No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
Women's Trials: The Approval of the First Oral Contraceptive Pill in the United States and Great Britain
Abstract
Journal of the History of Medicine and Allied Sciences 57.2 (2002) 117-160
On 23 June 2000 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 200 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. As with many drug firsts, many lessons can be learned from its development and use. Indeed, as we argue in this essay, the pill played a significant role in reshaping pharmacology, social perceptions of medication, and the regulatory process for new drugs during the second half of the twentieth century.
Developed in the 1950s, the pill was once optimistically hailed as a scientific cure for the world’s rising population and its consequent social and political ills (Fig. 1). 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 the 1960s. 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.
Adding to the growing knowledge about the pill and its widespread 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.
The pill redefined the very conception of contraception. In contrast [Begin Page 120] to previous methods of contraception, which often presented innumerable messy problems, from leaky condoms to poorly fitting diaphragms and rhythm miscalculations, the pill transformed contraception into something seen as simple, straightforward, and very reliable. In contrast to short-acting barrier contraceptives, however, the pill posed significant safety concerns for regulators. The very fact that it could be taken for such extended periods of time and by healthy women raised some anxiety. Such fears seem to have diminished quickly among the regulators between 1959 and 1960, the very time that the drug was being considered for approval as a contraceptive. Records do not reveal how regulators shifted their focus from potential problems with the pill to an overall appreciation of its medical benefits in comparison with botched abortions (which were never openly discussed) or with the risks of childbirth. The benefits of the pill compared to the risks of childbirth were calculated and defended openly during the approval process and used to defend the approval decision...
... Researchers John Rock and Gregory Pincus chose Puerto Rico as a site for a human clinical trial for a pill (Oral Contraceptive) due to the receptivity of Puerto Rican women for better planning even though it was counter to officials' concern about needs for population growth (Vimeo 2020). However, evidence indicates that Puerto Rican women may have become unwitting research subjects to sterilize them in these experiments (Junod and Marks 2002). women (4,925 OC group and 4,832 non-OC group) in the 1960s, this was considered a challenging randomized clinical trial, continuing for more than a decade and enrolling ten thousand subjects (Potts, Feldblum, and Haba 1982). ...
... (No effort to inform or warn subjects of adverse reactions was undertaken on the mainland as well.) (Junod and Marks 2002). Some have compared the study on women for oral contraceptives (O.C.) to the Tuskegee Syphilis Study (Vargas 2017). ...
... By 1964, 4 million women were using the only available Pill -Enovid (Vargas 2017). However, severe adverse reactions had dampened the early enthusiasm for the Pill(Junod and Marks 2002) ...
In 1898, the Treaty of Paris agreement concluding the Spanish-American War gave the U.S. rights to claim and colonize Puerto Rico, the Philippines, and Guam. Along with the many consequences of such colonization came reports of significant harm to the native populations in healthcare and medical research by the occupying forces. Reports about unethical medical treatment and research on Puerto Ricans and Filipinos have existed but are often ignored, yet they include experiments and treatment with Total Body Irradiation (TBI), research on oral contraception leading (for some) to sterilization, and careless use of contaminated vaccines on humans. Researchers failed to protect their subjects; shining a light on these unethical cases could help to further the process of moral reckoning with past abuses, encourage political reforms improving health and welfare, and promote higher ethical standards in healthcare and research on those with diminished autonomy/self-determination.
... The 1960s saw approval of the combined oral contraceptive pill (OCP) for use by married women in both the USA and the UK (White Junod and Marks 2002;Dhont 2010), but it was not available to single women until the early 1970s (Dhont 2010). The OCP offered the opportunity for women to control their fertility through the use of sex hormones, but this did not come without risk. ...
... In 1961 reports emerged that OCP use may be associated with venous thromboembolism and arterial thrombosis, with British researchers confirming the risk of thrombosis in 1962 (White Junod and Marks 2002). As safety concerns continued, detailed patient drug information leaflets were included in packets of the OCP to better inform women about the potential side effects of the drugs they were using (White Junod and Marks 2002;Utz 2011). ...
... In 1961 reports emerged that OCP use may be associated with venous thromboembolism and arterial thrombosis, with British researchers confirming the risk of thrombosis in 1962 (White Junod and Marks 2002). As safety concerns continued, detailed patient drug information leaflets were included in packets of the OCP to better inform women about the potential side effects of the drugs they were using (White Junod and Marks 2002;Utz 2011). 1969 saw the introduction of the progesterone only OCP to the UK (White Junod and Marks 2002; Family Planning Association 2010) which offered effective contraception for those women who experienced side effects using the combined OCP. ...
Background: The Office of National Statistics 2011 census reported 8,585600 women living in the United Kingdom (UK) between the ages of 45 and 59 years old. The natural menopause affects midlife women who have not experienced surgical or chemical interventions with the average age for menopause in the UK being 51 years. Menopause related changes are suggested to occur for
some women before their final menstrual period and can continue for a significant time after the cessation of menses. The aim of this study was to explore women's lived experience of menopause, how they made sense of their experience and to what extent experiences and perspectives were shared.
Methodology and methods: interpretative phenomenological analysis (IPA) was applied to explore the lived experiences of nine women aged 45-60 years old. Data were collected via semi structured interviews and analysis guided by the idiographic, phenomenological and hermeneutic principles of IPA.
Findings: data analysis generated eight super-ordinate themes: Physical losses, emotional losses, loss of traditional notions of feminine identity, liberation from biological restrictions, liberation from social expectations, "sisterhood": a shared female experience, making social comparisons with other women and women's knowledge. Three higher order concepts were developed encapsulating the super-ordinate themes and capturing the bio psychosocial experiences of the
women who participated in this study: Losses: “I kind of assumed that it was something that lasted for a year or two and then it went and you went back to normal” (Kate:36), Liberation: Freedom from “cultural baggage...to feel that you’re becoming yourself finally” (Kate:486) and Women’s Business: The “stuff of legend” that only can be experienced and shared by women (Rose:278).
Conclusion: findings challenge the dominant Western cultural narrative which explains menopause in terms of a transition. The language of menopause with its focus on 'symptoms', encouraged women to view and experience menopause in a negative way perpetuating Western cultural ideals situating youth as desirable and rendering older women invisible. This study offers an in-depth nuanced understanding of the complex, individualised nature of the natural
menopause for a specific group of women and how their lived experience results in a new 'normal' and an acceptance of the changing me: “You just get on with it” (Rose:347).
<br/
... A substantial increase in contraception took place in the United Kingdom after oral contraceptives became available to married and unmarried women in 1961 and 1967, respectively (13). To more specifically evaluate the potential role of contraception in the above finding, we divided the UKB data into cohorts in subsequent analysis. ...
... Interestingly, the coefficient β was positive in the first two cohorts (1950 to 1959) but became negative in all subsequent cohorts (1960 to 1989) (Fig. 1). The switch of the sign of β coincided with the availability of oral contraceptives and popularization of contraception in the United Kingdom (13). Because members of the 1950 to 1954 cohort were most likely still sexually active after 1960, their β value may have also been impacted by increased contraception. ...
Because human same-sex sexual behavior (SSB) is heritable and leads to fewer offspring, it is puzzling why SSB-associated alleles have not been selectively purged. Current evidence supports the antagonistic pleiotropy hypothesis that SSB-associated alleles benefit individuals exclusively performing opposite-sex sexual behavior by increasing their number of sexual partners and consequently their number of offspring. However, by analyzing the UK Biobank, here, we show that having more sexual partners no longer predicts more offspring since the availability of oral contraceptives in the 1960s and that SSB is now genetically negatively correlated with the number of offspring, suggesting a loss of SSB's genetic maintenance in modern societies.
... Beginning in the 1950s with the preclinical and clinical research for the first oral contraceptive, a number of development decisions were made, at least in part, due to CIMCs. For example, mestranol and a regimen of hormone-free days were both added because researchers decided monthly withdrawal bleeding was the most acceptable to contraceptive users, as well as possibly other contemporary influential stakeholders [9][10][11]. These decisions, made decades ago, still impact the current contraceptive method mix and contraceptive R&D today. ...
