Hormonal birth control

"Once marketed in the United States and Britain, Enovid/Enavid was freely available to women whose doctors would prescribe it, either as a treatment for infertility or for menstrual disorders. Medical doctors in both countries could then, as they can now, prescribe drugs for purposes other than those approved because neither country has ever sought to regulate the practice of medicine. The fact that so many women may (or may not) have had access to Enocid/Enavid years before it was formally approved by FDA as a contraceptive makes any discussion about the approval of the pill which centers upon numbers very difficult. The most commonly cited figure is that by 1959 more than 500,000 women were taking the drug for menstrual disorders in the United States."

"By the beginning of the 20th-century, the idea of oral contraception in conventional medicine had died. It was not to be revived until the century was half over. The woman who made it happen was Margaret Sanger (Riddle, 1992)."

"Developed in the1950s, the pill was once optimistically hailed as a scientific cure for the world’s rising population and its consequent social and political ills. Historians, however, have begun to show that the oral contraceptive did not prove to be the social panacea envisioned by its inventors, and that its history is more complex. Much of its history cannot be disentangled from the wider political, economic, and social issues of the day .Watkins, for instance, has shown that the availability of the pill in the United States had a major impact on the relationship between doctors and female patients in the1960s. Similarly, Critchlow has illustrated how the contraceptive controversy in American politics started with the appearance of the pill and continued with the debates surrounding RU-486, the abortion pill. More recently, Marks has challenged previous histories, which have championed the pill as a North American product that fuelled the sexual revolution, suggesting that its roots and subsequent adoption were much more diverse in origin and can only be understood within a wider international framework."

"G.D. Searle and Company made the first American application for the approval of Enovid to the FDA in 1957.The company sought approval for the use of Enovid in cases of menstrual irregularities, including amenorrhea, dysmenorrhea, and menorrhagia, as well as endometriosis (a painful proliferation of uterine tissue outside the uterus) and infertility. Incases of infertility, it had been shown that women who were given the drug for several months-to “rest” their ovaries-often went on to conceive, a phenomenon often referred to as the “Rock Rebound” effect. Although the original submission addressed only gynecological disorders, it was well known among many scientists that this particular formulation could prevent ovulation and therefore could be used as a contraceptive. Publications worldwide had reported Pincus’s work and has speculated on the pills clinical prospects."

"The pill, of course, is still on the market, and although it is still controversial in some corners, the social and medical concerns it originally engendered have now been supplanted by concerns over the abortion drug RU-486, approved in the United States in 1999. The pill, like other drugs before and after it, added experience and knowledge that strengthened the regulatory process. Moreover, early and continuing public criticism of the pill and its approval was crucial in opening up the larger debate over the safety, labeling, and information provided to consumers of prescription drugs in both countries. Seaman’s tireless, and at times heroic, efforts to mandate a “patient package insert” for the oral contraceptives cannot be overlooked as a major contribution to the history of the women’s health movement. Because of the knowledge gained from Enovid/Conovid, pharmaceutical researchers have gone on to create a new generation of oral contraceptives which are, in the words of journalist Robin Herman,“99.9% effective,” but are generally safer and have far fewer side effects than any of the original pill formulations. Only in 1995 was it established that a mutant gene (called factor V Leiden) puts some women at increased risk of venous thrombosis. With the recent commercial availability of genetic screening for this gene, women now have the option of being screened before they take the pill."

"[M]edical history is often swept clean, praising progress without remembering those who suffered to create it. For the most part, the popular narrative of the pill is one of celebration. When a 2009 Harvard Gazette story discussed Harvard’s role in creating the birth control pill, they did so without referencing the Puerto Rican trials or the asylum testing. Pincus and Rock are largely remembered for their contributions to women’s reproductive empowerment, without reference to their troubling methods."

"Pincus made his name in the field of experimental biology when, in 1934, he produced rabbits in vitro by parthenogenesis. In 1944, he established the Worcester Foundation for Experimental Biology where he surrounded himself with a group of brilliant young investigators. One of them was a Chinese immigrant, Min-Chueh Chang, who repeated and refined the experiments of Makepeace and established the experimental model to study the anti-ovulatory effect of sex steroids. The impetus for converting findings of animal experiments into human hormonal contraception was given by Margaret Sanger, founder of the Planned Parenthood Federation of America (PPFA). She approached Pincus in 1951 and provided a small grant to begin hormonal contraceptive research. In the same period, John Rock, an expert in the treatment of infertility, was experimenting with the oral administration of high doses of oestrogen (diethylstilboestrol) and progesterone to induce pseudo-pregnancy in infertile women. He reasoned that high doses of sex steroids promoted the growth of the uterus and the Fallopian tubes and so restored fertility; but he also found that this treatment suppressed ovulation. The biologist Pincus and the gynaecologist Rock shared their experience and their intention to develop a hormonal oral contraceptive."

