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Archive for September, 2010

Those following daily are beginning to get confortable with the jargon (I hope). For ease of newcomers following along , please consult the glossary of terms that I’ve written to make the terminology very understandable.

Title: ABORTION AND THE RISK OF BREAST CANCER: A CASE-CONTROL STUDY IN GREECE

(The discerning reader will recognize Trichopoulos as one of the authors in yesterday’s paper #2. This group is from Harvard University, Greece, and Sweden}

Authors: Loren Lipworth, Klea Katsouyanni, Anders Ekbom, Dimitrios Trichopoulos

Journal: International Journal of Cancer, 1995, 61:181-184

This study was a case-control study.

820 patients with confirmed breast cancer (BC) {The cases}.

795 orthopedic patients and 753 healthy visitors {The controls}.

The odds ratios (relative risks) were reported with 95% confidence intervals (CI).

It should be noted that the authors discuss in the introduction the controversy surrounding purported recall bias, and say the following of their subjects, all of whom reside in Greece:

Even before their legalization, induced abortions were practiced in Greece with widespread social acceptance. Although no validation has ever been undertaken in Greece, it is of interest that a study of induced abortion in relation to ectopic pregnancy and secondary infertility (Tzonou et al, 1993) has demonstrated associations similar to those expected on the basis of the collective published evidence regarding these diseases, that is, no significant association with ectopic pregnancy and a weak positive association with respect to secondary infertility. This can be interpreted as indicating that healthy women in Greece report reliably on their history of induced abortion.”

This is an important observation, because it is the claim of ardent pro-abort researchers such as Palmer and Rosenberg that recall bias manifests in healthy controls underreporting their prior abortions, thereby producing an appearance of increased risk in breast cancer patients who’ve had induced abortions.

Results:

The Odds Ratios (OR’s) are essentially the same as relative risk (RR).

The OR in breast cancer patients who had abortions matched to controls matched for age, parity status, age at first birth, menopausal status, Quetelet’s index, and alcohol intake were as follows:

Spontaneous abortion (miscarriage)- 0.97 (essentially no increased risk)
Induced abortion- 1.51 (51% increased risk)
Spontaneous and/or induced abortion- 1.38 (38% increased risk)

Among nulliparous women, there was no difference in breast cancer rates between nulliparous women who had abortions and those who did not. Among parous women, there was an OR of 1.76 (76% increased risk of BC) in parous women who had abortions compared to parous women who didn’t.

Finally, the most bracing result was in parous women who had abortion prior to First Full Term Pregnancy (FFTP) using nulliparous women as a control:

Induced abortion before FFTP. OR=2.06 (more than double the risk)
Induced abortion after FFTP. OR=1.59 (59% increased risk)

Discussion: The authors state,

“It appears, therefore, that the most important confounding bias (recall bias) was adequately controlled. Information bias with respect to induced abortion was is certainly possible, but not likely to be large in this study, given the permissive social environment with respect to induced abortion in Greece and the fact that the interviews were conducted in the hospital setting by hospital-associated health professionals…

“Thus an appropriate interpretation of these results, and to a considerable extent of the collective epidemiological evidence might be that an interrupted pregnancy does not impart the long term protection of a full term pregnancy attributable to terminal differentiation, whereas it may impart a small and occasionally demonstrable elevation of breast cancer risk on account of the transiently increased stimulation by estrogen.

“The higher excess risk associated with an abortion before rather than after first birth, noted in the present study, is compatible with the experimental evidence that terminal differentiation {conversion of cancer-prone Type 1 and 2 cells to cancer resistant Type 4 cells} depends on the occurrence of a full term pregnancy.”

The study was supported by European and Greek grants. Interesting to note as we go along the lack of spin in grants not given by the US National Cancer Institute, where Dr. Louise Brinton is head of epidemiology.

This October, please consider $upporting the following who desperately need our $upport to get the truth out*:

Breast Cancer Prevention Institute

Coalition on Abortion/Breast Cancer

*I have no institutional affiliation or membership with either group. Karen Malec and BCPI have been great resources for me, utterly generous with their time and resources.

