FACT SHEET MORNING AFTER PILL (MAP) & EMERGENCY CONTRACEPTION PILLS (ECP)

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OVERVIEW

MAP/ECP: WHAT IS IT?

METHOD OF OPERATION 

   MAP/EC pills act by delaying or inhibiting ovulation.

   and/or altering tubal transport of sperm and/or ova, inhibiting fertilization.

   and/or altering the endometrium (the lining of the uterus) thereby inhibiting implantation

SIDE EFFECTS 

RISK FACTORS

CANCER CONNECTION

LEGAL CONCERNS

Information regards to social, ethical concerns and bibliographical information by contacting CLCNS

Revision Date: 1/15/02 12:29 AM

“Facts About the “Morning After Pill”

March 20, 2001

 Hilary White

Campaign Life Coalition

Nova Scotia

Introduction

The so-called Morning After Pill (MAP) or Emergency Contraceptive Pill (ECP) is a means to end an already existing pregnancy in its very early stages. ECP’s are widely distributed and promoted as harmless post-coital contraceptives. Their proponents praise them as a means of curbing the numbers of teen-age pregnancies and say that they have only mild, temporary side effects. The abortifacient (abortion-causing) effect is hotly denied in the media and ignored by professional medical associations, family planning agencies and pharmaceutical manufacturers. But the facts are otherwise.

 

There are concerns by responsible doctors and pharmacists that the effect of an ECP on the woman could be seriously detrimental.  Evidence is growing that there is a causal link between high-dose hormone regimens and breast and cervical cancer.  Nothing is known about the long-term effects of ECP or of its effect after repeated use or its effect on the very young to whom it is being aggressively target-marketed.

Recently there have been efforts made world-wide to make ECP’s available without a doctor’s prescription. Despite assurances from Health Canada that the drug would only be available by prescription, the Canadian Pharmacists Association (CPHA) has, in conjunction with the Society of Obstetricians and Gynecologists of Canada (SOGC), started to lobby for it being made available over the counter or, as in the case in BC by the innovation of pharmacists prescriptions following a cursory patient interview.

Campaign Life Coalition feels that the public has not been sufficiently informed of the grave medical and social dangers of this drug and is seriously concerned about its indiscriminate distribution, particularly to young girls.

What Is Map And How Does It Work?

Emergency contraception (also known as the morning-after pill or MAP) is a high dosage of the birth control pill. It is recommended to be used after sexual intercourse, over a period of 72 hours followed by a second high dose 12 hours later to achieve the goal of preventing or ending pregnancy. There are three different ways birth control pills are currently being promoted for this use: progesterone alone, estrogen alone, or both of these artificial steroids together. These are the same steroids found in the typical birth control pill. There is no such thing as a specific morning-after pill, but rather double doses (or more) of existing birth control pills. Though no testing has been done to confirm the safety of these large doses of these chemicals for women, the US Food and Drug Administration and Health Canada have approved this use. “EC pills act by delaying or inhibiting ovulation, and/or altering tubal transport of sperm and/or ova, thereby inhibiting fertilization, and/or altering the endometrium (the lining of the uterus) thereby inhibiting implantation.” 1  IN fact, according to Dr.H. Robert C. Pankratz, the prevention of ovulation accounts for only about 25% of the drug’s effectiveness. 2

The idea of emergency contraception—or a morning-after pill—is based on the redefinition of pregnancy promoted by the American College of Obstetricians and Gynecologists in the nineteen sixties. Pregnancy was now claimed by bioethicists, doctors and “family planning agencies” like Planned Parenthood, to begin at the moment of implantation of an already existing embryo in the uterine wall of the mother. (It is still fully accepted by human embryologists that the moment when an ovum and sperm fused, that is, fertilization, is the moment of creation of a new and unique human being.) This politically motivated falsehood cleared the way for the proliferation of all forms of early interference in the procreative process and made it possible to promote the chemical birth control pill in a new way.

