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Still no pill for men? Double standards & demarcating values in biomedical research

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Full text: https://authors.elsevier.com/a/1eC3z8yuQtYUI Double standards are widespread throughout biomedicine, especially in research on reproductive health. One of the clearest cases of double standards involves the feminine gendering of reproductive responsibility for contraception and the continued lack of highly effective, reversible methods for cisgender men. While the biomedical establishment accepts diversity and inclusion as important social values for clinical trials, their continued use of inequitable standards undermines their ability to challenge unfair social hierarchies by developing male contraception. Thus, the gender/sex bias present in contraceptive research raises the “New Demarcation Problem”: If we accept that values can and will play important roles in science, how can we nevertheless distinguish positive influences of values from more corrosive bias? I argue that biomedical researchers ought to aim their clinical trials at equity and utilize methodologies that actually achieve that aim. More specifically, I contend that we can avoid the problem of double standards by gender/sex in contraceptive research by utilizing more equitable standards. My demarcation strategy captures dynamic interplay between values and their effects, with direct policy implications for institutions conducting, funding, and evaluating clinical trials. For male contraceptive trials, this involves shifting risk assessment from an individual model to a shared model for sexual partners.

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Feminist scholars have identified pervasive gender discrimination in science as an institution, as well as gender bias in the very content of many scientific theories. An ameliorative project at heart, feminist philosophy of science has inquired into the social and epistemological roots and consequences of these problems and into their potential solutions. Most feminist philosophers agree on a need for diversity in scientific communities to counter the detrimental effects of gender bias. Diversity could thus serve as a unifying concept for a potential consensus of the field. Yet there are substantial differences in the kinds and roles of diversity envisaged. This element argues that we need diversity, both in terms of social locations and of values, to overcome former biases and blind spots. Diversity as such, however, is insufficient. To reap its epistemic benefits, diversity also needs to be institutionalised in a way that counters various forms of epistemic injustice.
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Die ‚Pille für den Mann' wird seit mehreren Jahrzehnten als verheißungsvolle Perspektive anvisiert, die zu einer gleichberechtigten Verhütungspraxis beitragen könne. Trotz einem damit verbundenen Potenzial, geschlechterideologische Annahmen einer scheinbar natürlich gewordenen reproduktiven Verantwortungsübernahme zu transformieren, scheint ein Konzept von geschlechtsbezogener Natürlichkeit im Bereich der Reproduktionspraxis noch immer hegemonial zu sein. Dieser Artikel macht auf Begründungszusammenhänge jener reproduktiven Verantwortungsübernahme als vergeschlechtlichte aufmerksam. Die vorsorgliche Tätigkeit des Pillenehmens begreifen wir als Sorgearbeit. Entlang eines technofeministischen Ansatzes (Haraway) sowie eines philosophisch-anthropologischen Konzeptes von natürlicher Künstlichkeit (Plessner) diskutieren wir, ob die Pille für den Mann als eine feministische Technologie zu betrachten ist.
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Much research suggests that attitudes towards responsibility for use of contraception amongst young people are strongly gendered. However, decision making, if 'decisions' happen at all, is bound up with notions of hegemonic masculine and feminine roles as well as factors concerning relationship status. Data from two earlier qualitative studies were re-analysed with an emphasis on findings related to gender and responsibility for use of contraception. The first study investigated unintended conceptions amongst 16-20-year-old women. Interviews focused on knowledge and views about contraception, sex education and sexual health services. The second study involved focus groups with two groups of 14-18-year-old men to explore their views on sex education, sexual health and contraception. Almost all the young women said that young men viewed contraception as 'not their job'. In contrast, the young men thought that responsibility should be shared. The key issue, however, related to relationship status, with decision-making being shared in long-term relationships. There are some gender differences in accounting for decisions about use of contraception, however the key issue revolves around relationship status.
