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Archive for the ‘Birth Control’ Category

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In the wake of Pope Francis’ proposing contraception as a means of preventing microcephaly in the Zika virus epidemic, much is being made of his linking the modern day dilemma to the plight of nuns being raped in the Congo more than 55 years ago, and Pope Paul VI allegedly permitting the nuns to take contraceptives to prevent pregnancy. Of course, Francis missed some whopper pandemics ongoing globally as he held out contraceptives to the hispanics in his backyard, a matter I blogged on extensively over the weekend.

Canon lawyer Ed Peters addresses the high probability that Paul VI never issued such permission. His article is worth the read.

Assuming that Paul VI, or any other pope/bishop gave such permission in the 1960’s, we are in possession of hard medical data, and subsequent teaching from the Congregation of the Doctrine of the Faith (CDF) that would prevent any Pope from ever issuing such permission again.

To be clear, Humanae Vitae in 1968 put into succinct expression the constant 2,000 year teaching of the Church. It may be argued that this teaching applies to married couples and the marriage act that is frustrated and perverted by artificial contraception, and not to victims of rape who do not have an obligation to allow for the possibility of the transmission of life by the rapist. Only a monster would maintain that the Congo nuns needed to let nature take its course. So in the 1960’s when the pill was new, it seemed pretty obvious that its use in this circumstance would not be morally problematic.

That was then.

In the more than half-century since, we have learned quite a bit about the pill’s mechanisms of action. Different pills have different mechanisms. Broadly speaking, not all ovulation is prevented by the pill, and the uterine lining is thinned, making it generally inhospitable for a new embryo seeking implantation upon arrival from the Fallopian tube.

That spells abortion.

Progestin-only contraceptives increase by up to six-fold the incidence of ectopic pregnancy which is almost always lethal for the baby, and often lethal for the mother in the third world environs where Zika and other mosquito-transmitted endemic diseases lurk.

Then, there is the 2009 Dolle, et al. study on the effects of contraceptives on the rates of the most deadly form of breast cancer, Triple Negative breast cancer. In the study the age of first use of the pill was analyzed with stunning results on the rates of premenopausal Triple Negative breast cancer before the age of 45.

If a woman started the pill above the age of 22, her risk factor increased 250%

If a woman started the pill between ages 18-22, her risk factor increased 270%

If a woman started the pill below age 18, her risk factor increased 540%

So today we know that the pill causes breast cancer, ectopic pregnancy, and even the product inserts claim it may act as an abortifacient. It may well have induced cancer in all of those nulliparous women who as such are at increased risk of breast cancer. Add to that the 1974 CDF document, Declaration on Procured Abortion, and the following statement from paragraph 13:

“From a moral point of view this is certain: even if a doubt existed concerning whether the fruit of conception is already a human person, it is objectively a grave sin to dare to risk murder.”

Perhaps Paul VI permitted nuns to use oral contraceptives, which in no way for women religious is an offense against the marital act, as rape is a violent criminal act. But in light of what is now known, such a decision could never be made today for consecrated women being targeted for rape. It especially could never be made for married women in regions of endemic disease, not without eviscerating the 2,000 year teaching contained within Humanae Vitae.

True, your humble blogger is a medical microbiologist and not a moral theologian. But he was extensively educated in ethics and moral theology in undergraduate seminary studies and graduate seminary studies. The moral principles are clear. The epidemiology literature even moreso. The Church has various scientific pontifical commissions for advising the Holy Father and the Curia. It would be a good idea if Francis picked up the phone and had a few consultations with his commission members.

The Congo episode has been overtaken by the truth of God’s creation as revealed by science. That doesn’t increase tensions. Rather, it harmonizes medical science and the principles of moral theology on this matter.

Francis spoke very badly on this issue. While I share his concern for the poor, it is the poor who will suffer the most when International Planned Parenthood and Marie Stopes International swoop down on these women, with Francis’ words on their lips. He needs to come up to speed on issues he finds distasteful or distracting from his primary agenda. But the plight of the poor at the hands of these international parasites is just as pressing as hunger and all the rest.

 

 

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Even the dimmest wit in the Society of Jesus can make his thoughts plainly understood. So it must be that Pope Francis knew what he was saying when he broke with 2,000 years of sacred Tradition and magisterial teaching this week when he alluded to Paul VI permitting nuns being raped in Africa to use contraception to avoid pregnancy, and used that as the moral grounds on which to permit the use of contraception in the midst of the Zika virus outbreak. In his own words, as reported by the Associated Press:

Abortion is an evil in and of itself, but it is not a religious evil at its root, no? It’s a human evil. On the other hand, avoiding pregnancy is not an absolute evil. In certain cases, as in this one (Zika), such as the one I mentioned of Blessed Paul VI, it was clear.

