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Archive for September, 2010

Twin Scourges: Abortion and Breast Cancer

As a scientist, the most frequent question I am asked is, “When are they going to find a cure for (fill in the blank)?” It’s a great question and merits serious contemplation and public discussion, because the ones responsible for finding a cure are not just the scientists, but all of us. I have begun to answer that question by asking the following:

“What are you willing to do to find that cure?”

Read the rest here.

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The Absurdity of Recall Bias


Just a brief reflection upon the concept of recall bias with which we have been contending. Several authors, including the notoriously pro-aborts, Palmer and Rosenberg, have held out the contention that women who are healthy control subjects are more prone to not tell the truth when asked in a detailed health history if they have ever had an abortion than are women with breast cancer. This is the purported fatal flaw of retrospective studies, which employ self-reports from patients.

Supposedly women with breast cancer are busily searching for any culprit to blame.

We have seen consistent evidence of an increase in BC in women who have had induced abortions, and we shall see much more to come.

We have seen in paper #7 in this series a large prospective study (declared by the pro-aborts as the only valid type), one employing national health databases, that couldn’t hide that risk even when the authors did all in their power to dilute the magnitude of the reported risk by combining into a single category, risk groups of divergent incidence rates.

And we have not even seen the worst. Beginning on the first day of Breast Cancer Awareness Month we shall turn our sights on the Queen of All the Liars, Dr. Louise Brinton, epidemiology chief for the National Cancer Institute whose repeatedly alternating scientific papers and public policy statements have had the head-turning effect of a game at Wimbledon.

It is odd that the assertion is for healthy women to lie on one question out of so many, and for BC patients to be truthful on said question, especially when the stated rationale for much of the lying is that many of the women in the studies had abortions in the years before they were legal. Yet many of the BC patients too had their abortions in the years when abortion was illegal. So what makes BC patients given to greater veracity when their traumatic illness is grounds for denial that they could have inflicted this on themselves through the killing of their own baby?

We have seen the ABC link in the Greek study, and the declaration that abortion was widely accepted and openly practiced in Greece for years before its legalization; a reality that crushes the assumption of guilty silence in the control group creating an illusion of increased incidence in the BC case group. So the Greeks have the same elevated risk without any of the alleged confounding guilt

We have seen Rookus’ and van Leeuwen’s paper that supposedly established this phenomenon (and has been extensively held out as proof) to be founded on statistics so absurd that they are beyond taking seriously.

Finally, we have the assertion by many that the same relative risks of BC in most studies constitutes proof of error, proof of recall bias. Herein is perhaps the greatest lie of them all.

The data support the model that we know from the physiology of the breast and the data that we have from animal studies as well. The gold standard in science is the ability of an experiment to be reproduced by others with the same results. It’s called reproducibility, and we see it over and over in the ABC literature. Vatten, et al. really did the scientific community a grave disservice by obviously covering up the ABC link in their disgraceful analysis of nearly 700,000 subjects in the Norwegian prospective study.

They could have ended the debate, one way or the other. But the war rages on because of a series of cover-ups on the part of those who are in a position to control the conversation, in no small measure by controlling the grant funding.

Lest any think my statement partisan, I am not vested in any way in a particular outcome in all of this. If the data, honest data, showed absolutely no ABC link I would be the first to say let’s move on. Abortion is wrong on so many other levels that we don’t need the added fuel from an ABC link to stoke the fires of opposition. Besides, we live in an age of shrinking research grant pools. Every dollar is precious. If there were no ABC link, then we could move on and use that money more productively.

But there is a link, a very real and disturbing link. And there are very committed idealogues who value the right to slaughter babies over the lives and health of the women they claim to champion.

Some sisterhood.

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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. Also, consult the post that explains the essential background.

