A visit to the doctor's office reveals a young woman is six weeks pregnant. The news is not welcome. Perhaps she is nearing the completion of school, up for a promotion at work, or planning a career change. Maybe she doesn't want to marry the child's father. Whatever the circumstance, she's pregnant but doesn't intend to stay that way.
Had it been a few years earlier, she would have made an appointment for a surgical abortion at the nearest clinic. But now, since the dream of feminists and family planners has been realized, she can simply ask her physician for a dose of the latest weaponry in fatal assaults on unborn children - RU486.
RU486 (labeled as Mifeprex) in combination with a prostaglandin (Cytotec), causes her body to expel her unborn child. She doesn't have to cross pro-life picket lines at the abortion clinic, or endure seeing photographs of unborn children and hearing pleas to spare her child's life. She can "terminate her pregnancy" in the privacy of her own home.
Enthusiasm for RU486
Reproductive rights groups cheered the development of RU486, claiming it would grant women greater control over reproduction and privatize abortion. Since it works early in pregnancy, they believe RU486 removes the "moral stigma of abortion."
A Miami Herald columnist intoned that "embryos the size of a pea do not scream out in pain," and that pro-lifers would have a hard time picketing the homes of all the women who would use RU486. Consequently, abortion advocates believe RU486 will create an entirely new playing field for the abortion controversy.
RU486 could vastly expand the number of abortion providers. A national survey revealed that many more obstetrician/gynecologists, and even family physicians, who did not do surgical abortions would offer the abortion pill.1
History of the abortion pill
RU486 is the brainchild of French researcher Etienne-Emile Baulieu. He found a chemical mechanism that would prevent a pregnant woman's body from producing the hormone that sustains early pregnancy.
Roussel-Uclaf, the French subsidiary of Hoechst AG, patented the drug. Hoechst, a giant German conglomerate, has World War II ties to the poison gas used in the Holocaust.2 Wanting to avoid connection with another holocaust, they withdrew production of RU486 in 1988, until the French government ordered it back on the market as "the moral property of women."
For a few years, executive orders and federal legislation prevented the abortion pill from coming to our shores, but soon after President Bill Clinton took office, the Food and Drug Administration approved RU486 for testing in this country. Still, for a time, no American drug company was willing to risk a pro-life boycott.
Then, the Population Council gained permission to find a manufacturer, conduct tests, and bring RU486 to the U.S. They finally resorted to a Chinese manufacturer and created a new company, Danco, in the U.S. to market the pill. The FDA pushed to complete the process before Clinton left office. In September, 2000, the FDA approved RU486 with stipulations, including these: Doctors prescribing it must be able to assess how far along in pregnancy a woman is, be located near a hospital for emergencies, and provide surgical abortion as a back-up.3
This has had a somewhat chilling effect on the number of doctors and clinics willing to offer RU486. So has concern over the method's cost to women ($270 plus the cost of ultrasound and additional exams, totaling around $600). Another blow to abortion advocates came when Searle, the manufacturer of the method's second component, warned doctors against its off-label use, saying it could cause uterine rupture, leading to hystorectomy or even death.4
How the abortion pill works
In RU486: The Hidden Effects, Lawrence Roberge describes the abortion pill's mechanism of action: "Progesterone is necessary in the woman to maintain the lining of the uterus, which, during pregnancy is loaded with blood vessels, and acts as a life support system for the developing embryo. (Note: the developing life for the first sixty days post conception is medically referred to as an embryo, whereas after two months it is referred to as a fetus.) As the embryo implants into the uterine lining, the embryo grows dependent upon the mother's uterine blood supply for nutrients, oxygen, and waste removal. Thus, any cut-off of the blood supply would lead to the rapid death of the developing life.
"RU486 acts to block the effects of progesterone to maintain the uterine lining. As the progesterone signal is cut off in the uterus, the uterine blood vessel lining begins to break down, and subsequently the embryo dies.
