‘Children by choice, not chance’
This was the slogan of London's first birth control clinic in 1921. Maria Stopes founded it, and five other clinics opened shortly after. It was almost 30 years later that the pill was released to the market; it gave women an opportunity to have a choice in a world dominated by men. The pill had a massive positive impact on the world. Still, its story is marked by a lack of consent, informed choice, and disclosure intertwined with eugenics and colonialism.
The story of the pill started in the late 1930s when high doses of progesterone showed to halt ovulation in animal experiments. In the 1940s, Dr. Carl Djerassi produced progestin using Mexican wild yam root. This was the first step to making ‘the pill’ a reality. Also, in vitro fertilization was only possible with chemical control of the fertility cycle that the pill offered. It changed the world.
When it came to the market for the first time, the pill was marketed for ‘cycle regulation’; at the time, contraception was taboo, and in the USA, it was prohibited from public discussion. Doctors could prescribe hormones for any reason but birth control. Clinical trials for the pill were conducted in Puerto Rico, where the lack of prohibitive laws and overpopulation allowed the first large-scale trial. Women who reported nausea, blood clots symptoms, headaches, and dizziness were discounted as ‘unreliable witnesses’.
“The tragedy of the situation is that the more intelligent classes voluntarily restrict their birth rate, while the most vicious, most ignorant, and most helpless and hopeless part of the population multiplies with tremendous rapidity.”
-Governor of Puerto Rico wrote to Margaret Sanger, 1933
The pill was first prescribed only to married women and was only in 1972 that was legal for married women in the US. The first pill ever marketed had drastically different estrogen dosages compared to today; Enovid 10 was the first pill and had 9.85 mg of progestin norethynodrel and 150 μg of the estrogen mestranol. In 2012, pills had 0.1 to 3.0 mg of synthetic progestin and 20 to 50 μg of strogen mestranol.
Enovid
Dr Pincus approached the pharmaceutical company G.D. Searle, today a subsidiary of Pfizer, in the early 1950s to get funds to develop the first oral contraceptive. Searle immediately refused; it was illegal to advertise or sell any contraceptive product, and the catholic church saw the method as sinful, which could add up to a potential boycott. Also, at the time, it was thought that there was no market for a contraceptive pill. However, Searle ended up developing the pill accidentally. Frank Colton, a chemist at Searle, was able to synthesise norethynodrel, a synthetic progesterone. Later, it was found that this compound worked as an anti-ovulation compound.
In 1955, Enovid was approved by the FDA to treat gynaecological disorders. The pharmaceutical company got Dr. Pincus and Dr. Rock involved in the research; they both worked as researchers at Harvard. They tested the pill in Puerto Rico and on mentally ill women in a facility in Massachusetts. These clinical trials were marked in history for the lack of consent and informed choice of the women involved. Pincus did not have good fame in the scientific community at the time, so much so that in 1937, Harvard University (where he worked as an assistant professor) communicated that he would not receive tenure; James Reed, a historian, said that Pincus was seen as ‘a self-advertising Jew who published too soon and talked too much.’
Margaret Sanger (on the left) was one of the activists that made the pill a reality. Dr Carl Djerassi (on the right) was the first scientist to produce progestin from Mexican Wild Yam in the lab.
Margaret Sanger
Margaret Sanger was a nurse who, in 1916, opened the first birth control clinic in Brooklyn. She fought for women's rights and rejected the idea of full-time motherhood. She thought that women would never have the same rights as men unless they had sexual freedom. In 1914, she got arrested for writing ‘obscene’ articles in her newspaper The Women Rebel. She moved to Europe after she jumped bail for this. She married again, and her husband got arrested for handing out pamphlets with contraception info. She went back to America and opened the first birth control clinic. 10 days later, she got arrested for the illegal distribution of birth control products. After this, she tried other approaches and focused on recruiting doctors, scientists, and physicians. She approached numerous scientists at the time to develop a contraceptive method that women could take on their own, with or without consent of the men and preferably orally, all scientists said it would be impossible to develop such drug. Until she came across Dr. Pincus. Dr. Pincus recruited Dr. Chang, a friend, to work on this with him. They knew that progesterone injections prevented ovulation in rabbits. Still, no human experiments had been done, and progesterone was very expensive. They needed funding to start working on it, and some Women's Foundations were able to donate some money. But it was not enough. In 1942, Sanger’s second husband passed away, and she inherited 5 million dollars, which she donated to research. She was 83 then.
