It started around February, when Republicans were still eager to talk about contraception. The Obama administration, or so Mitt Romney charged in Colorado, was forcing religious institutions to provide “morning-after pills –in other words abortive pills — and the like, at no cost.”

It was, of course, a lie. Romney was conflating two different pills: emergency contraception, known as the morning-after pill, which prevents a pregnancy; and chemical abortion, or mifepristone, which ends a pregnancy of up to seven weeks’ gestation and isn’t covered under the new guidelines. Since both pills were marketed in the U.S. around the same time, even some pro-choicers have gotten confused. But Colorado happens to be the epicenter of people confusing them on purpose. It’s the birthplace of the Personhood movement and home to Focus on the Family, both of which have strategically called emergency contraception “abortion” on the scientifically unproven basis that they could block a fertilized egg from implanting.

There are a host of ironies here. Obama has earned the renewed support of reproductive-rights advocates by requiring health insurers to cover contraception, but the Center for Reproductive Rights is still taking him to court – with oral hearings being held this week before a New York federal court -– for overruling the FDA’s recommendation to lift the prescription requirement on emergency contraception for women under 17. That litigation has been winding its way through the system for over a decade, throughout the Bush-era politicization of the FDA, eventually resulting in a federal judge concluding that “the FDA repeatedly and unreasonably delayed issuing a decision on [the emergency contraception pill] Plan B for suspect reasons.” The FDA was ordered to explain why Plan B shouldn’t be available over the counter for girls 13 and up. When the Obama administration overruled the FDA’s recommendation to make it over the counter, U.S. District Judge Edward Korman suggested the Center for Reproductive Rights reopen its case.

“It seems to me that what we’re going through is a rerun of what happened before,” Korman remarked, referring to politics trumping the recommendations of medical professionals.

The Obama administration’s unspoken but unmistakable fear was of an election-cycle attack line that Michele Bachmann would use anyway: That teenage girls would be able to get Plan B from “the grocery store aisles next to bubble gum and next to M&Ms.” That was, in fact, an echo of the language President Obama himself used to invoke a highly unsupported bogeyman: that “a 10-year-old or 11-year-old going to a drugstore would be able to, alongside bubble gum or batteries, … buy a medication that potentially if not used properly can have an adverse effect.”

But there is another twist, so far mostly overlooked: Emergency contraception won’t be covered by insurance for everyone, since it’s available over-the-counter for those who can show I.D. proving that they’re 17 or older. They’ll still have to fork over around $50 a pop. But as long as girls 16 and younger need a prescription for the morning-after pill and they have insurance, it will be fully covered — effectively free. The same goes for women older than 17 who decide to jump through the hoops of getting a prescription, either for over-the-counter Plan B or the prescription-only generic and Ella versions.

As much as pro-choice advocates want to lift the barriers that make emergency contraception hard to get — because it’s more effective the faster you use it — one of those barriers, the prescription requirement, also mitigates another, the high cost. Said Adam Sonfield, a senior public policy associate at the Guttmacher Institute, of this catch-22, “It presents a tradeoff between cost and access.”

– – — – — – — – — – — – — – — – — – — – — – — – –

Part of the reason people get confused about emergency contraception and abortion is because lots of people are confused about the basic biology of pregnancy: specifically, that it doesn’t necessarily happen instantaneously and that sperm can live in the body for several days, during which time a woman can ovulate and an egg can potentially be fertilized and implant. Regular use of hormonal contraception prevents ovulation and the chance for fertilization; emergency contraception essentially works the same way except that it’s taken after sex, by which point ovulation may have already happened. But according to recent studies, there is no evidence that taking emergency contraception after ovulation and fertilization will stop the egg from implanting.

But the misinformation and misunderstanding have created a contradictory public health picture when it comes to emergency contraception. In some ways, it’s become more accessible. In 2010, the U.S. approved a longer-acting French variant of Plan B, known as Ella, and there are scattered experiments in convenient delivery, from a birth-control vending machine at Shippensburg University in Pennsylvania to a new bike messenger service in London, both of which caused minor news sensations. The annual “Back Up Your Birth Control” campaign has been promoting the line “EC=BC,” emphasizing that emergency contraception is birth control, not abortion — just in case that is a barrier for women who are considering taking it. And the Center for Reproductive Rights’ petition did manage to lower the age restriction from 18 to 17.

But there are more disturbing suggestions that misinformation is triumphing. A recent Boston Medical Center study found that many pharmacists were still often misinformed about the age requirement and were even more likely to wrongly refuse emergency contraception to 17-year-olds in low-income neighborhoods, where the rate of unintended pregnancy is higher. In Honduras, the Supreme Court upheld the criminalization of emergency contraception, which means women who use it could be jailed. Personhood initiatives, which oppose the morning-after pill, have so far failed in Colorado, Mississippi and Oklahoma, but they’ve introduced false doubts by providing even more opportunities for pundits and candidates to say “the morning-after abortion pill.”

It’s a problem that dates back decades: When, throughout the ’90s, the U.S. considered approving a French chemical abortion pill known as RU-486, it was widely called the “morning-after abortion pill,” including, often, in the New York Times. The distinction wasn’t pressed by the pro-choice community itself. “At the time, the prevailing medical wisdom was that there is a continuum rather than a bright line between EC and mifepristone,” said Gloria Feldt, who was president of Planned Parenthood at the time, with the benefit providing more options for women who did not wish to be pregnant. “It was also assumed that a formulation of mifepristone would eventually be made for use as a true ‘morning-after’ pill.” The widespread belief, she recalled, was that a chemical abortion pill would “solve all the abortion debate problems and guarantee privacy.”

Another problem was that although doctors and non-professionals had been giving women high dosages of regular birth control pills for decades as a form of emergency contraception, the science of exactly how emergency contraception worked remained unclear. The medical definition of pregnancy remains “implantation of a fertilized egg,” but let’s say you believe, as the Catholic Church does, that fertilization itself creates a human life. Anti-choice advocates obsess over what would happen if a woman who took emergency contraception did happen to ovulate anyway and an egg potentially was fertilized, which is enough reason for some of them to call postcoital contraception “abortion.” They have claimed that hormonal contraception makes the lining of the endometrium inhospitable to a fertilized egg, constituting “murder.” Even the official packaging for Plan B, the single-step version of emergency contraception, suggests that “in addition” to blocking ovulation and fertilization, “it may inhibit implantation (by altering the endometrium).”

Except that we now know it doesn’t, even if you walk down the path of remote maybes, which requires you to believe that a zygote, which may not implant for unknowable reasons, has the same rights as a living woman who doesn’t want to be pregnant. As Princeton’s Kelly Cleland pointed out recently, “The science has evolved considerably in the last 13 years. Newer evidence, published since the Plan B label was approved, provides compelling evidence that levonorgestrel EC (LNG EC) works before ovulation, but not after.” The International Consortium for Emergency Contraception and the International Federation of Gynecology & Obstetrics also note that two new studies have shown conclusively that if a woman has ovulated and an egg has been fertilized, it’s too late for emergency contraception to work. They recommended that the language on the product labeling be changed.

Of course, scientific evidence has rarely had much place in this debate. In the meantime, even the most non-ideological news sources keep making the mistake alongside the ideologues. Last week, a furor erupted after the Associated Press reported that “Women seeking to take emergency contraception like the so-called ‘morning after’ pill would have to do so in the presence of a doctor under a bill before the Alabama legislature.” That is, until Erin Gloria Ryan from Jezebel read the actual bill and saw that it was, in fact, a law meant to limit chemical abortion, not emergency contraception. (A spokesperson for the AP said a correction was being prepared). “The confusion over this issue is probably one of the reasons emergency contraception hasn’t had as positive an impact as hoped when it comes to lowering the abortion rate,” wrote Amanda Marcotte at RH Reality Check. “If women think it is some kind of abortion-ish thing, they probably think taking it is a big deal, instead of thinking of it more like taking the pill, since it’s basically the same thing.”

But talk about moved goalposts. If ’90s-era advocates had hoped that the ability to end a pregnancy in the safety of your home with RU-486 — the actual abortion pill, not the morning-after one — would defuse the abortion debate, their more recent counterparts hoped to take it to the next technological level by providing “tele-med” abortions. They would involve doctors seeing a woman over webcam with a nurse practitioner physically present, helping women in remote areas with ever-dwindling options for safe abortions to access them. But four states have already passed requirements meant to undercut these options by forcing a doctor’s presence, and the bill the Associated Press misreported was aiming to add Alabama to the list. All in all, there have been fewer gamechangers, and more cases of one step forward, two steps back.

The Etter Health Center at Shippensburg, a public school of 8,300 students in Appalachia’s scenic Cumberland Valley, provides the Plan B One Step emergency contraceptive along with condoms, decongestants and pregnancy tests.

The pill is available without a prescription to anyone 17 or older, and the school checked records and found that all current students are that age or older, spokesman Peter Gigliotti said.

The machine was installed after a request from the student association. The pill’s availability in a vending machine appears to be rare, if not unprecedented.

The idea started when Shippensburg conducted a survey about health center services several years ago, and 85 percent of the respondents supported making Plan B available, he said.

“The machine is in a private room in our health center, and the health center is only accessible by students,” Gigliotti said in a statement. “In addition, no one can walk in off the street and go into the health center. Students proceed to a check-in desk located in the lobby and after checking in are granted access to the treatment area.”

Taking Plan B within 72 hours of rape, condom failure or just forgetting regular contraception can cut the chances of pregnancy by up to 89 percent. It works best if taken within 24 hours.

Some religious conservatives consider the emergency contraceptive tantamount to an abortion drug. A spokeswoman for the National Right to Life Committee did not immediately respond to a request for comment.

Jessica Sheets Pika, a spokeswoman for the National Campaign to Prevent Teen and Unplanned Pregnancy, said that “if the health center is manned 24/7, that sounds like it’s a sufficient protection.”

“But if there’s a chance that people under 17 are able to access it, that’s a problem,” she added.

The drug isn’t covered or subsidized by the school. Its price at the vending machine is set by the school’s cost to the pharmaceutical company and is less than at off-campus pharmacies.

Thanks for the fact check on the South Carolina Gingrich-versus-Romney ad ["Gingrich’s ‘Baloney’-filled Attacks on Romney," Jan. 11]. Confusing the public about emergency contraception pills (ECP) is deliberate, pervasive, and routinely served by opponents of contraception.

Although fact-checking the fact-checking seems tedious sometimes, it is important to explain that available research on Plan B One-Step (“the morning after pill”) shows that it prevents pregnancy by preventing ovulation and/or fertilization.

Ron Hamel, a Catholic ethicist publishing the conclusions of five years of scientific review in the January-February 2010 issue of Health Progress, said: ” … virtually all of the evidence in the scientific literature indicates Plan B has little or no post-fertilization effect, that is, it has little or no effect on the endometrium that would make it inhospitable to implantation. Its mechanism of action is to disrupt ovulation.”

One objection frequently repeated by Plan B opponents is that there is language in the pill package that the drug may prevent implantation. However, Nicanor Pier Giorgio Austriaco, a priest, theologian, and scientist also studied the active drug’s effects and determined that it has no post-fertilization effect. On the argument of labeling, he stated that: “ … labels mean nothing without the scientific data to back up their claims.”

These conclusions are reinforced in the 2010 World Health Organization’s fact-sheet on levonogestrel (LNG) which states: “… LNG ECP use does not prevent a fertilized egg from attaching to the uterine lining.”

The important answer to the question on emergency contraception is that there cannot be an abortion before there is a pregnancy; therefore, preventing unwanted pregnancies prevents abortions. But even if you believe pregnancy is the same as fertilization, you no longer have to put up with the warmed-over baloney that Plan B is an “abortion pill.”

Thanks, again, for your excellent work.

Lon Newman
Executive director, Family Planning Health Services
Wausau, Wisc.

Health Progress

January-February 2010

Volume 91, Number 1

Thinking Ethically About Emergency Contraception

Critical judgments require adequate and accurate information.

BY RON HAMEL, Ph.D.

The controversy over the use of emergency contraception in Catholic hospitals for victims of sexual assault continues to be played out in various forums — in the literature, state legislatures, pharmacies, professional groups, state Catholic conferences, dioceses and Catholic hospitals themselves.

At its heart is whether medications used for emergency contraception have an abortifacient effect, that is, whether they prevent the implantation of a fertilized egg by altering the lining of the endometrium. On the belief that they do have such an effect, some either object to or prohibit their use in Catholic hospitals or agree to their use only in conjunction with testing for ovulation to ascertain whether the woman is at or around the time of ovulation (and, therefore, could become pregnant).¹ Obviously, for women who have been subjected to a sexual assault and who seek assistance at a Catholic hospital, much hinges on accurately understanding how these hormonal medications work.

Unfortunately, such understanding is not always in play. In many instances, critics base their moral judgments on prevailing beliefs or assumptions about mechanisms of action that may be based on drug manufacturer labeling, or on outdated scientific literature, or on mere supposition. Researchers have been virtually certain that the drugs prevent or disrupt ovulation, but they have generally been uncertain about other possible effects on sperm, cervical mucus, the process of fertilization and on the endometrium. Yet manufacturers and others typically list these specific effects as possible mechanisms of action.

But are such beliefs and assumptions about emergency contraceptives accurate and adequate? This is a critical question, for women who have been sexually assaulted and for the Catholic hospitals that care for them.

One of the well-known truisms in ethics is that good moral judgments depend in part on good facts. Absent adequate and accurate information, there is an increased possibility of a faulty analysis and, therefore, of an erroneous judgment. In addition, the moral judgment itself might be seen to lack credibility either because its basis is unclear or because it seems to fly in the face of reputable data.

Take one example. In late February 2007, in a LifeSiteNews interview, Bishop Elio Sgreccia, the then-president of the Pontifical Academy for Life, reaffirmed the academy’s 2000 statement that the “morning-after pill” is abortifacient and that physicians and Catholic hospitals are prohibited from administering it, even in cases of sexual assault.² Unfortunately, the 2000 statement employed the generic term “morning-after pill,” which can refer to a variety of medications with different mechanisms of action, and the statement made no reference to scientific literature substantiating its claim that the pill is abortifacient. In addition, the comment in the 2007 interview seemed not to take account of recent scientific literature on how these medications work, particularly in the case of levonorgestrel, also known as Plan B, the current standard treatment for women who have been sexually assaulted. Yet after the interview, despite the lack of evidence, some described both the bishop’s comment and the Pontifical Academy’s statement as “authoritative.”

