Pope John Paul II was a brave man. Speaking the truth in unstable and unfriendly countries, standing boldly against the popular demise of morality, traveling furiously even when weakened by sickness — no one could deny his courage.
But the pope did more than just model strength for us: He called us to it. His apostolic exhortation, Familiaris Consortio (On the Role of the Christian Family in the Modern World ), was such a call. This papal document sets out the seemingly impossible mission facing every married couple and every family in the world today: It alerts us to the fact that “the family is the object of numerous forces that seek to destroy it or in some way to deform it” and then reveals strategies for overcoming them. It shows a dying society the root of its problems and offers a renewed vision of human life, marriage, and family that will bring healing to a wounded humanity.
Given its urgent call to action, its sense of impending danger, and the fact that the pope himself called it a summa of the Church’s teaching on the family, it’s strange that this document has remained largely neglected since its publication 30 years ago. Why this reaction?
The answer lies in the fact that the teaching of Familiaris Consortio is incompatible with the secular belief system that has deeply affected our culture. The pope showed that there are two incompatible visions of reality. In presenting a biblical vision of man, he challenged the presuppositions of all secular rationalists (whether in society or in the Church) about the nature of man and woman, marriage and the family. In proclaiming “the plan of God for marriage and the family,” the pope called us all to a fundamental conversion, to the “acceptance of the Gospel.” Implied in this call is a conversion from the secular to the biblical view of reality. In this way, Familiaris Consortio stands out in the modern intellectual landscape as a sign of contradiction. While such signs are rarely welcomed, they are, nonetheless, a source of hope.
The Real Danger
Familiaris Consortio gives us a plan of action. First, it identifies the real and present danger: “At the present time, [there are] ideas and solutions which are very appealing, but which obscure in varying degrees the truth and the dignity of the human person…. These views are often supported by the powerful and pervasive organization of the means of social communication, which subtly endanger freedom and the capacity for objective judgment. Many are already aware of this danger to the human person.”
To respond to these ideologies, the pope constructed what is known as a “theological anthropology” — a view of the human person that respects his dignity by respecting his specific created nature. In the early Church, the very nature of salvation was threatened by the Christological heresies: A misunderstanding of Christ’s nature led inevitably to a misunderstanding of the nature of salvation. The Church fought vigorously against those early enemies of the truth. Today, the heresies that have arisen are not Christological but anthropological. Now, the very nature of man and our fundamental relationships with one another, as well as with God, are severely threatened. The pope’s construction of a theological anthropology was his answer to the modern heresies. Secular ideologies have systematically imposed their vision of reality on society. That vision has included a faulty egalitarianism, a reduction of all sexual differentiation to mere biology, and an understanding of the body and sexual relationships as merely instrumental. In this view, life is devoid of any metaphysical dimension (see the pope’s Letter to Families ).
In contrast to these destructive “heresies,” Familiaris Consortio‘s vision of human nature is based on the revelational witness of Scripture and grounded in the theology of creation. Like the Lord Himself, it takes us “back to the beginning” (cf. Matthew 19:1-6). This alone can overcome the false views dominating our society; the enemy must be revealed and a response formulated.
The Enemy Exposed
At the heart of the flawed secular view of reality lies a false notion of freedom. This faulty view leads inexorably to a disintegrative and destructive understanding of the person. Speaking about abortion, divorce, contraception, and other depersonalizing practices, John Paul II astutely revealed their root cause: “At the root of these negative phenomena there frequently lies a corruption of the idea and the experience of freedom, conceived not as a capacity for realizing the truth of God’s plan for marriage and the family, but as an autonomous power of self-affirmation, often against others, for one’s own selfish well-being.”
This distinction is difficult for the secular mind to grasp. As with every age, ours has been seduced by the First Temptation, the temptation to reject creaturely obedience to God and replace it with the lordship of “self.” While this grab for power may initially feel liberating, it ends in the isolation of self-captivity. Familiaris Consortio exposes the truth about the autonomous, self-referential individual. In rejecting his dependent relationship with God, man becomes depersonalized and destructive. Only by a fundamental reorientation toward the Creator and the acceptance of the structure, meaning, and purpose of human nature as it is divinely revealed can man discover his true self. For this reason, Familiaris Consortio begins with a fundamental call to conversion and states that “the Church is deeply convinced that only by the acceptance of the gospel are the hopes that man legitimately places in marriage and in the family capable of being fulfilled.” But a sophisticated modern society finds the simplicity and humility required for such a conversion difficult to accept.
Image and Likeness
Every good battle plan has a strategy. Familiaris Consortio is no different, but unlike the elaborate designs drawn by generals past, its power lies in its fundamental simplicity. The apostolic exhortation shows that the answer to the modern crisis lies in recovering the theology of creation as a vital part of any anthropological discourse. The fundamental reorientation toward the Creator requires our acceptance of creaturely status. Only in this way can the vertical dimension to human existence be rediscovered.
Of course, in a society that worships “self,” it’s extremely difficult to recall people to this saner view of reality — the view that we’re not the creators of our own nature. Nevertheless, Familiaris Consortio unabashedly proclaims that only in his relationship to God can man (and hence marriage and family) ever come into fullness of being: “Willed by God in the very act of creation, marriage and the family are interiorly ordained to fulfillment in Christ, and have need of His graces in order to be healed from the wounds of sin and restored to their ‘beginning,’ that is, to full understanding and the full realization of God’s plan.”
Human nature, marriage, and family are not social constructs subject to manipulation for the advancement of specific agendas. Rather, they’re formed and informed by God’s loving plan and interiorly oriented toward Christ. We’re called to be faithful to this will — not to any political expediency.
In calling us to battle, the pope isn’t leaving us unarmed. Familiaris Consortio provides tools that effectively defeat the destructive hold that secularism has on the modern mind. The document’s implicit critique of rationalism is fully developed in Letter to Families. There the pope shows that at the heart of modern rationalism lies its rejection of the metaphysical dimension. “Modern rationalism does not tolerate mystery…. Rationalism provides a radically different way of looking at creation and the meaning of human existence…. What is left except the mere temporal dimension of life?”
In the destructive framework of secularist thought, human nature and human acts have only temporary, utilitarian value. Meaning, if attached to any particular phenomenon, is only subjective. Inevitably, in the area of sexuality, the “other” is quickly reduced to a mere object, and the dignity of the human person is lost. The deeper dimensions of the human person, the marital covenant, and the family are incomprehensible to those who think this way. The modern world, having lost the capacity to reject the self-centered secularist framework, has also lost the language of love. Familiaris Consortio counters this by insisting on our essential identity as creatures made in the image of God:
God created man in His own image and likeness…. God is love and in Himself He lives a mystery of personal loving communion. Creating the human race in His own image and continually keeping it in being, God inscribed in the humanity of man and woman the vocation, and thus the capacity and responsibility, of love and communion. Love is therefore the fundamental and innate vocation of every human being.
Man is free only insofar as he is faithful to his created nature. Ultimately, he can only know love to the extent that he realizes his relationship to God. The pope showed that at the heart of human nature itself is the vocation to personal love and communion, which is a reflection of, and participates in, the life of the Trinity. This is possible precisely and only because man is made in God’s image. Because of this, human relationships possess a meaning far beyond mere biology. Indeed, “the love of husband and wife is a unique participation in the mystery of life and of the love of God himself.”
Part of our mission in today’s world is to recover the sense that there’s a profound symbolic dimension to the human person. The prevailing ethos is all against this. As Henri de Lubac noted in Sources of Revelation(1968), “If we said that our age repudiated… every kind of symbolism, we would still be stopping at appearances. What it does, rather, is to institute an anti-symbolism.” In contrast, Familiaris Consortioarticulates a profound hermeneutic of reality — one that allows for the intersecting of the physical and the spiritual. This hermeneutic is essential if the nature of human relationships is to be correctly understood. In reflecting on the meaning of the spousal covenant, Familiaris Consortio states: “Their belonging to each other is the real representation, by means of the sacramental sign, of the very relationship of Christ with the Church… the permanent reminder to the Church of what happened on the Cross.”
This transcendent dimension to human life has been virtually eradicated by the dominance of scientific rationalism, according to which whatever is not replicable in a laboratory is not real. But human nature, relationships, and actions can never properly be understood as only biological phenomena. They carry meaning far beyond their physical or temporal dimensions. All human reality (and its valuation) is tied to what the pope called the inscribed “vocation to love,” which is, in turn, linked to the divine nature and reflective of it. All of this depends on man’s status as imago dei (the image of God), which John Paul II considered “the most profound truth of man.”
This is incomprehensible to the secular mind. True to its own flawed logic, this view has provided for the development and acceptance of an increasingly depersonalized vision of human sexuality, one that includes contraception, in vitro fertilization, abortion, same-sex unions, embryonic stem cell research, and the like.
To counter this perversion of the human person, Familiaris Consortio confronts the dualistic tendency of our age by “going back to the beginning” and grounding our thinking in the original creative act. The anthropology the pope developed protects the essential dignity of the body and the human person: “In this way sexuality is respected and promoted in its truly and fully human dimension and is never ‘used’ as an ‘object’ that, by breaking the personal unity of soul and body, strikes at God’s creation itself at the level of the deepest interaction of nature and person.”
At issue is the value of the human body and its actions. Precisely because they have transcendent meaning, neither our gender nor our sexual relationships are without consequence. “Sexuality… is by no means something purely biological, but concerns the innermost being of the human person as such.”
This is diametrically opposed to secularism’s valuation of the human person and his actions. Love worthy of its name must involve the totality of the person. As Familiaris Consortio states, “Conjugal love involves a totality…. It aims at a deeply personal unity, the unity that, beyond union of one flesh, leads to forming one heart and soul; it demands indissolubility and faithfulness in definitive mutual giving; and it is open to fertility.”
The nature of love, the nature of the human person, and the nature of marriage require the total engagement of our human nature and an openness to life. By reiterating these truths, Familiaris Consortio not only explicitly endorses Humanae Vitae, but also provides a cogent theological and psychological defense of it. John Paul II reminded us that the teachings of Humanae Vitae provide the way to engage our sexuality in a fully human manner. “When couples, by means of recourse to contraception, separate these two meanings that God the Creator has inscribed in the being of man and woman… they act as ‘arbiters’ of the divine plan and they ‘manipulate’ and degrade human sexuality — and with it themselves and their married partner — by altering its value of ‘total’ self-giving.”
Sadly, it’s precisely this cogent defense of the teaching of Humanae Vitae that makes Familiaris Consortiosuch a hard sell in a secular environment.
Male and Female
A second hard sell was the pope’s rejection of modern reductionist ideas about gender. Society wants to force a sexless humanity (and the ubiquitous generic “person”) upon us. In contrast, Familiaris Consortiodevelops the idea of incarnational reality — that is, the belief that the physical can be expressive of a spiritual reality and that these two realities are intrinsically bound to each other. In particular, the body can never be separated from the person. The body itself is expressive of the person and bodily acts affect the person at the most profound level of his being. Secularism’s rejection of this connection has left many wounded in their bodies and in their souls. “As an incarnate spirit, that is a soul which expresses itself in a body and a body informed by an immortal spirit, man is called to love in his unified totality. Love includes the human body, and the body is made a sharer in spiritual love.”
Fundamental to created human nature is gender; maleness and femaleness are not arbitrary but essential to identity. Any reductionism on this point perverts our conception of the person. As Eric Mascal wrote inMan, Woman, and Priesthood (1978): “We have come to look upon sex in far too superficial a way, as if there were a kind of undifferentiated human nature…. Humanity is, so to speak, essentially binary; it exists only in the two modes of masculinity and femininity, and we can only understand it by studying them.”
This led the pope to encourage the genuine advancement of both men and women, but never in a reductionist manner. A proper anthropology allows for, values, and protects the similarity and distinctiveness of each gender. He wrote, “In creating the human race ‘male and female,’ God gives man and woman an equal personal dignity, endowing them with the inalienable rights and responsibilities proper to the human person.” But this never collapses into a homogenous interchangeability. Only by respecting the uniqueness and irreducibility of maleness and femaleness can we secure the positive and rich dynamic that is at the heart of gender. “All of this does not mean for women a renunciation of their femininity or an imitation of the male role, but the fullness of true feminine humanity which should be expressed in their activity.”
This is the great disease of the modern world: the rejection of the truly feminine. An adequate anthropology would prevent this. Similarly, the nature of maleness is unique, and the pope hinted at what this means: “In revealing and in reliving on earth the very fatherhood of God, a man is called upon to ensure the harmonious and united development of all the members of the family.” To lose the language of differentiation is to lose the language of love. Familiaris Consortio reveals that sexuality and acts proper to it are never only biological but are revelatory of both the human person and God’s relationship with man: “Sexuality… concerns the innermost being of the human person as such…. Their bond of love becomes the image and the symbol of the covenant which unites God and his people.” To nullify the value of the human body and its gendered specificity is not only to reject reality but also to diminish the way in which God’s salvific will is communicated to us. Screwtape himself could not have found a better means of attack.
Family: The Ecclesial Community
The attack isn’t only on the individual but on the context that brings the individual into integrated wholeness; it’s an attack on the family, which is the most basic and essential of human communities. The family must figure prominently in any authentic anthropology because man is never an isolated individual. As the pope stated: “The future of humanity passes by way of the family.” The attack against the family logically proceeds from modernity’s embrace of radical individualism, which pits the individual against any communitarian dimension of the person. Familiaris Consortio overcomes these destructive forces by discovering the original purpose and structure of the family. It urges “the rediscovery of the ecclesial mission proper to the family.”
Just as the incarnate soul can discover its purpose and meaning only in its relationship to God, so the communitarian aspect of man, embodied in the family, is only intelligible by its relationship to God’s will. “The family finds in the plan of God the Creator and Redeemer not only its identity, what it is, but also its mission…. Family become what you are. Accordingly, the family must go back to the ‘beginning’ of God’s creative act, if it is to attain self-knowledge and self-realization in accordance with the inner truth not only of what it is but also of what it does in history.”
The modern attacks against the family will succeed if the transcendent nature of the family is not fully grasped. If the spiritual dimension of reality is rejected, and if, like the body, the family is merely instrumentalized, then it can and will be distorted and destroyed. But for Familiaris Consortio, this is a falsification of the nature of family. According to the pope, the true interior structure of the family is found in its relationship to the body of Christ, the Church. “The Christian family constitutes a specific revelation and realization of the ecclesial communion, and for this reason too it can and should be called ‘the domestic Church.’ …But it is through the Cross that the family can attain the fullness of its being and the perfection of its love.”
The family cannot be understood as a social phenomenon subject to manipulation; to understand it thus is to distort its nature. The true purpose of the family lies in its relationship to the Cross and the salvation that was bought there. Indeed, “the Christian family is grafted into the mystery of the Church to such a degree as to become a sharer, in its own way, in the saving mission proper to the Church.” Attacks against the person, whether in terms of the body, gender, or his corporate reality (in the family), are ultimately attacks on the divine plan.
We’ve been given a mission. Sadly, the secular mind (whether in society or in the Christian community) disregards it because it doesn’t fit with the values of the age. The late pope’s insistence on the authentic value of the body, gender, and family as constituted by God is unacceptable to this mindset. That’s why the first call in this apostolic exhortation is to conversion. Familiaris Consortio confronts us with one of the key spiritual struggles of modern times and asks what vision of reality will win out.
So, the question remains: Will we become what we truly are — families created to reflect and participate in the very love of God Himself? And will we love one another totally with a covenantal love, faithful until death, respectful of our fecundity, icons of Christ’s own self-sacrificial love?
A difficult mission indeed, but for the grace of God.
This article originally appeared in the December 2001 issue of Crisis Magazine.
EDITORS NOTE: I would like to thank insidecatholic for reprinting this (unfortunately) still timely article… I had not read it before. May souls and their families benefit greatly from it being found here on The Orate Fratres as well.
This past week the Vatican announced changes made last May to procedures for dealing with what it calls “exceptionally serious crimes”. The revised list addressed serious crimes (graviora delicta) directed against bothmorals and the celebration of sacraments. Certain dissident groups within the Catholic Church having long sought the ordination of women–a serious abuse concerning the celebration of sacraments–were angered that the attempted ordination of women would be set on par with the moral crime of pedophilia. This wasn’t the case. But, it was an opportunity to gain some badly needed press for their long-frustrated and empty cause.
Most of the fringe press releases following the Vatican’s annoucement were filled with the same-old angry diatribes directed against “those mean old patriarchal types and the institutional church”, but at least one clever fellow was creative in his own criticisms–Although clear proof before both God and man that Catholics should never, ever, sing Negro spirituals…
For an accurate report on the Vatican annoucement: [CLICK HERE]
Mrs. Smith is thanking God today for babies and children. Whether you have children or not, whether they are grown up or not – we should all try to keep babies and children in our lives – we get way more from them than we could ever give them. We NEED our babies – please pray for an end to abortion.
Mrs. Cassiday Well said J – this is a message many of our medical personnel need to recognize as well. Just because a child isn’t going to be “perfect” in man’s eyes, doesn’t mean that child isn’t perfect in God’s eyes (or their mothers)….I still get angry over how many doctors suggested that I terminate Andrew….I still remember the look on the world renowned Pediatric Neurosurgeon when I calmly asked him to stop telling me to kill my child because it was never going to happen……
EDITOR NOTE: Keep these beautiful words in mind as you read about this terrible quiet revolution…
No. You won’t find this site making any case for the use of RU-486 as endometrial contraception. What you will find here is information on RU-486 and why you shouldn’t buy into any sales pitch being offered up by Planned Parenthood in their promotion of the chemical abortifacient.
You will also find people here who care enough about both the physical and spiritual lives of women and children that they are even willing to protest the distributor: Planned Parenthood of Southwest Oregon
In February 2010, Planned Parenthood of Southwest Oregon (PPF) announced plans to begin distribution of the chemical abortifacient RU-486 from its Ashland Clinic. Undoubtedly this will increase the number of abortions committed in Jackson County – PPF will heavily promote it and offer easy access to an abortion option which women “can do… in the privacy of their own home” (their words). We know that accessibility is a key to abortion numbers and with the gross misrepresentation which PPF has characterized the RU-486 protocol, we fear the worst. That is why Jackson County Right to Life has determined that picketing the Ashland PPF Clinic is necessary.
This is not a decision made lightly – no one wants to picket – but it is a measured response to a terrible situation that has developed. And while there is much background behind PPF’s decision to offer RU-486, the bottom line for the right- to- life movement is that distribution of RU-486 represents a significant effort to increase abortions and revenues for PPF. Our community needs to know the truth about this method of abortion and we need to change the mind of women who are in crisis pregnancies.
