By Richard D. Glasow, Ph.D.
Some Important Questions for “RU 486” Advocates

Background Facts and Figures

The RU 486/Cytotec prostaglandin (“RU 486”) abortion technique is expected to be approved for the U.S. market by the end of 2000, according to press reports.

We encourage authoritative and objective news coverage which presents a balanced picture of the pros and cons. This information page highlights some key hazards and unanswered questions about “RU 486” that the promoters should address.

For a national contact for interviews, you can call one of the leading experts on "RU 486," J.C. Willke, M.D., at (513) 729-3600 in Cincinnati, OH.

“RU 486” uses two powerful synthetic hormones to cause an abortion on women who are 5-to-7 weeks pregnant: RU 486 (generic name: mifepristone) plus Cytotec (a prostaglandin generic name: misoprostol).

The Population Council sponsored the U.S. trials and submitted an application for U.S. marketing to the U.S. Food and Drug Administration (FDA).

Shorthand references for three of the sources frequently quoted below

• FDA Hearing on “RU 486” (1996) is U.S. Food and Drug Administration, Reproductive Health Drugs Advisory Committee, transcript of the hearing on the New Drug Application for the Use of Mifepristone for Interruption of Early Pregnancy, July 19, 1996. The FDA's hand-picked panel of medical experts reviewed data and recommended that “RU 486” be approved for the market.

• Spitz, Barton, et al. NEJM (1998) is the Population Council's publication of the results of its U.S. test on 2,121 women at 17 sites: Irving M. Spitz, C. Wayne Barton, 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).

• Workshop for prospective chemical abortionists, March, 1999 is a session titled "Providing Medical Abortion Services" in San Francisco, CA on March 10, 1999, as part of a conference on "Issues and Options in Reproductive Health Care." Seattle abortionist Dr. Suzanne Poppema and two members of her staff with extensive experience with “RU 486” spoke. An audio tape of this session is available for purchase from Audio Magic in Mayville, NY at www.audiomagic.com.

Topics Covered
(click for a topic)
Safety Issues For Women

Informed consent?
Changing the abortion procedure?
Teenagers?
Are repeat abortions with “RU 486” safe?
Preexisting health conditions
Is ultrasound required?
Prostaglandin at home?
Searle's position on Cytotec and “RU 486”
Long-term adverse effects?
Will “RU 486” increase number of abortions?

Are the abortionists qualified?
Non-Ob/Gyn's Using “RU 486”?
Who pays for surgery?
Training for abortionists?
Will abortionists follow the FDA's rules?
Nurses Becoming Abortionists?

Will “RU 486” harm children?
Babies who survive “RU 486”
Will women return for three visits?
Contacting teenagers at home
Secret manufacturer to limit liability?

SAFETY ISSUES FOR WOMEN

Informed consent?

Q. How will the abortionist guarantee truly informed consent among non-English speaking women?

Background:

• The informed consent form used in the U.S. trials of “RU 486” was long and complicated, even in English.

• Even medical experts on the Food and Drug Administration's Advisory Committee who voted in July, 1996 to market “RU 486” questioned whether women would receive enough information to make an informed choice. In fact, the committee did not formally vote on the acceptability of the patient information leaflet because they had made so many comments and recommendations for changes and additions.

Source: FDA Hearing on “RU 486” (1996), pp. 292-303, 312.

• Three feminists who strongly favor unrestricted abortion said, "We contend that given the media hype and the lack of independent research on RU 486/PG, most women taking the drug are not informed and consent is relatively meaningless."

Source: Janice G. Raymond, Renate Klein, Lynette J. Dumble, RU 486 Misconceptions, Myths and Morals (Cambridge, MA: Institute on Women and Technology, 1991), p. 5. (Janice Raymond is Professor of Women's Studies and Medical Ethics at the University of Mass., Amherst.)

Changing the abortion procedure?

Q. Is the abortion procedure any different than what was tested in the U.S.? If it is different, how do women know it is safe?