Title: Pregnancy related protection against breast cancer depends on length of gestation

Journal: British Journal of Cancer (2002) 87: 289-290

Authors: LJ Vatten, PR Romundstad, D Trichopoulos, R Skjarven

Funding: Norwegian Cancer Society

So far we have seen research that has linked induced abortion with an increased risk of breast cancer. We have seen authors who stand behind their methods and results, but who attribute the increased link to a purported recall bias, which is claimed by the pro-abort researchers to be a function of these retrospective (self-report) studies. We have also seen one of the papers upon which these claims have been made, and have seen the appallingly sloppy and irresponsible statistics employed which simply strain credulity. Further, we have seen that spontaneous abortion (miscarriage) has no effect on breast cancer risk, as the estrogen levels in the mothers is abnormally low in these pregnancies. I have also been assailed by the usual suspects who claim that the retrospective studies are too small (a fair claim for a few, but not the majority).

Today we turn our attention to a paper employing a method touted by the pro-aborts: a prospective study. In this study National birth and cancer databases in Norway were employed to get an objective assessment of women from first birth in 1967 until the diagnosis of cancer, death from any cause, or the end of the follow-up period on December 31, 1997.

This study should please the pro-abort crowd for a couple of reasons. It’s prospective and it’s large, very large: 694,657 women.

Results: The study substantiated the data from some of the comparatively smaller studies we have thus far considered. For instance, it showed an increasing incidence of breast cancer with increasing age at first birth (95% CI):

Less than 20 years 1.0 (reference value)
20-24 years 1.10 (10% increased risk)
25-29 1.30 (30% increased risk)
30-34 1.48 (48% increased risk)
35+ 1.56 (56% increased risk)

So we see in a large prospective study the validation of the trends found in the smaller studies.

Now for the length of gestation in first pregnancy. As the length of gestation decreases, the risk of breast cancer increases (95% CI):

40 week gestation 1.0 (reference value)
37-39 weeks 1.08 (8% increased risk)
32-36 weeks 1.11 (11% increased risk)
less than 32 weeks 1.22 (22% increased risk)

So, from this short communication we see the validation of previous studies. We also see some major holes through which one could drive a truck.

In such a large data set, why didn’t the authors separate out spontaneous from induced abortions? They make an incredible claim that one study by Melbye shows no difference in breast cancer risk in women with either induced or spontaneous abortions. This, even though one of this study’s authors (Trichoupoulos from Harvard) published data to the contrary with 95% CI (We’ve already studied two of those papers here at Coming Home in the last week). So the authors lumped miscarriage in with induced abortion and still showed a 22% increased risk of breast cancer.

They could have, and should have, shown the data for induced and spontaneous abortions separately in this prospective study to put the issue of recall bias to bed, one way or the other. It would also be a good basis of comparison for those two categories’ results in the retrospective literature.

So why didn’t they?

The answer lies in the data reported. The data validate all other findings in the retrospective literature. The data also validate the proposed biological model, of placental lactogen maturing the breast cells in the last trimester.

Note even here the dishonesty built into the numbers, as week 32 (the earliest week reported) is in the middle of the third trimester. At this point, according to none other than Melbye, 90 % of the protective effect is already in place. Thus, the authors stratified the risk inherent in the remaining 10% of protective effect yet unachieved in the third trimester. They did nothing to show the loss of protective effect. In short, they lied.

A further masking of induced abortion’s effects is the lumping of miscarriage with induced abortion. As there are typically many more miscarriages than abortions, and since all earlier studies show no increased risk of BC with miscarriage, this too dilutes induced abortion’s real numbers.

Was this masking of the numbers regarding an ABC link intentional? I believe it was. The single greatest issue at stake in this paper was a refutation or validation of recall bias as an issue in the retrospective body of literature. The authors have all of the data before them and could re-crunch the numbers.

Taking the weak assumptions that underlie ‘recall bias’, the even weaker numbers (weak to the point of absurdity in an undergraduate statistics class) of the proposed evidence of recall bias by Rookus and van Leeuwen, the ham handed approach to an exquisite prospective data set of almost 700,000 women and the lack of population stratification to bolster the issue of recall bias, this scientist simply cannot believe that Vatten, et al. were so over-simplistic by any means other than intentional design.