The only true contraceptive effect of the MAP is the prevention of ovulation and it is impossible to select this action of the drug. If an ovum is in the Fallopian tube, the process of fertilization may begin within 15 to 30 minutes after intercourse. The "morning after" is already too late for any contraceptive effect to intervene. Thus some researchers conclude that "post-coital drugs act principally to terminate a viable pregnancy ... this mode of action could explain the majority of cases where pregnancies are prevented by the morning-after pill, "3 “They're not sure of the ins and outs of it, but it's thought to work in two main ways. First, by delaying ovulation, and second, by preventing implantation of a fertilized egg into the women's uterus. More often it would prevent implantation.” 4 (emphases added).

The two forms of MAP available in Canada at the moment are “Plan B”, the single hormone or “progesterone-only” pill and the older “Ovral”. Preven, the two hormone kit was taken off the Canadian market by its manufacturer in January because of lack of sales. “Plan B” is marketed as being less likely to produce uncomfortable side effects and is produced by Palatin Labs, Montreal.

How Effective are ECPs at Interrupting Pregnancy?

As the manufacturers of oral contraceptives (OC’s) have always stated, their products do not have a 100% success rate. With the greater number of random factors present in a single massive dose of hormones this percentage is significantly lowered. In fact, according to one researcher, "taking a high level of estrogen via ECPs within 72 hours of intercourse ... may, in fact, precipitate ovulation. This would make it more likely, rather than less, that fertilization will occur, "5 The oft-cited 74% effectiveness rate for ECPs is actually the average of a range of effectiveness from 55.3% to 94.2%.6

Side Effects

The following mild side effects are listed on the Plan B website7: Nausea, abdominal pain fatigue, headache, heavier menstrual bleeding, lighter menstrual bleeding, dizziness, breast tenderness, vomiting and diarrhea. What is not mentioned is the increased risk that the failure of the ECP will result in a potentially fatal ectopic pregnancy. It also fails to mention the possible long term effects of repeated use.

In the ordinary use of OC’s there are a host of serious side effects and possible complications which are increased with the age of the user, and with the user’s pre-existing medical conditions such as diabetes, heart disease and whether she smokes (see Risk Factors below). Since ECP’s are exactly the same chemicals as OC’s but in much larger doses, it stands to reason that the same dangers exist with both and would be significantly increased with the repeated use of ECP’s. Some of these include increased risk of: thrombophlebitis (blood clots in the legs), lung clots, heart attack, stroke, liver damage, liver tumor, gallbladder disease, and high blood pressure and depression. 8 It is not yet known what the long-term effect is of ECP’s or of its repeated use but again it is only reasonable to expect that since this is a much larger dosage these risks could only be more serious. 

Unlike any of the other serious health risks associated with ECP’s there is universal acknowledgement that they give absolutely no protection from sexually transmitted diseases. With the increase in sexual activity that may be expected with the wide and easy availability of ECP’s will naturally come an attendant increase in STD’s including the potentially fatal HIV infection.  

Risk Factors

“Women who smoke cigarettes and those who have experienced any of the following conditions are advised not to take ECPs: blood clots in the legs or lungs, cancer of the breast or reproductive organs, stroke, heart attack, and "any serious medical disorder such as diabetes, liver disease, heart disease, kidney disease, severe migraine headaches, or high blood pressure.”9 These are the normal warnings for risk factors that are found on any package of oral chemical contraceptive. None of these are listed on any of the promotional material for Plan B or on any of the major promotional websites.

The Cancer Connection

Women taking a combination of the hormones estrogen and progesterone have a greater risk of breast cancer than women using estrogen alone, according to a study reported by the American Medical Association. "In general, it's been found -- both in this study and other studies -- that it's really (women who are) current or recent users of hormones who have an increased risk of breast cancer."10 The study reported that menopausal women using the combination of estrogen and progesterone have a 20 percent higher risk of breast cancer than those who get estrogen alone.11 “…combined therapy resulted in a 24% increase in risk of breast cancer for every 5 years of use. When estrogen use was followed in the monthly cycle by progesterone, termed sequential combined therapy, the risk increased to 38% for each 5 years of use.”12 Again, it seems reasonable that the repeated use of the greatly increased dose of hormones in ECP that would be probable if it were made available over the counter would make all of the above medical complications much more likely.

