RU 486 (Mifepristone) (birth control)

Abortion became an increasingly divisive struggle in the United States at the end of the twentieth century. A symbol of this struggle was the battle over RU 486 (mifepristone), which had less to do with the pill itself than the politics of abortion. The compound was isolated by a team led by Etienne-Emile Baulieu at the French pharmaceutical company Roussell Uclaf in 1980. RU 486 (the test number given by the drug company) blocked the female hormone progesterone, making it impossible for the body to sustain a pregnancy. RU 486 was tested and tried in France beginning in 1982 and by 1988 the French government approved the use of mifepristone when combined with a drug designed to induce uterine contractions to bring about an expulsion of the sloughed uterine substance. As controversy mounted over the use of RU 486 as an abortion pill, Roussell Uclaf attempted to rid itself of the controversy by trying to abandon the drug but was forbidden to do so by the French government.

As knowledge about the drug spread, some 700,000 Americans signed a petition, which was carried to France by Eleanor Smeal and Peg Yorkin, the founders of the Feminist Majority, urging the company to market the drug in the United States. The U.S. Food and Drug Administration (FDA), under prompting from President George Bush, almost immediately placed the drug on an import alert list. Roussell Uclaf was reluctant to get involved in any controversy in the United States and still remained a reluctant manufacturer in France. In spite of this the drug was approved for use in Great Britain in 1991, and other European states followed.

One of the first acts of President William Clinton in 1993 was to instruct the Department of Health and Human Services to promote “the testing, licensing, and manufacture in the U.S.” of mifepristone. Roussell Uclaf, however, still refused to enter the U.S. market and instead donated its U.S. rights to the drug to the Population Council, a New York nonprofit group. Roussell Uclaf also gave up its patent rights in France and the rest of Europe to avoid a threatened boycott of its products. When no major U.S. pharmaceutical firm appeared willing to undertake the manufacture of the product, the Population Council encouraged Joseph Pike, an investor and lawyer, to put together a group to manufacture, test, and market the pill. Pike, however, was later forced out by the Population Council, and ultimately the newly founded Dan-co Laboratories in New York City began to arrange for the manufacture, distribution, and testing of the pill. Most of the names of those involved in manufacturing and testing the drug, however, were kept secret because of the fear of personal attacks on the employees and on agencies and companies involved. By the end of 1996, a total of 2,121 American women had participated in the experiment at seventeen sites around the country. Though the FDA ruled that the drug was safe and effective, it asked for more information about manufacturing and labeling. Such information was submitted but it took until October 2000 to approve the pill and allow it to enter the market. By that time the pill had been in use by over half a million women in some thirteen countries. RU 486 had been approved by the American Medical Association, American Medical Women’s Association, American College of Obstetrics and Gynecologists, and many other groups.

The U.S. procedure for administration of the pill followed the French example, which involves swallowing three pills in the presence of a physician or qualified medical personnel in a clinic or hospital. Two days later the woman returns to receives a dose of another drug, prostaglandin, which causes the uterus to contract. In the majority of cases, the sloughed off material is expelled within a few hours and the woman remains in the clinic for two or three hours. She is then given another prostaglandin pill and held for another hour. She returns to the hospital five or six days later for a physical checkup to be certain the expulsion of the material is complete. Etienne-Emile Baulieu, the inventor of the pill, believes the pill does not resolve the ethical issues surrounding abortion, but rather makes the process less invasive for the pregnant woman.

Twenty years after its invention in Europe, RU 486 was finally approved by the U.S. Food and Drug Administration in the year 2000.

Twenty years after its invention in Europe, RU 486 was finally approved by the U.S. Food and Drug Administration in the year 2000.

Obviously the pill is not for everyone. In France it is the personal preference of 20 percent of women who have abortions, whereas in Britain only 6 percent opt for it. Its advocates assume that many physicians who otherwise have been reluctant to be involved in abortion issues will be more likely to turn to this method because it simply involves prescribing a pill and not engaging in any invasive procedures. This might especially be true in areas where there are few abortion clinics or few physicians willing to be publicly associated with abortion. The use of RU 486 is very much a private affair, and 97 percent of those women who have used it reported they would recommend it to a friend. The FDA approved it for use during the first forty-nine days after a woman’s last menstrual period, when the embryo’s size varies from that of a pencil point to that of a grain of rice.

It should be added that RU 486 is not the only pill that can be used to induce an abortion, and as indicated in the entry on oral contraceptives, many of these can also serve as a morning-after pill. They, however, operate on a different principle. The so-called morning-after pills, Preven and Plan B, essentially high-dose birth control pills, were approved by the FDA in 1998, and as of this writing there is serious consideration of making them available without a prescription. In fact, the American Medical Association has urged that this be done. Although the morning-after pill has aroused less controversy than mifepristone, it has been condemned by the Vatican, and as of this writing Walgreen, the nation’s largest drug chain, has decided not to offer it at its pharmacies.

Although some of the antiabortion foes had indicated they would punish druggists who accept prescriptions for mifepristone, this in the long run would be counterproductive because the drug is also likely to become a major tool in the treatment of progesterone-encouraged cancers in the brain and other parts of the body because of its ability to inhibit progesterone.

Much of the story of mifepristone has been gathered from newspapers such as the Los Angeles Times and the NewYork Times and from news magazines such as Newsweek and Time from October and November 2000.

Next post:

Previous post: