Précis:
1) Practical doubt, or doubt as to the lawfulness of an action is, according to the teaching of moral theology, incompatible with right action; since to act with a doubtful conscience is obviously to act in disregard of the moral law. To act with a doubtful conscience is therefore, sinful
John Kippley remarked: “If you are doubtful about the morality of some action, you shouldn't act, but instead you should get advice and clarify your conscience. The wisdom of the axiom "you should not act on a doubtful conscience" is easily seen in the common example about the hunter who hears a lot of noise in the bushes but isn't certain if it's an animal or a fellow hunter. That happened to me the only time I ever went deer hunting-after struggling up a steep, brushy knoll on all fours I raised my head and looked into my friend's rifle barrel! Fortunately, he clarified his doubtful knowledge by waiting.”
2) The evidence to date supports the contention that use of “Emergency Contraceptive” does not always inhibit ovulation even if used in the preovulatory phase, and that it may unfavorably alter the endometrial lining regardless of when in the cycle it is used, with the effect persisting for days. In other words, the contraceptive effect is ambiguous and the abortifacient effect is probable. Hence, in such a state of practical doubt, the logic of the immorality of administering this drug is compelling.
Bishop Lori’s Blog: September 29, 2007
“Plan B, an issue previously discussed in this blog (“Sad State of the Constitution State”, April 24th—see “Archive”) is back in the news. Many of you posted comments about those media reports, so I’d like to offer a number of clarifications and some additional perspective.
"Last spring, the Connecticut Bishops worked hard to defeat the so-called “Plan B” legislation. It’s not that the Church opposes administering Plan B to victims of rape; these women have suffered a gravely unjust assault. Last year, nearly 75 rape victims were treated in the four Connecticut Catholic hospitals; no one was denied Plan B as the result of the Catholic hospital protocols which required both a pregnancy test and an ovulation test prior to the administration of that drug.
"What’s really at issue here is how much testing is appropriate to ensure that Plan B does not induce the chemical abortion of a fertilized ovum. There is uncertainty about how Plan B works. Its effect is to prevent fertilization of the ovum. Some believe, however, that in rare instances Plan B can render the lining of the uterus inhospitable to the fertilized ovum which must implant in it in order to survive and grow; many other experts dispute this. For their part, the Bishops of Connecticut felt it was best not only to administer the standard FDA-approved pregnancy test, but also an ovulation test. However, this course of action was only a prudential judgment, not a matter of settled Church teaching and practice. Other bishops and moral theologians hold that a pregnancy test alone suffices. Indeed, the Church does not teach that it is intrinsically evil to administer Plan B without first giving an ovulation test or that those who do so are committing an abortion.
"Unfortunately, Connecticut Legislature decided last spring to settle the question of whether both tests are necessary, instead of letting the Church do so in her own way. The Governor signed into law a measure that forbids health care professionals from using the results of an ovulation test in treating a rape victim. We bishops, as well as health care professionals, continue to believe this law is seriously flawed and should be changed. You should also know that we carefully explored with very competent experts the possibility of challenging the law. Unfortunately, such a challenge would most likely not succeed. Failure of the hospitals to comply would put them and their staffs at risk.
"In the course of this discussion, every possible option was discussed at length with medical-moral experts faithful to the Church’s teaching, with legal experts especially in the area of constitutional law, and with hospital personnel. “Reluctant compliance” emerged as the only viable option. In permitting Catholic hospitals to comply with this law, neither our teaching nor our principles have changed. We have only altered the prudential judgment we previously made; this was done for the good of our Catholic hospitals and those they serve.
"At the same time, we remain open to new developments in medical science which hopefully will bring greater clarity to this matter. Above all, we continue to pray for the healing of those who are victims of sexual assault.”
NCBC Statement in Response to the United States Food and Drug Administration'sApproval of Over the Counter Sale of "Plan B"September 1, 2006
The approval of the over the counter sale of "Plan B," sometimes known as the "Morning After Pill," represents a tragic betrayal of women. The non-prescription availability of this drug which has significant potential for serious side effects raises the question, "Why do women deserve less governmental protections than others?" The total dosage of levonorgestrel (the active ingredient in "Plan B") taken over twelve hours is six times the daily dosage found in a number of oral contraceptives which are sold by prescription only. All one needs to do is note the potential side effects of such a drug to realize that the health of women is not the driving force for this FDA approval. Women taking this drug without medical oversight may be subjected to serious side effects such as future ectopic pregnancies. Women deserve better.Supposedly there will be monitoring in place to assure that only teenagers eighteen years of age or older will have over the counter access to this drug. Parents' accounts of the difficulty of limiting their children's access to cigarettes and alcohol demonstrate how difficult it will be to enforce such provisions. Parents also deserve better.There are many euphemisms used to describe the manner of action of levonorgestrel, from the "Morning After Pill" to "Emergency Contraception." Both terms misrepresent the facts. Contraceptives are to prevent conception. Science tells us that conception occurs upon the union of a mother's egg and a father's sperm. Such a union can occur within minutes of intercourse. There is only a very small window of opportunity for the "Morning After Pill" to act as a contraceptive by the suppression of ovulation - if it is taken just prior to the time a woman ovulates. Otherwise, the "Morning After Pill" has great potential of being an abortifacient by making the womb inhospitable to the new human being engendered by his or her parents. The most vulnerable of human life becomes disposable.Each of us as a member of this society has the right to expect from our government better protections of human life and dignity. What does the approval of the over the counter sale of this drug say about us as a society? Is the most intimate act between a man and a woman, the natural outcome of which frequently is the creation of a new and unique human being, nothing more than a biological exercise with no responsibilities attached to it? What about the human being brought about through such an act? Does that human person have no rights once engendered by the act of his or her parents?The National Catholic Bioethics Center receives the news of the FDA approval of non-prescription distribution of "Plan B" with great regret. We all become vulnerable when compromises are made in the processes which have been established by our government to ensure drug safety; by our government which has been charged with protecting its members, especially the most vulnerable. John M. Haas is the publisher of The National Catholic Bioethics Center's publications, and Edward J. Furton is the Editor in Chief. Center's website: www.ncbcenter.org, or by calling the Center at 215.877.2660.