Background:

• Supporters of chemical abortion are trying to have the FDA approve at least three major changes from the procedure used in the French and American trials. One particularly important proposed change discussed in detail below is to make ultrasound optional instead of mandatory. A second change, also described in more detail below, is for the women to take the second drug, Cytotec prostaglandin, at home alone instead of an abortionist's office where they can be watched carefully for adverse side effects. A third alteration from the procedure used in the trials is the elimination of the CBC (complete blood count).

Sources: Dr. Suzanne Poppema, speech, Workshop for prospective chemical abortionists, March, 1999.

Carole Joffe, Reactions to Medical Abortion Among Providers Of Surgical Abortion: An Early Snapshot, "Family Planning Perspectives", vol. 31, no. 1 (Jan.-Feb, 1999), sections on "Changes in Office Routine", and "Status of Ultrasound." (Published by the Alan Guttmacher Institute, Planned Parenthood's special research affiliate, and available on the Internet.)

Dr. Wayne Bardin from the Population Council, FDA Hearing on “RU 486” (1996), pp. 61-62.

Teenagers?

Will teenagers below age 18 be allowed to use RU 486? (They were excluded from the U.S. test.) How do teens know “RU 486” is safe without tests?

Background:

Dr. Beverly Winikoff from the Population Council told the FDA that "No one under 18 was admitted to the trial because of informed consent issues."

Sources: Dr. Beverly Winikoff of the Population Council, FDA Hearing on “RU 486” (1996), p. 268.

Are repeat abortions with “RU 486” safe?

Q. How often can a woman use “RU 486”? Will there be a limit to the number of times? What could happen to her?

Background:

• In the U.S. test, 51% of the women had a previous abortion. (This roughly approximates the percentage of repeat abortions every year in the United States.)

Source: Spitz, Barton, et al. NEJM (1998), pp. 1242, 1246.

• There is no information about the effect of repeated use of the two powerful synthetic hormones in RU 486.

Source: FDA medical officer Dr. Ridgely Bennett, who reviewed the non-U.S. clinical findings, FDA Hearing on “RU 486” (1996), p. 132.

• Dr. Janet Daling, an FDA Advisory Committee member, stated at the hearing that "she would like to see some collection of (information about the effect of) multiple procedures for an individual woman."

Source: FDA Hearing on “RU 486” (1996), p. 285.

Preexisting health conditions

Q. What preexisting health conditions will bar women from using “RU 486”? Is the list of conditions any different than the U.S. test? Why?

Background:

• Women with any of the following 20 conditions or diseases (contraindications) were excluded from the U.S. trial:

less than 18 years of age

more than 35 years of age who smoked over 10 cigarettes a day and had another cardiovascular risk factor

liver disease

respiratory disease

renal disease

adrenal disease

cardiovascular disease

thromboembolism

hypertension

anemia

insulin-dependent diabetes mellitus

coagulopathy

known allergy to prostaglandins

in situ intrauterine devices (IUD)

breast-feeding

receiving anticoagulation therapy

receiving long-term glucocorticoid therapy

adnexal masses

ectopic pregnancies

had signs that they might abort spontaneously

Source: Spitz, Barton, et al. NEJM (1998), pp. 1241-1242.

• Population Council officials told the FDA in July, 1996 that “RU 486” will be used on women who would have been barred from the U.S. trial. For example, there will be no restrictions on age or smokers.

Source: FDA Hearing on “RU 486” (1996), pp. 61, 300.

Is ultrasound required?

Q. Will every abortionist be required to use ultrasound to precisely date the woman's pregnancy and guarantee she does not have a potentially life-threatening tubal pregnancy? (The effectiveness of “RU 486” drops sharply after seven weeks of pregnancy, and it has no effect on tubal pregnancy.)

Background:

• In the U.S. trial sponsored by the Population Council, every woman had her pregnancy measured “according to menstrual history, pelvic examination, and vaginal ultrasonography."

Source: Spitz, Barton, et al. NEJM (1998), p. 1242.

