10 October 2001
HON. MANUEL M. DAYRIT, MD, MSC
Department of Health
In the Matter of Levonorgestrel 750 mcg Tablet
Dear Mr. Secretary:
Each tablet contains 0.75 mg. Of Levonorgestrel [d)-)-13-beta-ethyl-
17-alpha-ethinyl-17-beta-hydroxygon-4en-3-one), a totally synthetic
The inactive ingredients present are lactose and starch.
Levonorgestrel (Gedeon Ritcher LTD-EGIP) is believed to act to
prevent ovulation, fertilization and implantation. It is not effective
once the process of implantation has begun.
Levonorgestrel (Gedeon Ritcher LTD-EGIP) is an emergency
contraceptive which can be used to prevent pregnancy if taken within
72 hours (three days) following unprotected intercourse or a
As an emergency contraceptive, Levonorgestrel (Gedeon Ritcher LTD-
EGIP) is indicated following any unprotected act of sexual intercourse,
When no contraception has been used
When a contraceptive method may have failed, including
- Condom rupture, slippage or misuse
- Diaphragm or cap dislodgement, breakage or early removal
- Failed coitus interruptus
- Miscalculation of periodic abstinence method
- IUD expulsion
- missed regular oral contraceptive pills for three or more
days in a cycle
In cases of sexual assault
The above parties were invited to give this Office written submissions within thirty (30) days, on the issue of whether or not the above named drug should be recalled and delisted from the Bureau's registry of drug products, based on the grounds cited by ABAYPAMILYA FOUNDATION.
The complainant, ABAYPAMILYA, subsequently filed its own submission on September 28, 2001.
"Studies about Levonorgestrel reveal that it is an abortifacient. Levonorgestrel operates to prevent a fertilized ovum from implanting into the uterus and thus aborts a pregnancy that has already began. It may be noted that implantation of the human embryo takes place around the 6th day after fertilization, with the human embryo now being a multi-cellular structure known as a blastocyst."
DR. LIM cited an article entitled "Life Begins at Conception," by PAUL A. BYRNE, M.D. (Neonatologist, American Board of Pediatrics, Sub-Board of Neonatal Prenatal medicine of the American Board of Pediatrics) published in VITAL SIGNS, September-October 1993, where Dr. Byrne wrote:
"Many textbooks on human embryology state that a new human life begins at conception (See e.g. Langman, Medical Embryology, p. 3 (1963): 'The development of a new individual commences with fertilization;' Thomas, Introduction to Human Embryology, p. 52 (1968); 'Fertilization is significant in that new life is created . . .'; O'Rahilly, Developmental Stages in human Embryos, p. 9 n. 1; 'the initiation of new life occurs at that moment when fertilization is completed by fusion of the two sets of chromosomes.' "I have never read a medical text or heard of any doctor writing or stating that what exists at conception is not a new human life."
She also cited DR. JEROME LEJEUNE, (Medical Doctor, Doctor in Science, Professor of Fundamental Genetics for over 20 years, and discoverer of the genetic cause of Down's syndrome) who had stated that it is important to understand the meaning of fertilization as the beginning of a human being.
"Data from studies of high-dose oral contraceptives indicate that the two ECP regimens described in these guidelines do not cause abortion; that is, they do not interrupt or damage a pregnancy, defined as beginning after implantation has occurred."
Grounded on such "definition" of pregnancy, it is the position of SCHWARZ PHARMA PHILS. that when Levonorgestrel acts to prevent implantation, as it admittedly does, there is nothing interrupted because prior to implantation, pregnancy has not begun, that is, no human life has begun to exist.
"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).
Dr. IRVING also cited MOORE & PERSAUD (6th ed.), "a zygote is the beginning of a new human being." She further cited LARSEN, Human Embryology (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 . . ." ; O'RAHILLY & MULLER, HUMAN EMBRYOLOGY & TERATOLOGY, "Fertilization is an important landmark because, under ordinary circumstances, a new, genetically distinct human organism is thereby formed. The ill-defined and inaccurate term pre-embryo . . . is not used in this book"; and CARLSON, HUMAN EMBRYOLOGY AND DEVELOPMENTAL BIOLOGY, (1994) which states in particular that, "Human pregnancy begins with the fusion of an egg and a sperm."
The origins of this embryological error can be traced back to the text Obstetric-Gynecologic Terminology, published by the American College of Obstetrics and Gynecology (ACOG) in 1972.
In this text, conception was specified to be "the implantation of the blastocyst." Conception was not, according to this revised definition, one and the same with fertilization. Consequently, pregnancy was re-defined as "the state of a female after conception and until termination of the gestation."1 As a consequence of this new definition, any interference with the viability of the human embryo, from the time of its creation until the time of implantation, was no longer an abortifacient action. According to this 'new' definition, no pregnancy (apparently) existed; hence no abortifacient actions are possible.
Having re-defined conception, which began the process of dismantling the continuum of fertilization, conception and pregnancy, a further reworking of pregnancy was initiated and approved at a meeting of the International Federation of Gynecology and Obstetrics (FIGO), in 1985. The Committee on Medical Aspects of Human Reproduction was asked by FIGO to "develop an accurate definition of pregnancy."