Objective
We sought to develop consensus recommendations for improved measurement of contraceptive-induced menstrual changes (CIMCs) in contraceptive clinical trials to build upon previous standardization efforts.
Study Design
We undertook a virtual consensus-building process using a modified Delphi approach, incorporating aspects of Nominal Group Technique and the Jandhyala method. The process consisted of four half-day meetings, developing recommendations within five topical working groups, a series of consensus questionnaires to assess recommendation agreement on a 4-point Likert-like scale, and opportunities for input and feedback throughout the process. Recommendations required at least 75% consensus to be included.
Results
Our interdisciplinary group—from 26 organizations and 13 countries in five global regions across academia, nonprofit research organizations, the pharmaceutical industry, and funding agencies— developed 44 consensus recommendations. These included recommendations on standardization, patient-reported outcome measure development aligned with current regulatory guidance, trial design, protocol development, participant recruitment, data collection, data analysis, and areas for exploratory research. Seven recommendations were deemed a priority by over 85% of our group.
Conclusion
Using a formal consensus-building process, we reached high levels of agreement around recommendations for more standardized and patient-centered measurement of CIMCs in contraceptive clinical trials, now and in the future.
Implications statement
Consensus recommendations on measuring bleeding changes and related outcomes in contraceptive clinical trials can improve reporting of standardized, patient-centered outcomes in future product labeling. These improvements can enable providers to offer more relevant counseling on contraceptives and permit greater comparability and data synthesis across trials to inform clinical guidance.
... As a treatment for menstrual symptoms, Enovid could pass through FDA scrutiny and enter the market, sidestepping (some) moral debates on birth control while maintaining the possibility of its off-label use as contraception. It was not until 1960 that Enovid's producer requested and received FDA approval for its use as a contraceptive (Junod and Marks 2002;Watkins 1998). The initial developers of the birth control pill knew that the hormones in the pill suppressed both ovulation and menstruation (Marks 2001). ...
Hasson provides an examination of menstrual suppression technologies and the implications they have on understanding menstruation as both quintessentially natural and socially constructed, and even what ‘counts’ as menstruation. Taking the case of birth control pills, Hasson studies menstrual suppression by analyzing medical journal articles, FDA advisory committee transcripts, and website marketing. Across these contexts, she finds that new definitions of ‘menstruation’ converge on the distinction between bleeding that occurs when women are taking hormonal birth control and when they are not. Finally, Hasson draws attention to the concept of redefining a biological process that is deeply significant for gendered embodiment, as well as a challenge to consider both the social and material construction of gendered bodies.
... The combined oral contraceptive pill (COC) was developed more or less by chance. The first progestin drugs were tainted with mestranol, a synthetic estrogen, during the first human study in Puerto Rico in 1956 [2]. After breakthrough bleeding occurred as a result of the products' purification and lower estrogen content, it was decided to keep the estrogen for cycle control, establishing the idea behind combined estrogenprogestin oral contraceptives [3]. ...
Hormonal contraceptives (HC) are widely used among women in reproductive ages. In this review, the effects of HCs on 91 routine chemistry tests, metabolic tests, and tests for liver function, hemostatic system, renal function, hormones, vitamins and minerals were evaluated. Test parameters were differently affected by the dosage, duration, composition of HCs and route of administration. Most studies concerned the effects of combined oral contraceptives (COC) on the metabolic, hemostatic and (sex) steroids test results. Although the majority of the effects were minor, a major increase was seen in angiotensinogen levels (90-375 %) and the concentrations of the binding proteins (SHBG [∼200 %], CBG [∼100 %], TBG [∼90 %], VDBP [∼30 %], and IGFBPs [∼40 %]). Also, there were significant changes in levels of their bound molecules (testosterone, T3, T4, cortisol, vitamin D, IGF1 and GH). Data about the effects of all kinds of HCs on all test results are limited and sometimes inconclusive due to the large variety in HC, administration routes and dosages. Still, it can be concluded that HC use in women mainly stimulates the liver production of binding proteins. All biochemical test results of women using HC should be assessed carefully and unexpected test results should be further evaluated for both methodological and pre-analytical reasons. As HCs change over time, future studies are needed to learn more about the effects of other types, routes and combinations of HCs on clinical chemistry tests.
... A pesar de que existe una gran variedad de anticonceptivos hormonales, los orales (ACO) son el método más prescrito a nivel mundial (5). En un estudio realizado en Bogotá sobre la percepción de su uso, se encontró que estos preparados orales y los inyectables eran los métodos más usados, ya que se encuentran en el listado de medicamentos del plan de beneficios del Sistema de Salud de Colombia, son asequibles y generalmente no causan irregularidades menstruales, lo que para las mujeres es un signo inequívoco de no estar embarazadas. ...
Objetivo: el uso de anticonceptivos hormonales ha crecido progresivamente en muchos países del mundo. Se trazó el objetivo de determinar los patrones de utilización de anticonceptivos hormonales en mujeres mayores de 15 años afiliadas al Sistema de Salud de Colombia. Materiales y métodos: Estudio de corte, que incluyó datos de mujeres mayores de 15 años con prescripciones y dispensaciones de algún anticonceptivo hormonal durante al menos tres meses continuos (abril- a junio-2016). Se creó una base de datos con información sociodemográfica, farmacológica (tipo de anticonceptivos, dosis, comedicaciones y comorbilidades. Se realizaron análisis descriptivos y multivariados buscando identificar factores asociados con comedicaciones de riesgo. Resultados: Se identificaron 34309 mujeres que recibieron anticonceptivos hormonales, con edad media de 27,2±7,0 años (rango:13-60,8 años). Los anticonceptivos más utilizados fueron inyectables de aplicación mensual (63,0%), inyectables de aplicación trimestral (19,1%), de administración oral (12,1%), los implantes subdérmicos (7,4%) y finalmente los dispositivos intrauterinos hormonales con 0,4%. El 5,7% de las pacientes (n=1957), estaban recibiendo alguna comedicación, especialmente con antihipertensivos (2,9%) y antimigrañosos (1,9%). Ser mayor de 45 años (OR:2,3; IC95%:1,7-3,0), utilizar dispositivo intrauterino hormonal (OR:2,4; IC95%:1,4-4,1) y anticonceptivo inyectable trimestral (OR: 1,7; IC95%:1,3-2,3) se asociaron con mayor probabilidad de recibir comedicaciones. Conclusiones. Las mujeres colombianas que acceden a anticonceptivos hormonales a través del Sistema de Salud están empleando principalmente presentaciones inyectables, con muy baja frecuencia de las orales, y en general tienen pocas comorbilidades que requieran tratamiento farmacológico, pese a que algunas tienen condiciones cardiovasculares que pueden implicar un potencial riesgo de eventos trombóticos.
... A substantial increase in contraception took place in the UK after oral contraceptives became available to married and unmarried women in 1961 and 1967, respectively (13). To more specifically evaluate the potential role of contraception in the above finding, we divided the UKB data into cohorts in subsequent analysis. ...
Because human same-sex sexual behavior (SSB) is heritable and leads to fewer offspring, it is puzzling why SSB-associated alleles have not been selectively purged. Current evidence supports the antagonistic pleiotropy hypothesis that SSB-associated alleles benefit individuals exclusively performing opposite-sex sexual behavior by increasing their number of sexual partners and consequently their number of offspring. However, here we show that having more sexual partners no longer predicts more offspring since the availability of oral contraceptives in the 1960s and that SSB is now negatively genetically correlated with the number of offspring, indicating a loss of SSB's genetic maintenance in modern societies.
... The product was redesigned in the 1920s, and introduced as a (Junod and Marks, 2002). such a situation, the company may decide to wait and may, in the meantime, apply other strategies to stimulate the build-up of the missing building blocks, such as networking strategies or lobbying strategies. ...
