Plan B or not Plan B.

On October 2 of 2001, the Pontifical Academy for Life taught that "from an ethical standpoint, the same absolute unlawfulness of abortifacient procedures also applies to distributing, prescribing, and taking the morning-after pill." Though strictly forbidden by Catholic Church teaching, the use of the morning-after pill, levonorgestrel (also known as Plan B) in cases of alleged rape is allowed in many Catholic hospitals in the U.S.A. Morally speaking, that use is strictly analogous to the example given by St. Thomas Aquinas, of a hunter shooting at something in the forest when not really sure that what he sees is an animal or a human being. If the hunter is not certain that a human being is not involved, it is gravely immoral to shoot.

Response to Church teaching

This Church teaching on Plan B is now quite openly and quite often debated, disregarded, or disobeyed. Ron Hamel and Michael Panicola, writing in Health Progress, Sep./Oct. 2002, a publication of the Catholic Health Association of the United States, stated that "emergency contraception (including the use of levonorgestrel) may be used in rape cases, provided previous pregnancy had been ruled out. They did not accept the hunter analogy, saying that the hunter is not sure if he is shooting at a deer or a human, whereas, in cases of sexual assault, the doubt is about whether there is anything there!" Furthermore, they maintain that the hunter intends to kill, but the doctor, in this case, has no intention to kill an embryo. They simply ignore and dismiss the possibility that the pill may cause an abortion. Daniel Sulmasy, M.D., head of Ethics at St. Vincent Medical Center, New York City, holds that "minimal risk acceptance" in medical practice allows the use of Plan B. It is true that one must balance risk against benefit when treating a disease. One wonders however, since when did a pregnancy or a potential pregnancy become a disease?

The scientific debate

Father Niconar Austriaco, O.P., in his article "Is Plan B an Abortifacient?" published in the winter 2007 issue of The National Catholic Bioethics Quarterly, stated that recent evidence suggests that levonorgestrel (LNG), "has little or no effect on post-fertilization events." That means, in other words, that it probably does not cause an abortion by preventing implantation of the embryo. He did admit, however, that to obtain the most accurate data on both the efficacy and the mode of action of Plan B, larger studies using transvaginal ultrasound in conjunction with an endocrine protocol described by Novikova et al (1) are needed. Despite this admission, Father Austriaco holds that the data to date cast serious doubt on the statistical claim that Plan B is an abortifacient.

Austriaco quoted another study that demonstrated that Plan B does not impair the ability of living human embryos to attach to endometrial tissue grown in the laboratory. (2)

In that study, embryos created by in vitro fertilization attached themselves to two different "endometrial constructs," one in the presence of plan B, and the other without Plan B. The embryo attachment rate was not lessened in the presence of Plan B. An "endometrial construct" is a simulation of normal endometrium grown by dissociating the epithelial and the connective tissue of endometria grown in culture on the surface of a gel. One wonders what exactly this experiment proves about the actual action of Plan B in a woman's body.

Father Austriaco criticized another study that suggested that Plan B caused abortion. (3) This study demonstrated that oral contraceptives decreased the thickness of the endometrium, and that such thinning had been shown to impede embryo implantation. The study concluded that Plan B would therefore make implantation difficult, possibly leading to an abortion. The study also argued that there is statistical evidence that Plan B, taken after ovulation, still reduces the expected number of pregnancies. Another more recent study (4) provided statistical evidence that suggests that levonorgestrel may cause an abortion. Father Austriaco counters that statistical and theoretical studies do not amount to demonstrative proof. He quoted a 2001 study by M. Durand et al. (5) that demonstrated that the histology of surgically sterilized women taking plan B was "indistinguishable from that of controls." This was interpreted as suggesting that Plan B would not, therefore, cause an abortion. On the other hand, a more recent study in 2005, also done by Durand et al., (6) suggested that levonorgestrel taken before the LH (luteinizing hormone) surge altered the luteal phase secretory pattern of glycodelin in the endometrium.

Hapangama et al. (7) suggest that levonorgestrel may have "a post fertilization, contraceptive effect." This, as human embryologists who have no conflict of interest know, is, in reality, prevention of implantation of the embryo, an abortion. Father Austriaco quotes the Durand et al, 2001, paper (8) as saying that levonorgestrel did not alter the presence of spiral arteries in the endometrium, a change considered crucial for implantation. This finding appears to be inconsistent with those of studies by Recep Yildizhan et al (9) and a study by Guttinger and Critchley (10)

Those studies showed that women who use the levonorgestrel-releasing system (LNC-IUS) showed significant thinning of the endometrium and a significant reduction in sub-endometrial blood flow in the spiral artery. The LNG-IUS is an intra-uterine device that releases levonorgestrel. It should be noted that the dose of Plan B given as a morning after pill is fifteen times that contained in an oral contraceptive pill. (11)

