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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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Judges order Arizona and Indiana to recognize gay ‘marriages’ on death certificates

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By Kirsten Anderson

Two federal judges have ordered Arizona and Indiana to recognize same-sex “marriages” on death certificates, although both states have laws defining marriage as a union between one man and one woman.

In Arizona, Judge John Sedwick ordered the state to issue a death certificate for George Martinez listing his marital status as “married” and his spouse as Fred McQuire.  The two were “married” in California in July, and Martinez died in September.  They had previously sued Arizona to recognize their out-of-state “marriage” as legal – a case that is still ongoing.

In his decision, Sedwick said that the majority of federal appeals courts have found that “marriage laws which discriminate between heterosexual couples and homosexual couples infringe a fundamental right.”  He said he thought it was likely that Arizona’s marriage protection law will soon be overturned. 

Sedwick’s decision applies exclusively to Martinez and McQuire.   The judge explained that given the likelihood of same-sex “marriage” becoming legal in Arizona, he didn’t want McQuire’s “marriage” to be excluded from recognition just because his “husband” died before the law could be overturned.  He said he hoped the decision would prevent “the loss of dignity and status coming in the midst of an elderly man’s personal grief.”

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Meanwhile, in Indiana, Judge Joseph Van Bokkelen presided over an agreement between the state and a lesbian couple, Veronica Romero and Mayra Yvette Rivera, who “married” in Illinois in March. The state agreed to recognize the couple’s “marriage” because Rivera is dying of ovarian cancer, and said they will issue a death certificate bearing Romero’s name as “spouse” when Rivera passes away. 

Indiana opted to concede the case mostly due to its striking similarities to an earlier case the state lost, in which Judge Richard L. Young ordered Indiana to recognize the “marriage” of Niki Quasney and Amy Sandler, who “wed” in Massachusetts in 2013.  Quasney also has terminal ovarian cancer, and the couple had argued that Sandler and her two children would suffer irreparable financial harm if the state does not recognize their “marriage” so that Sandler can collect death benefits when Quasney passes away. 

Both Indiana decisions apply only to the couples named specifically by the court; however, last week, a federal appeals court upheld an earlier ruling by Judge Young declaring the state’s marriage protection law unconstitutional. 

The state of Indiana has appealed that ruling to the U.S. Supreme Court.

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A topless activist with Femen attacks Belgian Archbishop Andrè-Joseph Leonard, who is known for his strong pro-life and pro-family stance.
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Why are pro-abortion protesters always taking their clothes off?

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By Jonathon van Maren

I’ve seen a lot of bizarre responses to pro-life activism. There’s the crude picket signs, the illiterate chants, the flashes of violence, the incoherent threats that so often seem to involve used tampons, and even activists dressed up like giant genitalia.

But there is one phenomenon that never ceases to stagger me with its counterproductive stupidity and moral blindness: The increasing prevalence of “feminist” protestors, almost exclusively women, stripping down to “protest” something—usually protection for the pre-born or some other dissent from the totalitarian death cult of the Sexual Revolution.

When people ask me what the weirdest response to pro-life work is and I try to explain this phenomenon, they find it hard to believe. So do I. But yet it happens, time and time again.

The suicidal tendencies of modern-day feminism would be almost laughable if they were not so depressing.

One student stripped down and sat on a folding chair in front of our pro-life display at the University of British Columbia. A few protestors decided to protest the launch of our 2012 national tour by going topless. Then, at a presentation in London, Ontario, a bunch of pro-abortion protesters showed up at a counter-protest organized by the Canadian Auto Worker’s Union, sans clothing. And of course, at last year’s March for Life a topless Femen protestor flung herself at a remarkably composed Catholic bishop as he spoke to the crowd, shrieking “F*** your morals!”

You’d think such behaviour would attract ire rather than admiration. But this is 2014 and most of our municipal governments use our taxpayer’s cash basically to fund a day dedicated to that type of behaviour when the Pride Parade rolls around.