"ON June the United States celebrated the fortieth anniversary of the approval of Enovid, the first oral contraceptive. From the time of the first clinical trials to the present, nearly million women have swallowed various formulations of the contraceptive pill, making it one of the most widely consumed class of drugs in the world. By the end of the twentieth century oral contraceptives had become a feature of everyday life, with more than 70 million women reaching for their pill packet on a daily basis around the globe. Widely regarded as a revolutionary drug in its early years, the pill might retrospectively be considered the first “designer” or “lifestyle” drug of the twentieth century."

"By 1967, British scientists had conclusively linked the pill with thrombosis, but they did so relying largely on epidemiological data. This increasing reliance on statistical evidence supported and advanced a more analytical and less communally determined drug approval process. This change in the risk-benefit equation calculations of a new drug, of course, may have been inevitable and had been initiated with an earlier drug, chloramphenicol, but it was the stature and novelty of Enovid that propelled it forward so dramatically. In the United States, concerns about the safety of the pill before 1967 led to the creation of the Food and Drug Administrations ”first permanent advisory committee, further changing the nature of the drug approval process and initiating what Jasanoff would later call the “fifth branch” of government in the United States."

"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."

"By the end of the fourth quarter of 1964, more than 4 million women had used Searle’s pill. Such unexpected and unprecedented popularity not only surprised the pharmaceutical industry, but amazed physicians, family planners, social reformers and politicians as well. The early enthusiasm for oral contraceptives, however, was soon dampened as the high hormonal doses of the first pill produced nausea, headaches, and dizziness so severe that some women abandoned the pill as quickly as they had embraced it."

"By the 1970s, however, there had been a sea tide of change in the evaluation of the safety of oral contraceptives since 1960. In 1962, before the British researchers established the statistical link with thrombosis, many physicians felt that the whole question of the pill’s side effects had been magnified, not by the actual danger, but by the concerns over thalidomide. No one disputed, however, that there was a need for more research to substantiate the concerns. By the time of the Nelson hearings, several large-scale studies of the pill and of thrombotic phenomena had been designed, and others were underway. The American Cancer Society, to cite a single example, initiated a seven-year study comparing 5000 pill users with 5000 nonusers. Experience with such large studies and interpretation of their results, as well as the new drug evaluation methods mandated by laws and regulations enacted in the wake of the thalidomide disaster, strengthened the entire new drug approval system worldwide."

"After her husband died on January 19, 1947, Katharine D. McCormick came into $35 million. A life-long feminist and birth control advocate, she spent the money on what Margaret Sanger, famous feminist and Planned Parenthood founder, explained to her as “the greatest need of the whole [Planned Parenthood] movement”—“a simple, cheap, contraceptive.” Feminists had dreamed of a birth control pill a woman could take without a man’s knowledge, and Rock and Pincus were their best chance yet."

"Ten years after its first release, the birth control pill made headlines again during the Nelson Pill Hearings, a Capitol Hill investigation into the pill’s safety. When feminist activists noticed that no women were being invited to testify, they interrupted the proceedings and testified from their seats. “Why isn’t there a pill for men?” activist Alice Wolfson shouted. “Why are 10 million women being used as guinea pigs?”"

"Almost every decade we have witnessed a breakthrough in oral contraception. Social and moral objections to birth control have gradually disappeared and, notwithstanding some pill scares, oral contraceptives are now one of the most used methods of contraception."

"It had already been known for several decades that sex hormones were able to suppress ovulation in animals. Ludwig Haberlandt, an Austrian physiologist is sometimes called the grandfather of the pill. Indeed, in 1921 he found that rabbits and guinea pigs became temporarily sterile after transplantation of ovaries from pregnant animals. These experiments paved the way for pharmacological studies on the effect of progesterone on ovulation. The anti-ovulatory effect of progesterone was demonstrated by A. W. Makepeace and co-workers in 1937 who injected progesterone in mated female rabbits. Large-scale experiments with progesterone, which hitherto had been extracted from animal ovaries became possible after Russell E. Marker, a professor of organic chemistry, found that progesterone could be manufactured from a substance named diosgenin, extracted from the root of a plant (Dioscorea mexicana) which grows in Mexican jungles."