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WE have induced reversible infertility, with little effect on libido, in five healthy young men by giving them tablets containing methyltestosterone and ethynyloestradiol. There were no undesirable side effects and we feel that this treatment may offer a practical approach to male oral contraception.
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Philosophy of Science After Feminism is an important contribution to philosophy of science, in that it argues for the central relevance of advances from previous work in feminist philosophy of science and articulates a new vision for philosophy of science going in to the future. Kourany’s vision of philosophy of science’s future as “socially engaged and socially responsible” and addressing questions of the social responsibility of science itself has much to recommend it. I focus the book articulation of an ethical-epistemic ideal for science, the Ideal of Socially Responsible Science, compare it to recent work in the same vein by Heather Douglas, and argue for some advantages of Kourany’s approach. I then ask some critical question about the view, particularly with respect to the source of values that are to be integrated into science and the status of values that are to be so integrated. I argue that Kourany is too sanguine about where the values that inquirers will use come from and that these values seem to be accorded too fixed a status in her account.
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Contraceptive decision making is likely to become more complex when male oral contraceptives are marketed and as sex‐role preferences become more egalitarian. A mailed survey of 47 married couples selected from a newspaper “Birth Listing” column in Columbus, Ohio was used to contrast spouses' views, to assess levels of actual and perceived consensus among partners, and to identify predictors of greater stated likelihood of male pill usage. Modest support was found for the hypothesis that more egalitarian sex‐role preferences are positively related to a greater belief in contraception as a shared responsibility, wives: r = .35, p < .01, husbands: r = .21, p < .10. No support was found, however, for the hypothesis that beliefs in shared contraceptive responsibility would lead to greater acceptance of a male pill. Wives were also more accurate, r = .57, p < .001, than husbands, r = .21, p < .08, in perceiving then‐spouse's attitudes toward male pill adoption. Results suggest that researchers need to focus on the process by which contraceptive usage is negotiated and renegotiated among married couples.
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In this study 62 men were surveyed as to their attitudes toward male birth control methods and expectations regarding female responsibility for contraceptive practice. A statistically significant relationship was found between these two variables indicating that men who tend to assign contraceptive responsibility to women have more negative attitudes toward male contraceptive use. Education and marital status were found to be significantly related to these attitudes as well.
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One hundred and fifty‐one men were interviewed in regard to contraceptive practices, life history, and personal outlook. In response to the question “Would you use a contraceptive pill for males if one were available?” 55.6% said yes, 18.5% said probably yes, 18.5% said probably no, and 7.3% said no. Dummy values of 3–2‐1–0 were assigned to these categories and then correlated with social‐demographic variables, test scores, and descriptions obtained from spouses and interviewers. Men who expressed greater willingness to use the pill preferred smaller families, scored lower on the California F scale, were more favorably disposed to population planning and abortion, and rated vasectomy, tubal ligation, and the contraceptive pill for females as acceptable methods of birth control. Observers described potential users as more introspective, labile, and prosocial, whereas potential nonusers were seen as more assertive, conventional, and self‐seeking.
