The recent recommendation by a Food and Drug Administration (FDA) advisory panel that the FDA approve the sale of Ella (ulipristal acetate) as an “emergency contraceptive” was practically a foregone conclusion. I can’t recall the last time the FDA rejected an application for any new “reproductive health” drug or device—no matter how risky it proved to be for mothers or unborn children?
The agency routinely approves drugs and devices to block reproduction that are later found unacceptably dangerous for women—the high-dose estrogen pill, the Dalkon Shield intra-uterine device, Norplant rods, Depo-Provera shots, nonoxynol-9, and the Ortho Evra patch, to name just a few. As evidence of the level of risk the FDA tolerates in the reproductive health pharmacopoeia, FDA has not recalled the patch, despite its link to the deaths of at least 29 apparently healthy young women due to blood clots. While some at the FDA may believe their deaths to be an acceptable trade-off so that others can avoid pregnancy, the victims’ families no doubt feel differently.
But the yet-unquantified risk to mothers is only part of the problem with Ella.
It is simply false and deceptive to promote Ella as an “emergency contraceptive” like Preven and Plan B. Depending when they are taken relative to ovulation and intercourse, Preven and Plan B may act primarily as contraceptives (by disrupting ovulation, for example), or sometimes as very early abortifacients (by modes of action that interfere with the embryo’s movement to the womb or ability to implant there).
The reason Ella is far more effective than Preven and Plan-B (complete failures at the population level!), and the reason Ella keeps working five days (or more) after “unprotected intercourse,” is that Ella—like its close chemical cousin RU-486—blocks progesterone receptors in the uterine lining. This destroys the capacity of the mother’s reproductive organs to produce the progesterone necessary to support the embryo through the first 10 weeks of pregnancy.
Because Ella is formulated precisely to prevent a newly conceived human being from implanting in and receiving nutrition from the uterine lining, or to disrupt the process if it has begun, the American Association of Pro Life Obstetricians & Gynecologists properly calls Ella an embryocidal drug.
And, as Cardinal Daniel DiNardo pointed out in his June 17 letter to the FDA: “Millions of American women, even those willing to use a contraceptive to prevent fertilization in various circumstances, would personally never choose to have an abortion. They would be ill served by a misleading campaign to present [Ella] simply as a ‘contraceptive’.”
As used in animal studies, Ella killed rat, rabbit, and monkey embryos, and caused severe congenital defects in embryos whose gestational age was advanced when Ella was administered. This is an important point. In all three major clinical trials in women, some women were later found to have been pregnant before the intercourse for which they sought “emergency contraception.” In addition, trials have shown that Ella fails to kill the newly conceived human embryos in about 2% of cases. The survivors may then face severe congenital anomalies. Lastly, Ella has been detected in maternal tissues 14 days after taking the drug, so children conceived during that period also could be deformed or killed by the drug.
The FDA must drop the fantasy that Ella is contraception, and reject Ella in order to safeguard the lives and health of children exposed to this poison pill.
[Wills is assistant director for Education & Outreach, USCCB Secretariat of Pro-Life Activities.]