Ethical Concerns

The use of oral contraceptives as a post coital “contraceptive” regimen came about by accident when a researcher discovered their effects on the endometrium. After the redefinition propaganda had been disseminated widely enough it came to be touted as a convenient “emergency” action to “erase last night” as one Planned Parenthood flyer puts it. However more and more pharmacists, even those who have no moral objections to contraception or even to abortion are concerned that the easy availability of ECP’s either over the counter or with a pharmacist’s prescription will erase the barrier of caution in the very young and lead to even greater levels of pre and extra marital promiscuity with an attendant rise in teenage pregnancy rates. They are especially vulnerable who are inundated with images of romantic, consequence-free sex from the media. If even the manufacturer does not know what are the long term effects of repeated massive doses of hormones on fully developed adults, the effects on younger women and girls can only be considered even more risky. It was recently estimated in Wales and Britain that it would be possible for children as young as nine to receive ECP’s without a parent’s knowledge or a doctor’s supervision.

It is obvious that, political semantics aside, the main medical function of ECP’s is to halt the progress of an already existing pregnancy. This considered, it should be remembered that abortion is seen as a grave moral wrong by many Canadians. To misrepresent this drug as a safe, effective and  harmless contraceptive is a public deception on a grand scale and will lead to government-sponsored suffering of many Canadian women and their families. 

The Conscience Connection 

This also raises problems of conscience for health care workers. In Washington State, a program was put in place to allow pharmacists to write prescriptions for ECP’s in 1997.13 In the training manual for this program, that is being used as a guideline for Canadian programs, are explicit instructions to the prescribing pharmacists to participate in deceptions of families and loved-ones of minors who seek this drug.  In Washington as in British Columbia there exist laws making it possible for minors to consent to medical treatment without parental consent. 

There is also the matter of the conscience of the pharmacist who may have strong moral prohibitions to prescribing a drug that could result in an early term abortion. To say that the pharmacist should refer the client to someone else does not absolve him or her from material participation in the procuring of an abortion. At the moment there is no legislation in place anywhere in Canada protecting a health care worker from job discipline or even litigation who wishes to refrain from performing acts that conflict with the dictates of his or her conscience. Forcing pharmacists and others to participate in such acts would be a grave burden and a source of severe work-related stress and concomitant illness and absenteeism. This was the case with the nurses at Markham Stouffville Hospital in Ontario.14 A case could be made that such coercion contravenes the conscience protection in the Canadian Charter of Rights and Freedoms.

             

Legal Concerns

Objections have been raised that pharmacists and their employers would be open to litigation for prescribing ECP’s or for dispensing them without a prescription. In the Washington training manual there is no mention of a pharmacist’s responsibility of ascertaining the presence of any contra-indicators for ECP’s such as diabetes or heart disease. In fact, the entire process is placed in the hands of the client who could answer any of the questions regarding age, consent, risk factors, incidents of sexual abuse or coercion in any way.  A teenage girl, frightened by the idea of being pregnant, too afraid to talk to her parents or to a responsible physician will quickly learn how to answer the questions put to her to receive the desired outcome. The result is a pharmacist who places his or her professional reputation and future in the hands of a child without the maturity necessary even to refrain from irresponsible sexual practices.

Social Concerns

It is absurd that at the same time the government is starting to become seriously concerned with the long-range consequences of the falling population, the so-called brain drain, the aging of the workforce and the anticipated huge strain on a shrinking tax base there is so much effort and expense going to restrict the number of births. Pierre Chaunu, professor emeritus of the Sorbonne and member of the French Academy is one of the world’s foremost demographers and he predicts, along with many scientists a drastic drop in the world’s population causing major social and economic upheaval in the next twenty years as the “baby boom” generation ages.15 

The rise in the rates of teenage pregnancy has exactly paralleled the increase in availability of birth control. The statistics are so well known that it hardly bears mentioning that the rate of teenage pregnancy skyrocketed since the introduction of the birth control pill and the legalization of other, less reliable forms and shows no sign of abating. It is also known that the rates of failure for any method of birth control are much higher for girls aged 15 to 24 than for older women.16 The obvious fact is that the more readily available a form of birth control the more sexual behavior is being engaged in. More sex equals more pregnancies. Younger girls tend to think that it could not possibly happen to them and so tend to engage in more reckless behaviors. This is abetted by a medical establishment that takes its cue from the sexually permissive culture and from libertarian organizations like Planned Parenthood that has as its mandate the promotion of unrestrained sexual activity.  