• Accurate dating of pregnancy is essential because the effectiveness of “RU 486” drops dramatically after seven weeks of pregnancy. In the U.S. test, the rate of complete abortion was 92 percent at seven-weeks-or less of pregnancy, 83 percent in the eighth week, and 77 percent in the ninth week.

Source: Spitz, Barton, et al. NEJM (1998), p. 1242.

• The Population Council, which is seeking FDA approval, is planning to dispense with the requirement to use ultrasound. Speaking at a conference in January, 1998, a senior Council official noted that "non-physicians can provide medical (chemical) abortion, just as they provide IUDs. Ultrasound is not essential to every setting", stated the published report.

Source: Report of conference sponsored by The Wellcome Trust and the Population Council on "Towards Safe and Effective Use of Medical Abortion," Bermuda, January 10-13, 1998, p. 11.

• Carole Joffe interviewed 25 experienced abortionists for their reaction to “RU 486” and wrote that "Most respondents emphatically felt it unthinkable to do medical (chemical) abortions without ultrasound, both to adequately size the very early pregnancies and to ascertain that the abortion has been completed. "She also observed that 'nearly all' surgical abortionists use ultrasound machines, but whether use of ultrasound should be part of the required protocol of medical (chemical) abortion is another matter. "

Source: Carole Joffe, "Reactions to Medical Abortion Among Providers Of Surgical Abortion: An Early Snapshot," Family Planning Perspectives, vol. 31, no. 1 (Jan.-Feb, 1999), section on the "Status of Ultrasound." (The article was published by the Alan Guttmacher Institute, Planned Parenthood's special research affiliate, and is available on the Internet.)

Prostaglandin at home?

Q. Will the pregnant woman take the second drug (Cytotec prostaglandin) at the abortionist's office or at home? If at home, how will the abortionist guarantee that she takes it on time? What would happen if she doesn't?

Background:

• Supporters of chemical abortion are trying to have the FDA approve a major change from the data on the trials in France and the U.S. that were presented to the FDA. They want to have the pregnant woman administer the second drug, Cytotec prostaglandin, at home instead of the abortionist's office.

• In March, 1999, Dr. Suzanne Poppema, an abortionist in Seattle, explained at a conference that the Population Council was seeking authority from the FDA to have women take the Cytotec orally at home instead of the abortionist's office. (Poppema is president of the National Abortion Federation, the trade association of abortionists, and spoke at a workshop specifically aimed at encouraging more physicians to perform chemical abortion by describing in detail how her office has been offering several forms of chemical abortion since 1994.)

Source: Workshop for prospective chemical abortionists, March, 1999.

• During the U.S. trial of RU 486, women were required to take the Cytotec prostaglandin at the abortionist's office and wait there for four hours to be monitored “for adverse events, such as nausea, vomiting, diarrhea, and abdominal pain." Women in this trial received free drugs and medical care.

Source: Spitz, Barton, et al. NEJM (1998), p. 1242.

Comment:

• Two reasons lie behind the push for women to take the Cytotec prostaglandin at home: cost savings and convenience for the abortionist. Apparently, many prospective abortionists won't use “RU 486” if they have to make extensive renovations to accommodate the nauseous and bleeding women who wait four hours after ingesting Cytotec.

Dr. Suzanne Poppema, who tested “RU 486” extensively, asserted to a group of prospective abortionists that "Not being able to use misoprostol at home is a barrier to entry to providing medical (chemical) abortion services." She explained that "Having a group of women doing a lot of bleeding and cramping in your office, when they would rather be home, racing to the bathroom when they need to go to the bathroom, because we were using oral misoprostol so they were not only having bleeding but they were also having diarrhea, doesn't do much for the [patient] flow in your clinic."

Source: Workshop for prospective chemical abortionists, March, 1999.

Searle's position on Cytotec and “RU 486”

Q. How can Cytotec prostaglandin, the second drug in “RU 486” technique, be used for abortion when its current labeling specifically bans it from being used for that purpose? (Cytotec's labeling also says it can cause birth defects.) Did the manufacturer of Cytotec, G.D. Searle, ask the FDA for a change in labeling? Will Searle take responsibility for birth defects?