Spirit & Life® "The words I spoke to you are spirit and life." (Jn 6:63)Human Life International e-NewsletterVolume 01, Number 87 October 05, 2007
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Plan A: Keep "Plan B" Out of Catholic Hospitals
On September 28th the Connecticut bishops issued an unfortunate statement allowing the Plan B abortion-causing drug to be used in cases of rape in Catholic hospitals. I have written respectfully and urgently to the Connecticut Catholic Conference (CCC) and to each bishop individually to ask them to withdraw this potentially precedent-setting statement, and I pray that they do so. I am extremely concerned that this statement will begin to have a domino effect on other Catholic hospitals and healthcare institutions, and I write to you today to ask your ongoing partnership in this concern.
First, let me be clear about our obligations as Catholics. While our bishops operate in union with the Vicar of Christ, no individual bishop or conference of bishops, however wise or holy, has the charism of infallibility. Our respect for our bishops is sometimes exercised in presenting them with the clear facts that their advisors may have missed. It is an expression of our filial cooperation in their ministry. In this case, we have no option but to humbly ask them to reverse their decision due to some extremely egregious errors contained in the statement.
Errors of factError number 1: "The administration of Plan B pills in this instance cannot be judged to be the commission of an abortion because of such doubt about how Plan B pills and similar drugs work."
The truth is that there is absolutely no doubt about how the Plan B pills work. Just ask the manufacturer, Barr Pharmaceuticals, whose product insert states: "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)." (My italics.) It's that third item that makes Plan B an abortion-causing drug. The same can be said for every chemical contraceptive.
Error number 2: "...the teaching authority of the Church has not definitively resolved this matter...." Here, regretfully, Catholics are led to believe that Rome has not unambiguously addressed the issue of Plan B (a.k.a., the "morning after pill") already.
The truth of this matter is evident by a simple recourse to a statement of the Pontifical Academy for Life on the Vatican's website. The Academy stated in a document issued in October of 2001 that "from the ethical standpoint the same absolute unlawfulness of abortifacient procedures also applies to distributing, prescribing and taking the morning-after pill. All who, whether sharing the intention or not, directly co-operate with this procedure, are also morally responsible for it." The Vatican did not need to invent any new teaching on the Plan B pills because these pills fall into the category of abortifacient contraception, pure and simple. The consistent teaching of our Church on abortion applies here.
Errors of judgment: There were other errors in judgment in the bishops' statement that confuse the issue from a moral point of view. The bishops state that "to administer Plan B pills without an ovulation test is not an intrinsically evil act." This type of language just confuses the issue. It would indeed be a seriously irresponsible act to administer a killing drug not knowing whether or not ovulation has occurred and a new life is present. It would be like a hunter shooting at something moving in a forest if he were not really sure that what he saw was an animal or a human being. To use the language of "intrinsically evil" would make us think - legalistically - that it would be okay to take an action if it were only possibly evil. Hair-splitting language like this does not give us guidance when our moral obligation is to err on the side of life whenever there is a doubt. Furthermore, Dr. Chris Kahlenborn has shown that Plan B only works to halt ovulation half the time. Thus fertilization may occur even after the pill is administered, and a chemical abortion would result.
The core of the matter.What we are faced with here is the long arm of the culture of death reaching into our Catholic institutions and coercing us to comply with its totalitarian dictates. The Connecticut state legislature, with the complicity of the governor, passed a law that forbad the use of ovulation tests in cases of rape - why? This unwarranted government intrusion into a purely medical decision was totally unnecessary and would not likely have affected any other institutions than Catholic ones. It is, in my opinion, a law that was drafted deliberately to coerce Catholic hospitals to comply with the contraceptive dictates of the abortion providers. Remember this same state was the origin of the 1965 Griswold v. Connecticut Supreme Court case which legalized contraception! It is no wonder that Connecticut is reaping the rotten fruit of the seeds that it sowed over forty years ago.
The bishops were forced into a "reluctant compliance" with this law, according to Bishop Lori of Bridgeport, but this is just the tip of the iceberg. Acts of blatant coercion of Catholic consciences are already far advanced and will only continue unless the Church is willing to stand up and rebuke the arrogance of these coercive measures and carve out strict realms of conscience which are unreachable by activist courts and corrupt politicians. That will require Church leaders to be willing to fight ferocious battles against the dictators of relativism in order to assert our rights of conscience and faith. All Catholics, but especially our leaders, will have to be clear-headed and uncompromising in the face of the temptations to put our Catholic institutions in league with the liars and manipulators of the culture of death.
I envision a day in which Catholic leaders may have to resign from lucrative positions in business and shut down Catholic healthcare institutions rather than cooperate in the arrogant and coercive programs of the culture of death. Actually, I think that day has already arrived.
What we can doOur greatest weapon in this battle against the culture of death is prayer. I ask you to pray for the bishops, above all, who are usually the target of attack by the culture of death and are often surrounded by compromisers. We need their strong moral leadership unfettered by lawyers and "ethicists" who prevent them from taking up arms in the culture wars. We are at a point in our Church's history where bishops and priests are being called to martyrdom for the sake of the Faith, and only prayer will give them that courage to embrace their vocations to the last drop of blood.
Secondly, we all need to make a firm decision to never be silent in the face of any form of chemical killing. Abortifacient contraception is a back-door plague which enters into lives, institutions and societies in the guise of the birth control "savior," but it is just one more way to kill, and with greater frequency at that.
Finally, stay tuned for more battles in more states with more Catholic healthcare institutions. One phone call I had with the legislative advisor of the Connecticut Catholic Conference gave me the impression that the domino effect is already happening in other episcopal conferences, and that concerns me deeply. The vigilance of many great pro-life forces, coupled with prayer and massive protests from people of conscience will undoubtedly give our Church leaders the courage to imitate the Good Shepherd, who laid down His life for His sheep.
Rev. Thomas J. Euteneuer,President, Human Life International
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Scientific Evaluation:
Polycarp.org: Dr. Christ Kahlenborn
The Annals of Pharmacotherapy: Vol. 36, No. 3, pp. 465–470.
Postfertilization Effect of Hormonal Emergency Contraception
Chris Kahlenborn, 1 Joseph B Stanford, 2 and Walter L Larimore3
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Scientific Evaluation:
Polycarp.org: Dr. Christ Kahlenborn
The Annals of Pharmacotherapy: Vol. 36, No. 3, pp. 465–470.