An Isolated Culture

It may seem to be beyond the immediate purview of Departments of Health but it is the responsibility of all citizens and especially those in decision-making positions to consider the larger social ramifications of their choices. The question must not only be, “is this good for individuals?” but, “Is this good for the social health of the entire Canadian community?”

The solution to the problem of unplanned pregnancies is in the development of more effective education systems before pregnancy and of support systems for the mother throughout her pregnancy and after the birth of her child. The options for adoption and assistance from the many services that exist from friends, family, churches, crisis pregnancy centres and government should be bolstered to remove the fear that makes both early and late term abortion seem like the only option. It is emotional, financial and social isolation that backs women into corners where the terrible choice of abortion seems like the only one.

Providing a desperate and frightened person with a false solution to a perceived problem is the equivalent of abandoning her personally. It confirms that there is something to fear. It is a message to the individual woman that no-one cares about the real situation she finds herself in and reinforces her perception that she is alone and that the only help she can receive is to kill her child. To the larger society it perpetuates the myth that a crisis pregnancy is a disaster for the woman and a shameful secret that must be covered up as quickly and quietly as possible. It cuts women off from their support networks and does nothing to affirm individual mothers. It devalues the vocation of motherhood in society as a whole.

The MAP “solution” perpetuates a cultural inclination to individualism and isolationism that is one of the greatest contributing factors to the host of modern social ills from child poverty, to substance abuse, to ageism.  It drives a wedge of secrecy and deception between family members. It erodes the relationship of trust between patients and doctors.

Our taxes will be better spent bolstering the organic support systems of the family and community so that fewer unplanned pregnancies occur. It is known that teenagers engage in sexual behavior to assuage feelings of loneliness, isolation, peer pressure and inadequacy.17 The message of MAP only re-enforces and affirms those feelings. It is time to build better solutions that address the real cause of the problem.

1US Food and Drug Administration, Federal Register Notice

2 Dr. H. Robert C. Pankratz. Medical Post. Letters to the editor: “Patients need right info about morning after pill: it's abortion.”

3”(Wilks, op. cit., p. 154, citing Grou, F. and I. Rodriges. "The morning-after pill; How long after?" Am. J. Obstet. Gynecol. 171:1529-34 (1994).)

4Jennifer Kessell, spokeswoman for Roberts Pharmaceuticals, Oakville, Ont., manufacturers of Preven. When asked about the effects of repeat exposure to Preven, Ms. Kessell's answered, "There's nothing known yet."

5Hanna Klaus, M.D., FACOG

61996 meta-analysis of ten clinical trials by Dr. James Trussel ACOG et al.

7www.go2planb.com/consumer_guide/

8 Princeton University Website: www.ec.princeton.edu. This website is maintained by the Princeton Office of Population research. 

9“Life Insight”. publication of the NCCB Secretariat for Pro-Life Activities. “Emergency Contraceptive Pills (ECPs, a.k.a. "Morning-After" Pills)”

10Dr. Walter Willett of the Harvard School of Public Health

11CNN Online news service, January 25th 2000

12 (US) National Cancer Institute report March 2000. http://cancernet.nci.nih.gov/index.html

13 This program received its funding from the David and Lucille Packard Foundation, an organization that contributed over US $64,993,720 in 2000 to organizations, particularly in the third world, promote the UNFPA world population control agenda. http://www.packfound.org/index.cgi?page=population

14 See coverage of the Markham Stouffville battle and further discussion of the conscience problems of ECP’s at www.consciencelaws.org

15 Zenit News Service October 2000. See attached.

16 Westside Pregnancy Resource Centre website http://w-cpc.org/sexuality/teens.html

17 See Lewis Harris Poll 1986, commissioned by Planned Parenthood (attached)

Appendix

(The following document was prepared for the [US] National Conference of Catholic Bishops to serve as a reference source in the debate over the use of live human embryos in medical research. The sources quoted are not Catholic but are taken from the standard works of the scientific field of human embryology. It has been edited for length.)

