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Posts Tagged ‘Ella’

Yesterday, Pam Belluck of the New York Times wrote an article entitled Abortion Qualms on Morning-After Pill May Be Unfounded. Reading the article from the perspective of the scientific layman, one could interpret the article as indicating that the original objections to morning after pills are being attenuated by advances in scientific understanding of their mechanisms and effects, and that remaining opposition is merely religious or philosophical objection being stubbornly clung to by the less enlightened in the biomedical community. Ultimately Belluck’s piece can only be charitably characterized as confused.

Reading the article, I noted that Dr. Donna Harrison, Director of Research for the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), was made to look like a weak, shallow hack. I know Dr. Harrison, quite well. Five minutes with Dr. Harrison is all one needs to realize that she possesses a brilliant mind with an encyclopedic grasp of ALL of the research in the field, pro and con. Belluck’s quotes from Dr. Harrison indicate that she chose not to report the scientific truth that I know Dr. Harrison communicated to her in a lengthy telephone conversation.

It’s a shame, because once again women are being denied the whole truth in the New York Times, a truth which is indispensable to making decisions founded on the facts.

Dr. Harrison wrote a reply in today’s National Review Online. Some of it is reprinted here. Follow the link at the end to read the rest at NRO. If people have questions regarding the mechanisms by which these drugs act, post your questions and we’ll get them answered.

Here’s Dr. Harrison:

The Times’s Convolution of Facts on Abortifacients
By Donna Harrison
June 6, 2012 12:30 P.M.

The recent New York Times article by Pam Belluck, asserting that so-called abortifacient drugs may not be abortive at all, is a wonderful example of convolution of facts to obscure reality. First of all, lumping together two very different drugs and calling them “morning-after pills” allows for clever confusion of what is known about the mechanism of action of each drug, and the role of progesterone in helping the embryo to implant and sustain the pregnancy.

First of all, Plan B and Ella are very different drugs with very different mechanisms of action. Plan B is a progestin, a type of progesterone. Progesterone is a hormone that must be in a woman’s body for her to be able to allow the embryo to implant and develop the placental connections between the embryo and the mother. But Plan B is a very large dose of progesterone, higher than the woman’s body would normally make. It is the effect of that high dose which is under debate.

Ella is a second-generation derivative of the abortion drug RU-486, and is equipotent with RU-486 in blocking the action of progesterone at the level of the ovary and endometrium, one of the facts I explain in my paper on this topic. Indeed, if taken before a woman ovulates, Ella will interfere with progesterone action and prevent the egg from being released. But the critically important question is what happens when you take Ella after ovulation. And the answer is clear. Ella blocks the action of progesterone at the level of the ovary, and blocks the action of progesterone at the endometrium, both of which interfere with implantation. Ms. Belluck is in factual error in her article. The European Medical Association technical review articles state that Ella is embryocidal. That means that Ella kills embryos. I attended the FDA Advisory Committee Hearing on approval of Ella, at which data were presented which demonstrated that Ella is around 95 percent effective in preventing a clinically recognized pregnancy. One of the Advisory Committee members repeatedly pointed out to the manufacturers that there was no way the effectiveness of Ella could be explained by delaying ovulation alone. This fact does not take an FDA Advisory Committee member to figure out. If Ella works even when a woman takes it after ovulation, then of course it doesn’t work in that woman by preventing ovulation.

The same Advisory Committee member stated that the manufacturer had an even bigger problem. If you consider the pregnancies which are mentioned in the NYT article, what Ms. Belluck failed to mention is that 90 percent of those pregnancies “miscarried” and the other 10 percent were “lost to follow-up”. So what the studies supporting the FDA approval of Ella actually show is that even the dose of Ella used as “emergency contraception” is high enough to interfere with the early development of the embryo in such a fashion as to increase the miscarriage rate if a pregnancy is recognized.

And here, abortion proponents speak out of both sides of their mouth. The quote from Trussell in the NYT article was particularly amusing. If you read his previous research papers, sometimes he claims over 90 percent efficacy from Plan B, and sometimes he claims around 50 percent efficacy. Why these differences? Well, as he so readily admits, you can’t get numbers of 90 percent efficacy without some sort of post-fertilization effect. So when the issue of mechanism of action is raised, suddenly the efficacy for Plan B gets “adjusted” to what would be expected from a drug with no post-fertilization effect. But, when issues of funding arise . . . well Plan B becomes much more effective.