So, avoiding pregnancy amidst the Zika outbreak is not an absolute evil? Enter proportionalism.

To be clear, he linked the use of contraceptives then to the situation he is addressing now.

Before proceeding with the moral nightmare this introduces, it is best to consider some infectious disease epidemiology and how Francis’ proportionalism betrays not only his duty to uphold all that his predecessors have taught, but also betrays a stunning ignorance of infectious diseases compounded by hemispheric blinders.

It has been reported that only 4% of Brazil’s current microcephaly cases are attributable to Zika. 17 out of 404 as of last week. And for that a Pope is willing to flush Humanae Vitae. Pia de Solenni did a masterful job at outlining the epidemiology of this outbreak, and the reader is advised to get it all here.

With Zika affecting the hemisphere from which this pope comes, and with which he has exclusively focussed his priestly life, Francis is missing some more pressing global numbers in maternal infectious disease and resulting rates of infant mobidity and mortality. There is so much more fertile ground for justifying contraception. Consider HIV/AIDS and some statistics from WHO.

Globally there are 36.9 million people living with HIV/AIDS. Of these, 2.6 million are children who contracted the virus from their mothers in utero, or through breastfeeding. Without any treatment, roughly 30-40% of pregnancies result in vertical transmission (mother to child) of HIV. With antiretroviral monotherapy, these rates can be cut in half. With combination antiretroviral therapy, the rates are cut to 2%.

So consider if 10 million women with HIV all get pregnant, and if they all have access to combination antiretroviral therapy, there would still be 200,000 babies born with HIV. Is the new teaching from the First Class Chair of Peter aboard the papal plane sufficiently broad to suggest a duty by HIV positive women to not reproduce?

Then there is the even broader health concern of global malaria. Roughly 50% of the world’s population are exposed to malaria, especially in Africa. According to WHO:

Malaria infection during pregnancy is a significant public health problem with substantial risks for the pregnant woman, her fetus, and the newborn child. Malaria-associated maternal illness and low birth weight is mostly the result of Plasmodium falciparum infection and occurs predominantly in Africa.

And in the WHO 2015 Fact Sheet on malaria:

According to the latest estimates from WHO, there were 214 million new cases of malaria worldwide in 2015 (range 149–303 million). The African Region accounted for most global cases of malaria (88%), followed by the South-East Asia Region (10%) and the Eastern Mediterranean Region (2%).

In 2015, there were an estimated 438 000 malaria deaths (range 236 000–635 000) worldwide. Most of these deaths occurred in the African Region (90%), followed by the South-East Asia Region (7%) and the Eastern Mediterranean Region (2%)…

Children under five are particularly susceptible to malaria illness, infection and death. In 2015, malaria killed an estimated 306 000 under-fives globally, including 292 000 children in the African Region. Between 2000 and 2015, the mortality rate among children under five fell by 65% worldwide and by 71% in Africa.

In the document, WHO goes on to discuss treatment and the issues of malaria in pregnancy:

Artemisinin-based combination therapies (ACTs) are highly effective against P. falciparum, the most prevalent and lethal malaria parasite affecting humans. Globally, the number of ACT treatment courses procured from manufacturers increased from 11 million in 2005 to 337 million in 2014. The African Region accounted for most (98%) manufacturer deliveries of ACTs in 2014.

Malaria infection during pregnancy carries substantial risks for the mother, her fetus and the newborn child. In Africa, the proportion of women who receive intermittent preventive treatment in pregnancy (IPTp) for malaria has been increasing over time, but levels remain below national targets. In 2014, an estimated 15 million of the 28 million pregnant women at risk of malaria did not receive a single dose of IPTp.

To their credit, and unlike Francis, there is no mention of preventing the transmission of life as a solution to endemic disease.

Were time to permit, one could detail all of the tropical diseases, among others, and the effects on fetuses and neonates. 1/3 of the world’s population is infected with TB. Cholera strikes millions, etc…

Is the prevention of life itself in a disease outbreak with 4% infant morbidity really the best Pope Francis can do? Where is his exhortation for governments to come to grips with the fact that all of Rachel Carson’s Silent Spring hysteria about DDT has been disproven by science over the past 50 years? Where is the exhortation to curb the mosquito populations spreading so many horrendous diseases? Where is the voice of a pope to his environmentalist friends to meet him half way and abandon their anti-human life agenda?

