by Marilyn Henderson, RN Freda M. Bush, MD

Medical Institute for Sexual Health
Website: www.medinstitute.org Email: This email address is being protected from spambots. You need JavaScript enabled to view it.

A recently released policy statement by the American Academy of Pediatrics encourages Pediatricians to counsel adolescent patients regarding contraception in order of effectiveness. The most effective contraception is the progestin implant and the second most effective device is the intrauterine device, or IUD. Historically, IUDs were not used in nulliparous women (those who had not previously given birth), nor in women outside of a monogamous relationship. The uterine cavity is usually larger in women who have already carried a pregnancy and it was believed that a smaller uterine cavity would not tolerate a foreign object well, expelling the IUD and increasing the risk of pregnancy. The concern for women who were not monogamous was the increased risk for sexually transmitted infections that could develop into pelvic inflammatory disease.

Additionally, patients who believe that life begins with conception, need to be counseled that although the chemicals included with the IUD (copper or progestin) are designed to inhibit sperm from reaching an egg, IUDs also affect the lining of the uterus, making it undesirable for implantation, if conception does occur.^1,2 In addressing the concern of conception occurring with an IUD in place, the Technical Report of the Academy of Pediatrics simply skirts the issue like this:

"The primary mechanism of action of both types of IUD is preventing fertilization by inhibiting sperm motility. The levonorgestrel IUDs also thicken cervical mucus. All mechanisms occur before implantation, when pregnancy begins, and inhibiting implantation is not believed to be a primary mechanism of action for either type of IUD."³

The report does not leave room for personal opinions and beliefs about when pregnancy begins, but simply states that pregnancy begins with implantation. Since the copper IUD, Paragard, is approved for use as an emergency contraception, there is even more concern for those who view the IUD as an abortive method of birth control. Paragard is reported to be 99% effective in preventing pregnancy,⁴ if inserted up to five days following unprotected intercourse.³ Medical Institute's greatest concern for IUD use in teens is sexually transmitted infections, which can lead to pelvic inflammatory disease and infertility (the inability to achieve pregnancy when desired). This concern is addressed in most of the current literature, but is not seen as a contraindication for IUD use. Interestingly, the CDC's fact sheet on PID⁶ lists the following risk factors for PID:

1. Have an STD and do not get treated;
2. Have more than one sex partner;
3. Have a sex partner who has sex partners other than you;
4. Have had PID before;
5. Are sexually active and are age 25 or younger;
6. Douche;
7. Use an intrauterine device (IUD) for birth control

Just being a sexually active teen is a risk factor for PID. When the IUD is inserted, a second risk factor is added. Another CDC Fact Sheet, "Sexually Transmitted Infections Among Young Americans", points out that "many young people have multiple sex partners", indicating that risk factors numbers 2 and 3 for PID might also be a concern. And finally, the Fact Sheet mentions that many infected teens are often unaware that they have an STI and have not had the proper screening for Chlamydia, indicating risk factor number 1. With five out of seven risk factors for PID specifically being a concern among teens, one must wonder about any recommendation for IUD use in youth.

The American Academy of Pediatrics Technical Report continues the mixed message with statements like this: "...past associations between infertility and IUD use among nulliparous women were attributable to STIs rather than IUDs"³(page e1262) and the CDC Practice Recommendations states, "Although women with STDs at the time of IUD insertion have a higher risk for PID, the overall rate of PID among all IUD users is low."⁵

The answer to the problem of STIs from both the CDC and the Academy of Pediatrics is condoms. Both organizations recommend that all patients be counseled on the use of condoms, regardless of their choice of contraception to help prevent STIs. However, in 2013, only 8.8% of sexually active high school students reported using condoms along with another method of birth control⁸, perhaps indicating that with the fear of pregnancy gone, there is little motivation to use condoms.

Fifty percent of all new cases of STIs occur in young Americans from 15–24 years of age. Ignoring the increased risk for PID and resulting infertility for the sake of preventing teen pregnancy is not in the best interest of our youth. Therefore, MI does not agree with the recommendation for IUD placement in adolescent girls.

References:

