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My article in today’s HeadlineBistro.

The first part of this series showed how the Food and Drug Administration’s (FDA) newest contraceptive drug, Ella (Ulipristal acetate), is in reality an abortifacient like RU-486. It argued that FDA’s marketing of Ella as strictly a contraceptive that denies its abortifacient capabilities, which are abundantly evident to most informed non-scientists, is the culmination of a series of lies through omission. Here in Part II, we will see all the safety data that the FDA deliberately ignored, and all of the safety investigations it didn’t bother to make the manufacturer perform.

In a June 2, 2010, letter to the FDA’s Advisory Committee for Reproductive Health Drugs, Dr. Donna Harrison, president of the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) outlined the deficiencies in the safety data and proposed labeling of Ella. This article summarizes those deficiencies and the reader is referred to the letter for the details.

The first great omission was that of transparency in the drug approval process. According to FDA Commissioner Dr. Margaret A. Hamburger, who wrote in a letter to her colleagues:

“FDA is advised by 49 committees and panels with more than 600 members. These committees provide advice on specific regulatory decisions, such as product approvals, and general policy matters, such as regulations and guidance. … [t]he primary goal of the advisory committee process is to bring high-quality input to FDA in order to support agency decisions.”

In reality, FDA required comment submissions from advisory groups such as AAPLOG by a deadline without any prior releasing of the data on the drug. Harrison and AAPLOG were forced to use the publicly available data from the European Medicines Agency, as Ella is already available in Europe, sold under the brand name EllaOne.

According to the European agency, “EllaOne is contra-indicated during an existing or suspected pregnancy.” Right there is the admission that this drug can serve as an abortifacient. But there are additional issues beyond the immediate embryocidal effects that are associated with this contraindication.

It is important to note that 2 percent of all pregnancies subjected to Ella will survive the treatment. That means 20,000 babies for every 1 million treatments, and no studies were performed on the toxicity of Ella on the surviving fetuses.

The European agency admits that there are very insufficient data regarding the developmental effects of Ella on surviving fetuses. It is beyond comprehension that no reproductive toxicity studies have been performed on Ella when International Conference on Harmonisation guidelines clearly requires such studies to be done. The European agency states:

“Reproduction toxicity data are insufficient due to lack of human and animal pharmacokinetic data. Due to its mechanism of action, [Ella] has an embryolethal effect in rats, rabbits (at repeated doses above 1 mg/kg) and in monkeys. The safety for a human embryo is unknown.”

The purpose of animal studies is to extrapolate to humans what is found in evolutionarily similar animals such as monkeys. Combining the mechanism of action described in Part I and the lethal effect for embryos in all tested animals, it isn’t difficult to make the connection that Ella has an embryolethal effect on humans.

Additionally, studies in monkeys indicate the presence of Ella in reproductive and other tissues 14 days after single dose administration, a presence that far exceeds the touted five-day window of drug effect. Many women will certainly use this drug more than once per menstrual cycle, so the lasting effects remain unresearched and unknown.

According to Harrison, the European agency based their safety assessment of Ella on a single 30 mg dose per menstrual cycle and based on that alone they “lowered or waived required safety, toxicology and pharmakodynamic study requirements for:

1. Human in vivo metabolism data
2. Single dose toxicology studies
3. Dose recovery studies
4. Carcinogenicity studies
5. Toxicokinetic documentation
6. Bioavailability and absorption studies
7. Mechanism of action with regard to threshold concentration effects
8. Formal dose proportionality studies
9. Information on drug interactions in patients with renal or hepatic impairment
10. Pharmacokinetic interaction studies.”

Were that all not enough, the European agency also identified other unstudied populations, such as women over the age of 35, women who are on concomitant hormonal contraceptives (use for “missed pill” contraceptive failure), lactating women, and adolescent females, for whom no safety or efficacy studies have been done.