This study validated every other trend in the body of retrospective literature. Even the 22% increased risk of BC in women whose pregnancies were interrupted in the middle of the protective effect period scream a validation of the 30-50% increased risks for induced abortions in the retrospective studies whose smaller numbers were not massaged.

Such recklessness constitutes a betrayal of women who are entitled to fully informed consent prior to a surgical procedure such as abortion. If any other surgical procedure raised women’s risk of breast cancer by 50% and the data were similarly massaged careers would end and lawsuits would abound.

When I was a graduate student we were taught that the only thing of value a Ph.D. has is his/her integrity, without which all else is naught. If these authors can’t be trusted to competently assess and report the data when millions of women’s lives hang in the balance, then what good are such people to society, to the scientific community? Is the next grant, the next paper, the next academic promotion, the adulation of pro-abort colleagues, the loss of one’s academic soul worth it?

One need only consider the epidemiologically marginal 50% increased risk of BC multiplied by the 1.8 BILLION women worldwide who have had abortions since 1960 (and the scores of millions more to come in the coming decade) to get the frightful numbers of women who have endured, and will endure the effects of such betrayal.

Scientific integrity matters.

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The ABC Literature: #6

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. Also, consult the post that explains the essential background.

A very busy weekend, so here in #6 is the article that should have been published on Sunday. I will catch up by later today, so as to keep my word about a paper/editorial per day.

Rookus and van Leeuwen respond to Brind, et al. in the matter of recall bias. Yesterday in #5 we saw part of the critique presented by Brind, et al. Today, the response from that same Journal issue:

Journal of the National Cancer Institute, April 16, 1997; Vol. 89, No. 8, 589-590.

“ Dr. Brind and colleagues argue that the small number of subjects exposed to induced abortions (12 of 225 case patients and 1 of 230 control subjects) in the southeast {Catholic} region does not justify this conclusion.

“We agree with them that subgroup analysis based on small numbers increases the probability of chance findings. However, the choice for comparing the two regions was not arbitrary Rather, it was based on a sound hypothesis: Populations with different religions and attitudes toward induced abortion may differ in their willingness to report induced abortions. Indeed we ended up with small numbers in the southeastern region, but precisely these numbers were found to have a large impact on the estimated relative risk (RR) of breast cancer after induced abortion…”

That second paragraph is stunning. First, they agree with Brind about the unreliability of the appallingly low numbers they found in the Catholic southeast region of the country, but then go on to use them anyway.

Their justification: A sound hypothesis that Catholics are morally superior and more truthful by nature.

Of course they didn’t exactly say it that way. They just hypothesized that the one Church in western Christendom that encourages a nightly examination of conscience, and has as a sacrament the process of self-confrontation and confession of sin, would produce more conscientious and truthful individuals than would those Protestants and seculars who do not have such ascetical practice.

Actually, they were probably more motivated by the cultural caricature of Catholic guilt.

What further argues against such a hypothesis is the very country where this study took place-the Netherlands. Famed for their embrace of prostitution, euthanasia, and Catholic Church attendance rates in the teens (percentagewise), it absolutely strains credulity that anyone could accept such a hypothesis. The Dutch have long ago abandoned their faith. They lead Europe in decadence and debauchery, in callous disregard for human life.

It is the Netherlands that has recently announced its interest in building a “hospital” whose sole purpose is physician assisted suicide and euthanasia, and was on that track at the time of the study. Yet the authors hypothesize behavior of Catholics more indicative of what one would expect in medieval Spain. The hypothesis was not predicated on a valid reading of Catholicism as it exists in the Netherlands, but only as it exists as a cultural caricature in the minds of the researchers.

The authors conclude their second paragraph by boldly embracing both the low numbers of subjects and the spurious data they generated. One has to admire them for their chutzpah.

