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Morning-after pills are one form of emergency (post-coital) contraception that reduces the chances of pregnancy when taken after unprotected sexual intercourse. It is commonly used as a prophylactic for pregnancy after birth-control failure, unprotected sexual intercourse, or rape. In 1999, the FDA approved the morning-after pill Plan B (a progestin-only formulation of

levonorgestrel) for prescription-only sale to women 18 and over. Subsequently, at a 2003

meeting between advisory committees, women’s health advocates collided with anti-abortionists

17 In contrast, some fetal-centric values are permissive of therapeutic abortion, such as teratologists who may discourage continuing pregnancy because of the risks of birth defects for the fetus, rather than any maternal condition or need (Löwy 2017). These non-natalist fetal-centric values are the subject of chapter 5 in part III.

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and social conservatives over a supplemental application for switching Plan B from prescription to over-the-counter access without an age restriction. Women’s health advocates wanted to increase access to this effective postcoital pill—regardless of how late it acted—while anti-abortionists sought to protect zygotic life by opposing such a pill. Although beyond this chapter’s scope on the pill’s mechanism, other critics of the switch also worried that it might promote adolescent promiscuity and disease transmission—despite disconfirming evidence available at the time (Jackson et al. 2003; see Wynn and Trussell 2006a, 2006b).

While advisers overwhelmingly voted for the switch (23 to 4), the FDA commissioner delayed approval for over two years, resulting in the resignation of Susan Wood, director of the Office of Women’s Health. In her public resignation letter, she suggested the reason was

ideological rather than “based on scientific and clinical evidence,” citing Thomas Henry Huxley:

“Science commits suicide when it adopts a creed” (Wood 2005, p. 1650). Although regulatory decisions always involve scientific and political considerations, both proponents and critics of the switch criticized the FDA for being “political” rather than “scientific,” i.e., that “politics trumps science” (Grimes 2004; compare, e.g., Drazen et al. 2004; Stanford et al. 2004).

Nonetheless, according to the US Government Accountability Office, the FDA’s decision to deny the switch to over-the-counter was “unusual” because of the top-down nature of the delay and the commissioner’s justification based on concerns about adolescents (GAO 2005).

Furthermore, the few advisers who opposed the switch, as well as the FDA commissioner, were political appointees of President George W. Bush, a strong opponent of contraception and abortion (for more on other aspects of the FDA decision, see Prescott 2011; Wynn and Trussell 2006a, 2006b).

While the agency eventually approved the drug for over-the-counter sale, it was the only

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drug to feature an age restriction (18+). Furthermore, its new label featured an unprecedented

“drug fact” on the carton conveying in detail the mechanism and its uncertainty: “this product works mainly by preventing ovulation (egg release). It may also prevent fertilization of a released egg (joining of sperm and egg) or attachment of a fertilized egg to the uterus

(implantation)” (figure 2.1, from FDA 2006, my emphasis). Given the controversy around its approval in the broader context of fetal-centrism, what was the role of values in this unique and powerful drug label?

Figure 2.1: The official “Drug Facts” for Plan B sold over-the-counter. Note the mechanism listed in boldface after the third bullet under “Other information.” Image source: FDA (2006, public domain).

115 3.1. Zygote-centrism and its critics

Zygote-centrism is the set of values and gender norms that prioritize the health, wellbeing, and

“rights” of fertilized eggs (zygotes) over those of the pregnant women who carry them. This view of women’s reproductive health is particularly common in the “pro-life” or “right-to-life”

movement, which was started by Roman Catholics in the 1960s (Williams 2016). Accordingly, in medicine these values are upheld primarily throughout the Roman Catholic healthcare system, such as the Catholic Health Association (CHA), the Catholic Medical Association (CMA), and the US Conference of Catholic Bishops (USCCB). During the time of these debates, the bishops oversaw 12% of US hospitals and required their adherence to the values and norms in the Ethical and Religious Directives for Catholic Health Care Faculties (USCCB 2001; see CFFC 2005;

Miller 2015). Unlike their critics, who typically maintained a secular stance in public, zygote-centrists often expressed religious beliefs and affiliations, typically from socially conservative branches of Judeo-Christianity, such as Mormonism and Roman Catholicism. Compared with their critics, the zygote-centrists in this debate included professors from relatively less

prestigious universities (e.g., University of Utah, University of South Florida), non-profit researchers who also practiced in family medicine, internal medicine, or pharmacy, and representatives of the “pro-life” movement (e.g., Human Life International, American Life League). A couple were present at the FDA meeting as voting consultants—notably the

physician Joseph Stanford—and non-voting members of the public. Zygote-centrists published their reviews in less mainstream journals of medicine and pharmacy—including Archives of Family Medicine and Annals of Pharmacotherapy—as well as journals affiliated with Catholic organizations and Christianity—such as Health Progress (CHA), The Linacre Quarterly (CMA), and Ethics and Medicine.

