Marys Medicine

Levonorgestrel in cases of rape: how does it work?

The Linacre Quarterly 81 (2) 2014, 117–129 Levonorgestrel in cases of rape: How doesit work? KATHLEEN MARY RAVIELE Dekalb Medical, Tucker, Georgia, USA The Ethical and Religious Directives for Catholic Health Care Services allows the use of an emergencycontraceptive for a woman who has been raped, as a defense against her attacker's sperm, provided thedrug prevents fertilization and does not act against a conceived human life. Catholic emergency roomsaround the country have been pressured to provide Plan B (LNG-EC) to patients seeking help after asexual assault. Catholic bioethicists have supported the use of this drug based on their interpretation ofthe scientific literature regarding its mechanism of action. This paper presents a review of the mechan-isms of action of LNG-EC when given during the fertile window, showing a high probability that itacts against human life rather than preventing fertilization, and proposes another class of drugs as apossible alternative.
Keywords: Emergency contraception, Rape, Levonorgestrel, Peoria protocol, Catholic hospitals,Dignitas personae, Meloxicam as accurate medical information. A femalewho has been raped should be able to The sexual assault of a woman is a horrific defend herself against a potential con- crime that can carry with it long-term ception from the sexual assault. If, after consequences to the woman such as sexu- appropriate testing, there is no evidencethat conception has occurred already, she ally transmitted diseases, post-traumatic may be treated with medications that stress syndrome, or pregnancy. The Ethical would prevent ovulation, sperm capacita- and Religious Directives for Health Care tion, or fertilization, all of which would be Services in directive 36 shows the care that contraceptive actions. It is not permissible, Catholic hospitals should take in protect- however, to initiate or to recommend treat- ing the victim of rape from possible ments that have as their purpose or direct consequences of the assault, including effect the removal, destruction, or interfer- pregnancy, as long as the agent used is ence with the implantation of a fertilized ovum. (emphasis added) Compassionate and understanding careshould be given to a person who is the The standard emergency contraceptive victim of sexual assault. Healthcare provi- used for this purpose is levonorgestrel (LNG-EC) 0.75 mg given within 120 enforcement officials and offer the person hours of the sexual assault and then psychological and spiritual support as well repeated 12 hours later, or 1.5 mg given in Catholic Medical Association 2014 The Linacre Quarterly 81 (2) 2014 a single dose. The medical literature cases the assailant is known to the victim, claims that the drug works primarily by and is often a relative. Only 26 percent of preventing ovulation. Despite concerns rape victims seek medical help after a rape, that this drug might work after fertiliza- tion, the use of this drug in Catholic emergency rooms in cases of rape was cerns a woman has after a rape are the mandated in some states Its use has been justified under the "three acquired a sexually transmitted disease, fonts" approach, described by including HIV, and of public knowledge Cataldo, as first, the moral object of the about the attack. The "rape trauma syn- act is self-defense against the sperm of the drome" is a common sequel with serious attacker; second "the intention of the sur- vivor must be to suppress ovulation in leading to disruption of existing relation- order to prevent the unjust circumstance ships and the ability to work or go to of the gametes meeting, and not to cause the death of a newly conceived human person who has been sexually assaulted being if fertilization has occurred." Lastly, should receive counseling for an extended "if the circumstances surrounding the act period by someone skilled in treating post-are not in due proportion, that is, they are traumatic stress syndrome. Approximately morally defective, then the act is immoral" 5 percent of women of childbearing age That is, tests must be who are fertile and not using contracep- done and a menstrual history obtained tion at the time of the attack will become that would assure the patient and doctor pregnant as a result of the assault that it is only remotely possible that the drug would be acting after fertilization.