The authors then go on to respond to this from Brind, et al.:

“To bolster their claim, Rokus and van Leeuwen also compared self-reports with prescribers’ records of oral contraceptive use in the two regions. They found a slight but significant tendency for southeastern control subjects, compared with western control subjects, to underreport the duration of their oral contraceptive use. However, since the authors found no evidence of reporting bias between case patients and control subjects (who had been matched for region), reporting bias could not logically be held accountable for the observed positive association between induced abortion and breast cancer.”

Rookus and van Leeuwen go on to embrace the lack of 95% confidence in those data stemming from more flawed research design. One cannot compare reporting disparities between control groups in different parts of the country and then suggest that the same holds true, or not, in case patients, and then make the leap that there is a difference (not seen or measured) between case patients and controls.

Brind, et al. have completely exposed Rookus and van Leeuwen’s work as:

1. Flawed in its hypothesis
2. Flawed in its design
3. Flawed in its results
4. Flawed in its statistics
5. Flawed in its conclusions, based upon the flaws in #’s 1-4 above.

Then, referring to a similarly flawed Swedish study, the authors state:

“The Swedish study by Lindefors-Harris, et al. is the only study so far in which reporting bias was directly evaluated. We agree with Brind et al. that it would be highly unlikely for women to report an induced abortion that never took place, which shows that the registry was not complete. Even so, however, the study does provide suggestive evidence that reporting bias was present, if we assume that the chance to be registered at the time of induced abortion was equal for women who would and would not develop breast cancer later on.”

So the guys with a terrible hypothesis and no data of their own suggest that another study with incomplete data could have been valid if one assumes conditions and numbers to have been present that support the hypothesis of recall bias. Imagining that I had the winning lotto numbers for last week makes for nice daydreams, but it doesn’t make me a real millionaire. Similarly, imagining numbers that would have/could have supported their hypothesis doesn’t make the hypothesis a validated assumption of objective reality.

This is pretty much the extent of the evidence for recall bias so often quoted by pro-abort researchers such as Palmer and Rosenberg who are desperate to explain away the implications of their research.

I’m including these letters/editorials, as they are an integral part of the scientific literature. They are opportunities for scientists to refute/defend/discuss the studies. They help us enter into the minds of the authors and see the work through their eyes, see their rationale.

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Revealing Autism

Today 9, soon to be 10 year-old Elizabeth asked us why we have taken Joseph on so many special trips. So today was the day that we told her about her 11 year-old brother’s autism, that all of those special trips have been us taking Joseph to the best specialists in the country. She accepted it well and in a spirit of reverent compassion because we presented it in just that manner.

Joseph doesn’t know because he isn’t ready to know. It’s an individual call.

Elizabeth had over an hour’s worth of questions that we answered slowly, deliberatively, and as thoroughly as we thought she could grasp. Then she asked THE question:

“So why do so many parents want to abort handicapped babies? Don’t they know what they’re missing?”

This from the little girl who awoke every school day at 6 AM for three years so that we could get Joseph to his speech therapy at 7AM and then to school. This from the little girl who sat in waiting rooms daily for a total of 8 hours per week, between all of the therapies, and never once in 7 years has uttered a complaint.

Beth grasps how much of her life, and ours, has been subordinated to Joseph’s needs. Yet she is bewildered that parents don’t understand what they are missing in aborting their handicapped children.

Love sees that which narcissism and fear obscure.

They are holy, these little ones. No doubt why Jesus says that the Kingdom of Heaven belongs to such as these.

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The ABC Literature: #5

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. Also, consult the post that explains the essential background.

A very busy weekend, so here in #5 is the article that should have been published on Saturday. I will catch up by later today, so as to keep my word about a paper/editorial per day.