John Rock
Dr. John Rock was a Harvard professor involved in the pill's development. He was a gynaecologist by training and started the Free Hospital for Women. He was catholic, but he did not oppose abortion; he believed that the woman's health was more important than the health of her fetus and that pregnancies should be terminated if the mother's health was compromised. He used to say to his daughter, 'Religion is a very poor scientist.'
‘Religion is a very poor scientist.’
-Dr. John Rock
Eventually, he started testing synthetic hormones in low-income patients to treat fertility. Many couples would come to his hospital afraid of getting pregnant again, and some women would come complaining of the opposite. Opposite to Pincus, he cared about the implications of his science in society. After his test, 80 of 132 women got pregnant with treatment. He corresponded with Pincus in a conference and found out that Pincus was using the same drug in rabbits to halt ovulation. A year later, they tested the compound at the Free Women's Hospital in a larger trial. They wanted to test whether the pill would make healthy women sick. Many women dropped the trial due to side effects, which mimicked pregnancy even though they weren't pregnant. After this, Pincus wanted to do a trial with more drastic and less ethical steps so he could control the experiment and understand the anti-ovulatory effect of the drug.
Gregory Pincus
Pincus was a Harvard researcher who was fascinated with developmental biology. He spent one year in Europe studying mammal eggs. In 1934, he announced to the National Academy of Sciences that he had fertilized rabbit eggs in a test tube, transplanted them into the body of a host mother, and brought the baby rabbits to term. This was quite radical at the time. The New York Times wrote an article portraying him as a sinister scientist trying to make babies from bottles. He had other breakthroughs while at Harvard, and in 1936, Harvard University listed his discoveries as the greatest in 3 centuries.
Harvard University, where Pincus and Rock worked, had an arrangement with Worcester State Hospital. Pincus tested the drug for 'tranquilizing effects' on 16 women in the hospital and published his results. At the time, Lancelet (where Pincus published his research) received letters from readers showing their disgust for the lack of ethics and valid permission for his research. This did not stop Pincus. However, in 1937, Collier's Magazine wrote an article about his research stating, "If babies were made in test tubes, it would be the ruin of women.". Pincus was now seen as a deviant. Harvard told him to go to Cambridge for a year, but then he would be done. He was probably a victim of anti-Semitism, but his research approach did not help either.
In the 40s, Dr. Pincus funded the Worcester Institute for Experimental Biology, an attempt to do science without university politics. When hormones similar to humans were found in Mexican wild yams, hormonal research changed forever. However, costs halted hormonal research. Animals were very expensive to maintain, and plants were much cheaper. Pharmaceutical companies were looking for the next wonder drug. Pincus wanted to start with creating the contraceptive pill at his new institute.
He wanted to work with Searle, but they were not enthusiastic about it initially due to his reputation. However, Searle was taking a very high risk by funding this type of research directly, so they let Pincus study it at his institute. Because of his bad fame, Searle kept a very low profile in Pincus's involvement in drug development. In 1957, Pincus said in an interview that he was 'against women's sexual freedom' but added, 'I am also opposed to sexual freedom among men.' He wanted to partially create the pill to answer a scientific question, not a social one.
At some point, Pincus sent the compound to female family members who complained about the series of side effects. Many years later, he told the New York Times in an interview that most of these side effects are psychogenic and only happen because 'women expect them.' He had this idea because he conducted a study with three groups of women: one group had the pill (that was informed of the side effects), a group that had a placebo but was not informed of the side effects, and a group that had the pill but were not informed of side effects. 23% of women in the first group reported side effects, 17% in the placebo group reported side effects, and 6% of women who took the pill without warnings reported side effects. This sole study convinced him that the pill had no serious side effects. This study was done with a very small sample size.
Searle was worried about his involvement in the clinical trials; his method was not ethical, but it was not illegal. Scientists did not have to get formal consent from patients back then. In the USA, the Nuremberg Code of 1947, which established the importance of informed consent, was not legally binding, and the Kefauver-Harris Drug Amendments of 1962 and the Belmont Report of 1979 had not been written.
In 1956, Pincus performed testicular biopsies on 20 schizophrenic men without anaesthesia, saying he was curious about 'castration anxiety.'
Katherine McCormick
Katherine McCormick funded what The New York Times called the 'most sweeping sociomedical revolution in history.' She was also involved in the women's suffrage movement and was vice president and treasurer of the National American Suffrage Association. Katherine was a biologist and the second woman to graduate from MIT. She married her husband, Stanley, who had schizophrenia. He passed away in 1947 and left his fortune of 35 million dollars to his wife.