"Now as the embryo is dead, the uterus may try to expel the embryo and its surrounding tissues. RU486 alone results in only about a 60 to 65 percent success rate. Therefore, doctors give a second very powerful drug, a prostaglandin called misoprostol [Cytotec], which causes very strong (and sometimes very painful) uterine contractions to expel the dead embryo. Using the dual drug system, RU486 and misoprostol, the success rate rises to 84 to 95 percent."5
The treatment cycle
The FDA approved the following protocol: Patients are to be given 600 milligrams of RU486 (Mifeprex), followed 48 hours later by a small dose of Cytotec. Women are observed for four hours after administration of Cytotec, and return within two weeks for a final assessment. Those whose pregnancies are not "interrupted" within that time have surgical abortions.6
A treatment cycle similar to this is used in France and other countries where the abortion pill is legal. The drugs are administered in a medical setting, under a doctor's care, after it's been determined the woman is pregnant and that her pregnancy has not gone beyond the recommended time frame. Medical staff must also screen patients, tell them about potential side effects, and receive assurances they will return for two or three additional visits.
In no way does this regimen resemble advocates' dream of an easy, "at home" abortion kit.7 That is why, without FDA approval, American abortion providers altered the protocol so that women are allowed to have RU486 through nine weeks and may take the second drug at home, sometimes in suppository form.
Complications
The abortion pill is also not as worry-free as many believed. France has reported three heart attacks, including one death, in relation to RU486. Canada ended its trials of the drug after a woman died. Two British women died, but their deaths were covered up for a while.8 During American tests in Iowa, one woman nearly bled to death, even though the local Planned Parenthood reported there had been no complications.9 As of March 2003, there were 46 hospitalizations after RU486 in the U.S. and one death due to an undiagnosed ectopic (tubal) pregnancy. 10
Later in 2003, a California teenager found out just how dangerous RU486 can be. So did her family - too late. Unmarried eighteen-year-old Holly Patterson was seven weeks pregnant when she visited her local Planned Parenthood office for a "medical" (drug-induced) abortion. One week later, she lay in a hospital emergency room - bleeding excessively, in pain, and in shock. Her father learned about her abortion shortly before she died of a massive infection caused by parts of the baby or placenta having been left behind. Her death was the second in the U.S., the first in a patient with no other apparent complications.11 Since then, several other deaths have been reported.
Shortly after Holly's death, Mr. Patterson lamented, "The medical community treats this as a simple pill you take, as if you're getting rid of a headache. The procedure, the follow-ups, it's all too lackadaisical. The girl gets a pill. Then she's sent home to do the rest on her own. There are too many things that can go wrong."12 Members of Congress are working to pass Holly's Law, which will repeal approval for the abortion pill.
Heavy bleeding is the most common side effect. The average woman bleeds eight to ten days. Most women also experience painful abdominal cramps. Many also suffer infections because RU486 suppresses the immune system.5 Other complications from Mifeprex and Cytotec include nausea, vomiting and diarrhea. Roughly one percent, like Holly Patterson, experience incomplete expulsion of their embryos.
What do women say?
Women say their involvement with this type of abortion seems more personal. They retain control of the abortion, and consequently bear more responsibility. They also see the results.
Newsweek magazine reported the experience of one woman who agreed to be interviewed during her time at the clinic. After the embryo was expelled, "Becky [saw] the curled-up fetus, the size and color of a cocktail shrimp. 'Look at that, honey,' Becky says to Richard [her husband]. Its hands are curled into tiny fists. 'It's sad. It's sad,' Becky murmurs, turning away. . . .
"Becky preferred the medical abortion to her surgical ones, even though it was more emotionally draining. She wanted to experience the pain, both emotional and physical, she says. She felt she should suffer for terminating her pregnancy, since for her, as for many women who have an abortion, the certainty that she did not want to carry the fetus to term did not make the decision any less morally or emotionally ambiguous.
"'There was a little bit of regret about seeing [the embryo], because it had little hands,' Becky says. 'I remember little fists. I felt more responsible this time.'"13
Other uses for RU486?
Aside from its use in abortions, RU486 has also been tested as a 'morning after' pill and a method of late-term abortion.14 For now, its only proven use is to cause the death of an unborn child in the fifth to ninth week of pregnancy.