The issue of recall bias stems from a paper we shall review this week by Rookus and van Leeuwen in the Netherlands. In the past week we have seen Palmer and Rosenberg refer to this study as the source of “reporting bias”, or “recall bias” as it is otherwise known. Before we delve into the Rookus and van Leeuwen study, we need to set the stage for understanding it and its assertion by considering a response to their study by Dr. Joel Brind of the City University of New York, along with fellow authors Vernon M. Chinchilli, Walter B. Severs, and Joan Summit-Long. Their response was a letter to the editor in:

Journal of the National Cancer Institute, April 16, 1997; Vol. 89, No. 8, 588-589.

Brind, et al., note that the Dutch paper reports a much greater relative risk (RR) of 14.6 {meaning 13-fold increase, which is gigantic} among women having had abortions from the Roman Catholic southeastern region of the Netherlands, compared to the more secular western region with a RR of 1.6 (30% increased risk). Clearly Roman Catholicism does not, when coupled with induced abortion, raise a woman’s risk of BC. How then to explain the whopping 13-fold increased risk in Catholic women, when the 30% increased risk in the more secular region is more in line with the similar data from around the world?

The answer resides in how the statistical analysis is performed. While a 95% CI was generated for these numbers, it is widely regarded in statistics that the actual sample size needs to be sufficiently large. For example, If I read in today’s paper that 66% of Americans are satisfied with the economic status of the country, I would become suspicious. If I then read that only three people were surveyed, my deep suspicions would be confirmed. The sample size was too small.

This is in fact what Brind et al., assert about the Dutch study. Only 13 women were included in the Catholic region of the country. In their own words, Brind, et al..:

“…this apparently huge difference was obtained by limiting the analysis to parous women only under the age of 45 years old, a subset containing only 13 subjects exposed to induced abortion in the southeast {Catholic region}. It is not prudent to make such a strong claim based on such a small sample, regardless of statistical significance.

“To bolster their claim, Rokus and van Leeuwen also compared self-reports with prescribers’ records of oral contraceptive use in the two regions. They found a slight but significant tendency for southeastern control subjects, compared with western control subjects, to underreport the duration of their oral contraceptive use However, since the authors found no evidence of reporting bias between case patients and control subjects (who had been matched for region), reporting bias could not logically be held accountable for the observed positive association between induced abortion and breast cancer.”

It is noteworthy to highlight the fact that the authors restricted the upper age limit to an age when many breast cancers are not yet detectable (45 yrs.), which serves to further skew the data.

When I was a psychology major as an undergraduate, we were made to take courses in statistics, quantitative analysis, research design, and tests and measurements. St. John’s University was rigorous in its emphasis on mastery of understanding valid vs. flawed research design and our ability to grasp the meaning of valid vs. invalid statistical analyses. The graduate program in biology was even more rigorous in this regard. It pays off abundantly when schools place such heavy emphasis in these areas, and young pro-lifers contemplating working in the pro-life field are well advised to take this coursework in college, regardless of their major, as Brind, et al. have demonstrated repeatedly that the great area of deception is here in the statistical arena.

As we go along, we shall see more of Brind’s exemplary work in exposing the shoddy research design and statistical analysis that served as the foundation for this fiction of reporting bias.

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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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. Also, consult the post that explains the essential background.

Title: Prolonged breastfeeding reduces risk of breast cancer in Sri Lankan women: A case–control study

Authors: Malintha De Silva , Upul Senarath, Mangala Gunatilake , Dilani Lokuhetty

Journal: Cancer Epidemiology 34 (2010) 267–273

Goal: To assess the association between duration of breastfeeding and the risk of breast cancer in Sri Lankan women.

The method in the author’s own words. It’s very clear and worth the read:

We conducted a case–control study in selected health care
facilities in the Western province of Sri Lanka from January to
December 2007. The cases were selected from three tertiary care
hospitals: the Cancer Institute Maharagama, the National Hospital
of Sri Lanka and the Colombo North Teaching Hospital. The Cancer
Institute Maharagama is the only referral hospital for cancer in Sri
Lanka, and provides care for the majority of cancer patients in the
country. The National Hospital of Sri Lanka and the Colombo North
Teaching Hospital also provide diagnostic facilities and initial
treatment for selected cancers, i.e., surgery for breast cancer.