GOOD FACTS ARE NECESSARY FOR GOOD ETHICS
What, in fact, do we find if we look at the scientific literature on how Plan B, a progestin-only form of emergency contraception, works?

Over the past five years, CHA staff have collected, reviewed and summarized the great majority of articles on emergency contraceptive medications’ mechanisms of action — both for combination drugs (such as Preven) and Plan B.³ In addition, CHA obtained two independent analyses of the literature — one by an ob-gyn and the other by a pharmacist. The reviews concluded that virtually all of the evidence in the scientific literature indicates Plan B has little or no post-fertilization effect, that is, it has little or no effect on the endometrium that would make it inhospitable to implantation. Its mechanism of action is to disrupt ovulation.

In a thorough review of the scientific literature, Fr. Nicanor Pier Giorgio Austriaco, OP, Ph.D., a priest, theologian and scientist, wrote in the Winter 2007 issue of The National Catholic Bioethics Quarterly:

Studies published in the past few months provide mounting evidence that levonorgestrel has little or no effect on post-fertilization events. In other words, given the limitations of scientific certitude, they suggest that Plan B, when administered once, is not an abortifacient. These human studies correlate well with earlier findings in rodents and monkeys that convincingly showed that the postcoital administration of levonorgestrel in amounts several times higher than typical doses given to women does not interfere with the post-fertilization processes required for mammalian embryo implantation. The evidence also addresses what until now has been a nagging, unanswerable question for pharmacologists: Why would levonorgestrel, a progesterone agonist that mimics the effect of progesterone, prevent implantation, when progesterone produced from the corpus luteum immediately after ovulation actually promotes implantation by converting the endometrium to deciduas? Answer: It does not.⁴

Several months later in the Autumn 2008 issue of the quarterly, responding to his critics, Fr. Austriaco offered an even more detailed argument in support of his conclusion.⁵ If Plan B is abortifacient, the author observes, it can have this effect in three primary ways. The first is by increasing the rate of ectopic pregnancies. However, he notes that the “combined data from five clinical trials with nearly six thousand women showed that the rate of ectopic pregnancies in women who have used Plan B is 1.02 percent as compared to the overall national ectopic pregnancy rate between 1.24 percent and 1.97 percent. In light of this finding, it is unlikely that Plan B increases the ectopic pregnancy rate … .”⁶

The second way in which Plan B could be abortifacient is by preventing implantation of an embryo. Fr. Austriaco noted that there are three ways in which this could occur. One is by altering the lining of the endometrium, making it inhospitable to implantation. “[M]orphological and biochemical analyses of endometrial biopsies of women who had taken Plan B eight or nine days prior to the biopsy have revealed that the drug does not dramatically alter the structures of this tissue. This suggests that the drug does not compromise endometrial development.”⁷

Another way in which the drug could make the endometrium inhospitable is by disrupting the function of the corpus luteum which releases hormones that are necessary for the proper development of the endometrium, including making it receptive to an embryo. After reviewing the scientific literature, Fr. Austriaco concluded that “[T]ogether, these data suggest that the risk of a post-fertilization effect from this mode of action for any particular individual woman, if it is real, would be vanishingly small.”⁸

The final manner in which Plan B could prevent implantation is by directly interfering with the implantation process itself. Fr. Austriaco replied: “[O]ne study that directly tested the ability of human embryos to implant on endometrial tissue exposed to LNG — though grossly immoral — does not support this mode of action for Plan B.”⁹ Two other recent studies confirm this conclusion.¹⁰

A third way in which Plan B could be abortifacient is by destroying an already implanted embryo. With regard to this possibility, Fr. Austriaco wrote: “[A] report from the FDA shows that Plan B does not increase the rate of pregnancy loss or the frequency of fetal abnormalities once a pregnancy has been established.”¹¹

Fr. Austriaco concluded his article: “[I] stand by my earlier conclusion: In light of the available scientific evidence and given the inherent limitations of the studies, it is unlikely that Plan B is an abortifacient.”¹²

What about the manufacturer’s label which claims that one of the drug’s mechanisms of action is to prevent implantation of a fertilized egg? Many appeal to the manufacturer’s label in their arguments against the use of Plan B. In Fr. Austriaco’s judgment, “labels mean nothing without the scientific data to back up their claims.”¹³

MORAL CERTITUDE, NOT ABSOLUTE CERTITUDE
While the preponderance of scientific evidence strongly suggests that Plan B does not have an abortifacient effect, the evidence stops short of providing absolute certitude. But is absolute certitude needed?

In the Catholic moral tradition, what is required of an agent when he or she makes a moral judgment is that he or she have moral certitude about the correctness of the action. In the words of Thomas Slater, SJ, author of a manual of moral theology: “In order to act lawfully and rightly, I must have at least moral certainty of the imperfect kind that the proposed action is honest and right. This degree of certainty will be sufficient, for ordinarily no greater can be had, as we have just seen. It is also required for right action; for if I am not at least to this extent morally certain that my action is right, I am conscious that it may be wrong.”¹⁴

What is meant by moral certitude? Moral certitude means that the agent has excluded all reasonable possibility of error. It stands between mere probability, where alternative opinions are equally plausible, and absolute certainty, where any theoretical possibility of error is not only excluded, but is impossible. Again, in the words of Fr. Slater:

Certainty in general is a firm assent of the mind to something known, without the fear of mistake. In mathematics and in other branches of exact science we can often attain absolute certainty, which rests on the evident truth of the principles which are employed to arrive at it. … In the science of morality we have frequently to be content with a lower degree of certainty than this; there is often some obscurity about the principles to be applied, and human acts are not the matter of necessary and unvarying law. We have to be content with what is called moral certainty. … I may be conscious that mistake is possible but not probable, as when a man has been condemned on evidence which has satisfied a jury of intelligent men. In such cases if there can be no prudent doubt about the justice of the verdict I have moral certainty of an imperfect but real kind. … Ordinarily greater certainty cannot be obtained in human affairs. … If I have this imperfect moral certainty that my action is right, I am justified in acting … .”¹⁵

How does moral certitude play out with regard to emergency contraception, and Plan B in particular? The first consideration deals with Plan B’s mechanism of action. Is there sufficient moral certitude that Plan B is not abortifacient? In other words, do the results of scientific research on how Plan B works rise to the level of moral certitude? Given the mounting evidence from the scientific literature that Plan B does not prevent implantation, there does seem to be moral certitude, of the imperfect kind, about the mechanism of action. It is, of course, theoretically possible that all of the studies that have been done could be mistaken, but this is not likely. Hence, if these scientific studies are correct, then Plan B is consistent with Directive 36 which states that a woman who has been sexually assaulted may be “treated with medications that would prevent ovulation, sperm capacitation, or fertilization.”¹⁶ Thus its use would not be prohibited by what follows in Directive 36: “It is not permissible, however, to initiate or to recommend treatments that have as their purpose or direct effect the removal, destruction, or interference with the implantation of a fertilized ovum.”¹⁷ Targeting implantation is not the purpose or direct effect of Plan B. Rather, its purpose and direct effect is to interfere with ovulation.

Second, is there moral certitude that a fertilized ovum will not be destroyed? Some argue that in order for moral certitude to be present, the woman who has been sexually assaulted must undergo an ovulation test to ensure that she is not at or around the time of ovulation such that she could become pregnant from the rape. For example, one advocate of ovulation testing says: “[C]atholic hospitals must have moral certitude that the possibility of an abortion is excluded. The ovulation test provides this certainty. … Therefore, moral certitude can be achieved only through the administration of the [luteinizing hormone] test. To administer emergency contraception when there is insufficient information as to its effect on the specific patient in question is not only morally illicit but medically unsound.”¹⁸

Given what has been said about Plan B’s mechanism of action, such testing is not required to achieve moral certitude. Furthermore, moral certitude in these situations is strengthened by the fact that the incidence of a pregnancy after rape is between <1 percent and 5 percent. Typically the estimate is put at about 3 percent.¹⁹ Given the scientific evidence regarding Plan B’s mechanism of action and the high probability that there is no fertilized egg present subsequent to the sexual assault, the requisite moral certitude exists that a fertilized ovum would not be destroyed by the administration of Plan B.

Finally, it is generally maintained in textbooks of moral theology that when human life is involved, one should always take the safer course. This is sometimes illustrated by the example of the hunter in the woods who sees movement behind bushes. Is the hunter free to shoot, believing that the movement results from a deer? The response in the manuals is no, because the movement could be caused by another hunter. Unless the hunter can resolve his doubt, the hunter must take the safer course and not shoot. This example might suggest that Catholic hospitals must not use emergency contraceptive medications at all in the belief that they might have an abortifacient effect — or, at least, that hospital personnel do as much as they can to reduce the possibility there might be an egg present that could be or might have been fertilized. They would do this by testing for ovulation.

In the situation under consideration, if there were a likelihood that a fertilized egg were present and if there were a likelihood that Plan B has an abortifacient effect, then the example and the obligation to take the safer course would be applicable. However, neither of these conditions is the case, because there is virtually no evidence that Plan B is abortifacient and, in cases of sexual assault, there is a very high probability that there is no fertilized egg present.²⁰ Hence, there does not seem to be an obligation to take the safer course. If one were obliged to take the safer course in these situations, in order to be consistent, one would also have to take the safer course in many of life’s other activities (e.g., driving one’s car, flying in a plane) as well as in the practice of medicine generally (e.g., agreeing to a surgery with a 25 percent risk of dying, undergoing chemotherapy that could have a lethal effect).

The administration of emergency contraception to women who have been sexually assaulted is a matter of utmost seriousness since it touches on human life. It is also a matter of utmost seriousness because it touches on the well-being of women who have been subjected to one of the most heinous of crimes. Any decision about whether or not to permit the dispensing of emergency contraceptive medications in Catholic hospitals and about the protocols for their administration has profound consequences.

Those who make such decisions, whether bishops, hospital executives, emergency room physicians, nurses or others, have a grave moral obligation to take seriously one of the first rules in making good ethical judgments, namely, to obtain adequate and accurate information about the matter at hand. To do any less is not only to shortchange the moral process, but also to risk significant harm to others. And once the best possible information is obtained, those making the decisions need to keep in mind that the use of emergency contraception for women who have been sexually assaulted is a matter about which moral certitude is sufficient. Given what is currently known about Plan B from scientific research, Catholic hospitals can respond with sensitivity, compassion and assistance to women who have been raped and are in need of care, while being confident that they are also remaining true to Catholicism’s fundamental commitment to respect for human life.

NOTES

1. If ovulation testing determines that the woman is at or around the time of ovulation, generally emergency contraception would not be administered out of concern that a possible abortifacient effect of the medication could result in the loss of an embryo.
2. Pontifical Academy for Life, “Statement on the So-Called ‘Morning-After Pill,’” (October 31, 2000), http://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/
   rc_pa_acdlife_doc_20001031_pillola-giorno-dopo_en.html
3. For information about the mechanism of action of emergency contraceptive medications generally: www.chausa.org/ECmedicationsReview; for information about Plan B’s mechanism of action: www.chausa.org/LevonorgestrelReview.
4. Nicanor Pier Giorgio Austriaco, “Is Plan B Abortifacient? A Critical Look at the Scientific Evidence,” The National Catholic Bioethics Quarterly 7, no. 4 (Winter 2007): 707.
5. Nicanor Pier Georgio Austriaco, “Colloquy: More on Plan B — Fr. Austriaco Replies,” The National Catholic Bioethics Quarterly 8, no. 3 (Winter 2008): 421-25.
6. Austriaco, 422.
7. Austriaco.
8. Austriaco, 423.
9. Austriaco.
10. Chun-Xia Meng et al., “Effect of Levonorgestrel and Mifepristone on Endometrial Receptivity Markers in a Three-Dimensional Human Endometrial Cell Culture Model,” Fertility and Sterility 91, no. 1 (2009): 256-64; Natalia Novikova et al., “Effectiveness of Levonorgestrel Emergency Contraception Given Before or After Ovulation: A Pilot Study,” Contraception 75, no. 2 (2007): 112-18. The immoral, but important study to which Austriaco refers is P.G.L. Lalitkumar et al., “Mifepristone, But Not Levonorgestrel, Inhibits Human Blastocyst Attachment to an In Vitro Endometrial Three-Dimensional Cell Culture Model,” Human Reproduction 22, no. 11 (2007): 3031-37.
11. Austriaco.
12. Austriaco, 424.
13. Austriaco, “Is Plan B Abortifacient?”, 707.
14. Thomas Slater, SJ, A Manual of Moral Theology, (New York: Benziger Brothers, 1925), 1:31.
15. Slater, 1:31-32.
16. United States Conference of Catholic Bishops, The Ethical and Religious Directives for Catholic Health Care Services, (Washington, D.C.: USCCB, 2001), Directive 36.
17. United States Conference of Catholic Bishops.
18. Marie Hilliard, “Dignitas Personae and Emergency Contraception,” Ethics and Medics 34, no. 2 (February 2009): 4.
19. Melisa M. Holmes, et al., “Rape-Related Pregnancy: Estimates and Descriptive Characteristics from a National Sample of Women,” American Journal of Obstetrics and Gynecology 175 (August 1996): 320.
20. Gerald McShane, et al., “Pregnancy Prevention after Sexual Assault,” in Peter Cataldo and Albert Moraczewski, eds., Catholic Health Care Ethics: A Manual for Ethics Committees, (Boston: The National Catholic Bioethics Center, 2001), 11, 16-17.

RON HAMEL is senior director, ethics, Catholic Health Association, St. Louis. Write to him at rhamel@chausa.org.

?One night late last year, Jason Melbourne walked into a CVS pharmacy in Mesquite, hoping against hope to walk out with an emergency contraceptive, or “the morning-after pill.” It wasn’t the morning after. He and his wife had their “accident” a few days before, and the 72-hour window in which EC is most effective was closing fast. The first four pharmacies he visited had told him they were out of stock.

He was finally referred to a CVS in Mesquite, some 15 miles away. They told him they had just one box left. But when he finally got there, the overnight pharmacist, Minni Matthew, told Melbourne she wasn’t going to sell it to him.

