O’Donovan, M. and Stuparich, J (eds), (1994) The Abortion Debate: Pro-Life Essays. ACT Right to Life Association, Canberra, Australia. pp112-126.
The major trend in regard to abortion is to achieve it earlier using pharmaceutical methods. With the Government promotion of condoms to prevent disease, many are also using condoms backed up by the "morning-after pill" as a means to prevent pregnancy. The failure rates of condoms are in the order of ten to fifteen pregnancies per hundred women years. It has long been medical practice to prescribe an overdose of the contraceptive pill as a "morning-after pill", when condoms fail or unprotected sexual intercourse has taken place.
The practical difficulty with the latter is that its effectiveness is really only in the day or so after sexual intercourse. Many women would only present when they miss their first period, too late for that method to be effective. During the 1980's, RU486, the so-called "French Abortion Pill" was developed. The new word "contragestive" has been used to describe it.
A second trend which is a concern to pro-life organisations is the move away from contraceptive pills which are designed primarily to suppress ovulation, to lower dose pills and progesterone-only pills which do not have such severe side effects as the combined higher-dose pills which were first used. The new generation of pills are more likely to be abortifacient. Serious questions arise for pro-life organisations in regard to the question of family planning and referral to family planning organisations such as the Government-conducted Family Planning Clinics and the Family Planning Association.
This essay presents an analysis of some of the literature in regard to RU486 and the second issue of pro-life referral to family planning clinics.
The so-called "abortion pill"(2) RU486 (Mifepristone) has been a source of great concern to pro-life organisations in Australia. Apart from the fact that RU486 causes abortions, pro-lifers have been concerned that the pill could be used on a regular basis; that it would be self-administered and would thus allow abortions to be achieved easily in the privacy and secrecy of the woman's home; that the language used to describe it hides the fact that it destroys a human life - the new word "contragestive" is used;(3) and finally that RU486 has been claimed to be under trial in Australia.
Some pro-abortionists have supported the agent as a much easier way of procuring an abortion than the surgical procedures involving curettage or vacuum aspiration.(4) Some have claimed that it could be used without a pregnancy test when pregnancy is a possibility and menses are delayed. It has been argued that this would avoid the problem of guilt, etc., in relation to abortion: the woman would not know whether she had been pregnant.
A number of these claims have no factual basis.
RU486 is a progesterone antagonist. It acts to inhibit the function of progesterone at the receptor level. In plain English that means that RU486 makes progesterone ineffective. Progesterone is essential for maintaining the lining of the uterus during pregnancy. Within a few days of administering RU486 the lining of the uterus sheds taking with it the embryo or foetus if the woman is pregnant.(5)
If administered very early in pregnancy the woman would experience this early abortion as a very heavy period. The common side-effects are heavy bleeding, nausea, vomiting, weakness and crampy abdominal pains.(6)
RU486 used on its own procures an early abortion in approximately 86% of cases.(7) However, if used in conjunction with other agents the success rate may be as high as 95-100%.(8) RU486 can also be used effectively in the second and third trimesters.(9)
However RU486 is unlikely to be used regularly. At first it was claimed that RU486 might be used to regularise cycles and prevent pregnancy,(10) but uncertainty about the prolonged effects and dosages needed have led to the conclusion that this would not be appropriate.(11) In addition the menses which follow the taking of RU486 are heavy and prolonged.(12) The agent is thus not likely to be particularly appealing as a once-a-month "contraceptive".
One of the problems inhibiting the use of RU486 as a "menstrual regulator" is that its effect is to block the function of progesterone,(13) and the rise in progesterone, on which so much depends, does not occur until the latter part of the cycle. Used too early in the cycle, the effectiveness of RU486 would be reduced. It is not effective in the absence of luteal phase levels of progesterone. RU486 does not regulate the timing of ovulation, thus the optimal time of administration may vary from cycle to cycle. Ovulatory cycles are often irregular, consequently a woman using RU486 as a "menstrual regulator" would need to monitor her cycle closely in order to be sure that RU486 was used after the progesterone rise had commenced.