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Perspectives in Biology and Medicine 47.4 (2004) 617-623 The Male Pill traces the kaleidoscopic history of hormonal methods of contraception for men, exploring why such methods have been so long in coming when those for women have been available for nearly 40 years. The common features of pituitary endocrine control, whereby gonadotropin withdrawal switches off the function of both gonads, could surely have led to the parallel development of such methods in both sexes, despite the widespread belief that millions of sperm daily were harder to suppress than a single egg ovulating each month. New male contraceptive methods could replace less effective male methods and would occupy niches, e.g., when delaying vasectomy, when female methods were not tolerated, and during the post-partum period. As an early investigator remarked, the much longer fertile life of men makes them a target population of great significance. We now know that preparations of androgens, given either alone for the suppression of gonadotropin hormones or combined with progestins (derivatives of natural progesterone) or with gonadotropin-releasing-hormone antagonists, effectively and reversibly suppress spermatogenesis in men (Anderson and Baird 2002; Kamische and Nieschlag 2004). Licensing one or another of these regimens will depend on their contraceptive efficacy in clinical trials, such as those recently conducted by the World Health Organization (Waites 2003). Interestingly, while novel androgens from a WHO steroid synthesis program were being ignored by the pharmaceutical industry, Chinese pharmacologists formulated an injectable testosterone undecanoate, an out-of-patent drug originally designed for oral administration. A trial involving over 1,000 couples testing the contraceptive efficacy of monthly injections of this newly-formulated long-acting androgen is nearing completion in China. It is likely that this monthly injectable will be the first male contraceptive drug to achieve registration in a national family planning program (Handelsman 2003). This represents the present scientific situation. The Male Pill also discusses the social and cultural revolutions needed to turn what the author, a social scientist, calls "the established sociotechnical networks" away from their exclusive focus on women and onto men. Nelly Oudshoorn, Professor of Gender and Technology at the University of Twente in the Netherlands, has had unprecedented access to the scientists and policy makers involved in the WHO's research and development program to develop male contraceptive methods. Her interviews reveal that the investigators themselves, building on earlier pioneering clinical studies, provided the commitment that has advanced the field so dramatically in the last two decades. Oudshoorn identifies the formidable opposition faced by advocates for the development of male contraceptive drugs. She relates how WHO and other public-sector agencies were forced to develop an R&D network "to compensate for the pharmaceutical industry's reluctance" to be involved. This network established the infrastructure for laboratory and clinical research through the so-called WHO Male Task Force, whose considerable public health achievements are described elsewhere (Waites 2003). Oudshoorn explains how the clinical investigators overcame the difficulties of recruiting men to participate in trials that risked pregnancy in their partners. This was undertaken in a medical climate rooted in the resistance of gynecologists and urologists and in a social climate influenced by media-driven distortions. The recently embedded view that fertility control was solely the woman's domain led to the pursuit of the development of the pill for women in the late 1950s, with the enthusiastic support of the pharmaceutical industry. By contrast, studies to develop contraceptive methods for men were left to academic scientists to pursue, with the support of public sector agencies only. Unfortunately, Oudshoorn's arguments are sometimes obscured by terms unfamiliar to the non-social scientist. For example, in a chapter entitled "Designing Technology and Masculinity: Challenging the Invisibility of Male Reproductive Bodies in Scientific Medicine," we are told that "the stabilization of...
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To judge from the rash of recent law review articles, it is a miracle that research with human subjects in the U.S. continues to draw breath under the asphyxiating heel of the rent-seeking, creativity-stifling, jack-booted bureaucrethics that is the current system of research ethics oversight and review. Institutional Review Boards (IRBs), sometimes called Research Ethics Committees (RECs), have been accused of perpetrating “probably the most widespread violation of the First Amendment in our nation's history,” resulting in a “disaster, not only for academics, but for the whole nation.” One member of the President's Council on Bioethics went so far as to assert, “There has been no greater damage to academic freedom in the United States in my lifetime. And my lifetime encompasses McCarthy and it encompasses political correctness, both.” Locked in the bureaucratic “iron cage” of IRB oversight, critics charge that researchers have been transformed into a vulnerable, exposed population, subject to domination, that has been likened in one case to a kind of “Tuskegee in reverse.”
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Recently, mainstream English-language news organisations have been reporting that a 'male pill' will soon be available. A common theme running through many published articles is that women will not trust men to use these new male contraceptives, though rarely is evidence provided to support this claim. In order to understand this disconnect between women's distrust for men as a group and their trust in their male partners, this paper examines three dominant ideologies of masculinity that inhibit men's contraceptive trustworthiness as a group. First, there is a cultural belief that men have an uncontrollable sex drive, which interferes with their ability to contracept. Second, there is a commonly held idea that men are incompetent in domestic tasks, which impairs their ability to correctly use contraception. Third, there is a social perception that men are not committed to pregnancy prevention, or at least not to the degree that women are.
