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What’s Up with Ella?

The department of Health and Human Services (HHS) clarified the contraception coverage in the Affordable Care Act last week. Initially, HHS relied on “good faith” that insurance companies would cover contraception at no cost to the patient. This new clarification specifies that one medication from each of 18 specific categories of contraception must be covered at no cost. The 18 categories are predictable including combination hormonal contraceptives, progestin only pills, IUDs, and more. The final category, however, seems out of place and warrants a second look. This category contains only one drug — Ella.

Ella is a fairly new medication being marketed as an emergency contraceptive. They call it the “week after pill.” Why then is Ella in its own category, separated from other emergency contraceptives? And why of the 18 categories, is Ella the only one identified by the name of the medication, rather than a type?

The simple answer is that Ella’s mechanisms of action are different than other emergency contraceptives (ECs) like Plan B and One-Step. Other ECs contain synthetic progestins like levonorgestrel. Only differing with progestin only pills in dosage, these ECs behave in a similar way to regular hormonal contraception. By inundating the body with large amounts of extra hormones all at once ECs can delay ovulation, block sperm and thin the lining of the endometrium making it inhospitable to implantation. 1

Ella, on the other hand, contains 30mg of ulipristal acetate, and is categorized as an Selective Progesterone Receptor Modulator (SPRM). The FDA has only approved two SPRMs to date: Mifepristone (RU-486) and Ella 2
(although SPRMs are being investigated for other uses regarding reproductive health).

The drugs are certainly not identical, but their placement in the same category should make us curious, and spur further examination. Mifepristone is an antagonist SPRM and it is used to terminate a pregnancy before 20 weeks gestation by blocking the body’s ability to appropriate 3 the progesterone needed to continue a pregnancy. 4 Ella is said to be incapable of this, but it is classified as both an agonist and antagonist SPRM. The main mechanism of action of Ella is (due to its agonist properties) to delay ovulation, and if ovulation were to occur, it attempts to create a luteinized unruptured follicle (LUF: i.e. keep the egg in it’s casing, which makes it impossible for fertilization to take place). Ella also decreases the thickness of the endometrium making it difficult for a fertilized egg to implant. 5 These traits make Ella very similar to other ECs. But Ella, like Mifepristone, is also an antagonist SPRM and is similarly able to bind to the progestin receptors, although its effects are not as potent.

In an article published in McGraw Hill’s Access Medicine, Dr. Stephen R. Hammes writes, “As may be expected, ulipristal has also provoked an adverse reaction in the United States by opponents of the termination of pregnancy.” Hammes goes on to explain the mechanisms of action for the drug saying, “Ulipristal is known to have anti-proliferative effects in the uterus at high doses; however, its most relevant actions to date are its ability to inhibit ovulation.” (While inhibiting ovulation may be the most relevant mechanism, it does not negate the drug’s other mechanisms). He concludes his article with this warning, “The drug should not be taken by women who are breastfeeding or who are pregnant and wish to remain so” (emphasis added).6

Ella’s ability to terminate an existing pregnancy is seen in animal trials of its only ingredient, Ulipristal Acetate. The European Medical Association says, “Ulipristal, mifepristone and lilopristone were approximately equipotent at the dose levels of 10 and 30 mg/day in terminating pregnancies in guinea-pigs when the animals were treated on days 43 and 44 of gestation.” In monkey trials half of the fetuses died when given Ulipristal Acetate in the first month of pregnancy.7

Admittedly, these animals were given a higher dosage of Ulipristal Acetate than Ella gives a human in one dose, but the drugs ability to bind progesterone receptors in an antagonist way, regardless of dosage, is significant. Anyone who has suffered miscarriage can tell you the importance of progesterone in the early stages of pregnancy.8 Low progesterone is cited as a major influence in the continuation of a pregnancy. 9 While progesterone is not completely blocked by Ella, it certainly is inhibited. Any inhibition of progesterone is likely to affect an “established pregnancy” and at higher doses, Ella is just as effective as Mifepristone.