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The ABC Literature: #2

So far, we have discussed the physiology of the breast and how it becomes prone to breast cancer (BC) under the influence of estrogen, a WHO Group 1 carcinogen. We have seen that the hormone placental lactogen, secreted in the third trimester, helps to mature 85% of the immature, cancer-prone cells of the breast into cancer-resistant cells. With each successive pregnancy, more of the remaining 15% of cancer-prone cells become cancer resistant. See here to catch up on the details.

I’ve written a brief glossary of the terms used in these studies here. If you see a term with which you are unfamiliar, you’ll find it in the glossary.

Today we look at an important paper in the breast cancer literature. This paper reports on the single greatest reproductive risk factor in the development of breast cancer: age at first birth. As we shall discuss after the summation of the paper, the results tie in very well with our model of breast physiology and the effects of induced abortion.

Title: AGE AT ANY BIRTH AND BREAST CANCER RISK

Authors: Dimitrios Trichopoulos, Chung Cheng Hsieh, Brian MacMahon, Tong-ming Lin, C. Ronald Lowe, Antonio P. Mirra, Bozena Raynhar, Lva J. Salber, Vasilios G. Valaoras, Shu Yuasa.

Journal: International Journal of Cancer, 1983, 31:701-704

{The authors of this international study are from Harvard University, Duke University, Yugoslavia, Wales, Greece, Taiwan, and Japan}

This case control study contained reproductive data from 4,225 women with BC (cases), and 12,307 hospitalized women without BC (controls). It is important to note that abortions prior to 5 months were excluded from the study.

Nulliparous women were used as controls for parous women.

All data are reported with the statistical significance of the 95% confidence interval.

Overall, the average age at first birth in this study was 24.8 years. The authors established an increase of 3.5% per year in the relative risk (RR) of developing breast cancer, for every year that women delay a first full term pregnancy (FFTP) after the age of 24.8 years.

The relative risk (RR) of breast cancer in parous women with multiple pregnancies is reported as follows for increasing ages with single through multiple births:

Age at first birth: 15. In these women, if the woman had one child per year beginning at age 15, then her RR of breast cancer was:

1 child- 0.52
2 children- 0.53
3 children- 0.38
4,5 children- 0.37

That means that this young mother’s lifetime RR is half of that of a nulliparous woman (52%) at one child and drops to almost 1/3 (37%) the risk of a nulliparous woman’s risk if she has 4 or 5 children.

Age at first birth: 18. In this group, if the women have a two-year interval between children, the RR’s are:

1 child- 0.58
2 children- 0.60
3 children- 0.45
4,5 children- 0.43

Age at first birth: 18 (that’s not a typo. It’s 18). Five-year interval between children. RR’s are:

1 child- O.58
2 children- 0.61
3 children- 0.49
4,5 children- 0.46

Age at first birth: 30. Two-year interval between children. RR’s are:

1 child- 0.87
2 children- 0.98
3 children- 0.84
4,5 children 0.8
3

Age at first birth: 35. One-year interval between children. RR’s are:

1 child- 1.03
2 children- 1.19
3 children- 1.05
4,5 children- 1.06

The numbers for the last category of women actually show slight increases in the risk for breast cancer.

Another curious phenomenon is the slight uptick in RR between a first and second pregnancy in all age categories, followed by a significant drop in RR in 3+ pregnancies. Even so, The RR’s are well below those of nulliparous women.

The results of this study are entirely consistent with what is known of breast physiology. The longer women delay a FFTP, the longer the immature Type 1 and Type 2 cells of the lobules have to become cancerous, and the longer the woman delays the protective effect of placental lactogen, which matures those cancer-prone cells in the last trimester.

These data present the most significant, but hardly the only, risk factor for BC. While the authors did not include women who had abortions, we shall see in many studies to come that there is a consistent RR of BC from induced abortion.

This October, please consider $upporting the following who desperately need our $upport to get the truth out*:

Breast Cancer Prevention Institute

Coalition on Abortion/Breast Cancer

*I have no institutional affiliation or membership with either group. Karen Malec and BCPI have been great resources for me, utterly generous with their time and resources.