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Objective: To determine contraceptive efficacy of hormonally induced sperm suppression to severe oligozoospermia or azoospermia. Design: Prospective, noncomparative contraceptive efficacy study. Setting: Multicenter study in 15 centers in nine countries. Participants: Three hundred ninety-nine normal, healthy, fertile men requesting a male contraceptive method. Intervention: Weekly IM injection of 200 mg T enanthate. Main Outcome Measure: Incidence of pregnancies in efficacy when couples relied on T injections alone for contraception. Results: Four pregnancies occurred during 49.5 person-years involving men with oligozoospermia (0.1 to 3 x 10⁶/mL) and none during 230.4 person-years in azoospermic men: pregnancy rates 8.1 (95% confidence interval [CI] 2.2 to 20.7) and 0.0 (95% CI, 0.0 to 1.6) per 100 person-years, respectively, or 1.4 (95% CI, 0.4 to 3.7) per 100 person-years for oligozoospermia and azoospermia (0 to 3 x 10⁶/mL) combined. Pregnancy rates were related to sperm concentration. Inadequate suppression of spermatogenesis occurred in eight men and escape from suppression occurred in four. Discontinuations were due to personal reasons (50 men, cumulative annual life-table rate 12.2% [95% CI, 9.1% to 16.1%]) and dislike of the injection schedule (21 men, 5.1% [95% CI, 3.2% to 7.9%]). Thirty-five men discontinued for medical reasons (9.4% 195% CI, 6.7% to 13.2%]), with no serious treatment-related side effects. After stopping injections, sperm output recovered; additionally, fertility was demonstrated in 33 couples. Conclusion: Suppression of spermatogenesis to azoospermia or severe oligozoospermia (≤3 x 10⁶/mL) induced by weekly T enanthate injections results in sustained, reversible contraception with good efficacy and minimal short-term side effects. New hormonal regimens with more convenient delivery and improved spermatogenic suppression would provide practical male contraception.
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This paper concerns a comparison of risk assessment practices of contraceptives for women and men. Our analysis shows how the evaluation of health risks of contraceptives does not simply reflect the specific effects of chemical compounds in the human body. Rather, we show how side-effects were rated differently according to the risk model that was adopted. Our analysis shows an important new aspect of risk assessment: lay perspectives of men are taken more seriously by experts and policymakers than those of women. In the case of male contraceptives, men’s wellbeing when using contraceptives was a central issue from the very beginning. Men’s emotional wellbeing and sexuality has been put on the international research agenda by the reproductive scientists themselves, and the need for long-term data about male contraceptives has been emphasised by the pharmaceutical industry. In the case of female contraceptives, the concern for the long-term effects of contraceptives was put forward by women’s health movements, and research into women’s mental health and libido when using hormonal contraceptives was initiated only at the instigation of women’s health advocates. We therefore conclude that the incorporation of lay interests in the experts’ methods of risk assessment shows a clear gender pattern. Whereas the perspectives of male contraceptive users have been emphasised and negotiated by authoritative spokespersons within the medical establishment, the incorporation of the interests and needs of female contraceptives users depended on women’s health advocates.
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Over the past twenty-five years, numerous articles in Hypatia have clarified, revised, and defended increasingly more nuanced views of both feminist empiricism and standpoint feminism. Feminist empiricists have argued that scientific knowledge is contextual and socially situated (Longino 1990; Nelson 1990; Anderson 1995), and standpoint feminists have begun to endorse virtues of theory choice that have been traditionally empiricist (Wylie 2003). In fact, it is unclear whether substantive differences remain. I demonstrate that current versions of feminist empiricism and standpoint feminism now have much in common but that key differences remain. Specifically, they make competing claims about what is required for increasing scientific objectivity. They disagree about 1) the kind of diversity within scientific communities that is epistemically beneficial and 2) the role that ethical and political values can play. In these two respects, feminist empiricists have much to gain from the resources provided by standpoint theory. As a result, the views would be best merged into “feminist standpoint empiricism.”
