Two and half years ago, the August 1995 issue of The RU 486 Report provided a comprehensive summary of the key facts about the RU 486/Cytotec prostaglandin (RU 486/PG) abortion technique. Since then, some of the information in that article has changed. For example, more details about the physical and psychological dangers emerged at the July 1996 hearing before the U.S. Food and Drug Administration (FDA) advisory committee, and the testing and marketing plans for the U.S. are totally different.

News about RU 486/PG has virtually disappeared out of the mainstream media because the plans to manufacture and distribute it in the U.S. appeared stalled. But the patent holder, the Population Council, has announced that it has finally found a manufacturer and plans to put the deadly technique on the market in 1999.

If the FDA grants approval for marketing, both national and local print and electronic media will be sure to give the event enormous "above the fold" play, and pro-life and pro-family advocates must be prepared to use this "teachable moment" to get our rebuttal out. In addition, if RU 486/PG goes on the market, our battle against it should not diminish, but steadily increase in intensity as we shift to a new arena. If anything, the stakes in the battle become even higher because (as one press account estimated), as many as 650,000 American women would use RU 486/PG annually. The lives of millions of unborn babies and thousands of women will be on the line.

By being prepared and pro-active, pro-life and pro-family organizations’ public relations and educational strategies should aim to both generate widespread public opposition and minimize usage of RU 486/PG. This campaign should be tailored to the needs of at least the following four target audiences:

• The general public needs to get the real facts about RU 486/PG. We know from public-opinion polling that the two arguments against RU 486/PG that may resonate best with a disinterested person. They should receive the "core message," which is given in the bold text below. The additional information with each item is intended to provide useful background.

• Pro-life and pro-family supporters also need the "core message" to correct misinformation they have received through the media. In particular, this group needs to hear that RU 486/PG is not a contraceptive and is not a miracle cure for breast cancer or anything else. It is only being used for abortion . In addition, this group needs to be reassured that the fight against RU 486/PG is not over and informed about what they could do to stop it.

• Women seeking abortions need the facts about the physical and psychological dangers to persuade them against using RU 486/PG.

• Doctors who currently do not perform abortions but may be interested in using RU 486/PG need to hear about local community opposition to the technique and the physical dangers to women which could trigger expensive medical liability lawsuits.

GIVING THE KEY FACTS TO EVERYONE

The following four key points form the "core message" that pro-life and pro-family advocates need to keep repeating at every opportunity.

Point One: What it is and how it works:

The RU 486 technique is not a "contraceptive" because it causes an abortion on a woman who knows she is pregnant. RU 486/PG kills an unborn baby whose heart has started to beat. It is a complicated two-drug, three-step procedure and not "easy" and "private" as abortion advocates have claimed.

Under the minimal safety standards that the FDA is likely to require, RU 486/PG is supposed to be tightly supervised by medical personnel, will require at least 3 visits to the abortion facility, will not be administered at home, and will not do away with late-term or partial-birth abortions.

Except as noted, the source of the data in this section comes from the presentation for approval of marketing before the U.S. Food and Drug Administration Reproductive Health Drugs Advisory Committee on July 19, 1996. The Population Council, holder of the U.S. patent, presented complete data from two "pivotal" (or key) French studies of RU 486/PG and incomplete data on the U.S. test of 2,121 women.

Woman takes two 300-milligram tablets of the "abortion pill" RU 486, waits briefly in the facility to watch for adverse reaction, and then goes home.

RU 486 is a powerful synthetic steroid hormone. [Please note that this description has been carefully selected and scientifically accurate and helps make the case against RU 486.] RU 486 blocks the action of progesterone, a hormone vital to maintaining the nutrient lining of the womb . If used alone RU 486 is about 60% to 80% effective in causing a complete abortion. The unborn baby starves to death when the lining of womb disintegrates.

• Day Three (48 hours later)—second visit to abortion facility

Every woman returns to the abortion facility. By this time, only about 3% of them will have had a complete abortion at home with expulsion of the dead baby.

