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
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
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
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
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
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.
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
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, smokers, 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
It certainly isn't safe for the baby who suffocates or starves to death.34 Furthermore, credulity is strained to label a drug that puts perfectly healthy women in the hospital and may not work nearly a quarter of the time in a "safe" or "effective" manner.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
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
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
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.
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 a surgical abortion, 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.
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 many women having surgical or chemical abortions feel a sense of relief immediately after the abortion, 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.
The U.S. Food and Drug Administration granted final marketing approval to RU486 on September 28, 2000.67 It is now available from physicians who meet the FDA's requirements and order the pills from Danco Laboratories, the drug's U.S. distributor.68
The FDA has mandated that the drug be made available to women who are no more than 49 days pregnant (7 weeks from their last menstrual period). Women taking the drug must sign a form indicating they are aware of the risks associated with the RU486/PG combination for them and their baby and promising to return for additional visits on day 3 (to take the prostaglandin) and about day 14 (to determine whether or not the abortion has taken place).69
Doctors prescribing RU486 are required to date pregnancies and diagnose ectopics. They also must be able, the FDA says, to provide "surgical intervention" in situations where there are incomplete abortions or severe bleeding, or to have in place arrangements for patients to obtain such services from other physicians who can perform these sorts of surgical procedures. Furthermore, the prescriber must "assure patient access to medical facilities equipped to provide blood transfusion and resuscitation, if necessary."70
Physicians must also sign a form indicating they have read and understood the "prescribing information," a detailed description of the RU486's clinical pharmacology, the drug's indications and contraindications, and relevant warnings and precautions. Included on this form are the prescribed protocol and failure and complication rates from French and U.S. clinical trials of the drug.71
The "prescriber agreement" further mandates that any hospitalization, transfusion, or "other serious event" is to be reported to Danco Laboratories, the supplier.72
Under pressure from pro-abortion groups 73 and many of their sympathetic allies in the medical establishment, 74 the FDA modified or set aside many of the patient protections considered just months before approval.75
While the FDA kept in place measures mandating strict distribution and monitoring of pills and continued to call for some limited follow up studies, 76 other regulations were scaled back or eliminated altogether.
Instead of special training in use of the drug, physicians now only have to certify that they have "read and understood the prescribing information" on RU486. While still being asked to date pregnancies and diagnose ectopic pregnancies, prescribers are no longer explicitly required to conduct or read ultrasounds to confirm their diagnoses.77
While the original regulations would have limited prescription of the drug to physicians who had the surgical training to handle incomplete abortions or serious complications sometimes associated with the drug, current measures require only that a physician not having such skills make arrangements with another physician with the appropriate surgical training.78
The rule that a doctor have admitting privileges at a hospital within an hour's drive of his practice was replaced by a much looser requirement that asked only that the physician assure that a woman had "access" to appropriate medical facilities.79
Though the FDA decided against dropping the second visit to the doctor to take the prostaglandin on day 3, it did drop the requirement, in place during American trials of RU486, that women stay at the clinic for four hours after taking the prostaglandin.80
While none of the modifications appear to make things any safer for women or their babies, these less stringent rules do potentially make things easier on the doctors and their pocketbooks.
Because of the looser regulations, physicians considering prescribing RU486 no longer necessarily have to obtain special training, buy expensive medical equipment, or spend as much time monitoring their patients. This opens up the pool of potential prescribers not only to long time abortionists presumed to have surgical skills and experience in dealing with abortion complications, but to ob-gyns, family practitioners, pediatricians, and others no matter what their medical specialty or surgical training.81
The FDA's decision to drop the ultrasound as an explicit requirement saves a doctor the expense of buying an ultrasound machine and undergoing special training or hiring new staff to conduct or read ultrasounds. Dropping the four hour wait that was once part of the second office visit in which the prostaglandin was given frees up office schedules, space, and bathrooms, making things more convenient for a doctor's staff and more comfortable for other patients who might be troubled by what they see aborting women going through.82
The FDA's decision to permit doctors to refer rather than treat patients for whom the method fails or causes problems doesn't make things easier on the woman, who must figure out how to get to yet another address, but does allow the doctor to make complications or late night trips to the emergency room someone else's problem.
