Introduction:
Emergency contraceptives (ECs), the morning-after pill, have global sales over a billion dollars annually, with estimated 2020 sales in the U.S. exceeding $268 million. I estimate U.S. sales exceed 6 million units annually. With prices ranging from $1 to $50 depending on the country, those sales translate into tens of million doses taken globally per year.
Contraceptives, by definition, PREVENT CONCEPTION. If an antipregnancy drug does something else, it is not an honest contraceptive. There is a huge theological, philosophical, and moral gap between contraception and it’s alternatives. Products like Plan-B (levonorgestrel) have three fundamental mechanisms of action. The trouble is, a woman will never know which mechanism she benefited from unless she has an ectopic pregnancy (EP).
Mechanisms of Action:
- Prevents ovulation.
- Prevents conception.
- Prevents implantation (including EP).
If the woman has not ovulated as of the time of taking the product, it will prevent ovulation. While sperm are viable in the fallopian tubes for up to five days, the egg will not show up to meet them. That is contraception.
If the woman ovulates but has not conceived at the time of taking the product, it will prevent the sperm from penetrating the egg. There is only a very narrow window of time for this mechanism, as the egg is only viable for 12 to 24 hours after ovulation, sperm generally find it within minutes of sex, and it takes Plan-B 1-4 hours to reach peak blood levels. This window is so narrow that Plan-B would have to be taken hours before coitus to have enough time to reach peak blood levels and work. That would be contraception, but preplanned rather than on an emergency basis.
Conception can occur somewhere between two minutes and five days after intercourse. If the woman has conceived and a new human life is created, the EC can prevent that new life from implanting in the wall of the uterus. That, by definition, is an ABORTIFACIENT – stopping a process that has actively started. From fertilization to implantation takes about 6 days, during which the cells of the fertilized egg will have divided several times forming the blastocyst. The unborn child is alive for 6 days. AND, in the case of ectopic pregnancies, can develop for weeks without implanting, even to the point of neural tube formation. Furthermore, ECs do not reduce a woman’s chance of an ectopic pregnancy. Quite the opposite.
Summary:
Before oral contraceptive pills (OCPs) gained broad acceptance in the early 1970s with low dose products like 1974’s Ortho-Novum 1/35, America’s ectopic pregnancy rate was 4.5 per 1000 known pregnancies. That rate restabilized at about 10 per 1000 between 1977 and 1980. When OCPs with levonorgestrel, like Nordette and TriPhasil, were introduced in the early 1980s, the rate of EP rose and stabilized at about 16.5 per 1000 for 15 years. When high-dose levonorgestrel, in the form of Plan-B and similar EC products, was approved for OTC sales in 2006, the rate of EP jumped to 21.5/1000. In 2007 the ectopic pregnancy rate in women age 25-29, the prime reproductive years of their lives, jumped to 42.5/1000. This jump can neither be explained by old age nor chlamydial infections. In 1989 the CDC stopped reporting national rates of ectopic pregnancy. By 2007 all published data collection had stopped. While OCP, STI, pregnancies, miscarriages, and all sorts of other women’s health issues are intensely monitored by the CDC and others, ectopic pregnancy, a serious complication and potentially lethal medical condition, has vanished from the surveillance landscape. At the same time, all monitoring of the morbidities of emergency contraceptives has stopped (Dr. Kimberly Daniels ignores ECs in this 2018 study). In an age where anything that opposes free access to emergency contraception and abortion is politically incorrect, I want everyone to ask themselves why the sudden stop to surveilling general EC use and EP rates? Ischemic stroke rates with OCP use continue to be studied. The general availability of ECs and willingness of pharmacists to participate in their sale is widely studied. Why not the correlation of ECs to EPs, the greatest health risk of the drug?
