By E. Christian Brugger
WASHINGTON, D.C., AUG. 25, 2010 (Zenit.org).- On Aug. 13, the U.S. Food and Drug Administration (FDA) announced the approval of a new «emergency contraceptive» called «Ella.» Its competitor, Plan B, is said to «prevent pregnancy» up to 72 hours (3 days) after intercourse. Ella boasts of 120 hours (5 days) of post-coital effectiveness. The drug is produced by the Paris-based pharmaceutical company HRA Pharma and will be marketed by Watson Pharmaceuticals based out of Morristown, New Jersey. The FDA advisors voted unanimously to approve the drug.
Pro-lifers are no strangers to the euphemistic tactics of abortion activists. But the new depths to which the FDA has sunk with its recent approval will test their patience. The secret that the Ella establishment doesn’t want you to know is this: from a pharmacological perspective, Ella is not an emergency contraceptive (EC). It is an abortion drug.
Chemical contraceptives, both long-term and emergency, use a synthetic version of the hormone progestin. Progestin has effects similar to the hormone progesterone, which is necessary for regulating the female menstrual cycle and supporting pregnancy. Progestin (alone, or in combination with estrogen) also can prevent ovulation, which is its primary contraceptive quality. The most common progestin drug in ECs is levonorgestrel, the active ingredient in several familiar brands, such as Plan B, Escapelle, Levonelle, NorLevo, and Next Choice.[1] The FDA refers to Ella as an emergency contraceptive, even comparing it in its literature to levonorgestrel.[2]
But Ella (generic name ulipristal acetate) is not a synthetic progestin that mimics the action of progesterone. The FDA press release states forthrightly that Ella is what is known as a «progesterone antagonist.»[3] Unlike progestins, progesterone antagonists block the action of progesterone. The drug binds to the progesterone receptor sites excluding progesterone from binding and hence eliminating its activity. Since progesterone is necessary for promoting and preserving a uterine lining hospitable to a nesting embryo, its suppression results in an environment hostile to embryonic life. The other common progesterone-blocking drug on the market is the abortion pill RU-486 (generic name mifepristone).
The FDA description insists that Ella’s mode of action is contraceptive, not abortive. It states flatly: «Ella is not indicated for termination of an existing pregnancy.»[4] While it is true that a progesterone antagonist can prevent ovulation, the drug’s principal value to the family planning industry is and has been as an abortion drug. Literature going back to the 1980s makes this very clear.[5] Deprived of a nutritive uterine lining, the embryo starves to death. Dress them up as «contraceptives» all you want, progesterone antagonists are abortion drugs.
By «pregnancy,» the FDA obviously means to include only the post-implantation period, employing the definition of pregnancy supported by the American College (now «Congress») of Obstetricians and Gynecologists, The Guttmacher Institute and Planned Parenthood (ACOG: «A pregnancy is considered to be established only after implantation is complete»).[6] A «termination of pregnancy» then does not include killing an embryo before implantation.
Are you starting to see the picture? If the killing is not a «termination of pregnancy,» then likely it will not be excluded from federal funding under the Hyde Amendment. Ella, then, unlike RU-486, will evade the federal restrictions on abortion funding.
Moreover, though most provisions of President Barack Obama’s health care plan will take years to go into effect, a handful take effect this September. Among them is the requirement that all new private plans (i.e., only those created or changed after Sept. 22, 2010) must cover certain «preventative» care and screenings for women and children. The final rules on what will be considered «preventative» are being written right now, to be unveiled next month. But «family planning services» are already listed among them. If Ella continues to be categorized as an EC, there is a strong likelihood that it will be included under mandatory coverage for preventative services for women.
In other words, federal funds would be allowed to cover Ella abortions, and private insurance plans will be forced to pay for them.[7]
Birth defects
Does Ella cause birth defects in children who survive their mother’s ingestion of the drug? We don’t know. Remarkably, the FDA while knowing its pharmacological kinship with RU-486, has performed no controlled human studies on the effects of Ella on an implanted embryo and fetus. One of the members of the FDA advisory committee even recommended against controlled studies arguing that pregnancy studies would be «biased» because women who experience negative outcomes are more likely to report than women experiencing no problems.[8] (So much for trusting women to report accurately.)
In animal studies, however, the FDA reported that 100% of confirmed pregnant rats and 50% of pregnant rabbits suffered miscarriage as a result of Ella ingestion.[9] Accordingly, the product labeling seriously cautions women with confirmed pregnancies to avoid the drug. Although no malformations were observed in the newborn rabbits that survived the drug’s effects, nobody doubts that Ella would be gravely dangerous to gestating fetuses.
The empirical question of whether or not progestin-based ECs such as Plan-B sometime act as abortifacients is still hotly debated; hence so too is the ethical conversation in Catholic bioethics whether or not they rightly can be used to treat victims of sexual assault.[10] But the evidence of the abortive effects of progesterone antagonist drugs such as Ella is conclusive. The empirical question is settled; and thus so too is the ethical question.
Notes
[1] Levonogestrel is also the active ingredient in the Intra-uterine contraceptive Mirena and the contraceptive implants Norplant and Jadelle. [3] www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm222428.htm [4] www.accessdata.fda.gov/drugsatfda_docs/label/2010/022474s000lbl.pdf; see sec. 5.1. [5] Nieman, et al., «The Progesterone Antagonist RU 486,» New England Journal of Medicine, vol. 316, no. 4 (January 22, 1987), 187-191; see also Marie Hilliard, «Ulipristal and Catholic Hospitals,» Ethics & Medics, vol. 35, no. 9 (Sept. 2010), p. 2, especially footnotes 13-15. [6] Quoted in Rachel B. Gold, «The Implications of Defining When a Woman Is Pregnant,» The Guttmacher Report on Public Policy, vol. 8, no. 2 (May 2005), 8; see also www.plannedparenthood.org/health-topics/pregnancy/how-pregnancy-happens-4252.htm [7] I Thank J. Margaret Datiles, Esq, for supplying this information on Ella and President Barack Obama’s plan for health care reform. [8] www.cwfa.org/printerfriendly.asp?id=19109&department=cwa&categoryid=life [9] www.accessdata.fda.gov/drugsatfda_docs/label/2010/022474s000lbl.pdf; see sec. 8.1 [10] Those interested in the scholarly conversation among Catholic bioethicists might be interested to read chapter eleven dedicated to the debate in the 2009 Catholic Health Care Ethics Manual, published by the National Catholic Bioethics Center in Philadelphia.* * *
E. Christian Brugger is a Senior Fellow of Ethics at the Culture of Life Foundation and is an associate professor of moral theology at St. John Vianney Theological Seminary in Denver, Colorado. He received his Doctorate in
Philosophy from Oxford in 2000.