Background:

• The packaging of Cytotec (generic name: misoprostol) is extremely explicit about the risk to pregnant women. The top of the bottle says "Warning" in red, with a note below in black of "Not for Pregnant Women." There is a box on the side of the bottle with a red background stating "CONTRAINDICATION / WARNING Contraindicated in women who are pregnant." "Contraindication" is an especially important term because it means that Cytotec should not be used by pregnant womenCperiod. In fact, Cytotec carries a FDA "Pregnancy Category X", which means either that studies in animals or humans demonstrate fetal abnormalities, or that adverse reaction reports indicate evidence of fetal risk.

• Searle's Vice President for Public Affairs, Charles L. Fry, explained the company's position in a letter to the editor in the March 19, 1993 Wall Street Journal. "Searle has never willingly agreed to make misoprostol available for use in abortion, nor is it the company's intention to do so," he said. Fry also wrote that "Searle strongly opposes any efforts to approve its use with RU-486 for abortion, either in the U.S. or elsewhere. Any other use of this product is outside its purpose. It is not Searle's intention or desire to become embroiled in the abortion issue."

Source: Letters to the Editor, Charles L. Fry, Wall Street Journal (March 19, 1993).

Long-term adverse effects?

Q. Have there been any studies about the long-term medical or psychological effects of “RU 486” on women beyond the usual two-week follow-up period? If not, how can women be assured that taking these two powerful hormones will not cause serious health problems later?

Background:

• Reporter Tony Kaye, a reporter who sympathetically discussed “RU 486” in the January 27, 1986 issue of The New Republic, accurately predicted that the first generation of RU-486 users will be guinea pigs for the drug's long-term side effects.

Source: Tony Kaye, "Are You For RU-486?" The New Republic (January 27, 1986), p. 14.

• Edouard Sakiz, then-chairman and CEO of Roussel Uclaf, the manufacturer of RU 486, told a leading French newspaper Le Monde in August 1990 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)."

Source: "Drug firm defends marketing strategy on abortion pill," reprint from Le Monde in Guardian Weekly (Aug. 19, 1990), p. 16.

• In 1991, three years after “RU 486” went on the French market, three feminists who strongly support unrestricted abortion observed in a book-length study of the abortion technique that "thousands of women have already been given a drug, whose molecular mechanism and biochemical properties are not extensively researched, let alone understood." They also complained that "Once more, as with the contraceptive pill, DES, fertility drugs and hormone replacement therapy, healthy women are used as living test-sites for an 'exciting new drug'."

Source: Janice G. Raymond, Renate Klein, Lynette J. Dumble, RU 486 Misconceptions, Myths and Morals (Cambridge, MA: Institute on Women and Technology, 1991), p. 67. (Janice Raymond is Professor of Women's Studies and Medical Ethics at the University of Mass., Amherst.)

• The feminists also indicated that there is a possibility that the powerful synthetic steroid RU 486 could damage a woman's ova and harm her subsequent offspring years later.

They said, "In other words, a drug which in fact might have long-term effects on folliculogenesis, ovulation and hence future fertility is declared 'safe and effective', whereas, in reality, the mechanism(s) by which it might exert this action remain(s) unknown."

They emphasized that "To our knowledge no long-term follow-up studies of women after RU 486/PG have been undertaken to evaluate later pregnancies and menstrual cycles."

Source: Janice G. Raymond, Renate Klein, Lynette J. Dumble, RU 486 Misconceptions, Myths and Morals (Cambridge, MA: Institute on Women and Technology, 1991), pp. 75, 76. (Janice Raymond is Professor of Women's Studies and Medical Ethics at the University of Mass., Amherst.)

•“RU 486” proponents have asserted that "Only through testing, careful observation, and actual use by people over a long period of time will certain things be learned about RU 486 and other antiprogestins." (emphasis added)

Source: Reproductive Health Technologies Project, booklet, "The Case for Antiprogestins. RU 486: The first in a new generation of birth control." (1992), p. 11.