The rate of ectopic pregnancy is directly related to the rate of conception. Women who take ECs have much higher rates of EP with much lower rates of known pregnancy based on the pre-EC/OTC standard of 16.5 EPs per 1000 know pregnancies. That implies that ECs are blocking fertilized eggs from gaining access to and/or implanting in the uterus. Any drug used for EC that reduces pregnancy rates by decreasing the chance of implantation is an abortifacient. This information, readily assumed 15 years ago, is utterly denied today with no good science to back up the claim. Beyond that, EP is the leading cause of death in early pregnancy and negatively affects future fertility. These are risks that if explained to all women would dissuade some from EC use.
Quick Facts:
- 30% of couples achieve pregnancy the first month they try. This is the best-case scenario for couples who time unprotected sex for procreation.
- 10% of couples have fertility problems and have significant difficulty in becoming pregnant.
- In 1970 0.45% of American pregnancies were ectopic.
- By 2006 2.15% of American pregnancies were ectopic.
- 2%-10% of pregnancies in women who use ECs are ectopic. 1, 2, 3
- The CDC stopped publishing ectopic pregnancy surveillance rates in 1989.
- All surveillance of general ectopic pregnancy rates stopped in 2007. There is no reason to believe ectopic pregnancy rates have not continued to rise.
- When interviewed in 2010, women ages 15-44 admitted to taking about 2 million doses of ECs per year.
- Estimated sales of ECs, based on 90% of the 62,000 U.S. retail pharmacies stocking the product and selling at least 100 units per year, are a minimum of 6 million units sold per year, meaning 2/3 of women are not willing to admit they took the product.
- 0.4% to 2% pregnancy rate, a risk reduction ranging from 95% to 75% compared to unprotected sex.
- Studies demonstrate no adverse effects for the baby if implantation occurs.
- Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic.
- There is no mention of the risk for decreased fertility rates following an EP.
- There is no mention that obese women with BMIs greater than 30 have a four-fold increase in pregnancy risk due to a 50% reduction in levonorgestrel blood levels.
The pregnancy rate reduction calculation uses an 8% risk of pregnancy as the standard risk for a single act of intercourse in the middle two weeks of a woman’s cycle. The manufacturer claims 0.4% of couples get pregnant when the woman takes Plan-B within 24 hours, a 95% reduction of the 8% risk. 0.9%-2% of couples get pregnant when the woman takes Plan-B by the 72-hour mark. Reported rates are higher.
This is how the expected risk works if 10,000 women have sex once:
- Pregnancy risk during menses (1st week of cycle), and the week preceding menses (4th week of cycle), placebo 0%, Plan-B 0%.
- Pregnancy risk during 2nd and 3rd week of cycle, placebo 8%, Plan-B 0.4% (1st 24 hours) to 4% (72 hours)
- Placebo results in 800 pregnancies, with 13 being ectopic (1.65% risk).
- Plan-B results in 40 to 400 pregnancies (depending on the women’s diligence and BMIs) with anywhere from 1 to 40 being ectopic (2.15% to 10% risk).
Ectopic Pregnancy: 1, 2, 3
Expected Maternal death rates:
An ectopic pregnancy occurs when a fertilized egg gets stuck somewhere, usually in the fallopian tube, and does not implant in the uterine wall. While the embryo is not viable it will grow, and without intervention can kill the mother. In 1970 the rate of ectopic pregnancy in the U.S. was 4.5/1000 pregnancies. Following the advent of safer, low-dose birth control pills such as Ortho-Novum 1/35 in the early 1970s, ectopic pregnancy rates steadily rose until plateauing at about 10/1000 between 1977 and 1980. When levonorgestrel OCPs, such as Nordette, entered the market in 1982, the rates rose again to about 16.5/1000 pregnancies. This increase was blamed primarily on a combination of the increasing age of women at the time of pregnancy (respective means of 21.4 years in 1970 and 23.7 years in 1985) and increasing rates of STIs (chlamydia) in a more sexually liberal society, with a passing nod to progestins. Unfortunately, while chlamydial infections increased from 35.2/100,000 in 1986 to 332.5/100,000 in 2005 (1, 2), ectopic pregnancy rates remained relatively flat during that time period. The ectopic pregnancy rate hovered around 16.5/1000 pregnancies until 2006. The CDC stopped publishing statistics on ectopic pregnancy in 1989, and data beyond 2007 is impossible to find.