Virtually every woman (97%) takes 400 micrograms of the prostaglandin (PG) Cytotec in tablet form. Cytotec is a powerful synthetic hormone (not a steroid), which causes contractions of the uterus, which expel the bloody contents of the uterus including the dead baby.

"Cytotec" is known in the press by its generic name—"misoprostol." It is approved for use as anti-ulcer drug and is not supposed to be used on pregnant women. A spokesman for the manufacturer, G.D.Searle, condemned the misuse of Cytotec for abortion in the March 19, 1993 Wall Street Journal. But a drug approved for one use, may be legally prescribed for another use.

It is not clear if, or how, the Food and Drug

Administration (FDA) can order Cytotec to be used with RU 486.

The woman waits in the abortion facility for 4 hours to watch for complications or a complete abortion. In the French test, 54% of women had a complete abortion at the facility. The remaining 46% of the women left to have their abortions alone at home or work. (About half of them had a complete abortion within 24 hours of taking Cytotec.)

• Day 14—3rd visit to abortion facility.

All women return for mandatory checkup.

By this time, the overall effectiveness of the two-drug combination is 93% to 95% of complete abortion in women 5-to-7 weeks (35 days to 49 days) pregnant.

About 5% to 7% of women have incomplete abortion or no abortion at all in one study of 1,681 French women. About 2.9% of women had an incomplete abortion and needed a D&C to scrape out the remaining tissue from the uterus. About 1.3% of women on whom the chemicals had no effect are encouraged to have a surgical abortion. (All did.) In the French study, .3% (three-tenths percent) of the women needed a D&C or vacuum aspiration to stop the bleeding. an acceptable level of safety depends on women complying with the whole regimen, including the follow-up visits. But compliance could be a major problem if RU 486/PG is widely used outside of the rigorously controlled test setting. For example, Dr. Suzanne Poppema, owner of a Seattle surgical abortion facility, explained in the April 12, 1993, American Medical News that even though U.S. abortion facilities routinely include follow-up visits in the price of an abortion "we’re lucky if 30% to 40% of these patients ever return." If compliance with surgical abortion is so low, why would compliance with chemical abortion be any better?

Point Two: Short- and long-term dangers

RU 486/PG will injure, and possibly kill, women. It could possibly deform babies who survive and harm the mother’s future offspring.

Data on the immediate complications such as bleeding comes primarily from the presentation about the key French studies at the FDA Advisory Committee hearing on July 19, 1996. A comprehensive review of the literature about adverse side effects and the lack of data about long-term studies is available in the "Citizen Petition" filed on February 28, 1995 with the FDA by 23 Members of Congress and 7 physicians and scientists. The Citizen Petition was summarized in the Feb.-Mar. 1995 issue of The RU 486 Report or contact: Americans United For Life at 343 Dearborn St., Suite 1804, Chicago, IL 60604-3816, phone: (312) 786-9494, FAX (312) 786-2131.

• Short-term Complications.

Prolonged and severe bleeding.

Excessive bleeding, especially among women who are miles from medical care, could be serious, or even fatal. In the U.S. test, 80%-to-90% of women said that the bleeding was heavier than their normal menstrual period. In the key French test of 2,480 women, 1.4% were treated for "medically severe bleeding." Of the total group, 21 (.8%) were hospitalized; two received surgical intervention to stop the bleeding; and 4 (.2% of total) received transfusions.

The first RU 486 patient in the Des Moines, Iowa test told TIME magazine (12/5/94): "I went to the restroom. When I started to stand, it was like a faucet turned on. There was a steady stream of blood. I passed a golfball-sized blood clot that scared me. . . .The bleeding was very heavy, heavier than a period. . . .By this time, I was bleeding severely, and I had diarrhea."

An Iowa physician who is favor of legalized abortion reported about treating another Iowa woman who took RU 486/PG in the Des Moines test and lost about half her blood. He saved her life by emergency surgery and a transfusion. Planned Parenthood of Des Moines tried to cover up this horrible incident by claiming that in the press that there had been "no complications."