It is accepted in the pro-life community that abortion, and its proponents, are among the most corrosive influences on the public health. The machinations behind the passage of Ella constitute a case study in how, yet again, women’s health is sacrificed at the altar of this modern-day Moloch. No serious scientist or physician can look at this appalling list of omissions in safety and toxicity studies, the lack of transparency surrounding the hearings, and conclude that the FDA had women’s health at heart. There are well-established, rigorous scientific and regulatory protocols for the approval of new drugs, a frightening number of which were either incomplete, or not engaged at all in the case of Ella.

This is primarily about population control, a driving ideology behind the Culture of Death. It is not only cultural, but civilizational suicide. The surest way to defeat this is at the grassroots level, by spreading the word among women of just how dangerous abortion is for them, and the conspiracy of silence among those scientists and physicians who have betrayed every ethical precept in railroading an unsuspecting public.

In addition to getting out the truth, our prayers and our support of crisis pregnancy centers are two of our greatest weapons in reestablishing a Culture of Life and a Civilization of Love.

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My Column in today’s Headline Bistro.

The FDA’s recent approval of Ella (Ulipristal acetate) as an emergency contraceptive is an action so fraught with lies and incomplete research, that it beggars the imagination. It is a tissue of lies built upon a foundation of lies. Let’s begin with the foundational lies and work our way up.

Ella is marketed as an emergency contraceptive because it can inhibit ovulation for up to five days. It also acts to prevent the implantation of the embryo and destroys the maternal component of the placenta (more on that later). So how is this not considered an abortifacient by the FDA?

The answer lies in the redefinition of both pregnancy and conception.

The American College of Obstetricians and Gynecologists (ACOG) has for over 25 years accepted a redefinition of both pregnancy and conception as starting at implantation of the embryo, rather than at the fertilization of the egg by sperm. That’s earth-shattering in its effect. The activist attorneys who lobby ACOG saw these drugs coming and worked to get the new definitions put in place well in advance.

The definitions are also tied to the in vitro fertilization industry. Fertilization used to take place solely within the woman’s fallopian tubes, so that conception and pregnancy were respectively both an event and a condition that were simultaneous. When fertilization occurs in a Petri dish, the mother has neither conceived, nor is she pregnant. It was absurd to discard these traditional definitions for those whose pregnancies begin in the natural manner, but then logic is neither the aim, nor the concern of the pro-abortion lobby. Apparently neither is ethics or truthfulness.

Ella, as will now be seen, works as an abortifacient – even under the revised and tortured definitions of conception and pregnancy. In order to understand how it works, we must consider for a moment the processes with which it interferes.

During a normal menstrual cycle, estrogen stimulates the lining of the uterus to grow and prepare for the implantation of the embryo. At mid-cycle the follicle of cells surrounding the egg in the ovary will rupture and release the egg into the fallopian tube. That follicle of cells becomes a structure called the corpus luteum, which produces the hormone progesterone. Progesterone travels to the uterine lining, binds to it and maintains the structural integrity of the uterine lining throughout the pregnancy, if one happens to occur.

If no baby is conceived, the corpus luteum dies at about 28 days. No corpus luteum, no progesterone. With no progesterone, the uterine lining (endometrium) breaks down and a new cycle begins. If, however, the woman does conceive, the corpus luteum will live for approximately 10 weeks (the first trimester), after which time it will die and the baby will take over its own housekeeping.

Ella acts in three ways to kill an embryonic human being.

First, Ella blocks the progesterone receptors on the surface of endometrial cells in the uterine lining. This is analogous to jamming a piece of metal into the lock on one’s front door. It prevents the key from being inserted and unlocking the door. By blocking the “keyhole” for progesterone (the key), progesterone cannot initiate the complex of events necessary for sustained development and maintenance of the uterine lining. This mimics the onset of a menstrual period with the breakdown of the endometrial lining of the uterus, leaving nowhere for the embryo to implant.