After the evidence has been gathered, This paper will demonstrate that well- and the patient has received treatment to designed medical studies, studying various cover any sexually transmitted diseases she aspects of the mechanism of action of could have acquired from the assault, it is LNG-EC, have shown that this drug is standard practice to do a pregnancy test to probably acting after fertilization a signifi- make sure the woman is not pregnant from cant amount of the time and therefore an act of intercourse two weeks or more cannot be given in a Catholic emergency before the assault; and if she is within 120 room because the second and third moral hours of the sexual assault, then she is fonts are not met. The possibility of ever achieving the goal of a drug being used which could include, by mouth, LNG-EC after a sexual assault acting only by a con- 0.75 mg, followed by a second dose twelve traceptive effect will be discussed.
hours later; LNG-EC 1.5 mg in a single Sexual assault of females is predomi- dose; the Yuzpe regimen of two Ovral oral nantly a crime against the young and has contraceptives, repeated in twelve hours; reached epidemic proportions in the mifepristone 10 mg in a single dose; uli- United States. There are approximately pristal acetate 30 mg in a single dose; or 683,000 adult women raped annually in insertion of a copper intrauterine device the United States, with only 6 percent into the endometrial cavity. For the sake of occurring past the age of thirty this discussion, we will only be assessing the moral judgment in using LNG-EC as majority of rapes (61%) occur in childhood an emergency contraceptive based on its and adolescence, and in 75 percent of known mechanisms of action.
Raviele – Levonorgestrel in cases of rape PROTOCOL FOR CATHOLIC HOSPITALS: IS be unreliable 39 percent of the time ( In addition they found awide range of cycle lengths with the first Saint Francis Medical Center in Peoria, day of one period to the first day of the Illinois, developed a rape protocol for next to be 21 to 35 days. With a longer Catholic hospitals to assure "that the effect cycle the woman could be on day 17 of her of the intervention would be truly contra- cycle but still be preovulatory and with a ceptive, and not abortifacient" shorter cycle she could be on day 13 of her 131). The emergency room rape cycle and be postovulatory. Although one protocol allows the administration of may suspect the woman is approaching LNG-EC if the woman's menstrual ovulation on pelvic exam with the presence history indicates she is preovulatory, her of highly fertile mucus at the cervical os, it physical exam is compatible with being in is impossible for a physician to determine the preovulatory phase, she has a negative whether the woman is preovulatory on a urinary luteinizing hormone (LH) test, pelvic exam, in particular in a woman who and has a serum progesterone level less has just been sexually assaulted.
than 1.5 ng/ml, which is compatible with How reliable are LH testing and pro- being preovulatory. If the LH surge is positive, indicating the woman will ovulate emergency room in determining where the in the next 24–36 hours, or the serum pro- woman is in her cycle? The LH surge gesterone level is between 1.5 and 5.9 ng/ goes on over a twenty-four-hour period, ml, then she is near ovulation and and is usually detected by testing a first- LNG-EC should not be given. If she is morning concentrated urine. A random postovulatory with a serum progesterone urine specimen, particularly late at night, level of 6 ng/ml or greater, the drug can be may not detect the LH surge. In addition, given because she is already postovulatory serum progesterone levels are not emer- and there is no harm in giving the drug. In gency tests, and the results often are not this case the patient is beyond her fertile available for twenty-four hours, even in window and possible conception, anyway.
major metropolitan hospitals, and even The Saint Francis Peoria Protocol is based longer in small community hospitals.
on the moral argument that Therefore, this protocol may not have atimely progesterone level available to help treatment provided under this protocol is determine if a woman is preovulatory in intended to prevent ovulation, sperm the emergency room.
capacitation, or fertilization. Excludedfrom this protocol are treatments thatwould have as their purpose or directeffect the removal, destruction, or inter- MECHANISMS OF ACTION OF EMERGENCY ference with the implantation of a fertilized ovum. 133) Even if the time of ovulation can be deter- Let us review the details of this protocol reasonable degree and see if that purpose can be fulfilled.
accuracy in the assault victim, what is the How reliable is the woman's menstrual mechanism of action of LNG-EC when history in determining where she is in her given during the fertile window? Several cycle, namely that she is preovulatory? In a recent studies have provided valuable study by Novikova et al., they found the information. There is a six-day fertile history of the first day of the last period to window when a woman can conceive, The Linacre Quarterly 81 (2) 2014 based on sperm survival of five days human life from conception to natural leading up to the day of ovulation and one death, drugs are not acceptable which day of oocyte survival carry interceptive, contragestive, and/or For the sake of this dis- cussion, these days are described as days against a human life at its earliest stages.