Pioneering companies of radically new technological innovations often suffer from a slow uptake of their innovations and struggle to find the right introduction strategy. This paper aims to conceptualize a Technological Innovation System framework that can be applied to formulate and study niche introduction strategies from a company perspective. It combines insights from two literatures: the socio-technical systems literature and the innovation & strategic management literature. This results in a framework consisting of seven Technological Innovation System building blocks and seven influencing conditions that can influence the building blocks. The Technological Innovation System building blocks in the framework are: product performance and quality; product price; production system; complementary products and services; network formation and coordination; customers; and innovation-specific institutions. The influencing conditions in the framework are: knowledge and awareness of technology; knowledge and awareness of application and market; natural, human and financial resources; competition; macro-economic and strategic aspects; socio-cultural aspects; and accidents and events. The framework can help explore the context around an innovation during the early stages of Technological Innovation System formation and specify the scope, timing and type of niche introduction strategies that fit this context. This is illustrated with two cases: dual-clutch transmission technology and photovoltaic cells.
... Second, the paucity of men participating in fertility and childbearing research may reflect social norms and the gendered nature of fertility and childbearing. The development of the first effective contraceptive pill in 1961 (Junod & Marks, 2002) has resulted in reproduction being socially constructed to be a female issue and responsibility. Therefore, engaging in childbearing research could be perceived as part of the female role and social norms could act as possible deterrents for men While the TPB has received support for its ability to predict and explain a wide variety of health behaviours (e.g., contraception, exercise)meta-analytic reviews have also shown the core constructs, attitudes, subjective norms and perceived behavioural control, to only account for approximately half of the variance in intentions (e.g., Armitage & Conner, 2001;Conner & Armitage, 1998;Cortis et al., 2017). ...
... The use of oral contraceptive which is often referred to as "family planning" has significantly improved infant, maternal and family health. [1,2] isolated and structurally revealed as Pregn-4-ene-3, 20dione (1) progesterone, but since the oral activity of progesterone is very low its daily intramuscular injection for continuous contraceptive purposes i.e. the inhibition of ovulation in human female is therefore impracticable a situation which thus influenced the modification of its basic molecular structure with the coming up of oral contraceptives [4] which was originally launched as a pill to be used containing a combination of nor-19-progestin with some quantity of synthetic estrogen. [5] This quest was born by Margaret Sanger in the middle of the 20 th century. ...
ABSTRACT
The aim of this study was to assess the concentrations of some plasma biochemical parameters in short and long
term users of oral contraceptives containing lower doses of estrogen and progestin composition as compared with
that of non contraceptive users (control). 5ml blood specimen each was collected into lithium heparinized
anticoagulated bottle from one hundred and fifty apparently healthy volunteers who were grouped into three with
group one consisting of fifty volunteers who have been on these oral contraceptives for a period of ≤ 5months
(short term users) aged 31-35 years (experimental group one), group two consisting of another fifty volunteers
who have been on these oral contraceptives for a period of ≥ 2 years (long term users) aged 31-35 years
(experimental group two) and group three consisting of the remaining fifty volunteers who were not on oral
contraceptives or any other medications before and during the course of this study aged 31-35 years (control
group). The plasma obtained from the spun blood specimens were used for the quantitative measurement of
creatinine, urea, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin and Creactive protein. The results showed that the mean values of plasma alanine aminotransferase, aspartate
aminotransferase, alkaline phosphatase, total bilirubin and C-reactive protein were significantly elevated (p≤0.05)
in the long term users of these oral contraceptives (experimental group two) as compared with that of non
contraceptive users (control group) while the mean values of plasma creatinine and urea were not significantly
different (p≥0.05) as compared with that of non contraceptive users (control group). However, the results went
further to show that there were no statistical significant differences (p≥0.05) in the mean values of all the plasma
biochemical parameters measured in the short term users of these oral contraceptives (experimental group one) as
compared with that of non contraceptive users (control group).In conclusion, this study has affirmed that plasma
alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, total bilirubin and C-reactive protein
concentrations are elevated in long term users of oral contraceptives containing lower doses of estrogen and
progestin composition for a period of ≥ 2 years aged 31-35 years. It is therefore recommended that long term users
of oral contraceptives containing lower doses of estrogen and progestin composition should embark on routine
laboratory investigations on these plasma biochemical parameters with the aim to bring the concentrations to
normal value if found elevated.
KEYWORDS: Studies, plasma biochemical parameters, short term users of oral contraceptives, long term users
of oral contraceptives, Lagos, Nigeria.
... Al mismo tiempo, esta idea se relaciona con la popularización de la píldora anticonceptiva, comercializada en 1957 en EE.UU. para tratar desórdenes ginecológicos y, posteriormente, en 1960, distribuida para uso anticonceptivo (White Junod y Marks, 2002). ...
Este artículo investiga las dialécticas que se establecen entre los personajes femeninos y masculinos en la serie de televisión Mad Men (Matthew Weiner, 2007-2015) a partir de un análisis cuantitativo y cualitativo del capítulo piloto “Smoke gets in your eyes” (Alan Taylor, 2007). Ambientado en el universo publicitario de la década de 1960 en Nueva York, el piloto sienta las bases temáticas, narrativas y estilísticas de la primera temporada de Mad Men, estrenada en el contexto mediático de la denominada primera oleada de la tercera época dorada de la televisión. Metodológicamente, empleamos la herramienta especializada Encuadres, un software creado por Jesús González Requena, que permite la manipulación analítica de los textos audiovisuales y la obtención de resultados cuantitativos por vía de computación. Con el fin de comparar la importancia de los personajes femeninos y masculinos en el universo narrativo de la serie, nos centramos en la segmentación del texto en escenas, planos y elipsis, así como en la obtención de porcentajes relativos a las presencias visuales, escénicas y verbales de cada uno de los personajes. De este modo, valorando los datos cuantitativos en relación al análisis cualitativo de Mad Men y la caracterización de sus personajes, llegamos a la conclusión que los hombres tienen una mayor presencia –lo cual se corresponde con su posición de poder–, y que las mujeres, no obstante, aprovechan más las oportunidades que se les presentan. Este último factor nos advierte de la emergencia incipiente y transformadora de los movimientos de reivindicación y empoderamiento femenino de los años 1960.
... In the approval of the first COC, regulators considered the risks of abortion and childbirth as factors in their approval decision for the contraceptive. 24 Additionally, psychological harms can be accounted for and used in risk determination. For example, while 5.4% of female users report mood changes, including depression, as an AE of their hormonal contraception (table 1), that is still lower than the 20%-22% of women who may experience maternal or postpartum depression. ...
Introduction
There is unmet need for male contraceptive options, but a recent injectable combination male contraceptive trial was terminated early due to adverse events (AEs).
Methods
We examined the frequency of reported AEs by male research participants compared with AEs reported in prescribing information of approved female hormonal contraceptive methods. Published data from trials of the top five most-used female hormonal contraceptives, supplemented by contemporary contraceptive research, were compared with the frequency of AEs reported in a male injectable hormonal contraceptive trial.
Results
We observed similar frequencies of AEs reported by users of male contraceptives compared with those reported by female users. Among quantitatively comparable AEs, compared with men, women reported experiencing higher frequencies of headaches, pelvic pain, and weight gain and similar frequencies of decreased libido. Compared with women, men reported experiencing higher frequencies of acne and mood changes. Men discontinued participation due to AEs at a lower frequency than women.
Conclusions
Female hormonal methods generally have similar frequencies of AEs to those reported in a recent male hormonal contraceptive trial, and male users had lower rates of discontinuation due to AEs. There were fewer serious AEs of the male contraceptive than reported in contemporary female trials which resulted in FDA licensure. This suggests there may be implicit bias in the scientific community regarding the level of acceptable risk for users of male contraceptive methods.
... While the concept of "justice" can be construed and understood in quite a narrow waywe wish to emphasize that there are historical and grouplevel concerns for people who have been marginalized. With respect to medical interventions, the examples of medical injustices that have been perpetrated at the group level include the Tuskegee Syphilis Study (53) and the Puerto Rican Birth Control study (54). ...
The growth in the direct-to-consumer genetic testing industry poses a number of challenges for healthcare practice, among a number of other areas of concern. Several companies providing this service send their customers reports including information variously referred to as genetic ethnicity, genetic heritage, biogeographic ancestry, and genetic ancestry. In this article, we argue that such information should not be used in healthcare consultations or to assess health risks. Far from representing a move toward personalized medicine, use of this information poses risks both to patients as individuals and to racialized ethnic groups because of the way it misrepresents human genetic diversity.