That’s considered “contraceptive” by ACOG and FDA because conception is now defined as implantation. However, the next two steps are abortifacient mechanisms under anybody’s definition.

The second way that Ella works to kill an embryonic human is that it inhibits the ability of the cells of the corpus luteum to produce progesterone, thus mimicking the death of the corpus luteum. Without the progesterone made by the corpus luteum in the first ten weeks of pregnancy, the placenta dies and the baby is starved of oxygen and nutrients. Hence, Ella is effective far beyond the five-day window being touted by FDA.

The third mechanism of action for Ella is that it blocks the progesterone receptors in the endometrial stromal tissue, directly killing the mother’s portion of the placenta. These last two mechanisms are the exact manner in which RU-486 works.

Thus we see that Ella simultaneously blocks the production of progesterone and blocks it from binding to its receptors in the uterine lining, producing a miscarriage. This can happen at any time in the pregnancy. It also acts to destroy the endometrium before the embryo reaches it for implantation.

If this level of outright lying and obfuscation is profoundly disturbing, the safety standards that were deliberately ignored and the clinical trials never performed on the road to approval are nothing less than scandalous. In Part II, the story of how Ella was shepherded past the safety standards in product development, clinical trials and FDA approval.

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ellaOne (Ulipristal 30 mg) is the new and improved version of RU 486. Its mechanism of action is similar in that it blocks the hormone progesterone from its effect of maintaining the endometrial lining of the uterus.

Recall that while estrogen is key to stimulating the growth and development of a new uterine lining (endometrium), progesterone is tasked with maintaining the structural integrity of that lining (to which the embryo attaches). In a normal menstrual cycle, the former egg follicle, the corpus luteum, produces progesterone and dies if no embryo has been produced. Thus the definition of menstruation is progesterone withdrawal from an estrogen-primed uterus.

If an embryo happens to be nestled in that endometrium and ellaOne is taken to block the effects of progesterone, the endometrium will break down, flushing the embryo out in the process.

Whereas RU 486 was taken as a morning after pill, ellaOne can be taken several days later.

The FDA is set to hold hearings on ellaOne this coming June 17. At those hearings we will hear of how this drug is not an abortifacient, that it is meant as emergency contraception to prevent pregnancy.

Enter the verbal engineering.

The pro-aborts have actually outrun their own verbal engineering, which is always engaged in as the necessary pre-requisite to social engineering. The American College of Obstetrics and Gynecology defines pregnancy as the implantation of the embryo. It used to be defined as conception. However, this definitional change does have a curious logical coherency.

In vitro fertilization (IVF) continues to spawn all manner of derivative evil. It is because of IVF that the definition of pregnancy was changed. A woman is said to be pregnant when she has conceived in her body (in vivo). However, when a woman donates eggs, which are then fertilized in a petri dish (in vitro), the woman is not said to be pregnant, and rightly so. She may have 30-40 live babies in their embryonic stage in a petri dish, but her body remains without child. Thus, a mother of 40 can remain never having been pregnant.

The definition needs to be reworked, back to conception, but including IVF. I propose the following:

Pregnancy: The status of a woman whose body possesses nascent human life from the moment of in vivo conception, or has received nascent human life through artificial implantation.

It makes a difference.

Through the current IVF-inspired definition, RU 486 is held to be an emergency contraceptive. Taken early enough, ellaOne could fit that same definition. However, ellaOne can be taken when the embryo has already implanted, running up against even the current and tortured definition of pregnancy. As such, there can be no doubt that ellaOne is an abortifacient. Thus the pro-aborts are now hard-pressed to find verbal engineering sufficient as to give them cover. However, what they lack in the way of rhetorical cover, they may well gain by brute political force.

FDA is always at the mercy of Congress and the White House for funding. With the demonic trinity of Obama-Reid-Pelosi, do they dare reject this new drug? It’s a dilemma to be certain.

November is coming.

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