Anovulants (Moral Aspect)

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ANOVULANTS (MORAL ASPECT)

An anovulant is a hormonal steroid derivative that suppresses ovulation by acting upon the hypothalmo-pituitary system to suppress the secretion of LH (luteinizing hormone) and FSH (follicle stimulating hormone). These actions eliminate follicular development and/or the LH surge without which ovulation cannot take place (see Goldzieher 1989, 34). During the early 20th century a number of scientists investigated the properties of the hormones estrogen and progesterone, and in 1921 the idea of a hormonal contraceptive pill was first proposed (see Marks 2001, 4148). The development of synthetic forms of estrogen (ethynyl estradiol) and progesterone (progestins) led to the development of pills that combine synthetic progestins and estrogens for a synergistic and more efficient suppression of follicular development and/or ovulation (combined oral contraceptives). At the same time, progestin-only oral contraceptives (mini-pill) were also developed.

Mechanisms of Action. The primary mechanism of combined oral contraceptives as reported in the medical literature is the inhibition of follicular development and ovulation. Other, secondary mechanisms are also recognized with varying degrees of evidence (see, for example, Rivera, Yacobson, and Grimes; Larimore and Sanford). These mechanisms include: alterations of cervical mucus which interferes with sperm penetration of the ovum; alterations of the endometrium (uterine lining) which might prevent implantation of the embryo; and changes to the Fallopian tubes which might interfere with sperm, ovum, and embryo transport (in the latter case possibly preventing implantation or causing an ectopic pregnancy). Progestin-only pills prevent ovulation less consistently than combined oral contraceptives and have similar secondary mechanisms.

Roman Catholic Moral Teaching. The Second Vatican Council reaffirmed the constant teaching of the Church that "God himself is the author of marriage and has endowed it with various benefits and with various ends in view . By its very nature the institution of marriage and married love is ordered to the procreation and education of the offspring" (Gaudium et spes, n. 48). The ordering of married love toward procreation is rooted in the very nature of the reproductive powers and in the nature of the conjugal act between the spouses. The complete, mutual self-surrender of the spouses to each other in their conjugal act necessarily includes the sharing of their reproductive capacity with each other (see Familiaris consortio, n. 32). In this sense the Church teaches that the procreative and unitive meanings of the conjugal act are inseparable because they are fulfilled in and through each other (see humane vitae, n. 12). "This connection," Humane vitae teaches, "was established by God, and Man is not permitted to break it through his own volition" (Humanae vitae, n. 12). The moral obligation to respect the procreative ordination of the conjugal act is stated in this norm of Humanae vitae : "But the Church, which interprets natural law through its unchanging doctrine, reminds men and women that the teachings based on natural law must be obeyed and teaches that it is necessary that each conjugal act remain ordained in itself to the procreating of human life" (n. 11).

Based upon these principles Catholic teaching has formulated prohibitions against contraceptive acts. Any action deliberately taken to thwart the procreative ordination of the conjugal act either as an end in itself or as a means to an end that is otherwise morally good is fundamentally contrary to married love and the dignity of the human person, and is, therefore, morally impermissible without exception. This prohibition applies to contraceptive acts before, during, or after the conjugal act (Humanae vitae, n. 14; see Catechism of the Catholic Church, n. 2370; and Veritatis splendor, ns. 7982) and applies to the contraceptive use of anovulants which are taken prior to the conjugal act, but which are also operative before, during, and after any given conjugal act they are intended to impede.

Non-Therapeutic and Therapeutic Uses. There may be morally justified therapeutic uses of anovulants, but their use for the purpose of preventing a future pregnancy that would threaten the physical or mental health of the woman should not be confused as a therapeutic use. The preservation of physical or mental health in this way is not the direct and immediate effect of using anovulants. Rather, these ends are achieved as the result of the prevention of pregnancy brought about by the action of anovulants. For example, the end of preventing the aggravation of a woman's underlying renal or cardiovascular disease is attained not from the anovulatory effect of the drug, but from the resulting prevention of pregnancy. The Church considers such acts to be direct sterilization: "Any sterilization which of itself, that is, of its own nature and condition, has the sole immediate effect of rendering the generative faculty incapable of procreation, is to be considered direct sterilization, as the term is understood in the declarations of the pontifical magisterium, especially of Pius XII. Therefore, notwithstanding any subjectively right intention of those whose actions are prompted by the care or prevention of physical or mental illness which is foreseen or feared as a result of pregnancy, such sterilization remains absolutely forbidden according to the doctrine of the Church" (Quaecumque sterilizatio, n.1).