"There is a vast difference between the original pill and the current forms of hormonal contraception. This evolution was characterised by the reduction of hormonal dosages, introduction of new progestins, elaboration of various oestrogen-progestin administration schemes and the development of alternative routes of administration. It was driven by the search for oral contraceptives causing less side effects, but also by competition between pharmaceutical companies, and was facilitated by advances in the knowledge of hormonal mechanisms and the monitoring of the endocrine and metabolic effects OCs elicit."

"Epidemiological studies by the Medical Research Council, in the UK, revealed that pill users were more susceptible than nonusers to thromboembolism9. On second thoughts, this complication could be anticipated because of the established link between high oestrogen levels and thromboembolism during pregnancy. Later, it was shown that oestrogens and ethinylestradiol in particular stimulate the synthesis of several clotting factors and hepatic proteins among which the renin substrate angiotensinogen, re-sponsible for pill-induced hypertension in susceptible women. This first pill scare led to the gradual reduction in the dosage of ethinylestradiol from 50 to 30, 20 and even 15 μg. This dose reduction was associated with less side effects such as breast tenderness, nausea and bloating. But, even at these low doses, oral contraceptives still exert a prothrombotic effect."

"Adding to the growing knowledge about the pill and its wide spread influence on twentieth-century history, we offer a detailed cross-cultural (or at least transatlantic) history of the actual processes by which the first pill formulation, Enovid (U.S.) and Enavid (U.K.) came onto the market. Such a detailed account of the marketing of the pill emphasizes that the birth control pill was introduced in various stages, rather than simply approved at a single point in time. The drug was first marketed in 1957 for treating gynecological disorders. Only in 1960 was it allowed to carry a contraceptive claim, and only after 1961 did reports begin to appear that the drug could cause serious, albeit rare, thrombotic complications (blood clots). Between the time that Enovid was approved as a menstrual regulator and then as a contraceptive, attitudes regarding the perception of safety changed greatly, as did the evaluations carried out to assess risk and efficacy."

"For most women, thalidomide came to epitomize the potential and unknown dangers posed by any drug used in pregnancy, while the horror that this drug inspired led directly to stronger laws governing the marketing of new drugs in Britain, the United States, and most of Europe between 1962 and 1964. As a drug intended to prevent pregnancy, the pill played a special role in the debate about the safety and efficacy of drugs."

"Much of the criticism of the pill, however, as Watkins has shown, arose from the fact that the pill altered the relationship between women and their physicians. In retrospect, it is clear that women’s rejection of medical paternalism underlay much of the social criticism leveled at the pill. We believe that the unique decision-making processes that introduced oral contraceptives and allowed them to remain on the market even after potentially dangerous side effects were discovered are an important and instructive example of the intermingling of science, policy, and practicability in the approval process for a revolutionary twentieth-century drug."

"The process by which the pill came to be marketed in Britain and the United States differed, according to the distinct drug regulatory mechanisms of each country. The United States had some premarketing control over the introduction of new drugs onto the marketplace, which had been established in 1938, but Britain had no premarketing controls aside from a requirement that all pharmaceutical manufacturers be licensed. In the end, however, both countries had similar versions of the pill on the market within months of each other."

"When Searle notified the FDA in 1959 that it wished to submit a supplemental application for Enovid to expand the drug’s labeling indications to include use as an oral contraceptive, it rapidly became clear that the American federal government wanted little to do with the process and saw it as no more than routine bureaucratic process of new drug review and approval at the FDA. As Critchlow and Watkins have discussed in great detail, there mere mention of contraception as a credible component of overseas aid had drawn the opposition of American Catholic bishops. Moreover, with the 1960 presidential election looming, neither President Eisenhower nor the Catholic presidential candidate, John Kennedy, wanted to make an issue out of contraception and the pending approval of the contraceptive pill. In Britain, the central government also vigorously refused to initiate debate over the pill. The British Ministry of Health had stated as early as 1955 that it did not want any involvement with contraceptive testing and approval. Again, in 1956, when news emerged of the possible availability of a contraceptive pill in the United States, the Medical Research Council, the main British government body responsible for clinical trials since 1919, refused to sponsor any monitoring of the new drug on the grounds that it was too politically and morally sensitive an issue for them to handle."