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Today begins the inexorable presentation of the scientific literature on the abortion/breast cancer (ABC) link. I’ve written a brief and simple glossary of the terms used (such as case-control, nulliparous, parous, relative risk, confidence interval, etc.) and their significance here. Please consult it as often as is necessary and ask questions liberally.

This gets easier to follow after a few rounds, so hang in there. Women’s lives depend on us getting the truth out to them. In short order we’ll generate plenty of pros armed with the simple truth of science!

Title: Induced and spontaneous abortion in relation to risk of breast cancer (United States)

Authors: Julie R. Palmer, Lynn Rosenberg, R. Sowmya Rao, Ann Zauber, Brian L. Strom, M. Ellen Wershauer, Paul D. Stolley and Samuel Shapiro

Journal: Cancer Causes and Control, 1997, 8, pp 841-849.

• Drs. Palmer, Rosenberg, Shapiro and Ms. Rao are with the Slone Epidemiology Unit, School of Public Health, Boston University. Authors are also affiliated with the Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer, New York, New York.

• It should be noted that the research was supported by U.S. National Cancer Institute grants RO1 CA55716 and RO1 CA45762

This study is a Case-Control study.

Cases- “1,835 women ages 25-64 years with pathologically confirmed, invasive breast cancer diagnosed within the previous year and no previous or concurrent malignancy other than nonmelanoma skin cancer.”

Controls- “4,289 women aged 25-64 admitted for nonmalignant or malignant conditions judged to be unrelated to reproductive factors.”

Nulliparous and parous women were analyzed separately because of the increased incidence of breast cancer in nulliparous women.

Results:

With a 95% confidence interval (meaning the researchers are 95% certain that the results are not due to chance) as the benchmark for statistical significance, nulliparous women who had 1 induced abortion only had a 40% relative risk of breast cancer , as did parous women with 1 abortion only. Remember that this risk is relative to women in the control group who had no induced abortions.

So in plain English, women who had 1 induced abortion, regardless of ever having had a child, had a 40% increased risk of developing breast cancer over women the same age, with the same parity status who never had abortions, and the authors are 95% certain that there is no other explanation.

An interesting result is that in parous women (those who’ve had children) the relative risk of breast cancer is zero before a first full term pregnancy (FFTP) and 30% after a first full term birth. This is an inversion of the data found elsewhere. It could very well be explained by the effects of human lactogen in the subsequent FFTP, which matures those immature Type 1 and Type 2 cells that proliferated in the aborted pregnancy, but never matured. The maturing of those cells into Type 4 cells in a future pregnancy, before they had a chance to become cancerous, is a logical conclusion based upon the breast physiology and the relatively long incubation time for cancer.

That there is a 30% increased risk of cancer in parous women whose abortion came after a FFTP may well be explained by additional stimulation of the lobules by estrogen in the aborted pregnancy, without the benefit of lactogen at the end. This would leave an increased number of cancer-prone Type 1 and Type 2 cells behind.

Now, incredibly, the authors suggest that this study suffers from a form of recall bias. This after stating that they were 95% certain that the results could not be due to chance. The authors believe that women with breast cancer are less likely to underreport an abortion than women without breast cancer. They offer no proof of this phenomenon other than the same assertions made by other breast cancer researchers with similar data. In other words, the phenomenon is a baseless assertion reverberating in the pro-abortion echo chamber.

Are we really to believe that breast cancer brings women closer to telling the truth of their previous abortions? Why the acuity of memory in a breast cancer patient vs. the control patients? The abortion question was just one in a long, detailed history taken during the study.

There is no rational basis for believing that women with breast cancer are more apt to recall and report an abortion than any other women. Still, with no proof that the alleged phenomenon exists, no instrument to measure the alleged phenomenon, no numbers on the alleged phenomenon, the authors conclude:

“The small elevations in risk observed in the present study and in previous studies are compatible with what would be expected if there were differential underreporting by cases and controls.”

