RU-486

On September 28, 2000, the Clinton-Gore Administration's Food and Drug Administration (FDA) approved the sale of RU-486 (mifepristone) for the performance of abortions up to 49 days after the beginning of the last menstrual period.

As the facts below indicate, with this approval, the Clinton-Gore Administration showed that it placed a higher value on promoting abortion than on protecting a woman's health.

The following text is a partial reproduction of "Mifepristone The French Abortion Pill " from the National Right to Life Committee Web Site. Used with permission from NRLC.

What is RU486?

RU 486 is a chemical compound that, taken in pill form, can induce abortion in women up to nine weeks pregnant. This compound gets the first part of its name from the French company, Roussel Uclaf, which first developed the abortion pill back in 1980. The "486" designation is the shortened version of the original "38486" compound number the pill was first assigned in the Roussel Uclaf laboratory.(1)

RU486 is also known by its generic name, mifepristone, and by Mifegyne, the name under which RU486 is marketed in Europe.(2) "Early Option" is the name under which it is to be sold in the United States.(3)

How does RU486 work?

RU486 is an artificial steroid that interferes with the action of progesterone, a hormone crucial to the early progress of pregnancy.(4) Progesterone stimulates the proliferation of the uterine lining which nourishes the developing child. It also suppresses normal uterine contractions which could dislodge the child implanted and growing on the wall of the mother's womb.(5)

RU486 fills the chemical receptor sites normally reserved for progesterone, but does not transmit the progesterone signal. Sensing what appears to be a drop in progesterone, usually a sign that pregnancy has not occurred, a woman's body shuts down the preparation of the uterus and initiates the normal menstrual process. The child, deprived of necessary nutrients, starves to death. The baby detaches and is swept out of the body along with the decayed uterine lining.(6)

What is the baby like at this time?

During the time frame that RU486 is operative, the baby is undergoing a rapid period of development.

It is at about the fifth week of pregnancy (measured from a woman's last menstrual period) that a mother first begins to suspect she is pregnant, so this is likely to be about the earliest that the chemical abortifacient is used. At this point, the child is about three weeks old(7) and approximately 2mm long (about 1/10 of an inch).(8) Even by this time, however, the baby's nervous system has begun to form(9) and his or her heart is likely to have already begun its first beats.(10) The child's heart will be beating strongly and steadily by the time he or she is just three and a half weeks old.(11)

The effectiveness of the RU486, or mifepristone, method begins to decline after 49 days, or 7 weeks of pregnancy.(12) By that time, the baby will be five weeks old and will have increased in size to 8mm, and his or her face, arms, and legs will be distinguishable.(13)

Before the end of the 9th week of pregnancy (7 weeks for the baby), the outer extreme of mifepristone's effectiveness,(14) the child's ears, fingers and toes will have formed and he or she will be 18mm, or nearly an inch tall, from crown to rump.(15)

Why does a typical RU486 abortion involve a second drug, misoprostol?

Acting alone, RU486 is able to induce an abortion only between 64% and 85% of the time, a rate abortifacient researchers consider "inadequate for general clinical use."(16) This is why, two days after taking the RU486, a woman is given a prostaglandin, usually misoprostol (trade name: Cytotec), to induce powerful uterine contractions to expel the shriveled corpse.(17) Because the use of a prostaglandin (PG) is part of the standard RU486 abortion protocol, it is perhaps more accurate to refer to this as an "RU486/PG" abortion.

The FDA declared RU486 "safe" and "effective." Is it really?

It certainly isn't safe for the baby who suffocates or starves to death.(18) And it strains credulity to label a drug that puts perfectly healthy women in the hospital and may not work nearly a quarter of the time"safe" and "effective."(19)

Despite careful screening to eliminate all but the most physically ideal candidates, 2% of those participating in U.S. trials of RU486 hemorrhaged.(20) One out of a 100 had to be hospitalized.(21) Several women required surgery to stop the bleeding and some bled so much that they had to have transfusions.(22) In the broader, less regulated medical marketplace, outside the careful monitoring of a clinical trial, complications could be expected to be both more common and more serious, especially for those women who do not have immediate access to emergency care.(23)

While tests in France yielded a 95-96% "success" rate,(24) the success rate in American trials for the two drug procedure has been considerably lower. Women in their fifth week of pregnancy aborted 92% of the time, while women in their seventh week aborted 77% of the time.(25) Outside the strict conditions of a clinical trial, reduced screening, monitoring, and compliance is likely to increase the "failure" rate.(26)

What physical side effects are common?

Nausea, diarrhea, vomiting, and painful cramping are quite often part of the package, and sometimes in clinical trials were themselves severe enough to put women in the hospital.(27) Less frequent, but potentially more serious, are side effects such as infection(28) or heart palpitations.(29)

Are there any long term physical consequences?