... Enovid was approved by the Food and Drug Administration (FDA) in 1957 to treat menstrual disorders. Enovid was widely used by women for various "gynecological disorders" before it was approved for contraception by the FDA in 1960 (Junod and Marks 2002). It took another decade of research data to show convincing evidence of the increased risk of venous and arterial thromboembolic events from oral contraceptives. ...
Since the 1960s, hormonal contraceptives have become the most commonly used method of pregnancy prevention in the United States and the world. Oral contraceptives are used by a large percentage of women, including Christian women. There are known health risks to women demonstrated in research published since Pope Paul VI's prophetic encyclical Humanae vitae in 1968. These risks include venous thrombosis, cardiovascular risks, and an increased risk of cancer. These risks are medically recognized with continued scientific debate on the degree. The risks are significantly increased with preexisting conditions and in certain demographic groups. Discussing known and potential treatment risks is a standard that is both accepted by the medical community and is increasingly expected by patients. This discussion can be accomplished by the mechanism and principle of informed consent. Depending on the circumstances, abstinence or fertility awareness-based methods (FABMs) should be presented to patients. FABMs are licit, safe, and effective methods of pregnancy prevention. Informed consent is the most effective means of providing patients with pertinent information on the significant risks of contraception.
Summary:
This article discusses the use of the informed consent to provide patients with information on the medical and ethical risks of oral contraceptives. FABMs and abstinence are presented as effective, safe, and licit preferences to oral contraceptives. Discussing known and potential treatment risks is accepted by the medical community and expected by patients (shared decision making). The authors discuss the historical context of Pope Paul VI's encyclical Humanae vitae in relationship to the development and rapid adoption of oral contraceptives.
... Very soon, hormonal birth control became tremendously popular, and .100 million women are current users of combined contraception, with higher prevalence in developed compared with developing coutries. 38,39 The use of sexual hormones as menopausal hormone therapy has become equally important. For a long time, menopause had been connected with a large number of physical and psychological problems in women. ...
The complexity of breast cancer etiology has puzzled scientists for more than 300 years. In this brief review, we emphasize the importance of reproductive and hormonal factors in relation to the risk of breast cancer. By following the historical course of how various risk factors have been determined, this study attempts to illustrate the origin of hypotheses, their subsequent rejection, and development of new hypotheses. Starting with the contributions of Italian physicians in the 18th century and covering the activity of British epidemiologists before World War II, this review ends up with the international collaboration that became increasingly important in the second half of the 20th century.
... By 1970, negative publicity surrounding the potential risks (mainly thrombosis) published in various British medical journals and newspapers may have influenced womens' decision against the use of oral contraceptives. 33 However, we did not observe an impact within our cohort, as oral contraceptives use increased steadily. Overall, 60% had reported ever use, which is identical to the percentage of oral contraceptive users reported from the Million Women Study. ...
Objective:
There has been considerable interest in the impact of reproductive factors on health but there are little data on how these have varied over time. We explore trends in reproductive/lifestyle factors of postmenopausal British women by analysing self-reported data from participants of the UK Collaborative Trial of Ovarian Cancer Screening (UKCTOCS).
Design:
Prospective birth cohort analysis.
Setting:
Population cohort invited between 2001 and 2005 from age-sex registers of 27 Primary Care Trusts in England, Wales and Northern Ireland and recruited through 13 National Health Service Trusts.
Participants:
202 638 postmenopausal women aged 50-74 years at randomisation to UKCTOCS between April 2001 and October 2005.
Interventions:
Women were stratified into the following six birth cohorts (1925-1929, 1930-1934, 1935-1939, 1940-1944, 1945-1949, 1950-1955) based on year of birth. Self-reported data on reproductive factors provided at recruitment were explored using tabular and graphical summaries to examine for differences between the birth cohorts.
Outcome measures:
Trends in mean age at menarche and menopause, use of oral contraceptives, change in family size, infertility treatments, tubal ligation and hysterectomy rates.
Results:
Women born between 1935 and 1955 made up 86% of the cohort. Median age at menarche decreased from 13.4 for women born between 1925 and 1929 to 12.8 for women born between 1950 and 1955. Increased use of the oral contraceptives, infertility treatments and smaller family size was observed in the younger birth cohorts. Tubal ligation rates increased for those born between 1925 and 1945, but this increase did not persist in subsequent cohorts. Hysterectomy rates (17-20%) did not change over time.
Conclusions:
The trends seen in this large cohort are likely to reflect the reproductive history of the UK female postmenopausal population of similar age. Since these are risk factors for hormone-related cancers, these trends are important in understanding the changing incidence of these cancers.
Trial registration number:
International Standard Randomised Controlled Trial Number: 22488978.
Ovarian cancer (OC) is the leading cause of gynecological cancer-related deaths in the United States. The purpose of this study was to evaluate long-term trends in OC incidence and incidence-based mortality rates (IBM) in the U.S. from 1975 to 2018 and to assess the effects of age, period, and cohort factors on OC incidence and mortality using an age-period-cohort model. We obtained data from the U.S. OC incidence/mortality data from the Surveillance, Epidemiology, and End Results database from 1975 to 2018. Joinpoint regression analysis was used to determine long-term trends and transitions, and an age-period-cohort model was used to quantify the effects of age, period, and cohort parameters on incidence and mortality. In addition, 1990 to 2019 U.S. OC data obtained from the Global Burden of Disease study served as a potential validation set. Between 1975 and 2018, 80,622 new cases of OC and 60,218 deaths from OC were reported in the U.S. The average annual percent change for OC incidence was −1.33 (95% CI: −1.64 to −1.02, P < .001), with a significant decrease in incidence at a rate of 7.80% (95% CI: −11.52 to −3.92) per year from to 2015–2018. IBM reached its peak for the U.S. population in 1994, with an age-standardized mortality rate of 6.38 (per 100,000 people). IBM rose first, peaked in 1986, and then declined at a rate of 0.39% (95% CI: −0.66 to −0.12) and 2.48% (95% CI: −3.09 to −1.85) per year from to 1986–2007 and 2007–2018, respectively. In addition, age-period-cohort model analysis showed the highest risk of OC incidence in 1980 to 1984 and the highest risk of OC death in 1985–1989. This study reported a significant decline in OC morbidity and mortality in the U.S. since 1986. In addition, this study analyzed the changes in trends in OC incidence and mortality by race/ethnicity in the U.S. Monitoring trends in OC incidence and mortality by race/ethnicity can help in the development of targeted prevention and treatment measures.
For years, reproductive surgery was the mainstay of reproductive care. As the evolution and ultimate success of in vitro fertilization (IVF) took hold, reproductive surgery became an adjuvant therapy, indicated mainly for severe symptoms or to enhance success rates with assisted reproductive technologies. As success rates for IVF have plateaued, and emerging data rekindles the enormous benefits of surgically correcting reproductive pathologiesthere is renewed interest amongst reproductive surgeons, in reviving research and surgical expertise in this area. In addition, new instrumentation and surgical techniques to preserve fertility have gained traction and will solidify the need to have skilled REI surgeons in our practice.
Advanced maternal age (AMA, >35 years at delivery) confers maternal and foetal risks, particularly with age >45 years and nulliparity, but longitudinal comparative data on age- and parity-specific AMA fertility is lacking. We used the Human Fertility Database (HFD), a publicly available, international database, to analyse fertility in US and Swedish women aged 35–54 from 1935 to 2018. Age-specific fertility rates (ASFR), total birth counts, and proportion of AMA births were evaluated across maternal age, parity, and time, and compared to maternal mortality rates during the same time. In the US, total AMA births nadired in the 1970s, and have risen since. Until 1980, most AMA births were to women completing parity 5 or higher; since then, most have been to low parity women. While ASFR in 35 to 39 year olds was highest in 2015, ASFR in women 40–44 and 45–49 were highest in 1935, though they have been rising recently, especially in low-parity women. While the same AMA fertility trends were seen in the US and Sweden from 1970–2018, maternal mortality rates have risen in the US despite remaining low in Sweden. Although AMA is known to contribute to maternal mortality, this discrepancy merits further consideration.
Background
With an increasing array of contraceptives in the market, it is important to understand how users perceive them and how their interests evolve over time.
Objectives
In this analysis, we aimed to examine the contraceptive interests of women and couples in Germany using data derived from social media posts.