In those years where chlamydial infections and ectopic pregnancies were both surveilled there is no evidence that rising chlamydial infection rates affected ectopic pregnancy rates. Plan-B was granted OTC status in 2006.
Plan-B was released in 1999 and gained OTC status in 2006. During the seven-year period from 1999 to 2005, ectopic pregnancy rates remained flat but then showed a 25% increase that coincided with Plan-B’s approval for OTC sales. The manufacturer, Barr Pharmaceuticals, anticipated an immediate doubling in sales by gaining OTC status. There was also a massive, unexpected 2007 spike in ectopic pregnancies in the 25-29 group (42.5/1000) that neither age nor chlamydial infections can explain. And that, coincidentally, is when all tracking of general rates of ectopic pregnancies ended.
Fertility rates are also negatively impacted by EP. In the non-EP population, 90% of couples succeed in becoming pregnant within 12 months. It takes couples who have experienced an EP 18 months to achieve a 65% pregnancy rate.
Why Ectopic Pregnancy Matters When Discussing Emergency Contraceptive’s Abortifacient Properties
There is a statistical relationship between conceptions, known pregnancies, and ectopic pregnancies. If ectopic pregnancy rates are higher than normal with women who take ECs, that implies the implantation/conception ratio is higher than normal, meaning fewer implantations than expected. A drug that increases the rate of failed implantation is a moral concern to many religious.
Between 2006 and 2010 there were:
- 20,970,000 births in America. (US Census)
- 4,049,515 abortions. (CDC)
- With an estimated 15% miscarriage rate, there were approximately 29,434,000 known pregnancies.
- The March of Dimes estimates up to 50% of all conceptions are unknown to women due to early failure. That implies up to 58,800,000 conceptions occurred between 2006 and 2010.
- 11% of the women ages 15-44 (5,800,000) admitted at least one use of an EC, nearly a three-fold increase from 2002. This number is under-reported, as it requires a woman to kiss-and-tell, so to speak.
- (under)Reported use: 59% once, 24% twice, 17% three or more times. This is about 1.66 uses per woman, or about 2 million doses per year.
- With a rate change from 1.65% to 2.15% (or higher), the five year period from 2006 to 2010 had a minimum total of 632,000 ectopic pregnancies, an adjusted increase of about 152,000 from the previous 5 year period.
- With a statistical all-use EC failure rate of 2% (0.4-4% has been reported), that is an estimated 200,000 pregnancies in women who took ECs for those 10 million doses.
- Industry estimates of ectopic pregnancies among women taking ECs range from 4,000 to 20,000 (2-10% of known pregnancies), resulting in 2 to 8 maternal deaths.
While the 2006-10 time period does show a net reduction of abortions by 72,227 (that time period had a net increase in live births of 93,408) that number is more than offset by the adjusted increase of 151,882 ectopic pregnancies, resulting in a net baby-loss of 79,655 for the 5 year period.
Today’s estimate that 2.15% of pregnancies in North America are ectopic is based on only two data points from 2006 and 2007. That data states that for every 49 known pregnancies, there is 1 ectopic pregnancy. This is over a 300% increase since 1974 when the first safer, low-dose birth control pills became available. It is a 25% increase since Plan-B was first approved by the FDA in 1999.
In 2013 Dr. Kimberly Daniels did a comprehensive review of EC usage from 2006 to 2010. She broke EC use down by age, number of uses per woman, reason for use, and personal demographics. She determined a total of 5.8 million women, and 1.64 million women age 25-29, admitted taking an EC between 2006 and 2010. Do you know what she did not do? She did not ask about failure rates, ectopic pregnancy rates, abortions, or live births, the biggest health risks that exist with using ECs. Virtually all maternal deaths associated with levonorgestrel will be associated with ectopic pregnancy, abortion, or live birth.