Postfertilization Effect of Hormonal Emergency Contraception
Chris Kahlenborn, 1 Joseph B Stanford, 2 and Walter L Larimore3
DATA SOURCES AND STUDY SELECTION: A MEDLINE search (1966–November 2001) was done to identify all pertinent English-language journal articles. A review of reference sections of the major review articles was performed to identify additional articles. Search terms included emergency contraception, postcoital contraception, postfertilization effect, Yuzpe regimen, levonorgestrel, mechanism of action, Plan B.
DATA SYNTHESIS: The 2 most common types of hormonal EC used in the US are the Yuzpe regimen (high-dose ethinyl estradiol with high-dose levonorgestrel) and Plan B (high-dose levonorgestrel alone). Although both methods sometimes stop ovulation, they may also act by reducing the probability of implantation, due to their adverse effect on the endometrium (a postfertilization effect). The available evidence for a postfertilization effect is moderately strong, whether hormonal EC is used in the preovulatory, ovulatory, or postovulatory phase of the menstrual cycle.
CONCLUSIONS: Based on the present theoretical and empirical evidence, both the Yuzpe regimen and Plan B likely act at times by causing a postfertilization effect, regardless of when in the menstrual cycle they are used. These findings have potential implications in such areas as informed consent, emergency department protocols, and conscience clauses.
KEY WORDS: contraception, levonorgestrel, postfertilization effect.
Ann Pharmacother 2002;36:465–470.
KEY WORDS: contraception, levonorgestrel, postfertilization effect.
Ann Pharmacother 2002;36:465–470.
Emergency contraception (EC) consists of hormones or mechanical devices used within 72 hours of sexual intercourse with the intent of preventing pregnancy. In the late 1960s and early 1970s, women used high-dose estrogens such as diethylstilbestrol as EC.1 This treatment was replaced in 1974 by combination high-dose oral contraceptives (OCs) (e.g., ethinyl estradiol/levonorgestrel) used within a 12-hour interval (i.e., the Yuzpe regimen) and, in later years, by Plan B, which consists of 2 levonorgestrel tablets.2 The intrauterine device, danazol (danocrine), and mifepristone have also been studied and promoted as EC, but the Yuzpe regimen remains the most prevalent form of EC in the US and Europe.3
The question as to whether hormonal EC sometimes acts after fertilization to prevent implantation, called a postfertilization effect (i.e., early abortion), is important and could have far-reaching implications given the differing attitudes in regard to its use and related issues such as informed consent, emergency department rape protocols, and conscience clauses. Postfertilization effect refers to any effect that reduces the survival rate of the zygote/embryo after fertilization, usually prior to clinical recognition of pregnancy. We use the term early abortion synonymously with postfertilization effect. We recognize that some physicians,4 geneticists, and ethicists have arbitrarily defined human life as beginning after implantation, thereby eschewing the possibility of an early abortion prior to implantation. However, we recognize the traditional definition of pregnancy: “the gestational process, comprising the growth and development within a woman of a new individual from conception through embryonic and fetal period to birth,” where conception is defined as “the beginning of pregnancy, usually taken to be the instant that a spermatozoon enters an ovum and forms a viable zygote.”5
In a previous review6 of the mechanism of action of OCs, we concluded that they act at times via a postfertilization effect, that is, after fertilization and prior to the clinical recognition of pregnancy. However, the Yuzpe regimen and Plan B have a different dose and time course for use, which may result in different actions on the reproductive system. This article reviews data on the use of the Yuzpe regimen and Plan B with regard to their mechanisms of action and any potential ethical implications of those mechanisms.
The Physicians' Desk Reference7 states: “ECPs (Emergency Contraceptive Pills) act primarily by inhibiting ovulation. They may act by altering tubal transport of the sperm and/or ova and/or altering the endometrium (thereby inhibiting implantation).” The Medical Letter2 ,8 stated in regard to hormonal EC: “Some studies have shown alteration in the endometrium, suggesting that they could also interfere with implantation of the fertilized egg, but other studies have found no such effects.” Therefore, the critical ethical questions are: Does use of the Yuzpe regimen or Plan B have a postfertilization effect; that is, does hormonal EC use at times cause an early abortion by altering the receptive properties of the endometrium? Can such an effect occur when EC is used in the preovulatory phase of the cycle, or does the postfertilization effect occur only when it is used in the ovulatory or postovulatory phase?
It is often asserted that hormonal EC use consistently stops ovulation. In an early study with oral contraceptives, Carr et al.9 found that a woman's estradiol, progesterone, luteinizing hormone (LH), and follicle-stimulating hormone concentrations decreased significantly once she started using OCs. Because an LH surge is presumed necessary for ovulation, this result has been cited by many as evidence that hormonal contraceptive use completely inhibits ovulation. However, the findings of the Carr et al. article cannot be extrapolated to today's Yuzpe regimen or Plan B for several reasons. First, although the article was written in 1979, when the doses of estrogen in OCs were higher than the doses in today's OCs, using high-dose hormones in mid-cycle is far different from using them for 21 days in a 28-day cycle. Second, the findings were based on the results of only 4 ovulating women. Therefore, data from that study cannot be used to establish that use of today's OCs or hormonal EC consistently suppresses ovulation.
Further data from hormonal assays confirm that EC use does not consistently stop ovulation. One study10 of the Yuzpe regimen that examined serum hormonal markers of ovulation noted that an LH peak concentration occurred within 4 days after the treatment in 5 of 9 women, with a subsequent increase of progesterone, suggesting that ovulation had occurred. A more recent trial11 using urine hormonal markers found an LH peak concentration within 1 day of treatment with the Yuzpe regimen in 2 of 8 women, with a subsequent confirmatory increase of progesterone.
Further data from hormonal assays confirm that EC use does not consistently stop ovulation. One study10 of the Yuzpe regimen that examined serum hormonal markers of ovulation noted that an LH peak concentration occurred within 4 days after the treatment in 5 of 9 women, with a subsequent increase of progesterone, suggesting that ovulation had occurred. A more recent trial11 using urine hormonal markers found an LH peak concentration within 1 day of treatment with the Yuzpe regimen in 2 of 8 women, with a subsequent confirmatory increase of progesterone.