What is an Embryo?

Some proponents of destructive embryo research try to deny moral status to all early human embryos. They have coined the term "pre-embryo" to describe human embryos in the first two weeks of development, seeking to justify destructive experimentation during this early stage. However, the term and concept of "pre-embryo" has never been accepted by Congress, the National Institutes of Health's Human Embryo Research Panel, or the National Bioethics Advisory Commission, and is rejected by contemporary textbooks on embryology.

The following references illustrate the fact that a new human embryo, the starting point for a human life, comes into existence with the formation of the one-celled zygote:

***

"Development of the embryo begins at Stage 1 when a sperm fertilizes an oocyte and together they form a zygote."

[England, Marjorie A. Life Before Birth. 2nd ed. England: Mosby-Wolfe, 1996, p.31]

***

"Human development begins after the union of male and female gametes or germ cells during a process known as fertilization (conception).

"Fertilization is a sequence of events that begins with the contact of a sperm (spermatozoon) with a secondary oocyte (ovum) and ends with the fusion of their pronuclei (the haploid nuclei of the sperm and ovum) and the mingling of their chromosomes to form a new cell. This fertilized ovum, known as a zygote, is a large diploid cell that is the beginning, or primordium, of a human being."

 [Moore, Keith L. Essentials of Human Embryology. Toronto: B.C. Decker Inc, 1988, p.2]

***

"Embryo: The developing individual between the union of the germ cells and the completion of the organs which characterize its body when it becomes a separate organism.... At the moment the sperm cell of the human male meets the ovum of the female and the union results in a fertilized ovum (zygote), a new life has begun.... The term embryo covers the several stages of early development from conception to the ninth or tenth week of life."

[Considine, Douglas (ed.). Van Nostrand's Scientific Encyclopedia. 5th edition. New York: Van Nostrand Reinhold Company, 1976, p. 943]

***

"Zygote. This cell, formed by the union of an ovum and a sperm (Gr. zyg tos, yoked together), represents the beginning of a human being. The common expression ‘fertilized ovum' refers to the zygote."

[Moore, Keith L. and Persaud, T.V.N. Before We Are Born: Essentials of Embryology and Birth Defects. 4th edition. Philadelphia: W.B. Saunders Company, 1993, p. 1]

Secretariat for Pro-Life Activities

National Conference of Catholic Bishops/United States Catholic Conference

3211 4th Street, N.E., Washington, DC 20017-1194 (202) 541-3070

Morning After Pill Scientific Submission

http://www.lifeissues.net/writers/irvi/irvi_19newdrug21-045.html

[Requested Scientific Submission to the FDA Concerning the "Morning-After" Pill; see also my attached article on the same, with extensive scientific and philosophical references. DNI]
New drug application 21-045, Levonorgestrel ("Plan B", and "Preven"), ("emergency contraceptives") and their possible abortifacient effects

FROM: Prof. Dr. Dianne Nutwell Irving, M.A., Ph.D.
5108 Randall Lane
Bethesda, MD 20816-1917
USA
301-229-4176
DNIrving@aol.com
December 5, 2003


TO: Ms Karen M. Templeton-Somers, and
The Joint Meeting of the Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health Drugs
Center for Drug Evaluation and Research (HFD-21)
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

RE: New drug application 21-045, levonorgestrel (ÒPlan BÓ, and ÒPrevenÓ)

--------------------------------------------------------------------------------

Dear Ms Templeton-Somers and Joint Committee Members:
As a former bench research biochemist/biologist (NIH/NCI) I am sending this scientific submission for your kind consideration on Levonorgestrel (Plan B and Preven) ("emergency contraceptives"), and their possible abortifacient effects.

