Articles that focus on the risks of contraception, only focus on one risk at a time, and always conclude that the benefits of contraception outweigh the risk. But the risks don’t come one at a time. Weigh carefully! #Ditchtherisk
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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.
- “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#. ↩
- Bastianelli, Carlo, and Manuela Ferris. “Emergency Contraception.” Expert Rev of Obstet Gynecol 6, no. 5 (2011): 569-76. ↩
- Olive, DL. “Role of Progesterone Antagonists and New Selective Progesterone Receptor Modulators in Reproductive Health.” Obstet Gynecol Surv. 57, no. 11 (2002): S55-63. ↩
- “Prescribing Information.” : Mifeprex (mifepristone) Medical Abortion Pill (ru486). Accessed May 21, 2015. ↩
- “Ella Full Prescribing Information.” Accessed May 21, 2015. http://www.ellanow.com/pdf/ella-full-prescribing-information.pdf. ↩
- 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. ↩
- “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 ↩
- 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 ↩
- “Causes.” Pregnancy Loss. Accessed May 21, 2015. http://www.pregnancyloss.info/causes.htm. ↩
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
The following article is not meant to endorse or disparage any political position or candidate. Rather, it is meant to help us examine ourselves and motives in the light of a recent events.
During a recent appearance on Fox News’ “Huckabee,” presidential hopeful Mitt Romney stated that he was in favor of the Personhood Amendment, which declares that human life begins at conception. Shortly after this, Romney was at a town hall meeting in Iowa where a woman stood up and voiced her concern that the Personhood Amendment would outlaw hormonal contraception, which is used by millions of women. Without missing a beat, Romney responded that he was not against hormonal contraception. He was against anything that effected life after conception, “contraception prevents conception. I am not against that.” The concerned citizen continued and urged Romney to have staff look into this statement because it is known that hormonal contraception prevents implantation, not always conception. He smiled, said thank you and changed the subject. Continue reading
In July 2011, the American Journal of Obstetrics and Gynecology released a pamphlet stating several doctors’ endorsement of Intrauterine Devices (IUD) as “as safe and effective birth control.” IUDs were once unpopular in the United States, nevertheless, use has persevered. Physicians are starting to recommend IUDs more frequently, especially non-hormonal, copper IUDs. However, as Delicia Yard of ClinicalAdvisor.com points out, “The devices may raise the risk of pelvic inflammatory disease and subsequent infertility.” Prescribing information for a popular IUD lists these common side effects: headache, abdominal/pelvic pain, irregular bleeding, depression, migraine, nausea, acne, back pain, genital tract infection, ovarian cysts, dysmenorrheal, breast pain, and unintentional expulsion of the device. Despite this, it has been said that IUDs are “the most cost-effective form” of birth control available.
How does this newly popularized birth control stand up to the Billings Ovulation Method (BOM)? Continue reading
Recently, the news has been full of stories on a contraceptive medication for males. Researchers seek to “even the playing field” when it comes to contraception options. Development of a male birth control pill is being explored, but many methods being considered are not pills at all. No matter the prescription, there are some important things to know about the options being pursued.
I have just been doing my daily research on birth control/family planning in the news. I come across all kinds of interesting studies and articles. Today I found one called, “My Big Fat Feminist Pregnancy.” I debating taking the time to read it, but decided to see what this feminist was writing about. It all centers around control: control of one’s body, control of ones decisions, control of one’s fertility, control of one’s career after children… CONTROL. She is not combative about it, but I read it feeling sad for this woman. Sad that she sees the only way of “controlling” fertility is the pill, sad that she fears her beloved career suffering because of her baby. Here are my responses…