If I had pulled that crap during my dissertation defense, my committee would have laughed me out of the room. But, as we shall see over and over on a daily basis for months to come, this is what happens when ideology (and not physiology) becomes the prism through which data are filtered.

This October, please consider $upporting the following who desperately need our $upport to get the truth out*:

Breast Cancer Prevention Institute

Coalition on Abortion/Breast Cancer

*I have no institutional affiliation or membership with either group. Karen Malec and BCPI have been great resources for me, utterly generous with their time and resources.

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As we begin our journey through the abortion/breast cancer literature it is useful to define a few terms that will be in constant use. If there are any questions about the terms, their usage, etc. please feel free to request a clarification.

I ask that all questions be asked here on the blog, and not on facebook, as there are readers from several forums, and it benefits all if the Q&A is at the source. Thank you in advance for your understanding.

So here they are, just a few definitions. For the math phobes reading, this is very basic stuff. Reading it once or twice will get the job done. In every posting, I shall link back to this list of definitions, and may add one or two as we go along.

First Full Term Pregnancy (FFTP)– The first pregnancy a woman brings to term.

The following are from Stedman’s Medical Dictionary, 27th Edition.

Parous– Pertaining to Parity

Parity– The condition of having given birth to an infant or infants, alive or dead; a multiple birth is considered as a single parous experience.

Nulliparous– Never having borne a child.

The following are from Infectious Disease Epidemiology, Theory and Practice, 2nd Edition by Nelson and Williams.

Case Control Studies– A group of persons with a disease—the cases—is compared with a group of persons without the disease—the controls.

Relative Risk (RR)– The relative risk (RR) is the attack rate among those exposed to the risk factor divided by the attack rate in those who were not exposed. If those who ate hors d’oeuvres were no more likely to become ill than those who did not, the attack rates would be equal and the RR would be 1.

{Gerry’s note: In this example if 15 out of 100 who ate the hors d’oeuvres got sick and 15 out of 100 who did not eat them got sick, then the formula would be RR=.15/.15, (15 % divided by 15%) which when divided comes out to 1. Therefore the hors d’oeuvres could not be implicated in the illnesses}

If those who ate hors d’oeuvres were more likely to become ill than those who did not, this ratio would be greater than 1 and the hors d’oeuvres would be a risk factor for illness.

{Gerry’s note: If 20 out of 100 who ate hors d’oeuvres got sick and 15 out of 100 who did not eat them got sick, then the formula would be RR=.20/.15 (20% divided by 15%) which when divided comes out to 1.333. This is .333 above no risk, which is 33% increased risk because of the hors d’oeuvres.}

Statistical Significance– To determine whether the association is statistically significant, the epidemiologist must be able to demonstrate that the results are unlikely to be explained by chance alone. Epidemiologists commonly use the 95% Confidence Interval.

95% Confidence Interval (CI)– (5% of the time the relative risk (RR) will be between the upper and lower limits of the CI if the experiment were repeated.

{Gerry’s note: In other words, the researcher is confident to within 95% that the results are repeatable and not explainable by chance alone}

Beginning with tomorrow’s post, we shall see that some researchers will establish relative risks within 95% confidence intervals —which is the benchmark used for statistical significance— then dismiss the results as statistically insignificant in their discussions. Dr. Louise Brinton does this in a 2009 paper while simultaneously referring to abortion as a known risk factor for breast cancer based upon RR and CI data that she simultaneously embraces and disowns.

Thus the mental illness of abortion apologetics and its corrosive effects on all that it touches, including scientific integrity.

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October is Breast Cancer Awareness Month, a time that we turn our attention to a devastating disease that can potentially strike one out of every nine of our mothers, aunts, wives, sisters, cousins, daughters, and friends. Naturally as we focus on this terrible disease we concern ourselves with raising money to fund research for a cure. This is as it should be. However, precious little attention is paid to getting out the word on what the scientific community has already discovered relative to prevention.