A ‘case’ of breast cancer was defined as a woman who was
newly diagnosed to have invasive breast cancer either by fine
needle aspiration (cytological) or core/excision biopsy (patholo-
gical), with or without a positive mammogram (radiological),
together with clinical diagnosis. The sample was restricted to
women aged 30–64 years and admitted to the surgical units of the
above mentioned hospitals. Among the excluded were those
having more than a 3-year delay between diagnosis and admission
for surgery, secondary deposits in the breast where the primary
malignancy was at another site and critically ill patients. All the
women who satisfied the above mentioned criteria were enrolled
in the study as ‘cases’ until the required sample size was fulfilled.

The control group was selected from Well Women Clinics
conducted in five Medical Officer of Health divisions in the
Western province, namely Pitakotte, Nugegoda, Wattala, Ragama
and Ja-ela. The Well Women Clinics offer screening services
including clinical examination of breasts and PAP smear test for
cervical cytology for apparently healthy women in the community.
However, these clinics do not provide mammographic screening
facilities for breast cancer. The controls were matched to the cases
by the respondent’s age group (5-year age groups) and parity, since
these 2 variables were well recognized risk factors, which would
otherwise confound the hypothesized association between breast
cancer and breastfeeding. Once a case was identified, two controls
comparable to the index case were selected from the immediate
Well Women Clinic out of the 5 clinic centers.

The data were collected by interviewing women by the trained
interviewers using a pre-tested, structured questionnaire.
The questions were focused to collect details of
breastfeeding and other potential confounding factors for breast
cancer. The lactation history was obtained for each live birth
separately, including details regarding duration of breastfeeding,
period of amenorrhea during breastfeeding, age at first lactation
and at most recent lactation. The total duration of breastfeeding
was calculated by summing up the number of months of
breastfeeding per each child. In addition, information was
collected on level of education, employment, family history of
breast cancer, menstrual and reproductive history, exposure to
passive smoking, use of alcohol and daily activity level.

Results: Data are reported with a 95% Confidence Interval

Among women with past history of abortion, the OR is 3.42 (More than triple the risk of developing BC).

Paasive smoking raised the risk three-fold (OR=2.96)

Breastfeeding 24 months or more compared to no breastfeeding OR=0.40 (60% reduction in breast cancer among breastfeeding women)

The results validate well-known data indicating an increase in BC among women exposed to cigarette smoke.

The data validate what is known about the protective effect of a full term pregnancy and prolonged exposure to lactogen and the general maturational effects of lactation hormones on the lobule cells during breastfeeding.

And the data support all the aforementioned risk associated with breast cancer in women who have not had the protective effect of a first full term pregnancy because of abortion.

Note to those who continue to assert that I am ideologically driven in my presentation of the data and rejection of the fantasy called recall bias, or reporting bias:

Ideology is manifest when researchers claim the presence or activity of a phenomenon for which they have absolutely no data. All that these folks have is a hunch. But there needs to be a way to test for this phenomenon. In paper #3 yesterday, we saw even stronger association between abortion and breast cancer in Greece where there are no cultural constraints on abortion, and a diminished likelihood of reporting error. Thus, the Greek study tells us that if anything, the underreporting is not in the control groups, but in the experimental groups here in America.

The Sri Lankan study shows an overwhelmingly high incidence of BC associated with abortion. This is a nation that is 70% Buddhist, 15% Hindu, 7.5% Muslim, and 7.5% Christian. Thus, there doesn’t appear to be the grounds for Palmer and Rosenberg’s contention of Catholic scruples as the source of reporting bias.

I am reporting the science. The ideologues are those who invent phenomena to attenuate data that challenge their most cherished beliefs and practices.

This study was entirely funded by Sri Lankan sources.

