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) “Mifeprex,” is the name under which it is to be sold in the United States,(3) though it will also be marketed as the “Early Option” pill.(4)
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.(5) 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.(6)
RU486 fills the chemical receptor sites normally reserved for progesterone, but does not transmit the progesterone signal. Failing to receive that signal, 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.(7)
Is this the “morning after” pill I’ve heard so much about?
No. Those pills operate in a different way and during a different time frame than RU486.
Morning after pills, or “emergency contraception,” are essentially very high, multiple dosages of birth control pills taken within 72 hours of unprotected intercourse. (8), (9)
While there have been some limited tests of RU486 as a morning after pill, with mixed results, (10) the only purpose for which the U.S. sponsor has sought government approval is for use to abort a confirmed pregnancy (11),(12)weeks after the baby has already attached himself or herself to the uterine wall. (13)
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 (14)and approximately 2mm long (about 1/10 of an inch).(15) Even by this time, however, the baby’s nervous system has begun to form (16) and his or her heart is likely to have already begun its first beats.(17) The child’s heart will be beating strongly and steadily by the time he or she is just three and a half weeks old.(18)
The effectiveness of the RU486, or mifepristone, method begins to decline after 49 days, or 7 weeks of pregnancy.(19) 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.(20)
Before the end of the 9th week of pregnancy (7 weeks for the baby), the outer extreme of mifepristone’s effectiveness,(21) 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.(22)
Does RU486 have any other, non-abortifacient, uses?
While researchers have proposed a long list of diseases and conditions that RU486 might be useful against, and in some cases, conducted limited testing, the only purpose for which the U.S. sponsor has pursued government approval is abortion. (23)
Because of its properties as a antiprogestin (a compound that inhibits the action of the hormone progesterone), some believe that it may be helpful in treating endometriosis, fibroids, breast cancer, and certain non-malignant brain tumors called meningomas. (24) Pro-life groups such as the National Right to Life Committee have never opposed the testing or use of RU486 for such therapeutic purposes, but evidence of its effectiveness in these applications, (25)as well as evidence of the pill’s promoter’s real interest in such applications, is limited. (26)
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.” (27) 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. (28) 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.
How long does a typical RU 486/PG abortion take and how many steps does it involve?
An RU486/PG induced abortion can take days, weeks, or never happen at all. It typically involves three (or more) visits to the doctor’s office over a two week period.
In her first visit, a woman is “counseled,” given a physical examination, perhaps an ultrasound, and if there are no obvious contraindications (common red flags such as high blood pressure, diabetes, heavy smoking, allergies, etc. that could make taking the drug deadly or dangerous for her (29), she is given the RU486 pills, which she takes in the presence of the abortionist.
Two days later, during a second visit to the doctor’s office, she is given the prostaglandin, which she takes orally or has inserted vaginally. Gradually, as the drug begins to take effect, she experiences powerful, painful uterine contractions which begin to work to expel the baby.
In U.S. trials, about half (49%) aborted during the four hours they spent waiting in the doctor’s office following the administration of the prostaglandin. An additional 26 % aborted sometime over the next 20 hours, on the bus ride home, at work, in the shower, etc. The rest who aborted did so at some point during the following two weeks. Between 8% and 23% (depending on how many weeks pregnant the mother was) never completely aborted or didn’t abort at all using the drugs.
A third visit some 14 days from the woman’s initial visit allows the doctor to confirm whether or not the abortion has been completed. If it hasn’t, the abortionist will encourage the woman to undergo a surgical abortion to guard against the possibility that she will give birth to a child who may have been injured by the drugs. (30), (31)
What sort of medical conditions might keep a woman from being offered the chemical abortion method?
Despite public claims of its ease and safety, the RU486/PG abortion method comes with a long list of contraindications, i.e., conditions that doctors believe should disqualify a woman from using the method or should at least call for heightened caution and monitoring among those selecting patients and administering the drugs because of the increased medical risks faced by such women.
Abortion researchers have recommended that women with adrenal failure, severe asthma, or receiving long-term glucocorticoid therapy not be given the drugs. Those same researchers recommend that the drugs be used cautiously in women with complicated diabetes mellitus, severe anemia, hemorrhagic [bleeding or clotting] disorders, or receiving treatment with anticoagulants. A prostaglandin sometimes used with RU486, sulprostone, has been associated with heart failure in women who were over 35, obese, smoked, or had other cardiovascular risk factors, though these have not yet been reported with the prostaglandin misoprostol.(32)
Other conditions that previous researchers have considered sufficient grounds to exclude women from clinical trials of the drugs include high blood pressure, bronchitis, menstrual irregularity, fibroids, endometriosis, use of IUD or oral contraceptives (in past three months), history of problem pregnancy, current ectopic pregnancy, pelvic inflammatory disease, allergies, epilepsy, adrenal insufficiency, recent intake of steroid or anti-inflammatory medication, or a history of liver, stomach, or intestinal disease.(33)
The FDA declared RU486 “safe” and “effective.” Is it really?