In order for him to buy the meds, the pharmacist said, she’d need to talk to and see the ID of his wife, who was at home with their two young children. He asked why, and she pointed to the fine print on the medication’s box, which says it can only be sold to someone age 17 or older. Melbourne pointed out that he was well over 17.

“I’ve bought this plenty of times in my life, and it’s never been a problem,” he said. “Are you telling me every other place I’ve bought it from has been wrong?”

Didn’t matter, Matthew said, since the medicine obviously wasn’t for him.

“Why don’t you show me the law that says you can’t sell this to a man?” Melbourne replied.

Things devolved from there. Melbourne Googled emergency contraception on his phone and confirmed that there was no law against selling the product to a man. He tried to show his phone to the pharmacist, he says, “but she didn’t want to see it.”

“You’re the only person who has it in the city, and I’ve driven 15 miles to get here,” Melbourne recalls telling her. “My wife is home with our 4-year-old and newborn son. She’s breastfeeding. She can’t drag my infant child out of the house and down here just to satisfy you.”

At that point, Melbourne says, Matthew retreated behind the counter. He shouted after her, “You got a pillow, Minni? Because I’ll be here all night. I’m not going anywhere until you show me a law against selling this to men.”

A pharmacy technician, who gave his name only as “Robert,” jumped in. He let Melbourne know that they don’t sell emergency contraception to men because they might be giving it to “rape victims.”

By then, Melbourne says, he was starting to “freak out.”

“I’m standing in line trying to get something that’s already a little controversial, a little embarrassing,” he says. “It’s for my wife. There are three customers behind me when the guy says that, so it looks like I’m a piece of shit now.”

Matthew then tried to tell Melbourne that the real reason he couldn’t buy the drug was because it was Plan B, the brand name, and that previously he’d always bought the generic version of the drug.

“What does this have to do with anything? It’s the same drug,” Melbourne, a full-time student who happens to be entering nursing school in the fall, shot back. He called his wife and put her on the phone with the pharmacist, but that wasn’t enough. Melbourne then asked for Matthew to call her supervisor, but the supervisor said no, too. At that point, Melbourne’s wife called a nearby Walgreen’s, who agreed to sell him the medicine. Melbourne went there, bought it, then promptly filed a complaint with the ACLU for gender discrimination.

Lisa Graybill, the legal director at ACLU of Texas, says that while denying emergency contraception to a man isn’t technically illegal, “it’s my understanding it’s contrary to the FDA guidelines. They say the medication is available to people over the ages of 17.”

Graybill says that refusing to sell EC to men on the grounds they may give it to minors is “misguided,” as she put it after a polite, diplomatic pause. “I’m not aware of a single case of a man reportedly buying it to push on his underage pedophile victim,” she says. She’s also not aware of men buying EC to force on people they’ve just raped.

“I don’t know where these ideas comes from,” she says. “I’m not telling you there’s never a case that that’s happened, but I’m not aware of any. That’s a sensational story that would get coverage if someone was criminally accused of doing that.”

The ACLU’s been down this road before. They received reports in July of 2010 that Walgreens stores in Texas, Mississippi and Oklahoma were refusing to sell EC to men. The ACLU called Walgreens out publicly, which seemed to solve the problem.

In an email, CVS spokesman Mike DeAngelis insisted to Unfair Park that they’ve already responded to the incident and appropriately briefed their stores on official company policy.

“CVS/pharmacy’s policy is to follow FDA regulations for the sale of emergency contraception, which allows this product to be sold without a prescription to customers who are at least 17 years old, regardless of gender,” he wrote. “It is our pharmacists’ responsibility to ensure that all customer needs are promptly and completely satisfied. As such, there is no company policy that prevents the sale of emergency contraception to a male customer.”

But DeAngelis was referring to a similar incident in Houston, which he called “isolated.” We told him that actually we were talking about incident in Mesquite. We also informed DeAngelis that we’d spoken with Angela Soto, the store manager of that particular Mesquite CVS. Though she wasn’t specifically aware of the incident with Melbourne, she confirmed to us that as she understood it, it’s “store policy” not to sell EC to men, “because we have to prove that whoever we sell it to is not any minor person.”

We pointed out that Melbourne was over 17. “Well, that’s the issue,” she replied. “We don’t know who he’s going to give it to.” She said she had also heard that “other stores” won’t sell EC to men on the grounds they may give it to women they’ve just raped.

“Those statements are contrary to our company policy,” DeAngelis said when we relayed the manager’s response. He said the company would look into it.

“I’m outraged,” Melbourne says. “I chased this thing all over town, then I get accused of using this for rape, even after they’ve talked to my wife on the phone. It makes me feel like a piece of crap.”

Graybill says that she “won’t contest” that the store’s policy, however logically shaky, may come from “a place of genuine concern” about underage girls. But ultimately, she says, “I think there’s just a gap in communication from corporate to the people on the line.”

“I really want them to be educated,” Melbourne says. “I’m tired of having to tell a pharmacist who’s in charge of a lot more drugs than that one what she can sell. They need to get it right. They need to do some follow up training. I don’t want this crap happening to me again, or to someone else.”

Today (Friday, January 6th), the President’s Council on Science and
Technology will hold its bi-monthly meeting, and 5 representatives from
different sectors of the reproductive health community will address the
Council during the public comment period at 1:30. The speakers will be:

* Dr. Francesca Grifo, Program Director of the Union of
Concerned Scientists Scientific Integrity Program

* Dr. Susan Wood, Associate Professor at the Jacobs Institute of
Women’s Health, George Washington University School of Public Health and
Health Service

* Mr. Wayne Shields, President and CEO of the Association of
Reproductive Health Professionals

* Dr. Doug Laube, MD, Obstetrician and Gynecologist; Board Chair
of the Physicians for Reproductive Choice and Health

* Ms. Kelly Cleland, MPA, MPH, Executive Director of the
American Society for Emergency Contraception; Research Staff at the
Office of Population Research at Princeton University

If you’re interested in watching a webcast of the meeting tomorrow,
click here. Each
speaker only has 2 minutes, so hopefully we will succeed in getting the
attention of the Council (and the President) in that brief amount of
time.

      Family Planning Health Services (FPHS) administers a statewide emergency contraception (EC) hotline which provides Plan B One Step ™ to women in need. Lon Newman, FPHS executive director, commented on the decision: “I am surprised by this administration’s willingness to divorce drug policy from medical evidence, but my response, is grim determination. I am not angry and I am not discouraged.”

     Newman explained that the statewide hotline (866-EC-FIRST or 866-323-4778) makes Plan B One Step ™ easily accessible by giving women access to prescribing clinicians and helping them find the fastest and the best no-cost or low-cost delivery in their area.  “It is important that people are aware of access to Plan B One Step ™ provided in Wisconsin with the Hotline,” explained Newman. “We want people to have swift access to this medication to help prevent unintended pregnancies. Mistakes can happen. We want people to know they have safe and sound options to help prevent an unintended pregnancy.”  National publicity has focused on the policy and controversy, and that may leave women ill-informed or misinformed. Newman gave examples of important points that Wisconsin women of reproductive age should know:

• Plan B – One Step ™ is available and accessible to all women at risk of unintended pregnancy through the statewide network of family planning providers, all of which

provide EC at low or no cost. The EC Hotline 866-EC-FIRST is able to connect people quickly to medication and resources in their area. Plan B One Step ™ remains available to women ages 17 and older over-the-counter.

• There is no medical evidence to support the claim that Plan B One Step ™ prevents implantation of a fertilized egg and it does not disrupt an existing pregnancy.(Source:  Contraception Volume 84, Issue 5 , Pages 486-492, November 2011)

There is a great deal of misinformation about this – often from otherwise reliable sources – and this mistaken belief is the reason many women of religious faith are uncertain about whether they should take Plan B One Step ™.

     Newman said that there has been a reduction in the unintended pregnancy rate among FPHS patients over the past six years. “Birth control methods have improved over the past few years and our ability to provide them has improved, but the major difference in our protocols has been the provision of EC in advance of need to our patients.  I believe that EC has prevented almost 200 unintended pregnancies and more than 75 abortions every year since 2006.”

     Newman, when asked about the broader repercussions of Secretary Sebelius’ decision, said that he fears it may foreshadow a separation between the Women’s Health preventive services recommendations of the Institute of Medicine and the Obama administration’s policy for the Affordable Care Act (which makes contraception available through insurance without co-pays or deductibles). “This administration has pledged to base policy on best medical evidence. The public must tell them that it’s time to prove it.”

“I regret that HHS has stepped in and overridden the FDA’s long-overdue decision to remove the unnecessary age restriction on Plan B One-Step emergency contraception,” said Rep. Gwen Moore. “The FDA’s proposal would have meant that emergency contraception would be brought out from behind the pharmacy counter, onto the shelves with other similar contraceptive methods. Medical experts, including the American Academy of Pediatrics, agree that Plan B is perfectly safe for over-the-counter use for anyone at risk of an unintended pregnancy, including younger women. I fervently hope that HHS is not putting politics or ideology over science in their decision.” 

Plan B One-Step is a safe and effective emergency contraceptive that is meant to be taken within 72 hours after contraceptive failure or unprotected intercourse. Plan B prevents fertilization from happening, and does not work if the woman is already pregnant.

“I thought we could all agree on the importance preventing unintended pregnancy, especially among teenagers,” said Rep. Moore. For the past few years, my home city of Milwaukee has worked very hard to reduce our epidemic teen birth rate. We’ve seen a 15% drop since 2005, when our teen birth rate was second in the nation only to Baltimore. But we still have a long way to go. A recent study released by United Way of Greater Milwaukee showed that statutory rape is among our biggest challenges to reducing teen pregnancy. Seventy-one percent of babies born to Milwaukee’s teenage girls were fathered by men at least 20 years of age. These pregnancies have serious consequences not only for these young women—who often experience tremendous isolation and vulnerability—but for their communities at large. Decisions like the one made today by HHS will only exacerbate the problem in places like Milwaukee.”

Plan B One-Step is a single-dose pill (1.5 mg levonorgestrel tablet) which is effective in decreasing the chance of pregnancy if taken within 3 days after unprotected sexual intercourse.  The product contains higher levels of a hormone found in some types of daily use oral hormonal contraceptive pills and works in a similar way to birth control pills.

Plan B One-Step was originally approved in July 2009 for use without a prescription for females age 17 and older and as a prescription-only option for females younger than age 17.  In February 2011, Teva Women’s Health Inc. submitted a supplemental application seeking to remove the prescription-only status for females younger than age 17 and to make Plan B One-Step nonprescription for all females of child-bearing potential.

The Center for Drug Evaluation and Research (CDER) completed its review of the Plan B One-Step application and laid out its scientific determination. CDER carefully considered whether younger females were able to understand how to use Plan B One-Step.  Based on the information submitted to the agency, CDER determined that the product was safe and effective in adolescent females, that adolescent females understood the product was not for routine use, and that the product would not protect them against sexually transmitted diseases. Additionally, the data supported a finding that adolescent females could use Plan B One-Step properly without the intervention of a healthcare provider.

It is our responsibility at FDA to approve drugs that are safe and effective for their intended use based on the scientific evidence.  The review process used by CDER to analyze the data applied a risk/benefit assessment consistent with its standard drug review process.  Our decision-making reflects a body of scientific findings, input from external scientific advisory committees, and data contained in the application that included studies designed specifically to address the regulatory standards for nonprescription drugs.  CDER experts, including obstetrician/gynecologists and pediatricians, reviewed the totality of the data and agreed that it met the regulatory standard for a nonprescription drug and that Plan B One-Step should be approved for all females of child-bearing potential.

I reviewed and thoughtfully considered the data, clinical information, and analysis provided by CDER, and I agree with the Center that there is adequate and reasonable, well-supported, and science-based evidence that Plan B One-Step is safe and effective and should be approved for nonprescription use for all females of child-bearing potential.

However, this morning I received a memorandum from the Secretary of Health and Human Services invoking her authority under the Federal Food, Drug, and Cosmetic Act to execute its provisions and stating that she does not agree with the Agency’s decision to allow the marketing of Plan B One-Step nonprescription for all females of child-bearing potential.   Because of her disagreement with FDA’s determination, the Secretary has directed me to issue a complete response letter, which means that the supplement for nonprescription use in females under the age of 17 is not approved.  Following Secretary Sebelius’s direction, FDA sent the complete response letter to Teva today.  Plan B One-Step will remain on the market and will remain available for all ages, but a prescription will continue to be required for females under the age of 17.

“We are thrilled that Teva Pharmaceuticals has submitted an application to the Food and Drug Administration (FDA) to remove the over-the-counter age restriction on its emergency contraceptive product, Plan B One-Step.

“Medical evidence shows that Plan B One-Step is a safe and effective back-up contraceptive option for women of all ages. There is no medical or scientific rationale for age restrictions on emergency contraception.  Although FDA’s request for new data from the company before removing the age restriction was unwarranted and unnecessary, we hope the FDA finally has all the information it needs to make a decision and will use this opportunity to confirm their commitment to public health and scientific integrity.

“Things don’t always work out as planned. Timely access to an effective backup method of contraception will give more women the chance to prevent an unintended pregnancy.”

Statement by Susan Wood, Associate Professor at the School of Public Health and Health Services at George Washington University, and Board member of the Reproductive Health Technologies Project:

“During the original review process for Plan B to go over-the-counter, the FDA reviewers repeatedly indicated that there was no medical or scientific need for new data on younger teens.  While it is good news that the FDA is now reviewing an application for removing the age restriction on over-the-counter Plan B One-Step, I hope this process does not set a precedent at the FDA for new data as a condition of approval for OTC access by teens under 17.  In addition to limiting the access for younger teens to emergency contraception, this approach could have unintended consequences, if FDA is setting out new data requirements for all OTC products used by teens.”

Background: Emergency contraception is a safe, effective back-up method of birth control that can prevent pregnancy in the first few days after unprotected sex or contraceptive failure. Current emergency contraceptive products on the market are dual labeled Plan B® One-Step and a Plan B generic, Next Choice®, as well as recently approved prescription product, ella®.

For more information about emergency contraception, please visit http://www.rhtp.org/contraception/emergency/default.asp

Authors

Kelly Cleland, MPA MPH, Elizabeth Raymond, MD MPH, James Trussell, PhD, Linan Cheng, MD, Haoping Zhu, MD

Précis

The rate of ectopic pregnancy when treatment with emergency contraceptive pills fails does not exceed the rate observed in the general population.