For all of his stated love of the poor, Francis has invited International Planned Parenthood and Marie Stopes to a blood meal on the very poor whose dignity he portends to uphold. By invoking Paul VI and the Congo episode with artificial contraception, he ignored NFP and the volumes written by his predecessors.

To permit artificial contraception for Zika is to have sold the family farm, to permit it for all developing nations where endemic disease is present.

Public health doesn’t involve nonexistence. Public health concerns itself with preventing and curing disease. It is clear that the Holy Father doesn’t grasp this essential truth that I learned in training as a medical microbiologist. Public Health officers cannot morally and ethically resort to killing patients or preventing human reproduction as a legitimate means of addressing crises.

The same holds true for popes.

Francis should stick to matters concerning his Holy Office, and in all humility allow himself to be guided by the unchanging wisdom of 2,000 years of magisterial teaching.

He. Is. Peter.

He should start behaving as such.

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Americans United for Life Just released this analysis in an email, and has given permission for its dissemination. Here is AUL on the Hobby Lobby decision today:

Today’s decision: The “contraceptive” mandate violates the Religious Freedom Restoration Act (RFRA) by requiring three closely held corporations to provide health insurance coverage for life-ending contraception in violation of the sincerely held religious beliefs of the companies’ owners. Assuming that the government has a “compelling interest” in the mandate (which the Court does not hold, but just assumes for purposes of this case), there are less restrictive means to accomplish their goal.

Breakdown:

Today’s decision applies to closely held corporations (e.g. the Green and Hahn family businesses). The Court strongly explains that these corporations are people:
· “Corporations, ‘separate and apart from’ the human beings who own, run, and are employed by them cannot do anything at all” (36)
· “[P]rotecting the free-exercise rights of corporations like Hobby Lobby, Conestoga, and Mardel protects the religious liberty of the humans who own and control those companies.” (18)

It is based on the Court accepting as their sincere religious belief that these drugs and devices can destroy an embryo:
· “The owners of the businesses have religious objections to abortion, and according to their religious beliefs the four contraceptive methods at issue are abortifacients. If the owners comply with the HHS mandate, they believe they will be facilitating abortions, and if they do not comply, they will pay a very heavy price . . . If these consequences do not amount to a substantial burden, it is hard to see what would.” (2)
· “Like the Hahns, the Greens believe that life begins at conception and that it would violate their religion to facilitate access to contraceptive drugs and devices that operate after that point” (14)
· “[T]he Hahns and Greens have a sincere religious belief that life begins at conception. They therefore object on religious grounds to providing health insurance that covers methods of birth control that, as HHS acknowledges [] may result in the destruction of an embryo. By requiring the Hahns and Greens and their companies to arrange for such coverage, the HHS mandate demands that they engage in conduct that seriously violates their religious beliefs.” (32)
· “the end that they find to be morally wrong (destruction of an embryo)…” (35)
· “HHS and the dissent note that providing the coverage itself would not result in the destruction of an embryo; that would occur only if an employee chose to take advantage of the coverage and to use one of the four methods at issue” (35)
· “The Hahns and Greens believe that providing the coverage demanded by the HHS regulations is connected to the destruction of an embryo in a way that is sufficient to make it immoral for them to provide the coverage.” (36)

The Court ruled the mandate failed the narrow-tailoring requirement of RFRA, pointing to the accommodation as a clearly less-restrictive means of accomplishing the Obama Administration’s stated goal. “HHS itself has demonstrated that it has at its disposal an approach that is less restrictive than requiring employers to fund contraceptive methods that violate their religious beliefs. . . . HHS has already established an accommodation for nonprofit organizations with religious objections.” (43)

The for-profit employers who object to all contraceptives (for example, many of the Catholic employers) should be protected by this ruling since the Mandate violates a sincere religious belief, even though it is not solely regarding the life-ending properties of some of these drugs and devices.
· The Court makes clear: “it is not for us to say that their religious beliefs are mistaken or insubstantial” (37) .
· And, most importantly, the Mandate (as applied to them) also clearly fails to be narrowly tailored means –e.g. non-profit Catholic employers are already “accommodated” with respect to all contraceptives.