Unfortunately, RU 486 advocates want to use RU 486/PG in Third-World countries where women are often anemic and malnourished and miles away from follow-up medical care.

Nausea.

In the key French study, 45% had nausea. The same woman mentioned in TIME said: "I was very nauseous in a couple of hours [after taking RU 486]. I threw up constantly for three days. I went to work. Luckily, there’s a restroom in my department. I moved a little slower. Usually, I’m very upbeat, but I wasn’t for those three days. It was like food poisoning. I couldn’t keep anything down."

Vomiting.

In the key French study, 25% of women vomited.

Pain.

In the key French study, 5% of the women received narcotics for the pain.

"Aimee," a 17-year-old American who had a RU 486 abortion in Britain had this experience reported the New York Times (3/23/94): "She grimaced. She had never known pain this bad, she said. . . .Taking the RU-486 pill for an abortion was worse than she had expected. ‘I felt like I was dying,’ she said minutes after expelling the tiny sac that contained the one-eighth-inch-long fetus. ‘It hurt so much. I had contractions coming so fast, and I was sick to my stomach and dry heaving. I couldn’t stop trembling and I felt so hot.’"

Other serious complications can result to women who have a wide range of illnesses and conditions, including asthma and diabetes. The "Citizen Petition" noted that some groups are a special risk, including African-American, Native-American, Asian-American, and obese women.

Death

At least one woman has died from the RU 486/PG technique, attributed to the prostaglandin Sulprostone. A French woman died in 1991, which compelled the French to change to a different prostaglandin, Cytotec. There have not been reported deaths from Cytotec. As noted above, at least one woman in the U.S. test almost died from loss of blood, and that could be a potential problem if RU 486/PG were to be marketed here.

• Long-term Complications 

Fetal deformity could result if RU 486 does not work, or the mother changes her mind and carries to term. RU 486 cuts off food and water early in pregnancy when the unborn baby’s arms and legs and major organs are forming.

A women taking RU 486 in France and the U.S. signs a form that she has been told that if "I decide to carry my pregnancy to term, I have been clearly warned that the child and/or I may be susceptible to risks, notably malformation of the fetus or child."

Pro-abortion advocates are keenly aware of this danger. At the FDA hearing in July 1996, the Population Council reported that out of the approximate number of 200,000 women worldwide who have taken RU 486 and prostaglandin for abortion in any form, 21 infants were carried to term. Most were healthy, but one died from a fatal immune disorder -- a complication rate of 4.7% among the live births.Possible damage to the mother’s ova. Pro-abortion feminists published a book-length study of RU 486/PG in 1991 in which they pointed out that RU 486 travels to every part of a woman’s body, including her ova. They said that there is a possibility that the powerful synthetic steroid RU 486 could damage her ova and harm her subsequent offspring years later. See: Janice G. Raymond, Renate Klein, and Lynette J. Dumble, RU 486 Misconceptions, Myths and Morals (Cambridge, MA: Institute on Women and Technology at the Mass. Institute of Technology, 1991). Psychological complications Clinical studies show that some women suffer psychological complications from surgical abortion. One key reason that abortion advocates want RU 486 is to give the woman more "control" over the abortion procedure. In surgical abortion, the doctor performs the abortion on the woman, who can shift some psychological responsibility to him or her. However, in a RU 486 abortion, the woman takes sole responsibility and in actuality performs her own abortion. That could cause more psychological complications. For example, "Katherine Foucault," a 30-year-old television producer, who had a RU 486 abortion in France, explained in a story in Hippocrates (2/95) "‘I was awake during the surgical abortion,’ she said. ‘Only local anesthesia was used. I felt some pain–but the next day I was fine. It was over. I forgot about it.’ ‘This latest experience with RU 486 was quite different. It didn’t hurt, but I had strong contractions. Waiting to use the bathroom in the clinic, I knew I was bleeding heavily, It wasn’t easy to wait.’ . . .’Alone in the bathroom, I pushed hard, very hard, until I felt something pass. I spent a minute looking at it. I wanted to reach out and touch it. It was so small, I thought. In eight months this could have been a baby.’" Another example in the same issue of Hippocrates was Julie Beale, a 21-year-old American studying in Paris, who explained that "I was at the clinic about six hours when finally I expelled it. When I looked at it, it had two dark spot like eyes and a little skeleton not quite formed." The reporter asked "You saw that?," and Beale replied "Yes." Then the reporter interjected "Are you sure? At