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The underdetermination argument establishes that scientists may use political values to guide inquiry, without providing criteria for distinguishing legitimate from illegitimate guidance. This paper supplies such criteria. Analysis of the confused arguments against value-laden science reveals the fundamental criterion of illegitimate guidance: when value judgments operate to drive inquiry to a predetermined conclusion. A case study of feminist research on divorce reveals numerous legitimate ways that values can guide science without violating this standard.
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This essay aims to clarify the value of developing systematic studies of ignorance as a component of any robust theory of knowledge. The author employs feminist efforts to recover and create knowledge of women's bodies in the contemporary women's health movement as a case study for cataloging different types of ignorance and shedding light on the nature of their production. She also helps us understand the ways resistance movements can be a helpful site for understanding how to identify, critique, and transform ignorance.
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The idea of increasing men's participation in family planning has received periodic attention for the past 20 years, but there is no generally accepted understanding of what men's involvement actually means. This paper examines the gender implications of ‘male involvement’ for the staff and decision-makers of service delivery programmes, and the gender dynamics surrounding the use of contraceptives, particularly male-dependent methods. It discusses the importance of taking into account the interplay between men's and women's roles, rather than focusing on women's situation (or men's) alone, with the aim of increasing equality between women and men. Finally, it cautions against forms of ‘male involvement’ which result in men usurping what was formerly women's territory and thereby worsening existing male dominance.
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Feminist philosophy of science has led to improvements in the practices and products of scientific knowledge-making, and in this way it exemplifies socially relevant philosophy of science. It has also yielded important insights and original research questions for philosophy. Feminist scholarship on science thus presents a worthy thought-model for considering how we might build a more socially relevant philosophy of science—the question posed by the editors of this special issue. In this analysis of the history, contributions, and challenges faced by feminist philosophy of science, I argue that engaged case study work and interdisciplinarity have been central to the success of feminist philosophy of science in producing socially relevant scholarship, and that its future lies in the continued development of robust and dynamic philosophical frameworks for modeling social values in science. Feminist philosophers of science, however, have often encountered marginalization and persistent misunderstandings, challenges that must be addressed within the institutional and intellectual culture of American philosophy.
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Modern contraceptives—especially long-acting, reversible contraceptives, or LARCs—are typically seen as a boon for humanity and for women, the majority of their users, in particular. But the disparity between the number and types of female and male LARCs is problematic for at least two reasons: first, because it forces women to assume most of the financial and health-related responsibilities of contraception, and second, because men’s reproductive autonomy is diminished by it. In order to understand how to change our current contraceptive arrangement, I want to look at some of the historical and contemporary factors that contribute to this disparity, especially gender norms that associate women with reproduction and distance men from it.1 One reason we need male LARCs is that most of our current contraceptives target women’s bodies. Today, there are eleven contraceptive options for women and only two for men.2 This means that women assume all associated financial and health-related burdens. On the whole, female methods tend to be more expensive than male methods3 because most require at least one physician visit, and some involve a renewable prescription. Many insurance plans do not cover contraception,4 and a man cannot bill his partner’s contraceptives to his plan (assuming his plan covers them) since, according to our individualistic medical model, they are seen as being only for her use and benefit.5 Side effects for female methods are more serious than for male methods, as well, in part because various contraceptive methods for women involve hormones, while no methods for men do.6 The most common reason women discontinue contraceptive use is unwanted side effects,7 and most forms of contraception have discontinuation rates approaching fifty percent after one year of use.8 Also, side effects not only cause women to stop using contraception, but fear of them also prevents women from starting new methods.9 Finally, the two available male forms of contraception, condoms and vasectomy, also carry fewer health