Women

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April 10, 2026

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April 10, 2026

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"In January 1970 experts assembled in the stately Senate chamber and began giving their testimony on the hazards of the Pill. Alice Wolfson, a member of the radical collective D.C. Women's Liberation, was sitting in the audience listening to the experts. Her group had come to the hearings because they had all taken the Pill at one time or another and had experienced side effects. The group was outraged that their doctors had never informed them of the risks when they prescribed the Pill. As they sat in the chamber and heard one male witness after another describe serious health risks, they were furious that there wasn't a single woman who had taken the Pill there to testify. After hearing one expert say, "Estrogen is to cancer what fertilizer is to wheat," the women spectators could no longer contain their anger. They stood up and started hurling questions at the men on the dais. The feminists set the room abuzz when they demanded, "Why are you using women as guinea pigs?" and "Why are you letting the drug companies murder us for their profit and convenience?" When told by Senator Nelson to sit down and remain quiet, they retorted, "We are not going to sit quietly! We don't think the hearings are more important than our lives!" Although Senator Nelson was the driving force behind the hearings, the young protesters were so angered by his failure to include women in the hearings -- and by what they viewed as his patronizing behavior --that they went on the attack. The group decided to protest the structure of the hearings and the men leading them, in addition to speaking out about the medical dangers of the Pill. The feminists' grievances gained national attention. National television networks covered the proceedings, and Wolfson's group appeared frequently on the nightly news during the hearings. An estimated eighty-seven percent of women between the ages of twenty-one and forty-five fol-lowed the hearings. Eighteen percent of them quit taking the oral contraceptive as a result of the hearings. In the hearings' aftermath, hormone levels in the Pill were lowered to a fraction of the original doses. A few years after the hearings, prescription rates rebounded, and the number of users in the United States peaked at approximately nineteen million. The real impact of the hearings was not on Pill usage, but on the nascent consumer health movement. D.C. Women's Liberation succeeded for the first time in making informed consent a national issue. In the aftermath of the hearings, the U.S. government would require the pharmaceutical industry to include a patient information sheet with complete information on side effects in every package of birth control pills sold. The growing women's movement was prompting women to assert control over their bodies, and in doing so it changed forever the way Americans take prescription medications."

- Hormonal birth control

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"McCormick apparently never understood that Searle had paid a large portion of Pincus’ salary for years. Rather, as McCormick explained to Abraham Stone, Pincus was “acquainted with some one [sic] in the Searl [sic] Company.” Exactly how he was able to convince them to provide free experimental drugs for the project on a large scale was never explained. In fact, Searle’s steroid chemists played an important role in the pill’s development. Although similar feats were being duplicated in a number of competing industrial laboratories, the large number of synthetic hormones that a they were producing gave Pincus an essential variety of compounds with a wide range of effects that he could try on animals, selecting for clinical trial only a few of the most promising out of the dozens that had some contraceptive effect. But McCormick has shielded from the commercial aspects of the project she was subsidizing. Nevertheless, her contribution was vital. She provided the funds that turned a desultory PPFA project into a crash program to develop an oral contraceptive. Pincus asked Searle for substantial help on the project only after he had suppressed ovulation in women with a progesterone regimen. By then he knew that he could develop an oral contraceptive. Searle’s cooperation simply hastened the process. When the first successful use of synthetic steroids as an oral contraceptive in women was announced in ‘’Science’’ in 1956, Sanger wrote McCormick: You must, indeed, feel a certain pride in your judgment. Gregory Pincus had been working for at least ten years on the progesterone of the reproductive process in animals. He had practically no money for this work and Dr. Stone and I did our best to get a few dollars for him and I think that the amount we collected went to pay the expenses of Chang [senior scientist, WFEB]. Then you came along with your fine interest and enthusiasm and with your faith and . . .things began to happen and at last the reports . . . are now out in the outstanding scientific magazine and the conspiracy of silence has been broken. Although “conspiracy of silence” may have been an exaggeration, throughout the late 1950s few scientists believed an oral contraceptive was at hand."

- Hormonal birth control

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"IN 1967 the National Science Foundation commissioned a study of the relationship between basic research and technological innovation. What role did “nonmission” research, research motivated solely by a desire for knowledge,, play in the development of new products of great economic and social significance, such as the electron microscope, the videotape recorder, and the oral contraceptive pill? Since the National Science Foundation existed to promote research, it was not surprising when the study revealed that 70 percent of the key events leading to technological innovation resulted from so-called nonmission research. Seventy-six percent of this basic work was done in university laboratories; 14 percent in research institutes and government laboratories. Industrial laboratories made only 10 percent of the original discoveries that advanced knowledge. Large diagrams were provided on which the red dots representing basic research stretched far into the past, while the blue symbols for “mission-oriented research” and the green symbols for “development and application” were clustered near the present. In the diagram explaining the origins of the pill, Arnold Berthold’s 1984 demonstration that castrated roosters do not behave like roosters was given equal billing with key events in the development of twentieth century endocrinology. The overall impression was one of a long chain of basic researches leading inevitably to an oral contraceptive."

