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Mifepristone (RU-486): The Medical Abortion

Katherine Kennedy

After an eight-year evaluation, as well as rigorous testing, of the drug mifepristone, the Food and Drug Administration approved it for use as an abortifacient in the United States on September 28, 2000. (1) Mifepristone, taken as a pill in doses, was deemed a safe and effective form of medical abortion. With their approval of the drug, the FDA limited the restrictions of it, potentially making it widely available to women across the U.S.. As a revolutionary method of abortion, mifepristone has spent the past twelve years under the scrutiny of the United States government. Originally produces and marketed in France by Roussel Uclaf, the drug, then known as RU-486, made its debut in 1988. (2) However, the Bush administration banned the drug's use in America that same year. Now, twelve years later, after President Clinton allowed for the commencement of testing the drug in 1992, mifepristone has been endorsed by the FDA - yet remains highly controversial.

In 1973 the Supreme Court announced its decision in what is now the landmark case of Roe v. Wade. On January 22, "the Court recognized for the first time that the constitutional right to privacy 'is broad enough to encompass a woman's decision whether or not to terminate her pregnancy.'" (3) This decision legalized abortion nationwide, overruling the legislation that had previously banned abortion in almost two-thirds of the states. (3) However, the Roe v. Wade decision also further defined the rules of abortion. At the point in pregnancy at which the fetus could feasibly sustain life outside of the womb, a state may prohibit abortion. (3) This aspect of the ruling allowed for science to step in - to determine when the decision is no longer that of the woman but of the state.

When does an embryo become a fetus and when is a fetus a person? Before 1973 this question lacked importance in the political field. But with the announcement of Roe v. Wade it took on a greater value. Now doctors, aided by new technology, are constantly redefining when it is an embryo becomes a living thing - saving babies as young as just 23 weeks old. Acts like these make science look as though it is often siding with the pro-life activists. (4)

A human gestation period is divided into three trimesters of approximately three months each for nine months total. In the first trimester the pregnancy starts with a fertilized egg that divides to become tissue and cleavage, which become an embryo. In these first three months the embryo goes through organogenesis and develops body organs, its heart beats after the fourth week, brain waves can be monitored after six weeks, and by the eighth week all major body parts are present. (4) At the end of the trimester the embryo has matured into a fetus. During the second trimester the fetus grows from the approximately 5cm it was at the end of the first trimester to about 30cm long. It also begins to move as it is continuing to mature. By the third trimester it becomes fully-grown, completely fills the capacity of the womb, and fully matured at about 50cm long. (5) Since the heart has been beating since the beginning of the first trimester, a fetus in the stages of the second and third trimesters are almost always considered alive and, therefore, state property to some extent unless there are extenuating circumstances. This means almost all abortions are received in the first trimester.

There are two types of abortion, surgical and medical. Three types of surgical abortion procedures are currently practiced in the United States today. The first is known as the manual vacuum aspiration. In this procedure the uterus is emptied with the use of a manual syringe. This is for the first trimester only - from the time that a woman knows she is pregnant to just before ten weeks of pregnancy. The second, known as dilation and suction curettage, may be preformed as late as fourteen weeks into the pregnancy. This procedure involves the emptying of the uterus with machine-operated suction and then cleaning the walls of the uterus with a curette. The third procedure, dilation and evacuation, is composed of two parts. First the cervix is opened and then the fetus, which may be up to twenty-four weeks old, is removed with medical instruments, suction, and the use of a curette to "scrape" and clean the walls of the uterus. (6)

While all three of these methods have proven to be safe (in fact 10% safer than the continuation of the pregnancy (6)) and all are completely 100% effective in regular pregnancies - they have become less available to the general public in the past few years. Today in the United States there are no abortion providers in 86% of all counties. One in four women must travel over fifty miles to go to a women's clinic. (4) This problem of availability is where the medical abortion with mifepristone becomes an important option.

When the FDA approved mifepristone for use in the United States, it did not limit its distribution to only doctors that already perform abortions, nor does it require a doctor to complete any type of training in order to distribute the drug. In fact any doctor who is able to establish the date of the pregnancy conclusively and provide surgical intervention in the event that something goes wrong, may write a prescription for and administer mifepristone. (4) In using mifepristone in a medical abortion a woman will make three visits to her doctor for treatment. The first will occur after she knows she is pregnant and the length of the pregnancy has been determined and is less than 49 days. During this visit, after signing a consent form and also making arrangements for a surgical abortion in the even that the medical abortion does not work, she will receive 600mg of mifepristone to be taken in the doctor's office and then she will be able to leave. The mifepristone alone is about 60-80% effective in causing an abortion, which is not effective enough to be used as a major dug on the market, so it is followed with a dose of misoprostol (already approved by the FDA). The patient may be given this second dose to take in the office or to go home and take. The abortion occurs usually after this second dose. A third visit takes place two weeks after the misoprostol; the doctor makes sure that the abortion is successful, if it is not the woman will undergo a surgical abortion. (5)

How does this work? There are two main female hormones. The first, estrogen, causes puberty when first produced in girls and menopause when no longer produces in women. The second is progesterone. Progesterone makes pregnancy possible, it prepares the uterus for a child by enlarging it and increasing mucus in the cervix. Mifepristone suspends the action of the progesterone and therefore, stops the pregnancy as without progesterone it cannot be sustained. The second dose of misoprostol is known as a prostaglandin. It is a hormone that contracts the uterus - effectively inducing labor and forcing the fetal tissue out of the uterus. After this a woman will go home, experience mild to moderate cramping, heavy bleeding as the uterus passes the fetal tissue, head aches, nausea, and a variety of other side effects. The abortion itself generally occurs in the first four to six hours after the dose of misoprostol but the side effects , especially bleeding, may last up to two to three weeks. However, the mifepristone and misoprostol combination is over 95% effective if taken within the first six to seven weeks of pregnancy. (1) (2)(5)(6)(7)

While pro-choice activists love the availability, privacy, and safety of the medical abortion with mifepristone, pro-life activists despise it for the same reasons. One argument against the new abortion drug is that it seems so relaxed that women will more easily forget about the ethical issues against abortion and opt for the convenience that mifepristone does provide. The fact that the abortion is meant to be carried out in the very first stages of life shifts the focus from a child to a bunch of formless tissue, leaving pro-lifers to restructure their campaigns. However, with the obvious advantages of mifepristone as well as its safety and efficiency records over the eight years it was tested , the FDA made correct choice in its approval of the use of the drug despite all arguments against it.

WWW Sources

1) Food and Drug Administration as well as Center for Drug Evaluation and Research information page on mifepristone. "Mifepristone Information"

2) Planned Parenthood information page on mifepristone. "Expanding Women's Options for Early Abortion"

3) Planned Parenthood information page. "Roe v. Wade: Its History and Impact"

4) CNN.COM political analysis of the FDA approval of mifepristone. "The Pill Arrives"

5) Life Issues Institute Inc. article on the medical and biological effects of RU-486. "RU486: Miracle or Cure"

6) Planned Parenthood information page on abortion. "Choosing Abortion - Questions and Answers"

7) Planned Parenthood information page on medical abortions. "Medical Abortions - Questions and Answers"




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