite the difficulties. But Gregory takes the setback badly. He paces around the small hospital office where they have set up their testing center, his eyebrows quivering with anger. He tells John that they need to find test subjects who are docile, constrained, and who can’t simply drop out at will. They need to find the human equivalent of rabbits in a cage.

So Gregory and John decide to move the experiment to Worcester State Hospital, an insane asylum in Massachusetts. They claim to be testing the pill’s potential as a tranquilizer. But in fact, the scientists are feeding the birth control pill to psychiatric patients, before carrying out surgical examinations of their ovaries. Because the women are in no fit state to give their consent, this stage of the trial is ethically dubious. But Gregory remains unperturbed. He desperately wants to perfect the pill – and is prepared to go to extraordinary lengths to do so.

As the testing continues, Gregory feels that the pool of subjects available at the psychiatric hospital is too small to provide enough data they'll need to persuade the Food and Drug Administration of their pill’s safety. He becomes convinced that they need to move their experiment somewhere with more relaxed birth control laws, and preferably somewhere with a large population living below the poverty line.

And so, in 1955, Gregory and John move their research to Puerto Rico. It’s the ideal place to continue their testing. A state-sponsored sterilization scheme is already in place to try and curb the growing population, and the US government is more likely to turn a blind eye to unethical clinical trials involving poor Hispanic women.

So John and Gregory select 265 Puerto Rican women from the poorest parts of San Juan to participate in the study. For three months, the volunteers are required to take one pill a day. And although the side effects again drive many participants to drop out, John and Gregory amass sufficient data to present their findings to the FDA. There is now no doubt about it: the pill is a simple and affordable means of preventing pregnancy. And on May 9th, 1960, the FDA approves the pill - now officially named Enovid - for commercial use, making it the first medical drug made specifically to treat people who are not sick.

Gregory will celebrate the feat as the breakthrough that will ensure him a proper legacy. But not everyone will be happy with the pill’s approval. There will be a fierce backlash against the birth control pill, both from America’s conservative, religious right and from doctors who question the negative side effects of the drug. This controversy will come to a head in 1970 when advocates for the pill will be forced to argue their case before Congress.

Act Three: The Pill on Trial


It’s January 1970 on Capitol Hill in Washington DC; ten years after the birth control pill was approved by the FDA.

Alice Wolfson, a tough-talking women’s liberation activist, sits on a bench inside the Senate Chamber, listening to experts speak about the potential hazards of the contraceptive pill. As the male experts give their testimony, Alice becomes more and more incensed. There isn’t a single woman speaking in today’s hearings – nobody who has actually taken Enovid who can speak first-hand about Enovid's negative side effects.

One year after the pill was approved by the FDA for contraceptive use, more than a million women were using the drug. It was at that time that the first significant side effects started to show. Women started suffering from blood clots and blocked arteries. Some reported cardiovascular problems and strokes. Last year, women’s health activist Barbara Seaman wrote a book entitled The Doctors’ Case Against the Pill, outlining the severe health risks associated with Enovid. At the time, Wisconsin Senator Gaylord Nelson was conducting hearings against the pharmaceutical industry for negligence. When he read Barbara Seaman’s book, he decided to take on the birth control pill too.

Now Alice listens as a medical expert describes the dangers of consuming the large amounts of estrogen and progesterone present in Enovid. When the expert states that “estrogen is to cancer what fertilizer is to wheat,” Alice won't bear it any longer. She jumps to her feet and shouts: “Then, why are you using women as guinea pigs? Why are you letting the drug companies murder us for profit?”

Other women stand up and start furiously demanding answers. Soon, the hearing descends into chaos. Even Senator Nelson comes under fire. Though he brought this case against the drug company manufacturing Enovid in the first place, Alice and her fellow activists criticize him for not including any women on the panel.

The anger of Alice and other feminists about and the contentiousness of the hearings nevertheless result in positive changes. The hormone levels in Enovid are reduced to a fraction of the original dose, making the pill safer to use. In the years that follow, reports of side effects go down and prescription rates soar into the multi-millions. In the aftermath of the hearings, the US government also introduces requirements for the pharmaceutical industry to include complete information on side effects in every package of birth control pills sold.

By 1972, birth control is legal to both married and unmarried women across all US states. The battle to provide affordable and effective contraception was dogged and hard-fought, and the full implications of the unethical testing on Puerto Rican women and psychiatric patients has still not been fully reckoned with. But despite its blemished history, the pill has allowed women to gain control over their bodies, and in so doing has reshaped society following the pill's approval by the FDA on May 9th, 1960.

Outro


Next on History Daily. May 10th, 1994. Nelson Mandela becomes South Africa’s first Black president, marking an end to the nation’s oppressive and segregationist Apartheid government.

From Noiser and Airship, this is History Daily, hosted, edited, and executive produced by me, Lindsay Graham.

Audio editing by Muhammad Shahzaib.

Sound design by Mischa Stanton.

Music by Lindsay Graham.

This episode is written and researched by Joe Viner.

Produced by Alexandra Currie-Buckner.

Executive Producers are Steven Walters for Airship, and Pascal Hughes for Noiser.