Thus RU486 could only be used effectively either by women who closely monitored the changes in the ovulatory cycle or after a positive pregnancy test. A question arises about whether RU486 would disturb the symptoms of ovulation in the subsequent cycle. It is certainly the case that RU486 causes a lengthening of the first post-treatment cycle. The latter factor would invalidate its use as a once-a-month "contraceptive".(14)
RU486 is not likely to be approved for use as a self-administered home abortion pill. The researchers say it should only be used under close medical supervision.(15) The major reason for this is that there is usually heavy, prolonged bleeding which may endanger the woman's health.(16) Follow-up treatments such as such as blood transfusion and curettage may be indicated in a small percentage of cases.(17)
The action of RU486 in inhibiting the effect of progesterone on the lining of the uterus is not the only direct effect. Some studies have shown that RU486 directly inhibits placental hormone secretion, having a direct effect on the embryo.(18) Thus RU486 not only brings about an abortion by affecting the lining of the uterus, it also directly damages the embryo.
The latter would be particularly relevant in the event that a woman chose not to have curettage after RU486 failed to procure an abortion. A complex range of legal and ethical issues would arise in that event. If a woman had been ambivalent in the first instance, one could well imagine her deciding not to go further in the event of RU486 failure. Her rights and the medical and pharmaceutical liabilities would provoke conflict in such circumstances. The damage done to the embryo and subsequently the child born at a later stage would be an issue which the Courts and the community would have to heed.
The medical literature also contains the information that while the hormonal functions of the woman return to normal after RU486 has been used, there may be lasting effects on the tissues of the uterus and cervix. One study shows that cell dynamics which depend on a continuity of progesterone will be irreversibly disrupted.(19)
The long-term effects and the potential for serious adverse reactions are not yet known. The literature claims that it is safe, but only time will tell. The effects of hormonal treatments of this kind can be insidious and may only appear much later as was the case with the early high dose contraceptive pill, with some fertility drugs, and with some morning sickness therapies.
RU486 can readily cross the blood-follicle barrier of human pre-ovulatory follicles. RU486 and its metabolites have been found in the egg follicles in the ovaries of women undergoing sterilization to whom RU486 had been administered thirty-four hours earlier.(20) A question must therefore arise about the potential for damage to the ovaries and the egg follicles and the risk to any children subsequently conceived by a woman who has undergone RU486 therapy.
RU486 does have some uses other than inducing abortion. Research has been done on it as a therapy following foetal death. Research has also been done on RU486 as an aid to ripening the cervix thus facilitating surgical abortion.(21) The agent may also be of therapeutic value in the treatment of breast cancer.(22)
The company which markets RU486 indicates that it is not trialling it in Australia, even though approval was given for a trial from the then Department of Community Services and Health. The trial was to be undertaken after foetal death in the second or third trimester of pregnancy. The company gave as its reason for not going ahead with the trial here, the controversy surrounding the development of the agent.
There is a very real danger that RU486 might be approved for use in Australia. No doubt the guidelines would require that it be administered under close medical supervision. However, medical practitioners who are passionately in favour of private abortions might well interpret "close medical supervision" liberally and, at risk to their patients, prescribe RU486 in such a way as to allow it to be used as a home abortion pill. Once in the hands of unqualified personnel RU486 might then be adapted for regular use after menses delay in spite of that use being contra-indicated and likely to have problems of ineffectiveness.
In summary then, RU486:
The major issues are firstly, whether the family planning advice given by the clinics is likely to be for methods which are abortifacient, and secondly, what the advice is likely to be if the method used fails.
The most common methods of reversible contraception used involve the oral contraceptive preparations. Of those, the most commonly used are combined formulas using oestrogen and progesterone such as triquilar and triphasil, and progesterone only formulas (the mini-pill) such as micronor or microval.
MIMS is a major reference book used by doctors in prescribing medication. It contains the manufacturer's information about the medications including what they contain, how they work, their recommended usages, risks, side-effects, how they are to be taken, and interactions with other medication.
The 1992 MIMS refers to the action of triquilar in the following way:
Combination oral contraceptives act primarily by suppression of pituitary gonadotrophin secretion resulting in inhibition of ovulation. In addition histological changes in the endometrium, including incomplete development of the secretory phase, reduce the likelihood of implantation and nidation of the ovum. Cervical mucus remains scanty and viscous throughout the treated cycles rendering sperm penetration less likely.