OUR PLAN IS AS FOLLOWS: We will picket the Ashland clinic, located at 1532 Siskiyou Blvd (near the corner of Siskiyou and Walker), on the 3rd Tuesday of each month from 12 noon to 2 pm, beginning June 15th. By picketing only once a month we are hoping more Pro-Lifers will be willing to interrupt their daily schedules and we will have a large turnout. We will picket on the opposite side of the street from the clinic. The picket will be RU-486 specific, that is, we are asking all of you to create your own sign, a sign that presents one fact about RU-486 in short and bold statements. We will refer to this as an “info-picket”. At the end of this letter is a fairly long list of RU-486 facts that the public needs to know since they won’t hear them from PPF or the media. If each of us picks a fact from the list and prepares it in the form of a picket sign, we expect that many eyes will be opened to the myriad of “secret” facts about the true nature of RU-486 and what it really does. We will also prepare the list as a handout to pass out to folks walking by. Finally, we will inform the media (as well as the police) of our intentions on the morning of each month’s picket. I would respectfully ask that no graphic images be included in this picket.
(For comprehensive information on RU-486 click here)
RU486: The Pill, The Process, The Problems
What is RU486?
RU 486 is a chemical compound that, taken in pill form, can induce abortion in women up to nine weeks pregnant. This compound gets the first part of its name from the French company, Roussel Uclaf, which first developed the abortion pill back in 1980. The “486” designation is the shortened version of the original “38486” compound number the pill was first assigned in the Roussel Uclaf laboratory. (1)
RU486 is also known by its generic name, mifepristone, and by Mifegyne, the name under which RU486 is marketed in Europe. (2) “Mifeprex,” is the name under which it is to be sold in the United States, (3) though it will also be marketed as the “Early Option” pill. (4)
How does RU486 work?
RU486 is an artificial steroid that interferes with the action of progesterone, a hormone crucial to the early progress of pregnancy. (5) Progesterone stimulates the proliferation of the uterine lining which nourishes the developing child. It also suppresses normal uterine contractions which could dislodge the child implanted and growing on the wall of the mother’s womb. (6)
RU486 fills the chemical receptor sites normally reserved for progesterone, but does not transmit the progesterone signal. Failing to receive that signal, a woman’s body shuts down the preparation of the uterus and initiates the normal menstrual process. The child, deprived of necessary nutrients, starves to death. The baby detaches and is swept out of the body along with the decayed uterine lining. (7)
Is this the “morning after” pill I’ve heard so much about?
No. Those pills operate in a different way and during a different time frame than RU486.
Morning after pills, or “emergency contraception,” are essentially very high, multiple dosages of birth control pills taken within 72 hours of unprotected intercourse. (8), (9)
While there have been some limited tests of RU486 as a morning after pill, with mixed results, (10) the only purpose for which the U.S. sponsor has sought government approval is for use to abort a confirmed pregnancy (11), (12) weeks after the baby has already attached himself or herself to the uterine wall. (13)
What is the baby like at this time?
During the time frame that RU486 is operative, the baby is undergoing a rapid period of development.
It is at about the fifth week of pregnancy (measured from a woman’s last menstrual period) that a mother first begins to suspect she is pregnant, so this is likely to be about the earliest that the chemical abortifacient is used. At this point, the child is about three weeks old (14) and approximately 2mm long (about 1/10 of an inch). (15) Even by this time, however, the baby’s nervous system has begun to form (16) and his or her heart is likely to have already begun its first beats. (17) The child’s heart will be beating strongly and steadily by the time he or she is just three and a half weeks old. (18)
The effectiveness of the RU486, or mifepristone, method begins to decline after 49 days, or 7 weeks of pregnancy. (19) By that time, the baby will be five weeks old and will have increased in size to 8mm, and his or her face, arms, and legs will be distinguishable. (20)
Before the end of the 9th week of pregnancy (7 weeks for the baby), the outer extreme of mifepristone’s effectiveness, (21) the child’s ears, fingers and toes will have formed and he or she will be 18mm, or nearly an inch tall, from crown to rump. (22)
Does RU486 have any other, non-abortifacient, uses?
While researchers have proposed a long list of diseases and conditions that RU486 might be useful against, and in some cases, conducted limited testing, the only purpose for which the U.S. sponsor has pursued government approval is abortion. (23)
Because of its properties as a antiprogestin (a compound that inhibits the action of the hormone progesterone), some believe that it may be helpful in treating endometriosis, fibroids, breast cancer, and certain non-malignant brain tumors called meningomas. (24) Pro-life groups such as the National Right to Life Committee have never opposed the testing or use of RU486 for such therapeutic purposes, but evidence of its effectiveness in these applications, (25) as well as evidence of the pill’s promoter’s real interest in such applications, is limited. (26)
Why does a typical RU486 abortion involve a second drug, misoprostol?
Acting alone, RU486 is able to induce an abortion only between 64% and 85% of the time, a rate abortifacient researchers consider “inadequate for general clinical use.” (27) This is why, two days after taking the RU486, a woman is given a prostaglandin, usually misoprostol (trade name: Cytotec), to induce powerful uterine contractions to expel the shriveled corpse. (28) Because the use of a prostaglandin (PG) is part of the standard RU486 abortion protocol, it is perhaps more accurate to refer to this as an “RU486/PG” abortion.
How long does a typical RU486/PG abortion take and how many steps does it involve?
An RU486/PG induced abortion can take days, weeks, or never happen at all. It typically involves three (or more) visits to the doctor’s office over a two week period.
In her first visit, a woman is “counseled,” given a physical examination, perhaps an ultrasound, and if there are no obvious contraindications (common red flags such as high blood pressure, diabetes, heavy smoking, allergies, etc. that could make taking the drug deadly or dangerous for her (29)), she is given the RU486 pills, which she takes in the presence of the abortionist.
Two days later, during a second visit to the doctor’s office, she is given the prostaglandin, which she takes orally or has inserted vaginally. Gradually, as the drug begins to take effect, she experiences powerful, painful uterine contractions which begin to work to expel the baby.
In U.S. trials, about half (49%) aborted during the four hours they spent waiting in the doctor’s office following the administration of the prostaglandin. An additional 26 % aborted sometime over the next 20 hours, on the bus ride home, at work, in the shower, etc. The rest who aborted did so at some point during the following two weeks. Between 8% and 23% (depending on how many weeks pregnant the mother was) never completely aborted or didn’t abort at all using the drugs.
A third visit some 14 days from the woman’s initial visit allows the doctor to confirm whether or not the abortion has been completed. If it hasn’t, the abortionist will encourage the woman to undergo a surgical abortion to guard against the possibility that she will give birth to a child who may have been injured by the drugs. (30), (31)
What sort of medical conditions might keep a woman from being offered the chemical abortion method?
Despite public claims of its ease and safety, the RU486/PG abortion method comes with a long list of contraindications, i.e., conditions that doctors believe should disqualify a woman from using the method or should at least call for heightened caution and monitoring among those selecting patients and administering the drugs because of the increased medical risks faced by such women.
Abortion researchers have recommended that women with adrenal failure, severe asthma, or receiving long-term glucocorticoid therapy not be given the drugs. Those same researchers recommend that the drugs be used cautiously in women with complicated diabetes mellitus, severe anemia, hemorrhagic [bleeding or clotting] disorders, or receiving treatment with anticoagulants. A prostaglandin sometimes used with RU486, sulprostone, has been associated with heart failure in women who were over 35, obese, smoked, or had other cardiovascular risk factors, though these have not yet been reported with the prostaglandin misoprostol. (32)
Other conditions that previous researchers have considered sufficient grounds to exclude women from clinical trials of the drugs include high blood pressure, bronchitis, menstrual irregularity, fibroids, endometriosis, use of IUD or oral contraceptives (in past three months), history of problem pregnancy, current ectopic pregnancy, pelvic inflammatory disease, allergies, epilepsy, adrenal insufficiency, recent intake of steroid or anti-inflammatory medication, or a history of liver, stomach, or intestinal disease. (33)
The FDA declared RU486 “safe” and “effective.” Is it really?
It certainly isn’t safe for the baby who suffocates or starves to death. (34) And it strains credulity to label a drug that puts perfectly healthy women in the hospital and may not work nearly a quarter of the time”safe” or “effective.” (35)
Despite careful screening to eliminate all but the most physically ideal candidates, 2% of those participating in U.S. trials of RU486 hemorrhaged. (36) One out of a 100 had to be hospitalized. (37) Several women required surgery to stop the bleeding and some bled so much that they had to have transfusions. (38) In the broader, less regulated medical marketplace, outside the careful monitoring of a clinical trial, complications could be expected to be both more common and more serious, especially for those women who do not have immediate access to emergency care. (39)
While tests in France yielded a 95-96% “success” rate, (40) the success rate in American trials for the two drug procedure has been considerably lower. Women in their fifth week of pregnancy aborted 92% of the time, while women in their seventh week aborted 77% of the time. (41) Outside the strict conditions of a clinical trial, reduced screening, monitoring, and compliance is likely to increase the “failure” rate. (42)
Claims of higher effectiveness and less frequent complications made since approval (43) have yet to be independently medically verified, though a higher incidence of pelvic infections has been reported. (44)
Didn’t an Iowa woman participating in the U.S. trials in 1994 nearly bleed to death?
Yes. According to Mark Louviere, the doctor who treated the woman, she lost between one-half to two thirds of her total blood volume and probably would have died if she had not had emergency surgery. (45) The doctor came forward after reading a press report that the Iowa portion of the trials had ended with “no complications”among the 238 women there who took part in the test. (46) “If near death due to the loss of half of one’s blood volume, surgery, and a transfusion of four units of blood do not qualify as a complication,” Louviere told the Waterloo Courier, “I don’t know what does.” (47)
What other physical side effects are common?
Nausea, diarrhea, vomiting, and painful cramping are quite often part of the package, and sometimes in clinical trials were themselves severe enough to put women in the hospital. (48) Less frequent, but potentially more serious, are side effects such as infection (49) or heart palpitations. (50)
Are there any long term physical consequences?
This is simply unknown at this point. It is known that RU486 crosses the blood follicle barrier and gets into the follicular fluid surrounding a woman’s ripening eggs. (51) What impact this will have on future pregnancies, or on children born later on, has not yet been adequately researched.
Are chemical abortions safer than surgical abortions?
Both chemical and surgical abortions have their risks, and it is not clear that they are directly comparable.
Promoters of the abortion pill often speak as if RU486/PG abortions are safer because they are earlier abortions. (52) While it is true that earlier surgical abortions are safer than later surgical abortions, (53) owing to the increasing size of the baby and the increasing complexity of the surgical procedure, (54) it isn’t clear that early chemical abortions are necessarily safer than later surgical abortions. Because the methods are so different, this is like comparing apples and oranges.
With surgical abortions, a woman faces the risks of cervical lacerations, (55) uterine or bowel perforations, (56) scarring, infection, and even permanent infertility. (57) These risks, due to the surgical process itself, may be avoided in a chemical abortion (provided a woman is not in that 8%-23% for whom the method fails (58)). But the woman undergoing a chemical abortion faces a whole new set of risks, ranging from hemorrhage (59) to heart failure, (60) typically not faced by the surgical patient.
Variations in the severity and frequency of these complications make it difficult to identify one method as safer than another. Significant injury or worse is possible with either method.
What about psychological after effects?
Though no long term studies have yet been done, the descriptions women give of their encounters with their aborted children raise great concern. Women who have undergone RU486/PG abortions talk about seeing tiny fists, eyes, or seeing their aborted babies laying in the toilet bowl or swirling in the shower drain. (61) Counselors at abortion clinics indicate it is common for women to express a desire to bury the baby, to perform some sort of ceremony to deal with their strong feelings. (62) These are hardly the reactions of women who consider this a blob of tissue. (63)
Whereas those who undergo surgical abortion only imagine what their unborn children look like and go through, women who have abortions with RU486 have vivid memories of their encounters with their children. (64) And while giving the woman more control over her abortion may assuage the abortionist’s guilt, it definitely increases a woman’s sense of responsibility for the abortion. (65)
While a sense of relief is what many woman having surgical or chemical abortions feel immediately after the abortion, we know from experience that the symptoms of post abortion trauma often do not show up until years later. (66) When women who have had RU486 abortions begin to deal with their experience, they will have more vivid memories and a greater sense of responsibility to deal with than those who underwent surgical abortions.
Available Under What Conditions?
What is the current status of RU486?
The U.S. Food and Drug Administration granted final marketing approval to RU486 on September 28, 2000. (67) It is now available from physicians who meet the FDA’s requirements and order the pills from Danco Laboratories, the drug’s U.S. distributor. (68)
What are the conditions under which it may be prescribed?
The FDA has mandated that the drug be made available to women who are no more than 49 days pregnant (7 weeks from their last menstrual period). Women taking the drug must sign a form indicating they are aware of the risks associated with the RU486/PG combination for them and their baby and promising to return for additional visits on day 3 (to take the prostaglandin) and about day 14 (to determine whether or not the abortion has taken place). (69)
Doctors prescribing RU486 are required to be able to date pregnancies and diagnose ectopics. They also must be able, the FDA says, to provide “surgical intervention” in situations where there are incomplete abortions or severe bleeding, or to have in place arrangements for patients to obtain such services from other physicians who can perform these sorts of surgical procedures. Furthermore, the prescriber must “assure patient access to medical facilities equipped to provide blood transfusion and resuscitation, if necessary.” (70)
Physicians must also sign a form indicating they have read and understood the “prescribing information,” a detailed description of the RU486’s clinical pharmacology, the drug’s indications and contraindications, and relevant warnings and precautions. Included on this form is the prescribed protocol and failure and complication rates from French and U.S. clinical trials of the drug. (71)
The “prescriber agreement” further mandates that any hospitalization, transfusion, or “other serious event” is to be reported to Danco Laboratories, the supplier. (72)
What happened to the regulations the FDA was considering back in June 2000?
Under pressure from pro-abortion groups (73) and many of their sympathetic allies in the medical establishment, (74) the FDA modified or set aside many of the patient protections it had considered just months before approval. (75)
While it kept in place measures mandating strict distribution and monitoring of pills and continued to call for some limited follow up studies, (76) other regulations were scaled back or eliminated altogether.
Instead of special training in use of the drug, physicians now only have to certify that they have “read and understood the prescribing information” on RU486. While still being asked to date pregnancies and diagnose ectopic pregnancies, prescribers are no longer explicitly required to conduct or read ultrasounds to confirm their diagnoses. (77)
While the original regulations would have limited prescription of the drug to physicians who had the surgical training to handle incomplete abortions or serious complications sometimes associated with the drug, current measures require only that a physician not having such skills make arrangements with some other physician with the appropriate surgical training. (78)
The rule that a doctor have admitting privileges at a hospital within an hour’s drive of his practice was replaced by a much looser requirement that asked only that the physician assure that a woman had “access” to appropriate medical facilities. (79)
Though the FDA decided against dropping the second visit to the doctor to take the prostaglandin on day 3, it did drop the requirement, in place during American trials of RU486, that women stay at the clinic for four hours after taking that the prostaglandin. (80)
Who benefits from the FDA’s adoption of looser restrictions on RU486?
While none of the modifications appear to make things any safer for women or their babies, these less stringent rules do potentially make things easier on the doctors and their pocketbooks.
Because of the looser regulations, physicians considering prescribing RU486 no longer necessarily have to obtain special training, buy expensive medical equipment, or spend as much time monitoring their patients. This opens up the pool of potential prescribers not only to long time abortionists presumed to have surgical skills and experience in dealing with abortion complications, but to ob-gyns, family practitioners, pediatricians, and others no matter what their medical specialty or surgical training. (81)
The FDA’s decision to drop the ultrasound as an explicit requirement saves a doctor the expense of buying an ultrasound machine and undergoing special training or hiring new staff to conduct or read ultrasounds. Dropping the four hour wait that was once part of the second office visit in which the prostaglandin was given frees up office schedules, space, and bathrooms, making things more convenient for a doctor’s staff and more comfortable for other patients who might be troubled by what they see aborting women going through. (82)
The FDA’s decision to permit doctors to refer rather than treat patients for whom the method fails or causes problems doesn’t make things easier on the woman, who must figure out how to get to yet another address, but does allow the doctor to make complications or late night trips to the emergency room someone else’s problem.
Has the abortion industry always been satisfied with such low safety standards?
Despite their current endorsement of the FDA’s loose regulatory standards on RU486, (83) the National Abortion Federation has, as recently as 1998, maintained that “all personnel performing abortions must receive training in the performance of abortions and in the prevention, recognition, and management of complications.” (84) Current FDA regulations require no special training in performing RU486/PG abortions or in preventing, recognizing, or managing complications that may arise from the method. (85)
What is the possible impact of these loose restrictions on the health of women taking RU486/PG?
There are real questions as to whether a doctor who has merely “read and understood” (86) prescribing instructions for RU486 really appreciates the medically complex, messy reality of chemical abortions. (87) Doctors who had abortion experience were so surprised by the amount of blood lost in RU486/PG abortions in U.S. trials that the sponsor of the trials offered this as a possible explanation of lower “success” rates (i.e., higher rates of incomplete abortions) in the U.S. than in France. (88)
The RU486/PG method drops off significantly in effectiveness after the 7th week of pregnancy (89) and is not an effective agent against ectopic pregnancies. (90) With ultrasound, the foremost diagnostic tool for dating and locating pregnancy, no longer required, errors in dating and diagnoses are more likely. (91) In the case of a missed date, an error could mean failure of the chemical method and the increased possibility of surgical intervention. (92) In the case of a missed tubal pregnancy, an error could mean a ruptured fallopian tube (which itself could be mistaken for an abortion) and tragedy for the mother as well as child. (93)
The absence of a surgical training requirement means that a woman for whom the method fails or one who faces serious complications may have to rely upon the help of a stranger whose name and number lies on a crumpled piece of paper at the bottom of her purse. The removal of the four hour wait at her second visit means she may face the most painful and dangerous part of her abortion all alone, precisely when she could require the greatest help, support, and medical care. (94)
Though the FDA still requires that a doctor assure “access” to appropriate medical services, the FDA’s abandonment of the provision that a doctor practice within an hour of a hospital where he or she has admitting privileges means that even if the patient is able to get to an adequately equipped hospital in time, her doctor may not be there to get her in or to treat her. If an ER staff is unfamiliar with chemical abortions and doesn’t recognize the danger a woman may be in, she could bleed to death. (95)
Will the current regulations protect women’s safety?
