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FDA Approves Dangerous ‘Ella’ Abortion Drug as Contraception

LifeSiteNews.com
LifeSiteNews.com

By Peter J. Smith

WASHINGTON, D.C., August 13, 2010 (LifeSiteNews.com) –  The U.S. Food & Drug Administration (FDA) approved Friday afternoon HRA Pharma’s “ella,” a new drug billed as an advanced form of "emergency contraception," for sale and distribution in the United States. However, pro-life advocates have raised the alarm on the drug’s safety and testing, and say ella is little more than a chemical abortion drug similar to RU-486, remarketed to the public as contraception. 

The FDA’s unanimous decision allows the drug to be marketed in the United States as an “occasional” emergency contraception, taken by a woman up to five days after sexual intercourse. The FDA warned, however, that it was unsafe for women to use ella more than occasionally, as they had no data on its safety over the long term. They also warned that women should be ruled out as pregnant before being prescribed ella, and women experiencing lower abdominal pain or who become pregnant after taking ella should be checked by their health care providers for ectopic pregnancy. (see release)

Pro-life leaders, however, were upset with the federal regulatory agency’s decision to approve the drug, pointing out that ella chemically works the same as RU-486. Therefore it not only can cause an abortion, but may also pose a risk to a woman’s health and life, and even have an adverse effect on later pregnancies. 

“The FDA underscored the point that this decision was driven by politics by releasing it late on a Friday when people are not paying attention,” said Wendy Wright, President of Concerned Women for America. “The meager trials done on ella indicate it may cause miscarriages and birth defects. Yet the FDA allowed the HRA Pharma to avoid fully testing the drug so women will be kept in the dark on what kind of serious complications it may cause to her and her baby.”

The chemical name for ella is ulipristal acetate, which functions as a progestin-blocker, or "selective progesterone receptor modulator (SPRM)."

Other forms of emergency contraception work by releasing massive amounts of progesterone into a woman's body, thereby suppressing ovulation, inhibiting sperm migration and reducing sperm capacity for fertilization. This can also have an abortifacient effect if the influx of progesterone changes the lining of the womb, preventing an already conceived embryo from implanting.

But ulipristal acetate works far differently, with far more effective abortifacient results. As a SPRM, it turns off the progesterone receptors in the body crucial not only for the beginning of pregnancy, but its continuance.

Mifeprostone, the drug taken in the two step RU-486 regimen, is also a SPRM, which also has been found to have had thousands of "adverse event reports" related to its use. Since the FDA approved it for sale in 2000, Mifepristone has been tied to 13 confirmed deaths, 9 of which were reported in the U.S. As of May 2006, when the FDA began reporting cases of women suffering from adverse effects of RU-486, 1,070 events were recorded, including six deaths, 9 life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection. 

Wright added that the best regulatory defense for women may be trial lawyers: the FDA, she said, appears to hold reproductive drugs to a lower standard than other drugs, and “treats serious complications and even death as preferable to pregnancy.”

“Make no mistake about it, ella is a dangerous abortion drug,” said Kristan Hawkins, Executive Director of Students for Life of America, in a statement calling upon the FDA to review and reverse its decision. “The FDA’s approval of ella for sale within the U.S. shows that the FDA has not done its job protecting women, particularly young women whom SFLA serves on a daily basis.” 
Students for Life of America and the “ella Causes Abortions Coalition” released a video Friday afternoon highlighting their concerns with ella’s possible effects and other questions unanswered by HRA Pharma. 

Unfortunately, little data currently exists to answer these questions. Ulipristal acetate was studied by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), but they admitted they lacked any concrete information as to the effects of the drug on women who do get pregnant. In 29 cases of women who became pregnant while testing ulipristal, 16 chose to have an induced abortion, six miscarried, another six said they were going to carry their babies to term, but they received no information regarding the status of their pregnancies.

But the labeling of ella as an emergency contraceptive, rather than an early abortion-inducing drug, may actually have another financial motive for HRA Pharma: the U.S. federal government may end up its biggest single customer. 

“By misclassifying ella as emergency contraception, this administration has paved the way to covertly allow federal funding for abortion through Medicaid, Title X, and international family planning programs,” said U.S. Rep. Chris Smith (R-N.J.), co-chairman of the bipartisan Congressional Pro-Life Caucus. Given President Barack Obama’s ideological commitment to abortion, said Smith, it was no surprise.

The congressman urged another Executive Order from President Obama preventing the federal government from funding ella or forcing insurance companies to cover it as an essential benefit. 

“The FDA is supposed to protect people from dangerous drugs and deceptive marking. Instead, today they have proven they are willing to be complicit in this abortion cover-up,” said Smith.

“At a minimum the drug should be classified as an abortion drug.  Women deserve to know that these pills they believe prevent pregnancy could actually kill their unborn child by withholding vital nutrients and effectively starving the child to death.”
 