The Court acknowledged the dangerous and radical view advanced by the Obama Administration: “Under HHS’s view, RFRA would permit the Government to require all employers to provide coverage for any medical procedure allowed by law in the jurisdiction in question—for instance, third-trimester abortions or assisted suicide. The owners of many closely held corporations could not in good conscience provide such coverage, and thus HHS would effectively exclude these people form full participation in the economic life of the Nation.” (45-46)

The decision does NOT decide the constitutionality/legality of the “accommodation.”
· “We do not decide today whether an approach of this type complies with RFRA for purposes of all religious claims.” (44)
· Footnote 40: “The principal dissent faults us for being ‘noncommital’ in refusing to decide a case that is not before us here. The less restrictive approach we describe accommodates the religious beliefs asserted in these cases, and that is the only question we are permitted to address.” (44)
· There is some troubling language. For example, there is this line on page 9 – “In addition, HHS has effectively exempted certain religious nonprofit organizations, described under HHS regulations as ‘eligible organizations,’ from the contraceptive mandate (emphasis added).”
o We do NOT think the “accommodation” is effectively an exemption – quite the opposite.
o Going forward the accommodation cases must emphasize that the “accommodation” still requires these companies to “arrange” for the coverage, given that they are providing the insurance plan.
· The Court does note that there could be another method (besides the “accommodation”) for achieving the government’s goal — namely, the government could provide the contraception coverage. That indicates that they could also find the accommodation fails to be narrowly tailored.
o “HHS has not shown that it lacks other means of achieving its desired goal without imposing a substantial burden on the exercise of religion . . . . The most straight forward way of doing this would be for the Government to assume the cost of providing the four contraceptives at issue to any women who are unable to obtain them under their health-insurance policies due to their employers’ religious objections.” (40-41)

Importantly, the Court did NOT rule on whether or not the Obama Administration’s stated goal was a compelling interest.
· In order to impose a substantial burden, the government must have a “compelling interest”
· “We find it unnecessary to adjudicate this issue” (pg 40) since it was not narrowly-tailored.
· Acknowledging there are arguments against this being a compelling interest: “The objecting parties contend that HHS has not shown that the mandate serves a compelling government interest, and it is arguable that there are features of ACA that support that view.” (39)
· And the Court acknowledges that “tens of millions” (page 11) have been exempted from the Mandate for non-religious reasons (including grandfathering) – a fact that undermines the government’s claim that forcing this Mandate is compelling (i.e. if it was compelling, they wouldn’t make those millions of exemptions).

The accommodation – whether or not it satisfies RFRA and the Constitution— may be decided by the Court next term.

Since the effect of today’s ruling is that the Obama Administration cannot impose its Mandate on family businesses with sincere religious objections, which it has not exempted, we should be prepared for the Obama Administration to, very soon, extend its “accommodation” at least to closely-held corporations. Because the “accommodation” applies to objections to all contraceptives (not limited to those with life-ending properties), we would expect the Obama Administration to “accommodate” for-profit employers for all the drugs/devices as well. At that point, it will be for the Green and Hahn families, and other family businesses, to decide whether the accommodation violates their conscience and/or whether they pursue litigation over it.

Some other good language from the majority opinion:

· “If the Hahns and the Greens and their companies do not yield to this demand, the economic consequences will be severe.” But the Court also recognizes that the Green and Hahn families would not want to drop insurance coverage for their employees altogether, also because of their religious beliefs: “[T]he Hans and the Greens and their companies have religious reasons for providing health insurance to their employees.”

· Life-affirming healthcare severely punished by Mandate: “If they insist on providing insurance coverage in accordance with their religious beliefs, the mandate clearly imposes a substantial burden on those beliefs” (38)

· “The plain terms of RFRA make it perfectly clear that Congress did not discriminate [] against men and women who wish to run their businesses as for-profit corporations in the manner required by their religious beliefs.” (2)

· “As we have seen, RFRA was designed to provide very broad protection for religious liberty.” (17)

· The dissent, points out the majority, disagrees with RFRA. It doesn’t like the law that broadly protects religious liberty. “In its final pages, the principal dissent reveals that its fundamental objection to the claims of the plaintiffs is an objection to RFRA itself.” (48)

· “Our responsibility is to enforce RFRA as written, and under the standard that RFRA prescribes, the HHS contraceptive mandate is unlawful.” (49)

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Whether pro-life, pro-choice, pro-family, or pro-homosexual, activists never speak on behalf of only themselves when speaking to issues. They speak for larger constituencies. For years there has been within the homosexual activist community a vocal group with a contempt for heterosexuals in general, and women in particular. “Breeders, ” is their word for us, sneered with a venomous contempt. I’ve heard it uttered since the 1980’s. Thus, the following story from LifeSite News comes as no surprise:

SYDNEY, November 6, 2013 (LifeSiteNews.com) – Women should be forced to abort their children for the next 30 years as a part of global population control, homosexual activist Dan Savage told Australian television on Monday.