MIMS also records that triquilar has a method failure rate of between 0.12 and 0.34 pregnancies per 100 women years. Expressed another way, if one hundred women were to use triquilar to avoid pregnancy for ten years, and they each take it as directed, then between one and three of them, on average, would have an unplanned pregnancy. The actual pregnancy rate is higher for reasons such as, user errors in which pills are missed or not taken during the same part of the day. Pregnancy may also result from interaction with other medication, such as barbiturates and some anti-biotics.
The secondary effect on implantation (the embedding of the embryo in the lining of the uterus) and nidation (the growth of the embryo in the uterus) is a matter of pro-life concern. The manufacturer refers to implantation and nidation of the ovum, but in reality at the time that the effect occurs it is no longer just an ovum (egg) but has been fertilized and hence is an embryo. Implantation normally occurs several days after fertilization.
It is not known how often the effects on ovulation and on the cervical mucus would fail to prevent conception, but in such cases the abortifacient effect of the changes to the lining of the uterus may occur. Women who take triquilar and similar combined pills should be aware that an effect of their actions, intended by the manufacturers, may be the loss of a human life at an early stage. The chance appears to be small but it does exist.
The action of triphasil is similar to that of triquilar. The MIMS records:
The hormonal components of triphasil inhibit ovulation by suppressing gonadotrophin release. Secondary mechanisms which may contribute to effectiveness of Triphasil as a contraceptive include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).
The pregnancy rates and interactions with other medication are similar to those associated with triquilar.
The 1992 MIMS records:
The primary mechanism through which norethisterone prevents conception is not known, but progesterone only contraceptives are known to alter the cervical mucus, increasing the difficulty of sperm penetration, exert a progestational effect on the endometrium interfering with implantation, and, in some patients, suppress ovulation.
The pro-life concern is that the effect of mini-pills such as micronor, because they are unlikely to suppress ovulation, are much more likely to be abortifacient. The lining of the uterus is altered so that if the effect on cervical mucus fails to prevent the passage of sperm, then embryos created are likely to be unable to embed and develop in the lining of the uterus. The mini-pills do carry a significant risk of loss of human lives at an early stage.
The MIMS also records a method of failure rate for progesterone-only formulations, such as micronor, of 3 pregnancies per hundred woman years. Expressed differently, if one hundred women were to take micronor to avoid pregnancy for ten years, and they took it exactly as directed, then, on average, 30 unplanned pregnancies would occur in the group.
Interaction with other medications are similar to those of the combined pills, such as triquilar and triphasil.
The 1992 MIMS records:
The primary mechanism through which microval prevents conception is not known, but progesterone-only contraceptives are known to alter the cervical mucus, exert a progestational effect on the endometrium, interfering with implantation, and, in some patients, suppress ovulation.
The pregnancy rates and interaction with other medications of microval are similar to those of micronor.
As the above information indicates, contraceptive failure with the oral contraceptives occurs both as a result of method failure and as a result of user error and interaction with other medications.
From a pro-life perspective the nature of the support and advice given to women in such instances is of great importance. This is particularly so when the use of a reasonably reliable method of contraception fails and the woman has no prior expectation of pregnancy.
I have given the figures for a ten-year period of use. In fact, if you take into account that many women become sexually active in their teens, their actual childbearing period is to be limited to two or three live births, and their naturally fertile life will extend over thirty years, the ten years of contraception is a very conservative figure. Most women will wish to avoid pregnancy for twenty to twenty-five years.
From a realistic pro-life perspective, permanent sterilisation apart, willingness to engage in sexual intercourse should be premised upon a willingness to accept the possibility of pregnancy and the birth of a child. A pro-life agency should thus promote a view that links sexual intercourse with a willingness to form a family. That view is not shared by the Family Planning Association.
The chances of a pregnancy can be greatly reduced by oral contraceptives. The chances can also be limited to an equivalent extent by the timing of sexual intercourse so that it does not coincide with the fertile stage of the cycle. Possibly fertile times can be identified readily by the presence of cervical mucus observed at the vulva on that day or the preceding three days.