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Note well: Despite strong connections to Catholic institutions, zygote-centrism is not simply the Catholic, the Christian, or even the religious view (but rather the “pro-life” view). For one, Catholics are a heterogeneous group in their beliefs and practices regarding reproduction (see Miller 2015, on Catholics for a Free Choice), and many zygote-centrists are non-Catholics, such as Mormons, Evangelical Protestants, and conservatives in general (Williams 2016).

Additionally, socially progressive Christian and Jewish sects supported increased access to emergency contraception at the FDA meeting (FDA 2003, p. 240). Nonetheless, zygote-centrism is historically rooted in Catholic theology, and it remains the dominant view among the Roman Catholic Church’s hierarchy.

Various women’s health advocates have criticized this view of women’s reproductive health. As we saw in chapter 1, throughout the history of the emergency contraception, there is a blurry line between researchers, doctors, feminists, and pharmaceutical representatives that advocated for increased access to the drug (ChoGlueck 2019; Prescott 2011). The individuals who criticized zygote-centrism included professors from relatively more prestigious universities (e.g., Princeton, Stanford, Edinburgh), non-profit researchers (some of whom also practiced in obstetrics-gynecology), and business executives. Several were present at the FDA meeting as either voting advisers—notably the demographer James Trussell—or non-voting pharmaceutical representatives. These defenders of the morning-after pill published their studies and opinion pieces in mainstream journals of medicine—such as the New England Journal of Medicine, the Journal of the American Medical Association, Human Reproduction, Fertility and Sterility, and the American Journal of Obstetrics and Gynecology—as well as journals affiliated with self-described “pro-choice” and “family planning” organizations—including Contraception (Association of Reproductive Health Professionals and the Society of Family Planning) and

117 Population Briefs (Population Council).

While joined in their antagonism toward zygote-centrists and social conservatives, these various women’s health advocates are not unified camp in terms of their beliefs, interests, or strategies. For instance, while some pathologized pregnancy and considered the drug a “cure,”

others rejected this medical model of pregnancy and its implicit devaluation of women (Prescott 2011). Furthermore, their judgment diverged at times, such as their disagreement over the testability of claims about the mechanism (see sub-section 4.2). Despite lacking unity, they opposed the zygote-centric view along several dimensions. The main sites of conflict were the ontology of when a woman’s pregnancy begins and another human life starts, the ethics of preventing and ending pregnancy, and the pragmatics of healthcare and medical decision-making.

3.2. Ontologies of reproductive health

Zygote-centrists defined ‘conception’ and ‘abortion’ to include earlier stages of embryological development than did their critics. For zygote-centrists, fertilization is the moment at which human life begins and a pregnancy is conceived (i.e., ‘conception’); therefore, the termination of pregnancy, i.e., ‘abortion,’ includes inhibition of development any time after a spermatozoon and ovum fuse (Larimore et al. 2004; Wilks 2000). In addition, zygote-centrists have included the zygote and later stages of embryonic development in the category of human persons (Wilks 2000, p. 19). To justify this ontology as “medical” (rather than merely religious or ethical), doctors have appealed to Mosby’s Medical, Nursing, and Allied Health Dictionary (Anderson 2002) for the “orthodox” or “traditional medical definition of pregnancy” (Wilks, 2000, p. 15;

Larimore et al., 2004, p. 690).

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For many of their critics, on the other hand, ‘conception’ was synonymous with implantation, so ‘pregnancy’ begins once an embryo implants into the endometrium.

Accordingly, ‘abortion’ excludes pre-implantation interference, which they define as “pregnancy prevention” rather than “pregnancy termination” (Glasier 1997, p. 1063; Trussell et al. 2004).

Some women’s health advocates criticized these zygote-centric beliefs because they could limit woman’s legal access to abortion (Gold 2005). Yet, unlike zygote-centrists, the advocates of emergency contraception did not have a common stance on when human personhood begins.

Gynecologists and medical researchers criticized the ontological categories of zygote-centrists by appealing to the America College of Obstetrics and Gynecology (ACOG) standardized

terminology (Hughes 1972) and the “Common Rule” for human subjects research from the Department of Health and Human Services (HHS 2009, sec. 46.202.f).

3.3. Ethics of reproductive health

These ontological beliefs dovetailed with ethical values, moral principles, and sexual norms.

Zygote-centrists argued that zygotes as human persons deserve full moral status. Thus, any interference after fertilization constitutes abortion, which violates “the first right of all humans—

the right to stay alive” (Wilks 2000, p. 20; see also Larimore and Stanford 2000; FDA 2003, p.

213). Zygote-centrists also adhered to the sexual norms that confined legitimate contraceptive use to cases of rape treatment and prior to fertilization (Ashley and O’Rourke 1997). While generally opposed to contraception, Catholic healthcare ethics allows this limited use in hospitals for emergencies, codified by USCCB (2001) directive #36:

Compassionate and understanding care should be given to a person who is the victim of sexual assault. Health care providers should cooperate with law enforcement officials and offer the person psychological and spiritual support as well as accurate medical

information. A female who has been raped should be able to defend herself against a

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potential conception from the sexual assault. If, after appropriate testing, there is no evidence that conception has occurred already, she may be treated with medications that would prevent ovulation, sperm capacitation, or fertilization. It is not permissible,

however, to initiate or to recommend treatments that have as their purpose or direct effect the removal, destruction, or interference with the implantation of a fertilized ovum.