See related coverage by LifeSiteNews.com:

FDA Readies Public Hearing for Next Generation Abortion Drug
http://www.lifesitenews.com/ldn/2010/jun/10060211.html 

Pro-life blogger concerned after RU-486 abortion Tweeter goes silent 
http://www.lifesitenews.com/ldn/2010/mar/10031208.html

Oregon Planned Parenthood Offers RU-486 Abortion in 'Privacy of Their Home' 
http://www.lifesitenews.com/ldn/2010/feb/10022513.html

Planned Parenthood Implicated in RU-486 Deaths of Four Women 
http://www.lifesitenews.com/ldn/2008/jun/08061907.html

Leading Researcher Proves RU-486 Causes Septic Shock Deaths 
http://www.lifesitenews.com/ldn/2005/jul/05072802.html

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PBS defends decision to air pro-abortion documentary ‘After Tiller’

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By Dustin Siggins

Under pressure for showing the pro-abortion documentary "After Tiller" on Labor Day, PBS' "POV" affiliate has defended the decision in response to an inquiry from LifeSiteNews.

The producers of the film say their goal with the documentary, which tells the stories of four late-term abortion doctors after the killing of infamous late-term abortionist George Tiller, is to "change public perception of third-trimester abortion providers by building a movement dedicated to supporting their right to work with a special focus on maintaining their safety.” 

POV told LifeSiteNews, "We do believe that 'After Tiller' adds another dimension to an issue that is being debated widely." Asked if POV will show a pro-life documentary, the organization said that it "does not have any other films currently scheduled on this issue. POV received almost 1000 film submissions each year through our annual call for entries and we welcome the opportunity to consider films with a range of points of view."

When asked whether POV was concerned about alienating its viewership -- since PBS received more than $400 million in federal tax dollars in 2012 and half of Americans identify as pro-life -- POV said, "The filmmakers would like the film to add to the discussion around these issues. Abortion is already a legal procedure."

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"This is an issue that people feel passionately about and will have a passionate response to. We are hopeful that the majority of people can see it for what it is, another lens on a very difficult issue." 

In addition to the documentary, POV has written materials for community leaders and teachers to share. A cursory examination of the 29-page document, which is available publicly, appears to include links to outside sources that defend Roe v. Wade, an examination of the constitutional right to privacy, and "a good explanation of the link between abortion law and the right to privacy," among other information.

Likewise, seven clips recommended for student viewing -- grades 11 and beyond -- include scenes where couples choose abortion because the children are disabled. Another shows pro-life advocates outside a doctor's child's school, and a third is described as showing "why [one of the film's doctors] chose to offer abortion services and includes descriptions of what can happen when abortion is illegal or unavailable, including stories of women who injured themselves when they tried to terminate their own pregnancies and children who were abused because they were unwanted."

Another clip "includes footage of protesters, as well as news coverage of a hearing in the Nebraska State Legislature in which abortion opponents make reference to the idea that a fetus feels pain." The clip's description fails to note that it is a scientifically proven fact that unborn children can feel pain.

The documentary is set to air on PBS at 10 p.m. Eastern on Labor Day.

Kirsten Andersen contributed to this article.

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Pete Baklinski Pete Baklinski Follow Pete

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He defended ‘real’ marriage, and then was beheaded for it

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By Pete Baklinski

A Christian man was executed during the night by a high-profile ruler after making an uncompromising defense of real marriage.

The Christian, who was renowned for his holiness, had told the ruler in public that his relationship with his partner was “against the law” of God. The Christian’s words enraged the ruler’s partner who successfully plotted to have him permanently silenced.

John the Baptist was first imprisoned before he was beheaded. The Catholic Church honors him today, August 29, as a martyr and saint.

While John’s death happened a little less than 2,000 years ago, his heroic stance for real marriage is more pertinent today than ever before.

According to the Gospel of Mark, the ruler Herod had ‘married’ his brother’s wife Herodias. When John told Herod with complete frankness, “It is against the law for you to have your brother’s wife,” Herodias became “furious” with him to the point of wanting him killed for his intolerance, bullying, and hate-speech.

Herodias found her opportunity to silence John by having her daughter please Herod during a dance at a party. Herod offered the girl anything she wanted. The daughter turned to her mother for advice, and Herodias said to ask for John’s head on a platter.

Those who fight for real marriage today can learn three important lessons from John’s example.

  1. Those proudly living in ungodly and unnatural relationships — often referred to in today’s sociopolitical sphere as ‘marriage’ — will despise those who tell them what they are doing is wrong. Real marriage defenders must expect opposition to their message from the highest levels.
  2. Despite facing opposition, John was not afraid to defend God’s plan for marriage in the public square, even holding a secular ruler accountable to this plan. John, following the third book of the Hebrew Bible (Leviticus 20:21), held that a man marrying the wife of his brother was an act of “impurity” and therefore abhorrent to God. Real marriage defenders must boldly proclaim today that God is the author of marriage, an institution he created to be a life-long union between one man and one woman from which children arise and in which they are best nurtured. Marriage can be nothing more, nothing less.
  3. John did not compromise on the truth of marriage as revealed by God, even to the point of suffering imprisonment and death for his unpopular position. Real marriage defenders must never compromise on the truth of marriage, even if the government, corporate North America, and the entire secular education system says otherwise. They must learn to recognize the new “Herodias” of today who despises those raising a voice against her lifestyle. They must stand their ground no matter what may come, no matter what the cost.