Abstract

Objective: The safety of emergency contraceptive pills has been extensively studied and confirmed, yet some concerns remain about whether their use increases the risk of ectopic pregnancy when treatment fails. The rate of ectopic pregnancy in the general population is estimated to range between 0.8% and 2% of all reported pregnancies. The objective of this study was to evaluate the existing data to estimate the rate of ectopic pregnancy among emergency contraceptive pill treatment failures.

Data Sources: Our initial reference list was generated from a 2008 Cochrane review of emergency contraception. In August 2009, we searched Biosys Previews, the Cochrane Database of Systematic Reviews, Medline, Global Health Database, Health Source,, Popline, and Wanfang Data (a Chinese database).

Methods of Study Selection: This study included data from 136 studies which followed a defined population of women treated one time with emergency contraceptive pills (either mifepristone or levonorgestrel), and in which the number and location of pregnancies were ascertained.

Results: Data from each article were abstracted independently by two reviewers. In the studies of mifepristone, 3 out of 494 (0.6%) pregnancies were ectopic; in the levonorgestrel studies, 3 out of 307 (1%) were ectopic.

Conclusion: The rate of ectopic pregnancy when treatment with emergency contraceptive pills fails does not exceed the rate observed in the general population. Because emergency contraceptive pills are effective in lowering the risk of pregnancy, their use should reduce the chance that an act of intercourse will result in ectopic pregnancy.

At least 36% of all pregnancies worldwide are unintended (1). In the event of contraceptive mishap or non-use, or nonconsensual intercourse, emergency contraceptive pills provide women with a means of preventing unintended pregnancy after sex. Emergency contraceptive pills have been shown to be safe, effective and well-tolerated; according to the World Health Organization’s Medical Eligibility Criteria, the benefits of their use always outweigh the medical risks (2).

The safety of emergency contraceptive pills has been extensively studied and is well-established (3). However, concern persists about whether their use increases the risk of ectopic pregnancy should treatment fail. This issue was first raised in New Zealand. Based on case reports of three ectopic pregnancies following use of levonorgestrel-only emergency contraceptive pills, the New Zealand Medicines and Medical devices Safety Authority warned in 2002 that “the possibility of an ectopic pregnancy should be considered” (4) if a pregnancy test is positive following use of levonorgestrel emergency contraceptive pills. In an editorial published a year later, the authors noted that 12 ectopic pregnancies in women who used levonorgestrel emergency contraceptive pills had been reported in the United Kingdom and that a handful of additional cases had been reported in other countries (5). As the authors acknowledge, this information cannot be used to calculate the probability that a pregnancy occurring after use of the treatment will be ectopic because the total number of pregnancies needed for the denominator of the calculation is unknown. Nevertheless, based on these case reports, Britain’s Committee on Safety of Medicines also advised that if a woman who has used progestin-only emergency contraceptive pills becomes pregnant, “the possibility of an ectopic pregnancy should be considered” (6). Recent published case reports cite ectopic pregnancy as a known risk of using levonorgestrel emergency contraceptive pills (7,8). Several patient information websites, including one provided by the United States National Library of Medicine and National Institutes of Health, currently note a potential link between use of emergency contraceptive pills and ectopic pregnancy (9-12). In addition, the patient labeling information in Ireland for NorLevo (manufactured by Cardinal Health France), a dedicated levonorgestrel emergency contraceptive pill, lists previous ectopic pregnancy as a contraindication (13).

Among women who have not used emergency contraceptive pills, the chance that a pregnancy will be ectopic has been estimated at 0.8% to 2% of all reported pregnancies (14-20). This range likely reflects differences in how rates are calculated and reported (21) as well as true variation in incidence among populations. Ectopic pregnancy is a potentially life-threatening condition, and accurate assessment of its risk factors is an important step in helping clinicians, public health professionals and pharmaceutical regulatory bodies generate optimal guidelines for women’s health.

Our prior review of 5 prospective efficacy trials of levonorgestrel-only emergency contraceptive pills suggested that the risk of ectopic pregnancy when that regimen fails is unlikely to be raised (22). Here we update that report with an additional 131 studies, including trials of emergency contraceptive regimens containing mifepristone as well as trials of levonorgestrel-only emergency contraceptive pills. These drugs are the active agents in most currently marketed dedicated emergency contraceptive products worldwide.

Sources

Our initial reference list was generated from a 2008 Cochrane review of emergency contraception (23). To ensure completeness and timeliness, we identified relevant studies by conducting computerized literature searches using the following databases and search terms:

• BIOSYS PREVIEWS: (CC=(Pharmacology – Reproductive system OR Reproductive system – Physiology “and” biochemistry OR Reproductive system – General “and” methods) AND MC=(Reproduction OR Gynecology OR Oncology) AND PY=(2004 OR 2005 OR 2006 OR 2007 OR 2008 OR 2009) AND TS=(postcoit* or post-coit* or emergenc* same contracept* or morning same after or ru-486 or mifepristone or levonorgestrel or ulipristal or cbd-2914 or cdb2914) AND TA=(Hominidae)
• COCHRANE DATABASE: (Topic: Fertility Regulation, Emergency Contraception)
• MEDLINE: ((MH “Contraceptives, Postcoital”) not PT case report not PT comment not PT editorial not PT review; date of Publication from: 200401-201012; English Language; Human)
• GLOBAL HEALTH: (emergency contracept* OR postcoit* contracept*)
• HEALTH SOURCE: (emergency contracept* OR postcoit* contracept*)
• POPLINE: (emergency contracept*) & (ru-486 / mifepristone / levonorgestrel / ulipristal / cbd-2914 / cdb2914)
• WANFANG DATA (Chinese): (emergency contraception, mifepristone, levonorgestrel)

Study Selection

Our review included any study published by August 2009 in English or Chinese with a defined population of women whom investigators treated one time with either levonorgestrel or mifepristone alone for emergency contraception, and in which the number and location of pregnancies were ascertained. We also included one large study with a levonorgestrel arm which we knew to have been completed by August 2009, but which was not published until February 2010. We did not include advance provision studies (in which emergency contraceptive pills are dispensed to study subjects in anticipation of future need) or repeat use studies. We did not include the newly-approved emergency contraceptive pill ulipristal acetate, which has been marketed in Europe since October 2009, as only three studies of this regimen had been published at the time of writing. We excluded studies of emergency contraceptive regimens containing both estrogen and progestin, as this regimen is now increasingly being replaced by the levonorgestrel-only regimen, and we also excluded studies of other combinations of drugs.

After appropriate studies were identified, data from each article were abstracted independently by two reviewers. If the study report did not explicitly state whether each pregnancy was intrauterine or ectopic, we contacted the authors to obtain this information. Each author whom we contacted responded to our queries, so we did not find it necessary to exclude any studies from the analysis based on missing information. We excluded from our analyses all subjects who were believed by the authors to have been pregnant before treatment. Discrepancies were identified and reconciled after reviewers re-assessed the original data.

Results

Our search identified 137 studies that fit our criteria. We excluded one study from our analyses because it was designed to measure bleeding effects of emergency contraceptive pills and explicitly excluded women who became pregnant after treatment (24). Among the remaining 136 studies, 114 were published in Chinese (25-138) and 22 were published in English (139-160). Mifepristone in doses from 10 mg to 600 mg was the most commonly-studied regimen in our review (Table 1). One-third of the studies included a levonorgestrel-only regimen.

Of the included studies, 130 (95.6%) ascertained pregnancy by urine or serum hCG assay 7 to 10 days from the expected onset of menses (sensitivity level of tests was generally not specified), followed by ultrasound in the event of a positive test. One additional study specified that all pregnancies were confirmed to be intrauterine histologically after termination. These studies using high-certainty ascertainment methods (ultrasound or histology) contribute 716 (89.1%) of the pregnancies in this review, including all six ectopic pregnancies. For 85 (10.6%) pregnancies, the author did not specify how pregnancy location was determined, but stated (either in the paper or in follow-up communication with us) that the location was known to be intrauterine. In three cases (0.4% of all pregnancies), pregnancy location was classified as “unknown”, because the study authors were unable to designate whether the pregnancy was intrauterine or ectopic.

Among the mifepristone study subjects overall, 494 pregnancies of known location occurred after treatment, 3 of which were ectopic, resulting in an ectopic pregnancy rate of 0.6% (Table 2). Among the 307 pregnancies of known location occurring after treatment with levonorgestrel, 3 (1%) were ectopic. Results did not differ significantly between studies published in English and those published in Chinese for either regimen (for mifepristone studies, p-value for Fisher’s Exact test = 0.30; for levonorgestrel studies, p=1.00). A full table detailing results of each study is available from the authors upon request.

We performed a sensitivity analysis assuming that pregnancies of unknown location (two pregnancies following treatment with levonorgestrel and one following treatment with mifepristone) were ectopic. The proportion of pregnancies that were ectopic among levonorgestrel recipients was then 5/309, or 1.6% (95% CI = 0.6%-3.7%), and the proportion among those treated with mifepristone was then 4/495, or 0.8% (95% CI = 0.2%-2.1%).

Conclusion

Our results indicate that use of emergency contraceptive pills, in the two forms widely available today, does not increase the risk that a pregnancy following treatment will be ectopic. Available ectopic pregnancy rates range from 0.8% to 2% of all reported pregnancies; our study detected a range of 0.6% to 1.1%, depending on the medication used. Even when we analyzed the data under the most conservative possible scenario (assuming pregnancies of unknown location to be ectopic), we still found that the rate of ectopic pregnancy following use of levonorgestrel (1.6%) and mifepristone (0.8%) does not exceed the top of the range of rates of ectopic pregnancies among the general population. Indeed, the rate for mifepristone emergency contraceptive pills is at the bottom of that range.

In order to create as much consistency as possible across studies, we carefully considered our inclusion criteria in light of the data that were available to us from each study. We excluded pregnancies that were determined to have begun before emergency contraceptive pill treatment, but did not exclude those that may have begun after treatment had occurred as this information was not always reported. Some studies reported that subjects took additional doses of emergency contraceptive pills after the study treatment. However, because we did not have this information for every study, we did not exclude these subjects from our review.

Our review has several additional limitations. We could not include all women who were treated because some were lost to follow up, and unfortunately, we cannot assess the magnitude of this problem because not all studies reported the number of subjects who were lost. In addition, the exact methods used to ascertain the existence and location of pregnancy are not entirely consistent from study to study. While most studies stated that ultrasound or histological examination was used, this is not explicitly specified in every study. For 10.6% of pregnancies, we relied upon the authors’ assertion that the pregnancies were intrauterine. It is possible that ascertainment procedures vary from study to study, and that ectopic pregnancy is therefore under-diagnosed and underreported. Finally, we cannot be certain what the expected ectopic pregnancy rate would have been in the particular populations studied if subjects had not been treated with emergency contraceptive pills. We found it notable that two of the three ectopic pregnancies among the mifepristone recipients occurred in one study arm in which only six pregnancies were reported (151), but these pregnancies did not occur at the same study site and therefore do not in themselves raise particular concerns about differential ascertainment of pregnancy location.

Despite these limitations, this review provides the most comprehensive assessment to date of the risk of ectopic pregnancy when emergency contraceptive pill treatment fails. Based on our results, we conclude that no situations exist in which clinicians should counsel women against use of emergency contraceptive pills based solely on concerns about ectopic pregnancy. Likewise practitioners and women should have no heightened concern that if treatment fails, the pregnancy is more likely to be ectopic than a pregnancy occurring in the absence of emergency contraceptive pills. Previous studies show that emergency contraceptive pills reduce the likelihood that an act of intercourse will result in a pregnancy (3,23,161,162). Therefore, emergency contraceptive pills reduce the chance that an act of sexual intercourse will result in ectopic pregnancy.

The Ellertson Innovation in EC award was established by ASEC in honor of Charlotte Ellertson, one of ASEC’s founders, and is given to an individual or group that has made a bold move to expand access to EC in the past year.

In December 2009, Newman partnered with Young Catholics for Choice in a Wisconsin campaign to promote discussion of EC. The energy and efforts of the young women visiting Wisconsin communities showcased the issue for young Catholic women. Newman commented at the time “Our role in this partnership is to help patients come to an informed decision.  The role of Young Catholics for Choice is to help members of our community come to a balanced understanding of these controversial issues from a faith-based perspective.” The campaign enjoyed the full support of David Nolan, Communications Director of Catholics for Choice, who said; “There is a real need for Catholics and people of all faiths to be educated so they can make their own ethical decisions – in this case, about emergency contraception. We’re proud to work with FPHS to share our perspective with communities in Wisconsin.”

FPHS promotes EC through outreach, education, collaboration, policy work and the placement of EC Lockboxes in many communities coordinating with the statewide EC Hotline – 866-ECFIRST.

In acknowledgement of this prestigious award Newman said, “FPHS’ board of directors and our staff should take well-deserved credit for winning this very competitive award from a very dedicated group of people who are making the world a better place. We are teaching women that EC prevents unwanted pregnancies and we are making EC easily available. The beneficiaries of these efforts to provide accurate medical information and compassionate care are the families in our communities. “

The Ellertson Innovation in EC award is given annually to an individual or group that has made a bold move to expand access to EC. The award was established by the ASEC in honor of Charlotte Ellertson, one of the group’s founders. This year the award was given to PROMSEX (Center for the Promotion and Defense of Sexual and Reproductive Rights), a leading non-governmental organization fighting for access to EC in Peru, and to Lon Newman, the innovative Executive Director of Family Planning Health Services in Wisconsin. The recipients were publicly recognized at the ICEC and ASEC meeting and received a monetary award.

A new lifetime achievement award was awarded for the first time this year to honor the memory of Felicia Stewart, a lifelong reproductive health advocate. The Felicia Stewart Lifetime Achievement award was given to Francine Coeytaux, an innovative and widely-respected women’s health and reproductive health specialist who has worked to expand reproductive health and rights in the United States and globally.

The International Consortium for Emergency Contraception and the American Society for Emergency Contraception commend all three award winners for their important efforts to ensure access to EC in both the United States and around the world.