Table 1 12–20 notes the major studies that have analyzed hormonal EC use. The estimated efficacy rates range from 56.9% to 90.9%, with the largest trial12 showing a 56.9% efficacy rate. The efficacy rate is the percent of reduction in the pregnancy rate of women who used hormonal EC compared with the estimated rate of women who did not. These rates are calculated from secondary data sources and have not been established via a randomized, controlled, prospective study (Appendix I3 ,20–28 ). This study,12 by the World Health Organization, found that in a group of about 400 women, 6 who used the Yuzpe regimen in the preovulatory phase became pregnant (10 were expected to become pregnant if no EC was used). In addition, 2 women who used Plan B in the preovulatory phase became pregnant (11 were expected). The preovulatory period is the time of the menstrual cycle that occurs more than 3 days prior to the expected day of ovulation. The expected day of ovulation in this study was estimated as the 14th day prior to the onset of the next menstrual cycle. Although this is an imprecise definition with the potential for significant misclassification, it is the best definition available for these studies. In addition, Glasier17 presented 2 cases of women who became pregnant after using the Yuzpe regimen while their progesterone concentrations were <1.5 href="http://www.polycarp.org/postfertilization_polycarp_1.htm#i1060-0280-036-03-0465-b12#i1060-0280-036-03-0465-b12">12 ,17 have shown that hormonal EC use, even in the preovulatory phase, does not consistently prevent pregnancy and, by definition, allows ovulation in those cases. Some have speculated29 that if ovulation is not inhibited, other mechanisms, such as a change in the viscosity of cervical mucus and/or an alteration in the tubal transport of sperm, ovum, or embryo, may come into play. However, there are no clinical data to address these theoretical mechanisms. In contrast, there are clinical data directly relevant to the potential effects of hormonal EC use on implantation.
EFFECTS ON IMPLANTATION [= Abortion]
OCs are known to adversely affect the implantation process,6 which has implications for the Yuzpe regimen and Plan B because they are composed of the same (or similar) hormones contained in today's OCs. OCs affect integrins, a group of adhesion molecules that have been implicated as playing an important role in the area of fertilization and implantation. Somkuti et al.30 noted: “These alterations in epithelial and stromal integrin expression suggest that impaired uterine receptivity is one mechanism whereby OCs exert their contraceptive action.” In addition, prostaglandins are critical for implantation, but OC use lowers uterine prostaglandin concentrations.31 ,32 Finally, it is well known that OC use decreases the thickness of the endometrium as verified by magnetic resonance imaging scans,33 ,34 and a thinner endometrium makes implantation more difficult.35–39 Because hormonal EC consists of hormones contained within OCs, it is possible that the use of hormonal EC has some of the same effects on the endometrium as does the use of OCs. A number of studies support this hypothesis, noting changes in endometrial histology,1 ,40 or uterine hormone receptor levels41 that persist for days after women used the Yuzpe regimen. All of these findings imply that use of the Yuzpe regimen unfavorably alters the endometrium.
In addition to the theoretical evidence that EC use adversely affects implantation, Hertzen and Van Look12 found that both use of the Yuzpe regimen and Plan B reduced the expected number of pregnancies when they were used in the ovulatory phase (17–13 d prior to the next menstrual cycle) and postovulatory phase (13 d prior to the expected menstrual cycle), as well as in the preovulatory phase (as discussed earlier). In the groups that used the Yuzpe regimen in the ovulatory phase, 17 pregnancies occurred (54 were expected if EC was not used), whereas 7 occurred in the postovulatory phase (11 were expected). In the group that used Plan B, 7 pregnancies occurred (53 were expected) in the ovulatory phase, whereas 2 occurred in the postovulatory phase (10 were expected). These data are highly consistent with the hypothesis that hormonal EC has a postfertilization effect on the endometrium. In the case of the use of hormonal EC in the ovulatory phase, it is still possible that other mechanisms might come into play (i.e., a change in the viscosity of cervical mucus and/or an alteration in the tubal transport of either the sperm, ovum, or embryo). However, we could find no data to support these theories.
One result of a postfertilization effect of hormonal EC use might be an increased proportion of recognized pregnancies that are ectopic. If the actions of hormonal EC on the fallopian tube and endometrium were such as to have no postfertilization effects, then the reduction in the rate of intrauterine pregnancies (IUPs) in women taking agents used in EC should be proportional to the reduction in the rate of extrauterine pregnancies (EPs) in women using hormonal EC. However, if the effect of hormonal ECs is to increase the EP/IUP ratio, this would indicate that one or more postfertilization effects are operating.6
The current proportion of clinical pregnancies that are ectopic is a little less than 2%.42 In the only study that we are aware of regarding hormonal EC and ectopic pregnancy, Kubba and Guillebaud43 noted that in 715 women who used the Yuzpe regimen, 17 pregnancies occurred, including 1 ectopic pregnancy (i.e., a 5.9% rate of ectopic pregnancy), supporting the possibility of one or more postfertilization effects. However, the confirmation of a postfertilization effect would take a much larger series of hormonal EC pregnancies to determine whether the proportion of ectopic pregnancies is indeed higher than in those not having used EC.
Relative Contribution of Postfertilization Effect Return to Top
As noted earlier, 2 small studies10 ,11 have suggested that when EC is used before ovulation, ovulation may be inhibited in 55–75% of the cases. Under the highly optimistic assumption that hormonal EC use prevents ovulation in 87.5% of women treated, Trussell and Raymond44 estimated that a mechanism “other than preventing ovulation accounts for 13–38% of the estimated effectiveness of the Yuzpe regimen.” This range is higher than 12.5% because hormonal EC is often used during or after ovulation when, by definition, mechanisms other than prevention of ovulation are in effect. The most likely candidate for the mechanism “other than preventing ovulation” is a postfertilization effect (by effects on the endometrium).
Relative Contribution of Postfertilization Effect Return to Top
As noted earlier, 2 small studies10 ,11 have suggested that when EC is used before ovulation, ovulation may be inhibited in 55–75% of the cases. Under the highly optimistic assumption that hormonal EC use prevents ovulation in 87.5% of women treated, Trussell and Raymond44 estimated that a mechanism “other than preventing ovulation accounts for 13–38% of the estimated effectiveness of the Yuzpe regimen.” This range is higher than 12.5% because hormonal EC is often used during or after ovulation when, by definition, mechanisms other than prevention of ovulation are in effect. The most likely candidate for the mechanism “other than preventing ovulation” is a postfertilization effect (by effects on the endometrium).
