Mifepristone, also RU-486, drug that is used to induce abortions. Mifepristone is used as an alternative to surgical abortions during the first seven weeks of pregnancy.
Mifepristone was developed in 1980 by French endocrinologist Etienne-Emile Baulieu, who was then a consultant to the French pharmaceutical company Roussel Uclaf. The drug was initially called RU-486 because it was the 486th in a series of compounds that the company tested. It has been used in France to induce abortions since 1988. Mifepristone has subsequently been marketed in many countries around the world, including the United Kingdom, Germany, Sweden, and China. However, the United States Food and Drug Administration (FDA) did not approve its use until September 2000. The delay in the United States was due primarily to opposition by conservative religious political activists.
Roussel Uclaf relinquished its patent rights to mifepristone in many countries, including the United States. It did so because of threats that people who oppose abortion would boycott the company’s other products. In the United States the company gave the patent rights to the Population Council, a nonprofit, private research organization. The Population Council spent at least $50 million to test the drug and get it approved by the FDA. Under the trade name Mifeprex, the drug is distributed by Danco Laboratories, a company that was established specifically for that purpose. Mifeprex is thought to be manufactured in bulk by a pharmaceutical company in Shanghai, China. No company in the United States was willing to manufacture the drug because of the controversy surrounding it. Mifeprex is not available in pharmacies. Instead, it is shipped directly to physicians who use it. Most health insurance agencies in the United States have expressed a willingness to pay for the drug.
HOW MIFEPRISTONE WORKS |
Mifepristone is used in conjunction with a drug called misoprostol, a prostaglandin marketed under the trade name Cytotec. In the United States misoprostol is used primarily to prevent stomach ulcers.
Mifepristone works by blocking the action of progesterone, a hormone necessary to sustain a pregnancy. Without progesterone, the fertilized egg detaches from the uterine wall, the cervix softens and opens, and the uterine lining breaks down. Misoprostol, given later, stimulates the uterus to contract and expel the fertilized egg. Because of its progesterone-blocking activity, mifepristone is being tested for a variety of other potential uses. These include inducing full-term labor; treating breast and ovarian cancer, as well as certain other tumors; and as a therapy for endometriosis.
In most cases a woman being treated with mifepristone visits her physician three times. On the first visit the patient takes three pills containing 600 milligrams of mifepristone, which starts the process. In the United States, the patient is required to sign an informed consent form on the first visit to indicate that she understands the risks and requirements of the procedure. Two days later, she returns and is given a pill containing 400 micrograms of misoprostol, which starts contractions. Typically, the woman might wait in the physician’s office or the clinic for up to four hours for the embryo to be expelled. At the third visit, two weeks later, a pelvic examination or a sonogram is conducted to ensure that the pregnancy has ended.
Nearly half the women in the U.S. studies experienced light or moderate bleeding after receiving mifepristone, and 3 percent aborted immediately. The rest did not begin to bleed until after they received misoprostol, and many suffered cramping. Most abortions are complete within two weeks, but a few take longer. In about 8 percent of women who were pregnant 49 days or less, surgery is necessary to complete the abortion.
The primary side effects of mifepristone include nausea, headache, weakness, and fatigue. Those of misoprostol include nausea and vomiting and, in a small number of women, diarrhea.
ADVANTAGES AND PRECAUTIONS |
The principal advantages of a drug-induced abortion, also called a medical abortion or a chemical abortion, are that anesthesia is not required, no medical instruments are used, and the procedure is not invasive. Theoretically, medical abortions can be performed by any physician in the physician’s office, whereas surgical abortions require a clinic or hospital. However, medical abortion becomes progressively less effective after the seventh week of pregnancy. In contrast, a surgical abortion requires only two visits, is over much more quickly, and is more effective in the later stages of pregnancy.
Medical abortion is not appropriate for all women. Women with an ectopic pregnancy—in which the embryo is lodged outside the uterus—cannot have it because it will not end such pregnancies. Women who have an intrauterine device (IUD) in place or who have been taking steroid therapy for a long time should not have a medical abortion. It is also not recommended for women who suffer bleeding disorders or who are taking blood-thinning drugs, women who have genetic blood diseases called porphyrias, or women who are allergic to prostaglandins.
CONTROVERSY |
The ethical issues surrounding mifepristone are virtually identical to those surrounding abortion itself—whether the process is moral. Antiabortion activists claim that abortion is the murder of an innocent human being and that the new drug simply provides physicians with a better weapon. Groups opposed to abortion argue that the ready availability of the drug will lead to a sharp increase in the rate of abortions. However, in France, where the drug has been in use since 1988, the annual number of abortions increased by only about 6 percent from 1990 to 1998, according to the French government’s Directorate of Health. Mifepristone is used in about one-third of the abortions performed in France.
Abortion foes in the United States began a campaign warning women that the drug is dangerous for them because they could suffer excessive bleeding or hemorrhaging. Antiabortion groups questioned the FDA’s highly unusual policy of keeping much information about the drug secret, including the names of distribution company officials and the identities of physicians who conducted clinical trials. The FDA responded that the secrecy was necessary to protect the officials and physicians from violence.
Mifepristone proponents argue that the drug makes the abortion process less invasive for pregnant women. They also point out that, by making abortion potentially available in any physician’s office, the drug eliminates the necessity for women to brave the picket lines and boisterous demonstrations now found outside abortion clinics. Use of mifepristone could also ease fears among abortion physicians, who are sometimes targeted by antiabortion activists with guns. Proponents also argue that mifepristone will increase the pool of health-care providers that include abortion services in their practice and thus will expand access to abortion.