While the current regulations and protocol may be better than nothing, women would have had more protection under the original protocol and the regulations proposed by the FDA in June of 2000.
Do prescribers plan to follow FDA approved procedures?
Even the modest limits and standards set by the FDA and agreed to by RU486’s U.S. sponsor may be too much for some members the abortion industry.
Representatives of Planned Parenthood and the National Abortion Federation told the Wall Street Journal that some abortionists in their organizations would be using different dosages and prescribing at later pregnancy dates than those specified in the FDA approved protocol, (96) and a National Abortion Federation “start up packet” made available to doctors specifically tells recipients that “Individual providers are not limited to the uses or regimens set forth in the FDA -approved labeling” and lists variations in dosage and protocol deviating from those set out by the FDA. (97)
While the efficacy and safety of these altered dosages have not been officially established, American trials did show a significant drop off in effectiveness when RU486 was used after the 49th day of pregnancy. (98) Those failing to abort will either face the added risk of surgery or the risk of giving birth to a baby whose development may have been affected by the drugs. (99)
An FDA official told of “variations” told the Wall Street Journal that “People should use the product according to the approved regimen” and said that if the distributor wanted to change the dosage or the label, it would have to submit new data to the FDA for review. (100)
What will women do if injured by the drugs? How will they collect if injured?
Hopefully, they will get treatment early enough to avoid death or permanent injury. If, however, they are killed or injured, it is unclear who, if anyone, will compensate them or their families for losses.
The manufacturer of RU486 is a state-owned pharmaceutical firm in Communist China, (101) adding unique political and cultural difficulties on top of the challenges that would normally be involved in suing a foreign company. (102)
The distributor and promoter of RU486 is a small single-product pharmaceutical firm started by a non-profit group and financed, in part, by large loans and foundation contributions. Total capital investment in Danco is only about $34.7 million to $36.7 million (103) and the market for the drug is relatively small, (104) leading one to wonder how many large awards could be sustained.
The manufacturer of the prostaglandin used in conjunction with RU486 has disavowed its use for abortion and has fought to keep its label from sanctioning such a use. (105) A recent letter to doctors by Searle warning against off label uses may make it easier for Searle to deny liability, leaving the doctor holding the bag. (106)
Individual doctors signing the FDA and manufacturer mandated document saying they have “read and understood” the prescribing information (107) may have more difficulty avoiding responsibility, since their decision to prescribe the pills to a given patient presumably comes with full knowledge of both the patient’s medical condition and the risks and contraindications associated with the drug.
Will American women be told of any problems with the drug?
The FDA says that all “Adverse events, such as hospitalization, blood transfusion, ongoing pregnancy, or other major complications” are to be reported to Danco Laboratories, the U.S. distributor for the drug. Danco, in turn, is supposed to report data on “safety outcomes” and “ongoing pregnancies” to the FDA. (108)
There is reason to be concerned about how forthcoming the abortion pill’s promoters will be about problems with the drug.
In U.S. trials of the drug, those testing the RU486/PG method in Des Moines, Iowa told the press there had been no complications among the participants, even though at least one woman who had been a part of that study lost between half and two-thirds of her blood volume and nearly died. (109)
The man now working as the medical director for Danco is the same man a September 12,1994 Chicago Tribune report referred to as “a self described maverick and longtime abortion rights activist” who had a run-in with the FDA over an earlier chemical abortion procedure. According to the Tribune, “contrary to accepted medical practice… without the permission of the Food and Drug Administration or sponsorship of a research institution,” Manhattan Dr. Richard Hausknecht started using methotrexate, a powerful anti-cancer drug, that year to chemically abort women who answered his advertisement and paid to be part of his “study.”
The Tribune said then that “other doctors find what he’s doing unethical and potentially dangerous, and federal regulators, who learned about this experiment last week, have warned him that he might have violated the law.” One fellow abortion researcher explicitly told the paper he considered what Hausknecht was doing “downright unethical.” Even a representative of the Population Council, the non-profit which later created Danco, the company Hausknecht now works for, then called his work “extremely risky” and told the Tribune “I hope his malpractice insurance is paid up.”
Even while admitting his “research” was “a little uncharted,” the Tribune says Hausknecht initially resisted any oversight of his work, saying “D n it, I’m not going to wait!” The FDA finally told him to cease what he was doing unless he got the backing of some medical institution and submitted his data and procedures to the FDA for review. Only then, after having already performed his “experiment” on 126 women, does the paper indicate Hausknecht decided to comply with the FDA’s wishes. (110)
What is the status of the prostaglandin used in conjunction with RU486?
The FDA has mandated that the prostaglandin misoprostol should be used in the second stage of of the RU486/PG chemical abortion, (111) even though this use contradicts instructions on misoprostol’s FDA sanctioned label.
The prostaglandin misoprostol is sold by pharmaceutical maker R.G. Searle, now part of Pharmacia, under the trade name Cytotec. Searle brought Cytotec to the market in 1988 as a special anti-ulcer medication for those, such as those suffering from arthritis, who take a lot of non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin. Searle’s FDA approved label, from the beginning, has stated that the drug is contraindicated for, or not to be used by, pregnant women because of its capacity to induce miscarriage. (112)
In a 1993 letter to the Wall Street Journal, Searle said directly that it did not want its product used with RU486 for abortion, a position it has never, as far as is known, publicly altered. (113)
When the FDA approved RU486, however, in September of 2000, it specifically mandated the use of misoprostol as a necessary part of the chemical abortion procedure. (114) Searle never sought approval for this use, and its label (package insert) is inconsistent with this use.
Information published in trade and medical journals indicates that the FDA has sought to get Searle to change its label to endorse this use. (115) If the FDA is successful is pressuring Searle to make such a change, the FDA will force Searle to accept a use of its product if finds objectionable and which could expose it to potentially serious liability.
How has the drug been received?
Despite enormous media hype and claims by the abortion industry that there is great demand for the drug, all available evidence indicates that RU486 has not been the breakthrough product the pills supporters dreamed of.
Polling of the doctors done by the Kaiser Family Foundation prior to approval found 44% of gynecologists and 31% of family practitioners saying they were likely to offer RU486 once the the FDA gave its approval. (116) Approval came in September of 2000, but doctors haven’t embraced the drug.
A second study done of the same group by Kaiser one year after approval found just 6% of gynecologists and 1% of family practitioners offering the drug. (117)
At least thirty of the nation’s major colleges and universities, including Princeton, Boston University, the University of Michigan, the University of North Carolina (Chapel Hill), the University of Oklahoma, (118) Florida State University, and UCLA, have indicated they will not offer the drug to their students. (119) Yale University is the only major university that has publicly indicated plans to make RU486 available on its campus. (120)
Though Danco, the distributor, reported it had received hundreds of orders, and abortion groups like Planned Parenthood said that it had been swamped with calls from women asking about the pill shortly after approval, the New York Times reported that most of the orders came from clinics already offering abortion and that many of the women who called were confused about what RU486 was or how it worked, believing it was a pill that could be taken at any stage of pregnancy to make the baby magically disappear. (121) Other reasons behind the reluctance of individual doctors to prescribe the pill are the time involved in counseling (122) and the expense of ultrasound equipment and training. (123)
Even among experienced abortionists, enthusiasm has not been universal. Despite years of advocacy and a recent “massive educational program,” only two-thirds of the National Abortion Federation’s 360 “member facilities” were indicating to the Federation in September of 2000 that they would be offering the drug. (124) One year later, even after spending $2 million on a national ad campaign promoting the drug, the National Abortion Federation was reporting that only “about half” of its members – not the two-thirds originally projected, were offering it. (125) Even among those offering or planning to offer RU486, some still believe surgical abortions are better because they are quicker, less painful, and involve fewer office visits and are telling their patients so. (126)
The price of an RU486/PG abortion, with Danco charging $270 for a single dose of the RU486 pills, is also an issue with abortion clinics. (127) The chemical option becomes even more expensive once the additional cost of three office visits, lab work, and counseling is factored in [to say nothing of the cost of one, maybe two ultrasounds], forcing the clinic staying within the FDA approved protocol to offer the RU486/PG method at a loss or to charge a rate substantially higher than that of a corresponding surgical procedure. (128)
Bringing RU486 to the U.S.
With all these problems, why did the FDA recommend its approval in the first place?
Good question. Under the first Bush administration, the FDA issued an import alert, prohibiting the import of the drug for personal use because of safety concerns it had about the drug. (129) Three days after being sworn into office, President Bill Clinton signed an executive order directing the Department of Health and Human Services and the FDA to take steps to promote the testing, licensing, and manufacturing of the drug in the U.S. (130)
Under the Clinton administration, the FDA took a very active role in efforts to bring the drug into the U.S. In the course of carrying out the president’s directive, the FDA:
* actively pressured French manufacturer Roussel Uclaf to submit a marketing application. (131)
* helped negotiate the transfer of manufacturing and marketing rights from Roussel Uclaf to the Population Council of New York once it became clear Roussel Uclaf would not submit an application of its own. (132)
* allowed the Population Council to use data from foreign studies in its marketing application, rather than require the Council to wait until it was ready to submit data from American studies. (133)
* allowed to Population Council to submit its marketing application despite not having a finalized deal with any manufacturer or any finished chemical product from its would-be manufacturer. (134) The FDA allowed the Population Council to use chemical and manufacturing data from Roussel Uclaf as the basis of the Council’s application, knowing that Roussel Uclaf would not be the manufacturer. (135)
* submitted the application to an advisory panel stacked with known abortion activists and RU486 supporters. (136)
* processed the application for RU486 in just six months, while potentially life saving drugs were taking as long as 17 months to be processed. (137)
Is that the way the drug approval process is supposed to work?
Hardly. The Food and Drug Administration is supposed to be an objective agency representing the health and safety interests of the American people, (138) not an agent for some manufacturer or some group with an ideological or political agenda.
Was this a normal approval? What is a “Subpart H?” approval?
The FDA approved RU486 under a special provision of the federal code governing drug approvals referred to as “Subpart H.” (139)
The U.S. Congress passed legislation creating the rules now reflected in “Subpart H” in 1992 as part of an effort to streamline the approval process for AIDS drugs that were being delayed from reaching the market by what many considered excessively lengthy and overly cautious safety analyses. (140) Subpart H provides an accelerated review for drugs under consideration for the treatment of “serious or life-threatening illnesses” that offer “meaningful therapeutic benefit to patients over existing treatments.” (141)
Though the FDA has made repeated declarations of RU486’s safety, its reclassification of “the termination of unwanted pregnancy” under Subpart H as a “serious condition” (142) allowing an accelerated approval, different standards of testing, higher levels of restrictions, and, if necessary, expedited withdrawal from the market for safety or other reasons, (143) has not received as much attention.
Was there anything suspicious about the timing of the approval?
Final government approval for RU486 came just over a month prior to the heavily contested 2000 U.S. presidential election, and close to the end of President Clinton’s last term in office. (144)
Bill Clinton initiated the process on January 22, 1993 when, just three days into his first term of office, he signed an executive order directing the FDA and the Department of Health and Human Services to take steps to promote the testing, licensing, and manufacturing of the drug in the U.S. (145)
Though compilation of U.S. trial data was still incomplete, the FDA accepted a marketing application for the drug and brought it up for a hearing in 1996, the year Clinton was running for a second term. (146) Though it did not grant final approval at the time, owing to then unresolved labeling and marketing issues, Clinton’s FDA did declare RU486 “approvable” in September of 1996, in the closing months of the 1996 presidential campaign contest. (147)
With all that help from the Clinton administration, what kept the drug from being approved right away?
Perhaps even the FDA could only bend the rules so far. Having questions about the training program (148) and lacking any drug sample or file from the firm that was to be the manufacturer, (149) the best the FDA could do by the time its deadline came to rule on the drug application was to issue an “approvable” letter, declaring that they were satisfied the drug was “safe” and “effective,” but saying final approval would await the resolution of certain unnamed “labeling” and “manufacturing” issues. (150)
Soon after the FDA issued its “approvable” letter in September of 1996, the Population Council and Joseph Pike, the man chosen by the Council to set up U.S. production of RU486 and handle financing of the project, became embroiled in controversy when would-be investors discovered in October 1996 that Mr. Pike was a disbarred lawyer with a criminal record. (151) These investors were also concerned about the unusual corporate structure Pike established and the integrity of his financial dealings and operations. (152)
A series of suits and countersuits between the Population Council, Mr. Pike, and the would-be investors ensued, (153) tying the drug’s sponsor up in court for several months and bringing unwanted negative publicity to the Population Council and the RU486 project. (154)
Just as those suits began to be resolved in the spring of 1997, (155) removing Pike from day to day management of the project, the Population Council received word that the Hungarian manufacturer, Gedeon Richter, that they had lined up to produce the drug for the United States, was pulling out of the deal. (156) Gedeon Richter gave no public reason for its withdrawal, but their withdrawal forced the Population Council to have to begin their search for a manufacturer all over again, setting back the project several years. (157)
The Population Council announced that it had found new manufacturers in early 1999 and predicted it would forward the information to the FDA needed to resolve outstanding issues on its application and have the drug on the American market by the end of the year. (158)
While the Council did forward data to the FDA sometime in 1999, (159) the FDA apparently did not find the response sufficient to warrant final approval. Instead, the FDA issued another “approvable” letter in February of 2000, confirming that the application was still active, but indicating there were still “remaining questions” to be resolved. (160) While the Population Council admitted that these were, once again, “manufacturing” and “labeling” issues requiring resolution, neither the FDA nor the Council gave further details as to what those outstanding labeling or manufacturing issues entailed. (161)
Why did the Population Council have such difficulty finding or keeping a manufacturer?
Early on, a spokesman for the Population Council indicated that several of the major drug companies they had originally talked to didn’t want to face the internal dissension that producing such a pill would bring. (162) This is not surprising. Who, having devoted their life to the production of life-saving medicines, wants suddenly to be associated with a drug that kills little children?
Companies may also have looked at what becoming “the abortion pill company” might do to their corporate image and bottom line. (163) As a product, RU486 offers relatively low profit potential against a rather hefty financial risk.
Unless abortion increases dramatically, the absolute maximal market is only about 1.3 million women a year (the number of abortions performed annually in the U.S.), with these women purchasing no more than three pills at a time. Even here, two-thirds to four-fifths of these women are not likely to be eligible to receive the drug because of the date of their pregnancies (over 7 weeks) or because of other disqualifying medical or physical conditions. (164)
The pill’s promoters have spoken of potential revenues from mifepristone sales as high as $100 million a year, (165) yet this would depend on its being used by nearly every one of those women who would have aborted in the first seven weeks of pregnancy, with hardly any one being screened out for some of the common medical conditions that would make a woman ineligible for the chemical method (early indications are that use is not high (166)). And this is before subtracting manufacturing costs or other expenses.
Even this number may be grossly inflated. Sales of mifepristone in France, Britain, and Sweden for 1996 combined totaled only $3.44 million. (167) It is hard to imagine any of the major pharmaceutical makers risking its corporate image and billions of dollars of sales (168) from its most popular products for such a relatively modest gain and the likelihood of an ongoing public relations nightmare. (169)
Add to that the enormous liability risk (170) if just one of those women suffers permanent injury or bleeds to death, (171) and association with the abortion pill becomes an increasingly unattractive option to any manufacturer tempted to take on the drug.
Wasn’t there a pro-life consumer boycott of Roussel Uclaf’s American subsidiaries?
The National Right to Life Committee (NRLC) and its pro-life allies launched a consumer product boycott of Roussel Uclaf’s American subsidiaries in 1994. People ordered tens of thousands of postcards from NRLC to send to Roussel’s subsidiaries to protest Roussel’s collusion in efforts to bring RU486 to the U.S. (172)
One week after NRLC published an advertisement in USA Today highlighting the consumer boycott of Allegra, (173) one of Hoechst Marion Roussel’s top sellers, Roussel Uclaf announced it was stopping European production and giving up all remaining rights to the drug. Hoechst AG, the parent company of both Roussel Uclaf and their joint drug conglomerate, Hoechst Marion Rousssel, told the Wall Street Journal that “its decision to transfer RU-486 production was already in the works, thanks to similar pressure, but admitted the boycott threats had an impact.” Speaking directly, a spokeswoman from Hoechst told the Wall Street Journal, “Hoechst cannot take the risk of a U.S. boycott.” (174)
The Companies Involved
Could you briefly explain all the companies that are involved or have been involved in the production of RU486? It all seems so confusing.
It is confusing, but we’ll try. The blanket of secrecy with which the Population Council has tried to cover all of its activities, as well as all the mergers and acquisitions going on in the world pharmaceutical market, make it difficult to determine precisely who is doing what.
What is the name of the French company who created RU486 and how is it tied to other chemical and pharmaceutical corporations?
Roussel Uclaf is the French pharmaceutical company which first developed RU486 in the early 1980s. (175) They were owned, first partly, then later, wholly, by German chemical giant Hoechst AG. (176) Together, Roussel and Hoechst owned several American subsidiaries – Hoechst Roussel Pharmaceuticals, (177) Copley Pharmaceutical, (178) and Hoechst Roussel Agri-Vet. (179)
Under pressure from the U.S. government, Hoechst and Roussel donated the American patent for RU486 to the Population Council of New York in 1994. (180) Roussel retained all remaining rights (those outside the U.S.) to RU486 and continued to manufacture the drug for European use until at least 1997. (181)
In 1995, Hoechst purchased American drug manufacturer Marion Merrell Dow (MMD), forming a new pharmaceutical company Hoechst Marion Roussel (HMR), (182) then supposed to be the world’s third largest pharmaceutical maker. (183) As part of the acquisition, HMR acquired several of Marion Merrel Dow’s best selling drugs such as Cardizem and Seldane, as well as rights to a new non-sedating antihistamine being developed by MMD called Allegra. HMR also got MMD’s manufacturer of generic drugs, the Rugby Group. (184)
HMR sold off The Rugby Group in 1998 (185) and Copley Pharmaceuticals in 1999. (186)
In 1999, Hoechst and HMR merged with another European pharmaceutical giant, Rhone Poulenc, to form Aventis. (187)
What about the American group who received the patent? What corporate entities has it set up to manufacture and distribute the abortion drug?
After receiving the U.S. rights to RU486 from Roussel Uclaf and Hoechst AG in 1994, the Population Council, working with a lawyer/entrepeneur by the name of Joseph Pike, set up a series of companies to handle various aspects of the production, distribution, and marketing of RU486.