Although there is no direct experimental evidence that links oral contraception with embryo loss, oral contraceptives are known to thin the endometrium and to alter its biochemical and protein composition. An endometrium of average thickness of 5 to 13 mm is needed to maintain a pregnancy. The average endometrial thickness in women taking oral contraceptives is 1.1 mm. In another study, levonorgestrel taken before the LH surge altered the luteal secretory pattern of glycodelin in serum and the endometrium. (12) Furthermore, treatment with emergency contraceptive pills containing only levonorgestrel during the peri-ovulatory phase may fail to inhibit ovulation but, nevertheless, reduces the length of the luteal phase and the total luteal phase LH concentrations. This observation suggests a post-fertilization effect--an abortion. (13)

Father Austriaco also quotes a study (14) that claimed the researchers could have expected three or four pregnancies among women who had intercourse during the fertile period of their cycle and took Plan B after ovulation had occurred. They observed three, suggesting that Plan B was not effective in "preventing pregnancy after ovulation." An accurate use of words would have been "preventing fertilization or implantation after ovulation." They claimed to have obtained exact information about the time when each woman ovulated, using serum luteinizing hormone (LH), estradiol, and progesterone blood levels to calculate the day of ovulation. It is well known, however, that LH assay may fail to indicate the presence of a pregnancy, if taken too early in pregnancy. (15) It is also known that the test currently used to detect ovulation in the Peoria Protocol, used in many Catholic hospitals, relies on luteinizing hormone assay that may fail to indicate the presence of a pregnancy, and on plasma levels of progesterone that may fail to distinguish whether a woman is in the phase before, or after, ovulation. (16)

Dr. Robert Barbieri, chief of Obstetrics and Gynecology at the Brigham and Woman's Hospital, Boston, has stated that "by measuring hormone levels, doctors can often determine whether a woman has ovulated of whether implantation has occurred but that it is nearly impossible to pin-point fertilization, the step between." (17) Ralph P. Miech MD, PhD has said that "fertilization due to rape cannot be determined with scientific certainty during a certain early time period during pregnancy. (18)

After intercourse the transit time of sperm is very rapid and there may be sperm at the entrance of the fallopian tube within minutes of ejaculation. (19) A review of the literature concerning the mechanism of action of hormone preparations used for emergency contraception published in January, 2001, showed that "neither the minimum length of time from coitus to fertilization when the oocyte is waiting for the sperm, nor the shortest interval when the sperm is waiting for the oocyte, have been determined. Therefore, the exact theoretical amplitude of the window for acting before fertilization is undetermined, less so, the actual window in real cases." (20) Furthermore, James Trussell, in an editorial in Contraception stated that, even though some are tempted to conclude that there is no post-fertilization effect, it is unlikely that this question can ever be unequivocally answered, and he said that we cannot conclude that emergency contraception "never prevents pregnancy after fertilization," that is, never causes an abortion. (21)

The euphemism about 'preventing pregnancy' is implicitly accepted by both Durand and Hapangama, and is defended by Trussell, who quoted the definition of "an established pregnancy" as beginning with implantation. This definition of pregnancy, as distinguished from fertilization, is also given by the U.S. Food and Drug Administration/National Institutes of Health, and also by the American College of Obstetricians and Gynecologists. Therefore, Trussell says, "Emergency contraceptives are not abortifacient." With this continuing debate about the effect of Plan B on the uterine endometrium and the uncertainty about the question of whether a woman who has been raped has not ovulated when given Plan B, no one can be certain about the mode of action of Plan B in any given case.

One more problem

In addition, a recent theoretical approach to the treatment of rape cases involves the use of gonadotropin-releasing hormone antagonists (GnRH antagonists). It is suggested that they might be medically useful and morally acceptable for use in rape cases. They inhibit ovulation, and are currently used in assisted reproductive technologies (IVF) and human cloning experimentation, procedures that are immoral. The argument is that if the use of these drugs would prevent ovulation, and again if they are nontoxic to an embryo already conceived, and if they do not prevent implantation, then such treatment would be morally licit. The problem remains, however, that contraception itself is an intrinsic evil. Those who favour the use of GnRH antagonists argue that contraception is permissible because, in the case of rape, it is a defense against an unjust aggression. This argument has been used, for instance, to justify the use of a condom during sexual intercourse, whether in marriage or outside of marriage.

Pope John Paul II, speaking to Indonesian bishops on June 7th, 1980, said, "Contraception is judged objectively so illicit that it can never, for any reason, be justified." This teaching notwithstanding, Godfried Cardinal Daneels of Belgium, and Cormac Cardinal Murphy--O'Connor of England stated in 2004 that any HIV positive person who decides not to abstain and has sex using a condom would be sinning against the fifth commandment. They held that if one opts to engage in unsafe sexual behaviour, it is morally justifiable to use a condom. Cardinal Daneels said also that other cardinals and bishops all over the world share his perspective! The question remains, are the contraceptive action of Plan B, and of GnRH antagonists, and the use of the condom to prevent the spread of sexually transmitted infections prohibited by Church teaching on contraception or not?