The World Health Organisation figures indicate that Billings Ovulation Method of observing mucus changes is more reliable than the mini-pill and about as reliable as the combined pills. The observation of the temperature rise that follows ovulation is also an indication of the fertile period having passed. Those natural methods can also be assisted, for women who find observation of the signs of fertility difficult, by the use of hormonal testing which is now available in a Do-It-Yourself Kit.
The disadvantage of the abstinence methods is that they do involve days of abstinence. The major advantages are that they do not involve the health risks and unpleasant side- effects of the oral contraceptives, do not carry the abortifacient risks of the oral contraceptives, foster a co- operative relationship between spouses in which responsibility for controlling fertility is shared, increase awareness of the changes in the woman's body, provide early warning of a variety of medical conditions, and provide information which assists couples who have difficulty conceiving.
A further problem with the Government family planning clinics is that the counsellors do not adequately teach or recommend the abstinence (fertility awareness or natural) methods. It would be appropriate for pro-life counsellors to make available to clients lists of Natural Family Planning teachers and clinics and to refer clients to them.
* Nicholas Tonti-Filippini BA (Hons), MA, is a Melbourne-based bioethicist.
This essay was written before March 1994 when trials of RU486 began in Melbourne and Sydney under the auspices of the World Health Organisation's Human Reproduction Program. See Melinda Tankard Reist, (1994) RU486 Trials - Controversy in Australia, Bioethics Research Notes, Vol.6(3), September, pp 25-26. - Eds.
1. The author gratefully acknowledges revisions of the text by Dr Mary Walsh.
2. Cahill LS. ‘Abortion Pill’ RU486: ethics, rhetoric, and social practice. Hastings Cent Rep 1987 Oct-Nov; 17(5): 5-8.
3. Dubois C; Ulmann A; Baulieu EE. Contragestion with late luteal administration of RU486 (Mifepristone). Fertil Steril 1988 Oct; 50(4): 593-6.
Baulieu EE. A novel approach to human fertility control: contragestion by the anti-progesterone RU486. Eur J Obstet Gynecol Reprod Biol 1988 Jun; 28(2): 125-9.
4. Bygdeman M; Van Look PF. Anti-progesterones for the interruption of pregnancy. Baillieres Clin Obstet Gynaecol 1988 Sep; 2(3): 617-29.
5. Bailieu EE; Ulmann A. Antiprogesterone activity of RU486 and its contragestive and other applications. Hum Reprod 1986 Feb; 1(2): 107-10.
Bailieu E. Fertility control in women: results with RU486 by the end of 1985. J Steroid Biochem 1986 Nov; 25(5B): 847-51.
6. Cameron IT; Michie AF; Baird DT. Therapeutic abortion in early pregnancy with antiprogesterone RU486 alone or in combination with prostaglandin analogue (gemeprost). Contraception 1986 Nov; 34(5): 459-68.
7. Ulmann A; Dubois C; Philibert D. Fertility control with RU486. Horm Res 1987; 28(2-4): 274-8.
Maria B; Stampf F; Goepp A; Ulmann A. Termination of early pregnancy by a single dose of mifepristone (RU486), a progesterone antagonist. Eur J Obstet Gynecol Reprod Biol 1988 Jul; 28(3): 249-55.
Dubois C; Ulmann A; Baulieu EE. 1988. op. cit.
8. Bygdeman M; Van Look PF. 1988. op. cit.
Cameron IT; Michie AF; Baird DT. 1986. op. cit.
Ulmann A; Dubois C; Philibert D. 1987. op. cit.
Rodger MW; Baird DT. Induction of therapeutic abortion in early pregnancy with mifepristone in combination with prostaglandin pessary. Lancet 1987 Dec 19; 2(8573): 1415-8.
Baird DT; Rodger M; Cameron IT; Roberts I. Prostaglandins and antigestagens for the interruption of early pregnancy. J Reprod Fertil Suppl 1988; 36: 173-9.
9. Frydman R; Fernandez H; Pons JC; Ulmann A. Mifepristone (RU486) and therapeutic late pregnancy termination: a double-blind study of two different doses. Hum Reprod 1988 Aug; 3(6): 803-6.
Urquhart DR; Bahzad C; Templeton AA. Efficacy of the antiprogestin mifepristone (RU486) prior to prostaglandin termination of pregnancy. Hum Reprod 1989 Feb; (2): 202-3.