• In the U.S. trial, in almost all cases, the abortionist did not follow up with women beyond 15 days.

Source: Spitz, Barton, et al. NEJM (1998), p. 1242.

Will “RU 486” increase number of abortions?

Q. Will marketing of “RU 486” increase the annual number of abortions in the U.S.?

Background:

• Abortion supporters claim that “RU 486” will not increase the annual number of abortions. They cite France as an example, where they note the number of abortions has not risen since “RU 486” was introduced over a decade ago.

Sources:

• "I don't think it (“RU 486”) will have any effect whatsoever on rates of abortion or rates of unintended pregnancy, said Gloria Feldt, president of the Planned Parenthood Federation of America." Quoted in "U.S. Abortions Continue To Decline", Associated Press, AP Online, January 6, 2000.

• "There has been no increase in the total number of abortions in France since the (“RU 486”) method was introduced in 1989." Fact sheet, Frequently Asked Questions, The Population Council web site, update of October 13, 1999, section on What is the European Experience.

• Pro-Life supporters say that the French experience is irrelevant in judging the impact of the abortion technique because the medical systems and population are too different.

In the U.S., 93% of abortions are performed in private “clinics” or doctor's offices, not hospitals. In France, public hospitals perform most abortions. The U.S. abortion industry is privately owned and operated. France has socialized medicine. The U.S. has fewer abortion facilities per capita than France. In 1996, the U.S. with a population of about 270 million had approximately 2,000 clinics, hospitals, and physician's offices that did abortions. In 1990, France with a population of about 58 million people had about 800 abortion facilities. The U.S. population is much more racially and economically diverse than France.
1. U.S. abortion supporters are counting on “RU 486” to increase the number of abortionists, particularly in non-urban areas. France did not need to increase the number of abortionists.

Sources:

• In France, “RU 486” abortion is generally available in public hospitals, said the Population Council's web site. Source: Fact sheet," Frequently Asked Questions, "The Population Council web site, update of October 13, 1999, section on What is the European Experience.

• In the U.S., only 14% of U.S. short-term, general, nonfederal hospitals performed abortions, according to the latest statistics. Abortionists in those hospitals did 7% of the U.S. abortions in 1996. Source: Stanley K. Henshaw, "Abortion Incidence and Services in the United States, 1995-1996," Family Planning Perspectives, vol. 30, no. 6 (Nov./Dec., 1998), available on the Alan Guttmacher Institute=s web site.

• Number of French abortion facilities: Alan Riding, "Abortion Politics Are Said To Hinder Use of French Pill," New York Times (July 29, 1990), which stated that "Some 4,000 doses (of RU 486) per month are not being sold to the country's 793 authorized abortion clinics." And Etienne-Emile Baulieu with Mort Rosenblum, "The Abortion Pill: RU-486 A Woman's Choice" (New York: Simon & Schuster, 1991), p. 92.

• Expanding the number of abortionists:

"We're talking about expanding the pool of (abortion) providers from literally a handful to many, many, many," stated Dr. Eric Schaff, an abortionist in Rochester, New York, who has conducted trials with “RU 486.

An August 3, 1994 San Francisco Examiner story pointed out that "While these [abortion] drugs won't immediately make the battle over abortion disappear, as some of their proponents have argued, they will eventually make the delivery of abortion services much more private and widespread." One of the key reasons is the impact on physicians. "Fewer and fewer physicians currently do abortions as part of their routine family or gynecological practices because of the controversy surrounding the procedure," noted the story, and "abortion drugs, however, would take some of the heat off doctors, say their proponents."

"It (“RU 486”) will mainstream abortion into regular medical care. "Dr. Suzanne Poppema, Seattle abortionist, quoted in Louise D. Palmer (Newhouse News Service), “RU-486 Revolution: FDA Poised to Approve Abortion Pill," Chicago Tribune (Jan. 5, 2000).