- Hormonal birth control

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"The efforts of Sanger and McCormick would have been for naught, however, if it hadn’t been for the medical folk traditions of the descendants of the w:Aztecs. The basic research for the pill became possible when Russell Marker discovered that generations of Mexican women had been eating a certain wild yam ⎯the Barbasco root, also called cabeza de negro⎯for contraception (Chesler, 1992). It was from these yams that Marker was able to extract the progestin that Gregory Pincus combined with estrogen to formulate the first birth control pill (Grimes, 2000). The first pill was far from perfect ⎯but its effectiveness, simplicity, and ease of use extended to millions of women an unheard-of control over reproduction, for the first time allowing them to truly separate vaginal intercourse from procreation (Bullough & Bullough, 1990). Margaret Sanger’s pill made the sexual liberation movement of the ‘60s a lot less risky than the one that occurred after World War I. More than 20years ago, the FDA proclaimed that “...more studies have been done on the pill to look for serious side effects than have been done on any other medicine in history” (Asbell, 1995). That scientific scrutiny has continued to this day. The pill of today, as well as other more recent combined hormone methods —the patch and the ring—offer safety and effectiveness with greatly decreased doses of hormone (Knowles &Ringel, 1998)."

- Hormonal birth control

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"Searle had originally asked the FDA to consider simultaneously an application for three dosages of Enovid: 10, 5, and 2.5 milligrams. Searle was particularly interested in promoting the lower dosage forms of Enovid because one of the chief criticisms of the pill up to this point had not been a medical one, but rather an economic one. Partly developed in response to concerns about world hunger, it was feared that Enovid would prove far too expensive for woen in poorer countries. The cost of the hormone was directly proportionate to the cost of the drug and the dose. Lowering the dose significantly lowered the cost of Enovid. Searle, therefore, had great incentive to prove the safety and efficacy of its lower dosage pills. As far as Searle officials were concerned, the lower dose of Enovid should not have required a separate NDA because they considered it merely an alternative dose of the same drug. As one Searle representative wrote when seeking approval of the lower dosage: “[I find it] very difficult to understand how less of a drug can be more dangerous than a larger dose...a basic fact of any drug use is adjustment of the dosage to a particular individual’s requirement. That’s all we are trying to do with the lower dosage forms of Enovid....I find it impossible to understand how one increases danger by reducing the dose.” The FDA, however, viewed the dosage question as an issue of efficacy and possibly safety in 1959. The lower doses produced an increased incidence of breakthrough bleeding. It was not immediately clear whether this was an indication that ovulation had not been effectively suppressed. If so, it would have undermined Enovid’s effectiveness as a contraceptive, rendering it unapprovable. The FDA was therefore very cautious in considering any alteration in the original dose formulation of the pill."

- Hormonal birth control

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"In Britain, publicity over the pill’s potential risks reached a crescendo in late 1969, when a number of British medical journals and popular newspapers published articles accusing the medical profession of being too complacent on the links between the pill and thrombosis. The debate intensified in December 1969 when Professor Victor Wynn, an endocrinologist and an expert on metabolic effects of anabolic steroids, appeared on a David Frost television program and detailed before millions of British viewers a panoply of risks associated with the pill. Appearing in a total of three Frost programs that month, one of which was broadcast to an audience in the United States, Wynn’s testimony caused public and parliamentary uproar. These broadcasts, together with the publication of the British epidemiological studies linking the pill with thrombotic complications, resulted in the British government warning doctors to no longer prescribe the higher dose (10-milligram) pills. In the United States, an impassioned public debate on the safety of the pill had also been inaugurated with the publications of journalists Morton Mintz and Barbara Seaman. Both journalists challenged what they characterized as the “diplomatic immunity” which had dominated news about the oral contraceptives up to that time by questioning not only the overall safety of the pill but the way in which the U.S. regulatory authorities had approved it. Mintz, in particular, widely publicized as fact that the pill had been tested on only 132 women prior to its approval for contraception and that its safety had not been proven before it went on the market. By the end of 1969 Senator Gaylord Nelson called for congressional hearings (known as the Nelson hearings) on the safety of the pill. The primary focus of the Nelson hearings was on safety and informed consent: Had women been adequately informed about the risks and significant side effects of the pill? Should the pill be removed from the market, or should new studies be instituted?"

- Hormonal birth control

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"In Britain, government control over the manufacture and supply of pharmaceutical drugs had been tightened in 1947 and 1957. Such restrictions, however, primarily concerned dangerous drugs and self-medication drugs, as well as biological products (e.g., antibiotics, vaccines, and insulin, all of which had to best and ardized by biological techniques). Products had to be scrutinized to insure that their manufacturing methods and potency testing met the stipulated requirements. Drugs subject to these restrictions were only a small minority in the pharmacopoeia. All other drugs could be released onto the British market without submitting to any formal procedure. In general, the British government took a laissez-faire approach toward pharmaceutical companies in the1950s. The only restriction imposed on drugs in this period was that they could not be advertised as curing cancer, venereal disease, or Bright’s disease. Britain and the United States thus had very limited testing requirements when the first pill was initially approved, and Enovid underwent governmental premarket review only in the United States. The 1938 Food, Drug and Cosmetic Act specified that a drug is not defined by its ability or lack of ability to treat a disease, but rather as any product “affecting the structure or function of the body.” This language had been incorporated into the 1938 law for the explicit purpose of giving the FDA jurisdiction over products such as obesity drugs (obesity was not considered a disease), nose straighteners, and especially contraceptive devices such as pessaries and condoms, which, like oral contraceptives, had both therapeutic and contraceptive applications. Therefore, by definition, Enovid was a product that clearly fell under the jurisdiction of the FDA."

- Hormonal birth control

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