The major issue concerns when a new living human being begins to exist. Scientifically, there is no question whatsoever that this occurs at fertilization -- in vivo, or in vitro. By the time of implantation, the living human embryo is approximately already 5-7 days old. This is not a "religious", "prolife", or subjective "belief" or "opinion", but rather it is an objective scientific fact that has been known scientifically for over a hundred years, e.g., with the publication of Wilhelm His' (the "Father of Human Embryology"), Anatomie menschlicher Embryonen (Leipzig: Vogel, 1880-1885).

If "break-through" ovulation has taken place, and if fertilization has taken place, then several chemical effects due to Levonorgestrel's mechanisms of action after that point could constitute abortion.

The scientific experts who are the experts on the issue of when a human being begins to exist, and on subsequent early human development from fertilization on, are human embryologists. Although many attempt to cast even the scientific issue in "subjective" terms, it needs to be realized that in the science of human embryology these scientific experts are professionally required to follow definitions of terms according to an International Nomina Embryologica Committee (INEC). This international committee meets every 3-5 years to examine, update and clarify which human embryological facts are scientifically demonstrated, accurate, and acceptable for human embryologists worldwide to employ in their own research, teaching and textbooks. In other words, these scientific definitions are not arbitrary, nor are they "relative". And among human embryologists globally there is 100% consensus on these objective scientific facts. If other scientists and physicians are not aware of these scientific facts, that is more a reflection of their lack of knowledge and/or credentials, rather than a reflection of any "confusion" on these scientific facts.

To demonstrate scientifically that normally a human being begins to exist at fertilization, please allow me to quote directly from several current human embryology textbooks (two of which are authored by members of the INEC: Moore and O'Rahilly). Note that O'Rahilly actually rejects the use of the false term "pre-embryo" in his human embryology textbook. These quotations also demonstrate scientifically that fertilization is also the beginning of the existence of a human individual, a human organism, a human embryo, normal human pregnancy, and the "embryonic period":

Keith Moore and T. V. N. Persaud, The Developing Human: Clinically Oriented Embryology (6th ed. only) (Philadelphia: W. B. Saunders Company, 1998): "Human development is a continuous process that begins when an oocyte (ovum) from a female is fertilized by a sperm (or spermatozoon) from a male. (p. 2); ibid.: ... but the embryo begins to develop as soon as the oocyte is fertilized. (p. 2); ibid.: Zygote: this cell results from the union of an oocyte and a sperm. A zygote is the beginning of a new human being (i.e., an embryo). (p. 2); ibid.: Human development begins at fertilization, the process during which a male gamete or sperm ... unites with a female gamete or oocyte ... to form a single cell called a zygote. This highly specialized, totipotent cell marks the beginning of each of us as a unique individual." (p. 18).
William Larsen, Human Embryology (New York: Churchill Livingstone, 1997): "In this text, we begin our description of the developing human with the formation and differentiation of the male and female sex cells or gametes, which will unite at fertilization to initiate the embryonic development of a new individual. ... Fertilization takes place in the oviduct ... resulting in the formation of a zygote containing a single diploid nucleus. Embryonic development is considered to begin at this point. (p. 1); ibid.: This moment of zygote formation may be taken as the beginning or zero time point of embryonic development." (p. 17).
Ronan O'Rahilly and Fabiola Muller, Human Embryology & Teratology (New York: Wiley-Liss, 1994): "Fertilization is an important landmark because, under ordinary circumstances, a new, genetically distinct human organism is thereby formed. (p. 5); ibid.: Fertilization is the procession of events that begins when a spermatozoon makes contact with a secondary oocyte or its investments ... (p. 19); ibid.: The zygote ... is a unicellular embryo." (p. 19); ibid.: "The ill-defined and inaccurate term pre-embryo, which includes the embryonic disc, is said either to end with the appearance of the primitive streak or ... to include neurulation. The term is not used in this book." (p. 55).