John the Baptist was not intolerant or a bigot, he simply lived the word of God without compromise, speaking the word of truth when it was needed, knowing that God’s way is always the best way. Were John alive today, he would be at the forefront of the grassroots movement opposing the social and political agenda to remake marriage in the image of man.

Click "like" if you want to defend true marriage.

If he were alive today he might speak simple but eloquent words such as, “It is against God’s law for two men or two women to be together as a husband and wife in marriage. Marriage can only be between a man and a woman.” 

He would most likely be hated. He would be ridiculed. He would surely have the human rights tribunals throwing the book at him. But he would be speaking the truth and have God as his ally. 

The time may not be far off when those who defend real marriage, like John, will be presented with the choice of following Caesar or making the ultimate sacrifice. May God grant his faithful the grace to persevere in whatever might come. St. John the Baptist, pray for us!

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The Wunderlich family Mike Donnelly / Home School Legal Defence Association
Thaddeus Baklinski Thaddeus Baklinski Follow Thaddeus

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German homeschoolers regain custody of children, vow to stay and fight for freedom

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By Thaddeus Baklinski

One year to the day since a team of 20 social workers, police officers, and special agents stormed a homeschooling family’s residence near Darmstadt, Germany, and forcibly removed all four of the family’s children, aged 7 to 14, a state appeals court has returned custody of the children to their parents.

The reason given for the removal was that parents Dirk and Petra Wunderlich continued to homeschool their children in defiance of a German ban on home education.

The children were returned three weeks after being taken, following an international outcry spearheaded by the Home School Legal Defense Association.

However, a lower court imposed the condition on the parents that their children were required to attend state schools in order for them to be released, and took legal custody of the children in order to prevent the family from leaving the country.

In a decision that was still highly critical of the parents and of homeschooling, the appeals court decided that the action of the lower court in putting the children in the custody of the state was “disproportional” and ordered complete custody returned to the parents, according to a statement by the HSLDA.

The Wunderlichs, who began homeschooling again when the court signaled it would rule this way, said they were very pleased with the result, but noted that the court’s harsh words about homeschooling indicated that their battle was far from over.

“We have won custody and we are glad about that,” Dirk said.

“The court said that taking our children away was not proportionate—only because the authorities should apply very high fines and criminal prosecution instead. But this decision upholds the absurd idea that homeschooling is child endangerment and an abuse of parental authority.”

The Wunderlichs are now free to emigrate to another country where homeschooling is legal, if they choose, but they said they intend to remain in Germany and work for educational freedom.

“While we no longer fear that our children will be taken away as long as we are living in Hessen, it can still happen to other people in Germany,” Dirk said. “Now we fear crushing fines up to $75,000 and jail. This should not be tolerated in a civilized country.”

Petra Wunderlich said, "We could not do this without the help of HSLDA,” but cautioned that, “No family can fight the powerful German state—it is too much, too expensive."

"If it were not for HSLDA and their support, I am afraid our children would still be in state custody. We are so grateful and thank all homeschoolers who have helped us by helping HSLDA.”

HSLDA’s Director for Global Outreach, Michael Donnelly, said he welcomed the ruling but was concerned about the court’s troubling language.

“We welcome this ruling that overturns what was an outrageous abuse of judicial power,” he said.

“The lower court decision to take away legal custody of the children essentially imprisoned the Wunderlich family in Germany. But this decision does not go far enough. The court has only grudgingly given back custody and has further signaled to local authorities that they should still go after the Wunderlichs with criminal charges or fines.”

Donnelly pointed out that such behavior in a democratic country is problematic.

“Imprisonment and fines for homeschooling are outside the bounds of what free societies that respect fundamental human rights should tolerate,” he explained.

“Freedom and fundamental human rights norms demand respect for parental decision making in education. Germany’s state and national policies that permit banning home education must be changed.

"Such policies from a leading European democracy not only threaten the rights of tens of thousands of German families but establish a dangerous example that other countries may be tempted to follow,” Donnelly warned.

HSLDA Chairman Michael Farris said that acting on behalf of the Wunderlichs was an important stand for freedom.

“The Wunderlichs are a good and decent family whose basic human rights were violated and are still threatened,” Farris said.

“Their fight is our fight," Farris stressed, "and we will continue to support those who stand against German policy banning homeschooling that violates international legal norms. Free people cannot tolerate such oppression and we will do whatever we can to fight for families like the Wunderlichs both here in the United States and abroad. We must stand up to this kind of persecution where it occurs or we risk seeing own freedom weakened.”

Visit the HSLDA website dedicated to helping the Wunderlich family and other German homeschoolers here.

Contact the German embassy in the U.S. here.

Contact the German embassy in Canada here.

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