In 2007 there were 10,226,000 women ages 25-29 in the U.S. 54% were married, with another 10-12% cohabitating, and only around 7% not sexually active at all. With an average of 60 sexual encounters per year, this group of women had sex about 500 million times. They led the nation with 1,208,000 births. They had 218,836 abortions. With a 15% miscarriage rate, they had 1,678,630 known pregnancies. They also led the nation with an estimated 71,000 ectopic pregnancies, over twice the 1998 expected rate. We can also guestimate that an absolute minimum of 4% of women ages 25-29 took at least one dose of EC that year, in excess of 400,000 doses. This would, in theory, result in 1,600 to 16,000 known pregnancies and 32 to 1600 EPs. Using 1998 EP rates, similar EPs in women who did not use ECs would have corresponded to pregnancies at a rate of 100 known pregnancies per 1.65 ectopic pregnancies, or 2000 to 100,000 pregnancies. Again, in theory, as a factor of ectopic pregnancies, the difference between pregnancies expected in women using ECs (1,600 to 16,000) and pregnancies expected in women NOT using ECs (2000 to 100,000) are failed implantations and thus chemically induced abortions.
Personally, I believe 400,000 doses taken is far below the real number. Triple it. About 90% of the 62,000 retail pharmacies across the United States stock emergency contraceptives and most sell in excess of 100 units per year. Every Walgreen’s store I worked at easily sold several units per day. If I were to guess, emergency contraceptive sales in the U.S. are at a minimum of 6 million units annually. 6 million doses would result in 24,000 to 240,000 known pregnancies and 480 to 24,000 ectopic pregnancies, helping explain the massive spike in 2007 among women ages 25-29. In 2007 107 women died due to complications from EP. Statistically, up to 9 of those cases can likely be traced back to emergency contraceptives.
Discussion:
Frankly, the exact numbers are not what’s important. What’s important is women do not know the moral, mental health, and physical health risks of relying on Plan-B as their A plan when date night turns into a spontaneous sexual encounter. No one is telling them the truth. Not NARAL, not Planned Parenthood, and not their local women’s health clinic or university health center. While some women are ambivalent, others see it as a moral line they would not cross if the truth be known. I had a female patient call me about a year ago, asking how Plan-B worked. When I explained its mechanisms of action, she burst into tears. She and her indiscretion had counted on Plan-B to be an honest contraceptive. Now she will never know.
Plan-B hit the market over 20 years ago. The original professional education modules available to pharmacists were honest about Plan-B’s mechanisms of action. That information caused a backlash in the profession. A lot of pharmacists are Christians, and providing abortifacients is against our religion. We have the inalienable right to conscientiously object and not be forced to participate. Groups like NARAL immediately began an active campaign harassing pharmacists for practicing their faith. Having spent most of my career in Portland, Oregon, I have endured my share of activist attacks, believe me. The campaign’s results are a mixed bag, with the biggest result simply revealing how evil, hateful, amoral, and manipulative people who promote abortion can get. In general, Christian pharmacists didn’t respond to the intimidation in the way NARAL hoped, but chain drug stores did.
Ultimately NARAL and their ilk found a workaround. The anti-life, pro-abortion crowd makes up half our country and the majority of our government and institutions of higher education. It was fairly easy for them to simply revise the truth and blandly state, without any proof, that Plan-B does not block implantation if conception occurs. It is a Big Lie moment. This “nothing to see here” falsehood has been repeated so many times, from the top down, that only old-school folks like me remember the pharmacology as originally taught. Research and publication on general ectopic pregnancy rates in the U.S. population have completely stopped. The CDC is no longer interested in publishing these rates, and will not touch ectopic pregnancy’s relationship to emergency contraceptives. No one will. It is really no different than Fake News media covering up Joe Biden’s age-onset dementia. Saying he is mentally intact over and over does not change that his brain is in an active state of decay. The numbers simply do not add up.