Ella creates its own category in the HHS contraception coverage because its action as an “emergency contraceptive” is significantly different than other ECs. And now, it is available at no cost to the American public. Moreover, being the only drug in the category ensures government enforced subsidization of Ella’s manufacturer Afaxys.

This information should be no more infuriating than the fact that all 18 categories of pharmaceutical contraceptives act in a way that can cause a fertilized egg to be expelled from the body. More on this topic here and here.

  1. “Emergency Contraception (Morning After Pill).” Emergency Contraception (Morning After Pill). Accessed May 21, 2015. https://web.archive.org/web/20100809110008/http://www.plannedparenthood.org/health-topics/emergency-contraception-morning-after-pill-4363.htm#.
  2. Bastianelli, Carlo, and Manuela Ferris. “Emergency Contraception.” Expert Rev of Obstet Gynecol 6, no. 5 (2011): 569-76.
  3. Olive, DL. “Role of Progesterone Antagonists and New Selective Progesterone Receptor Modulators in Reproductive Health.” Obstet Gynecol Surv. 57, no. 11 (2002): S55-63.
  4. “Prescribing Information.” : Mifeprex (mifepristone) Medical Abortion Pill (ru486). Accessed May 21, 2015.
  5. “Ella Full Prescribing Information.” Accessed May 21, 2015. http://www.ellanow.com/pdf/ella-full-prescribing-information.pdf.
  6. Hammas, Stephen R., and Laurence L. Brunton. “Ella: A Newly-Approved Selective Progesterone Receptor Modulator.” Access Medicine from McGraw Hill. Accessed May 21, 2015. http://www.medscape.com/viewarticle/735277.
  7. “CHMP Assessment Report for Ellaone.” European Medicines Agency Evaluation of Medicines for Human Use, 2009. Accessed May 20, 2015. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/001027/WC500023673.pdf
  8. DAYA, S. (1989), Efficacy of progesterone support for pregnancy in women with recurrent miscarriage. A meta-analysis of controlled trials. BJOG: An International Journal of Obstetrics & Gynaecology, 96: 275–280. doi: 10.1111/j.1471-0528.1989.tb02386.x
  9. “Causes.” Pregnancy Loss. Accessed May 21, 2015. http://www.pregnancyloss.info/causes.htm.
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The Death of “Life Begins at Conception”

The Death of “Life Begins at Conception”

Photo by: Ed Uthman

He who defines the terms, wins the debate. — Confucius

The HHS debate has fueled countless conversations about women’s health. One of the most prominent of these discussion surrounds the ‘mechanisms of action’1 of the birth control pill, emergency contraception and IUDs. One side says the pill has the potential to be an abortifacient. The other side says this is impossible because the pill prevents pregnancy and does not destroy it. Each side claims science. Each side claims logic. And each side claims to be on the side of women.

Logically, both sides cannot be true. After all, if you have scientific proof in our postmodernist society, what else do you need? Yet both dig in their ideological heels and will not budge. All the science in the world cannot clear up the debate for one simple reason — each side is using the same language to mean different things.

Those who claim the abortifacient potential of hormonal contraceptives, do so because they believe that “life begins at conception,” (by which they mean ‘fertilization’). From their perspective, through fertilization a new life is created, but is prevented from implanting on the uterine wall due to an inhospitable endometrium caused by the pill. That life is therefore lost and an early-term chemical abortion has taken place.

Those who deny the claim that the pill is abortifacient, don’t even acknowledge the issue of life in their argument. Rather, they employ the turn of phrase “a clinically recognized pregnancy” to refer to the moment when a fertilized egg implants on the uterine wall. According to their logic, since the pill cannot terminate a ‘clinically recognized pregnancy,’ it cannot be an abortifacient.

See the problem?

The question of the abortifacient nature of the pill depends on whether you are referring to the termination of a ‘clinically recognized pregnancy’, or the termination of a life. The true disagreement is over the definition of conception and it’s relationship to the beginning of pregnancy.