Catholics Call on Pope Benedict to Reconsider Vatican’s Ban on Contraceptive Pill

Fifty years ago this week, the US Food and Drug Administration approved the contraceptive pill. The man most prominently associated with the development and introduction of the pill, John Rock, was an Irish Catholic doctor from Boston. Dr. Rock didn’t set out to make waves with the Vatican; in fact, he was sure that his invention would gain approval from the Vatican and finally allow Catholics to practice safe and effective family planning. He was successful on both counts. Three different layers of a Vatican commission approved the pill back in 1965. But Pope Paul VI decided to ignore the findings of those panels and condemned Catholic women to a variety of unreliable methods if they were to follow the Vatican’s dictates. To this day, most Catholic women ignore the Vatican’s decree, and many millions of them have safer and more reliable family planning thanks to Dr. Rock’s pill.

The story of the pill’s genesis is a fascinating one. John Rock was an infertility expert who was a pioneer behind many modern methods of assisting couples to conceive. In the course of his work, he also met many fertile Catholic women who wanted to space the births of their children, and sometimes to avoid having children. The Vatican’s ban on artificial methods of contraception meant that they had to rely on so-called natural methods, when a couple can only have sexual intercourse during the time each month when a woman is infertile if they want to avoid pregnancy. This was unacceptable to many, unworkable for those who have unreliable cycles and impossible for women who could not negotiate their sexual relationship with their partners.

Rock, who worked with biologist Gregory Pincus to develop the pill, was convinced “that every couple should be able to choose freely the number of children they could afford — materially and emotionally — to bring into the world.”

Rock figured that he could invent a hormonal pill that suppressed ovulation and therefore extend the safe period for sex as long as a woman stayed on the pill. He reasoned that the Vatican would accept this, and Catholic women who did not want to go against the Vatican would be able to have a healthy sex life.

Contraception was an issue the Vatican had addressed before, and the advent of the pill raised new questions about Catholics and family planning. The Vatican had imposed a ban on “artificial” methods of contraception, such as condoms and diaphragms, in the1930 encyclical Casti Connubii. There was growing debate in the church about whether this ban should be continued, and if so, whether it should be broadened to include the new pill.

This was a huge issue for the Catholic church, and not long after the introduction of the pill, in 1963, Pope John XXIII convened a panel to study the matter. The papal commission on birth control was composed of bishops, priests and lay people, including married Catholic women. They considered Catholic theology, modern science and the lives that married Catholics lead. The commission voted overwhelmingly to recommend that the church rescind its ban on contraception. The pope, concerned that overturning the ban would call all of the hierarchy’s teachings into question, appointed a second commission, made up of 15 bishops, which also voted overwhelmingly to recommend that the church rescind its ban on contraception.

The results of these votes were leaked, and there was widespread rejoicing among Catholics. It was therefore a significant shock to Catholics — and indeed most of the world — when the encyclical Humanae Vitae was finally released by Pope Paul VI on July 29, 1968, proclaiming the teaching on contraception unchanged and unchangeable.

The pope had completely ignored the work and recommendations of his own commission, despite five meetings over three years and a vote by 30 of the 35 commission’s lay members, 15 of the 19 theologians and 9 of 12 bishops that the teaching be changed (three bishops abstained).

There is little need to reconvene a commission to study this issue. Not much has changed to negate the findings of the majority votes in the commission. Indeed, we have learned so much more about safe reproductive health that supports the real world application of the commission’s findings. It makes no sense to continue the Vatican’s wrong-headed approach to family planning. Even without the twin scourges of maternal mortality and HIV/AIDS, there are billions of good reasons to allow women to plan their families and to allow them to decide when and whether to have children: namely the 3.5 billion women in the world, of whom about 600 million are Catholic.

It would be a lasting and wholly positive legacy if the current pope got behind the majority report of the 1963-68 commission and lifted the ban on the use of contraceptives to allow Catholics to plan their families. Given the fact that today, in the United States, 97 percent of sexually active Catholic women above the age of 18 have used some form of contraception banned by the Vatican, it makes little sense to continue the ban. In fact, the ban does more harm to the Vatican and its teaching authority than would changing it.

Dr. Rock was a Catholic champion of women’s health. If the Vatican wants to regain some relevance and respect on this issue, it’s time to join him in his support for contraception.

Jon O’Brien is the president of Catholics for Choice

“A defender of the church,” proclaimed the Milwaukee Journal Sentinel headline for an extensive story about the new Archbishop-designate, Jerome Listecki. The subtitle for the article was: “Archbishop designate Listecki vows collaboration, but unafraid of debate.” The subtitle was probably derived from the bishop’s description of how he planned to participate in the political process. He said: “If we don’t challenge one another’s statements, then we’re relinquishing our responsibility to the common good.”

The following month, young Catholics for Choice (yCFC – a Washington D.C. based organization) and Family Planning Health Services (FPHS – an agency with family planning clinics in eight Wisconsin counties) formed a unique sectarian-secular advertising partnership, produced informational ads for broadcast, and then embarked on a two-day Wisconsin “road-trip” to draw media attention to their campaign and to build public (including the Catholic public) awareness and knowledge about emergency contraception.

The purpose of the joint media campaign was two-fold; 1) to inform the public about how Plan B works so they would have it on hand in advance of need and, 2) to inform Catholic women of reproductive age that the United States Conference of Catholic Bishops health care directives permit the use of emergency contraception to prevent pregnancies resulting from rape.

In the January 2010 issue of the Journal of the Catholic Health Association of the United States, Ron Hamel, Ph.D., makes it very clear that the ethics of access to emergency contraception for Catholics needs to be fully examined and explained. Professor Hamel’s article and the YCFC/FPHS EC campaign are an effort to fulfill that responsibility when there is significant resistance.

The campaign succeeded in getting a response from the Archbishop-designate and thus succeeded in its secondary purpose. The headline on the Christmas Eve edition of the La Crosse Diocesan newspaper is: “Bishop Rejects Young Catholics for Choice Message.” The front page column ran adjacent to the departing bishop’s message. But what he rejected so prominently: “ . . . that Catholics can disregard Church teaching on contraception, abortion, and human sexuality in general and remain Catholics in good standing,” was only weakly connected to the message that yCFC and Family Planning Health Services (FPHS) were promoting.

Bishop Listecki, like most of the Catholic protestors in front of the FPHS clinic, will allow “no room for interpretation,” once the bishop’s authority has been invoked. Many within the church see the bishop’s pattern of authoritarian rebukes, condemnations, and admonitions as futile efforts to suppress dissent and they understand they are not the views of other Catholics or even the other American bishops.  Just as importantly, the denials and condemnations are not solely inflicted on the faithful. The prayer vigil protestors’ and Bishop Listecki’s efforts to eliminate access to emergency contraception, if they succeed, would apply to women regardless of their faith.

Erik Cieslewicz and Brooke Sperry have produced a documentary about the joint campaign that will be released February 17^th, 2010.  The web-posting will occur on the same day that another Lenten prayer vigil outside an FPHS clinic (which does not provide abortion services) begins in central Wisconsin. The video shows the challenge as well as the fun of the effort to educate the public in the face of consistent efforts to suppress and to misinform. Earlier, “40 Days for Life” prayer vigils played a large part in motivating FPHS and yCFC to cooperate in the advertising effort to correct misinformation being spread by their opponents.

Enjoy the video!

The controversy over the use of emergency contraception in Catholic hospitals for victims of sexual assault continues to be played out in various forums — in the literature, state legislatures, pharmacies, professional groups, state Catholic conferences, dioceses and Catholic hospitals themselves.

At its heart is whether medications used for emergency contraception have an abortifacient effect, that is, whether they prevent the implantation of a fertilized egg by altering the lining of the endometrium. On the belief that they do have such an effect, some either object to or prohibit their use in Catholic hospitals or agree to their use only in conjunction with testing for ovulation to ascertain whether the woman is at or around the time of ovulation (and, therefore, could become pregnant).¹ Obviously, for women who have been subjected to a sexual assault and who seek assistance at a Catholic hospital, much hinges on accurately understanding how these hormonal medications work.

Unfortunately, such understanding is not always in play. In many instances, critics base their moral judgments on prevailing beliefs or assumptions about mechanisms of action that may be based on drug manufacturer labeling, or on outdated scientific literature, or on mere supposition. Researchers have been virtually certain that the drugs prevent or disrupt ovulation, but they have generally been uncertain about other possible effects on sperm, cervical mucus, the process of fertilization and on the endometrium. Yet manufacturers and others typically list these specific effects as possible mechanisms of action.

But are such beliefs and assumptions about emergency contraceptives accurate and adequate? This is a critical question, for women who have been sexually assaulted and for the Catholic hospitals that care for them.

One of the well-known truisms in ethics is that good moral judgments depend in part on good facts. Absent adequate and accurate information, there is an increased possibility of a faulty analysis and, therefore, of an erroneous judgment. In addition, the moral judgment itself might be seen to lack credibility either because its basis is unclear or because it seems to fly in the face of reputable data.

Take one example. In late February 2007, in a LifeSiteNews interview, Bishop Elio Sgreccia, the then-president of the Pontifical Academy for Life, reaffirmed the academy’s 2000 statement that the “morning-after pill” is abortifacient and that physicians and Catholic hospitals are prohibited from administering it, even in cases of sexual assault.² Unfortunately, the 2000 statement employed the generic term “morning-after pill,” which can refer to a variety of medications with different mechanisms of action, and the statement made no reference to scientific literature substantiating its claim that the pill is abortifacient. In addition, the comment in the 2007 interview seemed not to take account of recent scientific literature on how these medications work, particularly in the case of levonorgestrel, also known as Plan B, the current standard treatment for women who have been sexually assaulted. Yet after the interview, despite the lack of evidence, some described both the bishop’s comment and the Pontifical Academy’s statement as “authoritative.”

GOOD FACTS ARE NECESSARY FOR GOOD ETHICS
What, in fact, do we find if we look at the scientific literature on how Plan B, a progestin-only form of emergency contraception, works?

Over the past five years, CHA staff have collected, reviewed and summarized the great majority of articles on emergency contraceptive medications’ mechanisms of action — both for combination drugs (such as Preven) and Plan B.³ In addition, CHA obtained two independent analyses of the literature — one by an ob-gyn and the other by a pharmacist. The reviews concluded that virtually all of the evidence in the scientific literature indicates Plan B has little or no post-fertilization effect, that is, it has little or no effect on the endometrium that would make it inhospitable to implantation. Its mechanism of action is to disrupt ovulation.

In a thorough review of the scientific literature, Fr. Nicanor Pier Giorgio Austriaco, OP, Ph.D., a priest, theologian and scientist, wrote in the Winter 2007 issue of The National Catholic Bioethics Quarterly:

Studies published in the past few months provide mounting evidence that levonorgestrel has little or no effect on post-fertilization events. In other words, given the limitations of scientific certitude, they suggest that Plan B, when administered once, is not an abortifacient. These human studies correlate well with earlier findings in rodents and monkeys that convincingly showed that the postcoital administration of levonorgestrel in amounts several times higher than typical doses given to women does not interfere with the post-fertilization processes required for mammalian embryo implantation. The evidence also addresses what until now has been a nagging, unanswerable question for pharmacologists: Why would levonorgestrel, a progesterone agonist that mimics the effect of progesterone, prevent implantation, when progesterone produced from the corpus luteum immediately after ovulation actually promotes implantation by converting the endometrium to deciduas? Answer: It does not.⁴

Several months later in the Autumn 2008 issue of the quarterly, responding to his critics, Fr. Austriaco offered an even more detailed argument in support of his conclusion.⁵ If Plan B is abortifacient, the author observes, it can have this effect in three primary ways. The first is by increasing the rate of ectopic pregnancies. However, he notes that the “combined data from five clinical trials with nearly six thousand women showed that the rate of ectopic pregnancies in women who have used Plan B is 1.02 percent as compared to the overall national ectopic pregnancy rate between 1.24 percent and 1.97 percent. In light of this finding, it is unlikely that Plan B increases the ectopic pregnancy rate … .”⁶

The second way in which Plan B could be abortifacient is by preventing implantation of an embryo. Fr. Austriaco noted that there are three ways in which this could occur. One is by altering the lining of the endometrium, making it inhospitable to implantation. “[M]orphological and biochemical analyses of endometrial biopsies of women who had taken Plan B eight or nine days prior to the biopsy have revealed that the drug does not dramatically alter the structures of this tissue. This suggests that the drug does not compromise endometrial development.”⁷

Another way in which the drug could make the endometrium inhospitable is by disrupting the function of the corpus luteum which releases hormones that are necessary for the proper development of the endometrium, including making it receptive to an embryo. After reviewing the scientific literature, Fr. Austriaco concluded that “[T]ogether, these data suggest that the risk of a post-fertilization effect from this mode of action for any particular individual woman, if it is real, would be vanishingly small.”⁸

The final manner in which Plan B could prevent implantation is by directly interfering with the implantation process itself. Fr. Austriaco replied: “[O]ne study that directly tested the ability of human embryos to implant on endometrial tissue exposed to LNG — though grossly immoral — does not support this mode of action for Plan B.”⁹ Two other recent studies confirm this conclusion.¹⁰

A third way in which Plan B could be abortifacient is by destroying an already implanted embryo. With regard to this possibility, Fr. Austriaco wrote: “[A] report from the FDA shows that Plan B does not increase the rate of pregnancy loss or the frequency of fetal abnormalities once a pregnancy has been established.”¹¹

Fr. Austriaco concluded his article: “[I] stand by my earlier conclusion: In light of the available scientific evidence and given the inherent limitations of the studies, it is unlikely that Plan B is an abortifacient.”¹²

What about the manufacturer’s label which claims that one of the drug’s mechanisms of action is to prevent implantation of a fertilized egg? Many appeal to the manufacturer’s label in their arguments against the use of Plan B. In Fr. Austriaco’s judgment, “labels mean nothing without the scientific data to back up their claims.”¹³

MORAL CERTITUDE, NOT ABSOLUTE CERTITUDE
While the preponderance of scientific evidence strongly suggests that Plan B does not have an abortifacient effect, the evidence stops short of providing absolute certitude. But is absolute certitude needed?