−5, −4, −3, −2, −1, and 0 with day −1 The process of fertilization, also known indicating the day of the LH surge and as conception, occurs within 24 hours of day 0 indicating the day of ovulation. The ovulation at the distal end of the fallopian studies that accurately determined the tube. The newly created zygote travels timing of the drug relative to the day of down the fallopian tube until it reaches the ovulation by hormone studies and pelvic uterine cavity 3.5 days after conception. It ultrasound showed that the drug had forms the blastocyst stage at this point by different effects depending on the day it 4.5 days and implants in the endometrium was given in the fertile window and that at 7–9 days after conception. There is no some of the effects were immediate and test at this time that can determine that some were delayed. Since the 1970s, drugs fertilization has taken place or that a con- that interfere with the synthesis, secretion, ceptus is present until 12 days after or peripheral actions of progesterone have conception, by a serum quantitative β-hCG been tested as emergency contraceptives level. In order for successful implantation because progesterone and its effects on the to occur, the endometrium has to evolve endometrium are critical for the successful from the prereceptive phase to the recep- implantation and establishment of a preg- tive phase. According to Johnson nancy. Because of the variability in timingof the administration of the drug, if the the uterus can be thought of as a primar- emergency contraceptive worked only to ily hostile environment able to carefully prevent ovulation and interfere with fertili- control a potentially dangerous invasive zation, it would have limited success, so trophoblastic tissue. Clearly, for the con- according to researchers, ceptus to survive, its early developmentand transport must be coordinated pre- to achieve the highest possible efficacy, the cisely with the changing receptivity of the ideal emergency contraceptive drug needs uterus. This coordination is achieved by to act interceptively; that is, it should be the mediation of the steroid hormones.
capable of interfering with a physiological Progestagenic domination is required if event that occurs after fertilization—during the uterus and implanting blastocyst are the period of early embryonic development to engage effectively. 198) prior to implantation. There are still many details of that nine-day period leading up to implan- Any drug that interferes with ovulation tation that are not known, but from the and the process of fertilization would be research done so far, it is extremely contraceptive, but any drug that prevents complex and the proper levels of pro- normal development of the zygote and gesterone at critical times are necessary for successful implantation of the blastocyst, it to be successful.
would be preventing pregnancy by an In assessing whether a drug has had a interceptive or contragestive mechanism of purely contraceptive effect, the only par- action. Any drug which could disrupt a ameter that can be observed is to previously implanted embryo would be determine whether ovulation has occurred abortifacient. As a people who value all by ultrasound. There is no way to Raviele – Levonorgestrel in cases of rape determine whether sperm have made their Ovulation was suppressed in 80 percent way up to the fallopian tube or have ferti- of women receiving the drug on day 10 of lized the ovum at the end of the tube.
the cycle, when that day was four days or Studies that accurately assess when ovu- more before the LH surge (day −5 or lation occurs normally in a particular earlier), or on the first day of the fertile woman's cycle and whether the drug inter- feres with ovulation in a subsequent cycle received LNG-EC within 3 days of the are the most reliable determinants of a con- onset of the LH surge (days −4 to −2) all ovulated. Progesterone production after investigators who claim there is no effect of ovulation was found to be deficient in LNG-EC on post-fertilization events, but those who ovulated, and there was a fail to study the hormonal milieu through- shorter luteal phase, which would interfere out the luteal phase cannot make that claim with successful implantation. Women who accurately. In addition, the process that received the drug at the time of the serum allows successful implantation of the human LH surge (day −1) or 48 hours later (day blastocyst is quite complex and is not +1) all ovulated. The administration of the entirely understood at the present time.
drug on days −1 to +1 did not affect theproduction of progesterone or length ofthe luteal phase, indicating that there MECHANISMS OF ACTION OF LNG-EC: would likely be no harmful effect on survi- TIMING IS EVERYTHING! implantation. Durand et al. also could not Durand et al. studied the anovulatory find any histological change in the endo- effect of LNG-EC in forty-five women metrium in those women who received the who had been sterilized drug in the fertile window and who ovu- The first cycle was the control lated, which casts doubt on an alteration cycle, and the women themselves tested in the histology of the endometrium as a for urinary LH each day until it was mechanism of action, which has been fre- detected and then underwent daily ultra- quently cited for EC in the past. In sounds until ovulation occurred. Serum conclusion, they demonstrated in this LH levels were assayed daily until the pro- study that ovulation was not prevented by gesterone level reached 3 ng/ml. Daily LNG-EC when given in five of the six serum estradiol and progesterone levels days of the fertile window and therefore, were measured until the onset of menses.
prevention of ovulation is not its main Endometrial biopsies were also performed mechanism of action.
on day LH + 9, or eight days after ovu- In a later study, Durand et al. specifi- lation. During the study cycle, LNG-EC cally looked at three groups of women in was administered on day 10 of the cycle.