We know with absolute certainty that oral contraceptives (OC’s) and abortion both raise a woman’s risk of developing breast cancer. Renowned breast surgeon Dr. Angela Lanfranchi of the Breast Cancer Prevention Institute, along with City University of New York Professor of Endocrinology Dr. Joel Brind explain the mechanism:

Prior to a first full term pregnancy (FFTP) the cells that comprise the lobules of the breast are immature and cancer-prone Type 1 and Type 2 cells. Under the influence of the high levels of estrogen in OC’s and during pregnancy, the lobules of the breast roughly double in number. This results in a doubling of the number of cancer-prone Type 1 and Type 2 cells. In pregnancy, it isn’t until the third trimester under the influence of the hormone human placental lactogen that the immature cells mature into cancer-resistant Type 3 and Type 4 cells.

Read the details in this stunning pamphlet here.

The science is clear that the earlier a woman bears children, and the more she nurses, the greater her protection from breast cancer. The science of the past fifty years is also abundantly clear that having an abortion prior to a FFTP allows for the proliferation of the cancer-prone Type 1 and Type 2 cells, while terminating the pregnancy prior to the onset of the third trimester’s protective mechanism that converts these cells to the cancer-resistant Type 4 cells leads to increased incidence of breast cancer.. The risk of breast cancer in women having an abortion prior to a FFTP ranges from 40% to 90% in most cases. In girls under the age of 18 with a family history of breast cancer the risk becomes incalculably high.

Other institutes devoted to getting the word out about breast cancer in relation to OC’s and abortion are the Polycarp Research Institute, under the direction of Chris Kalenborn, M.D.; and The Coalition on Abortion/Breast Cancer, under the direction of Ms. Karen Malec. Malec’s website is loaded with links to the scientific data and refutations to the lies told by pro-abortion apologists such as Dr. Louise Brinton of the National Cancer Institute whose own research through the years has shown the link between abortion and breast cancer, and who convened a panel in 2003 to deny the validity of fifty years of research showing that link.

The full story on Brinton’s duplicity here.

Were all of that not enough Susan G. Komen for the Cure has been donating millions of dollars to Planned Parenthood, the largest provider of abortions and OC’s in the nation. Their claim is that PP provides mammograms (which aid in diagnostics but not the “Cure”). More on this here. In funding PP, Komen is contributing to new cases of breast cancer, a fact they steadfastly refuse to acknowledge. The truth, however, is that PP dispenses OC’s like candy. They encourage a lifestyle of delaying childbirth while pumping young girls and women full of the OC’s that raise their risk of developing breast cancer. Their services and the concomitant oncological sequellae consistently described in the scientific literature are completely at odds.

Though I quote statistics, these are just numbers that do not truly convey the gravity of Dr. Brinton’s duplicitous behavior, behavior that is nothing less than a betrayal of women by denying them the truth that needs to inform their informed consent to abortion and the use of OC’s.

Therefore, in honor of women, in honor of the hundreds of researchers who have been besmirched by Brinton and her cronies, I shall publish the results of one research paper/editorial per day beginning tomorrow and will do so every single day until I have exhausted my library of papers sometime in December or January. I shall publish the complete reference including researchers names and affiliated institutions, a synopsis of what they did, the hard numbers from the results and the authors’ conclusions. They will all be stored in the “Breast Cancer” folder in the “Categories” panel to the right.

I am deeply indebted to Ms. Karen Malec, President of the Coalition on Abortion/Breast Cancer for her generous time and efforts at bringing me up to speed on this topic, both in long telephone conversations and in sharing with me her library of scientific literature, which has saved me over a hundred hours of research and library time.

As the nation returns from summer vacation and October looms large, the pro-life community can do much by spreading the word about Dr. Lanfranchi’s and Karen Malec’s institutes that aim at prevention, and can do much by helping to fund their efforts at that ounce of prevention which is worth a pound of (Komen’s) “cure”. This year, please encourage all whom you know to help fund these two great institutes in their efforts to prevent this scourge in women, rather than forever mopping up Planned Parenthood’s mess. As the reader will see daily in the months to come, Malec and Lanfranchi hold the key to this scourge.

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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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