In contrast, the critics of zygote-centrism generally suggested allowing a greater

expression of women’s self-determination, such as through pregnancy planning and prevention with Plan B (Coeytaux and Pillsbury 2001; Grimes 2002). Some women’s health researchers and gynecologists argued that emergency contraception could be a legitimate therapeutic option regardless of when it acts because of the financial, psychological, and medical benefits for women (Trussell et al. 2004; ACOG 1997). While some of them focused on the maternal risks of pregnancy, others emphasized the social benefits, such as how greater access to morning-after pills could be a cure for the “epidemic” of unplanned pregnancy (Grimes et al. 2001; see also Prescott 2011; Trussell et al. 2004). Women’s Capital Corporation (the original drug sponsor) also promoted sexual norms of responsible planning by choosing its brand to send the “right public health message” that “when Plan A fails, you can go to Plan B” (Prescott 2011, p. 106).

3.4. Pragmatics of reproductive health

Connected to these divergent beliefs are practical differences including political and economic strategies and models of doctor-patient relations. As anti-abortionists, zygote-centrists sought to protect zygotic life by limiting access to abortifacient drugs and spreading information about their postfertilization potential via scientific publication (e.g., Kahlenborn et al. 2002; Wilks 2000). With this information, the USCCB lobbied for material exemptions for zygote-centric employers and institutions from legal requirements to furnish patients and employees with insurance coverage for such drugs (Miller 2015, p. 185). Furthermore, zygote-centric physicians

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and pharmacists refused providing or filling prescriptions with postfertilization potential (Larimore and Stanford 2000, p. 133; Wilks 2004).

While seemingly permissive, the bishops’ Directives limit women’s agency by allowing for treatment only after testing for ovulation and pregnancy (USCCB 2001, dir. 36). Thus, recent survivors of rape are subjected to the clinical-ethical judgment of hospital staff whether the threat to zygotic life is sufficiently low to offer treatment (Cataldo and Moraczewski 2001, Chapter 11). Furthermore, women are much less likely to be offered or prescribed emergency

contraception at Catholic hospitals (Smugar et al. 2000), with over 80% of Catholic hospitals never providing access (Bucar 1999). Despite stressing the importance of informing women of their hospitals’ restrictions (Pennsylvania Catholic Conference 1993), zygote-centrists justified the paternalistic displacement of the woman’s agency to protect not only embryos from abortion but also the institution of (heterosexual) marriage from corruption and the Church from scandal (e.g., Ashley and O’Rourke 1997; Pope John Paul II 1998).

The advocates of emergency contraception criticized zygote-centrists for decreasing women’s health and agency over their bodies rather than making them the primary decision-maker. Before FDA approval, Trussell and his colleagues promoted emergency contraception through publicly accessible information online, by phone, and elsewhere (see Trussell et al.

1998). Because requiring a doctor’s prescription suggested “special paternalistic scrutiny” of women, feminist health advocates like Francine Coeytaux and Barbara Pillsbury (2001) pushed for over-the-counter access without prescription or age restriction, supported by women’s health researchers (Ellertson et al. 1998, p. 229; Grimes et al. 2001).

Yet, promoting women’s rights and access with medication entangled the advocates of emergency contraception with commercial interests, specifically in developing its market (see

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also Murphy 2012). Sharon Camp, for instance, founded International Consortium for

Emergency Contraception (ICEC) to increase access to the drug and then Women’s Capital to distribute it more widely in order to reduce prices and increase women’s choices; nonetheless, her company relied on the Hungarian pharmaceutical Gideon Richter for manufacturing (Prescott 2011, pp. 103–4). Furthermore, Barr Pharmaceuticals’ subsequent acquisition of Plan B from Women’s Capital entailed further dependence of women’s health advocates on pharmaceutical companies who offered wider access in exchange for increased commercialization and

medicalization.

Thus, zygote-centrists espoused various beliefs, commitments, and strategies that

contained a host of normative elements. Their critics challenged their ontological views of when conception happens and, more importantly, over whether it entails new moral status. Rather than focusing on women’s health and wellbeing, zygote-centrists prioritized the rights of zygotes and the responsibilities of pregnant women to protect them. These anti-abortionists relied on the gender norms about “good mothers” who selflessly protect zygotes and “bad mothers” who carelessly use abortifacient contraceptives. To enforce these gender norms, zygote-centrists promoted knowledge about the abortifacient mechanism, strategized to limited Plan B’s access, and lobbied for exemptions to legal requirements to provide emergency contraception. Next, we see how these zygote-centric values enabled specific judgments about scientific evidence and how that zygote-centric reasoning resulted in the debated “drug fact” about its mechanism.