In the Catholic moral tradition, what is required of an agent when he or she makes a moral judgment is that he or she have moral certitude about the correctness of the action. In the words of Thomas Slater, SJ, author of a manual of moral theology: “In order to act lawfully and rightly, I must have at least moral certainty of the imperfect kind that the proposed action is honest and right. This degree of certainty will be sufficient, for ordinarily no greater can be had, as we have just seen. It is also required for right action; for if I am not at least to this extent morally certain that my action is right, I am conscious that it may be wrong.”¹⁴

What is meant by moral certitude? Moral certitude means that the agent has excluded all reasonable possibility of error. It stands between mere probability, where alternative opinions are equally plausible, and absolute certainty, where any theoretical possibility of error is not only excluded, but is impossible. Again, in the words of Fr. Slater:

Certainty in general is a firm assent of the mind to something known, without the fear of mistake. In mathematics and in other branches of exact science we can often attain absolute certainty, which rests on the evident truth of the principles which are employed to arrive at it. … In the science of morality we have frequently to be content with a lower degree of certainty than this; there is often some obscurity about the principles to be applied, and human acts are not the matter of necessary and unvarying law. We have to be content with what is called moral certainty. … I may be conscious that mistake is possible but not probable, as when a man has been condemned on evidence which has satisfied a jury of intelligent men. In such cases if there can be no prudent doubt about the justice of the verdict I have moral certainty of an imperfect but real kind. … Ordinarily greater certainty cannot be obtained in human affairs. … If I have this imperfect moral certainty that my action is right, I am justified in acting … .”¹⁵

How does moral certitude play out with regard to emergency contraception, and Plan B in particular? The first consideration deals with Plan B’s mechanism of action. Is there sufficient moral certitude that Plan B is not abortifacient? In other words, do the results of scientific research on how Plan B works rise to the level of moral certitude? Given the mounting evidence from the scientific literature that Plan B does not prevent implantation, there does seem to be moral certitude, of the imperfect kind, about the mechanism of action. It is, of course, theoretically possible that all of the studies that have been done could be mistaken, but this is not likely. Hence, if these scientific studies are correct, then Plan B is consistent with Directive 36 which states that a woman who has been sexually assaulted may be “treated with medications that would prevent ovulation, sperm capacitation, or fertilization.”¹⁶ Thus its use would not be prohibited by what follows in Directive 36: “It is not permissible, however, to initiate or to recommend treatments that have as their purpose or direct effect the removal, destruction, or interference with the implantation of a fertilized ovum.”¹⁷ Targeting implantation is not the purpose or direct effect of Plan B. Rather, its purpose and direct effect is to interfere with ovulation.

Second, is there moral certitude that a fertilized ovum will not be destroyed? Some argue that in order for moral certitude to be present, the woman who has been sexually assaulted must undergo an ovulation test to ensure that she is not at or around the time of ovulation such that she could become pregnant from the rape. For example, one advocate of ovulation testing says: “[C]atholic hospitals must have moral certitude that the possibility of an abortion is excluded. The ovulation test provides this certainty. … Therefore, moral certitude can be achieved only through the administration of the [luteinizing hormone] test. To administer emergency contraception when there is insufficient information as to its effect on the specific patient in question is not only morally illicit but medically unsound.”¹⁸

Given what has been said about Plan B’s mechanism of action, such testing is not required to achieve moral certitude. Furthermore, moral certitude in these situations is strengthened by the fact that the incidence of a pregnancy after rape is between <1 percent and 5 percent. Typically the estimate is put at about 3 percent.¹⁹ Given the scientific evidence regarding Plan B’s mechanism of action and the high probability that there is no fertilized egg present subsequent to the sexual assault, the requisite moral certitude exists that a fertilized ovum would not be destroyed by the administration of Plan B.

Finally, it is generally maintained in textbooks of moral theology that when human life is involved, one should always take the safer course. This is sometimes illustrated by the example of the hunter in the woods who sees movement behind bushes. Is the hunter free to shoot, believing that the movement results from a deer? The response in the manuals is no, because the movement could be caused by another hunter. Unless the hunter can resolve his doubt, the hunter must take the safer course and not shoot. This example might suggest that Catholic hospitals must not use emergency contraceptive medications at all in the belief that they might have an abortifacient effect — or, at least, that hospital personnel do as much as they can to reduce the possibility there might be an egg present that could be or might have been fertilized. They would do this by testing for ovulation.

In the situation under consideration, if there were a likelihood that a fertilized egg were present and if there were a likelihood that Plan B has an abortifacient effect, then the example and the obligation to take the safer course would be applicable. However, neither of these conditions is the case, because there is virtually no evidence that Plan B is abortifacient and, in cases of sexual assault, there is a very high probability that there is no fertilized egg present.²⁰ Hence, there does not seem to be an obligation to take the safer course. If one were obliged to take the safer course in these situations, in order to be consistent, one would also have to take the safer course in many of life’s other activities (e.g., driving one’s car, flying in a plane) as well as in the practice of medicine generally (e.g., agreeing to a surgery with a 25 percent risk of dying, undergoing chemotherapy that could have a lethal effect).

The administration of emergency contraception to women who have been sexually assaulted is a matter of utmost seriousness since it touches on human life. It is also a matter of utmost seriousness because it touches on the well-being of women who have been subjected to one of the most heinous of crimes. Any decision about whether or not to permit the dispensing of emergency contraceptive medications in Catholic hospitals and about the protocols for their administration has profound consequences.

Those who make such decisions, whether bishops, hospital executives, emergency room physicians, nurses or others, have a grave moral obligation to take seriously one of the first rules in making good ethical judgments, namely, to obtain adequate and accurate information about the matter at hand. To do any less is not only to shortchange the moral process, but also to risk significant harm to others. And once the best possible information is obtained, those making the decisions need to keep in mind that the use of emergency contraception for women who have been sexually assaulted is a matter about which moral certitude is sufficient. Given what is currently known about Plan B from scientific research, Catholic hospitals can respond with sensitivity, compassion and assistance to women who have been raped and are in need of care, while being confident that they are also remaining true to Catholicism’s fundamental commitment to respect for human life.

NOTES

1. If ovulation testing determines that the woman is at or around the time of ovulation, generally emergency contraception would not be administered out of concern that a possible abortifacient effect of the medication could result in the loss of an embryo.
2. Pontifical Academy for Life, “Statement on the So-Called ‘Morning-After Pill,’” (October 31, 2000), http://www.vatican.va/roman_curia/pontifical_academies/acdlife/documents/
   rc_pa_acdlife_doc_20001031_pillola-giorno-dopo_en.html
3. For information about the mechanism of action of emergency contraceptive medications generally: www.chausa.org/ECmedicationsReview; for information about Plan B’s mechanism of action: www.chausa.org/LevonorgestrelReview.
4. Nicanor Pier Giorgio Austriaco, “Is Plan B Abortifacient? A Critical Look at the Scientific Evidence,” The National Catholic Bioethics Quarterly 7, no. 4 (Winter 2007): 707.
5. Nicanor Pier Georgio Austriaco, “Colloquy: More on Plan B — Fr. Austriaco Replies,” The National Catholic Bioethics Quarterly 8, no. 3 (Winter 2008): 421-25.
6. Austriaco, 422.
7. Austriaco.
8. Austriaco, 423.
9. Austriaco.
10. Chun-Xia Meng et al., “Effect of Levonorgestrel and Mifepristone on Endometrial Receptivity Markers in a Three-Dimensional Human Endometrial Cell Culture Model,” Fertility and Sterility 91, no. 1 (2009): 256-64; Natalia Novikova et al., “Effectiveness of Levonorgestrel Emergency Contraception Given Before or After Ovulation: A Pilot Study,” Contraception 75, no. 2 (2007): 112-18. The immoral, but important study to which Austriaco refers is P.G.L. Lalitkumar et al., “Mifepristone, But Not Levonorgestrel, Inhibits Human Blastocyst Attachment to an In Vitro Endometrial Three-Dimensional Cell Culture Model,” Human Reproduction 22, no. 11 (2007): 3031-37.
11. Austriaco.
12. Austriaco, 424.
13. Austriaco, “Is Plan B Abortifacient?”, 707.
14. Thomas Slater, SJ, A Manual of Moral Theology, (New York: Benziger Brothers, 1925), 1:31.
15. Slater, 1:31-32.
16. United States Conference of Catholic Bishops, The Ethical and Religious Directives for Catholic Health Care Services, (Washington, D.C.: USCCB, 2001), Directive 36.
17. United States Conference of Catholic Bishops.
18. Marie Hilliard, “Dignitas Personae and Emergency Contraception,” Ethics and Medics 34, no. 2 (February 2009): 4.
19. Melisa M. Holmes, et al., “Rape-Related Pregnancy: Estimates and Descriptive Characteristics from a National Sample of Women,” American Journal of Obstetrics and Gynecology 175 (August 1996): 320.
20. Gerald McShane, et al., “Pregnancy Prevention after Sexual Assault,” in Peter Cataldo and Albert Moraczewski, eds., Catholic Health Care Ethics: A Manual for Ethics Committees, (Boston: The National Catholic Bioethics Center, 2001), 11, 16-17.

RON HAMEL is senior director, ethics, Catholic Health Association, St. Louis. Write to him at rhamel@chausa.org.

Catholic leaders know they have not persuaded one another, the public, or their own laity, to agree that contraception is evil. So when it comes to public policy, rather than engage in dialogue and debate, they seem to make a statement and end it with a “Dixi” (Latin for “I have spoken”) as though that is all that should be necessary.

For those who accept the authority of the Catholic hierarchy, that is enough.  But in the democratic process of establishing public policies that are respectful of Catholics and non-Catholics, it is unresponsive and insufficient.

Nonetheless, reproductive rights advocates have recently witnessed ultimatum upon ultimatum.

• Contraceptive benefits?                                         This College will close!
• Gay discrimination prohibited?                              No more poverty programs!
• Emergency contraception required?                        Emergency rooms to close!
• Pharmacists required to fill prescriptions?               They’ll be forced to quit!
• Health insurance reform with abortion coverage?     No health care reform!

This kind of tactic is often inaccurately called “blackmail,” but a better description would be “tantrum.” Infants and toddlers who, frustrated in their efforts to control the environment or their parents, sometimes act out emotionally, physically, and inappropriately.  Adults try to ignore this behavior and toddlers outgrow it.  “But,” www.KidsHealth.org advises us; “do not reward your child after a tantrum by giving in. This will only prove to your little one that the tantrum was effective.”

The message that we must persuade our elected officials and policy makers to learn is that good policy-making must be based on evidence, science, justice and reason and that means a civil discussion with an informed and engaged audience is key. We may not always be able to ignore childish political tantrums, but we must never accommodate and encourage them.

For this reason, Young Catholics for Choice (yCFC) and Family Planning Health Services (FPHS) will collaborate and a launch a Wisconsin-based advertising and media campaign to promote information about emergency contraception (EC). 

In terms of public discussion, misinformation and distortion about emergency contraception has confused the public, policy makers, and especially Catholic parishioners. Most people have an incomplete and inaccurate understanding of EC. Until that changes, for women who need EC, neither the health care principle of ‘informed consent nor the religious principle of ‘informed conscience’ will have real meaning.  The purpose of the campaign is to replace misunderstanding with evidence and knowledge so individuals, including people of every faith, can make decisions about emergency contraception with a more fully informed conscience.

Each of the four cities where the informational ads will run has a distinct example of the need for a more informed public.

· In Eau Claire, a Sexual Assault Nurse Examiner reported to us that an area Catholic hospital is violating the intent of state law because it refuses to offer EC to rape victims unless the victim submits to time-consuming, expensive, and unnecessary testing. 

· In Milwaukee, the new archbishop has declared his opposition to Wisconsin’s “Compassionate Care for Rape Victims” law based on a medically-unsupported belief that the most common form of EC (Plan B ™) “causes abortions.”

· In Green Bay, two television stations refused to run the ads we produced with Young Catholics for Choice earlier than 9:00 p.m. because they were “too controversial.”

· In Wausau, local priests routinely pray the rosary in front of our family planning clinic (which does not provide abortions or medical referrals for abortion) with signs that say “Stop Chemical Abortion” and “Family Planners Promote Child Promiscuity.”

Our collaborative informational advertising about emergency contraception will begin this week and bring together secular and sectarian voices to inform our citizens. There will be radio and television ads throughout Wisconsin (and on the web) to encourage women of reproductive age to go to www.EZEC.org to learn more about EC and to have Plan B™ on hand before they need it.

Speaking about political engagement and the Catholic Church, the new Archbishop of Milwaukee stated: “If we don’t challenge one another’s statements, then we’re relinquishing our responsibility to the common good.”  Our emergency contraception information campaign will meet that responsibility with sectarian and secular voices.

Please find below my summary and interpretation of a recent decision in Peru. My thanks to our colleagues at the Center for Reproductive Rights for helping me understand the implications of this case. Any errors are mine alone!

Peru’s Highest Court Rules Against EC

Peru’s Constitutional Court (Tribunal Constitucional) has stopped the Ministry of Health’s free distribution of EC in a decision issued on October 22^nd. In addition, this decision requires local distributors of EC to add a warning to the package insert stating that this product could cause an abortion.

The Court has decided on a case brought to them by a non-profit advocacy group in 2004. The decision released last week states that the Ministry of Health failed to adequately prove “the inexistence of the abortifacient effect, the inhibition of the implantation of the fertilized ovum in the endometrium.” The Court therefore concluded that EC could in fact cause an abortion, in violation of Peru’s constitutional protection of life. This decision contradicts the Mechanism of Action Fact Sheet issued by ICEC and the International Federation of Gynecology and Obstetrics issued in October 2008, as well as the World Health Organization’s Fact Sheet on Levonorgestrel-alone EC. Both these statements summarize a growing body of scientific literature that shows that delaying or preventing ovulation is the most likely and perhaps only mechanism by which EC effectively prevents pregnancy.

The decision means that the Ministry of Health cannot distribute EC for free through its public clinics. EC can still be sold in Peru, but only with a warning stating that it might cause an abortion.

The Court cited the US FDA website as well as drug labeling for Plan B and several other EC products as evidence that EC may prevent the implantation of a fertilized egg. It is clear that drug labeling is playing a key role in these cases, and it is unfortunate that many levonorgestrel-alone EC products carry labels that do not reflect current science.

This Peru case is very similar to ones in Ecuador and Chile, and may represent a trend towards protecting the rights of the “conceived” using weak science as a strategy to limit access to EC. Clearly, some Latin American courts are now considering that life begins at conception and not at implantation.  Along the same lines, efforts have been launched in several states in the US to “protect life from the beginning of biological development.”

