Ten years after it was introduced in Europe, the abortion pill mifepristone, known as RU 486, may soon be available in the United States. Already about 6,500 women have used the pill to induce abortion in clinical trials across the U.S., and the Food and Drug Administration is expected to approve it by the end of January. Predictably, pro-choice activists are heralding the drug's imminent arrival as a breakthrough for women. Just as predictably, antiabortion activists are not. Says Laura Echevarria, media director for the National Right to Life Committee: "This is the first time in history that the FDA has approved a drug explicitly for the purpose of taking a human life instead of saving a human life."

But in the long run, instead of fueling the national debate over abortion, the pill may ultimately take away some of its steam. Any doctor can prescribe the medication, which is taken during the first weeks of pregnancy in the privacy of a woman's own home. Thus, with no clinics to picket, the battleground may well disappear. And because the abortion occurs in the first stage of pregnancy (a recent New York Times/CBS News poll showed a majority of Americans find that acceptable), there may be little to debate.

That alone would mark a huge change. The drug, used by women in France, England, Sweden and China, took a decade to get here. Since it was first developed in the 1980s by a team of French scientists led by Etienne-Emile Baulieu, RU 486 has been mired in a moral minefield. The Pope called it "the pill of Cain—the monster that cynically kills its brothers." For years its French manufacturer Roussel-Uclaf refused to sell it in the U.S. for fear of controversy. Finally, fed up with being picketed by protesters on both sides of the debate, the company donated its U.S. rights to New York City's Population Council, a not-for-profit research organization, in 1994. The Council then began clinical trials seeking FDA approval. Eventually a consortium of anonymous investors known as the Danco Group agreed to manufacture and distribute mifepristone. Dr. Carolyn Westhoff, 48, an associate professor of obstetrics, gynecology and public health at Columbia University in Manhattan, is among the trial's principal researchers. Married to a computer programmer and a mother of two teenage children, Westhoff, a 1977 graduate of the University of Michigan Medical School, spoke with People's Giovanna Breu about the medical aspects of mifepristone and what it means for women.

How does mifepristone work?

It blocks the progesterone hormone receptors. Progesterone, a normal female hormone produced by the ovary, is needed to maintain a really early pregnancy. When a receptor in the uterus is blocked by mifepristone, the hormone can't act, and the pregnancy detaches from the uterus. It only works really early in a pregnancy because as the embryo develops, the placenta starts to produce its own hormones.

Exactly how early in the pregnancy should the drug be taken?

The greatest effectiveness is in the first seven weeks of pregnancy. You start counting from the first day of the woman's last normal period. It can be used as soon as a woman has a positive pregnancy test.

Can the drug be used to terminate all early pregnancies?

Before it is used a woman must not only have a positive pregnancy test but also a sonogram to make sure we can see in the uterus if there really is a pregnancy. Roughly only half of the time that an egg and sperm join does that then go on to be a fully established pregnancy. Also, 1 or 2 percent of pregnancies implant in the tube rather than the uterus, and other treatments should be used to remove those pregnancies.

How effective is mifepristone?

In the studies I have been doing, for women up to seven weeks pregnant, 97 percent didn't need any additional treatment.

What does treatment with mifepristone entail?

First, we typically will talk to a patient up to a week before we see her for this treatment. We like to make sure she has plenty of time to think through her plans for her life and how this pregnancy fits into that, and has talked about it with the other important people in her life. Women are not cavalier about making the decision. The women I deal with want to make a sensible choice.

Once use of mifepristone is agreed upon, what happens next?

The woman is evaluated, with medical history and physical exam, to make sure her general health is okay. Next comes the sonogram. If she is really pregnant, and it isn't too late to use mifepristone, there are then two steps: First, she is given the mifepristone, which detaches the pregnancy sac from the uterus and softens the cervix. Then she takes a second medicine, a synthetic version of a naturally produced hormone called prostaglandin, which causes the uterus to have contractions that push everything out. In Europe, 48 hours after taking the first medicine the woman will return to the doctor's office, receive the second medicine and have the expulsion there. In the U.S., women take the second medicine in the comfort and privacy of their own home.

Is the process painful?

Yes, pain and bleeding occur after using the second medicine. Women also fear what they might see. The size of the sac itself, which looks like a tiny balloon, is less than an inch across, and the embryo is the size of a grain of rice. What a woman really sees is blood and, infrequently, some blood clots. Mostly it just looks like a heavier version of her period.

What are possible side effects?

Often there is a substantial amount of cramping and bleeding that lasts longer than what occurs with a surgical abortion. During a medical abortion the cramps last several hours and can be quite severe, and the bleeding might easily continue for two weeks. It is not just, "Take a pill and you are not pregnant anymore." The process resembles a natural miscarriage to a large degree.

Does it affect fertility?

What we know so far is that it does not affect future fertility. The medications are gone from the body within hours.

How does it affect a woman psychologically?

A crisis pregnancy is a loss-of-control situation for a woman. A surgical abortion could be viewed as a further loss of control, because a doctor is solving the problem. A medical abortion may allow her to have a little control over her body.

Is this treatment less expensive than a surgical abortion?

Insurance companies that are willing to pay for an early surgical abortion, which can cost anything from $350 to more than $1,000, are usually willing to reimburse the patient the same amount for an early medical abortion. They seem to be treating them as equal.

Do you see women for a follow-up visit?

Yes. A woman must come back for a follow-up sonogram within two weeks to make sure she is no longer pregnant. It is also a good time to think about the future. We talk about family planning and all of the other important issues that might have been pushed aside because of the immediate crisis.

How is this drug different from the morning-after pill?

The morning-after pills Preven and Plan B are emergency contraceptives that can be used for up to three days after an unprotected act of intercourse, before pregnancy begins.

How do they work?

They have the effect of delaying the appearance of the egg so that the sperm and the egg never join. A woman never knows when she is going to have a broken condom or run out of pills. Every single or married woman ought to have emergency contraception available at home, because it will frequently prevent the need for having an abortion. No matter where you stand on the abortion debate that would seem desirable.

Is a medical abortion better for the patient than a surgical one?

From a medical point of view we can have successful treatment with either. It is really up to the woman. Both procedures are safe and effective very early. Neither of them are trivial. You need a doctor who is trained and thoughtful and paying attention just as you do with any kind of medical treatment.

Are there other uses for mifepristone?

This class of drugs may someday prove to be useful in treating endometriosis, uterine fibroids and even meningiomas, which are benign brain tumors. There should definitely be development and testing for those possible benefits.

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