She was a lifelong feminist and birth control advocate, and after Stanley's death, she contacted her friend Margaret Sanger. Katherine and Margaret met in 1917 when Sanger was lecturing in Boston. They were part of the suffragette movement. Katherine would help smuggle diaphragms from Europe into the country for Margaret's birth control clinic. Margaret introduced Katherine to Dr. Pincus, who working on the pill with Searle. Katherine was 77 the first time she met Pincus. At the time, Margaret advised her to spread her donations across different universities. Still, Katherine did not trust the academic approach, and wanted the results fast. Searle tested hundreds of combinations to identify a promising candidate for birth control. She joined Searle, and Rock and Pincus could start large clinical trials with her funds. McCormick wrote a letter to Sanger stating that she wanted a 'cage' of ovulating females to experiment with. Even after the pill was released, she kept donating money to improve the pill.
During World War I, McCormick was chairwoman of the association's War Service Department and a member of the Women's Committee of the Council of National Defense. When the pill was released to the market, all the scientists and doctors involved were under the spotlight, but her contributions were forgotten. Katherine also donated money to ensure that more women go into education. She founded an all-female dormitory to ensure that female students studying at MIT had a place to stay while they studied; this increased the number of female students going to MIT from 3% to 40%. At the time, MIT had limited funding to provide housing for women, and they were talking about turning MIT into an all-male school. In 1967, she passed away at 92; her death was not mentioned in any major newspaper.
Puerto Rico and eugenics
Puerto Rico was the perfect destination for the clinical trials in the eyes of Searle. It was overpopulated, laws were more liberal than in the USA, and they already had an established clinical network. Also, the rapid growth of the Hispanic population was worrying many Americans. Puerto Rico had very eugenicist legislation; they established family planning clinics in 1935 and authorised contraception in 1937. The U.S government funded these birth clinics in 1936 under New Deal programmes. These clinics were the recruitment grounds for Dr. Pincus's experiments.
In 1935, 16.5% of women who could bear a child were sterilised. A study conducted in 1988 showed that a third of Puerto Rican women were sterilised and that 16% of these women did not make the decision themselves. The governor of Puerto Rico wrote to Margaret Sanger, a birth control activist, that "The tragedy of the situation is that the more intelligent classes voluntarily restrict their birth rate, while the most vicious, most ignorant, and most helpless and hopeless part of the population multiplies with tremendous rapidity."
They recruited 265 "sufficiently intelligent" women for whom pregnancy would be acceptable, or at worst 'inconvenient,' says a memo from Pincus to Rock. Women who took the drug knew it prevented pregnancy but did not know it was a clinical trial or any of the known side effects; many women dropped out of the clinical trials in Puerto Rico due to side effects. The methods included daily smear and temperature. Scientists collect tissue from their uteruses monthly, and in some cases, women have large incisions to expose the abdominal cavity so they can observe ovaries in real time. The study did not involve financial compensation, but women wanted to get involved so they had access to reversible contraception. Many women who reported side effects in the clinical trials were discounted as 'unreliable.' Three women died during the trials, but none of the deaths were investigated.
‘Because of its semi-colonial status with the U.S., the ability to test on these women’s bodies seemed like these territories are an extension of us.’
- Gabriela Lavega, Professor of History of Science at Harvard
By the time the paper was published, 22% of women dropped out of the trials due to severe side effects. Other trials were conducted in Mexico and Haiti, and in 1960, the FDA approved the pill as a contraceptive drug.
Gabriela Lavega, professor of history of science at Harvard, says: ‘Because of its semi-colonial status with the U.S., the ability to test on these women’s bodies seemed like these territories are an extension of us.’
Ten years after its first release, birth control made the headlines; a Captain Hill investigation into the pill’s safety was being conducted, but no women were being invited to testify about the side effects. When Enovid was released in Puerto Rico, the women involved in the clinical trials could not buy it because of its price.
Gains
After two years of Enovid's release as a contraceptive, 1.2 million American women took the pill every day. In 1964 alone, Searle had 24 million net profits from the Pill sales. Even after other pharmaceutical companies released their version of the pill, many women stayed loyal to Enovid, which kept Searle's profits strong.
The pill was introduced in the UK in 1960, but only to married women until 1967. In 2007, 3.5 million women used the pill in Britain, aged between 16 and 49.