1). "ParaGard T380A Intrauterine Copper Contraceptive", Rev 6/2013, ParaGard – FDA prescribing information, side effects and uses, Retrieved Oct 2014 from Drugs.com, http://www.drugs.com/pro/paragard.html
2). Skyla (levonorgestrel-releasing intrauterine system, full prescribing information, Retrieved from website Oct. 2014, www.skyla-us.com
3). Ott Mary, et al, Committee on Adolescents, "Contraception for Adolescents: Technical Report," Pediatrics: Official Journal of the American Academy of Pediatrics, 2014;134;el257; originally published online September 29, 2014; DOI: 10.1542/peds.2014-2300. Retrieved Oct. 2014. (quote: p. e1262)
4). Belden P & Harper C, "The Copper IUD for Emergency Contraception, a Neglected Option," (Editorial), Contraception 85(2012) 338-339 
5). CDC, "U.S. Selected Practice Recommendations for Contraceptive Use, 2013: Adapted from the World Health Organization Selected Practice Recommendations for Contraceptive Use, 2nd Edition," prepared by: Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion, Morbidity and Mortality Weekly Report, Recommendations and Reports/Vol.62/No.5, June 21, 2013. (quote: p. 10) 
6). CDC, "Pelvic Inflammatory Disease (PID) – CDC Fact Sheet", Retrieved Oct 2014 at http://www.cdc.gov/std/pid/stdfact-pid.htm 
7). CDC, "Sexually Transmitted Infections Among Young Americans", July 2014. Retrieved Oct 2014 from http://www.cdc.gov/nchhstp/newsroom/2013/SAM-Infographic-2013.html?s_cid=nchhstp-nr-sam-008 
8). CDC, "Youth Risk Behavior Surveillance – United States, 2013," Morbidity and Mortality Weekly Report, June 13, 2014, Surveillance Summaries/Vol.63/No.

Reprinted with permission from the Medical Institute for Sexual Health: Marilyn Henderson, RN (1st Author listed) and Freda M. Bush, MD (2nd Author listed).

Despite the abundant availability of sterilization procedures, male and female condoms, spermicides in the form of gels, creams, foams, and films, sponges, cervical caps,diaphragms, copper and hormonal IUDs, a plethora of hormonal contraceptive drug combinations available as tablets, patches, vaginal rings, implants, and injections, and three approved “emergency contraception” tablets, half of all pregnancies in the United States are still unplanned. 

What is the solution? According to the Population Council, it is another contraceptive drug regimen.

This commentary is written to briefly evaluate an article titled, “Vaginal ring delivery of selective progesterone receptor modulators for contraception,” written by Dr. Jeffery T. Jensen of Oregon Health and Science University and published in Contraception¹. To provide some background, research is being conducted on the use of a drug called ulipristal—the active agent in ella®—through a ring inserted vaginally to prevent pregnancy by inhibiting ovulation.

This research is being conducted by the Population Council, which was founded in 1952 with the stated mission of helping “achieve a humane, equitable, sustainable balance between people and resources.”

Ulipristal belongs to a group of drugs called Selective Progesterone Receptor Modulators (SPRMs). The first SPRM approved for use in the United States was mifepristone, which is commonly known as “the abortion pill.” Mifepristone is effective at terminating implanted, growing pregnancies due to its ability to block progesterone, an essential hormone for pregnancy. Blocking of progesterone by mifepristone results in fetal detachment from the placenta, which is followed by vaginal expulsion of the fetus.

SPRMs such as ulipristal and mifepristone can both suppress ovulation as well as terminate implanted pregnancies. The manner in which they act depends primary on the timing of administration (when it is taken within a woman’s cycle), and potentially the serum concentration (amount of drug in the body).

Upon review of Dr. Jensen’s article, there are two primary concerns. First, women will be given a drug marketed to prevent contraception that also possesses an established capability to terminate implanted pregnancies. Second, SPRMs such as ulipristal have questionable safety for women, especially with long-term use. Both concerns will be briefly discussed in the following paragraphs under the topic headings, “Risk to Pregnancies,” and, “Risk to Women.”

Risk to Pregnancies

Dr. Jensen’s article stated that 32% of test patients (25 out of 78 women) still ovulated despite the use of ulipristal vaginal rings. There was no discussion on if pregnancies occurred in the 25 women who ovulated, nor was there a description of the outcomes for these pregnancies if any did occur. The future goal was identified to be a tripling of the dose of ulipristal given to women in order to decrease the percent of women who ovulate to 10%, but this is still a high percentage of women who may become pregnant, especially given the following: Ulipristal is proposed to be given on a daily basis via a vaginal ring inserted for three months. Women who do achieve pregnancy despite use of ulipristal, then, will expose their embryo/fetus for two months to a drug known to be “embryotoxic at low doses.”²

Furthermore, since the absence of menstruation is typical in women using ulipristal vaginal rings, women could be unaware of their pregnancy for months. Therefore, beyond the fetal risk from direct daily exposure to ulipristal, the fetus could also be exposed to risky behavior (including drug and alcohol use), and denied standard prenatal care simply because the mother is unaware of her pregnancy.

None of these concerns were addressed in the article.

Risk to Women

There are two key risks to women posed by use of SPRMs. The first risk is infection, which is increased due to a suppressed immune system and the potential for a deceased fetus, which would serve as a medium for bacterial growth prior to its vaginal expulsion. The second risk is related to changes in the lining of the endometrium, or wall of a woman’s womb.