Pike and the Council first established a non-profit called Advances in Health Technology to promote the drug and provide public education and handle doctor training. (188) Advances also received the license to manufacture and distribute mifepristone which it turned around and granted as sub-licenses to two other for profit companies set up by Pike, Danco Laboratories and Neogen Pharmaceuticals, Inc. Though neither was to be the actual manufacturer, Danco was supposed to be responsible for setting up the manufacturing and distribution of mifepristone as an abortifacient while Neogen was to arrange manufacturing and distribution of the drug for all other medical indications. (189)
Pike controlled both of the sub-licensees through a company called N.D. Management. (190) N.D. Management, in turn, was the sole general partner of a Neogen Investors and a limited partner, along with Neogen Investors, in a group named Neogen Holdings, L.P. Neogen Holdings was the sole shareholder of Danco, while Neogen Investors was the sole shareholder of Neogen Pharmaceuticals. (191) Outside investors thus gained some stake in both the abortifacient and non-abortifacient uses of mifepristone through their participation in Neogen Investors. (192)
Some confusion about the names of the various entities involved in the mifepristone project arose when Pike kept changing the name on the bank account in which cash proceeds from the Neogen Investors offerings were held. From 1995 to 1996, the name on the account was changed four times, from Neogen to Neogen Pharmaceuticals to Neogen Industries to Neogen Pharmaceuticals to Neogen Industries again. (193)
Pike was exposed as a disbarred lawyer and convicted forgerer in October 1996, leading to a series of lawsuits between the Population Council, Pike, and would-be investors. In announcing the settlement of suits between Pike and the Population Council, removing Pike from the project’s day to day operations in February of 1997, the Council also announced a change in the project’s corporate structure.
Advances in Health Technology, the non-profit which originally held the license for manufacturing and distributing mifepristone, was eliminated and replaced by a new company Advances for Choice, headed by Dutch former pharmaceutical executive Jack Van Hulst. Advances for Choice was supposed to pick up the training and education functions performed by Advances in Health Technology, and was to be publicly identified as RU486’s U.S. seller and distributor. The identities of the manufacturer and other involved companies were still to be kept secret. (194)
Court documents filed in May of that year, however, showed that Danco, the sublicensee charged with arranging the manufacturing and distribution of RU486, continued to exist, along with Neogen Investors, the group of investors putting money into the abortion pill project, and N.D. Management, the entity set up by Pike to oversee all aspects of the project handled by Danco and the various Neogen incarnations. Those documents further clarified that Danco was simply supposed to be the “marketer/seller of the finished product,” with other unnamed companies responsible for manufacturing the raw product and pressing it into tablet form. (195)
The name of the company the Population Council had originally contracted in 1996 to manufacture the raw mifepristone, Hungarian pharmaceutical firm Gedeon Richter, also surfaced in June of 1997, when the press learned through those same court documents that Richter had notified Danco and the Population Council of its intention to pull out of the deal at the end of February 1997. (196) Danco sued Richter in May to try to force Richter to fulfill the contract; the case and the identities of the litigants became known when a New York judge refused to seal the records. (197)
In the process of responding to press inquiries about the case and its implications for the timing of the abortion pill’s release, spokespeople for the Population Council let it be known that the name of the marketing arm had been changed once again, from Advances for Choice to Advances/Neogen, with the status of Jack Van Hulst, the gentleman originally tapped to be the CEO of Advances for Choice, in limbo. (198) Whether the new name represented a melding of the marketing, management, and investment functions, or a further joining of the abortifacient and the putative non-abortifacient divisions of the mifepristone project, the Council did not say.
A 1998 document referred to the Council’s licensee as Advances/The Neogen Group, though it is unclear whether this represented any further change or simply a variation on the latest designation. (199)
Reports appearing in 1999 and 2000 have referred to the Danco Group, rather than Advances/Neogen, as “the company licensed to to market RU-486” or the “company sponsoring mifepristone in the United States.” (200) Other reports vary the name, referring to this company as “Danco Laboratories,” (201) or Danco Laboratories, LLC. (202) Mother Jones magazine indicates that the Danco Group received this license in 1998. While articles have identified the Danco Group as “a start-up pharmaceutical company” in New York (203) (the original Danco Laboratories was set up in California (204) and incorporated in the Cayman Islands (205)), these reports and others suggest that other unnamed firms are the actual manufacturers. (206)
Did Roussel Uclaf’s involvement with RU486 in the United States end when it donated the patent to the Population Council in 1994?
Hardly. Court documents that came to light in 1997 reveal that despite Roussel Uclaf’s claim that its donation of patent to the Population Council in 1994 “eliminates its involvement in the manufacture and distribution of RU 486 in the U.S.,” (207) Roussel did several things to assist the U.S. mifepristone project after giving the U.S. patent to the Population Council.
Despite its claims of non-involvement, RU:
* supplied the pills used in the U.S. clinical trial conducted by the Population Council in 1994 and 1995. (208)
* functioned as the “stand-in” manufacturer on the Population Council’s marketing application to the FDA in 1996, supplying the Chemical, Manufacturing, and Control section of the Council’s marketing application, because the Council had yet to sign a firm contract with a manufacturer or obtain any product samples from a new manufacturing source. (209)
* furnished Gedeon Richter, the Hungarian firm that was to be the manufacturer of the drug for the Population Council, with Roussel’s complete Drug Master File (DMF) on mifepristone and contacted Richter directly “to offer any assistance it needed in completing its own DMF.” (210)
Who now controls the patent rights in Europe and other places outside the U.S.?
Roussel Uclaf, which gave away the U.S. patent to the Population Council in 1994, transferred its remaining RU486 rights (those outside the U.S.) to Edouard Sakiz, one of Roussel’s former chief executives, in April of 1997. (211)
Sakiz, who ran Roussel Uclaf back when RU486 was first developed and sold on the French market, (212) set up a new company, Exelgyn, to handle manufacturing, marketing and distribution of the drug. Though Roussel claimed that it was “ending its involvement with mifepristone” with the April 1997 transfer, (213) Hoechst [through Roussel Uclaf] continued to produce the pill while Sakiz was setting up his company and arranging for other companies to do the production and distribution. (214)
Roussel Uclaf is supposed to have actually stopped production and turned over its remaining stocks to Exelgyn in September of 1997. (215)
Made in China
Is RU486 being manufactured by a foreign company?
Yes. Press accounts have confirmed that the RU486 being sold in the United States is being made by the Hualian Pharmaceutical Company, a state-owned drug manufacturer located on the outskirts of Shanghai in Communist China. (216)
What sort of problems does the drug’s being manufactured in China create?
Members of the U.S. government have expressed special concerns about drug manufacturing in the Far East and the FDA’s ability to monitor these manufacturers. (217) The political, cultural, and geographic distance presents problems, not just for inspectors monitoring the integrity of manufacturing, storage, and shipping practices, but for those seeking information for suits or compensation for injuries. (218)
What sort of record does the Chinese manufacturer have when it comes to the safety and purity of exports?
Not stellar. The Hualian pharmaceutical firm now manufacturing RU486 has been among those Chinese firms cited for various drug import violations in recent years. In 1998, a study by the California Department of Health Services found high levels of contaminants in an herbal medication made by Hualian’s earlier incarnation, the Shanghai No. 12 Pharmacy Factory, known as composite tegafuri capsules, as well as high contamination levels in hundreds of similar products made at the same plant. (219)
Another drug (betamethasone) produced by Hualian was detained by FDA officials in Cincinnati in July of 2000 because of false or misleading labeling. This was during a time when the Chinese plant was undergoing an FDA re-inspection associated with the production of RU486, though inspectors there were not informed of the problem with the betamethasone intercepted in Cincinnati. (220)
Did the FDA find any sort of irregularities when inspecting the Chinese manufacturing plant for production of RU486?
Yes. FDA inspectors examining the RU486 manufacturing process encountered a number of irregularities during their visits of 1999 and 2000. In October of 1999, the inspector found that the methods and specifications section of the Chemistry and Manufacturing Controls report filed by Hualian “didn’t correspond to methods and specifications used by the firm.” (221)
An interpreter explained to the FDA inspector that Hualian had simply “copied information from the Roussel NDA [the original French manufacturer’s New Drug Application] in a number of sections rather than translate their own methods from Chinese to English.”
The inspector also said Hualian had inserted numerous references to the United States Pharmacopeia (USP – the legally recognized compendium of standards for drugs in the United States) in its Chemistry and Manufacturing Controls report after Hualian’s consultant told them the FDA wanted all raw materials to meet this standard, even though the references they inserted “have nothing to do with the testing they perform.” The FDA inspector gave up after four days of waiting for translations that correctly reflected Hualian’s testing practices. (222)
The problems of October 1999 supposedly resolved, the FDA returned for another inspection in July of 2000. Even this inspection found several deficiencies, but, based on promises of corrective actions by Hualian, the FDA authorized moving forward on RU486. (223)
What sort of confidence does the record of the Chinese manufacturing firm inspire?
Not much. Even if FDA inspectors attempted to act in charity and good faith, serious questions remain about the integrity of the manufacturing and testing processes at the Hualian factory. The factory has been identified as a source of tainted drugs shipped to the U.S. in the past and some question remains about Hualian’s willingness to disclose deficiencies or possible problems, especially given some of its recent actions in regard to this drug (see above).
Is the pill manufactured in China the same as the one made in France?
It isn’t clear whether the Chinese formula for RU486 is the same as the one tested and approved in the U.S. (224) If not, data from the U.S. trials of RU486, which used the French-made pill, (225) offer no reliable guide to the safety and efficacy of the Chinese product.
The Rest of The World
What European countries have recently approved the sale of RU486?
Until recently, only France, Britain, and Sweden offered the drug. However, in 1999, mifepristone was approved for use in several new European countries.
In April of 1999, Exelgyn asked the European Drug Agency, which oversees drug approvals for member countries of the European Union (EU), for permission to put the drug on sale in eight of the 12 remaining EU countries. Those countries were Austria, Belgium, Denmark, Finland, Germany, Greece, Spain, and The Netherlands. (226) Exelgyn chose not to apply to market the drug in Italy, Ireland, Luxembourg, and Portugal. (227)
Members of the EU have mutual recognition procedures whereby the drug authorizations of one country can be extended to others, (228) and it was under this procedure Exelgyn sought clearance in these eight countries. That was granted July 6, 1999. National governments in Germany, Greece, Belgium, and Finland had already given notification of permission for sale of the pill in their countries, while individual governmental notification was still pending in Austria, Denmark, Spain and the Netherlands at that time. (229)
Reports also indicate that Israel recently granted a license for the abortifacient, (230) and that Exelgyn also registered the drug in non-EU countries Switzerland and Russia. (231) Exelgyn had indicated it was prepared to apply for registration in Canada once the drug received final approval in the U.S., (232) and studies through the Population Council are currently underway there. (233)
Even where the abortion pill has full government approval, supply, training, and distribution issues still remain to be worked out, a task made all the more difficult in those countries with institutional opposition and complex nationalized health care bureaucracies. (234)
Do the abortion pill’s promoters have any intent to export the drug to third world countries?
Yes. The export of RU486 to the world’s developing countries has been in the minds of the pill’s developers and promoters from the very beginning.
Even before discovering RU486 and its unique abortifacient properties, Emile Baulieu admits he was looking for some way to deal with the “demographic,” i.e., population, “crisis” of so-called Third World countries. (235)
Baulieu’s vision had not changed in 1990 after seeing the drug approved in France, Britain, and Sweden. In his history of RU486, The “Abortion Pill,” Baulieu declared that, in developing countries, “Women badly need the [contraceptive] backup methods of effective contragestion and abortion. RU-486 has a vital role to play.” Beyond personal medical benefits Baulieu projected for the drug, Baulieu indicated he also believed RU-486 had a “broader role” in such countries helping “governments to dampen a population explosion which threatens to outstrip the world’s resources.” (236)
Though authorized development and distribution has, so far, been in largely western nations (China being the exception), the hope among abortion pill advocates is that U.S. approval will springboard RU486’s acceptance in other nations around the globe who look to America for guidance. (237)
Delegates from Kenya, India, South Africa, Cuba, Vietnam and others countries met in January of 1998 with representatives of Exelgyn and the Population Council to discuss the most effective way of tackling the issue of unsafe surgical abortions in the developing world “by the safe and effective introduction of early medical [i.e., chemical] abortion.” (238)
Several of the conference delegates, including the representative of the Population Council, complained that the complex protocol associated with RU486 (multiple visits, ultrasound to date the pregnancies, the need for surgical backup,etc.) inhibited the drug’s introduction to developing nations.
Roy Karnovsky, president of Advances/The Neogen Group [now known as Danco], the company set up by the Population Council to handle U.S. marketing for RU486, identified developing countries as those “with the most urgent need for this technology” and specifically asked whether the “unmet need for abortion and the morbidity and mortality from unsafe abortion in developing countries merit relaxation of the stringent requirements for quality in place in developed countries.” (239)
At the time, Exelgyn rejected the idea of a double standard for developed and developing countries, maintaining that medical and surgical care and backup should be available and that there should be strict distribution controls. (240)
The legality or illegality of abortion in these countries was not an issue for conference attendees, who declared that “Advocacy for abortion is essential irrespective of the prevailing legal position regarding provision of abortion services.” (241)
Considering the bleeding and other risks associated with the pill, isn’t this a dangerous idea?
Certainly. With the RU486/PG chemical method, it is essential that a woman have ready access to emergency medical care should serious complications develop. (242) Owing to the dearth of medical equipment or trained medical personnel in many of these developing countries, as well as transportation and infrastructure challenges, (243) disaster probably awaits any concentrated effort to bring this to the third world.
Why an abortion pill?
Why does the pro-abortion crowd want the abortion pill?
Abortion has become increasingly unpopular with doctors, women, and the American public.
Ostracized by the medical community and worn out by thousands of abortions, many doctors are dropping abortion from their practice and fewer doctors are taking their places. (244) Women use words like “intimidating,” (245)”invasive,” “mechanical,” “impersonal,” “abrupt,” (246) and “traumatic,” (247) to describe their abortion experiences. Increasing majorities, while perhaps not yet ready to proscribe all abortions, nevertheless see abortion as murder or at least the taking of human life, and something that should be limited. (248)
Chemical abortions, like RU486/PG, give supporters of abortion a chance to change the image of abortion, making it seem as simple as taking a pill (249) and concentrating on smaller, less developed babies whose destruction seems an easier political sell. (250) That the reality is far different — that these abortions offer a whole new set of significant risks, that the objective is still the destruction of a unique human life — is of little consequence to abortion’s promoters as long as their false perception holds.
1. Etienne-Emile Baulieu, The “Abortion Pill” (New York: Simon & Schuster, 1991), p. 25.
4. Rachel Zimmerman, “Awaiting Green Light, Abortion-Pill Venture Keeps to the Shadows,” Wall Street Journal, September 5, 2000. Stacey Schultz, in an earlier report, (“Long-awaited abortion pill will offer more privacy – but no less controversy,” U.S. News & World Report, February 28, 2000, p. 79), gave the trade name of the drug as “Mifeprex.”
5. André Ulmann, Georges Teutsch, and Daniel Philbert, “RU486,” Scientific American, Vol. 262, No. 6 (June 1990), pp. 18-24.
6. Arthur C. Guyton, Textbook of Medical Physiology, 6th ed., (Philadelphia: W.B. Saunders Co., 1981), p. 1012.
7. Baulieu, pp. 13, 16-18; Ulmann, pp. 18-20.
8. Planned Parenthood Federation of America, Inc., Emergency Contraception Handbook, Planned Parenthood booklet, 1999, pp. 8-9, 11.
9. Robert A. Hatcher, et al, Contraceptive Technology, 16th rev. ed. (New York: Irvington Publishers, 1994), pp. 453, 455, 459, 461.
10. A Psychosos, et al, “Hormonal anti-implantation agents: antiprogestins,” Human Reproduction Vol. 10, supplement 2 (December 1995), pp. 140-150; I.M. Spitz, et al, “Effect of mifepristone on inhibition of ovulation and induction of luteolysis,” Human Reproduction, Vol. 9, supplement 1 (June 1994), pp. 69-76; I.M. Spitz, A. Robbins, “Mechanism of action and clinical effects of antiprogestins on the non-pregnant uterus,” Human Reproduction Update, Vol. 4, No. 5 (September-October, 1998), pp. 584-593; Task Force on Postovulatory Methods of Fertility Regulation, “Comparison of three single doses of mifepristone as emergency contraception: a randomised trial,” Lancet, Vol. 353 (February 27, 1999), pp. 697-702.
11. Reproductive Health Drugs Advisory Committee, U.S. Food and Drug Administration, Transcript, “New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy,” (available from CASET Associates, Fairfax, Virginia); PPFA, Emergency Contraception Handbook, p.22.
12. Irving M. Spitz, et al, “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,” New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998), p. 1242.
13. Keith L. Moore, The Developing Human, 4th ed. (Philadelphia: W.B. Saunders Co., 1988), p.2.b
14. Keith L. Moore, The Developing Human, 3rd ed. (Philadelphia: W.B. Saunders, 1982), p. 94.
15. Lennart Nilsson and Lars Hamberger, A Child is Born (New York: Delacorte Press, 1990), p. 77.
16. Keith L. Moore and T.V.N. Persaud, The Developing Human, 5th ed. (Philadelphia: W.B. Saunders, 1993), pp. 385-386.
17. LIFE Educational Reprint #27, “Life Before Birth,” p. 6. Reprinted from LIFE, April 30, 1965.
18. Keith L. Moore and T.V.N. Persaud, The Developing Human, 5th ed., p. 65.
19. Irving M Spitz, C. Wayne Bardin, Lauri Benton, and Ann Robbins, “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,” New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998), p. 1243.
20. Moore and Persaud, The Developing Human, 5th ed., p. 3.
21. Spitz, et al., “Early Pregnancy Termination…”, p. 1243.
22. Moore and Persaud, The Developing Human, 5th ed., p. 4.
23. See transcript of FDA Mifepristone Hearings, “New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy.”
24. Committee on Antiprogestins, National Academy of Sciences, Clinical Applications of Mifepristone (RU486) and Other Antiprogestins (Washington, D.C.: National Academy Press, 1993), pp. 36-51.
25. F. Darro, et al, “Growth inhibition of human in vitro and mouse in vitro and in vivo mammary tumor models by retinoids in comparison with tamoxifen and the RU-486 anti-progestagen,” Breast Cancer Res Treat, Vol. 51, No. 1 (September, 1998), pp. 39-55; W.G. Schoonen, et al, “Effects of two classes of progestagens, pregnane and 19-norestosterone derivatives, on cell of human breast tumor cells: II. T47D cell lines,” Journal of Steroid Biochem and Mol Biology, Vol. 55, Nos. 3-4 (December 1995), pp. 439-44; L.M. Kettel, et al, “Preliminary report on the treatment of endometriosis with low-dose mifepristone (RU486),” American Journal of Obstetrics and Gynecology, Vol. 178, No. 6 (June 1998), pp. 1151-1156.
