FDA Misleads Women on New Abortion Drug Ella, Billed as Morning After Pill
by Wendy Wright and Kristan Hawkins
July 13, 2010
LifeNews.com Note: Wendy Wright is the president of Concerned Women for America. Kristan Hawkins is the executive director of Students for Life of America.
The abortion debate is shifting. Americans are uncomfortable with abortion. They definitely do not want tax dollars paying for abortions. Most doctors aren’t willing to participate.
So abortion advocates have a new plan: mislead and mislabel. They are steering the Food and Drug Administration (FDA) to mislead women by mislabeling the new drug Ella to avoid mentioning that it can cause an abortion. Women and health providers will be enticed by the claim that it can prevent a pregnancy, unaware that it also can abort a pregnancy. And by not being labeled an "abortion drug," it may skirt federal laws against funding abortions – and the government will pay for it.
The question is: Will the FDA go along with this scheme?
This new drug is close to being introduced in the market. It can be taken up to five days after sexual intercourse. The drug sponsor touts Ella’s ability to delay ovulation, but Dr. Jeffrey Bay, an FDA pharmacologist, admitted that Ella also may prohibit embryos from implanting in the uterus.
This is significant. Ella impacts embryos both before and after implantation by interfering with the hormone needed to line the uterus to support an embryo.
An FDA advisory panel recently approved Ella as an "emergency contraceptive." However, the drug contains virtually the same chemicals as the abortion drug RU-486 and acts the same way. By blocking progesterone receptors, it starves the baby to death.
Despite this, the FDA panel voted unanimously not to inform women that Ella may do more than prevent ovulation. Incredibly, it went further by discouraging studies to determine if Ella can cause birth defects in babies who survive.
The European Medicines Agency (EMA) admitted, "Extremely limited data are available on the health of the foetus/new-born in case a pregnancy is exposed" to Ella. It also noted that Ella "is embryotoxic at low doses."
RU-486 was approved without adequate trials and, even with restricted distribution, has resulted in thousands of complications – including deaths. Ella’s clinical trials looked at by the EMA reported on a single dose per menstrual cycle in a limited group of women. In the real world, it will be used more frequently and by all types of females. If the drug is approved for contraceptive use, it could later be approved for sale over the counter.
What if women use Ella more than once in a cycle? EMA noticed an effect on all tissues, particularly the liver, "if the drug is used again a month later … in repeated dose this could result in toxicity due to accumulation."
If this isn’t enough, clinical tests of Ella were conducted only on females 16 years of age and older. If approved, Ella could be used by girls younger than 16, the side effects for whom are unknown.
Planned Parenthood told the FDA panel that it dispenses the morning-after pill Plan B after its approved 72-hour limit. It boldly states on websites how it violates the safety guidelines for the dangerous RU-486. (Several women who died from RU-486 abortions went to Planned Parenthood.) If Ella is approved, there is no doubt it will be given to women beyond the five-day window in order to take advantage of its abortion-causing mechanism.
If Ella does not cause abortions, does not cause birth defects and is not dangerous to use multiple times, the drug sponsor should prove it. The FDA would require this of any other drug. It should not have lower standards for reproductive drugs used by women.
Women deserve better than this. The FDA should not be party to this deception of women for profit.
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