Savage, whose anti-bullying program “It Gets Better” was heavily promoted by President Barack Obama, made the statement during a four-member panel during the “Festival of Dangerous Ideas.”

Audience member Lisa Malouf closed the program by asking, “Which so-called ‘dangerous idea’ do you each think would have the greatest potential to change the world for the better if it were implemented?”

After a moment’s thought, Savage replied, “Population control. There’s too many G-d d—-ed people on the planet.”

“You know, I’m pro-choice, I believe that women should have a right to control their bodies,” he added. “Sometimes in my darker moments, I’m anti-choice. I think abortion should be mandatory for about 30 years.”

The audience responded with overwhelming applause at the suggestion that the world’s women lose control of their fertility.

There is much, much more in the article. Get the rest here.

So very many thoughts come immediately to mind when I read such sentiments from activists such as Mr. Savage. First, if there are so many people in the world, why do the activists not elect to remove themselves voluntarily? Why must it be that someone else must die, that women be forced to abort their children for the next 30 years, or be forcibly sterilized? Of course, death is never the answer, in any constituency. However, note who Mr. Savage did not mention.

Why has Savage not gone on a rant against the number of people in the U.S. who live with HIV/AIDS and the total cost of their care, especially as he is on record as stating that the majority of HIV cases fall disproportionately among gay/bi men? If one considers the CDC data indicating that lifetime cost of the new HIV cases diagnosed in 2009 will come in at $16.6 BILLION {for a mostly sexually transmitted disease}, or if one accepts the CDC projected lifetime cost per HIV patient of $367,134 (2009 dollars) and multiplies by the 1,148,200 HIV/AIDS patients over the age of 13 that CDC estimates to be living in the US, the total cost is a staggering $421.54 BILLION

No word from Mr. Savage on his constituency. However, by the reckoning of his fellow travelers, if it’s carbon or fiduciary footprinting that is hurting the developing nations, 421 billion dollars could do a great deal of good.

Instead, it must be someone else who dies, someone else who pays the heavy price for the self-loathing of the planetary messiahs. These are frightfully dangerous people, and the wild applause of the audience Mr. Savage was addressing indicates that the societal depravity that makes him a sought-after guest has metastasized significantly.

The grave danger of this new century is that the very vocal, one-world order folks who are on an inexorable march are also the same folks who are busy promoting and legislating one-child policies, forced sterilizations and abortions, and setting up the collapse of the world economy by the middle of this century as populations completely implode. Graver still, there is no longer a world superpower that stands for human dignity. That used to be the United States, who now ties “reproductive health” packaging to US foreign aid in developing nations. Those packages mandate abortion and contraception for cultures that want no part of them.

All of this is driven by the political left, which includes the activists such as Mr. Savage. It isn’t paranoid or conspiratorial to see the political alliances before our very eyes, to see common cause amongst the disparate groups on the left and the social engineering that has toppled the greatest civilization the world has ever known.

A new Dark Age is settling upon us, and it is truly cause for alarm. Look to China’s 336 million forced abortions for proof. While we must use the political machine to assert our values, the values that built the civilization which gave birth to that political machine, we must also become ardent evangelists. The ultimate cause behind this darkness is a people who have lost sight of their great dignity.

The savages of this world are busy spewing hatred and self-loathing and the Church is losing ground, rapidly. The only antidote to their venom is the Gospel, the good news of our true identity. In the Catholic Church today, that light burns dimly under a bushel. That needs to change in dramatic fashion.

Mr. Savage and his fellow travelers have seen to that imperative.

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When tsunamis make landfall they can be rebuffed by mighty cliffs of granite, or accommodated by soft sandy beaches which allow the mighty waves to strip them, leaving them disfigured and littered with the tsunami’s wasteful debris and shattered bodies when the floodwaters retreat back into the abyss from whence they came. So it seems that the Church in America, once a towering giant, has become increasingly accommodating to the Culture of Death as it washes over her with impunity.

The examples over the past year alone abound. Revelations in last week’s New York Times that the Archdiocese of New York has been paying for union employees’ contraception and abortion benefits, “under protest,” are just the latest in a string of surrenders.

In this latest disaster, the Archdiocese claims that there is a difference between fighting the HHS Mandate and the union contracts inherited when they got into the latest arrangement. Read the Archdiocese’s refutation here.