The pro-life movement does not oppose legitimate uses of any drug, but warns that once a drug is approved for one use, it is difficult to prevent misuse. For example, while waiting for RU486 to be approved, abortionists tested another drug already on the market that is lethal to unborn babies. Methotrexate, an approved cancer-fighting drug, taken in combination with the Cytotec (which is only approved for treating ulcers) works much the same way as RU486.
Objection to RU486
Any form of abortion, whether accomplished by surgical instruments or drugs, is abhorrent to God (Proverbs 6:16-17). It makes no difference how early in pregnancy an abortion occurs because the unborn child is alive from the moment of conception. Having human parents and distinct DNA, he or she is a distinct human being created in God's image. According to Psalm 139:13-16, every unborn child is a person who is known, understood, and valued by God.
Were RU486 safer than aspirin or cured the common cold, pro-lifers would still object to it being used to cause abortions. As Carrie Earll, a bioethics analyst, noted, "Mifeprex is unique as it is the first drug approved for the U.S. market for the sole purpose of ending a human life. It has no therapeutic value to the patient (the mother) and its success is measured in its ability to destroy the preborn baby in the womb."15
Endnotes
1. Kaiser Family Foundation's National Survey of Health Care Providers on Medical Abortion, press release 9/16/98, http://www.kff.org/womenshealth /1431-ru486_rel.cfm.
2. John C. Willke, M.D., address at the National Right to Life Convention, Minneapolis, MN, June, 1989.
3. Approval Letter MIFEPREXTM (mifepristone) Tablets, 9/28/00, Center for Drug Evaluation and Research to Population Council, http://www.fda.gov/cder/foi/appletter/2000/20687appltr.htm.
4. Warning letter regarding off-label use of Cytotec, 8/23/00, Searle to health care providers, http://www.fda.gov/medwatch/safety/2000/cytote.htm. See also http://www.fda.gov/cder/drug/advisory/mifeprex200603.htm and http://www.fda.gov/cder/foi/label/2005/020687s013lbl.pdf.
5. Roberge, RU486: The Hidden Effects, 1998, http://pages.map.com/lroberge/ru486.htm. Silvestre, et al, "Voluntary Interruption of Pregnancy with Mifepristone (RU486) and Prostaglandin Analogue," New England Journal of Medicine, 322:10, 3/8/90, p. 646.
6. Spitz, et al, "Early Pregnancy Termination with Mifepristone and Misoprostol in the United States," NEJM, 338:18, 4/30/98, 1241.
7. Raymond, et al, RU486: Misconceptions, Myths and Morals (Cambridge, MA: Institute on Women and Technology), 1991.
8. Day and Bisset, "Revealed: Two British women die after taking controversial new abortion pill," Sunday Telegraph, 1/18/04.
9. Louviere, "Pro-Abortion Group Lies about RU486," Waterloo Courier Opinion, 9/24/95, p. F3.
10. Letter with new safety information, 4/19/02, Danco Laboratories to health care providers, http://www.fda.gov/medwatch/SAFETY/2002/
mifeprex_deardoc.pdf.
11. Hall, "Questions abound about why pregnant teen died," San Francisco Chronicle, 9/24/03, p. A21. Manier, "Teen's death rekindles abortion pill battle," Chicago Tribune, 11/30/03. Kaufman, "Death after abortion pill reignites safety debate," Washington Post, 11/3/03, p. A03.
12. Guthrie, et al, "After daughter's death, father wants close look at RU486," San Francisco Chronicle, 9/20/03, p. A17.
13. Rosenberg, et al, "Blood and Tears," Newsweek, 9/18/95, p. 66.
14. "Lower Dose Mifepristone Effective in Second Trimester Abortions," British J Obstetrics and Gynaecology, 103, 1996, p. 706.
15. Earll, "Will Holly Patterson die in vain?" Family News in Focus, 11/3/03, http://www.family.org/cforum/fnif/commentary/a0028707.cfm.