Study Design
Social listening analysis.
Methods
Posts from Urbia—a German Internet community—mentioning at least one reversible contraceptive method between April 2006 and April 2021 were carefully selected by searching for a defined set of keywords and phrases. The frequency of mention of each method was studied and their trend over the last 5 years was analyzed. The significance of trends was evaluated using Mann–Kendall test. Additionally, 656 random posts were individually assessed for method transitions and problems associated with specific contraceptives.
Results
The contraceptive pill was the most frequently mentioned method of contraception followed by natural family planning methods, condom, hormonal coil, and copper/gold coil. Although general interest in hormonal contraception was higher compared to non-hormonal, interest in the pill decreased and interest in natural family planning and copper/gold coil increased. Most women switched from the pill to non-hormonal methods, almost half of them using a condom. Almost all migrations to natural family planning were from the pill and most migrations to non-hormonal intrauterine devices such as the coil were from hormonal methods. The common problem associated with most contraceptives was side effects.
Conclusion
Social media provides valuable information about contraceptive experiences that can be used to monitor contraceptive prevalence patterns and attitudes within a large population in a very short span of time. A good understanding of how various contraceptives are currently perceived helps in identifying strategies for improving existing family planning policies.
Plain language summary
Currently, there are a variety of contraceptive products available in the market. To understand how users perceive them and how their interest evolves over time, we analyzed social media posts from Urbia, a German Internet platform. We scraped posts between 2016 and 2021 from the “child-desire” and “contraception” forums and analyzed the relative frequency of mentions of different contraceptive methods. We also looked at 1000 individual posts from 1000 different users, analyzed method switches and the problems associated with individual methods of use. The oral pill was the most frequently mentioned method of contraception followed by natural family planning methods, condom, hormonal coil, and copper/gold coil. Over the last 5 years however, the mention of the pill dropped, whereas the mentions of natural family planning and copper or gold coil increased. Further analysis of individual posts showed most women migrating from the pill to other non-hormonal methods such as natural family planning and condom. Almost all migrations to natural family planning were from the pill and most migrations to non-hormonal intrauterine devices such as the coil were from hormonal methods. The most common problem associated with the pill and non-hormonal intrauterine devices was side effects. Through this analysis we show that social media serves as a useful tool to monitor contraceptive prevalence and attitudes within a large population in a very short span of time. Our findings give policy makers an idea on the topics where more counseling and education may be required to help women and couples find their best suited method of contraception.
El objetivo principal es averiguar en qué medida los espectadores acceden al punto de vista subjetivo de los personajes femeninos de la serie Mad Men (Matthew Weiner, 2007-2015). Para ello, nos centramos en el análisis del piloto, El humo ciega tus ojos (Alan Taylor, 2007). Empleamos una metodología de análisis cuantitativo y cualitativo del texto audiovisual. Para la extracción de datos cuantitativos utilizamos Encuadres, un software creado por el profesor Jesús González Requena. A continuación, llevamos a cabo un análisis textual de los instantes en los que accedemos al punto de vista subjetivo de los personajes femeninos de la serie.
This article examines the West German controversy over Duogynon, a ‘hormone pregnancy test’ and the drug at the centre of the first major, international debate over iatrogenic birth defects in the post-thalidomide era. It recovers an asymmetrical power struggle over the uneven distribution of biomedical knowledge and ignorance (about teratogenic risk) that pitted parent-activists, whistleblowers and investigative journalists against industrialists, scientific experts and government officials. It sheds new light on the nexus of reproduction, disability, epidemiology and health activism in West Germany. In addition, it begins to recover an internationally influential discourse that, in the post-thalidomide world, seems to have resuscitated antenatal drug use as safe until proven harmful.
This dissertation is focused on the controversies surrounding the birth control pill. Since 2014, journalistic articles about the side effects of the medication and its possible health risks have been circulating in the media more frequently. It was evident that an increasing number of young women, belonging to the urban middle classes, started to refuse the pill in search of other contraceptive methods considered "less aggressive" to the woman's body. It is from this ―movement‘s‖ observation that this dissertation develops itself. Regarding the methodological aspects, interviews were carried out both with women who use the medication and with women who - after a long period of use - start to refuse it. Through the compilation of narratives, it sought to access what some of the young women in the contemporary world think, say, and live. Locating the pill, either as a medication for the treatment of menstrual disorders, or as a lifestyle medication, or as a contraceptive method - without necessarily disassociating its different uses - has proved crucial to ascertain the ways in which different controversies circulate and the ways how some social relationships are transitioning. With regard to some of these changes, it was possible to observe transformations: in the ways in which doctor-patient relationships are being constituted; in the ways in which some women perceive, experience and construct notions of what body, health, and libido are; in the ways in which men and women relate to each other and share, or not, contraceptive responsibility; as well as in the ways in which other epistemologies of Science come into play nowadays. In addition to ascertaining, as well, how notions of risk and benefit to women's health are also subject to changes according to different contexts.
Keywords: Social Anthropology. Controversies. Birth control pill. Health. Women.
This paper analyses the major ethical issues raised by direct-to-consumer communications (DTCC) of pharmaceutical drugs, with a view to proposing ethical standards of practice for the marketing profession. A case-based analysis of four types of marketing practices is used to highlight the main ethical dimensions of DTCC. The ethical implications are then unpacked using the specific lenses of prominent ethical theories, so that non-experts in ethics—i.e., marketing professionals—can understand the implications for their daily practice. To synthesize the essential ethical imperatives related to DTCC, an oath for marketing professionals is offered as a guide to ethical conduct.
The Holocaust is one of the most researched and documented genocides in history, and yet it remains an inconceivable tragedy, for it is challenging to comprehend the mass killings, inhumane conditions, and sheer hatred that the European Jews faced during World War II. Literature has long been used as an educational tool about the realities of life. In contrast to history textbooks, literature allows readers to dive into the psyche of those persecuted; adheres to the historical events, while permitting artistic exploration of personal narratives; and creates a space where the unspeakable experiences and dehumanization during the Holocaust can be spoken, shared, and contended with. The literary reading process entails a dialogue between the reader and the narrative, thus generating an inquiry-based education on the Holocaust. Holocaust literature is sustained by survivors’ stories of resilience. Although these tales of resilience often do not have traditionally happy endings, they depict that people must contend with their past suffering and offer an educational tool to transmit testimony in the hopes of inspiring resilience in others. Holocaust literature provides a platform to meaningfully communicate personal narratives, which demystifies the tragedy as an isolated incident, educates readers on the historical realities of the Holocaust, and places responsibility on everyone to resist indifference. Through exploration of the artistic forms and historical elements of selected works of Holocaust literature, this paper will demonstrate that literature is a valuable tool in educating on the Holocaust and has merit as an integral part of school curricula.
Die Tage vor den Tagen werden in Fach- und Laienkreisen nicht selten als kritische Tage im Menstruationszyklus der Frau wahrgenommen. Die 'Störungsbilder' des Prämenstruellen Syndroms (PMS) und der Prämenstruellen Dysphorischen Störung (PMDS, engl. PMDD) haben sich mittlerweile gesellschaftlich etabliert. Die vorliegende Arbeit nähert sich der Thematik von medizingeschichtlicher Seite, indem sie Darstellungen des Prämenstruums in populärmedizinischen und wissenschaftlichen Texten vom Anfang des 19. Jahrhunderts bis in die Gegenwart untersucht. Sie umfasst einen historischen Überblick über die Entwicklungen vom 19. Jahrhundert bis zur Etablierung des PMS und der PMDD im 20. und 21. Jahrhundert. Auch unterschiedliche Theorien zur Genese prämenstrueller Veränderungen und Beschwerden werden herausgearbeitet. Der Fokus liegt insbesondere auf dem Einfluss medizinischer Lehren und soziokultureller Faktoren (bspw. der Frauenbewegung, der Degenerations-, und Konstitutionslehre) auf die Darstellungen des Prämenstruums in medizinischen Texten.
Ever since Vincent Knapp published his 1999 article “How old is Endometriosis?” [1], there seems to have been renewed interest in identifying just when endometriosis was discovered as a distinct disease entity.