The important aspect of this study, in LNG-EC in divided doses on day −4 and contrast to others, was their ability to pin- day −3 (Group 1), on day −1 or the day of point the exact day of the cycle in which the LH surge (Group 2), and day +1 or LNG-EC was administered, relative to two days after the LH surge (Group 3) the LH surge. As an aside, they found that urinary LH was falsely positive in long-term effect of a premature rise in 13.3 percent of cycles, and they concluded progesterone from the administration of that serum detection of LH was more LNG-EC given during the fertile window at a time when progesterone levels are The Linacre Quarterly 81 (2) 2014 normally low, by measuring daily pro- and +11. They found elevated levels of gly- gesterone and glycodelin levels in the codelin around the time of ovulation and luteal phase. An endometrial biopsy was proposed that another mechanism of performed on day +8 with staining for action of LNG-EC might be its effect on glycodelin-A. Glycodelin-A is an impor- sperm to make them incapable of binding tant progesterone-regulated glycoprotein, to the zona pellucida of the oocyte, thus normally present in low amounts in the preventing fertilization. However, a study endometrium, except in the late luteal published in 2007 by do Nascimento et al.
phase, around the time of implantation.
looked at the effect on sperm recovered Glycodelin-A is a potent inhibitor of sperm-zona binding, and therefore may forty-eight hours after LNG-EC was interfere with fertilization, but it also plays given in a single dose of 1.5 mg a role in the feto-maternal defense mech- anisms, preventing maternal rejection of difference in the acrosome reaction of the the blastocyst. They found that "levonor- gestrel taken for emergency contraception glycodelin-A levels, making it unlikely prior to the LH surge alters the luteal that sperm function was affected by phase secretory pattern of glycodelin in LNG-EC. In addition there was no effect serum and endometrium" on cervical mucus by the high dose pro- 451). The normally high levels of gestogen as viable sperm were found in glycodelin-A in the late luteal phase, trig- the uterus 36–60 hours after intercourse gered by the rise in progesterone after and 24–48 hours after LNG-EC.
ovulation, inhibits the natural killer cells of Palomino et al. studied the effect of the mother that would reject the blastocyst administration of LNG-EC on the day of as a foreign body; however, LNG-EC, a the LH surge and found, as Durand did, high dose synthetic progestogen, adminis- that giving this drug on that day of the tered prior to ovulation, triggers an early cycle does not prevent ovulation nor does surge of glycodelin-A, so that by the time it disrupt progesterone receptors, plasma the blastocyst is ready to implant, the gly- levels of glycodelin-A, or L-selectin ligand codelin levels have decreased, and that and integrin which are other factors inhibition of the natural killer cells would necessary for implantation no longer be present, resulting in maternal rejection of the new life. This provides strong evidence that LNG-EC has an postfertilization effect, which led to pre- interceptive or contragestive effect in pre- mature excitement by Catholic bioethicists venting a clinically detectable pregnancy.