• A review of the history of the abortion industry in the U.S. during the 1970s demonstrates that adding more abortionists will mean more abortions. In other words, if women have more access to an abortionist, the number of abortions will rise just as they did after the U.S. Supreme Court Roe v. Wade decision in 1973.Source for 1982 and 1996 statistics: Stanley K. Henshaw," Abortion Incidence and Services in the United States, 1995-1996," Family Planning Perspectives, vol. 30, no. 6 (Nov./Dec., 1998), available on the Alan Guttmacher Institute's web site.

ARE THE ABORTIONIST QUALIFIED?

Non-Ob/Gyn's Using “RU 486”?

Q. Will non-Ob/Gyn's use “RU 486”? If so, will non-surgeons be performing operations on the 5-to-7 % of women who must have surgery for incomplete or failed abortion?

Background

A representative of the company distributing “RU 486” indicated at the FDA Advisory Committee hearing that non-surgeons would be trained in seminars to handle the women who needed surgery for incomplete or failed abortion.

But members of the Advisory Committee, including those who voted in favor of marketing “RU 486," expressed strong reservations about having general practitioners and family physicians routinely performing suction aspiration abortions.

For example, FDA Advisory Committee member, Dr. Richard Azziz said" I think that it is an error, and probably needs to be addressed now, to train nonsurgeons to do a procedure which is a D&C (dilation and curettage) on a pregnancy uterus, which is extremely risky." And another member, Dr. Vivian Lewis, said "I do not think you can teach somebody to do a surgical evacuation of the uterus in a simple seminar with a mannequin or something."

The Advisory Committee chairman, Dr. Ezra Davidson, pointed out to the Population Council's representatives that "I think what you are hearing from the committee as the issue of skills (of prospective abortionists using “RU 486”) being discussed (is) there is considerable unease about how the certification (of abortionists) and documentation is going to be done to ensure safe delivery of this regimen and management of its complications."

Source: Discussion by FDA Advisory Committee members about the RU 486 distribution system, FDA Hearing on “RU 486” (1996), pp. 318-326.

Who pays for surgery?

Q. Who is going to pay for the surgery and emergency-room costs of the 5-to-7 % of women who have incomplete or failed abortions?

Background:

• At the FDA hearing in 1996, representatives of the Population Council assured the Advisory Committee members that indigent or non-insured women would not be charged extra for surgical abortion which would be part of the chemical-abortion package.

Source: FDA Hearing on “RU 486” (1996), pp. 271-272.

Comments:

• In the U.S. trial of “RU 486, 8% of the women had surgery after taking both drugs. If “RU 486” were to be used by 650,000 women annually as some abortion advocates have predicted, an estimated 52,000 women a year would require surgery.

• Will local abortionists fulfill the Population Council's promise to women and perform the surgical abortion for free? And will the abortionist pay the woman's emergency-room bills?

• What will happen if the abortionist refers the woman with complications to another physician to perform the surgery? Will the abortionist pay the second doctor's bill?

Training for abortionists?

Q. How much training will non-Ob/Gyn's have before using “RU 486”? How will women know that the abortionist is qualified to handle complications and surgery?

Background:

At the FDA Advisory Committee hearing in 1996, the prospective distributor of “RU 486” described plans to train non-Ob/Gyn's and non-surgeons how to perform surgical abortions on women who have complications from “RU 486” Members of the FDA Advisory Committee, including those who voted in favor of marketing “RU 486”, expressed strong reservations about having general practitioners and family physicians routinely performing suction aspiration abortions.

For example, Dr. Richard Azziz said "I think that it is an error, and probably needs to be addressed now, to train nonsurgeons to do a procedure which is a D&C (dilation and curettage) on a pregnancy uterus, which is extremely risky.” And Dr. Vivian Lewis said "I do not think you can teach somebody to do a surgical evacuation of the uterus in a simple seminar with a mannequin or something."

Source: Discussion by FDA Advisory Committee members about the drug distribution system, FDA Hearing on “RU 486” (1996), pp. 318-326.