In point of fact, any drug which can act to prevent pregnancy after a woman has ovulated must have some post-fertilization effect. Whether it kills the embryo directly, or prevents the embryo from travelling down the tube, or prevents the embryo from implanting, or interferes with ovarian function, or increases immune rejection of the embryo, or directly destroys the placenta, some mechanism must be in place to interfere with the normal embryo functioning and then kill the living embryo.

Get the rest here.

Tomorrow, a deeper analysis of the subject.

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In 1962, Receiving Distinguished Civilian Service Medal from President Kennedy. Photo: New York Times

What does a regulatory agency do when it has betrayed the public they are sworn to protect, through the deliberate flouting of hard-won stringent, safety-testing protocols? Create an award in the name of a 96 year-old heroine who set those standards a half century ago, then trot her out in a ceremony today and make her its first recipient.

This is precisely what is happening today, as reported in yesterday’s New York Times. FDA commissioner Dr. Margaret Hamburg is honoring Dr. Frances Oldham Kelsey with the newly minted Kelsey Award.

In a move that is layered with unfathomable levels of irony and rank hypocrisy Hamburg (who helped shepherd the new abortifacient Ella through the regulatory process as merely a “contraceptive,” and flouting an appalling number of safety inquiries) is honoring the woman who saved countless American babies circa 1960, myself included, from the ravages of thalidomide. It was Kelsey who defeated William S. Merrell Company’s application for thalidomide in the United States by linking the drug to the hideous birth defects it induced in embryos of mothers taking the drug for morning sickness.

Thalidomide Baby c. 1960

Read this blog’s two part series on Hamburg’s shameful and unethical role in Ella’s approval here and here.

Now 96, nearly deaf and mostly immobile, one can only guess what Dr. Kelsey knows of Dr. Hamburg’s retrograde administration of the agency that Kelsey helped develop into a powerhouse of stringent testing and transparent disclosure. But the question remains,

“Why a Kelsey Award at this juncture in FDA history?”

The answer can only be that FDA is either assuaging a guilty conscience, or creating the public perception that they value the very thing they have for two decades seriously degraded. In more pithy and enlightened circles it’s called hypocrisy: pretending to be that which one has no intention of ever being.

The juxtaposition of the recent Ella approval and labeling process and the public appeal to Dr. Kelsey’s great scientific and ethical virtues leave little doubt that Hamburg’s motivation is both the assuaging of a guilty conscience as well as rank hypocrisy.

It is also a breathtaking example of cowardice, the using of a woman nearly one hundred years old, and her great work in exposing the thalidomide scandal, as a smokescreen for FDA’s increasingly cozy relationship with industry and its recent betrayal of women and the 2 percent of babies who will survive Ella exposure, with absolutely no studies performed on the teratogenic effects of Ella on them.

The great difference in fifty years is that Kelsey began her work at FDA thirteen years before Roe v. Wade, in a time when the drug being ingested by women was being taken because these women wanted their babies and wanted as smooth a pregnancy as possible.

Hamburg, fifty years later, shepherded an abortifacient around Kelsey’s stringent safety testing regulations. But these babies don’t matter because they are unwanted from the outset. Their fates really don’t matter much. Evidently, their mothers matter little more.

I have long admired Dr. Kelsey. My younger siblings and I owe her much more than could ever be expressed in words. Her 1962 Distinguished Civilian Service Medal, awarded by President Kennedy, was richly deserved. She is a great woman who made her way at a time and in an environment that was extremely hostile to women with Ph.D.’s in science and medicine.

Dr. Kelsey Today. Photo: New York Times

Now at the twilight of her life, she deserves a much better fate than a cynical award, cynically awarded by a woman who has repudiated through her administration of FDA all that Dr. Kelsey worked so hard to build.

Perhaps, after much avoidable human misery FDA will yet come back to an appreciation of Dr. Kelsey’s vision, and return as an agency to its senses. In so doing it will have removed the stain of dishonor from this award that bears the name of one of the great pioneering women of science.

One hopes.

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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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