It certainly isn’t safe for the baby who suffocates or starves to death.(34) 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” or “effective.”(35)
Despite careful screening to eliminate all but the most physically ideal candidates, 2% of those participating in U.S. trials of RU486 hemorrhaged. (36) One out of a 100 had to be hospitalized.(37) Several women required surgery to stop the bleeding and some bled so much that they had to have transfusions.(38) 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.(39)
While tests in France yielded a 95-96% “success” rate, (40) 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. (41) Outside the strict conditions of a clinical trial, reduced screening, monitoring, and compliance is likely to increase the “failure” rate. (42)
Claims of higher effectiveness and less frequent complications made since approval (43) have yet to be independently medically verified, though a higher incidence of pelvic infections has been reported. (44)
Didn’t an Iowa woman participating in the U.S. trials in 1994 nearly bleed to death?
Yes. According to Mark Louviere, the doctor who treated the woman, she lost between one-half to two thirds of her total blood volume and probably would have died if she had not had emergency surgery. (45) The doctor came forward after reading a press report that the Iowa portion of the trials had ended with “no complications”among the 238 women there who took part in the test. (46) “If near death due to the loss of half of one’s blood volume, surgery, and a transfusion of four units of blood do not qualify as a complication,” Louviere told the Waterloo Courier, “I don’t know what does.” (47)
What other 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. (48) Less frequent, but potentially more serious, are side effects such as infection (49) or heart palpitations. (50)
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. (51) What impact this will have on future pregnancies, or on children born later on, has not yet been adequately researched.
Are chemical abortions safer than surgical abortions?
Both chemical and surgical abortions have their risks, and it is not clear that they are directly comparable.
Promoters of the abortion pill often speak as if RU486/PG abortions are safer because they are earlier abortions. (52)While it is true that earlier surgical abortions are safer than later surgical abortions, (53) owing to the increasing size of the baby and the increasing complexity of the surgical procedure, (54) it isn’t clear that early chemical abortions are necessarily safer than later surgical abortions. Because the methods are so different, this is like comparing apples and oranges.
With surgical abortions, a woman faces the risks of cervical lacerations, (55) uterine or bowel perforations, (56)scarring, infection, and even permanent infertility. (57) These risks, due to the surgical process itself, may be avoided in a chemical abortion (provided a woman is not in that 8%-23% for whom the method fails (58). But the woman undergoing a chemical abortion faces a whole new set of risks, ranging from hemorrhage (59) to heart failure, (60)typically not faced by the surgical patient.
Variations in the severity and frequency of these complications make it difficult to identify one method as safer than another. Significant injury or worse is possible with either method.
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. (61) 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. (62) These are hardly the reactions of women who consider this a blob of tissue. (63)
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. (64) 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. (65)
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. (66)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
1. Etienne-Emile Baulieu, The “Abortion Pill” (New York: Simon & Schuster, 1991), p. 25.
2. Baulieu, p. 191.
3. U.S. Food and Drug Administration, “Mifepristone Label,” available at www.fda.gov/cder/foi/label/2000/20687lbl.htm.
4. Rachel Zimmerman, “Awaiting Green Light, Abortion-Pill Venture Keeps to the Shadows,” Wall Street Journal, September 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.”
5. André Ulmann, Georges Teutsch, and Daniel Philbert, “RU486,” Scientific American, Vol. 262, No. 6 (June 1990), pp. 18-24.
6. Arthur C. Guyton, Textbook of Medical Physiology, 6th ed., (Philadelphia: W.B. Saunders Co., 1981), p. 1012.
7. Baulieu, pp. 13, 16-18; Ulmann, pp. 18-20.
8. Planned Parenthood Federation of America, Inc., Emergency Contraception Handbook, Planned Parenthood booklet, 1999, pp. 8-9, 11.
9. Robert A. Hatcher, et al, Contraceptive Technology, 16th rev. ed. (New York: Irvington Publishers, 1994), pp. 453, 455, 459, 461.