49 days, there is only the amnion sac," and Beale explained "Yes, I think about this often. I haven’t talked about it to anyone. I feel quite empty. If I had expelled this at home, I’m sure I would have kept it. I couldn’t have just flushed it down the toilet. Here, at the clinic, they put a border on your actions. Maybe that’s good."

Edouard Sakiz, then-chairman and CEO of Roussel Uclaf, the manufacturer of RU 486, told a leading French newspaper Le Monde in August 1989 that "As abortifacient procedures go, RU-486 is not at all easy to use. In fact it is much more complex to use than the technique of vacuum extraction. True, no anaesthetic is required. But a woman who wants to end her pregnancy has to ‘live’ with her abortion for at least a week using this technique. It’s an appalling psychological ordeal (emphasis added)." No long-range studies have been done to determine the adverse side effects of using these two powerful synthetic hormones. Complications could show up years later as they have with other drugs.Point Three: Increasing the Number of Abortions Marketing of RU 486/PG will increase the annual number of abortions beyond the already appalling 1.5 million per year. Abortion advocates promote RU 486/PG to increase "access" to abortion by encouraging more physicians to perform them. Twenty-five years of abortion experience shows that when the number of abortionists goes up, the number of abortions also increases. Two opinion polls of physicians indicate that large numbers of doctors— even family practitioners who currently perform hardly any abortions—could become abortionists if RU 486/PG were to become available. A 1994 survey of all of the family practitioners, Ob/Gyns, and general surgeons in rural Idaho revealed 26% of those who did not perform abortions "indicated that they would definitely prescribe RU-486 if it became available; [and] an additional 35% were uncertain," reported the authors in the October 1995 American Journal of Public Health. In September 1995, the Kaiser Family Foundation released the results of a even more definitive study of a nationally representative sample of physicians. The research found that 33% of Ob/Gyns currently perform abortions, a substantial decline from the 1980s. Unfortunately, the poll also revealed that a significant portion of the Ob/Gyns and family practitioners would use RU 486/PG if it became available. Of the Ob/Gyns who do not perform abortions, 18.4% said that they would be "very likely" to use RU 486/PG if approved in the U.S., and an additional 14.9% said that it would be "somewhat likely." If those two groups did use RU 486/PG, then the percentage of Ob/Gyns performing abortions would increase from the current 33% to 55%. Of the Ob/Gyns, 83.6% indicated that they were "very familiar" or "somewhat familiar" with the RU 486/PG/prostaglandin technique, and 93.7% regarded it as "very safe" or "somewhat safe." There is also a much more worrisome increase among family practitioners. The survey found that only 3% currently perform abortions, but that could increase to 28% if RU 486/PG were to be put on the market. Another disturbing fact is that 16% of the Ob/Gyns and 42% of the family practitioners said that they were "not familiar at all" with RU 486/PG. Ruth Katz, director of public health programs at the foundation, "suggested even more physicians may be willing to prescribe RU-486 after they learn more about it," reported the September 25, 1995 Wall Street Journal.Point Four: Status of Marketing and Testing The FDA in the U.S. tentatively approved RU 486/PG for abortion in September, 1996 as "safe and effective," but marketing has been stalled by the lack of a manufacturer and lawsuits among the prospective investors. RU 486/PG abortion has been on the market in four countries for a number of years: France since 1989, the United Kingdom since 1991, Sweden since 1992, and the Peoples Republic of China since about 1989. About 200,000 women have used some form of RU 486/Prostaglandin for abortion. Probably about 70,000 women in France have used the form of RU 486/PG that is planned for the U.S.