[Addendum: O'Rahilly and Muller 2001:
The term 'pre-embryo' is not used here for the following reasons: (1) it is ill-defined because it is said to end with the appearance of the primitive streak or to include neurulation; (2) it is inaccurate because purely embryonic cells can already be distinguished after a few days, as can also the embryonic (not pre-embryonic!) disc; (3) it is unjustified because the accepted meaning of the word embryo includes all of the first 8 weeks; (4) it is equivocal because it may convey the erroneous idea that a new human organism is formed at only some considerable time after fertilization; and (5) it was introduced in 1986 'largely for public policy reasons' (Biggers). ... Just as postnatal age begins at birth, prenatal age begins at fertilization." (p. 88) (Note: O'Rahilly is one of the originators of The Carnegie Stages of Early Human Embryological Development, and has sat on the international Nomina Embryologica Committee for decades -- DNI).

Bruce Carlson, Human Embryology and Developmental Biology (St. Louis, MO: Mosby, 1994): "Human pregnancy begins with the fusion of an egg and a sperm." (p. 3); " ... finally, the fertilized egg, now properly called an embryo, must make its way into the uterus ...." (p. 3).
Carlson (1994), p. 407: "After the eighth week of pregnancy the period of organogenesis (embryonic period) is largely completed and the fetal period begins." O'Rahilly and Muller (1994), p. 55: "The embryonic period proper ... occupies the first 8 postovulatory weeks ... The fetal period extends from 8 weeks to birth ... ."; Moore and Persaud (1998), p. 6: "The embryonic period extends to the end of the eighth week ... After the embryonic period, the developing human is called a fetus. During the fetal period (ninth week to birth) ... ."
It is also an objective scientific fact that the use of many "contraceptives" can be abortifacient, including the "morning-after pill", or "emergency contraception", as stated by Moore (a member of the INEC):

(Keith Moore and T.V.N. Persaud, The Developing Human: Clinically Oriented Embryology (6th ed. -- use this edition only)(Philadelphia: W.B. Saunders Company, 1998), pp. 45, 58, 59, 532)
-- "Inhibition of Implantation: The administration of relatively large doses of estrogens ("morning-after pills") for several days, beginning shortly after unprotected sexual intercourse, usually does not prevent fertilization but often prevents implantation of the blastocyst. Diethylstilbestrol, given daily in high dosage for 5 to 6 days, may also accelerate passage of the dividing zygote along the uterine tube (Kalant et al., 1990. Normally, the endometrium progresses to the secretory phase of the menstrual cycle as the zygote forms, undergoes cleavage, and enters the uterus. The large amount of estrogen disturbs the normal balance between estrogen and progesterone that is necessary for preparation of the endometrium for implantation of the blastocyst. Postconception administration of hormones to prevent implantation of the blastocyst is sometimes used in cases of sexual assault or leakage of a condom, but this treatment is contraindicated for routine contraceptive use. The "abortion pill" RU486 also destroys the conceptus by interrupting implantation because of interference with the hormonal environment of the implanting embryo.
"An intrauterine device (IUD) inserted into the uterus through the vagina and cervix usually interferes with implantation by causing a local inflammatory reaction. Some IUDs contain progesterone that is slowly released and interferes with the development of the endometrium so that implantation does not usually occur." (p. 58)
-- [Question Chapter 2, #5 for students:]
"#5. A young woman who feared that she might be pregnant asked you about the so-called "morning after pills" (postcoital birth control pills). What would you tell her? Would termination of such an early pregnancy be considered an abortion?" (p. 45)
[Answer #5 for students:]
"Chapter 2
#5. Postcoital birth control pills ("morning after pills") may be prescribed in an emergency (e.g., following sexual abuse). Ovarian hormones (estrogen) taken in large doses within 72 hours after sexual intercourse usually prevent implantation of the blastocyst, probably by altering tubal motility, interfering with corpus luteum function, or causing abnormal changes in the endometrium. These hormones prevent implantation, not fertilization. Consequently, they should not be called contraceptive pills. Conception occurs but the blastocyst does not implant. It would be more appropriate to call them "contraimplantation pills". Because the term "abortion" refers to a premature stoppage of a pregnancy, the term "abortion" could be applied to such an early termination of pregnancy." (p. 532)
-- [Question chapter 3, #2 for students]:
"Case 3-2
A woman who was sexually assaulted during her fertile period was given large doses of estrogen twice daily for five days to interrupt a possible pregnancy.
-- If fertilization had occurred, what do you think would be the mechanism of action of this hormone?
-- What do lay people call this type of medical treatment? Is this what the media refer to as the "abortion pill"? If not, explain the method of action of the hormonal treatment.
-- How early can a pregnancy be detected?" (p. 59)
[Answer Chapter 3, #2 for students:]:
"Chapter 3-2 (p. 532)
Diethylstilbestrol (DES) appears to affect the endometrium by rendering it unprepared for implantation, a process that is regulated by a delicate balance between estrogen and progesterone. The large doses of estrogen upset this balance. Progesterone makes the endometrium grow thick and succulent so that the blastocyst may become embedded and nourished adequately. DES pills are referred to as "morning after pills" by lay people. When the media refer to the "abortion pill", they are usually referring to RU-486. This drug, developed in France, interferes with implantation of the blastocyst by blocking the production of progesterone by the corpus luteum. A pregnancy can be detected at the end of the second week after fertilization using highly sensitive pregnancy tests. Most tests depend of the presence of an early pregnancy factor (EPF) in the maternal serum. Early pregnancy can also be detected by ultrasonography."
Given these objective scientific facts, please allow me to apply them to the specific case of Levonorgestrel.