26. Regina Sitruk-Ware, in “Les antiprogesterones,” Presse Med, Vol. 28, No. 38 (December 4, 1999), pp. 2123-2131, talks about the use of RU486 for endometriosis, fibroids, and meiningomas, but focuses largely on abortion and labor induction properties examined in large clinical studies.
27. Sophie Christin-Maitre, Philippe Bouchard, and Irving Spitz, “Medical Termination of Pregnancy,” New England Journal of Medicine, Vol. 342, No. 13 (March 30, 2000), p. 951. While Christin-Maitre, et al specifically referred to the efficacy of mifepristone among women 49 days pregnant or less when recounting these percentages, Ulmann, in Scientific American, p. 23, reported a range of 65% to 80% efficacy. Other studies using similar doses obtained “completion” rates of 65.2% (RU486 Collaboration Group, “Termination of early pregnancy by RU486 alone or in combination with prostaglandin,” Chinese Journal of Obstetrics & Gynecology, Vol. 25 (1990), pp. 31-4, 62) and 63.5% (Zheng Shu-rong, “RU 486 (mifepristone): clinical trials in China,” Acta Obst. Gyn. Scand, Vol 149 (1989), supplement, pp. 19-23.
28. Irving M. Spitz, C. Wayne Bardin, Lauri Benton, and Ann Robbings, “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,” New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998), pp. 1241-1243.
29. See the NRL-Educational Trust Fund fact sheet “RU486: Risks & Dangers,” for a full list of contraindications and references.
30. Irving M. Spitz, C.Wayne Bardin, Lauri Benton, and Ann Robbins, “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,” New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998).
31. Oregon Health Sciences University, “Consent Form” for “Evaluation of the Efficacy, Safety and Acceptability of Mifepristone and Misoprostol in Inducing Abortion in Pregnant Women with Amenorrhea of up to 63 Days” (ORS #3703, Protocol 166B), 12/1/94.
32. Christin-Maitre, et al, “Medical Termination of Pregnancy,” pp. 952-953.
33. Raymond, et al, RU 486: Misconceptions, Myths, and Morals, pp. 34-37; B. Couzinet, N. Le Strat, A. Ulmann, E-E. Baulieu, G. Schaison, “Termination of early pregnancy by the progesterone antagonist RU 486 (mifepristone),” New England Journal of Medicine, Vol. 315 (December 18, 1986), pp. 1565-70; L. Silvestre, C. Dubois, M. Renault, Y. Rezvani, E-E. Baulieu, A. Ulmann, “Voluntary interruption of pregnancy with mifepristone (RU486) and a prostaglandin analogue: a large-scale French experience,” New England Journal of Medicine, Vol. 322 (March 8, 1990), pp. 645-648.
34. See comment of Mary Jo O’Sullivan, MD, Reproductive Health Drugs Advisory Committee member, U.S. Food and Drug Administration, “New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy,” transcript by CASET Associates (Fairfax, VA), p. 290.
35. Spitz, et al, NEJM, pp. 1243-44.
36. FDA Mifepristone Hearing, p. 65.
37. Spitz, et al, NEJM, p. 1243.
38. Spitz, et al, NEJM, p. 1243.
39. See comments of FDA Reproductive Health Drugs Advisory Committee Member Cassandra Henderson, MD, at pp. 278-280, 291-292.
40. FDA Hearing, pp. 28, 30-31.
41. Spitz, et al, NEJM, p. 1243.
42. See comments of Henderson, Sullivan, FDA Hearling, pp. 278-280, 291-292.
44. Shari Roan, “Abortion Pill Is Safe in First Year of Use in U.S., Proponents Say” Los Angeles Times, 10/1/01.
45. Statement of Mark Louviere, MD, FDA Mifepristone (RU486) Hearing, 7/19/96, pp. 223-227.
46. Associated Press, “Iowa ‘abortion pill’ test heralded as a success,” Des Moines Register, September 2, 1995, Metro section, p. 5.
47. Tom Carney, “‘Abortion pill’ test goes awry for one patient,” Des Moines Register, Metro section, p. 1, 5.
48. Spitz, et al, NEJM, pp. 1243-1245.
49. Spitz, et al, NEJM, p. 1244.
50. FDA Mifepristone (RU486) Hearings, pp. 50, 55.
51. Janice G. Raymond, Renate Klein, Lynette J. Dumble, RU486: Misconceptions, Myths and Morals, Cambridge, MA: Institute on Women and Technology, 1991, pp. 75-76.
52. Testimony of Beverly Winikoff, Program Director of Reproductive Health, Population Council at FDA Mifepristone Hearings, p. 81; Margaret Talbot, “This Pill Will Change Everything About Abortion,” The New York Times Magazine, July 11, 1999, p. 41; Aaron Zitner, “What ever happened to RU-496?” The Boston Globe Magazine, November 23, 1997, p. 39.
53. Jack Pritchard, et al, Williams Obstetrics, 17th ed. (Norwalk, CT: Appelton-Century-Crofts, 1985), p. 483.
54. Warren M. Hern, Abortion Practice (Philadelphia: J.B. Lippincott, 1984), pp. 26-35.
55. Kenneth F. Schulz, et al, “Measures to Prevent Cervical Injury During Suction Curettage Abortion, “The Lancet, May 28, 1983, p. 1182.
56. Philip G. Stubblefield, “First and Second Trimester Abortion,” in Gynecologic and Obstetric Surgery, ed. David H. Nichols (Baltimore: Mosby, 1993), pp. 1023-1024; Stephen G. Kaali, et al, “The frequency and management of uterine perforations during first-trimester abortions,” American Journal of Obstetrics and Gynecology, August 1989, pp. 406-408.
57. David N. Danforth, ed. Obstetrics and Gynecology, 5th ed. (Philadelphia: J.B. Lippincott, 1986), pp. 217, 257, 382-383, 887; Nichols, Gynecologic and Obstetric Surgery, p. 260; Pritchard, Williams Obstetrics, 17th ed., p. 484; Leon Speroff, et al, Clinical Gynecological Endochrinology & Infertility (Baltimore: Williams & Wilkins, 1983), pp. 156- 157.
58. Spitz, “Early Pregnancy Termination…,” p. 1241.
59. Spitz, “Early Pregnancy Termination…,” p. 1243; Statement of Mark Louviere, FDA Mifepristone Hearings, pp. 223-225.
60. Alan Riding, “Frenchwoman’s Death Linked to Abortion Pill and a Hormone,” New York Times, April 10, 1991, p. A-10.
61. Debra Rosenberg, Michelle Ingrassia, and Sharon Begley, “Blood and Tears,” Newsweek, p. 68. Louise Levanthes, “Listening to RU486,” Health, January/February 1995, p. 88.
62. Judith Gaines, “Women describe pros, cons of RU486,” Boston Globe, May 8, 1995, p. 1.; “Prepare now to counsel patients on RU486,” Contraceptive Technology Update, April 1995, p. 53.
63. Levanthes, p. 88-89.
64. Levanthes, pp. 87-89; Gaines, p. 1; Rosenberg, pp. 66-68.
65. Levanthes, p. 88; CTU, p. 52.
66. Anne C. Speckhard and Vincent Rue, “Postabortion Syndrome: An Emerging Public Health Concern,” Journal of Social Issues, Vol. 48, No. 3 (1992), pp. 95-119. See also Vincent Rue, Anne Speckhard, James Rogers, and Wanda Franz, “The Psychological Aftermath of Abortion: A White Paper,” presented to C. Everett Koop, Surgeon General of the U.S., September 15, 1987. For an earlier reference, see W. L. Sands, “Diagnosing Mental Illness; Evaluation in Psychiatry and Psychology,” in Psychiatric History and Mental Status, eds. Freedman and Kaplan (Atheneum, 1973), p. 31.
72. Danco Laboratories, “Prescribing Information,” Mifeprex Early Option Pill packet, available from Danco Laboratories, P.O. Box 4816, New York, NY 10185, or from FDA website at http://www.fda.gov/cder/drug/infopage/mifepristone (comprised of “Mifepristone Label,” “Medication Guide,” and “Patient Agreement”).
73. Jean Marbella, “FDA fuels abortion pill debate,” Baltimore Sun, June 12, 2000.
74. Letter from American College of Obstetricians and Gynecologists and American Medical Association to Jane Henney, FDA Commissioner, July 24, 2000.
75. Nancy Gibbs, “The Abortion Pill,” TIME, October 9, 2000, p. 43.
81. Carole Joffe, “Medical Abortion and the Potential for New Abortion Providers: A Cautionary Tale,”Journal of the American Medical Women’s Association, Vol. 55, No. 3 (Supplement 2000), pp. 151-154. See also Sherry Kay Stolberg, “FDA Adds Hurdles in Approval of Abortion Pill,” New York Times, June 8, 2000.
82. Carole Joffe, “Reactions to Medical Abortion Among Providers of Surgical Abortion: An Early Snapshot,” Family Planning Perspectives, Vo. 31, No. 1 (January-February 2000), pp. 35-38.
83. National Abortion Federation News Release, Statement of Vicki Saporta, Executive Director, “National Abortion Federation Opposes Legislation That Would Impose Restrictions on Mifepristone (RU-486) Already Rejected As Medically Unnecessary by the FDA,” February 6, 2001.
84. Maureen Paul, et al, “Appendix: National Abortion Federation 1998 Clinical Policy Guidelines,” republished in A Clinician’s Guide to Medical and Surgical Abortion (New York: Churchill Livingstone, 1999), p. 256.
87. Carole Joffe, “Reactions to Medical Abortion Among Providers of Surgical Abortion: An Early Snapshot,” Family Planning Perspectives, Vo. 31, No. 1 (January-February 2000), pp. 35-38.
88. Thomas H. Maugh II, “Abortion Drug Is Safe, U.S. Study Finds,” Los Angeles Times, April 30, 1998, p. A4.
89. Irving M. Spitz, C. Wayne Bardin, Lauri Benton, and Ann Robbins, “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,” New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998), pp. 1241-1247.
90. Mifeprex label, available at http://www.fda.gov/cder/foi/label/2000/20687lbl.pdf Also see O.M Avrech, et al, “Mifepristone (RU486) alone or in combination with a prostaglandin analogue for termination of early pregnancy: a review,” Fertility & Sterility, Vol 56 (1991), pp. 385-293.
91. Maureen Paul, et al, A Clinician’s Guide to Medical and Surgical Abortion (New York: Churchill Livingstone, 1999), pp. 41, 50.
92. Irving M. Spitz, C. Wayne Bardin, Lauri Benton, and Ann Robbins, “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,”New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998), pp. 1241-1247.
93. F. Gary Cunningham, et al, “Chapter 32: Ectopic Pregnancy,” Williams Obstetrics, 19th ed. (Norwalk, CT: Appleton & Lange, 1993), pp. 691-719, particularly, pp. 696, 705..
94. FDA “Mifepristone Hearing” transcript of Reproductive Health Drugs Advisory Committee meeting, July 19, 1996, pp. 48-49, available at http://www.fda.gov/ohrms/dockets/ac/96/transcpt . C. Wayne Bardin, the doctor who oversaw the new drug application for the Population Council, told the FDA advisory panel that 65% of all “adverse events” that were reported were observed during the 4-5 hours the women spent in the clinic after taking the misoprostol.
95. The case of Dr. Mark Louviere, reported in the September 24, 1995 edition of the Waterloo Courier (p. F3), is instructive. Louviere’s patient was fortunate that he recognized her danger and rushed her to emergency surgery.
96. Sarah Lueck, “Groups Offer Abortion-Drug Variations,” Wall Street Journal, October 30. 2000, p. B2.
97. National Abortion Federation, “Early Medical Abortion with Mifepristone or Methotrexate: Overview and Protocol Recommendations,” October 2000, p. 36.
98. Irving M. Spitz, C. Wayne Bardin, Lauri Benton, and Ann Robbins, “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,” New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998), pp. 1241-1247.
100. Sarah Lueck, “Groups Offer Abortion-Drug Variations,” Wall Street Journal, October 30, 2000, p. B2.
101. Philip P. Pan, “Chinese To Make RU-486 For U.S.,” Washington Post, October 12, 2000, p. A1.
102. Rep. Chris Smith (R-NJ) raises a similar concern in AP reporter Paul Recer’s wire story “Abortion Pill,” October 13, 2000.
103. Rachel Zimmerman, “Awaiting Green Light, Abortion Pill Venture Keeps to the Shadows,” Wall Street Journal, September 5, 2000.
104. Rachel Zimmerman, “Awaiting Green Light, Abortion-Pill Venture Keeps to the Shadows,” Wall Street Journal, September 5, 2000. Zimmerman quotes internal documents saying that Danco expects to be used for 29% of all abortions in the U.S. after 4 years. With annual abortions now running about 1.3 million a year (according to the Alan Guttmacher Institute, quoted in the New York Times, 12/30/00), even this optimistic prediction would represent only about 385,000 sales a year, a relatively small demand in the large U.S. pharmaceutical market. See AP, “Novartis tops Merck in global drug sales,” Bergen Record, March 24, 1999.
105. Michael Cullen, Medical Director, U.S., Searle, “Important Drug Warning Concerning Unapproved Use of Intravaginal or Oral Misoprostol in Pregnant Women for Induction of Labor or Abortion,” Letter to Health Care Practitioners, August 23, 2000. In an earlier letter, Searle Vice President Charles L. Fry, specifically said that Searle did not want its product used in conjunction with RU486 for abortion (“Searle Against Use Of Its Drug in Abortion” Letter to the Editor, Wall Street Journal, March 19, 1993, p. A11).
109. Associated Press, “Iowa ‘abortion pill’ test heralded as a success,” Des Moines Register, September 2, 1995. Dr. Mark Louviere, “Group lied when it said ‘abortion pill’ test resulted in no complications,” Waterloo Courier, September 24, 1995, p. F3. Tom Carney, “‘Abortion pill’ test goes awry for one patient,” Des Moines Register, September 21, 1995, p. 1M.
110. Carol Jouzaitis, “Doctor’s abortion-drug technique draws fire,” Chicago Tribune, September 12, 1994, Section 1, pp. 1, 14.
119. Robert Gold, “Many schools opt not to offer RU-486 pill” Michigan Daily, November 27, 2000, via COMTEX Newswire, 11/27/00.
120. Darlene Superville, “Abortion Pill-Colleges,” Associated Press, April 17, 2001.
121. Gina Kolata, “Wary Doctors Spurn New Abortion Pill,” New York Times, November 14, 2000, pp. D1,7.
122. Gina Kolata, “Wary Doctors Spurn New Abortion Pill,” New York Times, November 14, 2000, pp. D1,7.
123. Carole Joffe, “Medical Abortion in social context,” Supplement to American Journal of Obstetrics & Gynecology, vol. 83, no. 2 (August 2000), pp. 512-513. See also Carole Joffe, “Reactions to Medical Abortion Among Providers of Surgical Abortion: An Early Snapshot,” Family Planning Perspectives, Vo. 31, No. 1 (January-February 2000), pp. 35-38.
124. National Abortion Federation, “Statement” September 18, 2000.
125. National Abortion Federation release, “ONE YEAR AFTER FDA APPROVAL OF MIFEPRISTONE…,” September 24, 2001.
126. Gina Kolata, “Wary Doctors Spurn New Abortion Pill,” New York Times, November 14, 2000, p. D7.
127. Rachel Zimmerman, “Wrangling Over Abortion Intensifies as RU486 Pill Nears the Market,” Wall Street Journal, November 14, 2000, p. B1.
128. Gina, Kolata, “As Abortion Rate Decreases, Clinics Compete for Patients,” New York Times, December 30, 2000.
129. Import alert 66-47, Import Operations Branch, Food And Drug Administration, April 17, 1990.
130. William J. Clinton, “Memorandum for the Secretary of Health and Human Services; Subject: Importation of RU-486,” January 22, 1993.
131. David Kessler, FDA Commissioner, Letter to Roussel Uclaf President Edouard Sakiz, January 22, 1993; David Kessler, Letter to Wolfgang Hilger, CEO of Hoecht AG, February 3, 1993; Philip Hilts, “Door May be Open for Abortion Pill To Be Sold in U.S.” New York Times, February 23, 1993; “Battle Looms Over Abortion Pill,” Boston Globe, February 26, 1993; Associated Press, “Abortion Pill,” April 15, 1993.
132. Letter, Department of Health and Human Services Secretary Donna Shalala to Representative Ron Wyden (D-OR), February 8, 1994; Roussel Uclaf, Press Release, May 16, 1994; Hearing, “RU-486, Status Report on the U.S. Commercialization Project, Transfer of Antiprogestin Technology to the United States,” Subcommittee on Regulation, Business Opportunities, and Technology, of the Committee on Small Business, U.S. House, Serial No. 103-80, May 16, 1994; Letter, Lester Hyman, of Roussel Uclaf, to FDA Commissioner David Kessler, May 20, 1994; Letter, Edouard Sakiz, president Conseil de Surveillance of Roussel Uclaf, to FDA Commissioner David Kessler, May 25, 1994.
133. Letter FDA Commissioner David Kessler, to Roussel Uclaf President Edouard Sakiz, December 14, 1992;
134. Danco v. Richter, filed in the Supreme Court of the State of New York, May 9, 1997, pp. 7, 9.
135. Danco v. Richter, p. 9.
136. Letter from Richard D. Glasow, Wanda Franz, Brian Lopina, Tom Minnery, J.C. Willke, Beverly LaHaye to FDA Commissioner David Kessler, July 10, 1996.
137. “‘Priority’ NDAs approved ten months faster than standard applications – GAO Report to Kassebaum…” F-D-C Reports (“The Pink Sheet”), November 13, 1995, pp. 9-10.
138. The FDA refers to itself as “The Nation’s Foremost Consumer Protection Agency” on its website at http://www.fda.gov and is the agency set up by Congress to monitor the safety of foods and medicines sold in the United States.
141. Department of Health and Human Services, Food and Drug Administration, Final Rule, 21 CFR, Parts 314 and 601, “New Drug, Antibiotic, and Biologic Product Regulations; Accelerated Approval,” Federal Register, 57 FR 58942, December 11, 1992.