Long-acting contraceptives are the most effective reversible contraceptive methods. Increasing patients’ access to these contraceptives may translate into fewer unintended pregnancies and lead to substantial individual and public health benefits. However, development of long-acting products can be complex and challenging. This review provides ( a) an overview of representative development programs for long-acting antipsychotics as cases for conceptual translation to long-acting contraceptives, ( b) several case examples on how modeling and simulation has been used to streamline the development of long-acting products, and ( c) examples of challenges and opportunities in developing long-acting contraceptives and information on how exposure-response relationships of commonly used progestins may enable regulators and developers to rely on prior findings of effectiveness and safety from an approved contraceptive to streamline the development of long-acting contraceptives. The US Food and Drug Administration is seeking assistance from stakeholders to provide data from studies in which pharmacokinetic and pharmacodynamic or clinical outcomes of hormonal contraceptives were evaluated and not previously submitted.
Expected final online publication date for the Annual Review of Pharmacology and Toxicology, Volume 61 is January 7, 2021. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.
Special bilingual issue: Cinematograph for industries and in companies (1890-1970): history, players, uses and configurations
In this article, I analyze women’s negative experiences with the fourth generation of contraceptive pills: controversial drugs Yaz and Yasmin. Drawing on in-depth interviews with 24 contraceptive users residing in Canada, I highlight how women who have experienced deleterious side effects understand the risks of hormonal contraception and advocate for changes in health risk communication and prescription drug regulation. Findings show that interviewees did not feel they received adequate risk information prior to starting their new drug regimen nor did they think that pregnancy risks should be used as a comparison point for placing hormonal contraceptive risk into perspective. Patient views were generally underlined by a critique of professional risk/benefit assessment techniques and procedures. To illustrate how the modern complexities of health risk assessment extend to the realm of hormonal contraceptives, I here provide a detailed examination of women’s negative experiences while on the pill.
Cambridge Core - History of Medicine - Eponyms and Names in Obstetrics and Gynaecology - by Thomas F. Baskett
In den letzten Jahren haben sich im Bereich der Verhütung einige Neuerungen ergeben. Gleichzeitig haben kontroverse Daten zur Sicherheit der Antibabypille zu viel Verunsicherung von Patientinnen aber auch Ärzten und Ärztinnen geführt. Da es sich bei der Verhütung nicht um lebensnotwendige Eingriffe, sondern im weitesten Sinn um einen Lifestyle-Eingriff handelt, ist die Sicherheit der angewandten Methode umso wichtiger — im klassischen Sinne: nihil nocere.
This retrospective reviews the policies that affect the fertility of American women, both policies designed to alter fertility intentionally as well as those that change childbearing unintentionally. Becker's seminal work on the economics of fertility serves as the theoretical foundation for this literature. After describing Becker's economic model, we review the empirical literature on fertility responses to social welfare policies, tax policies, the mandated health care coverage of infertility treatments, abortion policies, and government-sponsored family planning services. We also address several Supreme Court cases that have played an important role in the interpretation of these policies. Where relevant, this retrospective describes the distributional effects of these natalist policies. We also discuss the limitations of this literature and identify important gaps. Unlike most developed countries that have created strategies to increase fertility to support their ageing population, the United States spends considerably less time and thought on this issue. Our reading of the literature suggests that we have many public policies that have affected and continue to influence the fertility choices made by families in the United States and that this is a topical area that deserves more attention in policy debates. © 2012 by the Association for Public Policy Analysis and Management.
Accumulating evidence suggests that exposure to endocrine disruptors leaching from plastics and the lining of food containers may adversely affect human health. Most studies have focused on their impact on the reproductive system. Cardiovascular disease is a leading cause of death and disability globally, and the classical risk factors for heart disease play important roles in initiating and promoting heart disease in men and women. Yet sex and sex hormones influence the incidence and course of cardiovascular disease. Therefore, it follows that estrogenic endocrine disruptors contaminating the environment have the potential to promote or alter cardiovascular disease risk, incidence, or progression. Bisphenol A (BPA) is a high production volume chemical that leaches from plastics and sealants used in everyday life. Here, using BPA as an exemplar, we describe studies designed to identify the amount of exposure in the general population, the extent to which this exposure is linked to cardiovascular disease in humans and model organisms and discuss some mechanisms for harm. We conclude that BPA exposure is present throughout the life course and that acute and chronic exposure in rodents is associated with a reduced capacity to respond normally to various cardiac stresses.
En este artículo se pretende analizar cómo se recibieron y resignificaron las recomendaciones internacionales para limitar la natalidad en algunos países de América Latina, y de modo particular en Argentina, durante las décadas de 1960 y 1970. Tras una caracterización de los primeros programas de planificación familiar que se desarrollaron en Chile, Perú, México, Brasil y Bolivia, la autora se concentra en el caso argentino para indagar los motivos y consecuencias de sus políticas públicas restrictivas sobre la regulación de la fecundidad en un contexto en que la mayor parte de la región aplicaba medidas opuestas. AbstractThis article analyzes the way international recommendations to reduce birth rates in certain Latin American countries, particularly Argentina, in the 1960s and 1970s were received and resignified. After a description of the first family planning programs developed in Chile, Peru, Mexico, Brazil and Bolivia, the author focuses on the case of Argentina to explore the causes and consequences of its public birth control policies in a context in which most of the region adopted opposite measures.
The emergence of new rights, specifically in this case what are known as "sexual and reproductive" rights, has reinforced the legitimate conquest of female autonomy, but has brought about its hypertrophy. This phenomenon leads to consequences such as the use of contraceptive methods that attempt to "liberate" women from one of the aims in exercising their sexuality: pregnancy. The article reflects on the origin of women's emancipation, which proceeds from an inadequate interpretation of texts in the Old Testament to the changes in women's role in society, recognition of some of their secularly oppressed rights, and up to the emergence of so-called women's liberation. This itinerary has crystallized in the gender ideology, as a refined product of a sexual liberation that has led to a distortion of female sexuality and its biological, psychological and social dimensions.
Breast cancer is the most common cancer in women in Finland. It is often
considered as a disease of affluent, Western societies with many known risk
factors such as late age at first birth, small number of children, and sedentary
lifestyle, among others. In addition, there are more novel exposures that are
popular in modern Western societies and carry suspected carcinogenic
potential, including use of hormonal contraceptives and personal use of hair
dyes. The aim of the thesis was to evaluate the roles of such lifestyle factors
and to assess how they contribute to the risk factor spectrum. The thesis is
composed of four sub studies; Study I estimating the association between the
use of hormonal contraceptives and breast cancer risk and Study II aiming at
determining whether the use of hair dyes independently increases risk of
breast cancer. Study III estimated the proportion of women who had an
opportunistic mammography before the age 50 years and assessed the roles
of breast cancer family history and educational level in having a
mammography. Study IV investigated the impact of major life events in
breast cancer-specific mortality.
Self-reported survey data was used as source of exposure information in
all sub studies. Information on the outcomes of interest, namely breast
cancer diagnosis and breast cancer-specific deaths were retrieved from the
Finnish Cancer Registry. In Studies I and II, analyses by conditional logistic
regression were conducted to estimate odds ratios (OR) and 95% confidence
intervals (CI). In Study III, percentages of women reporting opportunistic
mammography were calculated either directly of by Kaplan-Meier method. In
Study IV, different Cox models were used to estimate breast cancer-specific
mortality hazard ratios and 95 % confidence intervals.
Use of hormonal intrauterine device (HR IUD) increased the risk of breast
cancer in post-menopausal women by 52% (OR 1.52, 95% CI: 1.14-2.02),
relative to users of copper IUD. Use of other hormonal contraception was by
contrast associated with risk of breast cancer in younger women (OR 1.32,
95% CI: 1.08-1.61), when compared to never-users. An OR of 1.23 (95% CI:
1.11-1.36) was observed for women using hair dyes, relative to those who had
never dyed their hair. Opportunistic mammography was also found to be
very common, with more than 60% of responders reporting having had a
mammography before screening age. Mammographies were also more
common in women who had breast cancer family history and/or higher
education. A large number of experienced negative life events was associated
with 4% higher risk of breast cancer-specific mortality, some positive events
accordingly lowering it.