This is simply unknown at this point. It is known that RU486 crosses the blood follicle barrier and gets into the follicular fluid surrounding a woman's ripening eggs.(30) What impact this will have on future pregnancies, or on children born later on, has not yet been adequately researched.

What about psychological after effects?

Though no long term studies have yet been done, the descriptions women give of their encounters with their aborted children raise great concern. Women who have undergone RU486/PG abortions talk about seeing tiny fists, eyes, or seeing their aborted babies laying in the toilet bowl or swirling in the shower drain.(31) Counselors at abortion clinics indicate it is common for women to express a desire to bury the baby, to perform some sort of ceremony to deal with their strong feelings.(32) These are hardly the reactions of women who consider this a blob of tissue.(33)

Whereas those who undergo surgical abortion only imagine what their unborn children look like and go through, women who have abortions with RU486 have vivid memories of their encounters with their children.(34) And while giving the woman more control over her abortion may assuage the abortionist's guilt, it definitely increases a woman's sense of responsibility for the abortion.(35)

While a sense of relief is what many woman having surgical or chemical abortions feel immediately after the abortion, we know from experience that the symptoms of post abortion trauma often do not show up until years later.(36) When women who have had RU486 abortions begin to deal with their experience, they will have more vivid memories and a greater sense of responsibility to deal with than those who underwent surgical abortions.

Why does the pro-abortion crowd want the abortion pill?

Abortion has become increasingly unpopular with doctors, women, and the American public.

Ostracized by the medical community and worn out by thousands of abortions, many doctors are dropping abortion from their practice and fewer doctors are taking their places.(37) Women use words like "intimidating,"(38)"invasive," "mechanical," "impersonal," "abrupt,"(39) and "traumatic,"(40) to describe their abortion experiences. Increasing majorities, while perhaps not yet ready to proscribe all abortions, nevertheless see abortion as murder or at least the taking of human life, and something that should be limited.(41)

Chemical abortions, like RU486/PG, give supporters of abortion a chance to change the image of abortion, making it seem as simple as taking a pill(42) and concentrating on smaller, less developed babies whose destruction seems an easier political sell.(43) That the reality is far different -- that these abortions offer a whole new set of significant risks, that the objective is still the destruction of a unique human life -- is of little consequence to abortion's promoters as long as their false perception holds.

NOTES

1. Etienne-Emile Baulieu, The "Abortion Pill" (New York: Simon & Schuster, 1991), p. 25.

2. Baulieu, p. 191.

3.. Rachel Zimmerman, "Awaiting Green Light, Abortion Pill Venture Keeps to the Shadows, " Wall Street Journal, Sept. 5, 2000. Stacey Schultz, in an earlier report ("Long-awaited abortion pill will offer more privacy - but no less controversy," U.S. News & World Report, February 28, 2000, p. 79) gave the trade name of the drug as "Mifeprex."

4. André Ulmann, Georges Teutsch, and Daniel Philbert, "RU486," Scientific American, Vol. 262, No. 6 (June 1990), pp. 18-24.

5. Arthur C. Guyton, Textbook of Medical Physiology, 6th ed., (Philadelphia: W.B. Saunders Co., 1981), p. 1012.

6. Baulieu, pp. 13, 16-18; Ulmann, pp. 18-20.

7. Keith L. Moore, The Developing Human, 3rd ed. (Philadelphia: W.B. Saunders, 1982), p. 94.

8. Lennart Nilsson and Lars Hamberger, A Child is Born (New York: Delacorte Press, 1990), p. 77.

9. Keith L. Moore and T.V.N. Persaud, The Developing Human, 5th ed. (Philadelphia: W.B. Saunders, 1993), pp. 385-386.

10. LIFE Educational Reprint #27, "Life Before Birth," p. 6. Reprinted from LIFE, April 30, 1965.

11. Keith L. Moore and T.V.N. Persaud, The Developing Human, 5th ed., p. 65.

12. Irving M Spitz, C. Wayne Bardin, Lauri Benton, and Ann Robbins, "Early Pregnancy Termination with Mifepristone and Misoprostol in the United States," New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998), p. 1243.

13. Moore and Persaud, The Developing Human, 5th ed., p. 3.

14. Spitz, et al., "Early Pregnancy Termination...", p. 1243.

15. Moore and Persaud, The Developing Human, 5th ed., p. 4.

16. Sophie Christin-Maitre, Philippe Bouchard, and Irving Spitz, "Medical Termination of Pregnancy," New England Journal of Medicine, Vol. 342, No. 13 (March 30, 2000), p. 951. While Christin-Maitre, et al specifically referred to the efficacy of mifepristone among women 49 days pregnant or less when recounting these percentages, Ulmann, in Scientific American, p. 23, reported a range of 65% to 80% efficacy. Other studies using similar doses obtained "completion" rates of 65.2% (RU486 Colloboration Group, "Termination of early pregnancy by RU486 alone or in combination with prostaglandin," Chinese Journal of Obstetrics & Gynecology, Vol. 25 (1990), pp. 31-4, 62) and 63.5% (Zheng Shu-rong, "RU 486 (mifepristone): clinical trials in China," Acta Obst. Gyn. Scand, Vol 149 (1989), supplement, pp. 19-23.