A Simple Habit of Speech

The Guttmacher Institute states, “According to both the scientific community and long-standing federal policy, a woman is considered pregnant only when a fertilized egg has implanted in the wall of her uterus.”2 This confidently definitive statement ignores the fact that of the four major medical dictionaries used in the United States since 1900 (Dorland’s, Stedman’s, Taber’s and Mosby’s), three of them currently define pregnancy as beginning with fertilization, and not implantation.3

Throughout the 20th century, definitions of both pregnancy and conception have evolved, but the major shifts can be traced to political influence rather than medical advancements in the field of gynecology. In 1963, Dr. Bent Boving published a book suggesting that pregnancy should begin at implantation rather than fertilization. He remarked, “the social advantage of [the pill] being considered to prevent conception rather than to destroy an established pregnancy could depend on something so simple as a prudent habit of speech.”4 Two short years later, in 1965, the American College of Obstetricians and Gynecologists (ACOG) published it’s first Terminology Bulletin which proliferated Boving’s definition: “conception is the implantation of a fertilized ovum.”5

Medical dictionaries reflected this debate as well, but only temporarily. In all four of the dictionaries, the definitions of both pregnancy and conception were directly linked with fertilization. Dorland’s changed their definitions to refer to implantation in 1981, but changed it back in 2000. Stedman’s similar changes only lasted from 1972-1982. Taber’s Dictionary consistently defined conception and pregnancy in terms of fertilization until the 2 most recent editions published in 2001 and 2005. Mosby’s Dictionary has consistently defined conception and pregnancy in terms of fertilization and has not changed at all.

Long-Standing Federal Policy

Guttmacher also touted, “long-standing federal policy” as grounds for the understanding that implantation marks the beginning of pregnancy. Federal policy is political, not scientific. It reflects agendas of partisanship, not advances in science. Policy is rarely objective, and certainly is not ordered toward, or constrained by the scientific method. Rather it uses expedient theories as the foundation for whatever suits its ends best. The federal definition of pregnancy only exists because the winds of culture blew it into the limelight. Scientific fact had very little to do with it.

Curiously, scientific fact also appears to have had little to do with the definition changes in the medical community. There were no major medical advances in the field of gynecology that lead to Dr. Bent Boving’s suggestion to shift the definition of pregnancy in 1963. The same is true of the ACOG’s decision to publish the terminology bulletin in 1965. In a subsequent ACOG publication, Dr. Richard Sosnowski — head of the Southern Association of Obstetricians and Gynecologists — voiced his concern over these unwarranted changes saying, “…with no scientific evidence to validate the change, the definition of conception as the successful spermatic penetration of an ovum was redefined as the implantation of a fertilized ovum. It appears to me that the only reason for this was the dilemma produced by the possibility that the intrauterine contraceptive device might function as an abortifacient.” 6

If medical discovery was not the impetus for the change, what was it that provided the motivation? A few years prior to Dr. Boving’s statement, the FDA first approved the birth control pill to be marketed as a contraceptive. By 1962, 1.2 million women were using the pill. In 1965, the supreme court case Griswold v. Connecticut, nullified state laws across the country by giving married couples the right to use hormonal birth control citing patient confidentiality.7 Following that ruling, it is estimated that the number of married women on the pill jumped to 6.5 million, with hundreds of thousands of unmarried women also able to obtain prescriptions.8 This is the cultural context in which the ACOG released its first terminology bulletin, effectively evading all medical dictionaries’ input, and perpetuating a “prudent habit of speech.” Today, the ACOG is regarded as an authority on gynecological health, independent and superior to all other sources. It is solely from the definitions set out by the ACOG, without regard to many other qualified sources, that Guttmacher claims ‘medical consensus.’

