The Food and Drug Administration (FDA) recently approved ella® (ulipristal acetate), a new drug closely related to Mifeprex (Mifepristone, otherwise known as “RU 486”). Like Mifeprex, ella has the potential to cause the death and abortion of an established pregnancy growing in the womb.
Wait a minute: I thought “emergency contraception” is supposed to prevent pregnancy, not abort one?! Actually, that depends upon how one defines “pregnancy.” A number of years ago, the medical community arbitrarily decided to redefine the start of pregnancy as at the point the embryo attaches to the womb. This flies in the face of the scientific reality that at conception, when the sperm and egg unite, a living being is formed already containing the blueprint (DNA) for eye/hair color, sex, fingerprints, etc., and this being is actively growing BEFORE he/she reaches the womb and attaches.
Plan B is the most common form of “emergency contraception.” According to the Plan B package insert for patients: “Plan B® is believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium). It is not effective once the process of implantation has begun.” This latter mechanism prevents a newly formed living being from attaching. Many consider this a form of early abortion.
HRA Pharma, the company that manufactures the new drug, ella, claims that it is not an abortion pill. They claim that used at the dosage prescribed (important little caveat) it “just” prevents ovulation and/or implantation. Whoa, stop right there. We’ve already established that a new life has already formed before implantation and preventing implantation is a kind of abortion. But wait, it gets worse. Remember, ella is in the same drug family as Mifeprex, THE abortion pill. When women take Mifeprex, the newly attached and growing tiny human dies because the connection to the womb is dissolved. ella and Mifeprex both work the same way. ella doesn’t “just” prevent ovulation and implantation, but it also has the potential to abort an attached and growing pregnancy.
So, ella differs from Plan B in a HUGE way. Plan B does not disrupt a pregnancy once it is attached to the womb; however, like Mifeprex, ella CAN.
So, this brings me to this question: what is to keep doctors and women from using ella to abort pregnancies? Answer: nothing. Once the FDA approves a drug for a given indication, the FDA has NO power to control how it is used henceforth. Enter the “off-label” use of medications. This means that doctors are using a medication for a reason other than what it was originally approved for by the FDA. This practice is legal, although on the risky side. Often, there is very little scientific data (i.e. studies showing a benefit) to support off-label use of a given medication. So, the people who end up taking the drugs in these situations are essentially guinea pigs.
Doesn’t the FDA put any new drug application through a rigorous evaluation before allowing it to be sold on the market? Surely, a drug that will be used in young women who are at risk for pregnancy was thoroughly “checked out” before approving its use? You decide. Here is a list of people groups in which the drug has NOT been studied:
- Women over age 35
- Women who are taking hormonal contraceptives (birth control pills, patches, rings, etc.)
- Breast-feeding women
- Adolescent females
Hmm…is there anything else that is not known about ella? Glad you asked. The potential impact on a pregnancy that is exposed but survives has not been thoroughly evaluated. Remember Plan B? Women are not supposed to use it as regular contraception, according to manufacturer’s instructions, but they do. They will likely do the same with ella and there is data lacking on the safety of repeated use.
Okay, so there are a number of concerns with this drug, now approved by the FDA. At least women have another option to help reduce unintended pregnancies, right? Wrong. If Plan B’s impact on pregnancy and abortion rates is any indicator of how effective ella may be, the news is not reassuring. Studies have shown that where Plan B is given to women, pregnancy and abortion rates remained essentially unchanged. Did you catch that? That means that Plan B has had ZERO impact on accomplishing its goal. So who has benefited? The pharmaceutical company. I predict one change with the introduction of ella: the abortion rates will go up as it becomes not another “emergency contraceptive” on the market, but another abortion pill masquerading as one.
Women deserve to know what they are being given. Get the word out.
Sandy Christiansen, MD, FACOG is Care Net's National Medical Consultant. To read more about ella, visit http://www.ellacausesabortions.com/. If you're planning to attend the Care Net National Conference in September 2010, sign up for the "Medication Abortions" workshop with Dr. Julie McDonald to learn more. 
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