risks than their corresponding female methods, female barrier contraceptives and tubal ligation.10 It is no wonder that women sometimes continue to use a particular contraceptive even if they are not happy with it simply because it is their best worst option.11 Another reason we should develop male LARCs is so that men can more feasibly and effectively share contraceptive responsibility with their partners. Neither of the two male contraceptives currently available is well suited to the contraceptive needs of men in long-term, monogamous relationships. And for men who still want to maintain the possibility of having biological children, the only method available to them is the male condom. Yet given the condom’s high failure rate of 16 percent during typical use, men are not able to regulate their reproduction as effectively as women can—many female hormonal methods and IUDs have failure rates under three percent.12 The lack of effective and reversible options for men leads many men to rely on their partners for contraception. And even if men use a condom, they often depend on women to use another form of contraception concurrently to minimize the possibility of pregnancy. This dependence on women reduces men’s reproductive autonomy. Men have to trust that their partners are correctly and consistently using contraception. If a pregnancy unintended by either or both partners does occur, men have no recourse. They cannot mandate that a woman get an abortion. Regardless of the circumstances under which the pregnancy transpired, men are still held socially and financially responsible for any children they father. Women tend to be more associated than men with reproduction in general, and relatively recently, particularly with contraceptive responsibility. Prior to the invention of the birth control pill, contraceptive use was tied to the actual sex act, and for this reason men had to participate in it (for example, by using a condom or withdrawing). Additionally, men were often involved in decisions about and use of contraception because of their traditional role as heads of their households.13 Contraceptive responsibility began to shift from being a shared responsibility to being solely a woman...
Article
Methods of contraception for use by men include condoms, withdrawal and vasectomy. Prevalence of use of a method and continuation rates are indirect measures of acceptability. Worldwide, none of these "male methods" accounts for more than 7% of contraceptive use although uptake varies considerably between countries. Acceptability can be assessed directly by asking about intended (hypothetical) use and assessing satisfaction during/after use. Since they have been around for a very long time, there are very few data of this nature on condoms (as contraceptives rather than for prevention of infection), withdrawal or vasectomy. There are direct data on the acceptability of hormonal methods for men but from relatively small clinical trials which undoubtedly do not represent the real world. Surveys undertaken among the male general public demonstrate that, whatever the setting, at least 25% of men - and in most countries substantially more - would consider using hormonal contraception. Although probably an overestimate of the number of potential users when such a method becomes available, it would appear that hormonal contraceptives for men may have an important place on the contraceptive menu. Despite commonly expressed views to the contrary, most women would trust their male partner to use a hormonal method.
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Hormonal male contraceptive regimens effectively and reversibly suppress sperm production, but there are few large-scale efficacy studies. The safety, contraceptive efficacy, reversibility, and feasibility of injectable testosterone undecanoate (TU) in tea seed oil as a hormonal male contraceptive was assessed. This was a multicenter, phase III, contraceptive efficacy clinical trial. Participants: A total of 1045 healthy fertile Chinese men were recruited throughout China into the study. Injections of 500 mg TU were administered monthly for 30 months. A definition of severe oligozoospermia (< or =1 x 10(6)/ml) was used as a criterion of spermatogenic suppression and as the threshold for entering the contraceptive efficacy phase. The primary outcome was pregnancy rate in the partner. Other outcomes include: semen parameters, testis volumes, reproductive hormone levels, and safety laboratory tests. Forty-three participants (4.8%) did not achieve azoospermia or severe oligozoospermia within the 6-month suppression phase. A total of 855 participants entered into the efficacy phase, and 733 participants completed monthly TU treatment and follow-up. There were nine pregnancies in 1554.1 person-years of exposure in the 24-month efficacy phase for a cumulative contraceptive failure rate of 1.1 per 100 men. The combined method failure rate was 6.1%, comprising 4.8% with inadequate suppression and 1.3% with postsuppression sperm rebound. No serious adverse events were reported. Spermatogenesis returned to the normal fertile reference range in all but two participants. Monthly injection of 500 mg TU provides safe, effective, reversible, and reliable contraception in a high proportion of healthy fertile Chinese men.