The evidence to date supports the contention that use of EC does not always inhibit ovulation even if used in the preovulatory phase, and that it may unfavorably alter the endometrial lining regardless of when in the cycle it is used, with the effect persisting for days. The reduced rates of observable pregnancy compared with the expected rates in women who use hormonal EC in the preovulatory, ovulatory, or postovulatory phase are consistent with a postfertilization effect, which may occur when hormonal EC is used in any of these menstrual phases.
This interpretation of the cited literature has important ramifications, given the polarizing opinions about EC use.45 For example, many state laws contain conscience clauses in which medical personnel (e.g., physicians, pharmacists, nurses, physician assistants, nurse practitioners) cannot be forced to participate in, or refer for, any surgical or drug-induced abortions. Therefore, evidence in favor of a postfertilization effect may have legal implications for healthcare providers who either prescribe or have objections to prescribing these agents.
Emergency department protocols could also be impacted by evidence of a postfertilization effect. For example, emergency departments of Catholic hospitals usually allow either no use of hormonal EC in their rape protocols or limited use (i.e., preovulatory use of hormonal EC).45 Catholic hospitals that do allow hormonal EC use prior to ovulation may wish to reassess their policies given the findings that EC use does not consistently stop ovulation and has the potential of causing a postfertilization effect even when used prior to ovulation. Most large secular hospitals have fewer limitations on the use of hormonal EC as part of their rape protocols. Nevertheless, evidence of a postfertilization effect from use of hormonal EC is important to physicians who must make a moral decision about prescribing or referring for a drug that can cause an early abortion.
This interpretation of the cited literature has important ramifications, given the polarizing opinions about EC use.45 For example, many state laws contain conscience clauses in which medical personnel (e.g., physicians, pharmacists, nurses, physician assistants, nurse practitioners) cannot be forced to participate in, or refer for, any surgical or drug-induced abortions. Therefore, evidence in favor of a postfertilization effect may have legal implications for healthcare providers who either prescribe or have objections to prescribing these agents.
Emergency department protocols could also be impacted by evidence of a postfertilization effect. For example, emergency departments of Catholic hospitals usually allow either no use of hormonal EC in their rape protocols or limited use (i.e., preovulatory use of hormonal EC).45 Catholic hospitals that do allow hormonal EC use prior to ovulation may wish to reassess their policies given the findings that EC use does not consistently stop ovulation and has the potential of causing a postfertilization effect even when used prior to ovulation. Most large secular hospitals have fewer limitations on the use of hormonal EC as part of their rape protocols. Nevertheless, evidence of a postfertilization effect from use of hormonal EC is important to physicians who must make a moral decision about prescribing or referring for a drug that can cause an early abortion.
There are potential limitations in our conclusions. Because no controlled trials have been done with women using EC, our conclusions are based on the existing data of case series with historical controls. However, these are the best available data for hormonal EC use. In addition, we have assumed, based on our discussions with physicians and laypeople across the country, that a significant number of physicians and patients would be concerned about a possible postfertilization effect. Although some evidence does exist to support our assumption,45 ,46 further research is needed. Nevertheless, the principle of informed consent would state that it is important to inform women who may use hormonal EC about this possible effect so that they can choose based on the best available data.
Regardless of the personal beliefs of the physician or provider about the mechanism of hormonal EC use, it is important that patients have information relevant to their own beliefs and value systems. It has been suggested to us by some that postfertilization loss attributed to hormonal EC use would not need to be included in informed consent until it is either definitely proven to exist or proven to be a common event. However, rare but important events are an essential part of other informed-consent discussions in medicine, primarily when the rare possibility would be judged by the patient to be important. For example, anesthesia-related deaths are rare for elective surgery; nevertheless, it is considered appropriate and legally necessary to discuss this rare possibility with patients before such surgery because the possibility of death is so important. Therefore, for women to whom the induced death of a zygote/embryo is important, failure to discuss the possibility of this loss, even if the possibility is judged to be remote, would be a failure of informed consent. Furthermore, based on the data reviewed in this article, it seems that a postfertilization effect is probably more common than is recognized by most physicians or patients. This is particularly true because in the studies done to date, women have been more likely to request treatment after intercourse that occurred near the time of ovulation than after intercourse that occurred earlier in the cycle.44
Some have suggested to us that an overemphasis of possible postfertilization effects might make women choose not to use EC and therefore increase the incidence of unplanned pregnancies. Both of these views fail to acknowledge the value of a woman's right to make decisions based on informed consent. During informed-consent discussions, overemphasis of any single possible risk may not result in appropriate informed consent; however, failing to mention a possible risk would be a failure of adequate informed consent. Therefore, discussion of a potential postfertilization risk should occur and should be kept within the perspective of the available medical evidence.
Proper informed consent requires patient and physician comprehension of information, the disclosure of that information, and the sharing of interpretations. If a postfertilization mechanism of hormonal EC use violates the morals of any woman, the failure of the physician or care provider to disclose that information would effectively eliminate the likelihood that the woman's consent was truly informed.