that this proved LNG-EC did not act In another study of thirty sterilized against life. However, that can be said only women, designed similarly to their pre- when the drug is given on the day of the LH surge, not the other days of the fertile administered LNG-EC on cycle day −3 window. Studies such as this confuse some and found that twenty out of the thirty readers because generalizations are then women ovulated, but the luteal phase was significantly shortened fertilization effect on the conceptus or its They assayed serum levels of LH, estrone and estradiol in the periovulatory An additional study reported by Noé period. Glycodelin levels in serum and et al. in 2010, evaluated women who uterine flushings were obtained on days 0 Raviele – Levonorgestrel in cases of rape intercourse A history of mechanisms than suppression of ovu- the last menstrual period and time of intercourse was obtained and blood work was done the day LNG-EC was given In an article published in Health Pro- and daily for the next five days. Measure- gress for the Catholic Health Association ments of serum LH, estradiol, and in 2010, Sandra Reznik, a physician and progesterone levels as well as daily pelvic researcher in reproductive pharmacology, ultrasounds to measure the diameter of the stated "It is virtually undisputed that levo- follicle were performed. Of the 337 norgestrel prevents ovulation" women who participated in the study, 215 59). She argued that the other women had relations during the infertile mechanisms of action listed by the manu- time of the cycle as determined by lab facturer on the package insert were work and thus 63.7 percent of the women incorrect when they stated it could prevent received the drug unnecessarily. A total of 87 women were preovulatory in days −5 to "absolutely no data to support this state- −1, and 35 women were on day 0 or later. ment" 61); however, she Of the 87 women treated before ovulation, made these statements without reviewing 62 women ovulated as determined by the studies described above that showed ultrasound, for an ovulation rate of 71 that this drug is not effective at preventing percent in patients given the drug on days ovulation and thus prevention of ovulation −5 to −1, yet no pregnancies occurred in should not be considered its main mech- these women. The paper stated that 15 anism of action.
women did not attend the follow-ups so it Reznik's incomplete review of the could not be determined whether they research literature on LNG-EC was fol- ovulated, but they were included in the lowed by an article by Ron Hamel, who is analysis. Excluding them would have the senior ethicist for the Catholic Health raised the percent that ovulated despite Association. He stated that criticism of LNG-EC to 86 percent. According to the the use of LNG-EC in Catholic hospitals in cases of rape was based on expected to occur in 13 out of the 87women, but despite ovulation occurring, prevailing beliefs or assumptions about no pregnancies were clinically evident after mechanisms of action that may be based on LNG-EC. This is additional strong evi- drug manufacturer labeling, or on outdatedscientific literature, or on mere supposition.
, 62, emphasis added) Of the 35 women who took LNG-EC He confidently stated that the literature on the day of ovulation or after, all ovulated shows that the drug prevents ovulation and there were the usual number of preg- and that all other mechanisms of action nancies, indicating that LNG-EC does not are mere possibilities. He reminded his interfere with the establishment of a preg- nancy if it is given the day of ovulation or One of the well-known truisms in ethics later. They stated in their conclusion: is that good moral judgments depend inpart on good facts. Absent adequate and in the current study, FR (follicular accurate information, there is an increased rupture or ovulation) occurred in some possibility of a faulty analysis and, there- two-thirds of women taking LNG-EC fore an erroneous judgment. preovulatory; this suggests that other The Linacre Quarterly 81 (2) 2014 Based on a faulty understanding of the ability of sperm to fertilize an oocyte.
literature on LNG-EC and a failure to Therefore, it appears that the circum- accept that better studies showed that it is stances necessary to achieve fertilization of a poor anovulant, I propose that the initial an ovum are not affected by LNG-EC judgment that LNG-EC works to prevent unless it is given at the beginning of the ovulation and has little postfertilization fertile window. It also appears that the one effect should be reevaluated. Hamel went parameter that could be easily assessed in on to criticize Bishop Elio Sgreccia of the the emergency setting, the LH surge, Pontifical Academy for Life who reaf- instead of being a criterion for not giving it, would be a day the drug could be given contraception acted against life and that as it would not prevent ovulation anyway Catholic physicians and Catholic hospitals and would not have an adverse effect on should not administer it in cases of rape.
the conceptus or on implantation. The Hamel pointed to an article by Austriaco period of time in which we have to be in 2007, in which he interpreted the concerned about the effect of LNG-EC medical literature as saying a postfertiliza- on survival of the conceptus and successful tion effect would be extremely small implantation is when the drug is given on However, Austriaco did cycle days −4 to −2. As has been demon- not have the three studies by Durand et al.
strated here, there is no way of knowing if and the article by Noé cited above to aid the woman is in that part of her cycle in his review.
when she presents to the emergency room The other factors that could account for after a rape, and as the drug does not a contraceptive effect of LNG-EC would prevent ovulation or fertilization on those be an inhibition of sperm transport, capa- days, but is still highly effective in preventing citation, and prevention of fertilization.
a pregnancy, it has to be acting after fertili- Studies on various aspects of sperm func- zation has taken place.
tion after LNG have not supported this asa mechanism of action.