143. Department of Health and Human Services, Food and Drug Administration, Final Rule, 21 CFR, parts 314 and 601, “New Drug, Antibiotic, and Biologic Product Regulations; Accelerated Approval,” Federal Register, 57 FR 58942, December 11, 1992.
151. According to documents filed in court by KCC Delaware (KCC Delaware v. Joseph D. Pike, et. al, filed in Superior Court of the State of California for the County of Los Angeles, October 31, 1996), Pike pled guilty to a forgery charge in 1996 in connection with a real estate deal he was involved with in North Carolina in 1985.
152. In addition to KCC Delaware v. Joseph D. Pike, see Gina Kolata, “Business Dispute May Delay Introduction of Abortion Pill,” New York Times, November 1, 1996.
153. KCC Delaware v. Joseph D. Pike, NeoGen Investors, N.D. Management, Population Council, Advances in Health Technology, Case No. SC044748, filed in Los Angeles Superior Court, Santa Monica, California, October 31, 1996; Population Council, Advances in Health Technology v. Joseph D. Pike, Case No. 96605505, filed in Supreme Court, New York City, November 4, 1996; Joseph D. Pike v. Giant Group, Ltd., KCC Delaware, Burton Sugarman, et.al., filed in San Diego Superior Court, California, November 13, 1996.
154. Jane E. Allen, Wire Story “Company Seeking Share of U.S. RU-486 Manufacturing Sues for Fraud,” Associated Press, October 31, 1996; Andrea Orr, Wire Story, “U.S. licensee of abortion pill sued for fraud,” Reuters, October 31, 1996; Tamar Lewin, ” Dispute May Delay Abortion Drug in the U.S.,” New York Times, November 6, 1996, p. A16; Amanda Covarrubias, Wire Story, “Abortion Pill,” Associated Press, December 17, 1996. In addition, see The Population Council v. Joseph D. Pike, in which the Council asserts that “Pike’s fraud now imperils the mifepristone project,” and claim that “Unless that Pike is expeditiously removed, it will be much more difficult, and perhaps impossible, to raise the additional funds that are still needed to fund the project, and another weapon with which to attack the project will be furnished to its ideological opponents” (¶ 6).
155. Settlement of Population Council, Advances in Health Technology v. Joseph D. Pike was announced February 12, 1997. Pike retained a financial stake but relinquished day to day control of the RU486 project. Settlement of suits between KCC Delaware, the Giant Group and Jospeph Pike, the Population Council, and Advances was announced November 12, 1997, though litigation between KCC Delaware and one of the subcompanies Pike managed (NeoGen) was still pending. Terms of those settlements were not disclosed.
156. See Danco Laboratories, Ltd. v. Chemical Works of Gedeon Richter, Case No. 97/602406, filed in the Supreme Court of the State of New York, County of New York, May 7, 1997, p. 12.
157. Carlyle Murphy, “Abortion Pill Dispute May Delay Debut,” Washington Post, June 11, 1997, p. A1; Carlyle Murphy, “Abortion Pill’s U.S. Sponsor Suing Hungarian Drug Firm,” Washington Post, June 12, 1997, p. A3; John Sullivan, “Another Delay in Store for French Abortion Pill on U.S. Market,” New York Times, June 13, 1997, p. A16.
158. Laura Fraser, “The Abortion Pill’s Grim Progress,” Mother Jones, January/February 1999, p. 41-43; Marc Kaufman, “Abortion Pill Inches Closer to Production,” Washington Post, Health section, p. 7.
159. Joyce Howard Price, “Approval seen near for the abortion pill,” accompanying chart (“Abortion Pill: A Chronology”), Washington Times, p. A3.
160. FDA Talk Paper T00-18, February 18, 2000.
161. Marc Kaufman, “FDA Again Delays Abortion Pill Approval,” Washington Post, February 19, 2000, p. A2.
162. AP report, “Abortion pill study being run surreptiously,” Richmond Times-Dispatch, October 28, 1994, quoting C. Wayne Bardin, then research director for the Population Council.
163. Margaret Talbot, ” This Pill Will Change Everything About Abortion,” The New York Times Magazine, July 11, 1999, p. 42. For discussion, see Kathleen Day, “Protest Fears Spur Effort to Keep Name of Abortion Pill’s Maker Secret,” Washington Post, September 21, 1996, p. D1.
164. Actually, because RU486 is effective only if taken early on in pregnancy, and because a substantial number women would not be allowed to take the drug because of disqualifying physical conditions, the potential market is likely to be much smaller. In France, only about 20-33% use the drug for abortions. Applying that percentage to abortion figures in the U.S. reported to the Centers for Disease Control (1,184,758 for 1997), that market shrinks to somewhere between 236,952 and 390,970 women a year.
166. The examples are numerous, but for some anecdotal data, see Dorsey Griffith, “Few using abortion drug, survey finds,” Sacramento Bee, October 3, 2001; Brian Basinger, “Abortion pill legal, unused: Doctors, women stay with surgery,” Jacksonville Times-Union, September 23, 2001; Karen Auge, “Ru-486 has scant effect on abortions,” Denver Post, September 24, 2001.
167. Bloomberg News, “Pill for Abortion Ends Production,” New York Times, April 9, 1997, p. D2.
168. Associated Press, “Novartis tops Merck in global drug sales,” Bergen Record, March 24, 1999.
169. Aaron Zitner, in “What ever happened to the abortion pill?” (The Boston Globe Magazine, November 23, 1997, p. 46), says
Even the highest estimates place annual U.S. sales at just over $100 million. While that may seem like a lot, big pharmaceutical companies often demand far more. U.S. consumers, for example, spent more than $11 billion on drugs to treat high blood pressure last year and more than $1.4 billion on antihistamines, according to the research firm Scott-Levin.
See also comments of Hoechst spokeswoman Catherine Euvrard in Joseph Schuman, “Firm Gives Up Rights to RU-486,” Washington Post, April 9, 1997, p. C12.
170. Aaron Zitner, “What ever happened to RU-486?” The Boston Globe Magazine, November 23, 1997, pp. 46-47.
171. In addition to the case of the Iowa woman mentioned above who nearly bled to death during the American RU486 trials, a woman by the name of Nadine Walkowiak died in France in 1991 after taking the pills (Alan Riding, “Frenchwoman’s Death is Linked to Abortion Pill and a Hormone, New York Times, April 10, 1991, p. A-10). A French court there awarded her survivors around $100,000 in damages in November of 1996 (Letter from Thierry LeFevre, La Trêve de Dieu to Randy O’Bannon, April 28, 1997). Awards in America might be expected to be significantly higher.
172. Other groups were supplying boycott postcards and lists of their own.
173. National Right to Life Educational Trust Fund, Advertisement, “What’s Wrong with Allegra? – the Company it Keeps,” USA Today, April 2, 1997.
174. Douglas Lavin, “Hoechst Will Stop Making Abortion Pill,” Wall Street Journal, April 1 [says 1st, but must be 7th or later], 1997, p. A3.
175. Etienne-Emile Baulieu, The “Abortion Pill” (New York: Simon & Schuster, 1991), pp. 16-17.
176. Roussel Uclaf, 1994 Annual Report, p. 3. “Hoechst Buying Drug Maker Roussel Uclaf,” Los Angeles Times, December 12, 1996, p. 3D.
177. Roussel Uclaf, 1994 Annual Report, p. 31.
178. Elyse Tanouye, “Hoechst Unit Plans to Acquire Stake in Copley,” The Wall Street Journal, October 11, 1993, pp. A3 and A6.
179. Roussel Uclaf, 1994 Annual Report, p. 42.
180. Roussel Uclaf, 1994 Annual Report, p. 7.
181. Joseph Schuman, “RU-486 Parent Co. Unloads Rights,” Washington Post, April 8, 1997, p. C12.
182. Roussel Uclaf, 1995 Annual Report, p. 8.
183. Charles R.T. Crumpley, “Marion acquisition terms are approved,” The Kansas City Star, May 5, 1995, p. A1.
184. Thomas S. Mulligan, “Gemany’s Hoechst to Buy U.S. Drug Maker,” Los Angeles Times, May 5, 1995, p. D1.
185. Watson Pharmaceuticals Press Release, “Watson Pharmaceuticals Completes Acquisition of The Rugby Group,” March 2, 1998.
186. “Teva acquires Copley from Hoechst,” Chemical Week, Vol. 161, No. 31 (August 1999), p. 5.
188. Gayle Kirshenbaum, “The Stealth … to Market,” George, March 1997, p. 116.
189. Population Council and Advances in Health Technology v. Joseph D. Pike, filed in Court of the State of New York County of New York, Case No. 96605505, November 4, 1996, paragraphs 16 and 17, pp. 9-11.
190. Population Council and Advances in Health Technology v. Joseph D. Pike, filed in Supreme Court of the State of New York County of New York, Case No. 96605505, November 4, 1996, paragraph 4, p.3.
191. Population Council v. Pike, paragraph 18, p. 11.
192. See Exhibit 1, Population Council v. Pike, referenced on p. 11.
193. Population Council v. Pike, paragraph 27 and note 2, pp. 17-18.
194. Caryle Murphy, “Abortion Pill Accord Clears Way for Sales,” Washington Post, February 13, 1997, p. A1.
195. Danco Laboratories v. Chemical Works of Gedeon Richter, Supreme Court of the State of New York, County of New York, Case No. 97/602406, May 7, 1997, paragraphs 9-11, p. 3.
196. Caryle Murphy, “Abortion Pill Dispute May Delay Debut,” Washington Post, June 11, 1997, p. A1; Caryle Murphy, “Abortion Pill’s U.S. Sponsor Suing Hungarian Drug Firm,” Washington Post, June 12, 1997, p. A3; “Population Council RU-486 1997 Marketing Target Will Be Missed,” F-D-C Reports – “The Pink Sheet,” June 16, 1997, pp. T&G 12-13.
197. “Firm I.D.’d in U.S. abort pill deal,” New York Daily News, June 13, 1997, p. 38.
198. Murphy, Washington Post, June 11, 1997 and “The Pink Sheet”, June 16, 1997.
199. Population Council and the Wellcome Trust, “Towards Safe and effective use of medical abortion,” report of meeting, Bermuda, January 10-13, 1998.
200. Marc Kaufman, “Abortion Pill Inches Closer to Production,” Washington Post, Health p. 7; Stacey Schultz, “Long-awaited abortion pill will offer more privacy – but no less controversy,” U.S. News & World Report, February 28, 2000, pp. 79-80.
201. Marc Kaufman, “FDA Again Delays Abortion Pill Approval,” Washington Post, February 19, 2000, p. A2; F-D-C Reports, “Mifepristone,” “The Pink Sheet,” February 21, 2000, p. 36; UPI wire story, “‘Abortion Pill’ gets FDA approvable letter,” February 19, 2000; Reuters wire story, “French abortion pill moves closer to U.S. market,” February 18, 2000.
202. “Mifepristone approval delayed, supporters look to action by FDA,” Contraceptive Technology Update, Vol. 21, No. 5, p. 53.
203. Wire report, Reuters Health, February 19, 1999; Marc Kaufman, Washington Post, March 23, 1999.
204. “Mifepristone $100 Mil. U.S. Market Potential Reported to Investors,” F-D-C Reports, “The Pink Sheet,” November 11, 1996, p. T&G 4.
205. Danco v. Richter, paragraph 1, p. 1.
206. Reuters Health, 2/19/99; Kaufman, Washington Post, 3/23/99; Fraser, Mother Jones, Jan/Feb 1999. See also Marc Kaufman, “FDA Again Delays Abortion Pill Approval,” Washington Post, February 19, 2000, p. A2.
207. Press Release, Roussel Uclaf, “RU 486: US Patents Rights Transfer to the Population Council,” May 16, 1994.
208. Lawrence Lader, A Private Matter (New York: Prometheus Books, 1995), p. 227.
209. Danco v. Richter, pp. 7, 9.
210. Danco v. Richter, p. 8.
211. Joseph Schuman, “Firm Gives Up Rights to RU-486,” Washington Post, April 9, 1997, p. C12; Douglas Lavin, “Hoechst Will Stop Making Abortion Pill,” Wall Street Journal, April 9, 1997, p. A3; Bloomberg News, “Maker Abandons Abortion Pill,” New York Times, April 9, 1997.
212. Etienne-Emile Baulieu, The “Abortion Pill” (New York: Simon & Schuster, 1990), pp. 25-50.
213. Letter from Jean-Pierre Godard, President du Directoire, Roussel Uclaf, to Dr. Wanda Franz, president, National Right to Life, May 30, 1997.
214. Joseph Schuman, “Firm Gives Up Rights to RU-486,” Washington Post, April 9, 1997, p. C12.
215. Michèle Aulagnon, “Tirs croisés contre la pilule abortive,” Le Monde Diplomatique, Avril [April] 1998, p. 27.
216. Philip P. Pan, “Chinese To Make RU-486 For U.S.,” Washington Post, October 12, 2000, p. A1.
217. Letter from Rep. Tom Bliley (R-VA), Chair of the U.S. House Commerce Committee, to Jane Henney, M.D., FDA Commissioner, September 25, 2000.
218. Rep. Chris Smith (R-NJ) raises this sort of concern in AP reporter Paul Recer’s wire story, “Abortion Pill,” AP Financial, October 13, 2000.
219. Aaron Zitner, “RU-486 Firm Tied to Impurities,” Los Angeles Times, October 20, 2000.
220. Letters from Rep. Tom Bliley, Chair, U.S. House of Representatives Commerce Committee, to Jane Henney, M.D., Commissioner, Food and Drug Administration, October 18, 2000, and November 1, 2000.
221. Letter from Rep. Tom Bliley, Chair, U.S. House of Representatives Commerce Committee, to Jane Henney, M.D., Commissioner, Food and Drug Administration, October 18, 2000, p.4.
222. Letter from Rep. Tom Bliley, Chair, U.S. House of Representatives Commerce Committee, to Jane Henney, M.D., Commissioner, Food and Drug Administration, October 18, 2000, p. 4.
223. Letter from Rep. Tom Bliley, Chair, U.S. House of Representatives Commerce Committee, to Jane Henney, M.D., Commissioner, Food and Drug Administration, October 18, 2000, p. 5.
224. Regina Sitruk-Ware, a representative of Exelgyn, the current French supplier, told a 1998 Population Council sponsored conference that the Chinese synthesis for the abortion pill is different from the one developed by the French and said only that the pills are “very similar.” See “Strategy for the introduction of Mifepristone,” Population Council and The Wellcome Trust Conference, Towards Safe and Effective Use of Medical Abortion, Bermuda, January 10-13, 1998, Report of Meeting, p. 16.
225. Lawrence Lader, A Private Matter (New York: Prometheus Books, 1995), p. 227.
226. FT Asia Intelligence Wire, “Europe – permission to sell RU 486 abortion pill in 8 countries,” July 21, 1999.
227. Agence France Presse, “Germany authorises abortion pill,” July 6,1999.
230. Judy Siegel, “Assuta starts using abortion pill,” The Jerusalem Post, August 31, 1999.
231. Brad Evenson, “Abortion pill headed for Canada,” National Post, July 17, 1999.
232. Evenson, National Post, July 17, 1999.
233. Kim Bolan, “French abortion pill tested in Vancouver,” Vancouver Sun, July 7, 2000.
234. Bloomberg News, “Switzerland: Cosan Delays Plans for Selling Abortion Pill Amid Protests,” September 29, 1999; Carol J. Williams, “Reunited Germany Divided Over Abortion Rights Issue…,” Los Angeles Times, July 18, 1999, p. A14.
235. Etienne-Emile Baulieu, The “Abortion Pill,” (New York: Simon & Schuster, 1991), p. 19. Also see Baulieu’s comments on pp. 68, 78-79, and the view expressed by Baulieu in Chapter Seven, “On a Planet Approaching Six Billion,” pp. 156-170.
236. Baulieu, The “Abortion Pill,” p. 156.
237. Summary of seminar “Commercial challenges in bringing Mifepristone to developing countries,” by Roy Karnovsky, President, Advances/The Neogen Group, at meeting Towards Safe and Effective Use of Medical Abortion, sponsored by Population Council and Wellcome Trust, Bermuda, January 10-13, 1998, p. 15.
238. Population Council and Wellcome Trust, Toward Safe and Effective Use of Medical Abortion, Report of Meeting, Bermuda, January 10-13, 1998, p. 4.
239. Karnovsky at 1998 Bermuda conference, p. 14.
240. Regina Sitruk-Ware, Head of Medicine/Research & Development, Exelgyn Laboratories, Seminar “Strategy for the introduction of Mifepristone,” given at 1998 Bermuda conference, p. 16.
241. 1998 Bermuda conference, p. 7. See also discussion on p. 25.
243. Shuba Ambardekar, “Back up intervention,” pp. 23-24, and Nguyen thi Nhu Ngoc, “Abortion in Viet Nam: Current situation and trend in policy,” p. 13, both in Towards Safe And Effective Use of Medical Abortion, Population Council Conference, Bermuda, January 10-13, 1998, pp. 23-24;
244. Christine Russell, “Percentage of Physicians Doing Abortions Declines,” Washington Post, September 23, 1995, p. A3; Gina Kolata, “Under Pressures and Stigma, More Doctors Shun Abortion,”New York Times, January 8, 1990; Warren Hern, “Hunted by the Right, Forgotten by the Left,” New York Times, March 13, 1993, p. 21; Amy Goldstein, “U.S. Abortion Services Drop,” Washington Post, January 22, 1995, p. A1.
245. Philip J. Hilts, “Clinic Trials of French Abortion Pill Begin in U.S.,” New York Times, October 28, 1994, p. A28.
246. Judith Gaines, “Women describe pros, cons of RU486,” Boston Globe, May 8, 1995, p. 1.
247. Andrea Sachs, “Abortion Pills on Trial,” TIME, December 5, 1994, p. 46. See also “Prepare now to counsel patients on RU486,” Contraceptive Technology Update, April 1995, p. 52.
248. Between July of 1989 and January of 1998, the CBS/New York Times poll saw a shift from 40% to 50% of those calling abortion “murder;” those saying abortion was not murder dropped from 47% to 38% in the same time frame. A January 22, 1998 poll by CNN/Gallup/USA Today found 58% of all Americans believing that abortion should be legal only under certain circumstances and 17% holding abortion should be illegal in all circumstances – a total of 75% rejecting the current policy of abortion on demand.