"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."

"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?"

"As Watkins has discussed, the Nelson hearings infuriated many women. During the 1960s many feminists had begun to protest against the paternalistic attitudes of the state and male-dominated medicine. After the hearings, women were critical of the process, which excluded testimony from female patients, and angry about the analogies to women as guinea pigs. Many responded by parading in front of the hearings carrying placards demanding “Feed the Pill to your guinea pigs at the FDA not live women.” After the hearings, women’s groups, particularly the Washington D.C.-based Women’s Liberation group, called for new separate hearings centered around women’s concerns, angrily arguing that, “In spite of the fact that it is women who are taking the pill and taking the risks, it was the legislators, the doctors, and the drug company’s representatives, all men of course, who were testifying and dissecting women as if they were no more important than the laboratory animals they work with every day.” In this charged atmosphere, there is no doubt that what feminists took away from the writings of journalists and the Nelson hearing proceedings was that women had indeed served as guinea pigs as drug companies prospered, and that, even ten years later, physicians were still not sure if the pill was safe."

"The trials began with small-scale tests on rats and rabbits. Each day, for a period of five days, re-searchers pumped immature female rabbits full of the reproductive hormones estrogen and progesterone. On the fifth day, the scientists allowed the rabbits to copulate, then removed their fallopian tubes and examined them for signs of egg fertilization. For years, Massachusetts scientists worked diligently on hundreds of caged rabbits in a basement lab on a shoestring budget, searching for the perfect compound. On June 23, 1960, a decade after the tests began, the hormonal birth control pill hit the market. The idea was simple: Take a little white pill once a day, avoid accidental pregnancy. The implications were revolutionary."

"On June 23, 1960, a decade after the tests began, the hormonal birth control pill hit the market. The idea was simple: Take a little white pill once a day, avoid accidental pregnancy. The implications were revolutionary. Women could work without fear of becoming pregnant. Sex before marriage be-came less risky. Sex after marriage became less fraught. Feminist historians herald this day as the be-ginning of the sexual revolution—but the story of the birth control pill is also one of conflicting ideologies and medical exploitation. The Harvard-educated scientists who formulated the pill relied on invasive tests and shaky medical consent."

"When the Pill came on the market in 1960, it was enthusiastically embraced by the medical profession and the public. But by the end of the decade, after a crisis over the drug Thalidomide (which was prescribed for morning sickness and caused birth defects) and increasing reports of potential health risks from the Pill, confidence in the drug was ebbing. In 1969 concerns came to a head with the publication of The Doctor's Case Against the Pill."

"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."

"With the arrival of the birth control pill in 1960, many believed the Church was about to change the position it had held for centuries. The Church was in the midst of reform, and in this climate of modernization it seemed possible that the Vatican might bend on birth control. Since 1957, Church law had allowed women with "irregular" cycles to take the Pill to regularize their cycle and enable them to better practice the rhythm method. Approval of the contraceptive pill, many believed, was soon to follow. Pro-Pill Catholics had a powerful ally on their side. John Rock, the eminent Catholic physician who had carried out Pill trials with Dr. Gregory Pincus, publicly argued that the Pill was merely an extension of the body's normal functioning. Since the Pill used the same hormones already present in the female reproductive system and did not tamper with sperm, Rock believed the Church should view the Pill as a "natural" form of contraception. The Vatican convened a commission to study the question of the Pill, but the Church would take eight years to determine its policy towards the Pill. In the interim, the Pill quickly became the most popular method of birth control among American women —regardless of religion."

"The introduction of oral contraception in 1960 was not the result of one person's fortuitous discovery as happened with X rays or penicillin. It was, rather, the product of small accretions of knowledge resulting from the effort, talent, and determination of many people over a period of years."

"The chemical history of the pill begins with the isolation of progesterone in May 1933 by Corner and Allen. With the help of Dr. Hickman from the research laboratory of the Eastman Kodak Company, they used high-vacuum distillation of the oils extracted from corpora lutea to isolate the hormone in a crystalline form which they named progestin. Before the end of that year, Wintersteiner and Allen determined the structural formula of the hormone (C21 H30 O2). This admittedly was not difficult, since the structural formula of pregnanediol was known from previous work by Butenandt. As Allen later recalled, the correct structural formula of progesterone had originally been sketched on a napkin during a lunch with William Strain, long before the definitive structural proof was furnished! In the summer of 1934 the isolation of crystalline progesterone hormone was announced also by Butenandt and Westfall in Danzig, by Slotta et al. in Breslau, and in Switzerland by Hartman and Wettstein. A short time later Butenandt and Schmidt converted pregnandiol to progesterone, and Fernholz succeeded in synthesizing progesterone from stigmasterol."