The prevalence of classical breast cancer risk factors, such as obesity and
alcohol use have increased markedly over the past decades in Finland. Parity
and total fertility are continuing to decline. These factors are more and more
commonly complemented by risk effects produced by use of exogenous
hormones and cosmetics such as hair dye. Considering increasing usage,
further research on the effects of HR IUD use is needed with other
populations and a prospective study design. More research is also needed on
the long-term effects of hair dye use.
With respect to opportunistic mammography, it would be important to
start registering the examinations to be able to take them into account in
evaluation of the practices and effectiveness of organized screening. Women
should also be more extensively informed of the harms of opportunistic
mammography, such as accumulating radiation burden and the potential
consequences of false positive or negative findings. The observed negative
effects of negative life events and positive effects of some positive life events
in breast cancer mortality give grounds for more holistic planning of
treatment and patient follow up.
The symptom burden of midlife ovarian senescence and its impact on physical, emotional, and sexual well-being has long been perceived as disruptive to the personal, social, and professional aspirations of postmenopausal women. Low serum estrogen levels prevailing after menopause have also been associated with accelerated aging of tissues and organs, particularly the skeletal and cardiovascular systems [1, 2]. With the triumphant development of the oral contraceptive pill in 1960 [3], hope grew that biological challenges unique to the female post-reproductive years can too be conquered with the use of synthetic sex steroids. This hope was stoked as well by Wilson’s negative portrayal of the menopause as an “estrogen deficiency state” which “must be replaced” to avoid the “tragedy” and “decay” of menopause [4, 5]. Within a decade of Wilson’s influential assertions, the number of menopausal women who had taken up long-term estrogen therapy had soared [6]. Few years later, a significant body of observational data would demonstrate that such menopausal hormone therapy (MHT) is not only effective for control of troublesome symptoms but may also have benefits for the prevention of chronic diseases commonly associated with female aging [7–9]. The promise that a pill may improve life’s quality, and possibly its quantity, by increasing the odds of avoiding a heart attack or a hip fracture captured the attention of tens of millions of menopausal women whose ranks in the USA were growing rapidly as the baby boom generation matured. The promise of MHT also captured the attention of employers and the insurance industry who have a perennial interest in workforce wellness and of the pharmaceutical industry who saw a tremendous opportunity for growth. In 1991, the 102nd US Congress got involved as well, passing the Women’s Health Equity Act of 1991 [10]. While this act failed to become law, significant portions of it were ultimately included in the NIH Revitalization Act of 1993 which did become law, appropriating significant resources for women’s health research [11]. This confluence of public and private interests set the stage for accelerated investigation in menopausal medicine, including federally funded research developed and coordinated by the newly minted Office of Women’s Health at the National Institutes of Health (NIH). With cancer, heart disease, and osteoporosis as the leading causes of death, disability, and impaired quality of life in older women, the NIH launched in 1993 a landmark 15-year effort, the Women’s Health Initiative (WHI), to study these matters with scientific rigor. The role of MHT figured prominently in this effort with the inclusion of two long-term prospective randomized controlled trials (RCTs) – the WHI estrogen and progesterone (WHI-EP) and the WHI estrogen (WHI-E)-alone hormone trials. The publication of results in 2002 and 2004 of these WHI hormone trials formed a watershed event with worldwide changes in clinical practice and social attitudes toward acceptance of MHT. The WHI results inspired not only new and innovative MHT research but also a second look at existing MHT data that had predated WHI. This chapter summarizes five decades of MHT research in chronological order and highlights trends in clinical practice which swayed the research agenda and in turn were influenced by the results.
Customers who initiate innovation is a topic frequently discussed in the marketing literature. However, the literature largely ignores non-customers – individuals or firms not using products in the category – as potential initiators of innovation in general and of radical innovation in particular. We argue that non-customers have high knowledge of their own needs, but their knowledge of technology is insufficient to self-generate an innovation. By approaching a potential supplier with a high knowledge of technology but an insufficient knowledge of the need, a unique dyad is created, characterized by a bilateral knowledge gap that stimulates increased learning and co-creation of a potentially radical innovation. We use an historical approach to examine the technological and social antecedents and consequences of three innovations initiated by non-customers: air-conditioning, the pill, and the jeep. We contend that non-customers can initiate innovations that may potentially change industries, create new markets, and have long-term social and economic effects.
Despite a great deal of feminist work that has highlighted its social construction, menstruation seems a self-evidently “natural” bodily process. Yet, how menstruation is defined or what “counts” as menstruation is rarely questioned. Examining menstruation alongside technologies that alter it highlights these definitional questions. In this article, I examine menstrual suppression through an analysis of medical journal articles and FDA advisory committee transcripts, paired with websites used to market menstrual suppression to consumers. Across these contexts (clinical research, FDA regulation, and advertising), new definitions of menstruation converged on a distinction between bleeding that occurs when women are taking hormonal birth control and when they are not. The case of menstrual suppression birth control pills provides an opportunity to study the work of redefining a biological process understood as quintessentially natural and deeply significant for gendered embodiment, as well as a challenge to consider both the social and material construction of gendered bodies.
This paper explores the reception and assimilation of knowledge on oral contraception by gynaecologists in Spain, starting with an analysis of a wide spectrum of medical publications, especially journals. We observe that the management of synthetic hormones in Spain followed a similar pattern to that in other European countries. Thus, the option of inhibiting ovulation as a therapeutic measure was known and used during the 20 years that followed the Spanish civil war. However, its contraceptive use had to overcome the restrictions of a dictatorial regime, its pro-natalist ideology and the predominance of the catholic church. After a decade of doubts, the church had included the pill in their general condemnation of sterilisation and abortion. Nevertheless, professional pressure, religious admonition and directly suppressive action failed to prevent development of the first contraceptive medical services from 1969 onwards.
Millions of women in the United States and abroad use oral contraceptive pills. These popular contraceptives are the most common reversible birth control method in the United States, and a wide variety of pills are available for prescription. Oral contraceptives provide safe and effective protection against pregnancy and offer several noncontraceptive benefits. Over the years, advances in the laboratory and knowledge gained through epidemiologic data promoted the development of new contraceptive preparations. Generations of oral contraceptives emerged over time, containing lower doses of estrogens and new and novel progestins. The current review discusses the clinical characteristics of oral contraceptives, with emphasis on basic pharmacology and the evolution of various contraceptive formulations and regimens.
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.
Just as in the United States, where inventors are confronted with a choice between protecting their inventions by taking out patents or relying on the law of trade secrets, so in the United Kingdom a similar choice exists between patents and reliance on the law of breach of confidence. The choice arises because in modern patent law, a patent will only be granted where the invention is disclosed in a specification, and that disclosure is published before the patent grant. As the law of confidentiality will only protect information that possesses the key quality of ‘relative secrecy’, the act of taking out a patent means that the law of confidentiality is no longer available: Once ‘published’ in the specification, the secret ceases to exist. Of course, the patentee may retain other information (so-called ‘know-how’) that is secret and can be exploited distinctly from the patent, but as regards the invention itself, patenting and protection through confidence are necessarily alternatives.
Oral contraceptives have now been used clinically for over 15 yr. The present brief review discusses the discovery and development of the first oral contraceptive.
We have previously reported the results of a retrospective study of the relationship between oral contraceptives and deep vein thrombosis and pulmonary embolism occurring in the absence of an evident predisposing cause. The present paper describes a similar investigation of the relationship between oral contraceptives and thromboembolism following certain surgical procedures.
Of 30 patients with thromboembolism, 12 (40%) had been using oral contraceptives during the month preceding surgery, while only 9 of 60 matched controls (15%) had been doing so. From these data it is estimated that the risk of postoperative thromboembolism is increased threefold to fourfold by the use of contraceptive steroids.
It is recognized that few of the episodes of deep vein thrombosis and pulmonary embolism that occur postoperatively are detectable clinically, and that not all of these are recorded in discharge summaries or diagnostic indexes. Despite these considerations, we have been unable to detect any important bias in the data which could account for the observed association between oral contraceptives and the development of postoperative thromboembolism.