Finally, there is in our view a potential for negative psychological impact on women who value human life from conception onward, and have not been given informed consent about hormonal EC use, and later learn of the potential postfertilization effects. Their responses could include disappointment, guilt, sadness, anger, rage, depression, or a sense of having been violated by the provider. To assume that all patients will not care about a postfertilization effect is not supported by the literature.45 ,47–49
1. Yuzpe AA, Thurlow HJ, Ramzy I, Leyshon JI. Post coital contraception — a pilot study. J Reprod Med 1974;13:53–8. [PubMed Citation]2. Plan B: a progestin only contraceptive. Med Lett 2000;42:10 3. LaValleur J. Emergency contraception. Obstet Gynecol Clin North Am 2000;27:817–39. [PubMed Citation]4. Hughes EC, ed. Committee on terminology, American College of Obstetricians and Gynecologists. Obstetric–gynecological terminology Philadelphia: FA Davis. 1972 5. Mosby's medical, nursing, & allied health dictionary. 6th ed. Philadelphia: Mosby. 2002 6. Larimore WL, Stanford J. Postfertilization effects of oral contraceptives and their relationship to informed consent. Arch Fam Med 2000;9:126–33. [PubMed Citation]7. Physicians' desk reference. 54th ed. Montvale, NJ: Medical Economics. 2000:1335 8. An emergency contraceptive kit. Med Lett 1998;40:102–3. 9. Carr BR, Parker CR, Madden JM, MacDonald PA, Porter JC. Plasma levels of adrenocorticotropin and cortisol in women receiving oral contraceptive steroid treatment. J Clin Endocrinol Metab 1979;49:346–9. [PubMed Citation]10. Ling WY, Robichaud A, Zayid I, Wrixon W, MacLeod SC. Mode of action of dl-norgestrel and ethinylestradiol combination in postcoital contraception. Fertil Steril 1979;32:297–302. [PubMed Citation]11. Swahn LM, Westlund P, Johannisson E, Bygdeman M. Effect of post-coital contraceptive methods on the endometrium and the menstrual cycle. Acta Obstet Gynecol Scand 1996;75:738–44. [PubMed Citation]12. Hertzen H, Van Look PFA. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet 1998;352:428–33. [PubMed Citation]13. Webb AMC, Russell J, Elstein M. Comparison of Yuzpe regimen, danazol, and mifepristone (RU 486) in oral postcoital contraception. BMJ 1992;305:927–31. 14. Zuliani G, Colombo UF, Molla R. Hormonal postcoital contraception with an ethinylestradiol–norgestrel combination and two danazol regimens. Eur J Obstet Gynecol Reprod Biol 1990;37:253–60. [PubMed Citation]15. Yuzpe AA, Smith RP, Rademaker AW. A multicenter clinical investigation employing ethinyl estradiol combined with dl-norgestrel as a postcoital contraceptive agent. Fertil Steril 1982;37:508–13. [PubMed Citation]16. Ho PC, Kwan MSW. A prospective randomized comparison of levonorgestrel with the Yuzpe regimen in post-coital contraception. Hum Reprod 1993;8:389–92. [PubMed Citation]17. Glasier A, Thong KJ, Dewar M, Mackie M, Baird DT. Mifepristone (RU-486) compared with high-dose estrogen and progestogen for emergency postcoital contraception. N Engl J Med 1992;327:1041–4. [PubMed Citation]18. Van Santen MR, Haspels AA. A comparison of high-dose estrogens versus low-dose ethinylestradiol and norgestrel combination in postcoital interception: a study in 493 women. Fertil Steril 1985;43:206–13. [PubMed Citation]19. Percival-Smith RK, Abercrombie B. Postcoital contraception with dl-norgestrel/ethinyl estradiol combination: six years experience in a student medical clinic. Contraception 1987;36:287–93. [PubMed Citation]20. Trussell J, Rodriguez G, Ellertson C. Updated estimates of the effectiveness of the Yuzpe regimen of emergency contraception. Contraception 1999;59:147–51. [PubMed Citation]21. Glasier A. Emergency contraception. Br Med Bull 2000;56:729–38. [PubMed Citation]22. Dixon GW, Schlesselman JJ, Ory HW, Blye RP. Ethinyl estradiol and conjugated estrogens as postcoital contraceptives. JAMA 1980;244:1336–9. [PubMed Citation]23. Schwartz D, Mayaux MJ, Martin-Boyce A, Czyglik F, David G. Donor insemination: conception rate according to cycle day in a series of 821 cycles with a single insemination. Fertil Steril 1979;31:226–9. [PubMed Citation]24. Barrett JC, Marshall J. The risk of conception on different days of the menstrual cycle. Popul Stud 1969;23:455–61. 25. Wilcox AJ, Weinberg CR, Baird DD. Timing of sexual intercourse in relation to ovulation. Effects on probability of conception, survival of the pregnancy, and sex of baby. N Engl J Med 1995;333:1517–21. [PubMed Citation]26. Hacker NF, Moore JG, Essentials of obstetrics and gynecology. 3rd ed. Philadelphia: WB Saunders. 1998 27. Diamond EF. Ovral in rape protocols. Ethics Medics 1996;2110:2 28. Wilcox AJ, Dunson D, Baird DD. The timing of the “fertile window” in the menstrual cycle: day specific estimates from a prospective study. BMJ 2000;321:1259–62. 29. Glasier A. Emergency postcoital contraception. N Engl J Med 1997;337:1058–64. [PubMed Citation]30. Somkuti SG, Sun J, Yowell C, Fritz M, Lessey B. The effect of oral contraceptive pills on markers of endometrial receptivity. Fertil Steril 1996;65:484–8. [PubMed Citation]31. Dawood YM, Ibuprofen and dysmenorrhea. Am J Med 1984;771 A.:87–94. 32. Bieglmayer C, Hofer G, Kainz C, Reinthaller A, Kopp B, Janisch H. Concentration of various arachidonic acid metabolites in menstrual fluid are associated with menstrual pain and are influenced by hormonal contraceptives. Gynecol Endocrin 1995;9:307–12. [PubMed Citation]33. Brown HK, Stoll BS, Nicosia SV, Fiorica JV, Hambley PS, Clarke LP. Uterine junctional zone: correlation between histiologic findings and MR imaging. Radiology 1991;179:409–13. [PubMed Citation]34. Demas BE, Hricak H, Jaffe RB. Uterine MR imaging: effects of hormonal stimulation. Radiology 1986;159:123–6. [PubMed Citation]35. Abdalla HI, Brooks AA, Johnson MR, Kirkland A, Thomas A, Studd JW. Endometrial thickness: a predictor of implantation in ovum recipients?. Hum Reprod 1994;9:363–5. [PubMed Citation]36. Dickey RP, Olar TT, Taylor SN, Curole DN, Matulich EM. Relationship of endometrial thickness and pattern to fecundity in ovulation induction cycles: effect of clomiphene citrate alone and with human menopausal gonadotropin. Fertil Steril 1993;59:756–60. [PubMed Citation]37. Gonen Y, Casper RF, Jacobson W, Blankier J. Endometrial thickness and growth during ovarian stimulation: a possible predictor of implantation in in-vitro fertilization. Fertil Steril 1989;52:446–50. [PubMed Citation]38. Schwartz LB, Chiu AS, Courtney M, Krey L, Schmidt-Sarosi C. The embryo versus endometrium controversy revisited as it relates to predicting pregnancy outcome in in-vitro fertilization — embryo transfer cycles. Hum Reprod 1997;12:45–50. [PubMed Citation]39. Shoham Z, Carlo C, Patel A, Conway GS, Jacobs HS. Is it possible to run a succesful ovulation induction program based solely on ultrasound monitoring: the importance of