The Associated Press is reporting that Plan B (emergency contraception) will soon be available without a prescription for teens 17 and under. We expect the FDA to shortly announce its compliance with the court decision we reported on last month that slammed the FDA for its politically driven decision to impose an age restriction. We hope that this is the first step in making Plan B accessible and affordable for all women who need it.

A young mother visiting our Women Infants and Children’s nutrition clinic in Central Wisconsin was frightened by a male picketer as she came into our clinic a few weeks ago.  Other women, sometimes our patients, sometimes our employees, have felt threatened by the “40 Days for Life” anti-birth control demonstrators leading a Lenten protest that began yesterday in front of our clinic in Central Wisconsin and in 131 other communities across the nation.

I haven’t asked the clients if they are visiting our clinic to get food for their infants or prenatal nutrition education. I haven’t asked whether they use natural family planning, or condoms, or hormonal birth control pills, or the patch, or an IUD.  I don’t ask whether they are married or faithful or abstinent.  I don’t ask whether they are Catholic, Protestant, Jewish, Buddhist or non-believers.  Neither do the demonstrators who intimidate them.

My agency is a non-sectarian health care provider with a mission to prevent unintended pregnancies and to improve maternal and child health.  We’re proud to support access to safe, legal voluntary reproductive health care as a human right. More than 95% of all American women use modern contraceptive methods. The women who come to us do not come to get an abortion or an abortion referral.  We prevent abortions, we do not provide them.

The 40 Days for Life demonstrators know that women and men come to us for birth control. Other local clinics also provide confidential birth control.  Unlike us, they may make medical referrals for pregnancy termination when necessary.  Walgreens and Wal-Mart deliver hormonal birth control pills and every hospital emergency room in Wisconsin is now required to give out emergency contraception to rape victims.

No theological or political issue is going to be resolved by frightening the women who come to us for health care.  We have been providing high-quality affordable and confidential health care for 36 years and we will continue to provide that care as long as there are women who choose to come to us to receive it.

Listening to the spokesperson for Pro-Life Wisconsin as he defended the new ‘right of conscience’ regulations on Wisconsin Public Radio last week reminded me of the wisdom of the tale.

For 30 years, regulations and federal laws have struck a delicate balance between the rights of patients to receive health care and the rights of health care providers. The new regulations, issued by Health and Human Services Secretary Leavitt, expand the rights of health care providers so extensively that the rights of the patient to receive care are obliterated. The new regulations give the right to refuse to provide health care to all virtually all employees for any health care service they might ‘morally object to.’

Matt Sande, speaking on behalf of Pro-Life Wisconsin, defended the broadest possible right to refuse saying: “These rights aren’t qualified in any way. That’s as it should be. We just have to work around it. We may not understand or agree with an individual’s objection, but we must protect and defend them. . . If we pick and choose which rights we protect, then we won’t have rights for anyone.”

Would this right to refuse apply to physicians who provide abortion services in South Dakota who have been required by state law to inform their patients that terminating a pregnancy is ending a separate, unique human life and that consequences may include depression and suicide? These physicians certainly have moral objections to the content of that message. Health and Human Services Secretary Leavitt has said that, where state laws and the rights of conscience regulations are in conflict, the federal government will help “bring the state into compliance.”

Would volunteers at federally funded abstinence-only “crisis pregnancy centers” have federal civil rights protection for refusing to give out inaccurate and incomplete information [Waxman Report] about the effectiveness of condoms to prevent pregnancy and HIV transmission? As he described patients who ‘may have to go somewhere else,” Mr. Sande said; “One person’s convenience should not trump another person’s right of conscience.”

The moral of the fable is that we are often the source of our own destruction.

The first weakness of the ‘rights of conscience’ regulation expansion is an assumption that only anti-abortion and anti-family planning advocates have moral convictions. The probability that health care employees will refuse to comply with anti-choice or anti-contraception requirements has been overlooked.

The second weakness is a faith-based denial that absolute rights do not exist on this earth. Individual rights require constant, vigilant, rational and empathic balancing. Whether it is the right of a patient to informed consent or the right of the state to protect a fetus, purity is an impossible standard.

The Obama administration must immediately refuse to enforce these regulations and Congress must immediately begin the process to rescind them. In this case, ideologues have given their enemies the means of their own destruction and the regulations must be brought to earth.

King County wants to ax family planning services for poor women & teens in Rainier Valley, White Center, etc. Can you help?
Many of you already know that King County is facing a major budget crisis. What you may not know is that the budget currently being deliberated by the King County Council eliminates no less than FIVE family planning clinics – including the valley’s own Columbia Public Health Center in the Genessee Business District – as well as family planning and STD services for teens in juvenile detention. The clinics on the chopping block could close as early as the end of 2008.

According to our friends in the family planning loop:
Eliminating Family Planning just doesn’t make financial sense. Making free family planning services available to poor women actually saves us money. In fact, for every $1 invested in family planning, we save $4.

Cutting family planning and STD services constitutes a misuse of taxpayer money, as we are only deferring the cost until a later time. Furthermore, we are doing so at the expense of poor women and their families. I realize that cuts must be made somewhere, but to do so by targeting the most vulnerable members of our community is simply unethical.

Access to birth control and STD services is the single most effective way to reduce unintended pregnancies, to reduce state-supported births and abortions, and to contain the spread of STDs. Additionally, these services function as a critical entry point into broader medical care and social services for low-income women and their families.
Now, while some teen patients may be able to continue getting family planning services at the pediatric clinic, if these budget cuts pass there will be no services whatsoever for adult women.

In other words, without these clinics, thousands of poor women and teens in King County will have no place else to go for reproductive and sexual health care.

For more information, go here.

You can help!
Take a moment to urge lawmakers against this short-sighted solution. Tell them not to balance the budget on the backs of our neediest neighbors and to restore funding to the family planning clinics at White Center, Columbia (Columbia City), Renton, North (Northgate), and Northshore (Bothell), as well as family planning and STD services at juvenile detention, in the 2009 budget.

There is no time to waste, as the King County Council will adopt the 2009 budget by next Mon., Nov. 24, so if you’d like to see funding restored to these vital family planning services, contact the council TODAY urging them not sacrifice the reproductive health of our community’s most vulnerable citizens.

Three ways to make your voice heard:
1. Attend the last remaining County Council Budget Hearing TODAY at 1:30 pm at King County Council Chambers (516 Third Ave., Room 1200). Sign up to testify or hold a “save family planning” sign.

2. Testify electronically to the County Council – it only takes a minute – go here to share your comments.

3. Email the King County Council directly:
bob.ferguson@kingcounty.gov, larry.gossett@kingcounty.gov,
kathy.lambert@kingcounty.gov, larry.phillips@kingcounty.gov,
julia.patterson@kingcounty.gov, jane.hague@kingcounty.gov,
pete.vonreichbauer@kingcounty.gov, dow.constantine@kingcounty.gov,
reagan.dunn@kingcounty.gov

cc: Executive Ron Sims (exec.sims@kingcounty.gov), David Fleming, Director of Public Health – Seattle & King County (david.fleming@kingcounty.gov), Bob Cowan, Director of the Budget Office (bob.cowan@kingcounty.gov), and your state legislators. To find your legislators, go here.

A Range of Concerns Would Need to Be Addressed
To Ensure that All Women Benefit

A growing number of women’s health advocates are urging bolder and potentially transformative steps toward greater “contraceptive convenience,” with the aim of making contraceptive use easier and more sustainable for women, according to a new Guttmacher policy analysis. These advocates argue that many of the ways in which contraceptives are made available in the United States are no longer grounded in the reality of current scientific advancements or modern women’s lives.

Research shows that half of all adult women at risk of unintended pregnancy are inadequately protected because, over the course of a given year, they don’t use contraceptives at all, use them inconsistently or incorrectly, or have a gap in use lasting more than a month. A complex web of reasons contributes to women’s difficulties in using contraceptives, ranging from method dissatisfaction to life disruptions. Advocates of a contraceptive convenience agenda are pushing for measures to break down many of the medical and societal barriers to better use.

“In a variety of ways, society makes women’s contraceptive access needlessly hard, and it can and should be made easier. By stripping away layers of medical intervention or requirements that are outmoded or unnecessary, we can go beyond current efforts to make contraceptive service delivery more user friendly,” says Sneha Barot, author of the new analysis. “For instance, many women’s health experts have concluded that a number of hormonal contraceptives—including the birth control pill—should be available to women directly at pharmacies, without the requirement of a doctor’s prescription. Such steps would make contraceptives easier to obtain and use without interruption, and would also decrease other financial and logistical hurdles.”

Barot’s analysis points out, however, that proposals to “demedicalize” contraception also raise serious concerns. For example, removing the prescription requirement for oral contraceptives could make pills unaffordable for low-income women if it also resulted in the removal of private insurance and Medicaid coverage. Likewise, eliminating the need to go to doctors or family planning clinics for contraceptives could jeopardize access to other preventive health services normally provided in these settings. Minority communities, especially, could be affected, potentially aggravating existing inequalities.

“Any efforts to push for over-the-counter status would need to resolve serious challenges —including cost and access to health care—that marginalized populations would be facing,” says Barot. “To make contraceptives easier to use, even without the benefit of instructions from a doctor, would also mean revamping package labeling to make it more comprehensible and accurate.”

Barot further notes that a number of other measures also need to be pursued to truly make contraceptives easier for women to obtain and use. One of the most important of these is to create a fundamental shift in societal attitudes toward contraception, so that users will face fewer restrictions—and more support.

“Making access to and use of contraceptives easier is not trivializing an important reproductive health issue or promoting irresponsible attitudes or behavior—quite the opposite,” says Barot. “‘Convenience’ in the area of contraceptive access would translate into practical and meaningful support for women who are trying to avoid unwanted pregnancies, improve their health, and better plan their lives.”

Click here to read “Making the Case for a ‘Contraceptive Convenience’ Agenda,” by Sneha Barot, in the Fall 2008 issue of the Guttmacher Policy Review.

Click here for more information on:

Improving contraceptive use in the United States

Facts on contraceptive use

Facts on contraceptive services

September 26 marks World Contraception Day, which highlights the many ways using modern birth control methods benefits women and their partners. Access to contraceptives allows couples worldwide to make responsible decisions about when to become parents and also helps secure women’s full and equal participation in modern society. Using any form of contraception dramatically reduces a woman’s chance of getting pregnant and either having an abortion or giving birth to a child she did not intend. The most effective methods virtually eliminate that risk.

Contraceptive use in the United States

• Women who use contraceptives have far fewer unintended pregnancies and, by extension, abortions than do nonusers. About half of all unintended pregnancies in the United States occur among the small proportion (11%) of sexually active women who were not using any form of contraception in the month they got pregnant.
• Americans understand the value and benefits of contraception and overwhelmingly support and use it. In the United States, 98% of sexually active Americans use a method at some point in their lives. But finding the right method can be challenging for many women, and using contraceptives consistently and correctly over a lifetime is difficult.
• Unintended pregnancy and abortion are increasingly becoming concentrated among low-income and minority women, who often lack access to high-quality contraceptive counseling and services. This underscores the urgent need to increase investments in subsidized family planning services through the federal Title X program, as well as by increasing eligibility for such services under Medicaid.
• Publicly funded family planning clinic services already enable U.S. women to prevent 1.4 million unintended pregnancies each year, an estimated 600,000 of which would end in abortion. Without these services, the annual number of unintended pregnancies and abortions would be nearly 50% higher. Among many other benefits, family planning clinic services also save $4.3 billion in public funds each year.

Contraceptive use worldwide

• In the developing world, unplanned pregnancies are mainly the result of low rates of contraceptive use. About 200 million women worldwide have an unmet need for effective methods of contraception.
• Worldwide, a third or more of all pregnancies are unplanned, resulting in high rates of abortions that are often unsafe when they occur in developing countries. Abortion rates are lowest in Western Europe, where effective contraceptive use is very high. In contrast, abortion rates are much higher in Africa, Latin America and the Caribbean, where contraceptive use is low, notwithstanding the fact that abortion in these regions is highly restricted.
• The United States and other industrialized countries should greatly increase their investment in international family planning assistance. The many benefits of such programs include better maternal health and child survival; less recourse to abortion, especially unsafe abortion; and more protection against sexually transmitted infections, including HIV/AIDS. Family planning assistance also fosters social and economic development and helps safeguard the environment.

Click here for more information on:

The facts on contraceptive use in the United States

The facts on publicly funded contraceptive services in the United States

Improving contraceptive use in the United States

The broad benefits of investing in international family planning assistance

Unmet need for contraceptives in developing countries

Facts on abortion worldwide

Last week the Journal of the American Academy of Pediatrics published a study showing that urban minority teen girls lacked knowledge about emergency contraception. Almost all of the sexually active adolescents had heard of emergency contraception, but were not knowledgeable about how it works or when to take it. Girls who were not sexually active had less information.

In 2006, FPHS did a Wisconsin study on whether teens who called family planning clinics, emergency rooms, and crisis pregnancy centers got information to help them get EC. The findings were that family planning clinics did well, emergency rooms were not prepared to deal with telephone inquiries, and crisis pregnancy centers typically did not have accurate or useful contraceptive information.

As family planning providers, here’s what we are doing about it (with a lot of collaboration):

We explain to every woman and girl of reproductive age who calls the hotline or visits our clinics that she should have Plan B on hand and should understand when to take it. The most common reasons are that she may forget to take birth control pills, a condom may beak, or unplanned/non-consensual sex may put her at risk of an unwanted pregnancy. The woman at risk makes the decision when to take Plan B. Having it on hand enables her to act promptly.

Every female patient of reproductive age who visits any one of our seven clinic locations or who calls the statewide toll-free response line (1-866-ECFIRST) is offered Plan B and receives education that emergency contraception is more effective the sooner it is taken after unprotected sex. Most of our callers are low-moderate income and underinsured, so they are eligible for Wisconsin’s Medicaid Family Planning Waiver. For them, prescription Plan B will be provided at no charge.

• She can receive them in the mail to an address of her choice.
• She can pick up EC at any one of 62 family planning clinics throughout the state.

If it is an emergency and she can’t get to a local family planning clinic:

• She can have EC shipped via overnight express.
• She can go to a local pharmacy where we have faxed her prescription.
• She could go to one of several sexual assault service agencies with our EC on hand.
• She can go to an off-hours lock-box at one of our seven clinic sites.