INFORMING PRO-LIFE/PRO-FAMILY SUPPORTERS

Correcting Misinformation Judging from phone calls and personal contacts, it is apparent that many pro-life and pro-family supporters are either misinformed, or uninformed, about RU 486/PG. Unfortunately, many of them receive their information about the abortion technique from the general print and electronic media that routinely parrot the myths and misrepresentations of RU 486 advocates. An important task is to explain the "core message," with special emphasis on correcting the misconception that RU 486 is a "contraceptive." Many people who oppose abortion of unborn babies may be unwilling to also oppose RU 486 because they believe that it is contraceptive and they do not want to take a stand against contraception. They need education on how RU 486/PG causes abortion. Many pro-life and pro-family supporters are also misinformed about the false claims that RU 486 cures many serious diseases and conditions. None of those are true. RU 486 has been tested for a wide range of uses, but none have proven out. The September-October 1997 issue of The RU 486 Report provides a comprehensive survey of the medical literature on non-abortion research of RU 486. For the past decade, Pro-Family and Pro-Life advocates have repeatedly pointed out that the RU 486 advocates’ claims about these non-abortion uses are either widely exaggerated or just false. But the media generally ignored them. Unfortunately, during the past five years,. these unsubstantiated claims have gained the status of "common knowledge" or "accepted wisdom," and they continue to surface. They need to be refuted. Abortion advocates have claimed that RU 486 is a potential cure for the following diseases or conditions: AIDS, abnormal uterine bleeding, breast cancer, Cushing’s Syndrome, ectopic pregnancy, endometriosis, glioma (malignant tumor of the central nervous system), intrauterine fetal death, labor induction, meningioma (rare non-malignant, benign brain tumor), premenstrual syndrome (PMS), prostate cancer, and uterine leiomyomatas (benign pelvic tumors, also known as fibroids). Obviously, such a long list borders on the ridiculous. One claim that RU 486 is a potential cure for breast cancer is especially important because of the American public’s sensitivity to the problems of that disease. Medical research has shown that RU 486 does not cure breast cancer. Here are some important facts that the media has not reported widely: In 1992, the U.S. National Cancer Institute (NCI) wrote a letter to a Congressman stating publicly that it did not pursue research on RU 486 for breast cancer for the following reasons: (1) "At this point, there is little preclinical or clinical data to suggest that RU-486 will offer any advantage over other currently available hormone therapies." (2) "RU-486 is not novel, has not demonstrated a potential for cure, and at this time offers, at best, the possibility of only modest, transient benefit to a fraction of the women with advanced breast cancer." (3) "In short, RU-486 did not, and does not now, appear to primary (and almost exclusive) use for RU 486 is abortion. RU 486 is not a "miracle" drug and is years away from marketing in the U.S. for any purpose except abortion.

Actions Needed to Stop RU 486/PG Abortion

• Keep the faith. Another important issue to emphasize to the pro-life/pro-family constituency is not to lose heart. All is not lost. Despite claims from RU 486 supporters for years that approval was "just around the corner," our opposition was successful in holding off approval for almost a decade. In addition, our persistent educational and media efforts pointing out the facts about the hazards of RU 486/PG have kept the abortion advocates more "honest."

• Inform others about the dangers of RU 486/PG abortion.