endometrial measurements. Fertil Steril 1991;56:836–41. [PubMed Citation]40. Ling WY, Wrixon W, Zayid I, Acorn T, Popat R, Wilson E. Mode of action of dl-norgestrel and ethinylestradiol combination in postcoital contraception. II. Effect of postovulatory administration on ovarian function and endometrium. Fertil Steril 1983;39:292–7. [PubMed Citation]41. Kubba AA, White JO, Guillebaud J, Elder MG. The biochemistry of human endometrium after two regimens of postcoital contraception: a dl-norgestrel/ethinylestradiol combination or danazol. Fertil Steril 1986;45:512–6. [PubMed Citation]42. Aboud A. A five-year review of ectopic pregnancy. Clin Exp Obstet Gynecol 1997;24:127–9. [PubMed Citation]43. Kubba AA, Guillebaud J. Case of ectopic pregnancy after postcoital contraception with ethinyloestradiol–levonorgestrel. Br Med J 1983;287:1343–4. [PubMed Citation]44. Trussell J, Raymond EG. Statistical evidence about the mechanism of action of the Yuzpe regimen of emergency contraception. Obstet Gynecol 1999;93:872–6. [PubMed Citation]45. Golden NH, Seigel WM, Fisher M, Schneider M, Quijano E, Suss A. Emergency contraception: pediatricians' knowledge, attitudes and opinions. Pediatrics 2001;107:287–92. [PubMed Citation]46. Spinnato JA. Mechanism of action of intrauterine contraceptive devices and its relation to informed consent. Am J Obstet Gynecol 1997;176:503–6. [PubMed Citation]47. Wilkinson J, Ethical problems at the beginning of life. In: Wilkinson J, ed. Christian ethics in health care: a source book for Christian doctors, nurses and other health care professionals Edinburgh, Scotland: Handsel Press. 1988:176–208. 48. Ryder RE. Natural family planning: effective birth control supported by the Catholic Church. BMJ 1993;307:723–6. 49. Tonti-Filippini N, The pill: abortifacient or contraceptive: a literature review. Linacre Quarterly 1995 Feb.:5–28.
Appendix I. Critique of EC Efficacy
The measure of efficacy is critical to an analysis of a possible postfertilization effect. For example, if hormonal EC use had a 0% efficacy rate, the question of a postfertilization effect would be irrelevant. Hormonal EC use received Food and Drug Administration approval without evidence of a randomized, controlled, prospective study regarding its effectiveness.3 ,21 Rather, effectiveness was estimated based on the studies we have reviewed in this article. We noted the efficacy rates based on the raw data versus Trussell et al.'s20 calculated estimates for each of the 8 trials presented in Table 1 . Trussell et al. used the latter estimates to calculate an overall efficacy rate of 74.1%, while the raw data yield a figure of 65.7%.
In these studies, the pregnancy rates of the cohort were compared with pregnancy rates estimated from historical controls. Specifically, the control pregnancy rates were based on the procedure developed in the Dixon Study,22 which estimated the expected rate of pregnancy in women from a single act of intercourse on a particular day of the menstrual cycle. Dixon based the probability of pregnancy per specific day on 2 major studies: Schwartz et al. (1979)23 and Barrett and Marshall (1969).24 In subsequent analyses, Trussell et al. dropped the Schwartz study, which was based on artificial insemination, and added another historical control group from a cohort of women trying to achieve pregnancy in North Carolina in the early 1980s.25 In doing this, Trussell et al. were in fact not comparing contemporaneous cohorts and controls. This major design problem may render the conclusions of the studies uncertain for 2 reasons:
1. In the 1960s, the rate of infertility was lower than in later years. For example, “infertility increased 177% among married women aged 20 to 24 years between 1965 and 1982.”26 Therefore, the rate of infertility would be expected to be lower for the Barrett controls than for the study cohorts (women using EC). In addition, Wilcox et al.25 noted that “women were excluded if they had a serious chronic illness or if they or their partners had a history of fertility problems.” None of the case studies reported specifically screening for infertility. It is therefore probable that both of the historical control studies had a lower rate of infertility than the case studies. If this is true, then studies of EC use that employ historical controls for comparison may overestimate the effectiveness of EC use in preventing or ending a pregnancy.
2. Selecting controls from women who were not seeking to use EC to avoid pregnancy may lead to differences that could affect the results. For example, some controls came from the Barrett and Marshall study,24 which examined 241 couples who were using a natural family planning method based on basal body temperature. Some of these women were trying to conceive, as were the women enrolled in the Wilcox et al. trial.25 None was known to be under the stress of a rape or other high-stress situation. However, the cohort in the 8 trials cited by Trussell were trying to prevent or end their pregnancy and were probably under more emotional stress than the controls who desired pregnancy. If 2 groups of women are examined, one that desires pregnancy and the other that does not and is under stress, the fertility rates in each group may vary markedly because it is possible that under extreme stress, the secretion of ovulatory hormones from the pituitary gland could be inhibited. For example, Diamond27 noted a prospective study in Minnesota of 4000 women who had been raped and none had become pregnant. This may reflect an endogenous hormonal change whereby the women's bodies inhibited ovulation during or shortly after the time of the sexual assault.
3. All of the EC studies are based on a fixed timing of ovulation relative to cycle length (e.g., 14 d before the next menstrual cycle). However, the length of the luteal phase varies significantly, both between women, and to a lesser extent, within the same woman, even for women of regular cycles.28 Therefore, the assignment of conception probabilities based on day relative to ovulation is imprecise.
We believe for the above-noted reasons that the estimates of efficacy rates for hormonal EC use are highly tentative and require further analysis.
We believe for the above-noted reasons that the estimates of efficacy rates for hormonal EC use are highly tentative and require further analysis.
1Chris Kahlenborn MD, Department of Internal Medicine, Altoona Hospital, Altoona, PA; Department of Internal Medicine, Bon Secour Hospital, Altoona, E-mail: kahlen@alt3.com
2Joseph B Stanford MD MSPH, Assistant Professor, Department of Family and Preventive Medicine, University of Utah, Salt Lake City, UT
3Walter L Larimore MD, Associate Clinical Professor, Community and Family Medicine, University of South Florida, Tampa, FL; Vice-President, Medical Outreach, Focus on the Family, Colorado Springs, CO.