With regard to sperm function, Yeung BIOETHICAL PRINCIPLES IN THE USE OF et al. looked at sperm motility, acrosome AN EMERGENCY CONTRACEPTIVE IN RAPE reaction, zona binding oocyte fusion capacity of sperm treated According to Cataldo the principle of with 1, 10, and 100 ng/ml of LNG for double effect should not be applied to the three hours. They showed that LNG-EC use of LNG-EC in cases of rape because affected sperm function only at high con- he views the possible interceptive or con- centrations and therefore was unlikely to tragestive effects of the drug to be play a role in the effectiveness of this drug improbable and therefore to prevent pregnancy A study by Brito et al. also found no effect the inability to foresee reasonably that an on the acrosomal reaction in sperm in the abortifacient effect will occur as a result of uterus 36–60 hours after coitus and 24–48 receiving an anovulatory hormonal medi- hours after LNG-EC administration, or cation disqualifies this possibility as atrigger for the application of the principle on the number of sperm in the uterus of double effect. 136) Their conclusion wasthat a single dose of 1.5 mg LNG does Therefore, he feels the traditional sources not impair the quality of cervical mucus or of a moral act: the object, the intention, sperm penetration of the cervix or the Raviele – Levonorgestrel in cases of rape considered and are fulfilled in this case.
Alongside methods of preventing preg- We would all agree that the object of nancy which are, properly speaking, giving an EC in the case of rape is to contraceptive, that is, which prevent con- protect the woman from the sperm of her ception following from a sexual act, there attacker. However, if you ask either the are other technical means which act afterfertilization, when the embryo is already woman or the doctor giving her LNG-EC constituted, either before or after implan- what they are intending in taking the tation in the uterine wall. Such methods drug, their intention is to prevent a preg- are interceptive if they interfere with the nancy, not to prevent ovulation. In fact, 50 embryo before implantation and contra- percent of women who conceive from a gestative if they cause the elimination of rape will obtain an abortion. Obstetrician- the embryo once implanted.
gynecologists will say that they understandthat one of the mechanisms of action of In order to promote wider use of the inter- LNG-EC is to prevent successful implan- ceptive methods (emphasis added), it is tation of a conceptus. The manufacturer sometimes stated that the way in which states that this is a mechanism of action of they function is not sufficiently under- LNG-EC in the accompanying drug stood. It is true there is not always information, and from the research pre- complete knowledge of the way that sented above that is certainly probable. If different pharmaceuticals operate, butscientific studies indicate that the stated intention is to prevent ovu- inhibiting implantation is certainly present, lation, then that eliminates all synthetic even if this does not mean that such hormones and progesterone antagonists as interceptives cause an abortion every time treatments, as they are poor anovulants.
they are used, also because conception Lastly, the circumstances for licit use of does not occur after every act of sexual LNG-EC in cases of rape presented by intercourse. It must be noted, however, the Peoria protocol—which assumed the that anyone who seeks to prevent the drug worked primarily to prevent con- implantation of an embryo which may ception—including a history, medical possibly have been conceived and who exam, a urinary LH, an emergency pro- therefore either requests or prescribes gesterone level, and a pregnancy test such a pharmaceutical, generally intends would not accurately reassure the physician an abortion (emphasis added). n. 23, original emphasis except that this is a time in the woman's cycle where indicated otherwise) when the drug will not affect survival andimplantation of a conceptus. There is no A recognized moral authority, the Congre- way to determine where she is in the gation for the Doctrine of the Faith, states fertile window in an emergency room that this is an immoral act if the drugs setting, and there is already a misunder- given act in any way other than as a contra- standing that she should not get the drug ceptive. Because of the intrinsic value of during the LH surge when that is in fact every human life, no matter the circum- the time it is least likely to cause sub- stances of conception, we have to err on the sequent harm to a conceptus, as compared side of protecting an innocent life.
with taking it on days −4 to −2 of the fertile What is the probability that human window, when it will not prevent ovulation, lives are lost as a direct effect of but will prevent survival of the conceptus.