Indeed, there is a difference between an illegally imposed government mandate to provide contraception, sterilization and abortion, and willingly staying in the healthcare field where the powerful union drives such services being mandated in the insurance plans.

To what degree is the Archdiocese compelled in all of this? From their statement it is clear that they feel the greater need to remain in the healthcare field because there is a proportionally greater good to be done. The larger moral question is how much good done by the archdiocese washes the blood of a single aborted baby from the diocesen hands that paid for the abortion? How is this argument different from the woman who feels the pressure from family to abort? Or the woman who pervceives the great good that will not be accomplished in her life if the baby prevents her from getting a college education? Is the emotional plight of the abortion-minded woman under duress not more compelling? Yet she incurs automatic excommunication if she knows the penalty. What of those in diocesan offices who maintain the involvement with the unions and write the checks?

Undoubtedly great arguments can be made for all of the good that would not be done if we abandoned the field, but it’s still a proportionalist argument being deployed against moral absolutes. Unfortunately, our opponents have been handed a PR win on this one.

In other matters, the silence of the bishops in the run-up to the scheduled vote in February regarding admitting gay scouts in BSA was deafening. When BSA rescheduled the vote, we had a second chance to speak out against this disastrous move, but neither the bishops, nor the Catholic Commmittee on Scouting condemned it.

A year ago when New York State voted to adopt gay marriage Cardinal Dolan rued that he was caught flat-footed. What can be the excuse of the USCCB on the Boy Scouts? My observations on what is so wrong with that move here.

Through it all, we have witnessed Cardinal Dolan welcoming Vice President Biden to St. Patrick’s Cathedral, going out of his way to assure that he does not declare Governor Cuomo, who is seeking the liberalization of New York’s abortion laws, a Catholic in bad standing. Which means that he is regarded publicly as a Catholic in good standing; abortion and gay marriage notwithstanding.

Are we surrendering on all of these issues? We welcome the “Catholic” politicians with open arms who are at the same time accelerating the implementation of a diabolical agenda.

In this Year of Faith, as our churches continue to empty, an unsolicited thought for our leaders. If fundamental moral truths and goods are not worth fighting for, then don’t be surprised when many find that there isn’t much worth staying for.

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It is difficult to imagine that any public official could possibly march to the left of Barack Obama or HHS Secretary Kathleen Sebelius, but today Federal District Court Judge Edward Korman did just that when he approved the sale of Plan B to children of any age. Previously, Sebelius ordered that based on the science, children were not capable of complying with the directions of safe use of the drug. Here is Sebelius in her own words not too long ago:

A Statement by U.S. Department of Health and Human Services Secretary Kathleen Sebelius

Plan B One-Step is an emergency contraceptive, sometimes referred to as the “morning after pill.” Plan B One-Step is currently labeled over the counter to women ages 17 years and older, but is sold behind the pharmacy counter. It is available by prescription only to women 16 years and younger. My decision does not change any current availability of the drug for all women.
In February 2011, Teva Women’s Health Inc. submitted to the FDA a supplemental new drug application for Plan B One-Step. This application sought to make Plan B One-Step available over the counter for all girls of reproductive age. The science has confirmed the drug to be safe and effective with appropriate use. However, the switch from prescription to over the counter for this product requires that we have enough evidence to show that those who use this medicine can understand the label and use the product appropriately. I do not believe that Teva’s application met that standard. The label comprehension and actual use studies did not contain data for all ages for which this product would be available for use.
FDA has recommended approval of this application in its Summary Review for Regulatory Action on Plan B One-Step. After careful consideration of the FDA Summary Review, I have concluded that the data, submitted by Teva, do not conclusively establish that Plan B One-Step should be made available over the counter for all girls of reproductive age.
The average age of the onset of menstruation for girls in the United States is 12.4 years. However, about ten percent of girls are physically capable of bearing children by 11.1 years of age. It is common knowledge that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age. If the application were approved, the product would be available, without prescription, for all girls of reproductive age.
The Secretary of the Department of Health and Human Services is responsible, acting through the FDA Commissioner, for executing the Federal Food, Drug, and Cosmetic Act. Today’s action reflects my conclusion that the data provided as part of the actual use study and the label comprehension study are not sufficient to support making Plan B One-Step available to all girls 16 and younger, without talking to a health care professional. Plan B One-Step will still be available over the counter to women ages 17 and older.
Because I do not believe enough data were presented to support the application to make Plan B One-Step available over the counter for all girls of reproductive age, I have directed FDA to issue a complete response letter denying the supplemental new drug application (SNDA) by Teva Women’s Health, Inc..