SPRMs are well-documented to produce antiglucocorticoid effect, which means they suppress the immune system. The Department of Health and Human Services’ Emerging Clostridial Disease Workshop found that mifepristone’s effect on the immune system resulted in the “clinical findings of rapid fulminating lethal shock syndrome” that was neither preventable nor treatable.³ It is established that ulipristal has a “high affinity” for progesterone and glucocorticoid receptors. The concern for ulipristal to have antiglucocorticoid effects was mentioned in the article, but no evaluation of this concern was provided.

Dr. Jensen’s article stated SPRM-associated endometrial effects “were frequently observed,” and were reported in 41% of women using the ulipristal ring. Since the endometrial effects such as endometrial hyperplasia or cancer are dose-dependent, it is reasonable to assume higher concentrations of ulipristal will result in a higher incidence of this adverse effect. Therefore, in the future it can be expected to have a greater risk when the dose is tripled in an effort to increase the percentage of women who will not ovulate. According to the article, a six-month study is being conducted to evaluate the long-term safety of using ulipristal vaginal rings, but this timeframe is unrealistically short.

In conclusion, development of SPRMs has been highly controversial due to their innate ability to terminate implanted pregnancies and the risks they pose to women. Nonetheless, SPRMs have been rushed through the FDA approval process under the subpart H, which is a fast-track reserved for “new drugs to treat serious or life-threatening diseases.”⁴

The push to develop ulipristal as “contraception” is being completed without evident concern for fetal effects and in an apparent absence of appropriate communication to patients about ulipristal’s ability to terminate implanted pregnancies.

Concern for the risk to women due to ulipristal appears to be secondary to the priority placed on preventing unplanned pregnancies. While a goal of reducing unplanned pregnancies is commendable, realistically, unplanned pregnancies will never be completely eliminated—and maybe they shouldn’t be. When did unplanned pregnancies become equivalent to horrific diseases like cancer or the plague that would be worthy of risking women’s health and exposing fetuses to toxic agents?

As a pharmacist and a woman, I hope the scientific community can begin to take a more proactive approach to solving unplanned pregnancies, rather than continually pushing for chemical solutions that pose an often under-reported and under-studied risk to women and their fetuses.

Sources

1. Jeffrey T. Jensen , “Vaginal ring delivery of selective progesterone receptor modulators for contraception,” Contraception 86 (2012), http://www.contraceptionjournal.org/article/S0010-7824%2812%2900804-9/abstract (accessed March 11, 2013).

2. European Medicines Agency. CHMP Assessment Report for EllaOne. Document reference EMEA/261787/2009.

3. Department of Health and Human Services. Emerging Clostridial Disease Workshop. Summary of Proceedings. May 2006.

4. Code of Federal Regulations. Title 21, Chapter 1, Part 314, Subpart H, “Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses,” Sec. 314.500.

By Amy Scheuring, Executive Director, Women’s Choice Network

The recent barrage of news coverage following Susan B. Komen for the Cure’s proposed defunding of Planned Parenthood, as well as the Roman Catholic Church’s response to President Obama’s proposed healthcare mandate have many wondering: What’s wrong with contraceptives?

For over 50 years, we’ve heard that pills, injections, devices, and hormones will prevent “unwanted” pregnancy, protect women’s health and stop everything from AIDS to acne, creating a happy, healthy, and sexually fulfilled generation of men and women.  

After more than 40 years of government-subsidized contraceptives, why shouldn’t we welcome additional healthcare packages that require an assortment of miracle drugs and preventative hormones to be offered by every employer? Part of the answer lies in the stunning facts about the collective failure of these products to deliver on their promises:

• According to Planned Parenthood’s Guttmacher Institute, 53% of women obtaining an abortion were using birth control when they got pregnant.  
• At the Women’s Choice Network Centers, almost 65% of our pregnant clients were using birth control when they got pregnant.
• Hormonal birth control methods do not prevent STIs or AIDS, and condoms are virtually useless against many viral forms of STIs, such as Human Papilloma Virus (HPV).
• Teens using birth control pills and injectables feel safer, leading them to engage in sex more frequently than peers who are not using birth control.
• One highly touted study indicates that 99% of sexually active women ages 15-44 have used at least one form of birth control, but the fact remains that half the pregnancies in the U.S. are still “unintended.”

As we consider whether our future health care should include contraceptives, let’s remember that many who suffer because of a previous abortion or STI have relied on their false promises. The pursuit of true sexual intimacy—joyfully building a family and strengthening a lifetime commitment—has been replaced by a false notion that, given the proper health care, we can control or eliminate the inconvenient “outcomes” of sex.  

So, what’s wrong with contraceptives? Before we even enter into the moral, economic, or social arguments, the answer is clear: They simply don’t work as promised.

While contraceptives entrench themselves as the gateway drug to abortion, birth control proponents are still stuck in the mid-20th century, clinging to the hopeless assertions that if we just spend more, educate earlier and use birth control “better,” the desired outcomes will one day kick in.

After four decades of government-funded birth control, and all our best efforts to create a world where sex has no consequences, are we any better off? You decide.