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Instead, these women are now generally referred to as “brave.” Even the popular, but tiresomely far-left website Upworthy recently pushed a video with a street activist protesting harassment by misogynist pigs by standing on the street in her lingerie. (Little tip: Protesting the fact that some misogynists define you by your body by voluntarily showing them what they wanted to see in the first place isn't defiance, it's acquiescence. Protesting the fact that these guys aren't treating you with dignity by acting like you have none is counter-productive. “That guy crudely suggested he wants to see me naked! Well, I’ll show him! By showing him exactly what he wants to see! Wait…”)

A bit of research into the infamous nude activist group Femen (“Our mission is protest, our weapon is bare breasts”) shows just how exploitative (inadvertent though it may sometimes be) this entire phenomenon is. In recent documentary the group’s leader, Viktor Svyatski, admitted that he had perhaps started the group to “get girls,” and that he carefully selected only the most attractive girls for his group. The documentary also revealed that Svyatski had described the Femen girls as “weak,” and was often verbally abusive with them.

Again, the suicidal tendencies of modern-day feminism would be almost laughable if they were not so depressing.

But the phenomenon of public nudity is also more than just incoherent protest—it is a way of forcing people to accept any and all manifestations of the Sexual Revolution. As I noted some time ago:  The public is now regularly subjected to crude and wildly exhibitionist “Gay Pride Parades” and “Slut Walks.” These are not considered to be optional festivals hosted by tiny minority groups. No, politicians who refuse to attend are labelled as heretics by the high priests of the New Moral Order, which is of course not an order at all, but a proud lack thereof.

Liberal activists don’t want the State to be outside the bedroom anymore, they want the State in the bedroom—loudly applauding the acts they see taking place, refraining from any judgment but one of approval, and paying for pills and bits of rubber to ensure that such acts do not go awry and result in reproduction or infection.

Your prayers are not welcome in public, but your privates are. The Emperor has no clothes, and is quite enjoying it—so long as the chilly breezes of moral truth don’t leak out of drafty cathedrals to cause discomfort.  

There may be hope on the horizon, as indicated by the wild popularity of such books as Wendy ShaIit’s A Return to Modesty, as well as increasing disinterest in topless beaches in places like France. Some “feminists” have responded to such trends with irritation, grumbling that all the hard-won ground they had fought for is being spurned by the ungrateful brats of today. But perhaps, instead, many women are realizing that allowing men to freely objectify them in public is not all it’s cracked up to be.

Perhaps people have begun to rediscover a human value that was once enormously prized, but now almost forgotten: Dignity.

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Abortion ‘doula’: I was trained to ‘support’ women choosing gendercide

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By Ben Johnson

A young woman who volunteers as an assistant in the abortion industry says she was trained to be “supportive” of women who chose to have sex-selective abortions and 11-year-olds who opted to remain in a sexual relationship with their much older rapist.

Alex Ronan also describes the conscious decision to lie to patients and the graphic, bloody details of her first year as an abortion doula in an article published Sunday in New York Magazine.

An abortion “doula” – a Greek word that literally means “female slave” – is supposed to comfort women during the abortion procedure. The 23-year-old received her training from Lauren Mitchell, who co-founded The Doula Project with Mary Mahoney in 2007.

“We sat in the park, eating pie,” Ronan remembered:

She gave us a sheet with situations so exaggeratedly horrible they seemed unreal: An 11-year-old in for an abortion who asks for birth control when she’s alone with the doctor. Her mother works nights; she’d been left with a friend who has a twentysomething son. She calls him her boyfriend; he will go to jail. A woman who says she’d like to do another ultrasound to see if it’s definitely a girl, because she’ll only keep it if it isn’t. A drug addict covered in track marks with two kids in the foster-care system who refuses birth control.

“What do you assume?” Mitchell asked of each case. “How can you be supportive?”

The 23-year-old said, as the training went on, she realized these cases were not hypothetical. “Later, I learned from Mahoney that all the examples were real cases that had come from her first six months working as an abortion doula.”

Planned Parenthood and other abortion providers have repeatedly been caught covering up statutory rape – by pro-life sting operations and outraged parents – as well as facilitating sex-selective abortions.

Faced with the reality of abortion, Ronan said she felt “embarrassed” by “the limits of my compassion. I judged these women on the worthiness of their reasons ('Would she really only keep a boy?' I wondered) and found myself questioning why those who come in for late-term abortions had waited so long to decide.”