The use of anovulants can have a direct therapeutic effect in the treatment of several conditions, such as dysmenorrhea, chronic anovulatory disorders, dysfunctional uterine bleeding, and endometriosis (see Merck Manual, 1792; 18011805; 1808; 18101811). Cases in which the use of an anovulant has a direct therapeutic effect and is intended as such can be morally justified even though there is also a sterilizing effect. Pope Pius XII addressed this issue in 1958 concluding that the inhibition of ovulation by the use of pills would be morally licit as a necessary remedy of a "condition of the uterus or the organism" (Pope Pius XII, 395). Pope Paul VI reiterated this teaching in Humanae vitae : "The Church, moreover, does allow the use of medical treatment necessary for curing diseases of the body although this treatment may thwart one's ability to procreate. Such treatment is permissible even if the reduction of fertility is foreseen, as long as the infertility is not directly intended for any reason whatsoever" (Humanae vitae, n. 15). The teaching of the Church on the distinction between direct sterilization and directly therapeutic actions with foreseen but unintended sterilizing effects is also represented in the document from the United States Conference of Catholic Bishops, Ethical and Religious Directives for Catholic Health Care Services (ERDs), n. 53.

The Church teaches that the human zygote is an actual human individual from the moment it is formed and must be "respected and treated as a person" from that first moment (Donum vitae, I, 1; see Evangelium vitae, n. 60). If, therefore, a human zygote or embryo does not implant in the uterus because of the secondary mechanisms of an anovulant, the effect of the drug would be abortifacient. The use of anovulants for contraceptive purposes is intrinsically immoral, but also to sustain a risk of an abortifacient effect over an extend period of time only compounds the serious moral gravity of the act.

Pregnancy Prevention after Sexual Assault. Anovulants are also used for pregnancy prevention in the treatment of survivors of sexual assault. A commonly used method, known as the Yuzpe regimen, involves the administration of two doses of an increased combined formulation of estrogen/progestin pills. The first dose is given within 72 hours of the sexual assault, and the second dose is taken 12 hours following the first. There are differing reports in the medical literature about the various possible mechanisms of these pills in this regimen. Studies show a range of possibilities, from the inhibition of ovulation as the primary mechanism to a greater prominence of other mechanisms such as prevention of implantation (see Swahn et al. 1996; Trussell and Raymond 1999). Clinically, this regimen can be provided at any time during the woman's menstrual cycle.

The Catholic moral tradition has recognized that a woman may licitly take actions in self-defense against the unjust aggression of sexual assault before, during, and after an assault (see Bayer 1985; Noonan 1965). Lingering effects of the assault such as the attacker's semen and the risk of fertilization are considered a part of the aggression. Thus, measures may be taken to prevent fertilization in self-defense. According to the ERDs, Catholic health facilities may provide hormonal intervention that would prevent ovulation only if, after appropriate testing, there is no evidence that conception has occurred. No interventions are permissible that "have as their purpose or direct effect the removal, destruction, or interference with the implantation of a fertilized ovum" (ERDs, n. 36). Catholic health facilities have developed hormonal intervention protocols that include tests and other criteria for identifying the ovulatory phase of the woman so that anovulants are administered only during a phase in which a possible abortifacient effect can be avoided with moral certitude. Because absolute certitude is not attainable in this matter, and because it is not a question of already knowing that some entity is present which might be a human being, no certitude greater than moral certitude is required (see McShane et al. 2001, 11/1111/17).

Bibliography: e. j. bayer, Rape Within Marriage: A Moral Analysis Delayed (Lanham, Md. 1985). g. j. mcshane, et al., "Pregnancy Prevention after Sexual Assault," in Catholic Health Care Ethics: A Manual for Ethics Committees, ed. p. j. cataldo and a. s. moraczewski (Boston 2001), 11/111/22. j. w. goldzieher, Hormonal Contraception: Pills, Injections & Implants (San Antonio 1989). w. l. larimore and j. b. stanford, "Postfertilization Effects of Oral Contraceptives and Their Relationship to Informed Consent," Archives of Family Medicine 9 (February 2000): 126133. l. v. marks, Sexual Chemistry: A History or the Contraceptive Pill (New Haven 2001). National Conference of Catholic Bishops, Ethical and Religious Directives for Catholic Health Care Services, 4th ed. (Washington, D.C. 2001). j. t. noonan, jr., Contraception: A History of Its Treatment by the Catholic Theologians and Canonists (New York 1965). pope pius xii, "An Address to the Seventh International Hematological Congress in Rome, September 12, 1958," The Pope Speaks 6, 4 (December 1960): 392400. r. rivera, i. yacobson, and d. grimes. "The Mechanism of Action of Hormonal Contraceptives and Intrauterine Contraceptive Devices," American Journal of Obstetrics and Gynecology 181 (November 1999): 12631269. m.-l. swahn, et al. "Effect of Post-Coital Contraceptive Methods on the Endometrium and the Menstrual Cycle," Acta Obstetrica et Gynecologica Scandinavica 75 (1996): 738744. The Merck Manual, 16th ed., ed. r. berkow (Rahway, N.J. 1992). j. trussell and e. g. raymond, "Statistical Evidence About the Mechanism of Action of the Yuzpe Regimen of Emergency Contraception." Obstetrics and Gynecology 93 (May 1999): 872876.

[p. j. cataldo]