According to their drug insert, Levonorgestrel states that "is believed to act to prevent ovulation, fertilization and implantation." As also stated therein, "After a single act of unprotected intercourse the treatment fails in about 2% of women who use it within 72 hours after intercourse." This failure rate is "based on one-time use. If Levonorgestrel ... is used on more than one occasion the cumulative failure rate will be higher." Accordingly, even Gedeon Ritcher LTD-EGIP admits that pregnancies can occur even with one-time use, and with more frequency when used more that once.

It has been demonstrated above that fertilization is the beginning of the existence of a new whole living human being. The fact that these pregnancies have taken place indicates that "break-through" ovulation and fertilization have occurred -- and can occur -- and that Levonorgestrel has failed contraceptively.

Levonorgestrel also, however, can prevent this living human embryo/being from implanting in the woman's uterus (which normally takes place about 5-7 days post-fertilization). Quite obviously, as explicitly indicated by the scientific quotations above, if "break-through" ovulation and fertilization have taken place, then to prevent this new living human being from implanting would be abortifacient. Indeed, as demonstrated above, "It would be more appropriate to call them 'contraimplantation pills'. Because the term 'abortion' refers to a premature stoppage of a pregnancy, the term 'abortion' could be applied to such an early termination of pregnancy."

For these scientific reasons, I would submit that Levonorgestrel should not be allowed to be distributed, and I request that the U.S. Federal Drug Administration take the above objective scientific facts into their considerations.

For your information, I am willing to submit about 55+ xerox copies of pages from the several outstanding and current human embryo textbooks from which I quote above Ð all of which are in concert with the international nomenclature committee. I will also attach a recent publication of mine: D. N. Irving, "When does a human being begin? 'Scientific' myths and scientific facts", International Journal of Sociology and Social Policy, 1999, 19:3/4:22-47.

In closing, I would suggest that both women and men would be precluded from giving ethically or legally valid informed consent by not being given the accurate objective scientific facts about human embryology and early human embryological development (as provided, e.g., above). It should also be considered that there are many women and men who, although they may personally condone genuine contraception, would not personally condone or desire abortion. These people have the right to know what the objective scientific facts of human embryology are so that they may make a truly informed decision as to whether or not to buy or take Levonorgestrel or any other contraceptive or "emergency contraception".

Thank you very much for your kind consideration. If there are any questions, please advise.

Sincerely,

Prof. Dr. Dianne Nutwell Irving, M.A., Ph.D.


UNDER THE TABLE
Why the U.S. Food and Drug Administration
Should Not Approve the
Over-the Counter Distribution of
Morning After Pills

Report by Population Research Institute
requires Adobe Reader to view.

65 page report.

under_the_table.pdf