LNG-EC? Yeung, Laethem, and Tham The immoral conditions of giving EC calculated that three to thirteen percent of after a rape are discussed in Dignitas perso- the time, a post-fertilization effect from nae which states: The Linacre Quarterly 81 (2) 2014 the mechanism of action of LNG-EC that If there are at least 683,000 women this is not a remote possibility as many have in the U.S. of childbearing age raped each led us to believe. This drug does not work year, with a probability of pregnancy of consistently to prevent ovulation and fertili- 5 percent, this would result in 34,150 chil- zation. Secondly, he proposes that the dren conceived as a result of rape. If given administration of emergency contraceptive LNG-EC, by Yeung and Tham's calcu- hormones is not intrinsically evil because lations, this would mean the deaths of they are given for other disorders in 1,024 to 4,439 children from the use of women. That is an incorrect conclusion as LNG-EC in cases of rape in this country the dosage of LNG-EC is equivalent to fifty "mini-pills" of a progesterone-only When looking at the problem of preg- oral contraceptive and is not physiologic.
nancy after rape, is the distress for the He also states that a Catholic physician mother from the pregnancy more signifi- can prescribe these drugs as long as the cant than the possibility, which is not intention is to prevent ovulation and ferti- remote, of causing the death of a child? lization. However, as shown above we With good obstetrical care and emotional know that this drug is a poor anovulant support, the woman's life is not in and does not appear to have an effect on immediate danger because of the preg- sperm motility or capacitation, making nancy. She is not obligated to raise the this drug's mechanism of action more than child after birth, but could place the child, a contraceptive and contrary to the prin- who is after all, biologically hers, up for ciples of Dignitas personae quoted earlier.
adoption. The poor anovulant effect of Lastly, he states LNG-EC, and likely interceptive or contra- it is not the case that the prevention of gestive effects of the drug poses a significant implantation of a conceptus is a necessary risk of interrupting a conception, and thus cause of the morally permissible good the good effect for the woman of not effect of preventing conception from going through a clinical pregnancy is out- taking place. 316) weighed by the bad effect on the embryo.
Sulmasy argues that giving EC is moral Noé et al. showed that despite at least from the principle of double effect, that is, 71 percent of the women ovulating when it is an action that is good in itself but there they were given LNG-EC during the are two effects–an intended and otherwise fertile window, there were no pregnancies not reasonably attainable good effect (preven- when at least 13 would have been tion of a pregnancy as a result of a sexual expected, therefore it was having an effect assault), and an unintended yet foreseen evil post-fertilization. And so the use of effect (remote chance of ending the life of the LNG-EC in cases of rape is not justified conceptus); and this is licit as there is a due by the principle of double effect, because proportion between the intended good and the harmful effect on the conceptus is not the permitted evil He a remote possibility.
claims that giving EC has two effects:preventing conception and possibly pre-venting implantation of a very early IS THERE A POSSIBLE ALTERNATIVE? embryo. Certainly we do not have to have100 percent certainty that LNG-EC can No progesterone agonist or antagonist can never act against a new human life, but we be used as an emergency contraceptive have shown with this review of studies on because of the likely effects on survival of Raviele – Levonorgestrel in cases of rape the conceptus and the receptivity of the 2004, were exposed to NSAIDs in the endometrium which could interrupt the first trimester. They did not find NSAID normal development of this early human exposure to be a major risk factor for birth life. Is there any other class of drugs that defects, but they did find a moderate are more in keeping with the intention of preventing ovulation? phthalmia, amniotic bands/limb body wall Jesam et al. studied a partially selective defects, pulmonary valve stenosis and cyclooxygenase (COX)-2 inhibitor, melox- neural tube defects, which had not been icam, as an emergency contraceptive.