"The early production of progesterone was extremely complex and laborious and the resulting product prohibitively expensive. Butenandt required a ton of cholesterol, obtained from the brains and spinal cords of cattle and the grease from sheep's wool, to obtain 20 lbs of starting material from which commercial quantities of progesterone could be produced. Progesterone, when available, was quoted at $l,000/gm. What opened the door for the development of the pill were two advances in steroid chemistry: the introduction of a new technique that changed progesterone from an expensive rarity to the cheapest of all steroid hormones, and the subsequent modification of the progesterone molecule to make it effective orally."

"I invented the pill at the request of a woman."

"Historically, contraception was believed to affect the voice negatively. However, more recent studies using low-dose oral contraceptive pills (OCPs) show that they stabilize the voice. However, stabilization generally occurs only during sustained vowel production; connected speech appears unaffected. Therefore, singers may be the only population that experiences clinically increased vocal stability as a result of taking hormonal contraceptives."

"[Margaret Sanger] said that when she started out in 1912, one of the first things she thought of was a new method for women to use. She after all was a nurse. She was an obstetrical nurse. She knew about birth control. She knew what methods were out there, and she knew they were lousy. She knew they worked sporadically. She knew it took the cooperation of the male and the female, the man and the woman, to make the method work. This was not always satisfactory, and she wanted to apply science and medicine to her feminist mission of giving women control of childbearing, so from the very early days in 1912, she dreamt of a pill. She knew the science wasn't there yet, which is why it took over four decades for this to happen."

"The history of the development of oral contraceptives (OCs) has been a progressive reduction in dosage to what is now probably the lowest does that is compatible with the desired therapeutic effect -- to inhibit ovluation. Yet, controversy and argument continue."

"There is not the slightest doubt that a woman who is over 35, who smokes, and who, in addition, may be obese and has hypertension should not use OCs. Progestogen (mini) OCs have a slightly higher failure rate and a greater incidence of irregular bleeding than have combined OCs. The mini OC has little place in women who need effective hormonal contraception and good cycle control. The mini OC may have a place in a patient who finds other contraception unacceptable and in whom estrogens are contraindicated specifically."

"The possibility of hormonal contraception was postulated as early as 1919 by the physiologist Ludwig Haberlandt in Innsbruck. The same year, he began to test his hypothesis in animal experiments. In 1924 he succeeded in his efforts to render mice infertil by orally administering ovarian and placental extracts. He failed to have his method tried in women."

"One of the early female graduates of the Massachusetts Institute of Technology, Katharine McCormick believed in science and in the advancement of women. Margaret Sanger witnessed unwanted pregnancies -- and desperate abortion attempts -- when she worked as a nurse among New York's poorest women. Though they came from different worlds, the two women set out to improve women's lives through "birth control," a phrase Sanger coined. When Sanger and McCormick first met in 1917, women had been working for decades to achieve the vote. Thirty-nine years had gone by since a constitutional amendment for women's suffrage was first proposed, and three more years would pass before the states ratified it. At a time when women struggled for voting rights, job opportunities, or access to education, both McCor-mick, a suffragist, and Sanger, a birth control proponent, were outspoken advocates for giving women more control over their own lives. Thirty years later, McCormick's sizable inheritance combined with Sanger's tireless advocacy would bring about the birth control pill and spark a revolution. "An estimated eighty percent of all American women born since 1945 have taken the Pill," says historian An-drea Tone, giving them the ability to plan their reproductive lives."

"McCormick's involvement with the Pill is extraordinary. I think she's one of the most underappreciated figures in not just Pill history, but the entire history of scientific and technological innovation. First of all, it was very uncommon for a woman in the 1950s to have the kind of fortune that McCormick had. She had a fortune that was so vast that, as John Rock said at one point, she couldn't even spend the interest on the money that she had. So she was unique from the get-go in simply having this access to capital... At the time, the pharmaceutical companies which had historically been involved in some kinds of birth control production, like condom production and diaphragm production, saw the Pill project also as too controversial. Many large companies had passed on the opportunity to develop the Pill, including Pfizer and Merck, because they just didn't want to touch it. And so, were it not for McCormick, it's unclear how the Pill would have been developed. She really deserves credit for single-handedly financing one of the most important developments of the 20th century."