Sebelius received Obama’s support for her decision. From news reports at the time of the ruling:

Obama said that as a father of two daughters, he thinks the government should “apply some common sense” to rules governing over-the-counter medicine. He said he understood Sebelius’ concern about letting medication with potentially adverse side effects be available to 10-year-old girls “alongside bubble gum or batteries” at drugs stores.
“I think most parents would probably feel the same way,” he said. Asked point blank if he supports Sebelius’ decision, Obama said, “I do.”

While the Judge today said that his decision was supported by science, it remains for the Judge to enlighten both the regulatory and scientific/medical communities as to what secret studies he was privy to in his decision-making. The truth is that every study, including those by Teva, the manufacturer of Plan B, indicate that half of all women taking the drug were incapable of following the directions on the product insert for correct use of the drug and/or failed to understand that Plan B is not meant to replace regular contraceptives or be used more than once in a menstrual cycle.

Further, studies have indicated that when used by teens the rate of Chlamydia infection rose (presumably from increased sexual activity). Additionaly, studies have indicated that the incidence of teen pregnancy was not lowered by the use of Plan B.

Perhaps even more disturbing is the lack of understanding by the judge that children’s medications are dispensed on a milligram of drug per kilogram of body weight basis. This is because standard adult doses would be double, triple, or even quadruple the necessary amount in children whose bodies are often 1/4 the mass of an adult’s. There are NO KNOWN STUDIES of the effects of the single, adult dose of Plan B on girls under age 18, which makes the specter of girls twelve and thirteen years old purchasing this drug over the counter just as frightening as can be. There are also no long term studies of Plan B’s. effects on adults, either. So the whole enetrprise is one, large human experiment.

It isn’t impossible to imagine a young girl whose body mass is half that of an eighteen year-old’s taking this dangerous hormonal drug after every act of sex, up to several in one month. This drug is several times the dose taken daily by women using oral contraceptives. Recall that half of all grown women studied couldn’t grasp this reality.

Our daughters have become lab rats in Judge Korman’s great experiment. Better he should leave such matters to those of us trained in the field, and that he stick to the law. It is now open season on girls, whose gynecologic standard of care would be improved if they were accorded the same standards that govern veterinary medicine. If vets did to animals what we do to our women, they would lose their licenses and be prosecuted for cruelty. That’s how far gynecologic medicine and its governmental regulation have sunk.

Below, an interview I gave earlier this year at a medical conference in Washington, DC, dealing with this issue of targeting children.

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A review of the Popes in the twentieth century find them fighting a fierce battle against the forces of secularism, atheism, and malevolance that have consumed Western Civilization. Collectively these forces, referred to as “Modernity,” are merely contemporary expressions of the evils that have collapsed empires and civilizations for thousands of years. The election of our new Holy Father, Francis, must be evaluated in light of the twentieth century popes, beginning with Pius XI.

Just a few months after the Lambeth Conference of 1930, where the Anglicans opened the door to contraception, Pope Pius XI issued Casti Connubii, the great defense of marriage that resonates especially today in the United States:

Venerable Brethren and Beloved Children, Health and Apostolic Benediction.

How great is the dignity of chaste wedlock, Venerable Brethren, may be judged best from this that Christ Our Lord, Son of the Eternal Father, having assumed the nature of fallen man, not only, with His loving desire of compassing the redemption of our race, ordained it in an especial manner as the principle and foundation of domestic society and therefore of all human intercourse, but also raised it to the rank of a truly and great sacrament of the New Law, restored it to the original purity of its divine institution, and accordingly entrusted all its discipline and care to His spouse the Church.

5. And to begin with that same Encyclical, which is wholly concerned in vindicating the divine institution of matrimony, its sacramental dignity, and its perpetual stability, let it be repeated as an immutable and inviolable fundamental doctrine that matrimony was not instituted or restored by man but by God; not by man were the laws made to strengthen and confirm and elevate it but by God, the Author of nature, and by Christ Our Lord by Whom nature was redeemed, and hence these laws cannot be subject to any human decrees or to any contrary pact even of the spouses themselves. This is the doctrine of Holy Scripture;[2] this is the constant tradition of the Universal Church; this the solemn definition of the sacred Council of Trent, which declares and establishes from the words of Holy Writ itself that God is the Author of the perpetual stability of the marriage bond, its unity and its firmness.[3]

Pius XI’s successor, Pius XII would famously condemn Nazism and help orchestrate the rescue of Jews, going on to win the universal praise of Europe’s Jews both during and immediately after World War II. The greatness of the man and his actions would only be rivaled by the magnitude of the calumny against him a generation later by a socialist playwright.