249. Sue M. Halpern, “RU-486: the unpregnancy pill,” Ms., April 1987, p. 56.
250. Margaret Talbot, “This Pill Will Change Everything About Abortion,” The New York Times Magazine, July 11, 1999, p. 41; Kim Painter, “Earlier, easier abortions,” USA Today, August 4, 1999, p. D1; Rebekah Saul, “The Political Challenges And Educational Opportunities Around Very Early Abortion,” The Guttmacher Report, February 1999, p. 6.
An Analysis of the Catechetical Program “Generations of Faith”
By Cate VanLone-Taylor
Saint Don Bosco, pray for Catechetical Truth
“Now I urge you, brethren, note those who cause divisions and offenses, contrary to the doctrine which you have learned, and avoid them. For those who are such do not serve our Lord Jesus Christ, but their own belly, and by smooth words and flattering speech deceive the hearts of the simple.” (Romans 16:17)
“Beware of false prophets, who come to you in sheep’s clothing, but inwardly they are ravenous wolves. You will know them by their fruits. Do men gather grapes from thornbushes or figs from thistles? Even so, every good tree bears good fruit, but a bad tree bears bad fruit. A good tree cannot bear bad fruit, nor can a bad tree bear good fruit. Every tree that does not bear good fruit is cut down and thrown into the fire. Therefore by their fruits you will know them.” (Matt 7:15-20)
In the past three decades, a great change initiated by liberal Catholic educators and theologians has attempted to revolutionize the methodology of catechetical instruction. The models used are drawn from the ‘whole community catechesis’/‘shared Christian praxis’ model originated by Thomas Groome and Bill Huebsch.
This model seeks to involve the entire faith community, thus providing lifelong catechetical formation for parishioners of all ages. A strong emphasis is placed on the sharing of “faith stories” a type of ‘lived’ theology, instead of textbooks, citing the General Catechetical Directory, #158 which states: “the community is proposed as the source, locus and means of catechesis.” Detailed below are some of the dangers involved in such an approach.
Catholics United for the Faith (CUF) Green Bay,WI : Attention has also been drawn to the program “Generations of Faith,” which is designed for “parish faith-formation,” but is distinguished by its lack of clear Catholic teaching. The proposed “antidote” to programs such as this is the use of texts such as the Catechism of the Catholic Church and the Faith and Life catechism series.
Catholic Answers Forums: Generations of Faith: “Its only as good as your priest. If your priest takes the reins, and is a good teacher of the faith, and has some control of the people who teach the other “segments” (e.g catechists or teens) then it can be great. Its good because it actually revolves around the liturgical year which is something lost on Catholics in the U.S., and has the entire family coming, rather than using children’s religious education as a baby-sitting service. THAT SAID, if the priest is not the one in control, if it goes the way of much catechesis in many parishes, then it can be a disaster because more people are influenced.”
Catholic Answers Forum: Our parish is instituting this Generations of Faith with is led by two laywomen who are rather liberal. Thier idea is to direct all “spirituality” to the lowest common denominator so they “get the love of Jesus in their hearts” Well it goes downhill from there and I’m on the “core team” who advises on content. I’m only there to try to make it seem Catholic otherwise it would be CINO – same stuff you could get at any Baptist parish! (sigh)
Catholic Culture (written by noted Catholic author Donna Steichen): John Roberto founded the Center for Ministry Formation in 1978, and served as its director until 2000. While at CMF he founded the Generations of Faith Project, developed it with funding from the Lilly Endowment, and now, as its director and project coordinator, conducts training workshops across the US for staffs at the growing number of parishes that are initiating the Generations of Faith program. Seven hundred parishes in 60 dioceses are already using GOF; 21 parishes in the Raleigh diocese signed on last December. Roberto consistently argues against textbooks, citing such varied authorities as the General Catechetical Directory, #158 (“the community is proposed as the source, locus and means of catechesis”), and Maria Harris (more on her below), has openly stated: “the church is the curriculum, content, and catechist.”
Faith formation is event-centered, developed around the events of our shared life as Church. Faith formation demands a unified, life-long catechesis. Through events, Generations of Faith has a 6-year curriculum: the Church year of feasts and seasons, sacraments and liturgy, rituals and prayers, spirituality, justice, and service. Beliefs and practices for living as a Catholic emerge from the life of the faith community. The content emerges out of the event. A text is not the curriculum; the curriculum is the life of the Church. An introductory video for Generations of Faith offers colorful footage of cheerful intergenerational groups, with adults mingling, eating (food is always part of the event), chatting, and praying in parish centers and churches, while happy children construct craft projects or paint primitive symbols, dramatize Bible stories, or sing in choirs. These parishes appear to offer the kind of warmly welcoming ambiance Protestant converts often say they keenly miss when they become Catholics.
In place of weekly catechism classes for children, these programs feature a single monthly assembly or “faith festival,” where parishioners of all ages gather for a meal, see a dramatic presentation of a Bible story, hear an address about a community problem, or celebrate the event of the month (cited as examples were Advent, Lent, Thanksgiving, and Kwanzaa). After a general prayer service, all break into peer clusters for discussion, singing, or art projects. The entire group joins together for closing prayer. On their way out, participants pick up take-home materials that will reinforce the evening’s theme, help prepare for the next event, or suggest some form of community service or political activism.
Illiteracy and Alienation
Because the problems of religious illiteracy and alienation are authentic and acute, the presentation was attractive even to skeptical listeners, daring to hope that it might mean the beginning of real change. Generations of Faith is endorsed by NCCL as an initiative to revitalize American Catholic life. In the right hands, with sound doctrinal instruction as its centerpiece, the social component of whole community catechesis certainly could enrich parish life. There is enormous hunger among the laity to hear and understand the eternal truths and moral teachings that neo-modernists in the catechetical movement long ago jettisoned.
The Generations of Faith film, like other “whole community catechesis” literature on display, skims over questions about specific doctrinal content. (“The parish is the content.”) Detailed examination of the GOF materials and their sources reveals alarming resemblances to the hollow Renew I and II and RCIA projects that engage the laity in uninstructed, heterodox “faith-sharing” without authentic “indoctrination” to let them know what the Church really teaches. GOF credits the contributions of a feminist former nun Maria Harris, and such other “foundational thinkers,” as Anglican John Westerhoff; Sister Catherine Dooley, OP, of the religious education department at Catholic University of America; and progressive Francoise Darcy Berube, whose 1996 book, Religious Education at a Crossroads exhorts educators not to “turn back in fear” to the catechism model of the rigid “good old days.”
Listed beside the General Directory for Catechesis and various USCCB documents, among course texts and resources for a Certificate in Lifelong Faith Formation to be offered in January 2005 by the Center for Ministry Development, along with Bill Huebsch and Maria Harris , are the names of still other architects of the specious “catechetical renewal”: Sister Kathleen Hughes, RSJC, James D. Davidson, William D’Antonio, Jane Redmont, William Shannon, Loughlan Sofield, ST. These professionals are deeply implicated in the present decline in religious literacy, yet they still seem certain they’ve been heading in the right direction these forty years. Why haven’t they arrived at their destination, then? There simply hasn’t been time yet, they explain.
Bernard Lee, SM, is director of the Institute for Ministry at Loyola University, New Orleans, and a member of the Call to Action Speakers Bureau. In his presentation on Small Christian Communities, he said that “reform” councils like Vatican II produce a backlash. He counseled: “Until the backlash is out of your system, you can’t really get on with the reforms.”
At the banquet where he accepted NCCL’s 2004 Catechetical Award, former Christian Brother Gabriel Moran (whom NCCL correctly credits with “reshaping the field of religious education”) said turmoil is to be expected after a council, and new building cannot begin until the resistance is cleared away. Moran is near the end of his career, and his wife Maria Harris is now too ill to travel; they do not expect to see the triumph of their lifework. But Moran still thinks triumph will come, despite general recognition by their peers that religious education has been devastated.
It seems odd that NCCL chose to present its award to a man who bears so much responsibility for the devastation. It is rather like elevating a horse to the college of cardinals.
*Donna Steichen is the author of Ungodly Rage: The Hidden Face of Catholic Feminism, and Prodigal Daughters: Catholic Women Come Home to the Church, (both from Ignatius Press).
Fashion Me a People Conference—This Conference was recently held in Orlando (January, 2008) sponsored by the Center for Ministry Development (CMD) in partnership with Harcourt Religion Publishers, the purveyors of textbooks to the schools of the Orlando Diocese. Their curriculum resources highlight “Generations of Faith Online”, a service of CMD, which has been funded by grants from the Lilly Endowment, a Protestant Foundation seeking to undermine the orthodoxy of the Catholic Church in order to encourage ecumenism with other Christian religions based on the lowest common denominator of beliefs. They promote worship exploration teams to develop ideas for visual enhancement of the sanctuary and innovative “worship services.”
The speakers at this Conference included the curious theology of Thomas Groome, a dissident ex-priest and consultant to Harcourt Publishers, noted for his zeal in undermining the Catechism of the Catholic Church in order to promote catholicity (note the small “c”) of ecumenism with other Protestant groups.
Research on Authors / Contributors of Generations of Faith:
Bishop Robert Morleno, Diocese of Madison: (Regarding dissenting theologians) “Associations with “anti-Catholic groups” such as Call to Action, Catholics for a Free Choice, Women’s Ordination Conference, FutureChurch, CORPUS, DignityUSA, and others which profess “serious departures and denials of the authentic teaching of the Catholic Church could “certainly be grounds for removal” for a person who is responsible for teaching catechesis and “passing on the Church’s teaching.”
Sister Kathleen Hughes: Sister Kathleen Hughes, RSCJ, (Lay Presiding: The Art of Leading Prayer). Sister Hughes, a feminist liturgist, was for many years a member of ICEL, a group that provided problematic English liturgical translations. (Helen Hull Hitchcock, Adoremus Bulletin)
Catholic Culture Library: Sister Kathleen Hughes has for many years been a member of ICEL (the International Commission on English in the Liturgy) and a consultant to the NCCB Committee on the Liturgy. Five years ago, she says, she addressed the Congregation for Divine Worship, in Rome, on the subject of inclusive language. In a lecture last September at Maryville University in St Louis, she said she expects to see women ordained in her lifetime. She also announced that the Latin word deus is too often improperly translated as “Father,” adding, “We need more metaphors for God.”A former professor of liturgy at Chicago’s Catholic Theological Union, Sister Hughes is the newly-elected Provincial of the Religious Sisters of the Sacred Heart of Jesus and the author of several books, including Silent Voices, Sacred Lives of which I feel impelled to remark that if these ladies only could be silenced, the whole Church would be better off. http://www.docstoc.com/docs/23726149/The-Madeleva-Lectures-in-Spirituality” Note: other feminist theologians that signed this decree were Sr. Joan Chittister and Sr. Monica Hellwig. Google them using “dissent” “heterodox” or “liberal” and you will come up with many hits. Former Sr. Maria Harris (deceased) husband- former Brother Gabriel Moran
Amazon Book Review: “Women’s spirituality, suggests educator Harris, is a “dance of the Spirit” consisting of seven steps: “Awakening, Discovering, Creating, Dwelling, Nourishing, Traditioning, and Transforming.” Very much an interfaith book (Harris draws on Christianity, Judaism, Buddhism, and Hinduism), this is also quite feminist in a gentle way and should appeal to questing women with a New Age bent.The Madeleva Manifesto ” http://www.cta-usa.org/reprint07-00/theologians.html” http://www.docstoc.com/docs/23726149/The-Madeleva-Lectures-in-SpiritualityMs. Harris was a member of “Call to Action” as is her husband.*Note: other feminist theologians that signed this decree were Sr. Joan Chittister and Sr. Monica Hellwig. Google them using “dissent” “heterodox” or “liberal” or “feminist theology” and you will come up with several pages hits.
“Young Catholics languish in ignorance because no one ever taught them the content of the faith. Many of those who are old enough to have been catechized in pre-conciliar times are now uncertain whether the Church still holds as true the tenets they learned in their youth, because they have heard those beliefs mentioned so seldome–if ever–during the past 30 years. Hispanic Americans, unsatisfied by what they are taught in Catholic parishes, are streaming out to hear Jesus preached in evangelical churches. As measured by public behaviors and attitudes, Catholic sexual morality is no better than that of any other group, and worse than some. Can this wasteland be restored? If reform is possible, the first step must be to understand our present predicament.
The catechetical collapse of the past 35 years has not been an isolated phenomenon. One of the most prominent partisans in the campaign that produced the “new catechetics,” Father Berard Marthaler, cheerfully concedes that it “has had a symbiotic relationship with biblical scholarship, the liturgical movement, and the ‘new theology.'”
The “new catechetics” movement, already established in Europe and taking root in the United States, seemed before the Second Vatican Council to be a generally benign attempt to teach the faith in a more vital way. What–or who–turned it into a catechetical revolution? Why did the Catholic religious and academics who embraced it first stop teaching Catholic doctrine, and then (with courageous exceptions) begin to ridicule the very notion of teaching it, and even to denigrate those who objected? Candidates for the title of chief culprit are abundant.
Most of those involved in this movement seem to have been acquainted each other, often through encounters at academic centers, especially the Catholic University of America (CUA). Their influence seems to have been more a function of their positions and their efficient collaboration than of the intellectual force of their ideas, which tend to sound naive today.
It may be impossible to name one person as most responsible for the current state of religious instruction in the United States. But no one has a stronger claim than Father Gerard Sloyan who, in 17 years in CUA’s Religious Education department–ten as chairman–reorganized the entire curriculum, and thus changed the religious attitudes of a key cohort of religion teachers. It was he who first hired dissenter Charles Curran, in 1964. His 1967 book, Speaking of Catholic Education–by its praise for Dutch Catechism, its clear distaste for the term “transubstantiation,” its displacement of personal sin by a “fundamental option” for or against God, and its call to defer First Confession until after First Communion–proves that the toxic ideas of the revolution were fully formed by the mid-1960s.
Children, Father Sloyan declared, cannot learn doctrine; they can only experience religious emotions. Let them participate in the liturgy, treat them with respect and kindness, and their religious emotions will develop. He implied that rote memorization of theological propositions was the sum and substance of traditional catechesis, when in fact it was only one valuable element in a living culture that was also built on sacramental practice, liturgical and devotional prayer, stories of saints, Bible stories, and frequent reference to the social obligations imposed by membership in Christ’s Mystical Body.
In 1967, Sloyan left CUA to teach at Temple University, remaining there for 25 years. Later he returned as a “distinguished lecturer,” but the move seems not to have sweetened his temper. “Is Agape Any Match for Fear and Loathing in the Religious Psyche?” Sloyan’s contribution to The Echo Within, a 1997 collection of essays published to honor Berard Marthaler on his academic retirement, is a fuming denunciation of orthodox Catholics. Characterizing them as ignorant, rigid, repressed, ideologically infected, infantile, censorious, malicious, and uncharitable, he says he offers these diagnoses, “in the friendliest possible spirit.”
Given the views of his mentor, it seems small wonder that Sloyan’s protégé, former Christian Brother Gabriel Moran (Maria Harris’ husband) , strayed from orthodoxy. Many observers, admirers and critics alike, propose Moran as the most influential man in the catechetical revolution. Michael Warren, editor of Source Book for Modern Catechetics, says, “Few persons in the United States have made a contribution to the catechetical scene as complex and difficult to assess as Gabriel Moran.”
Moran’s work influenced many in the catechetical movement to reject divine revelation–the Church’s deposit of faith–in favor of “on-going revelation”–in effect, the interpretation of one’s own experiences as private revelation. This meant not simply that catechists should enliven the students’ understanding of the Gospel by connecting it to their life experiences, but that the students could find revelation only in their own experience. A student “would have to reject any document from the past pretending to divine revelation,” Moran wrote. As Msgr. Michael Wrenn has observed, that category includes the Gospel.
Moran was not alone in his opinion. Piet Schoonenberg, SJ, a Dutch theologian linked to the Dutch Catechism, was making the same point In the same era. In 1970, Schoonenberg wrote:
“From a mere approach to the message, experience has become the theme itself of catechesis. Catechesis has become the interpretation of experience. It has to clarify experience, that is, it has to articulate and enlighten the experience of those for whom the message is intended.”
The most phenomenal thing about this thesis was its reception. To an astonishing extent, Catholic educators and publishers proved willing to jettison Christian belief and substitute a radically individualistic “noble savage” romanticism straight out of Jean Jacques Rousseau. According to a 1997 essay in The Echo Within, Moran was then unaware of its antecedents, but he has not changed his mind over the ensuing 30 years. “In adopting ‘revelation’ as central, Christianity prepared for its own undoing,” he writes.
“Christian writers cannot get anywhere by assuming the existence of or investigating an object named ‘Christian revelation,'” Moran argues, declaring the theory of revelation to be “a modern invention and a disastrous one.” God continues to speak today, he says, but speaking does not mean revelation, a term that implies “assertions of truth.” Speaking, he explains, could mean compassion, care, love, or forgiveness. As to truth, he says “much contemporary thought” holds that “the first thing to ask of a statement is not whether it is true but whether it is interesting.” At most, “God’s speaking” can only provide human understanding with “a glimpse of the truth.”
Finally, Moran tells us that Christians must stop equating “‘Jesus Christ’ with ‘God and man,'” because that “has the effect of creating the great middleman, who is then neither divine nor human. ‘Jesus Christ’ becomes the name of a storehouse of truths, the revelation of God.”
After leaving the Christian Brothers, Moran became a professor of (non-denominational) religious education at New York University. His wife, Maria Harris, a former Sister of St Joseph of Brentwood, also represents herself as a religious educator, and has taught women’s studies at several institutions. Most notably, she combined those genres in a post-Christian guide to feminist self worship, Dance of the Spirit: The Seven Steps of Women’s Spirituality.
I think that really the Catholic Church in the US experienced a “revolution” no less damaging that the Cultural Revolution in China or what went on in Cambodia. It is the job of those who come after to clean up the damage of the craziness of their elders.
†Ad Majorem Dei Gloriam† website:
From the book “Homosexuality and Christian Faith“, we quote Maria Harris directly:“At the end of the 20th century, individuals are probably no wiser than they ever have been about their sexual lives, but the human race undeniably has a different understanding of sexuality from what it had in the past. Studies subsequent to the two Kinsey Reports have confirmed the fact that the human race has an imaginative diversity of sexual expression. Sexual intimacy between consenting partners of the same sex seems to be nothing less and nothing more than part of that wonderful range of expression.What would (Saint) Paul make of today’s sexual scene? It really is not possible to lift people out of one place in history and situate them in another. Presumably they could learn the language of a new era if given time to adjust. ….A Christian today might even think that (Saint) Paul would see homosexuality as part of God’s creation, sanctified by the Incarnation. The world of our bodily senses is not a veil that obscures divinity. The material world, whatever its groans and travails, is the expression of divine goodness. The best impulses of that world – the genuine struggles for the fulfillment of bodily existence – cannot be dismissed…People’s sexual expressions have to be seen within that context.”James D. Davidson
Writes for “America”, “National Catholic Reporter”,”Commonweal” and “Ligourian”: all liberal Catholic publications. Google for many articles to read. It is worth noting that he does not write for more orthodox Catholic publications such as ‘First Things’.