That is focusing on the practical — As for dealing with other dimensions such as the moral, the medical, the historical and the political, there are good sources of information about emergency contraception and how we came to be where we are:

Health Care Education and Training has an excellent website about how EC works.

The Wisconsin Family Planning and Reproductive Health Association (WFPRHA) took several preparatory steps on the way to wide EC access, including:

1) an assessment tool to help nursing professionals determine whether and when a report must be made for a sexual assault under Wisconsin law.
2) several coalition-building conferences to build public/policy support.
3) statewide training for reproductive health professionals in 2005 on how EC works and what are the best medical practices for its use. The association is planning to review and update the training in 2009.

The most important piece of the puzzle is that Wisconsin’s Department of Health Services implemented policies that enable uninsured and underinsured low and moderate income women to receive Medicaid-paid contraceptive services and supplies. Being able to give EC at no charge in advance of need is the foundation on which EC access is based.

As for results: at FPHS clinics, positive pregnancy tests as an annual percentage of total patients has dropped from (pre-Family Planning Waiver) 5.5% (about 350 positive pregnancy tests) to 2% (about 180 positive pregnancy tests) for the last three years. There may be a non-EC explanation, but it’s not likely. Because preventing unwanted pregnancies is how we can define EC success, for FPHS, free EC in advance has been a success. Maybe it is as simple as that.

2006 Emergency Contaception Survey Report

U.S. Representatives

Abercrombie, Neil

Ackerman, Gary

Allen, Tom

Andrews, Robert

Arcuri, Mike

Baird, Brian

Baldwin, Tammy

Berkley, Shelly

Berman, Howard

Bishop, Tim

Bishop, Sanford

Blumenauer, Earl

Boswell, Leonard

Boucher, Rick

Brady, Robert

Braley, Bruce

Brown, Corrine

Capps, Lois

Capuano, Mike

Carnahan, Russ

Carson, Andre

Christensen, Donna

Courtney, Joe

Crowley, Joe

Cummings, Elijah

Davis, Susan

DeFazio, Peter

DeGette, Diana

Delahunt, William

DeLauro, Rosa

Emanuel, Rahm

Engel, Eliot

Fattah, Chaka

Frank, Barney

Giffords, Gabrielle

Gonzalez, Charlie

Green, Gene

Grijalva, Raul

Hall, John

Hare, Phil

Harman, Jane

Higgins, Brian

Hinchey, Maurice

Hodes, Paul

Holmes Norton, Eleanor

Holt, Rush

Honda, Mike

Hooley, Darlene

Inslee, Jay

Israel, Steve

Jackson, Jr., Jesse

Johnson, Hank

Kind, Ron

Kucinich, Dennis

Larsen, Rick

Lee, Barbara

Levin, Sander

Lewis, John

Loebsack, Dave

Lowey, Nita

Maloney, Carolyn

Markey, Ed

McCollum, Betty

McDermott, Jim

McGovern, Jim

McNerney, Jerry

Michaud, Michael

Miller, Brad

Miller, George

Mitchell, Harry

Moore, Gwen

Moore, Dennis

Moran, James

Nadler, Jerry

Olver, John

Pascrell, Bill

Roybal-Allard, Lucille

Rush, Bobby

Ryan, Tim

Schakowsky, Jan

Schiff, Adam

Schwartz, Allyson

Scott, Bobby

Sires, Albio

Slaughter, Louise

Smith, Adam

Solis, Hilda

Stark, Pete

Sutton, Betty

Tauscher, Ellen

Thompson, Mike

Tierney, John

Towns, Ed

Tsongas, Niki

Udall, Mark

Van Hollen, Chris

Wasserman-Schultz, Debbie

Waxman, Henry

Weiner, Anthony

Welch, Peter

Wexler, Robert

Woolsey, Lynn

U.S. Senators

Baucus, Max

Boxer, Barbara

Brown, Sherrod

Cantwell, Maria

Cardin, Benjamin L.

Dodd, Christopher J.

Durbin, Richard J.

Feingold, Russ

Feinstein, Diane

Harkin, Tom

Kennedy, Edward M.

Kerry, John F.

Lautenberg, Frank R.

Leahy, Patrick J.

Lincoln, Blanche

McCaskill, Claire

Menendez, Robert

Mikulski, Barbara A.

Murray, Patty

Obama, Barack

Reid, Harry

Rodham Clinton, Hillary

Sanders, Bernie

Schumer, Charles E.

Stabenow, Debbie

Tester, Jon

Whitehouse, Sheldon

Wyden, Ron

The Association of Reproductive Health Professionals issued this alert to it’s membership. Please consider following this link to easily and electronically express your opinion about this proposal to HHS Secretary Leavitt.

http://capwiz.com/nfprha/home/

Dear ARHP member,

We have an urgent matter to bring to your attention. Recently, the Bush Administration proposed new regulations under which the Department of Health and Human Services (HHS) would redefine pregnancy as beginning prior to implantation and adopt a definition of abortion that includes many forms of contraception, including some birth control pills, IUDs, and emergency contraception. Both of these proposed definitions are alarmingly at odds with science. This regulation would also allow health care providers and facility staff to refuse to provide any medical service – if doing so would violate their moral beliefs.

If adopted, the new regulations could mean that providers of federally-funded family planning services could no longer guarantee their patients access to contraception. We cannot tolerate this last ditch attack on family planning as the Bush Administration prepares to leave office.

To make it quick and easy for you to learn more about and take action on this outrageous proposal, ARHP has partnered with our colleagues at the National Family Planning and Reproductive Health Association (NFPRHA). Please click here (http://capwiz.com/nfprha/home/) to easily and electronically express your opinion about this proposal to HHS Secretary Leavitt.

Thank you for your quick response on this critical issue.

Sincerely,
ARHP Policy Team

May 7^th is National Teen Pregnancy Prevention Day and a good time to study what’s working and what’s hindering out national progress.  It would also be a good time for parents of teens to consider their own vital role in sex education.

A recent local radio call-in program appearance reminded me of how our beliefs and values about sex, sex education, and sexual health can twist policy discussion and interpersonal communications into a maze of confusion and conflict.  It seems that one of the reasons the United States has the highest teen pregnancy rate of all the industrialized nations might be that our teens have to try to make sense out of nonsense.

Several callers to the radio program made these points: 

·        Teen pregnancies are increasing.

·        Abortions are increasing.

·        Sex education encourages risky sexual behavior.

·        Access to birth control encourages risky sexual behavior.

·        Requiring parental consent for birth control would reduce risky sexual behaviors.

·        Gardasil (new cervical cancer-prevention vaccine) is dangerous, even killing girls and young women.

·        Access to reproductive health care “gives teens permission” to become sexually active.

The reality is that, according to research and evidence, none of those points is true:

·        Even though the national teen birth rate rose 3% between 2005 and 2006 after a 34% fourteen year drop, the pregnancy rate continued to decline.

·        In 2005, the abortion rate was the lowest in 34 years at 19.4 abortions per 1,000 women aged 15 to 44 compared to 29.3 abortions per 1,000 women in 1981.

·        Comprehensive sex education does not increase sexual activity, lower the age of first sexual intercourse, or increase the frequency of sex or the number of sex partners among sexually active youth.

·        Access to birth control and reproductive health care does not encourage risky behavior; in fact it reduces the risks of those behaviors among sexually active people.

·        Requiring parental consent reduces the number of teens who seek health care, but does not reduce their sexual risk-taking behaviors.

·        Gardasil is safe and effective, with the most common side-effect being pain at the injection site.  The FDA is constantly monitoring vaccine recipients and safety. Girls and young women should be vaccinated.

·        Access to cardiac care doesn’t give us permission to overeat and watch TV and seatbelts don’t encourage us to drive recklessly.  Unfortunately, teens don’t ask health care providers for permission to have sex and if they did, we wouldn’t give it to them.

Before we teach teens about sex, we have to make sense out of the nonsense ourselves. We have to update our knowledge – especially in areas that are controversial or challenging to our cherished beliefs.  Most important, we have to be able to distinguish between fact and opinion and between science and belief.

Through the past generation, our sex education and our sexual health care policies have been determined more by politics and ideology than by science or evidence. Add the rapidly expanding knowledge about reproductive health and the result is that most adults are poorly prepared to educate teens on sexual health and wellness or about risks and consequences.

Beyond the basic biology of reproduction, here is a contemporary study guide for parents of teens:

• One in four teens has a sexually transmitted infection:  what are the most common diseases and how should you protect yourself?
  • What is HPV and how does it relate to cervical cancer? 
  • What is Gardasil?
• What is emergency contraception (Plan B)?  How does it work?  When should a reproductive age female take it?
• What is the law on minors and sexual activity?  When is it legal to have sexual intercourse?  What are the penalties?
• What is the effectiveness of condoms?
• What are the most common and effective forms of birth control? How do they work?
• Can my teen get confidential reproductive health care?  Where? Why? How?

Parents are the primary sex educators of their children. The more parents know, the more likely they are to do a good job — but it isn’t called “The FACTS of life” for nothing.

I found this article in the Green Bay Press Gazette today. Given the topics it discusses, I thought it would be a perfect fit for BTW.

Rape victims have option of getting emergency contraception

By Sara Boyd

A new law requiring medical professionals to provide emergency contraception for patients of sexual assault — with unbiased and medically factual information — means a change to the local health-care system.

To some, it’s a welcome chance for victims of sexual assault to get the peace of mind they deserve. To others, it violates constitutional rights and religious beliefs.

Assembly Bill 377, coined the Compassionate Care Bill, states hospitals that provide emergency services must immediately administer emergency contraception and necessary subsequent doses upon the request of a victim.

The Department of Health and Family Services will monitor hospitals for compliance. Medical professionals who refuse must pay up to $5,000 for each violation.

Gov. Jim Doyle signed the bill in March, stating sexual assault victims deserve the “most comprehensive and compassionate services” available.

However, Dr. Amy Schueckler, an OB-GYN at the A & A Alexandrina Center of Green Bay, said the services violate her religious beliefs and are rules she does not feel comfortable complying with.

“I believe it does go against the First Amendment for freedom of speech or religion because there are a number of faiths that understand that the emergency contraception has as one of its mechanisms of action to destroy life,” she said. “That is not what they believe is proper or true.”

Patricia Finder-Stone, a retired registered nurse from De Pere, said emergency contraception prevents a pregnancy but does not cause an abortion, which can be a misperception. The passing of the Compassionate Care Bill is a positive step for reproductive health care, she said.

“It will certainly give the women a lot of relief,” she said. “The trauma of rape is in itself devastating for any woman, and the feeling that you might be pregnant as the result of this assault, and having to carry a child would be a lifetime of memory of that dreadful assault.”

Bellin Health, Aurora BayCare Medical Center and St. Mary’s Hospital Medical Center refer sexual assault patients to St. Vincent Hospital’s sexual assault program.

Dr. Chris Watson, chief medical officer at Bellin, said once the patient is determined to not have any immediate life-threatening injuries, they are sent to St. Vincent’s sexual assault nurse examiner.

Although St. Vincent’s mission falls in line with the Catholic Church, Watson said he believes the hospital will comply with the state.

St. Vincent officials have stated they will continue to follow the Wisconsin Catholic Conference position to remain neutral on the issue, said Sean Schultz, marketing communication specialist at St. Vincent.

“We follow state guidelines as all the hospitals do,” she said.

Matt Sande, director of legislation for Prolife Wisconsin, said the group is looking into challenging the bill on the basis that it is unconstitutional.

Schueckler said the bill puts medical professionals in a tough spot as they are being forced to comply with a law that goes against a number of ethical beliefs.

“Personally, I would not distribute a pill that would kill another young life,” she said. “I’m sympathetic to the other physicians and professionals that are obliged legally to do something against their morals.”

Finder-Stone said the patient’s needs come first, and that includes the option to take an emergency contraceptive.

“That’s No. 1 in nursing ethics,” she said.

Nancy Nusbaum, former director of the state’s crime victim services, said a sexual assault victim deserves a full range of options at such a critical time — no questions asked.

“When a patient, especially a patient who’s traumatized, goes to a medical professional … they expect that that medical professional is going to do everything in the universe to help them,” she said. “And not draw a line somewhere in between.”

. . . but the PLW ad goes on to state that; “emergency contraception is a powerful, high dose of steroids that tricks a woman’s body into thinking it is pregnant” and can cause “chemical abortions and deadly blood clots.” PLW promiscuously crammed as many misleading and unsupported claims into one short statement as it possibly could, but the main and most clearly refutable points are often heard and too often echoed across the country: ‘chemical abortions’ and ‘blood clots.’

The latest World Health Organization information is explicit that EC works by preventing ovulation and fertilization. There is no evidence that EC prevents implantation and there is substantial evidence that Plan B’s rate of not preventing implantation of a fertilized egg fully explains the pregnancies that occur after the pills have been taken. In other words, the primary argument that opponents of EC make (we should not risk the destruction of a single fertilized egg) is scientifically, theoretically, and statistically head-of-a-pin microscopic.

Weighed against the larger risks of an unwanted, untimely, or risky pregnancy or perhaps an abortion at a later stage of a real pregnancy, the microscopic objection should vanish completely. And, since unlike many forms of hormonal birth control, Plan B does not contain estrogen, PLW’s warning about ‘blood clots’ seems to be based on their own beliefs and very little else. Again, weighing the risks of a real pregnancy against the theoretical . . . this argument should also disappear completely.

What will not disappear and what is impossible to ignore in this debate about possibilities, is the question of why an organization opposed to abortions would discourage women at risk of unwanted pregnancy from acting to prevent those pregnancies? Why is an organization repulsed at the idea of risking a single fertilized egg acting in a way that puts women (including those who will subsequently abort an unwanted pregnancy) at a greater risk of pregnancy?

To a rational person seeking to reduce abortions, an unproven possibility of the presence of a fertilized egg and a theoretical possibility of preventing a potential implantation on the uterine wall is simply not morally or ethically equivalent to an unwanted pregnancy. The imbalance is dramatically and clearly shown when the woman at risk is likely to have an abortion if she becomes pregnant.

Spring break is a good time for anti-abortion advocates and supporters of accurate safer-sex education alike to call for sexual responsibility and restraint. Perhaps we can agree to exercise responsibility and restraint in our advertising too. Opponents of abortion, like Pro-Life Wisconsin, could demonstrate that they will not risk increasing the number of abortions to quench an insatiable desire for public attention.

Bill provides contraceptives for rape victims