To the Editor.—
The Friday, Jan 16, 1970, issue of the Washington Post, page A7, quotes one of the eminent scientists who testified at the January hearings of the Nelson Committee as saying "that `industrial pressure' and the `urgency of the population problem' led in 1960 `to a most prompt and indulgent endorsement of the pill' by the Food and Drug Administration and birth control advocates." The story also quotes the same expert as stating that "intensely venal pressures... to neutralize the best efforts of any of us,... who proposed... a more orderly procedure for testing and licensing the pill."The more recent testimony of Dr. Edwards and Dr. Jennings before the same hearings did little to clarify the actual process which occurred in 1960. This is hardly surprising, since neither was on board at the time.Since in 1959 there was only one manufacturer, and we were it, and
The Food and Drug Administration (FDA) has recently made two important changes in its policy for the study and evaluation of drugs in women: (1) sex-specific analyses of the safety and efficacy of drugs will be required as part of all new drug applications, and (2) it will no longer be recommended that women of childbearing potential be restricted from participating in the earliest phases of drug trials. These changes have come about as a result of continuous efforts to individualize therapy, to improve upon the safety and efficacy of drugs, and to respond to important questions about whether the drug development process produces adequate information about the effects of drugs in women. In turn, these efforts are the outgrowth of a long history in the United States of changes in the clinical care for women, changes in the use of women as research subjects, changing attitudes about the balance between protection and risks for women in clinical trials, and national movements by women to focus on issues of their health care and to transform the male-oriented model of clinical research. The new FDA guidelines, published in July 1993, will provide guidance to researchers on accumulating valuable information on how drugs work in women and will help make it possible for physicians and other caregivers to consider the effects of gender on health and treatment.
Bulletin of the History of Medicine 70.2 (1996) 266-295
In the 1950s, the practice of contraception gained a measure of respectability, in the wake of endorsement by medical authorities and growing concern over world population growth. Yet a kind of moral stigma remained -- the product of Catholic opposition, the public glorification of postwar family values, and the birth control movement's early associations with radicalism. Several proponents applied the controlled clinical trial model to the testing of contraceptive methods, in an effort to redefine fertility control as a purely scientific problem. In this paper, I will discuss two examples: the field trials of (1) "simple methods" of contraception, and (2) intrauterine contraceptive devices (IUDs), sponsored by the Population Council and the Planned Parenthood Federation of America (PPFA).
In the first set of trials, the Planned Parenthood Federation, with Council assistance, attempted to demonstrate statistically that the "simple methods" were as "use-effective" as the spring diaphragm, which had been its standard prescription for the previous thirty years. The goals of the project were both clinical and organizational. The ostensible objective was the availability of more and better contraceptive methods. But the Federation sought as well to establish contraception as a scientific medical field and itself as an authoritative public health organization. Of the two, the organizational goal was the more decisively achieved.
The Population Council, with Federation assistance, subsequently sponsored a major study to determine the safety and effectiveness of the redesigned IUD. The Council, in these trials, also had a double agenda: the improved availability of contraception, and the rehabilitation of the IUD, to legitimize its use in a program of global population control. Again the field trials produced a statistical result that contributed to the organizational goal more directly than to the clinical.
The attempt to legitimize contraception through the authority of scientific research was hardly new: Margaret Sanger, at her early clinics and through the Birth Control Federation, PPFA's predecessor; gynecologist Robert Latou Dickinson, on his own and through the National Committee on Maternal Health; and the philanthropic activist Clarence Gamble had all sponsored various tests and studies of contraceptive methods. The Federation budgeted some of its sparse funds toward basic research, and its Sanger Research Bureau regularly tested commercial spermicides for safety and effectiveness. Sanger herself in the 1950s had put her energies and Katherine McCormick's money behind Gregory Pincus's steroid research at the private Worcester Foundation. But none of these projects had had the backing or recognition of the academic medical leadership, which would have conferred legitimacy.
The controlled clinical trial methodology, although it was not yet widely used in the 1950s, was a potentially powerful legitimating tool. As Harry Marks has demonstrated, medical elites at the AMA and the universities promoted the clinical trial in this period as the key to a standardized medical practice based on the impartial authority of statistics. The Salk polio vaccine trials of 1954 had not only shown the vaccine to be effective, but had also legitimated the status and programs of the National Foundation for Infantile Paralysis, a nonacademic, nonmedical organization of lay volunteers. The polio vaccine had also met specific clinical needs, thus supporting the claims of the trial methodology to provide a rational basis for medical practice.
But fertility control is not analogous to infectious disease prevention. Disease is an abnormal event, defined by specific medical parameters, while the outcome of a successful prevention program is continued normal health. A woman's fertility is a normal, but mutable, part of her life and health for thirty to forty years -- at times welcome, at others problematic, occasionally provoking a crisis, but always interwoven with the complexities of her physiology, lifestyle, relationships, and social worlds. There are no precise parameters and there is no single optimal outcome: the desired outcome at any given time can best be defined only by the woman herself.
The Federation and the Population Council attempted to use the clinical trial methodology to solve a set of organizational and clinical problems that appeared to be nearly congruent. The women enrolled as test subjects in the contraceptive trials, and their partners, framed the questions differently from the sponsoring organizations...
Today it is estimated that over 100 million women worldwide have taken the oral contraceptive pill since 1956, when the first clinical trials were undertaken. Since its introduction on to the American market in 1960 and the British one in 1961, the pill has become one of the most popular contraceptives in both countries. Unlike other forms of drugs, which have primarily been formulated to prevent or cure illness, the oral contraceptive pill was designed to be given to healthy women over long periods of time, making the necessity for regulation and medical monitoring that much more pertinent. Focusing on the USA and Britain, this paper concentrates on the different ways in which each country has monitored and secured the safety of the pill between 1960 and 1970. While the British government decided to phase-out high dose oestrogen contraceptive pills associated with thrombotic disease in 1969, such pills continued to be available in the USA through to the 1980s, with measures instead being directed towards supplying better information to patients about the possible side-effects of the pill. The paper explores the reasons for this difference in policy, showing how it was shaped by the particular research orientation of each country as well as the specific legal, medical, social and political traditions within Britain and the USA.
Synthetic, orally active substances with effects resembling those of progesterone have become available. They differ not only in dosage but also in the details of their action on various organs. Their double effect in preparing the uterus for nidation and suspending ovulation should make them useful in both the positive and the negative aspects of planned parenthood. The antifertility action has been tested by 715 patients using five different preparations. After exclusion of imperfect data there remained observations on 3,082 months of therapy with 22 pregnancies, giving a pregnancy rate of 8.6% as compared with about 4% for other contraceptive measures. Both unfavorable and favorable side-effects were reported. The use of progestational drugs in this way depends not on local but on systemic actions, the extent of which has not been completely determined. Nevertheless, it suggests a relatively simple form of family planning in addition to other important uses in gynecology and obstetrics.
The aims of preliminary and large-scale clinical trials of oral contraceptives (OCs) and the findings of a series of early large-scale clinical trials of norethynodrel are presented. Preliminary trials will attempt to assess the ability of an OC agent to: 1) postpone menstruation in women with regular cycles; 2) inhibit ovulation; and 3)produce secretory changes in the endometrium. Large-scale clinical trials will attempt to establish: 1) the optimum strength of a pill for adequate contraception and minimal side effects; 2) the simplest method of administration; and 3) patient acceptability of the method. The 1st trial involved 2.5 mg plus .035 mg ethinyl estradiol-3-methyl ether (EE) the 2nd trial was composed of women from Trial 1 with a dose increase to 5 mg norethynodrel plus .075 mg EE and the 3rd trial consisted of women just beginning the regimen of Trial 2. 14 pregnancies occured in 48 women in Trial 1 while there were no pregnancies in Trial 2. There was no significant difference between those who started on the 5 mg dose and those who transferred to it except for the incidence of nausea during the first cycle of Trial 3. The incidence of nausea was about 40% in each trial during the first cycle but it rapidly diminished. There were 9 women in all 3 trials who discontinued use because of side effects. The number of cycles with breakthrough bleeding was less with higher doses of norethynodrel and EE although patients transferred to the higher dose did not show an improvement in breakthrough bleeding. The incidence of amenorrhea was considerably higher than reported in other studues.(1%-9% compared with .7%-3.2%).