FDA Advisory Committee Gives Thumbs Up to New Abortion Drug Ella
by Steven Ertelt
June 17, 2010
Washington, DC (LifeNews.com) — An FDA advisory committee today cast two votes giving a thumbs up to the new abortion drug Ella, which supporters are falsely billing as a morning after pill. The Advisory Committee for Reproductive Health Drugs gave its approval to the early abortion drug on two 11-0 votes.
The panel said the "investigational emergency contraceptive pill" known as ulipristal, that would potentially be sold under the name Ella in the United States, is safe and effective at preventing pregnancy.
The committee said women could use the drug to prevent pregnancy when taken up to five days after intercourse — and did so by redefining the beginning of pregnancy from conception to implantation. In so doing, the panel ignored the fact that the drug kills a unique human being at the earliest point of pregnancy.
If the FDA ultimately approves the drug, and it usually follows the recommendations of its advisory panels, the ella drug would be an "improvement" over the current Plan B morning after pill that can be used 72 hours after sexual intercourse.
The panel made its decision based on data from two phase III clinical trails the French drug maker HRA Pharma sponsored.
The studies showed 1.51 percent of women using ella (or ellaOne in Europe) became pregnant when using the drug 72 hours after intercourse while 2.81 percent became pregnant when using the Plan B drug.
However, Wendy Wright, the president of Concerned Women for America, said the ella abortion drug maker could not answer other questions.
"The drug sponsor couldn’t provide information on whether Ella can cause birth defects, or what happens to women who are pregnant who take it. And yet the committee strongly recommended not giving a woman a pregnancy test," she told LifeNews.com after the hearing.
"In Europe, Ella is contra-indicated (not to be used) in pregnancies. But the FDA committee voted to not to test women to detect if they’re pregnant. They are telling doctors to be willfully blind when giving the drug," Wright continued.
"The committee voted to deceive women," Wright complained.
Donna Harrison, MD, president of the American Association of Pro-Life Obstetricians and Gynecologists, also testified at the FDA hearing.
According to MedPage today, she the ella abortion drug should not be approved "because there is insufficient data in the company’s trials to conclude what effect, if any, ulipristal has on pregnancy outcomes if a woman becomes pregnant despite taking the drug."
Kirsten Moore, president and CEO of Reproductive Health Technologies Project, told the panel it should not put on the label that women should get a pregnancy test before taking the drug and the panel agreed with that decision. As a result, pregnant women may see their unborn children killed by unknowingly taking the abortion drug and thinking it will merely prevent conception.
The FDA will likely approve prescription-only status for the ella drug and Erin Gainer, the CEO of HRA Pharma, said, "We currently have no plans to request over-the-counter status for this drug."
But that was the case with the Plan B drug until abortion advocates pushed for over the counter sales and then push to sell the drug to minors without a physician visit or parental consent or notification.
Before the hearing, Wright informed LifeNews.com her group had a host of concerns about the ella pill.
Earlier this week, the Food and Drug Administration declared Ella safe and effective for women and released documents saying ella, made by French drugmaker HRA Pharma, appears to work with no unexpected side effects. https://lifenews.com/nat6418.html
Wright also says anyone billing the new Ella abortion drug as a means of preventing abortions is misleading the public.
"Advocates for the morning-after pill claimed that it would dramatically reduce pregnancies and abortions. Now they admit that’s not true. They also admit that morning-after pills are not as effective as previous studies — which the FDA relied on — claimed," she said.
"The same advocates claim that RU-486 is safe, but the families of the women who died from that drug will beg to differ," she continued.
In fact, at least 13 women around the world — and potentially dozens more — have died from using the RU 486 (or mifepristone) abortion drug. Another 1,100 in the United States alone have been injured by it, with some women having such severe problems it required a hospital visit and complete blood transfusion.
The abortion drug acts as an abortion agent by destroying the life of the new person conferred at conception, or fertilization.
That’s the view of a national organization of pro-life obstetricians and gynecologists as well as a pro-life legal group — both of which have filed papers with the FDA asking the agency not to approve the drug for over the counter sales.
Americans United for Life and the American Association of Pro Life Obstetricians & Gynecologists told the FDA a study in England confirms the pro-life perspective that ulipristal acts as an abortion drug.
Anna Glasier, of NHS Lothian in Edinburgh, led a study of more than 5,500 women in the UK published online in The Lancet medical journal. It found fewer pregnancies among those women given the ellaOne drug within five days of intercourse.
And for women who took the drug between 3-5 days after having sex, only women taking the traditional morning after pill became pregnant. They’s because all of the women using ulipristal during that time period had abortions.
"AAPLOG has concluded from publicly available information that ulipristal acetate is an abortifacient of the same type as mifepristone (RU 486) and that its approval as an emergency contraceptive raises serious health and ethical issues," the letter says. "Furthermore, ulipristals potential effects on women who used the drug off-label and upon ongoing pregnancies are essentially unexamined and untested."
The medical literature, AAPLOG says, has established that ellaOne has the "ability to destroy established pregnancies, as well as prevent implantation."
Related web sites:
Concerned Women for America – https://www.cwfa.org
Americans United for Life – https://www.aul.org
American Association of Pro-Life Obstetricians and Gynecologists – https://www.aaplog.org
Sign Up for Free Pro-Life News From LifeNews.com
Daily Pro-Life News Report Twice-Weekly Pro-Life
News Report Receive a free daily email report from LifeNews.com with the latest pro-life news stories on abortion, euthanasia and stem cell research. Sign up here. Receive a free twice-weekly email report with the latest pro-life news headlines on abortion, euthanasia and stem cell research. Sign up here.