17. Irving M. Spitz, C. Wayne Bardin, Lauri Benton, and Ann Robbings, "Early Pregnancy Termination with Mifepristone and Misoprostol in the United States," New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998), pp. 1241-1243.

18. See comment of Mary Jo O'Sullivan, MD, Reproductive Health Drugs Advisory Committee member, U.S. Food and Drug Administration, "New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy," transcript by CASET Associates (Fairfax, VA), p. 290.

19. Spitz, et al, NEJM, pp. 1243-44.

20. FDA Mifepristone Hearing, p. 65.

21. Spitz, et al, NEJM, p. 1243.

22. Spitz, et al, NEJM, p. 1243.

23. See comments of FDA Reproductive Health Drugs Advisory Committee Member Cassandra Henderson, MD, at pp. 278-280, 291-292.

24. FDA Hearing, pp. 28, 30-31.

25. Spitz, et al, NEJM, p. 1243.

26. See comments of Henderson, Sullivan, FDA Hearling, pp. 278-280, 291-292.

27. Spitz, et al, NEJM, pp. 1243-1245.

28. Spitz, et al, NEJM, p. 1244.

29. FDA Mifepristone (RU486) Hearings, pp. 50, 55.

30. Janice G. Raymond, Renate Klein, Lynette J. Dumble, RU486: Misconceptions, Myths and Morals, Cambridge, MA: Institute on Women and Technology, 1991, pp. 75-76.

31. Debra Rosenberg, Michelle Ingrassia, and Sharon Begley, "Blood and Tears," Newsweek, p. 68. Louise Levanthes, "Listening to RU486," Health, January/February 1995, p. 88.

32. Judith Gaines, "Women describe pros, cons of RU486," Boston Globe, May 8, 1995, p. 1.; "Prepare now to counsel patients on RU486," Contraceptive Technology Update, April 1995, p. 53.

33. Levanthes, p. 88-89.

34. Levanthes, pp. 87-89; Gaines, p. 1; Rosenberg, pp. 66-68.

35. Levanthes, p. 88; CTU, p. 52.

36. Anne C. Speckhard and Vincent Rue, "Postabortion Syndrome: An Emerging Public Health Concern," Journal of Social Issues, Vol. 48, No. 3 (1992), pp. 95-119. See also Vincent Rue, Anne Speckhard, James Rogers, and Wanda Franz, "The Psychological Aftermath of Abortion: A White Paper," presented to C. Everett Koop, Surgeon General of the U.S., September 15, 1987. For an earlier reference, see W. L. Sands, "Diagnosing Mental Illness; Evaluation in Psychiatry and Psychology," in Psychiatric History and Mental Status, eds. Freedman and Kaplan (Atheneum, 1973), p. 31.

37. Christine Russell, "Percentage of Physicians Doing Abortions Declines," Washington Post, September 23, 1995, p. A3; Gina Kolata, "Under Pressures and Stigma, More Doctors Shun Abortion,"New York Times, January 8, 1990; Warren Hern, "Hunted by the Right, Forgotten by the Left," New York Times, March 13, 1993, p. 21; Amy Goldstein, "U.S. Abortion Services Drop," Washington Post, January 22, 1995, p. A1.

38. Philip J. Hilts, "Clinic Trials of French Abortion Pill Begin in U.S.," New York Times, October 28, 1994, p. A28.

39. Judith Gaines, "Women describe pros, cons of RU486," Boston Globe, May 8, 1995, p. 1.

40. Andrea Sachs, "Abortion Pills on Trial," TIME, December 5, 1994, p. 46. See also "Prepare now to counsel patients on RU486," Contraceptive Technology Update, April 1995, p. 52.

41. Between July of 1989 and January of 1998, the CBS/New York Times poll saw a shift from 40% to 50% of those calling abortion "murder;" those saying abortion was not murder dropped from 47% to 38% in the same time frame. A January 22, 1998 poll by CNN/Gallup/USA Today found 58% of all Americans believing that abortion should be legal only under certain circumstances and 17% holding abortion should be illegal in all circumstances - a total of 75% rejecting the current policy of abortion on demand.

42. Sue M. Halpern, "RU-486: the unpregnancy pill," Ms., April 1987, p. 56.

43. Margaret Talbot, "This Pill Will Change Everything About Abortion," The New York Times Magazine, July 11, 1999, p. 41; Kim Painter, "Earlier, easier abortions," USA Today, August 4, 1999, p. D1; Rebekah Saul, "The Political Challenges And Educational Opportunities Around Very Early Abortion," The Guttmacher Report, February 1999, p. 6.