Soon, she would see cases she would never forget. She bookends her article with two stories that reveal the pain women suffer in the process and the gory details the procedure burned into her mind.

She saw an emergency that ended in a hysterectomy on her first day.

The abortionists moved up the late-term procedure after seeing the woman's reaction to laminaria. “I hear one doctor tell the other that there’s too much blood,” Ronan writes. “They have to cut into Dee’s abdomen to get a clearer picture of what was going on...Eventually, they have to remove the uterus; there isn’t any other way.”

After the procedure, “What’s called the products of conception bucket is mostly filled with bloody gunk. I make out a doll-size arm, fist curled. It feels like I shouldn’t look, but I can’t turn away,” she admits.

Soon, she got her opportunity to “support” a minor in an “abusive” relationship. Afterwards, “Eliana” asked Ronan, “Do you think I’m too young for an abortion?”

“I tell her no. I think she’s making a really responsible choice,” she writes. “She looks at me, says, 'Do you even know how old I am?' I shake my head no. 'I’m 14,' she says.”

Ronan did not indicate that she or anyone at the abortion facility reported the abuse, or encouraged Eliana to do so.

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When abortion volunteers speak to one another, they acknowledge they have seen everything – “the patients who have second thoughts, and the ones who get abortions for reasons that make you feel uncomfortable. These images are the stuff of pro-life campaigns, the ones that try to make women change their minds.”

Rather than help women face the facts, she said she often acts as a “distraction” to women. “When the patients stand, I see the blood stains on the white paper, a little or a lot,” she writes. “I step between them and the bed, to block their view of the blood.” Mitchell suggested doulas make small talk about astrology, but the writer chooses to talk about the Kardashians.

Part of that abortion industry's “distraction” involves lying, Ronan confesses. As a part of the abortion process, you “quickly learn that you do whatever you need to and ... sometimes you are dishonest. In the beginning, I shadow a more experienced doula as she reassures a patient that the woman in the next room screaming wildly is not here for the same procedure, though, of course, she is.”

She has also seen women who did not want to have abortions but feel they have no other option.

“A doula tells me a story about a woman who wanted to continue the pregnancy but had lost her job, run through all her savings, and was living in a homeless shelter.” For this reason, crisis pregnancy centers offer free medical procedures, diapers, baby clothes, and sometimes financial support to struggling mothers.

Another woman chose life too late. She scheduled a second-trimester abortion, because her child might not belong to her boyfriend. That morning, after the two-day procedure had been initiated, he told her they should keep the child anyway. “I can't, though, right?” she asks. “Since she’s already done laminaria, it’s unclear what would happen if she stops at this point.” She ended up aborting to assure the child would not be born with a birth defect. “I don't know what she wants and I don't know that she does, either,” Ronan says.

Ronan also reveals the often icy indifference of the industry to women's suffering.

She remembers another second-trimester patient named “Princess” who began having contractions, yet the doctor pushed her abortion back all day long. When she feels her child coming out, about to be born alive, the doula seeks help, but the coordinator tells her “coolly” that the doctor is unavailable. After she pleads for help, the abortionist dispatches an attending physician who performs the abortion.

“The fetus comes out easily; they put it in the bucket and shove it near me. It is fully intact, curled on its left side, fists closed, knees bent up,” Ronan writes. Looking at the dead child's mother, she thinks to herself, “He sleeps just like you.”

She immediately has “a second thought, an act of distancing: He looks more like an alien than a person.” An employee at Dr. Kermit Gosnell's late-term abortion facility, Sherry West, said one child who was murdered after being born alive screamed and screeched “like a little alien.”

But for all the pain they have witnessed, abortion doulas are relatively unmoved about what they are doing.

Doula Project co-founder Mahoney has admitted “those pictures pro-life activists flash are real.”

“When you see the procedure, you must decide, as a pro-choice person, whether you are in or out,” Mahoney said. “I have never been more in.”

Ronan seems to be in for the long haul, as well. Abortion “strikes me as strangely similar to birth, only the opposite word and a different outcome.”

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