"Introduction of the birth control pill in the United States in 1960 marked the end of a relatively short period of time (< 10 years) to intentionally produce an oral contraceptive, and the beginning of a relatively long period of controversy surrounding the use of the pill. Availability of the pill had an impact on various aspects of social life, including women's health, fertility trends, laws and policies, religion, interpersonal relationships and family roles, feminist issues, and gender relations, as well as sexual practices among both adults and adolescents. The pill proved to be highly effective from the outset. Although safety issues developed with the earlier formulations, continued evolution of pill hormones and doses has resulted in a greatly improved and safe oral contraceptive. A broad range of noncontraceptive health benefits also is associated with the pill. These health effects are significant, as they in-clude protection against potentially fatal diseases, including ovarian and endometrial cancers, as well as against other conditions that are associated with substantial morbidity and potential hospitalization and associated costs. The popularity of the pill has remained high, with rates of use in the past 30 years in the United States ranging from one-quarter to almost one-third of women using contraception. Almost 40 years after its introduction, the pill's contraceptive efficacy is proven, its improved safety has been established, and the focus has shifted from supposed health risks to documented and real health bene-fits."

"By the end of their reproductive years, more than 80% of US women will have used oral contraceptives (OCs), for an average of about 5 years. The pill has had a dramatic impact on social life in the US, affecting women's health, fertility trends, laws and policies, religion, interpersonal relations, family roles, women's careers, gender relations, and premarital sexual practices. The emergence of the women's rights movement of the 1960s and 1970s was significantly related to the availability of the pill and the control over fertility it enabled. This capability allowed women to make choices about other life arenas, especially work. Over the past 40 years, both the content and dose of the steroid components of OCs have changed significantly, with consequent reduced health effects. This improved safety profile has been further bolstered by the identification of women with risk factors such as smoking, high blood pressure, history of cardiovascular disease, and diabetes with vascular disease. In recent years, the emphasis has shifted from the health risks of OC use to the noncontraceptive health benefits."

"Progestin-only contraceptives are known to alter the cervical mucus, exert a progestinal effect on the endometrium, interfering with implantation, and, in some patients, suppress ovulation."

"Oral contraceptives (OC) convey a protection against ovarian, endometrial and perhaps colorectal cancer. However, OC use is associated with excess risk of breast (current or recent use only), cervical and liver cancer. Benefits and risks of OC use on cancer were reviewed in 2005 by a Working Group at the International Agency for Research on Cancer, which concluded that combined OCs are carcinogenic to humans, based on an increased risk for hepatocellular carcinoma, cervical and (for current use only) breast cancers. The Working Group also concluded that there is conclusive evidence that OCs have a protective effect against cancers of the ovary and endometrium."

""It is the prerogative of the human intellect to dominate the energies offered by irrational nature and to orient them towards an end conformable to the good of man." In regard to your question as to why the pill is so bad if it is permitted by the Church to be used sometimes and at other times it is forbidden. The answer is that the pill is not intrinsically evil, of itself. It is made up of varying levels of the hormones called progestogens and estrogens. There is nothing evil about these hormones; God Himself created them! Yet He created them with a biological purpose of giving the female body the potential for fertility . . ."

"When one approaches the cycle of a woman's body from the standpoint that God made it and has made it for a purpose, one can then understand the relation of the pill to this cycle. To be blunt, a woman's cycle is ordered toward fertility, toward life. The pill, when used as an oral contraceptive, is ordered toward infertility, toward death. The pill (made up of estrogen and progestogen) is ordered toward infertility because it inhibits the release of the follicle stimulating hormone and stops the luteinizing hormone from triggering ovulation. The pill is ordered toward death because both estrogen and progestogen "change the endometrium in such a manner that even if ovulation did take place, implantation of the fertilized egg would be unsuccessful." In some cases, a child is conceived, and the pill acts as an abortifacient. This is the murder of an innocent!"

"On the 50th birthday of the pill, it is appropriate to recall the milestones which have led to its development and evolution during the last five decades. The main contraceptive effect of the pill being inhibition of ovulation, it may be called a small miracle that this drug was developed long before the complex regulation of ovulation and the menstrual cycle was elucidated. Another stumbling block on its way was the hostile climate with regard to contraception that prevailed at the time."

"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)."