A visit to the doctor's office reveals a young woman is six weeks pregnant. The news is not welcome. Perhaps she is nearing the completion of school, up for a promotion at work, or planning a career change. Maybe she doesn't want to marry the child's father. Whatever the circumstance, she's pregnant but doesn't intend to stay that way.
Had it been a few years earlier, she would have made an appointment for a surgical abortion at the nearest clinic. But now, since the dream of feminists and family planners has been realized, she can simply ask her physician for a dose of the latest weaponry in fatal assaults on unborn children - RU486.
RU486 (labeled as Mifeprex) in combination with a prostaglandin (Cytotec), causes her body to expel her unborn child. She doesn't have to cross pro-life picket lines at the abortion clinic, or endure seeing photographs of unborn children and hearing pleas to spare her child's life. She can "terminate her pregnancy" in the privacy of her own home.
Enthusiasm for RU486
Reproductive rights groups cheered the development of RU486, claiming it would grant women greater control over reproduction and privatize abortion. Since it works early in pregnancy, they believe RU486 removes the "moral stigma of abortion."
A Miami Herald columnist intoned that "embryos the size of a pea do not scream out in pain," and that pro-lifers would have a hard time picketing the homes of all the women who would use RU486. Consequently, abortion advocates believe RU486 will create an entirely new playing field for the abortion controversy.
RU486 could vastly expand the number of abortion providers. A national survey revealed that many more obstetrician/gynecologists, and even family physicians, who did not do surgical abortions would offer the abortion pill.1
History of the abortion pill
RU486 is the brainchild of French researcher Etienne-Emile Baulieu. He found a chemical mechanism that would prevent a pregnant woman's body from producing the hormone that sustains early pregnancy.
Roussel-Uclaf, the French subsidiary of Hoechst AG, patented the drug. Hoechst, a giant German conglomerate, has World War II ties to the poison gas used in the Holocaust.2 Wanting to avoid connection with another holocaust, they withdrew production of RU486 in 1988, until the French government ordered it back on the market as "the moral property of women."
For a few years, executive orders and federal legislation prevented the abortion pill from coming to our shores, but soon after President Bill Clinton took office, the Food and Drug Administration approved RU486 for testing in this country. Still, for a time, no American drug company was willing to risk a pro-life boycott.
Then, the Population Council gained permission to find a manufacturer, conduct tests, and bring RU486 to the U.S. They finally resorted to a Chinese manufacturer and created a new company, Danco, in the U.S. to market the pill. The FDA pushed to complete the process before Clinton left office. In September, 2000, the FDA approved RU486 with stipulations, including these: Doctors prescribing it must be able to assess how far along in pregnancy a woman is, be located near a hospital for emergencies, and provide surgical abortion as a back-up.3
This has had a somewhat chilling effect on the number of doctors and clinics willing to offer RU486. So has concern over the method's cost to women ($270 plus the cost of ultrasound and additional exams, totaling around $600). Another blow to abortion advocates came when Searle, the manufacturer of the method's second component, warned doctors against its off-label use, saying it could cause uterine rupture, leading to hystorectomy or even death.4
How the abortion pill works
In RU486: The Hidden Effects, Lawrence Roberge describes the abortion pill's mechanism of action: "Progesterone is necessary in the woman to maintain the lining of the uterus, which, during pregnancy is loaded with blood vessels, and acts as a life support system for the developing embryo. (Note: the developing life for the first sixty days post conception is medically referred to as an embryo, whereas after two months it is referred to as a fetus.) As the embryo implants into the uterine lining, the embryo grows dependent upon the mother's uterine blood supply for nutrients, oxygen, and waste removal. Thus, any cut-off of the blood supply would lead to the rapid death of the developing life.
"RU486 acts to block the effects of progesterone to maintain the uterine lining. As the progesterone signal is cut off in the uterus, the uterine blood vessel lining begins to break down, and subsequently the embryo dies.