• Write the company officials of the prospective manufacturer of RU 486 to urge them to stay out of the abortion business. A Hungarian drug company, Gideon-Richter, signed a contract to manufacture RU 486 for the U.S. market and then backed out. The company is being sued to require it fulfill the contact. Address: Lajos Pillich, Chairman, Gedeon Richter, 19-21 Gyomroi Ut, Budapest H 1103, Hungary.• Boycott the products of Hoechst Marion Roussel drug company products, especially the antihistamine Allegra. This company and its parent, the German chemical giant Hoechst AG, control the use of RU 486 worldwide. The boycott is aimed at pressuring them to withdraw the abortion drug from the market. Roussel Uclaf, one of the predecessor companies of Hoechst Marion Roussel, developed, manufactured and distributed RU 486 in Europe. Roussel Uclaf provided the RU 486 for the U.S. on 2,121 U.S. women, and provided the documentation about the French tests that is the basis for the application to the U.S. FDA for marketing here. Roussel Uclaf claimed that it "donated" the RU 486 patent to the Population Council and has no responsibility for U.S. use. We do not believe them for the following two reasons: (1) In 1988, Roussel Uclaf tried to shift the blame for RU 486 to the French government by claiming that the Health Minister had "ordered" RU 486 put on the market. A court case later revealed that the "order" never existed. In short, Roussel Uclaf lied to get the pressure off itself. (2) The company refuses to publish or release any documentation about the patent. In 1997, Hoechst announced that it had "donated" the European rights to RU 486 to a spin-off company set up by the former president of Roussel Uclaf. Again there is no documentation that Hoechst Marion Roussel really got out of the abortion-pill business.

EDUCATING WOMEN SEEKING ABORTIONS Since the general media coverage about RU 486/PG has been overwhelmingly positive and upbeat, women seeking abortions will probably not be deterred from using the technique based on what they have heard or read. The truth about the dangers must come through an alternative source. In an effort to discourage a woman from using RU 486/PG, pro-life/pro-family advocates can point out that her baby has a beating heart and the short- and long-term effects and dangers of RU 486/PG listed above.

DISCOURAGING DOCTORS FROM USING RU 486/PG Abortion advocates have long asserted that marketing RU 486/PG will increase U.S. women’s "access" to abortion services because more physicians would perform abortions in their private offices. But local educational efforts to remind physicians of the community’s and patient’s opposition to abortion could prevent the spread of the dangerous chemical abortion method. Although some abortion zealots such as Eleanor Smeal seem confident about recruiting more physicians, there obviously is no guarantee that it is inevitable. But many ob/gyns, and most family practitioners who refuse to perform abortions for philosophical or moral reasons need continued support.

In the broad context, the same reasons that physicians have articulated for not performing surgical abortions also apply to RU 486/PG. One of the key ones is community and patient opposition and the fear of being known as an abortion provider. Although most RU 486/PG abortions will require administering pills, it seems unlikely that a doctor will be able to hide the fact that he or she performs them. As reporter Carol Jouzaitis pointed out in the October 30, 1994, Orange County Register, "the logistics of accommodating women for several hours of medical observation would be daunting." "It doesn’t fit early into a normal practice," Jeannie Rosoff, the president of Planned Parenthood’s special research affiliate, told Jouzaitis. "If you’re a physician, do you want a group of women (having abortions) sitting for four hours in your waiting room with people who come in for colds and in-grown toenails," Rosoff asked. The extra space and staff required might discourage some physicians.

In addition, pro-life and pro-family advocates should educate their local physicians about the professional drawbacks of using RU 486, especially the threat of medical liability lawsuits. Most are completely unaware of the extensive short-term dangers to the woman, which have been well documented. Also, the lack of long-term studies open physicians up to additional risk. The potential liability is particularly severe in cases of continuing pregnancy. The RU 486/PG "drug cocktail" has no effect at all on about 1 out of 100 women. If such a woman does not return for all three visits and does not have a surgical abortion, she has a definite risk of having a deformed child. In Europe, twenty-one children have been carried to term after an attempted RU 486/PG abortion; three had abnormalities, one fatal. Family practice physicians and ob/gyns need to realize that they might jeopardize their careers if they use RU 486/PG.

SUMMARY
In summary, the responsibility for getting the truth out about RU 486/PG falls to the Pro-Life/Pro-Family Movement because no one else will do it. The information above provides an outline of the key points to stress to various audiences. Here is a final "sound-bite" of data that summarizes the key points: "The Pro-life movement (or the name of your organization) strongly opposes the RU 486 abortion technique because it kills an unborn baby whose heart has started to beat, has already killed and injured women, can deform babies who survive the abortion attempt, may harm a woman’s subsequent offspring, and will increase the number of abortions beyond the already appalling 1.5 million per year.