[This letter from Lon Newman appeared at Factcheck.org.]
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.”
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.
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
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.
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
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.
Nicanor Pier Georgio Austriaco, “Colloquy: More on Plan B — Fr. Austriaco Replies,” The National Catholic Bioethics Quarterly 8, no. 3 (Winter 2008): 421-25.
Austriaco, 422.
Austriaco.
Austriaco, 423.
Austriaco.
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.
Austriaco.
Austriaco, 424.
Austriaco, “Is Plan B Abortifacient?”, 707.
Thomas Slater, SJ, A Manual of Moral Theology, (New York: Benziger Brothers, 1925), 1:31.
Slater, 1:31-32.
United States Conference of Catholic Bishops, The Ethical and Religious Directives for Catholic Health Care Services, (Washington, D.C.: USCCB, 2001), Directive 36.
United States Conference of Catholic Bishops.
Marie Hilliard, “Dignitas Personae and Emergency Contraception,” Ethics and Medics 34, no. 2 (February 2009): 4.
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.
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.
In an unprecedented decision that has prompted outrage by women’s health providers and advocates, Department of Health and Human Services Secretary Kathleen Sebelius, overruled recommendations of the Food and Drug Administration’s Center for Drug Evaluation and Research that would have made Plan B One Step ™ available to all as an over-the-counter product. Plan B One Step ™ has been available without a prescription to women 17 and older, but a prescription has been required for younger women; the proof-of-age restriction has kept the product behind the counter. The sooner Plan B is taken after unprotected sex, the more effectively it reduces the risk of pregnancy.
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.”
Washington, DC – Congresswoman Gwen Moore expressed her disappointment in a decision by the U.S. Department of Health and Human Services (HHS) to overrule the Food and Drug Administration’s (FDA) proposal to significantly expand young women’s access to a critical medication that can prevent unintended pregnancies.
“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.”
The U.S. Food and Drug Administration (FDA) has been carefully evaluating for over a decade whether emergency contraceptives containing levonorgestrel, such as Plan B One-Step, are safe and effective for nonprescription use to reduce the chance of pregnancy after unprotected sexual intercourse.
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.
Statement by Kirsten Moore, President & CEO of the Reproductive Health Technologies Project, on the filing of an application by Teva Pharmaceuticals with the Food and Drug Administration that would remove the over-the-counter age restriction on Plan B One-Step®:
“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®.
[Our friend Kelly Cleland presented this paper a few weeks ago at the International Consortium on Emergency Contraception. We talked to her in our podcast, and this is the paper she was referring to.]
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.