A note to any professional nay-sayers. There is only one way to prove me wrong. Try to prove me right and fail. Self-affirming, echo-chamber biases are worthess. To achieve this you will need the EC manufacturers to tell you how many units are sold to American pharmacies on an annual basis. Then you will need the CDC to require manditory reporting of all morbidity and mortality (pregnancies, ectopic pregnancies, abortions, live births, and maternal deaths) associated with the use of high dose levonorgestrel. That would require all providers of prenatal care to interview patients regarding EC use, all Planned Parenthood clinics to report data candidly (LOL! – you are talking about people so evil they traffic in dead baby parts), all providers treating EP to interview patients regarding EC use, AND a brazenly honest patient population who actually remember what cycle day they took the EC and will openly admit, “I hooked up on Tinder, took Plan-B, got pregnant anyway and had an abortion.” Then you will have to tell the truth about your findings. Good luck with that.
References:
- https://www.aafp.org/afp/2000/0215/p1080.html
- https://www.aafp.org/afp/2004/0815/p707.html
- https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021998lbl.pdf
- https://www.bmj.com/rapid-response/2011/11/02/ectopic-pregnancy-after-progesterone-only-emergency-contraception
- https://www.cdc.gov/mmwr/preview/mmwrhtml/00031632.htm
- https://www.cdc.gov/mmwr/preview/mmwrhtml/ss6001a1.htm
- https://www.cdc.gov/mmwr/volumes/68/ss/ss6811a1.htm#T23_down
- https://www.cdc.gov/nchs/data/databriefs/db112.pdf
- https://www.cdc.gov/nchs/products/databriefs/db327.htm
- https://www.cdc.gov/std/stats/archive/Surv2005.pdf
- https://www.census.gov/data/tables/2007/demo/age-and-sex/2007-age-sex-composition.html
- https://www2.census.gov/library/publications/2010/compendia/statab/130ed/tables/11s0080.pdf
- https://www.census.gov/prod/2011pubs/p70-125.pdf
- https://ectopic.org.uk/patients/trying-to-conceive/
- https://www.everycrsreport.com/reports/RL33728.html
- https://www.globenewswire.com/news-release/2019/08/23/1906065/0/en/Global-Contraceptive-Pills-Markets-2013-2018-2019-2024.html
- https://www.globenewswire.com/news-release/2020/10/05/2103778/0/en/Global-Emergency-Contraceptive-Pills-Industry.html
- https://www.marchofdimes.org/complications/miscarriage.aspx
- https://www.mayoclinic.org/diseases-conditions/ectopic-pregnancy/symptoms-causes/syc-20372088
- https://www.mayoclinic.org/diseases-conditions/pregnancy-loss-miscarriage/symptoms-causes/syc-20354298
- https://www.mayoclinichealthsystem.org/hometown-health/speaking-of-health/ectopic-pregnancy-signs-treatment-and-future-fertility
- https://www.medicalnewstoday.com/articles/chances-of-getting-pregnant-first-time-trying#after-first-year
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2598671/
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3093105/
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4944814/#R4
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5001799/
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- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6767325/
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- https://pubmed.ncbi.nlm.nih.gov/21496755/
- https://pubmed.ncbi.nlm.nih.gov/22270271/
- https://pubmed.ncbi.nlm.nih.gov/31447973/
- https://www.prnewswire.com/news-releases/global-emergency-contraceptive-pills-market-to-reach-us-12-bn-by-2022—persistence-market-research-643948633.html
- https://www.uptodate.com/contents/ectopic-pregnancy-epidemiology-risk-factors-and-anatomic-sites
- https://www.projectveritas.com/news/guilty-verdict-against-david-daleiden-as-abortion-industry-flexes-its-muscle/
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