Reprints available from The Annals of Pharmacotherapy
2Joseph B Stanford MD MSPH, Assistant Professor, Department of Family and Preventive Medicine, University of Utah, Salt Lake City, UT
3Walter L Larimore MD, Associate Clinical Professor, Community and Family Medicine, University of South Florida, Tampa, FL; Vice-President, Medical Outreach, Focus on the Family, Colorado Springs, CO.
Reprints available from The Annals of Pharmacotherapy
Press Commentary:
Bishops Conferences Admit to Approving Abortifacient Drugs for Rape at Catholic Hospitals
Catholic Medical Association Opposes Measure - Calls for Vatican clarification
Catholic Medical Association Opposes Measure - Calls for Vatican clarification
By John-Henry Westen
HARTFORD, May 2, 2007 (LifeSiteNews.com) - The Catholic Medical Association, the largest professional organization of Catholic physicians in the U.S. is resolutely opposed to the use of the abortifacient morning after pill (also known as 'emergency contraception' or its generic name Plan B) in Catholic Hospitals because of its potential to cause abortions. Nevertheless, the Catholic Bishops of both Connecticut and Wisconsin and other states have publicly admitted that their Catholic hospitals are distributing such pills to rape victims. In testimony before the Wisconsin Senate Committee last week, the Wisconsin Catholic Conference noted that Catholic hospitals were in fact already administering the morning after pill with the use of pregnancy tests. Kim Wadas, Associate Director for Health Care at the Conference, told the committee, "Catholic hospitals in Wisconsin can and do treat victims with emergency contraception." (see the full testimony here: http://www.wisconsin.nasccd.org/bins/wisconsin/content/pages... <http://www.wisconsin.nasccd.org/bins/wisconsin/content/pages/Advocacy/Testimony/sb129tst-EC%20treatment.pdf?_resolutionfile=ftppath> ) In a joint April 25 letter signed by the Bishops of Connecticut, Archbishop of Harford Henry Mansell, and Bishop of Bridgeport William Lori, the prelates state: "It is important to repeat that Connecticut's Catholic hospitals do provide emergency contraception." Later in the letter they add, "We would not object to passage of a statute that would require all hospitals to adopt protocols requiring the distribution of Plan B to sexual assault victims when medically appropriate." (see the letter at the Connecticut Catholic Conference website - Copy and paste the following link into your browser) connecticut.nasccd.org/bins/connecticut/content/documents/Bishop's%20Letter%20on%20Plan%20B.pdf ) LifeSiteNews.com has learned that some Catholic hospitals in Massachusetts, Colorado, New York, California, Washington also offer so-called 'emergency contraception' to some rape victims. The bishops of these dioceses believe they are allowing the use of emergency contraception only in cases where "appropriate testing" has determined that the woman is not pregnant and thus the pill, in halting ovulation may prevent a pregnancy occurring as a result of the rape. The science however does not definitively back up their hopes. Medical evidence, accepted by the largest association of Catholic doctors in the United States, demonstrates that the pregnancy tests used cannot accurately detect a pregnancy at fertilization but only after implantation which takes more than a week after the new life is formed. A more stringent protocol known as the ovulation method used in some Catholic hospitals, seeks to determine if the patient has ovulated and if the test indicates she has not, the pills can be given. However, medical evidence demonstrates considerable doubt that even these tests can detect a potential fertilization in time to prevent an abortion caused by administration of the pill. (for a detailed look at this aspect of the medical evidence see here: http://www.lifesite.net/ldn/2007_docs/UScatholichospitalsand... <http://www.lifesite.net/ldn/2007_docs/UScatholichospitalsandrapetreatment.pdf>) Even if such tests could accurately determine that ovulation has not yet occurred another difficulty exists. A study by Dr. Chris Kahlenborn in 2003 found that the pill only works to halt ovulation half the time. Thus fertilization may occur even after the pill is administered, and an abortion would result since in addition to stopping ovulation the pills act to weaken the lining of the uterus making implantation unsustainable. See Dr. Kahlenborn's study here: <http://www.polycarp.org/postfertilization_polycarp_1.htm>
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Dr. Kathleen Raviele, the President-Elect of the Catholic Medical Association, told LifeSiteNews.com that the science is complex and "Bishops can't be expected to understand all of the medical nuances of this." She says however that the situation as it stands requires reassessment. "In everything we err on the side of life," she said and thus the administration of the morning after pill in Catholic hospitals is "not justified." At its Annual Meeting in 2003, the Catholic Medical Association passed a resolution correcting theologians who have erroneously suggested that it would be legitimate for Catholic hospitals to provide "emergency contraception" to rape victims. The Catholic doctors said that the term 'emergency contraception' is "a misnomer as it does not consistently prevent fertilization". The resolution concludes that the drug, "has the potential to prevent implantation whether given in the pre-ovulatory, ovulatory, or post-ovulatory phase, that it cannot be ethically employed by a Catholic physician or administered in a Catholic Hospital in cases of rape". Raviele added that the most common morning after pill currently in use, Plan B, has many negative side effects such as nausea and dizziness, and the medical literature is pointing to use of the abortion drug RU-486 as a replacement. "The next emergency contraceptive on the horizon is going to be a low dose of RU-486 since it has no side effects," she warned. Dr. Kahlenborn, who, with two other physicians, did the study on the effect of the morning after pill told LifeSiteNews.com, no one knows for sure how the morning after pill works. Acting in an area of life and death in uncertainty, suggests Dr. Kahlenborn, is reckless. "The bishops who approve this are approving potential abortions," he said. "You have the Catholic doctors telling you this and even Protestant doctors," said Kahlenborn speaking of the Catholic Medical Association and the two Protestant and Mormon physicians who co-authored the study on the morning after pill. "Who are the bishops listening to?," he asked rhetorically. The Catholic Health Association is an association led by theologians which advises the bishops on such matters and it approves of the limited use of the morning after pill in Catholic hospitals for rape victims. Dr. Kahlenborn wondered about reliance on theologians for opinion on medical science rather than on medical doctors. "Basically saying your theologians are smarter than all the doctors out there," he said. Given the complexities involved, Dr. Kahlenborn suggested that a new Vatican intervention would be required to clear up the situation. "The only way I really think its going to change is if the Vatican does something," he concluded. To politely request that the Pontifical Academy for Life clarify the situation write: pav@acdlife.va See related LifeSiteNews.com coverage: US Catholic Bishops in Wisconsin and Connecticut Drop Opposition to Abortion-Causing Emergency Contraception
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