Note: Canadian women have been able to purchase the morning after pill without a prescription for three years, but a governmental panel is considering removing more limits by putting the drug on store shelves and make is so consulting with the pharmacist is no longer necessary. Opponents of the idea say the policy would make Canada the industrialized nation with the most permissive procedures on purchasing the Plan B pill. A representative from the nation's pharmacists group says the new policy opens the door for teenagers and young girls to purchase the drug without any input from a medical professional, which is not in the girls' best interests. (LifeNews.com, 1 May 2008)

Editorial Note: The abortifacient "Plan B" (Levonorgestrel) drug has just been approved for distribution without any medical consultation on the front shelves of Canadian pharmacies after a decision handed down by the National Association of Pharmacy Regulatory Authorities on May 15. Clients will now be able to purchase the single-dose pill without speaking to a pharmacist first (National Post, May 16, 2008).

Even secular pharmacists were concerned with the decision to make Plan B freely available on pharmacy shelves. "We really don't believe it is in the best interest for women," said Janet Cooper of the Canadian Pharmacists Association. "For it to be out there with the condoms or the Tylenol sends a message that this is not a big deal. It is."

Endnotes

(1.) N. Novikova et al. "Effectiveness of Levonorgestrel Emergency Contraception Given Before or After Ovulation: A Pilot Study," Contraception, 75.2 (Feb., 2007) 112-118.

(2.) P.G.L. Lalitkumar et al. "Mifepristone, But Not Levonorgestrel Inhibits Human Blastocyst Attachment to an in vitro Endometrial Three Dimensional Cell Culture Model." Human Reproduction 22.11(Nov. 1, 2007): 3031-3037.

(3.) C. Kahlenborn et al. "Post Fertilization Effect of Hormonal Emergency Contraception," Annals of Pharmacotherapy, 36.3 (Mar.2002): 465-470.

(4.) R.T. Mikolajczyk and J.B. Stanford, "Levogestrel Emergency Contraception: A Joint Analysis of Effectiveness and Mechanism of Action," Fertility and Sterility, 88.3, (Sept. 2007): 565-571.

(5.) M. Durand et al. "On the Mechanisms of Action of Short-term Levonorgestrel Administration in Emergency Contraception," Contraception, 64.4 (Oct. 2001): 227-234.

(6.) M. Durand et al. Late follicular phase administration of levonorgestrel as an emergency contraceptive changes the secretory pattern of glycodelin in serum and endometrium during the luteal phase of the menstrual cycle. Contraception, 2005, 71: 451-7.

(7.) D. Hapangama et al. The effects of peri-ovulatory administration of levonorgestrel on the menstrual cycle. Contraception, 2001; 63: 123-9.

(8.) See reference number 5.

(9.) Recep Yildizhan et al. Marmare Medical Journal, 2004, Cilt. 17, Sayiz, Sayfa (lhr) 053-057.

(10.) A. Guttinger and H.O. Critchley, 'Endometrial effects of intra-uterine levonorgestrel', Contraception, 2007, June; 75 (6 Suppl 1). 593-598.

(11.) Bergh, J.B. et al. Sonographic evaluation of emergency contraception in vitro fertilization cycles; a way to predict pregnancy? Acta Obstet Gynecol. Scand., 1992; 71: 624-628.

(12.) Yai Ngai, S. et al. A randomized trial to compare 24 hours vs. 12 hours double dose regimen of levonorgestrel for emergency contraception, Human Reprod. 2005, Jan. 20 (1); 307-8.

(13.) See reference number 6.

(14.) See reference number 1.

(15.) Glasier, A. et al. "Comparison of mifepristone and high dose oestrogen- progestogen for emergency post-coital contraception." N Eng J Med. 1992; 327: 1031-4.

(16.) Webb, A.M.C. et al. "Comparison of Yuzpe regime, danazol and mifepristone in post-coital contraception." BMJ., 1992; 35: 927-31.

(17.) Liz Kowalczyk, "Groups, doctors, seek wider use of 'morning after' pilI." The Boston Globe, Feb. 28, 2003.

(18.) A proposed treatment for rape victims, lifeissues.net 2006.

(19.) Bruce M. Carlson, Human Embryology and Developmental Biology, second edition, 1999. Mosby.

(20.) Horatio B. Croxatto, et al. 'Mechanism of action of hormonal preparations used for emergency contraception; a review of the literature.' Contraception, 2001; 63: 111-21.

(21.) James Trussell, B. Phil and Ph D and Beth Jordan, MD. Aug. 2006, Contraception editorial (V 74, N 2) Mechanism of Action of Emergency Contraceptive Pills.

John B. Shea, MD FRCP(C)

John B. Shea, MD FRCP(C) specializes in bioethical problems in the light of Catholic teaching