10. A Psychosos, et al, “Hormonal anti-implantation agents: antiprogestins,” Human Reproduction Vol. 10, supplement 2 (December 1995), pp. 140-150; I.M. Spitz, et al, “Effect of mifepristone on inhibition of ovulation and induction of luteolysis,” Human Reproduction, Vol. 9, supplement 1 (June 1994), pp. 69-76; I.M. Spitz, A. Robbins, “Mechanism of action and clinical effects of antiprogestins on the non-pregnant uterus,” Human Reproduction Update, Vol. 4, No. 5 (September-October, 1998), pp. 584-593; Task Force on Postovulatory Methods of Fertility Regulation, “Comparison of three single doses of mifepristone as emergency contraception: a randomised trial,” Lancet, Vol. 353 (February 27, 1999), pp. 697-702.
11. Reproductive Health Drugs Advisory Committee, U.S. Food and Drug Administration, Transcript, “New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy,” (available from CASET Associates, Fairfax, Virginia); PPFA, Emergency Contraception Handbook, p.22.
12. Irving M. Spitz, et al, “Early Pregnancy Termination with Mifepristone and Misoprostol in the United States,” New England Journal of Medicine, Vol. 338, No. 18 (April 30, 1998), p. 1242.
13. Keith L. Moore, The Developing Human, 4th ed. (Philadelphia: W.B. Saunders Co., 1988), p.2.b
14. Keith L. Moore, The Developing Human, 3rd ed. (Philadelphia: W.B. Saunders, 1982), p. 94.
15. Lennart Nilsson and Lars Hamberger, A Child is Born (New York: Delacorte Press, 1990), p. 77.
16. Keith L. Moore and T.V.N. Persaud, The Developing Human, 5th ed. (Philadelphia: W.B. Saunders, 1993), pp. 385-386.
17. LIFE Educational Reprint #27, “Life Before Birth,” p. 6. Reprinted from LIFE, April 30, 1965.
18. Keith L. Moore and T.V.N. Persaud, The Developing Human, 5th ed., p. 65.
19. 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.
20. Moore and Persaud, The Developing Human, 5th ed., p. 3.
21. Spitz, et al., “Early Pregnancy Termination…”, p. 1243.
22. Moore and Persaud, The Developing Human, 5th ed., p. 4.
23. See transcript of FDA Mifepristone Hearings, “New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy.”
24. Committee on Antiprogestins, National Academy of Sciences, Clinical Applications of Mifepristone (RU486) and Other Antiprogestins (Washington, D.C.: National Academy Press, 1993), pp. 36-51.
25. F. Darro, et al, “Growth inhibition of human in vitro and mouse in vitro and in vivo mammary tumor models by retinoids in comparison with tamoxifen and the RU-486 anti-progestagen,” Breast Cancer Res Treat, Vol. 51, No. 1 (September, 1998), pp. 39-55; W.G. Schoonen, et al, “Effects of two classes of progestagens, pregnane and 19-norestosterone derivatives, on cell of human breast tumor cells: II. T47D cell lines,” Journal of Steroid Biochem and Mol Biology, Vol. 55, Nos. 3-4 (December 1995), pp. 439-44; L.M. Kettel, et al, “Preliminary report on the treatment of endometriosis with low-dose mifepristone (RU486),” American Journal of Obstetrics and Gynecology, Vol. 178, No. 6 (June 1998), pp. 1151-1156.
26. Regina Sitruk-Ware, in “Les antiprogesterones,” Presse Med, Vol. 28, No. 38 (December 4, 1999), pp. 2123-2131, talks about the use of RU486 for endometriosis, fibroids, and meiningomas, but focuses largely on abortion and labor induction properties examined in large clinical studies.
27. 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 Collaboration 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.
28. 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.
29. See the NRL-Educational Trust Fund fact sheet “RU486: Risks & Dangers,” for a full list of contraindications and references.
30. 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).
31. Oregon Health Sciences University, “Consent Form” for “Evaluation of the Efficacy, Safety and Acceptability of Mifepristone and Misoprostol in Inducing Abortion in Pregnant Women with Amenorrhea of up to 63 Days” (ORS #3703, Protocol 166B), 12/1/94.
32. Christin-Maitre, et al, “Medical Termination of Pregnancy,” pp. 952-953.
33. Raymond, et al, RU 486: Misconceptions, Myths, and Morals, pp. 34-37; B. Couzinet, N. Le Strat, A. Ulmann, E-E. Baulieu, G. Schaison, “Termination of early pregnancy by the progesterone antagonist RU 486 (mifepristone),” New England Journal of Medicine, Vol. 315 (December 18, 1986), pp. 1565-70; L. Silvestre, C. Dubois, M. Renault, Y. Rezvani, E-E. Baulieu, A. Ulmann, “Voluntary interruption of pregnancy with mifepristone (RU486) and a prostaglandin analogue: a large-scale French experience,” New England Journal of Medicine, Vol. 322 (March 8, 1990), pp. 645-648.