reported before, as well as oral clefts, COX-2 is an enzyme that regulates the which had been reported with naproxen formation of prostacyclins, prostaglandins use. A retrospective review of 14,915 women exposed to these drugs in the first It serves an important function in vasodi- trimester versus 5,546 controls showed lation and platelet aggregation. Disruption that NSAIDS were not a major cause of of COX-2 production causes reproductive birth defects, but there was a small statisti- failure in mice, including preventing ovu- cally significant increased incidence of rare birth defects. Nielsen et al. also found no decidualization Jesam significant association with congenital et al. found that at doses of 30 mg/day malformation, low birth weight or preterm taken for five days during the late follicular birth, but did find an increased risk of phase and the day of the LH surge, 90.9 percent of women failed to ovulate or had authors could not be sure that the drugs dysfunctional ovulation with no effect on were prescribed in some instances to LH, progesterone, estradiol levels, or cycle control cramping from a miscarriage, length. A non-hormonal drug which however. In an infertility work-up, a targets only ovulation would be a licit history of NSAID use is taken and emergency contraceptive in cases of rape if women are advised to stop using these the intention is to prevent ovulation.
medications as they could be interfering However, although this drug effectively with ovulation.
targets ovulation when given during the Meloxicam has been shown to be a fertile window, it can have other effects on highly effective anovulant, throughout the the conceptus.
five pre-ovulatory days of the fertile Non-steroidal anti-inflammatory drugs window and including the day of the LH (NSAIDs) are commonly used in preg- surge, but one should avoid its use after nancy, particularly in the two weeks after ovulation, as it can disrupt survival of the ovulation before the woman knows she is conceptus and implantation. If we return to pregnant with as many as 23 percent of the Peoria protocol presented earlier, along pregnant women in the United States with the other testing discussed, if the pro- reporting taking them during the first tri- gesterone level is less than or equal to 2.0 ng/ mester They may be ml or if an LH surge is detected, meloxi- taken for headache, cramping, pain, and cam could be started in the emergency respiratory infections. The National Birth room. Even if an emergency progesterone Defects Prevention Study is an ongoing level cannot be obtained, it could be fol- case–control surveillance study to identify lowed up the next day and if the level is risk factors for birth defects. A total of less than or equal to 2.0 ng/ml, the victim 3,173 women in the study, who would could start meloxicam at that time, and deliver from October 1, 1997 to December the physician could feel comfortable that The Linacre Quarterly 81 (2) 2014 the drug will act primarily as an anovulant.
Cataldo, P.J. 2009. Argument in favor of Further discussion on drugs such as this in the use of levonorgestrel in cases of cases of rape needs to be carried out to assist sexual assault. In Catholic health careethics: A manual for practitioners, 2nd ed., Catholic physicians and Catholic hospitals to "first do no harm." A.S. Moraczewski, 134–41. Philadelphia: In summary, the literature on LNG-EC The National Catholic Bioethics Center.
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subsequent bioethical conclusions, that 2008. Instruction Dignitas personae (oncertain this drug primarily works to prevent ovu- Pauline Books and Media.
lation and fertilization and could be used licitly by physicians in Catholic hospitals C.A. Moore, C.A. Hobbs, M.A. Cleves, in cases of rape. Often it appears that the literature on LNG-EC is contradictory, but Defects Prevention Study. 2012. Lack of as each study is reviewed, it can be seen that periconceptional vitamins or supplements it looks at a different part of the elephant, as that contain folic acid and diabetes it were. The timing of its administration mellitus–associated birth defects. American relative to the day of ovulation shows a Journal of Obstetrics and Gynecology 206: different effect of the high dose of this proges- 218e 1–218. e13.
Davis, T.J. Jr. 2007. Plan B and the rout of tagen both immediately and days later in the religious liberty. Ethics & Medics 32(12): woman's cycle, resulting in several mechan- isms of action to prevent pregnancy. We can conclude from these studies that LNG-EC is a poor contraceptive. Alternatives need to M.J. Munuce, L. Hautala, R. Koistinen, be sought that are in keeping with the L. Andrade, and L. Bahamondes. 2007.
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BIOGRAPHICAL NOTE Contraceptive efficacy of emergency con-traception with levonorgestrel given before Kathleen M. Raviele M.D. is a fellow in or after ovulation. Contraception 81: 414– the American College of Obstetricians and Gynecologists and is a past president Novikova, N., E. Weisberg, F.Z. Stanczyk, H.B. Croxatto, and I.S. Fraser. 2007.
of the Catholic Medical Association. She Effectiveness of levonorgestrel emergency is in the private practice of gynecology.
Her email address is

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