There are real questions as to whether a doctor who has merely "read and understood" 83 prescribing instructions for RU486 really appreciates the medically complex, messy reality of chemical abortions.84 Doctors with abortion experience were so surprised by the amount of blood lost in RU486/PG abortions in U.S. trials that the sponsor of the trials offered this as a possible explanation of lower "success" rates (i.e., higher rates of incomplete abortions) in the U.S. than in France.85
The RU486/PG method drops off significantly in effectiveness after the 7th week of pregnancy 86 and is not an effective agent against ectopic pregnancies.87 With ultrasound, the foremost diagnostic tool for dating and locating pregnancy, no longer required, errors in dating and diagnoses are more likely.88 In the case of a missed date, an error could mean failure of the chemical method and the increased possibility of surgical intervention.89 In the case of a missed tubal pregnancy, an error could mean a ruptured fallopian tube (which itself could be mistaken for an abortion) and tragedy for the mother as well as child.90
The absence of a surgical training requirement means that a woman for whom the method fails or one who faces serious complications may have to rely upon the help of a stranger whose name and number lies on a crumpled piece of paper at the bottom of her purse. The removal of the four hour wait at her second visit means she may face the most painful and dangerous part of her abortion all alone, precisely when she could require the greatest help, support, and medical care.91
Though the FDA still requires that a doctor assure "access" to appropriate medical services, the FDA's abandonment of the provision that a doctor practice within an hour of a hospital where he or she has admitting privileges means that even if the patient is able to get to an adequately equipped hospital in time, her doctor may not be there to get her in or to treat her. If an ER staff is unfamiliar with chemical abortions and doesn't recognize the danger a woman may be in, she could bleed to death.92
The FDA has mandated that the prostaglandin misoprostol should be used in the second stage of the RU486/PG chemical abortion, 93 even though this use contradicts instructions on misoprostol's FDA sanctioned label.
The prostaglandin misoprostol is sold by pharmaceutical maker R.G. Searle, now part of Pharmacia, under the trade name Cytotec. Searle brought Cytotec to the market in 1988 as a special anti-ulcer medication for those, such as those suffering from arthritis, who take a lot of non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin. Searle's FDA approved label, from the beginning, has stated that the drug is contraindicated for, or not to be used by, pregnant women because of its capacity to induce miscarriage.94
In a 1993 letter to the Wall Street Journal, Searle said directly that it did not want its product used with RU486 for abortion, a position it has never, as far as is known, publicly altered.95
When the FDA approved RU486, however, in September of 2000, it specifically mandated the use of misoprostol as a necessary part of the chemical abortion procedure.96 earle never sought approval for this use, and its label (package insert) is inconsistent with this use.
Information published in trade and medical journals indicates that the FDA has sought to get Searle to change its label to endorse this use.97 If the FDA is successful in pressuring Searle to make such a change, the FDA will force Searle to accept a use of its product it finds objectionable, which could expose serious liability.
Good question. Under the first Bush administration, the FDA issued an import alert, prohibiting the import of the drug for personal use because of safety concerns of the drug.98 Three days after being sworn into office, President Bill Clinton signed an executive order directing the Department of Health and Human Services and the FDA to take steps to promote the testing, licensing, and manufacturing of the drug in the U.S.99
Under the Clinton administration, the FDA took a very active role in efforts to bring the drug into the U.S. In the course of carrying out the president's directive, the FDA:
Hardly. The Food and Drug Administration is supposed to be an objective agency representing the health and safety interests of the American people, 107 not an agent for a manufacturer or group with an ideological or political agenda.
Final government approval for RU486 came just over a month prior to the heavily contested 2000 U.S. presidential election, and close to the end of President Clinton's last term in office.108
Bill Clinton initiated the process on January 22, 1993 when, just three days into his first term of office, he signed an executive order directing the FDA and the Department of Health and Human Services to take steps to promote the testing, licensing, and manufacturing of the drug in the U.S.109
Though compilation of U.S. trial data was still incomplete, the FDA accepted a marketing application for the drug and brought it up for a hearing in 1996, the year Clinton was running for a second term.110 Though it did not grant final approval at the time, owing to then unresolved labeling and marketing issues, Clinton's FDA did declare RU486 "approvable" in September of 1996, in the closing months of the 1996 presidential campaign contest.111
Yes. Press accounts have confirmed that the RU486 being sold in the United States is being made by the Hualian Pharmaceutical Company, a state-owned drug manufacturer located on the outskirts of Shanghai in Communist China.112
Members of the U.S. government have expressed special concerns about drug manufacturing in the Far East and the FDA's ability to monitor these manufacturers.113 The political, cultural, and geographic distance presents problems, not just for inspectors monitoring the integrity of manufacturing, storage, and shipping practices, but also for those seeking information for suits or compensation for injuries.114
It is unclear whether the Chinese formula for RU486 is the same as the one tested and approved in the U.S.115 If not, data from the U.S. trials of RU486, which used the French-made pill, 116 offer no reliable guide to the safety and efficacy of the Chinese product.
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.117 Women use words like "intimidating," 118 "invasive," "mechanical," "impersonal," "abrupt," 119 and "traumatic,"120 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.121
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 122 and concentrating on smaller, less developed babies whose destruction seems an easier political sell.123 The reality is far different - these abortions offer a whole new set of significant risks, and the objective is still the destruction of a unique human life. These truths are of little consequence to abortion's promoters as long as their false perception holds.
Source: National Right to Life, www.nrlc.org.