34. 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.
35. Spitz, et al, NEJM, pp. 1243-44.
36. FDA Mifepristone Hearing, p. 65.
37. Spitz, et al, NEJM, p. 1243.
38. Spitz, et al, NEJM, p. 1243.
39. See comments of FDA Reproductive Health Drugs Advisory Committee Member Cassandra Henderson, MD, at pp. 278-280, 291-292.
40. FDA Hearing, pp. 28, 30-31.
41. Spitz, et al, NEJM, p. 1243.
42. See comments of Henderson, Sullivan, FDA Hearling, pp. 278-280, 291-292.
43. Statement of Planned Parenthood, 9/24/01, available at www.plannedparenthood.org/about/pr/92401mifepristone.html.
44. Shari Roan, “Abortion Pill Is Safe in First Year of Use in U.S., Proponents Say” Los Angeles Times, 10/1/01.
45. Statement of Mark Louviere, MD, FDA Mifepristone (RU486) Hearing, 7/19/96, pp. 223-227.
46. Associated Press, “Iowa ‘abortion pill’ test heralded as a success,” Des Moines Register, September 2, 1995, Metro section, p. 5.
47. Tom Carney, “‘Abortion pill’ test goes awry for one patient,” Des Moines Register, Metro section, p. 1, 5.
48. Spitz, et al, NEJM, pp. 1243-1245.
49. Spitz, et al, NEJM, p. 1244.
50. FDA Mifepristone (RU486) Hearings, pp. 50, 55.
51. Janice G. Raymond, Renate Klein, Lynette J. Dumble, RU486: Misconceptions, Myths and Morals, Cambridge, MA: Institute on Women and Technology, 1991, pp. 75-76.
52. Testimony of Beverly Winikoff, Program Director of Reproductive Health, Population Council at FDA Mifepristone Hearings, p. 81; Margaret Talbot, “This Pill Will Change Everything About Abortion,” The New York Times Magazine, July 11, 1999, p. 41; Aaron Zitner, “What ever happened to RU-496?” The Boston Globe Magazine, November 23, 1997, p. 39.
53. Jack Pritchard, et al, Williams Obstetrics, 17th ed. (Norwalk, CT: Appelton-Century-Crofts, 1985), p. 483.
54. Warren M. Hern, Abortion Practice (Philadelphia: J.B. Lippincott, 1984), pp. 26-35.
55. Kenneth F. Schulz, et al, “Measures to Prevent Cervical Injury During Suction Curettage Abortion, “The Lancet, May 28, 1983, p. 1182.
56. Philip G. Stubblefield, “First and Second Trimester Abortion,” in Gynecologic and Obstetric Surgery, ed. David H. Nichols (Baltimore: Mosby, 1993), pp. 1023-1024; Stephen G. Kaali, et al, “The frequency and management of uterine perforations during first-trimester abortions,” American Journal of Obstetrics and Gynecology, August 1989, pp. 406-408.
57. David N. Danforth, ed. Obstetrics and Gynecology, 5th ed. (Philadelphia: J.B. Lippincott, 1986), pp. 217, 257, 382-383, 887; Nichols, Gynecologic and Obstetric Surgery, p. 260; Pritchard, Williams Obstetrics, 17th ed., p. 484; Leon Speroff, et al, Clinical Gynecological Endochrinology & Infertility (Baltimore: Williams & Wilkins, 1983), pp. 156- 157.
58. Spitz, “Early Pregnancy Termination…,” p. 1241.
59. Spitz, “Early Pregnancy Termination…,” p. 1243; Statement of Mark Louviere, FDA Mifepristone Hearings, pp. 223-225.
60. Alan Riding, “Frenchwoman’s Death Linked to Abortion Pill and a Hormone,” New York Times, April 10, 1991, p. A-10.
61. Debra Rosenberg, Michelle Ingrassia, and Sharon Begley, “Blood and Tears,” Newsweek, p. 68. Louise Levanthes, “Listening to RU486,” Health, January/February 1995, p. 88.
62. 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.
63. Levanthes, p. 88-89.
64. Levanthes, pp. 87-89; Gaines, p. 1; Rosenberg, pp. 66-68.
65. Levanthes, p. 88; CTU, p. 52.
66. 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