WCCO TV: August 9, 1999 Reverend Dr. Cornelius Plantinga, Jr., author of Not the Way It’s Supposed to Be: A Breviary of Sin and dean of the Chapel for Calvin College in Grand Rapids, Michigan and Jane Redmont, feminist Catholic theologian from Berkeley, California.
October 10 National Catholic Reporter ran a front-page article about the “Critical Mass,” a feminist “liturgy” held in Oakland’s Bishop Begin Plaza [see November Faith], describing the pseudo-ritual, which included divesting a mock male priest, as an authentic Catholic Mass: “I understand the body of Christ in a way I had not before…” wrote contributor Jane Redmont, who also participated in the event as a member of its planning committee. “This is my body, I say, touching a woman’s arm and shoulder. This is my blood, I say, touching another woman, of a different age and race from my own. You are my flesh and blood, we are saying, and Christ’s flesh and blood. We know this in the breaking of the bread and the sharing of the cup; we know this in touching each other’s bodies.”Redmont continued, “We have disagreed over terminology and theology, we have varying relationships to Jesus and to the local church. Some of us are more attached than others to biblical and historical sources and authorities….Some choose to stay but not to have their names listed anywhere: fear of losing church-related or Catholic academic jobs.”A week after Redmond’s story, the National Catholic Reporter editorialized that the Oakland event is “too critical to shrug off” because “women are not going to disappear.” “One doesn’t have to endorse the liturgy–and certainly there are liturgists and Catholic feminists who would take issue with the event in Oakland–to recognize the importance of taking it seriously,” read the editorial.
Amazon Book Review: Editor Mary Jo Weaver has gathered a great group of prominent theologians, academicians and scholars to write about “hot button” issues facing liberal/progressive American Catholics. What she has produced is an outstanding collection of essays that give voice to that group. Each essay examines a different issue, such as birth control/abortion, the role of women in the church, the liturgy and many more. The essays are academic in nature yet accessible to all readers in its style and tone. If you’re a liberal/progressive Catholic and want need some support for when people attack your views, this book is a must. Msgr. William Shannon
While many theologians such as McBrien, Father Francis Sullivan at Boston College and Monsignor William Shannon in Rochester, NY, berated the Vatican and accused it of forcing good people out of the Church, Dr. Joyce Little, a theologian at St. Thomas university in Houston, said that those who encouraged women to believe they could be ordained if only enough pressure were put on the Vatican have a lot to answer for. “http://www.ewtn.com/library/ISSUES/VATBAN.TXT“
Catholic Education Resource Center:www.catholiceducation.org) Chesteron once remarked that he loved the Catholic Church because it had prevented him from becoming a child of his age. William Shannon, sadly, is very much a child of his age, as are his Catholic compatriots in the media. I daresay that in a hundred years, his introduction to Merton’s masterpiece will seem far more dated than the text it introduces. Indeed, it is Merton who gets the last word on Shannon. It occurs when Merton realizes the error of his old life: “I saw clearly enough that I was the product of my times, my society, and my class. I was something that had been spawned by the selfishness and irresponsibility of the materialistic century in which I lived. However, what I did not see was that my own age and class only had an accidental part to play in this. They gave my egoism and pride and my other sins a peculiar character of weak and supercilious flippancy proper to this particular century: but that was only on the surface. Underneath, it was the same old story of greed and lust and self-love, of the three concupiscences bred in the rich, rotted undergrowth of what is technically called “the world,” in every age, in every class.
Mark Gauvreau Judge. “Strangers in the House: When Catholics in the Media Turned Against the Church.” Crisis (November, 2003): 41-45.”
Catholic Exchange website- August 18, 2005. Author: Rich LeonardiConsider Fr. William H. Shannon’s “The Resurrection: How We Know It’s True.” Here is an excerpt from the section called “The Resurrection: An experience of faith”:The point which I am trying to lead up to is the realization that seeing the risen Jesus was not an experience of empirical data; it was an experience of faith. For the very best that empirical experience might have achieved was an experience of resuscitation, not resurrection. Think of Lazarus in John’s Gospel (Jn 11:1-45). He was mortal and he died. He was resuscitated and therefore was living again, but even after his resuscitation he was still mortal. Hence people could see him before and after because in both cases he was mortal. Lazarus was as much a subject of empirical data after his resuscitation as before his death. The mortal Jesus — the Jesus before His death — could, like the mortal Lazarus, have been experienced as a fact of empirical data; the risen Jesus, however, could only be experienced by faith. For resurrection is not returning from the dead. It is a leap beyond death to an entirely different kind of existence. Such a leap cannot be empirically verified. Father Shannon’s speculations run counter to Pope John Paul II’s orthodox description of the Resurrection: Christ’s Resurrection is the strength, the secret of Christianity. It is not a question of mythology or of mere symbolism, but of a concrete event. It is confirmed by sure and convincing proofs. The acceptance of this truth, although the fruit of the Holy Spirit’s grace, rests at the same time on a solid historical base. (From remarks given before praying the Regina Caeli on Sunday, April 21, 1996) Thus, it simply isn’t consistent with Catholic teaching for Father Shannon to state that the Resurrection “was not an experience of empirical data” and that the risen Jesus “could only be experienced by faith.” Instead, in the pope’s words, it was a public, “concrete event” backed by “convincing proofs” and resting on “a solid historical base.” No later than 15 years after Christ’s earthly ministry, St. Paul wrote in his first letter to the Corinthians that 500 “brethren” saw the risen Jesus “at one time.” He did not write, as Shannon would have it, that they just sensed Him spiritually. As the Vatican wrote just last winter, “the appearances of the Risen Lord and the empty tomb are the foundation of the faith of the disciples in the Resurrection of Christ, and not vice versa.”Am I making too much of a fuss about this? I don’t think so. Let’s remember who reads these Catholic Updates — RCIA candidates, participants in adult faith formation groups, perhaps someone shaky in his faith who wants to be certain of what the Church teaches. That they should be handed something like Father Shannon’s wrong musings on the Resurrection is a shame. That his musings bear the imprimatur of the Archdiocese of Cincinnati is, well, something worse.Gabriel Moran (there are 10 pages of ‘hits’ when I googled the word dissent)
Catholic Culture: Can Reform Come? ” http://www.catholicculture.org/news/features/index.cfm?recnum=20884Christian Brother Gabriel Moran: many observers, admirers and critics alike, propose Moran as the most influential man in the catechetical revolution. Michael Warren, editor of Source Book for Modern Catechetics, says, “Few persons in the United States have made a contribution to the catechetical scene as complex and difficult to assess as Gabriel Moran.”Moran’s work influenced many in the catechetical movement to reject divine revelation–the Church’s deposit of faith–in favor of “on-going revelation”–in effect, the interpretation of one’s own experiences as private revelation. This meant not simply that catechists should enliven the students’ understanding of the Gospel by connecting it to their life experiences, but that the students could find revelation only in their own experience. A student “would have to reject any document from the past pretending to divine revelation,” Moran wrote. As Msgr. Michael Wrenn has observed, that category includes the Gospel.
The Rosary Light & Life – Vol 43, No 2, March-April 1990: Brother Gabriel Moran, for whom the basis of theology is not supernatural revelation but experience, wrote in his book “Catechesis of Revelation” :”Revelation consists only in present conscious experience of people. (p. 13) . . . There is no revelation except in God revealing Himself in personal experience . . . One must choose to structure it (the curriculum) according to the people precisely because that is where revelation is. (p. 144) . . . People who demand that there be a higher norm of truth than human experience are asking for an idol.” (p. 45)
AD 2000Book Reveiw: A Generation Betrayed should be read by bishops, priests, teachers, parents – indeed, by everyone interested in religious education. It not only throws a flood of light on what is wrong in modern catechetics, but shows with admirable clarity what the Church really teaches on the vital issues being so tragically contested today. Such muddled thinking is hardly surprising given the prevalence of the lightweight new catechetics – spearheaded by such experts as Thomas Groome and Gabriel Moran – over the past 30 years or so in most Australian dioceses.William D. Antonio
Marys Advocates www.marysadvocates.org/clsawho.html) At the Canon Law Society of America’s 1992 annual convention, William D’Antonio explained how laity who reject the Pope’s traditional teachings, and the autocratic rule that undergirds them, are affirming the liberating principles of Vatican II, especially those enunciated in the Constitution on the Church in the Modern World. (1) D’Antonio supported those who engage in pre- or non-marital sex, use contraceptives, support friends who divorce and remarry, and vote for pro-choice candidates
Common Dreams. org: http://www.commondreams.org/views02/0504-04.htm. “Is The Pope Catholic?”“…Karol Wojtyla has shaped a hierarchy that is intolerant of dissent, unaccountable to its members, secretive in the extreme and willfully clueless about how people live. Probably no institution run by a fraternity of aging celibates was going to reconcile easily with a movement that embraced the equality of women, abortion on demand and gay rights. It is possible, though, to imagine a leadership that would have given it a try. In fact, Pope Paul VI indicated some interest in adopting a more lenient view of birth control, and he handpicked a committee of prominent Catholics who endorsed the idea almost by acclamation. The pope agonized, and then astonished Catholics by reaffirming the old ban. “If you want to look for where credibility on human sexuality got lost, it got lost there,” said the Catholic University sociologist William D’Antonio.”
Amazon Book Review:Voices of the Faithful: American Catholics Striving For Change (2007): Dr. William D’Antonio and Rev. Anthony Pogorlec at the Catholic University of America, in this important Church in the 21st Century book, leaves the reader with little doubt that those who have membership in VOTF are indeed “Loyal Catholics Striving for Change. Thomas Groome
Catholic Culture Website: Compilation on Thomas Groome This is a very large file which extensively documents the the “shared Christian praxis” approach which is foundational to programs such as Generations of Faith. Groome also dissents against the Church’s doctrine on the male-only ministerial priesthood. In his book Sharing Faith (1991), he asserts that “the exclusion of women from ordained ministry is the result of a patriarchal mind-set and culture and is not of Christian faith.”http://www.catholicculture.org/culture/library/view.cfm?id=6516” Bill Huebsch
Los Angeles Lay Catholic Mission; June 2006: Los Angeles Religious Education Congress: A large proportion of speakers have addressed both the congress and Call to Action gatherings. Among more than a dozen Call to Action speakers appearing at the 2006 Religious Education Congress in Los Angeles were: Capuchin Father Michael Crosby, who spoke on injustice in the Church; Father Donald Cozzens, of Cleveland’s John Carroll University, who has famously written that the priesthood is becoming a gay profession; Edwina Gateley, an eccentric feminist whose performances resemble English music hall comedy more than religious presentations; Bill Huebsch, current head of Twenty Third Publications, who talked about parish adult education.
Catholic Answers Forum -Feb. 14, 2007- Re: Whole Community Catechesis: “I am a DRE for a cluster of 4 parishes and I have to concur that the state of knowledge among most Catholics is pretty bad across the board. The problem with doing “whole community catechesis” is that many of the parents generation do not attend Mass and do not seem to care to learn about the Faith. My parish did Generations of Faith and it failed gradually and miserably… fewer and fewer attending. Many parents just drop their kids off at religious education as baby-sitting some time. I don’t mean to be cynical, but it is frustrating.”
AD MAJOREM DEI GLORIAM (Fall, 2004) Report on Los Angeles Religious Education Congress:“When God came, He didn’t come as a catechism. God did not come as a moral code or a doctrinal system or theology school. He came as a person. God is love….This love is messy – not an easy love. Following the law – law has boundaries that are very clear. Who’s in, who’s out? Who’s allowed to come to communion, who’s not? Who’s a practicing Catholic, who’s not? Love is not….When you love someone, you don’t ask, ‘are you a good Catholic?’ Love transcends that. Theology is precise, love is is not. Love is ragged around the edges. Doctrine can be collected in a book, love cannot. Love is beyond the boundaries of that. Love transcends it all. When we give a dinner party at our home, we don’t ask, ‘are you in a valid marriage?’” – Catechist Bill HuebschConclusionsBased on the research done on the Generations of Faith catechetical approach, and its contributors who demonstrate their dissent from authentic Catholic teaching (demonstrated by the articles and links I have attached), I fear that not only our youth, but also poorly catechized parishioners could be harmed by heterodox teachings imbedded in the materials provided by The Center for Ministry Development, which publishes and promotes GOF. Those of us who have been given the grace to seek out and learn all we can about our faith, must do our part in protecting God’s faithful from error.
The name (Bartholomaios) means “son of Talmai” (or Tholmai) which was an ancient Hebrew name, borne, e.g. by the King of Gessur whose daughter was a wife of David (2 Samuel 3:3). It shows, at least, that Bartholomew was of Hebrew descent; it may have been his genuine proper name or simply added to distinguish him as the son of Talmai. Outside the instances referred to, no other mention of the name occurs in the New Testament.
Nothing further is known of him for certain. Many scholars, however, identify him with Nathaniel (John 1:45-51; 21:2). The reasons for this are that Bartholomew is not the proper name of the Apostle; that the name never occurs in the Fourth Gospel, while Nathaniel is not mentioned in the synoptics; that Bartholomew’s name is coupled with Philip’s in the lists of Matthew and Luke, and found next to it in Mark, which agrees well with the fact shown by St. John that Philip was an old friend of Nathaniel’s and brought him to Jesus; that the call of Nathaniel, mentioned with the call of several Apostles, seems to mark him for the apostolate, especially since the rather full and beautiful narrative leads one to expect some important development; that Nathaniel was of Galilee where Jesus found most, if not all, of the Twelve; finally, that on the occasion of the appearance of the risen Savior on the shore of the Sea of Tiberias, Nathaniel is found present, together with several Apostles who are named and two unnamed Disciples who were, almost certainly, likewise Apostles (the word “apostle” not occurring in the Fourth Gospel and “disciple” of Jesus ordinarily meaning Apostle) and so, presumably, was one of the Twelve. This chain of circumstantial evidence is ingenious and pretty strong; the weak link is that, after all, Nathaniel may have been another personage in whom, for some reason, the author of the Fourth Gospel may have been particularly interested, as he was in Nicodemus, who is likewise not named in the synoptics.
No mention of St. Bartholomew occurs in ecclesiastical literature before Eusebius, who mentions that Pantaenus, the master of Origen, while evangelizing India, was told that the Apostle had preached there before him and had given to his converts the Gospel of St. Matthew written in Hebrew, which was still treasured by the Church. “India” was a name covering a very wide area, including even Arabia Felix. Other traditions represent St. Bartholomew as preaching in Mesopotamia, Persia, Egypt, Armenia, Lycaonia, Phrygia, and on the shores of the Black Sea; one legend, it is interesting to note, identifies him with Nathaniel.
The manner of his death, said to have occurred at Albanopolis in Armenia, is equally uncertain; according to some, he was beheaded, according to others, flayed alive and crucified, head downward, by order of Astyages, for having converted his brother, Polymius, King of Armenia. On account of this latter legend, he is often represented in art (e.g. in Michelangelo’s Last Judgment) as flayed and holding in his hand his own skin. His relics are thought by some to be preserved in the church of St. Bartholomew-in-the-Island, at Rome. His feast is celebrated on 24 August. An apocryphalgospel of Bartholomew existed in the early ages.
FRONT ROYAL, Va., April 21 /Christian Newswire/ — Once again, “American Idol” is aligning itself with pro-abortion groups. Among the groups benefiting this year’s “Idol Gives Back” fund-raising campaign are Save the Children and the United Nations Foundation. “Idol Gives Back,” which airs tonight, will feature several celebrities who will urge Americans to make a donation.
Save the Children has a working relationship with what it calls “prominent international organizations.” Several of these groups are actively pro-abortion, including Better World Fund, Center for Reproductive Rights, Planned Parenthood Federation of America, Population Action International, and the U.S. Committee for UNICEF.
In 2001, Save the Children worked with Planned Parenthood, the Population Action Council, and the pro-abortion Audubon Society on its five-year “Planet Campaign.” Funded by the rabidly pro-abortion/ population control David and Lucile Packard and Bill and Melinda Gates Foundations, the purpose of the campaign was to “raise awareness of the connections between international family planning and the health of children, women and the environment.” The Planet Campaign used television and print advertising, community outreach, special events, and other activities to spread its message. Save the Children said the campaign’s website provided “an international forum for discussion of, and action on, women’s reproductive health—including family planning—in various countries and diverse cultures around the world.”
Save the Children has stated that “family planning” has been a “critical component” of its work for nearly 20 years. The group quoted a UNICEF document which stated that “family planning could bring more benefits to more people at less cost than any other single technology now available to the human race.” Save the Children noted that the report identified “access to family planning” as a “key factor contributing to maternal and child survival and well-being.”
Several divisions of the United Nations have donated funds to Planned Parenthood and the body has wholeheartedly embraced its abortion and population control agenda.
“It is laudable that the people involved with ‘American Idol’ want to help the poor,” said LDI President Douglas R. Scott, Jr. “But it is tragic that they would choose to do so through groups like the Save the Children and the United Nations Foundation. These groups have far too much deadly baggage.” Of course, what many people do not know, because “American Idol” has not chosen to mention it, is that Simon Cowell is the chief executive officer of International Save the Children. This is surely why Save the Children was selected as a recipient charity.
“‘American Idol’ should stop using the contestants to raise money for groups when they are keeping the activities of these charities a secret,” Scott said. “‘American Idol’ should practice full disclosure and give those contestants who may wish to decline participation in ‘Idol Gives Back’ the opportunity to do so without repercussions.”
“If you believe the plight of preborn children is as important as the plight of the poor, do not participate in ‘Idol Gives Back,'” Scott urged. “We are caring people who want to do our part to help those less fortunate, but we will do so through organizations that do not view the killing of human beings as a ‘solution’ to poverty and other adult-created problems.”
It is worth noting that “American Idol” recently supported a fund-raising campaign by Planned Parenthood of Los Angeles.
Life Decisions International (LDI) is dedicated to challenging the Culture of Death, concentrating on exposing and fighting the agenda of Planned Parenthood. LDI’s chief project is a boycott of corporations that fund the abortion-committing giant. To learn more about Planned Parenthood, please click here.