Pius XII responded more in action than by Encyclical, and 80% of the priests and religious of eastern Europe paid with their lives for the response of the Church through the sheltering of Jews.

Pope John XXIII set the Church on the course toward engaging the world in a new and fresh manner by calling for the Second Vatican Council. Himself a veteran of the First World War, as stretcher bearer and chaplain, John served Pius XII as Cardinal during the Second World War, orchestrating the rescue of Jews. During his papacy, as reported by Wiki:

In 1965, the Catholic Herald quoted Pope John as saying:

We are conscious today that many, many centuries of blindness have cloaked our eyes so that we can no longer see the beauty of Thy chosen people nor recognise in their faces the features of our privileged brethren. We realize that the mark of Cain stands upon our foreheads. Across the centuries our brother Abel has lain in blood which we drew, or shed tears we caused by forgetting Thy love. Forgive us for the curse we falsely attached to their name as Jews. Forgive us for crucifying Thee a second time in their flesh. For we know what we did.”[6]

In the time between the Lambeth Conference of 1930, and 1968, the year it seemed the world was teetering on the brink of anarchy, the world had seen WWII, the Holocaust, Cold War, Korean War, Vietnam War, Wars to end colonialism around the world, a rash of assasinations, the advent of the sexual revolution, Margaret Sanger’s Negro Project, the eugenic sterilizations of scores of thousands of humans, the development of the birth control pill, and the complete abandonment of the unified condemnation of contraception by all of Christendom except for the Catholic Church.

In that year of 1968, Pope Paul VI issued Humanae Vitae, which reaffirmed 2,000 years of Catholic Christian teaching on the right use of sex in marriage, and which underscored Casti Connubii. Five years later the United States would adopt legalized abortion, going on to slaughter 56 million babies, adding to the 1.8 Billion abortions worldwide since 1960.

In that time, a little-known bishop from behind the Iron Curtain would write an even less well-known book, Love and Responsibility. He would follow Paul VI as John Paul II, who would take on radical feminism, communism, capitalism, and the sexual revolution in the most intellectually and theologically proliferative pontificates of all time.

Along the way, the formality of the Papacy began to change. John XXIII dropped the regal “we” when visting youth in institutions, using the more personal, “I”. The Second Vatican Council changed a great deal, and Paul VI ended the practice of papal coronations. John Paul II eschewed a great deal of formality and reveled in the presence of youth.

Pope Benedict XVI eliminated the papal tiarra from the papal coat of arms, a practice maintained by Pope Francis, who has also eschewed the use of the papal apartment, wearing of the Apostolic Stole during his first appearance, and has adopted a host of other less formal and common touches.

While the papacy has undergone something of an informal transformation in recent decades, the responses of the popes have only grown firmer and more frequent in the face of Europe’s and America’s civilizational collapse. Benedict made an outreach to Europe the thrust of his papacy, an attempt to convert the cradle of Christianity from the embrace of ‘modernity’ and return her to her former dignity and glory.

He was roundly rebuffed, and so the torch has been passed to the brown peoples of the Southern Hemisphere where the Church is alive and growing, where nations battle against United States and European demands for legalization of abortion, gay marriage and contraception as prerequisites for financial aid.

From this hemisphere comes a pope who rode the bus to work, eschewed a palace in favor of a small apartment, and who cooked his own meals. He was the bishop of an impoverished people and sees the world somewhat differently than those of us in the Northern Hemisphere. He will not bend to us, but bend us to his vision of the world as seen through the eyes of a shepherd whose people’s plight has been largely unseen by America and Europe.

Pope Francis has dealt with the evil of poverty and the evil of a United States and Europe who have tried to leverage his people’s poverty by coupling the abandonment of the faith as a prerequisite for foreign aid. There will be many who find his approach difficult to bear. Wounded pride will be the leaven of that difficulty.

Those in the media and on the left who are praising his simplicity will be disappointed, bitterly so, when that does not translate into an embrace of a “liberal” agenda. This Pope, like his predecessors, begins from where his predecessors have left off. It is too early to say where he will place his emphasis, but I suspect that the artificial dichotomy between the life issues championed by the orthodox wing of the Church, and the social justice issues championed by the anarchist wing, may well be reunited by a Pope uniquely positioned to do so.

We in the north have largely abandoned the faith. It will be interesting to see how the south leads now that the light of faith and universal leadership has been handed to them.

Time will tell.

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