"Now as the embryo is dead, the uterus may try to expel the embryo and its surrounding tissues. RU486 alone results in only about a 60 to 65 percent success rate. Therefore, doctors give a second very powerful drug, a prostaglandin called misoprostol [Cytotec], which causes very strong (and sometimes very painful) uterine contractions to expel the dead embryo. Using the dual drug system, RU486 and misoprostol, the success rate rises to 84 to 95 percent."5
The treatment cycle
The FDA approved the following protocol: Patients are to be given 600 milligrams of RU486 (Mifeprex), followed 48 hours later by a small dose of Cytotec. Women are observed for four hours after administration of Cytotec, and return within two weeks for a final assessment. Those whose pregnancies are not "interrupted" within that time have surgical abortions.6
A treatment cycle similar to this is used in France and other countries where the abortion pill is legal. The drugs are administered in a medical setting, under a doctor's care, after it's been determined the woman is pregnant and that her pregnancy has not gone beyond the recommended time frame. Medical staff must also screen patients, tell them about potential side effects, and receive assurances they will return for two or three additional visits.
In no way does this regimen resemble advocates' dream of an easy, "at home" abortion kit.7 That is why, without FDA approval, American abortion providers altered the protocol so that women are allowed to have RU486 through nine weeks and may take the second drug at home, sometimes in suppository form.
Complications
The abortion pill is also not as worry-free as many believed. France has reported three heart attacks, including one death, in relation to RU486. Canada ended its trials of the drug after a woman died. Two British women died, but their deaths were covered up for a while.8 During American tests in Iowa, one woman nearly bled to death, even though the local Planned Parenthood reported there had been no complications.9 As of March 2003, there were 46 hospitalizations after RU486 in the U.S. and one death due to an undiagnosed ectopic (tubal) pregnancy. 10
Later in 2003, a California teenager found out just how dangerous RU486 can be. So did her family - too late. Unmarried eighteen-year-old Holly Patterson was seven weeks pregnant when she visited her local Planned Parenthood office for a "medical" (drug-induced) abortion. One week later, she lay in a hospital emergency room - bleeding excessively, in pain, and in shock. Her father learned about her abortion shortly before she died of a massive infection caused by parts of the baby or placenta having been left behind. Her death was the second in the U.S., the first in a patient with no other apparent complications.11 Since then, several other deaths have been reported.
Shortly after Holly's death, Mr. Patterson lamented, "The medical community treats this as a simple pill you take, as if you're getting rid of a headache. The procedure, the follow-ups, it's all too lackadaisical. The girl gets a pill. Then she's sent home to do the rest on her own. There are too many things that can go wrong."12 Members of Congress are working to pass Holly's Law, which will repeal approval for the abortion pill.
Heavy bleeding is the most common side effect. The average woman bleeds eight to ten days. Most women also experience painful abdominal cramps. Many also suffer infections because RU486 suppresses the immune system.5 Other complications from Mifeprex and Cytotec include nausea, vomiting and diarrhea. Roughly one percent, like Holly Patterson, experience incomplete expulsion of their embryos.
What do women say?
Women say their involvement with this type of abortion seems more personal. They retain control of the abortion, and consequently bear more responsibility. They also see the results.
Newsweek magazine reported the experience of one woman who agreed to be interviewed during her time at the clinic. After the embryo was expelled, "Becky [saw] the curled-up fetus, the size and color of a cocktail shrimp. 'Look at that, honey,' Becky says to Richard [her husband]. Its hands are curled into tiny fists. 'It's sad. It's sad,' Becky murmurs, turning away. . . .
"Becky preferred the medical abortion to her surgical ones, even though it was more emotionally draining. She wanted to experience the pain, both emotional and physical, she says. She felt she should suffer for terminating her pregnancy, since for her, as for many women who have an abortion, the certainty that she did not want to carry the fetus to term did not make the decision any less morally or emotionally ambiguous.
"'There was a little bit of regret about seeing [the embryo], because it had little hands,' Becky says. 'I remember little fists. I felt more responsible this time.'"13
Other uses for RU486?