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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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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It was nine years ago today that I sat in bumper-to-bumper traffic atop the Triboro Bridge, just a few miles north of downtown Manhattan and watched the fireball erupt from the South Tower of the World Trade Center, knowing that it was the precise region of the building where friends worked. In fact, I witnessed three of their incinerations: sudden, deliberate, and unprovoked.

For as agonizing as the attacks were to see unfold before me on the bridge that day, the worst was yet to come. It was the stress of the aftermath.

Because all bridges were closed within New York City within moments, I was unable to get home to my wife and two babies until 3 AM, only to be jolted out of a restless sleep by the sound of fighter jets flying combat air patrols making their turn over our house. We were a nation with sterilized air space and a city with an aircraft carrier offshore sending squadrons of combat jets to protect us.

The sight of physicians and nurses pacing about in the streets outside of St. Vincent’s hospital waiting to lavish their care on the thousands of victims who would never arrive. Parks, street corners, walls filled with posters of missing persons, posted by desperate loved ones. Looking out of our bedroom window from the hilltop we lived on with a commanding view of the New York harbor, night after night, after night, the sky glowed over lower Manhattan from the fires that would burn for months. The endless replays of people jumping to their deaths, of the buildings collapsing.

Then came the worst of all. As I commuted to and from work after grad school, my commute took me over the Brooklyn Bridge a mile from Ground Zero: the unforgettable stench of close to 3,000 corpses deliquescing in the mountain of rubble, my friends and neighbors among them.

We were a city that was stopped dead in our tracks. The indomitable New Yorkers simply stopped, as time stood still. Then something at once beautiful and incongruous happened. It lasted for months. We were courteous to one another on the road. No road rage. No honking. No mad dashing. We were actually deferential. That ocean of goodness in the hearts of New Yorkers, so often masked by the hectic pace of our city’s life, came bubbling to the surface. We felt acutely the bonds of kinship in our common humanity.

As Shakespeare had Henry V say after the Battle of Agincourt, “Here was a royal fellowship of death.”

It became evident when the shock began to wear off, when sometime the following January the streets began to sound more like the old New York. We had begun to heal.

In the months to come, I would learn the names of many more people that I knew from high school and college who perished that day, and for me healing would take a great deal longer than I had thought.

It is hard to forgive a rather large movement of people who seek to kill us simply because of who we are. Unlike the murderer who is apprehended and securely behind bars, the existential threat is real and ongoing. We are at war with men who declared their war on us. Their terms are clear: last man standing.

In this instance I simply do not know how to forgive. Nor do I feel so inclined. If ever a conflict qualified under the “just war” doctrine, this one qualifies. These murderers are equal opportunity killers, turning on fellow Muslims who do not share in their death cult. Does forgiveness not come after the war is over? Can we kill an enemy that we are simultaneously forgiving? Can we kill those we have already forgiven?

It is a unique challenge: to be committed entirely to upholding the dignity of all human life and being committed to a just war, meeting the murderers on the battlefield in a fight of their own choosing. The nations where they live are some of the most brutally repressive on the planet. Stonings, beheadings, amputations of limbs and sense organs as punishments, public hangings, burkahs…

They have chosen war as the means to advance their vision of the world, placing it between Christian civilization and their eighth century barbarism.

But choosing Christian civilization will require more than defeating the enemy wherever he hides and plots. Islam is overtaking Christianity in Europe simply because they are having large families and Christians are contraceiving and aborting themselves out of existence. France, Italy and Spain are projected to have Muslim majorities by the middle of this century. If radical Islam is patient, they will win through attrition.

We can’t very well blame them for having families as we commit civilizational suicide. Contraception, abortion, passive and active euthanasia, healthcare rationing, embryolethal research; ours isn’t such a pretty track record either.

In the interim, I am left with the memories of that terrible day nine years ago and its aftermath. They are memories that are a looking glass into the future if we do not come to our senses and turn from our own death cult a la Margaret Sanger, who is Catholicism’s Osama bin Laden.

And I feel lost. I simply don’t know how to forgive it all.

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