The Question of Life

In its journal, The Guttmacher Report on Public Policy, the author explains the evidence for the perceived medical consensus. Her introductory sentence reveals an attitude that further affects the phrase “Life begins at Conception.” She says, “The question of when life begins is an eternal one, debated by philosophers and theologians for centuries, and likely destined to forever elude consensus. However, on the separate but closely related question of when a woman is considered pregnant, the medical community has long been clear: Pregnancy is established when a fertilized egg has been implanted in the wall of a woman’s uterus.”

In one sentence, “Life” is removed from the realm of science and relegated to the ambiguous world of the philosophers; pregnancy alone has been deemed scientifically quantifiable. This removal relativizes key terms and makes possible other semantic shifts in the abortion debate. The result is that, while each side uses the same terms, these terms no longer have an objective definition, but mean whatever the speaker wants them to mean.

In reality, while the question of ‘existence’ has been the realm of the philosophers, ‘life’ is a biological reality. Dr. Maureen L. Condic discusses, in great detail, the development of the human organism using the kinds of criteria scientists employ to distinguish different cell types. In her paper, “When Does human Life Begin? A Scientific Perspective,” she says, “Based on a scientific description of fertilization, fusion of sperm and egg in the “moment of conception” generates a new human cell, the zygote, with composition and behavior distinct from that of either gamete. Moreover, this cell is not merely a unique human cell, but a cell with all the properties of a fully complete (albeit immature) human organism; it is “an individual constituted to carry on the activities of life by means of organs separate in function but mutually dependent: a living being.”9

The fusion of the sperm and the egg (fertilization) takes place approximately one week before a “clinically recognized pregnancy” is established. Scientific advancement has been able to observe the behavior of the zygote, down to the second. And using established definitions of biology it is clear that a human organism (i.e. life) is present before implantation takes place.

Yet, by shifting the definition of pregnancy a mere seven days, and relegating ‘life’ to an ethereal concept, some have attempted to render the phrase, “Life begins at Conception” as scientifically irrelevant and medically invalid.

So, is the pill an abortifacient? The answer is all about the definitions.

  1. Articles on this site have discussed, at length, the ‘mechanisms of action’ of the pill. You can find them here and here. A paper on the subject, published by the Stanford University Medical Center written by an MD can be found here.
  2. Gold, Rachel. “The Implications of Defining When a Woman Is Pregnant.” The Guttmacher Report on Public Policy 8, no. 2 (2005). Accessed January 1, 2015. https://www.guttmacher.org/pubs/tgr/08/2/gr080207.html.
  3. Gacek, C. “Conceiving Pregnancy: U.S. Medical Dictionaries and Their Definitions of Conception and Pregnancy.” The National Catholic Bioethics Quarterly, 2009, 541-555.
  4. Boving, B.G. “Implantation Mechanisms.” In Mechanics Concerned with Conception, edited by C.G. Hatman, 386. Pergamon Press, 1963.
  5. “Terms Used in Reference to the Fetus.” American College of Obstetricians and Gynecologists Terminology Bulletin 1 (1965).
  6. Sosnowski, Dr. Richard. “The Pursuit of Excellence: Have We Apprehended and Comprehended It?”American College of Obstetrics and Gynecology 150, no. 2 (1984): 117.
  7. “A Brief History of the Birth Control Pill.” PBS.com. http://www.pbs.org/wnet/need-to-know/health/a-brief-history-of-the-birth-control-pill/480/.
  8. Elizabeth, Watkins. On the Pill: A Social History of Oral Contraceptives, 1950-1970. Baltimore, Maryland: Johns Hopkins University Press, 2001.
  9. Condic, Dr. Maureen. “When Does Human Life Begin? A Scientific Perspective.” White Paper 1, no. 1 (2008).
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Rachel Held Evans (a self professed pro-life, woman of faith, Christian feminist) recently wrote a blog entitled “Privilege and the Pill.” She wished to express her opinion, “as a pro-life woman of faith who supports affordable access to birth control.” Denny Burke and Andrew Walker wrote a response here 1 addressing the political concerns which prompted her blog. However, there were many additional points in Mrs. Evan’s piece that needed to be addressed. Continue reading

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