Wolf JP; Sinosich M; Anderson TL; Ulmann A; Baulieu EE; Hodgen GD. Progesterone antagonist (RU486) for cervical dilation, labor induction, and delivery in monkeys: effectiveness in combination with oxytocin. Am J Obstet Gynecol 1989 Jan; 160(1): 45-7.
10. Swahn ML; Wang G; Aedo AR; Cekan SZ; Bygdeman M. Contraception
1986 Nov; 34(5): 469-81.
Nieman LK; Choate TM; Chrousos GP; Healy DL; Morin M; Renquist D; Merriam GR; Spitz IM; Bardin CW; Baulieu EE et. al. The progesterone antagonist RU486. A potential new contraceptive agent [published erratum appears in N Engl J Med 1987 Feb 12; 316(7): 420] N Engl J Med 1987 Jan 22; 316(4): 187-91.
Baulieu EE; Ulmann A; Philibert D. Contragestion by antiprogestin RU486: a review. Arch Gynecol Obstet 1987; 241(2): 73-85.
11. van Santen MR; Haspels AA. Interception. IV: Failure of mifepristone (RU486) as a monthly contragestive, "Lunarette". Contraception 1987 May; 35(5): 433-8.
Nieman LK; Loriaux DL. The use of anti-progesterones as a medical IUD. Baillieres Clin Obstet Gynaecol 1988 Sep; 2(3): 609-16.
12. Cameron IT; Michie AF; Baird DT. 1986. op. cit.
13. Nieman LK; Loriaux DL. 1988. op. cit.
14. LLahteenmLaki P; Rapeli T: KLaLariLainen M; Alfthan H; Ylikorkala O. Fertil Steril 1988 Jul; 50(1): 36-8.
15. Couzinet B; Le Strat N; Ulmann A; Baulieu EE; Schaison G. Termination of early pregnancy by the use of progesterone antagonist RU486 (Mifepristone). N Engl J Med 1986 Dec 18; 315(25): 1565-70.
16. Gao J; Qiao GM; Wu YM; Wu ME; Zheng SR; Han ZB; Fan HM; Yao GZ; Meng U; Dubbois C; et. al. Pregnancy interruption with RU486 in combination with dl-15-methyl-prostaglandin-F2 alpha-methyl ester: the Chinese experience. Contraception 1988 Dec; 38(6): 675-83.
Couzinet B; Le Strat N; Ulmann A; Baulieu EE; Schaison G. 1986. op. cit.
17. Maria B; Stampf F; Goepp A; Ulmann A. 1988. op. cit.
Gao J; Qiao GM; Wu YM; Wu ME; Zheng SR; Han ZB; Fan HM; Yao GZ; Meng U; Dubbois C; et. al. 1988. op. cit.
18. Das C; Catt KJ. Antifertility actions of the progesterone antagonist RU486 include direct inhibition of placental hormone secretion. Lancet 1987 Sep 12; 2(8559): 599-601.
Bischof P; Sizonenko MT; Herrmann WL. Trophoblastic and decidual response to RU486: effects on human chorionic gonadotrophin, human placental lactogen, prolactin and pregnancy-associated plasma protein-A production in vitro. Hum Reprod 1986 Jan; 1(1): 3-6.
Bygdeman M; Van Look PF. 1988. op. cit.
19. Baulieu EE; Ulmann A; Philibert D. 1987. op. cit.
20. Cekan S; Aedo AR; Segersteen E; Van Look P; Messinis I; Templeton A. Levels of the antiprogestin RU486 and its metabolites in human blood and follicular fluid following oral administration of a single dose. Hum Reprod 1989 Feb; 4(2): 131-5.
21. Durlot F; Dubois C; Brunerie J; Frydman R. Efficacy of progesterone antagonist RU486 (mifepristone) for pre-operative cervical dilatation during first trimester abortion. Hum Reprod 1988 Jul; 3(5): 583-4.
22. Romieu G; Maudelonde T; Ulmann A; Pujol H; Grenier J; Cavalie G; Khalaf S; Rochefort H. The antiprogestin RU486 in advanced breast cancer: preliminary clinical trial. Bull Cancer (Paris) 1987; 74(4): 455-61.
Baulieu EE; Ulmann A. 1986. op. cit.
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