As a consequence of the ACOG action in 1972, and the subsequent redefining of pregnancy in 1985, there has been an increasing trend in the deviations from definitional orthodoxy. Some examples of the re-defining of pregnancy are:
"The prevention of pregnancy before implantation is contraception and not abortion." 2 (Glasier 1997)
Mr. WILKS emphasized that --
These statements are, in the strictest sense of the word, non-sense. A woman is pregnant because fertilization has been completed and conception has occurred, not because implantation has taken place. Implantation is, from both a time and developmental perspective, separate to conception/fertilization. Implantation of the human embryo takes place around the sixth day after fertilization3 with the human embryo now a multi-cellular structure known as a blastocyst. As Mosby's correctly states: "Pregnancy - the gestational process, comprising the growth and development within a woman of a new individual from conception through the embryonic and fetal periods to birth.4
I respectfully draw your attention to another example of meaning manipulation. Those who seek to promote postcoital birth control re-name the human embryo a "pre-embryo",5 a "fertilized ovum"6 or a "fertilized egg."7 Again, these are non-sense terms without any basis in science. They are ideological definitions only, fully in conflict with contemporary embryology. To recall: "Human development begins with fertilization, a process during which a sperm unites with an oocyte (ovum)." (Their emphasis).8 This distinction in terminology is critical. The full range of bioethical issues linked to the morning-after pill is centred upon this point."
"The State . . . shall equally protect the life of the mother
and the life of the unborn from conception . . . "
thus, expressly recognizing the right to life from the moment of conception.
"The intention is to protect life from its beginning, and the assumption is that human life begins at conception, that conception takes place at fertilization." (IV RECORD of the Constitutional Commission 799, cited in Bernas, J., The 1987 Constitution of the Republic of the Philippines, Manila: 1996 ed., p. 78)
So does the product literature attached by SHWARZ PHARMA to its written submission to this Office:
We note that standard medical textbooks already refer to the anti-implantation effect of certain drugs. This is pointed out by Dr. IRVING as follows:
"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 INEC9):(Annex "A", p. 3). "Keith Moore and T.V.N. Persaud,10 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 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. . ."
"All the evidence to date supports the contention that emergency contraception does not always inhibit ovulation and that it unfavorably alters the endometrial in regard to implantation. In addition, the reduced rates of observable pregnancy over the expected rates in women who receive hormonal EC in the ovulatory or post-ovulatory phase point to an abortifacient effect. Thus, the available medical evidence suggests that an abortifacient effect is likely one of the significant mechanisms by which EC reduces rates, even if given prior to ovulation."
So does Pharmacist, Mr. WILKS, as follows:
" . . . the levonorgestrel [LNG] approach clearly has an anti-developmental impact on the endometrium.(Annex "B", pp. 8-9) "Work by Kubba et al (1986) specifically referred to levonorgestrel, noting its ability to change "the nature" of the hormonal receptors within the endometrium.12 Dr Rabone (1990) reported that levonorgestrel caused a reduction in the number of estrogen and progesterone receptors within the endometrium. As Dr Rabone reported: "The concentration of these receptors is critical for the normal development of the endometrium to a stage that will support implantation.
"Simon and co-workers have also reported that altered estradiol/progesterone ratios (E2/P), which will occur with high doses of levonorgestrel, are associated with the impairment of endometrial receptivity."
To us, what is of great concern is simple fact pointed out by Mr. WILKS that:
" . . . the levonorgestrel-only post-coital dose is equal to taking 40 to 50 standard once-a-daily progesterone-only birth control pills."
(Annex "B", pp. 9-10).
The same facts were presented to us by local medical doctors who submitted their written responses to this Office:
1. The Philippine Obstetrical and Gynecological Society Foundation, Inc. (POGS):
"These potent progestogens such as Postinor do not prevent fertilization but inhibits implantation by decidualizing the endometrium rendering it non-receptive to implantation. In this case the so called Postinor is considered abortifacient."
2. The Philippine College of Pharmaceutical Medicine:
"Human development begins at fertilization, when a sperm units with an oocyte to form a single cell, a zygote. A zygote is the beginning of new human being. When you prevent this new human being from being implanted in the uterus, pregnancy is terminated and ABORTION occurs.
"Postinor can therefore be considered as abortifacient. The use of abortifaciens is illegal and not allowed in the Philippines."
3. The Philippine Medical Association(PMA) :
"It is the firm view of the PMA that intentional abortion is or assisted abortion directly or indirectly or in any manner whatsoever is criminal in nature. In view henceforth, condemns the use of drugs or medicines or any device for purposes of inducing abortion.
"Henceforth, if Postinor is indeed found to be abortifacient, then the PMA supports the call for recall and delisting from BFAD's registry of drug products."
ART. 89. Mislabeled Drugs and Devices. -- A drug or device shall be deemed to be mislabeled: i) if it is dangerous to health when used in the dosage, or with the frequency of duration prescribed, recommended or suggested in the labeling thereof;ART. 15. Imported Products. --
a) Any consumer product offered for importation into the customs of the Philippine territory shall be refused admission if such product:
x x x 2) is or has been determined to be injurious, unsafe and dangerous.
x x x
ART. 18. Prohibited Acts. -- It shall be unlawful for any person to:
a) manufacture for sale, offer for sale, distribute in commerce, or import into the Philippines any consumer product which is not in conformity with an applicable consumer product quality or safety standard promulgated in this Act.
"2.3 -- This procedure of review and evaluation does not preclude however the BFAD from submitting a recommendation to immediately ban a drug and all products containing it in cases where there is a clear finding of serious or lethal toxicity constituting undue risk to public safety. In which cases, the BFAD shall submit its finding and recommendation, together with records of substantial evidence to the Secretary of Health for immediate action."
(SIGNED) WILLIAM TORRES, Ph. D.
Director (Sgd.) 1/10/01