Aside from its use in abortions, RU486 has also been tested as a 'morning after' pill and a method of late-term abortion.14 For now, its only proven use is to cause the death of an unborn child in the fifth to ninth week of pregnancy.
The pro-life movement does not oppose legitimate uses of any drug, but warns that once a drug is approved for one use, it is difficult to prevent misuse. For example, while waiting for RU486 to be approved, abortionists tested another drug already on the market that is lethal to unborn babies. Methotrexate, an approved cancer-fighting drug, taken in combination with the Cytotec (which is only approved for treating ulcers) works much the same way as RU486.
Objection to RU486
Any form of abortion, whether accomplished by surgical instruments or drugs, is abhorrent to God (Proverbs 6:16-17). It makes no difference how early in pregnancy an abortion occurs because the unborn child is alive from the moment of conception. Having human parents and distinct DNA, he or she is a distinct human being created in God's image. According to Psalm 139:13-16, every unborn child is a person who is known, understood, and valued by God.
Were RU486 safer than aspirin or cured the common cold, pro-lifers would still object to it being used to cause abortions. As Carrie Earll, a bioethics analyst, noted, "Mifeprex is unique as it is the first drug approved for the U.S. market for the sole purpose of ending a human life. It has no therapeutic value to the patient (the mother) and its success is measured in its ability to destroy the preborn baby in the womb."15
Endnotes
1. Kaiser Family Foundation's National Survey of Health Care Providers on Medical Abortion, press release 9/16/98, http://www.kff.org/womenshealth /1431-ru486_rel.cfm.
2. John C. Willke, M.D., address at the National Right to Life Convention, Minneapolis, MN, June, 1989.
3. Approval Letter MIFEPREXTM (mifepristone) Tablets, 9/28/00, Center for Drug Evaluation and Research to Population Council, http://www.fda.gov/cder/foi/appletter/2000/20687appltr.htm.
4. Warning letter regarding off-label use of Cytotec, 8/23/00, Searle to health care providers, http://www.fda.gov/medwatch/safety/2000/cytote.htm. See also http://www.fda.gov/cder/drug/advisory/mifeprex200603.htm and http://www.fda.gov/cder/foi/label/2005/020687s013lbl.pdf.
5. Roberge, RU486: The Hidden Effects, 1998, http://pages.map.com/lroberge/ru486.htm. Silvestre, et al, "Voluntary Interruption of Pregnancy with Mifepristone (RU486) and Prostaglandin Analogue," New England Journal of Medicine, 322:10, 3/8/90, p. 646.
6. Spitz, et al, "Early Pregnancy Termination with Mifepristone and Misoprostol in the United States," NEJM, 338:18, 4/30/98, 1241.
7. Raymond, et al, RU486: Misconceptions, Myths and Morals (Cambridge, MA: Institute on Women and Technology), 1991.
8. Day and Bisset, "Revealed: Two British women die after taking controversial new abortion pill," Sunday Telegraph, 1/18/04.
9. Louviere, "Pro-Abortion Group Lies about RU486," Waterloo Courier Opinion, 9/24/95, p. F3.
10. Letter with new safety information, 4/19/02, Danco Laboratories to health care providers, http://www.fda.gov/medwatch/SAFETY/2002/
mifeprex_deardoc.pdf.
11. Hall, "Questions abound about why pregnant teen died," San Francisco Chronicle, 9/24/03, p. A21. Manier, "Teen's death rekindles abortion pill battle," Chicago Tribune, 11/30/03. Kaufman, "Death after abortion pill reignites safety debate," Washington Post, 11/3/03, p. A03.
12. Guthrie, et al, "After daughter's death, father wants close look at RU486," San Francisco Chronicle, 9/20/03, p. A17.
13. Rosenberg, et al, "Blood and Tears," Newsweek, 9/18/95, p. 66.
14. "Lower Dose Mifepristone Effective in Second Trimester Abortions," British J Obstetrics and Gynaecology, 103, 1996, p. 706.
15. Earll, "Will Holly Patterson die in vain?" Family News in Focus, 11/3/03, http://www.family.org/cforum/fnif/commentary/a0028707.cfm.