Will abortionists follow the FDA's rules?

Q. Are abortionists required to follow the protocol approved by the FDA? What happens if they don't?

• How will women know if their abortionist is following the FDA-approved procedures? If a woman is harmed when the abortionist doesn't follow the procedure, does she have a stronger legal case for compensation?

Nurses Becoming abortionists?

Q. Will women using “RU 486” have direct contact with a physician any time during the abortion process?

Background:

• Non-physicians can provide “RU 486” abortions, according to the administrator of Dr. Suzanne Poppema's abortion office in Seattle. At a workshop in March, 1999, she told her audience of prospective chemical abortionists that "a nurse-
practitioner or a certified nurse-midwife, or a physician's assistant can provide non-surgical abortions in your facility. If that's true, it's a great way to add revenue to your clinic."

Source: Workshop for prospective chemical abortionists, March, 1999.

WILL "RU486" HARM CHILDREN?

Babies Who Survive “RU 486”

Q. What happened to the babies of women who took RU 486 and still carried to term? How many such cases do they estimate will occur in the U.S. each year? If a baby is born with deformities caused by RU 486 or Cytotec, who will pay for the care?

Background:

• At least one baby died from an immune disease after her or his mother took RU 486 and carried to term. Among the women who have used “RU 486” worldwide, by July, 1996, at least 21 women changed their minds after taking RU 486 and carried their babies to term. Three of those babies had congenital abnormalities, reported the Population Council to the FDA in July, 1996. One baby had a club foot; one had "some abnormal fingernails," and the third had "an immune disease which led to death."

Source: Dr. Wayne Bardin of the Population Council, FDA Hearing on “RU 486” (1996), p. 35.

• “RU 486” advocates know that deformed babies are a very real possibility. Sally Burgess-Griffin, director of Hope Clinic for Women, Granite City, Illinois, sponsor of a RU 486 trial, told her local newspaper that "I have not heard of any cases of (deformed babies born after administration of RU 486). But that wouldn't be surprising to me, frankly."

Source: Teri Maddox, “RU 486, Debate over safety, morality continues during Hope Clinic testing," Belleville (IL) News-Democrat (August 15, 1995).

• During the U.S. test of RU 486, women were explicitly warned of the dangers of birth defects if they carried to term.. "We advised women about what the animal data showed and said that there was a considerable risk to them if they changed their mind because unusually teratologic effects in animals will translate, or have a high possibility of translating, to teratologic effects in humans, "explained Dr. Wayne Bardin of the Population Council at the FDA Advisory Committee meeting.

Source: Dr. Wayne Bardin of the Population Council, FDA Hearing on “RU 486” (1996), p. 34-35.

• Abortion supporters expect that hundreds of thousands of U.S. women will use RU 486 each year. For example, "The Feminist Majority Foundation has predicted that in the future about 50 percent of abortions will be medical (chemical)," reported the July 11, 1999 New York Times Magazine. (That would be about 650,000+ abortions with “RU 486” per year.)

Source: Margaret Talbot, "The Little White Bombshell," New York Times Magazine (July 11, 1999), p. 48.

Will women return for three visits?

Q. How will the abortionist insure that women will return for the mandatory follow up to check whether the drugs worked? Are there going to be any special procedures for non-English- speaking women or low-income women who are too poor to own a telephone?

Background:

• In the U.S. carefully controlled test, "5 percent of the women did not return for final confirmation of the outcomes of their pregnancies," reported the sponsors. "This occurred despite repeated attempts to contact them."

• Of those 106 women, "five had continuing pregnancies when last seen at visit 2." Moreover, "In other studies, the loss to follow-up has ranged from 3 to 11 percent."

Source: Spitz, Barton, et al. NEJM (1998), p. 1246.

(Comment: Abortion advocates project that 650,000 women might use “RU 486” annually. With a dropout rate of 5%, which is a conservative figure, 32,500 women would not return for the mandatory third visit. It is likely that many women might carry to term or need medical care to deal with the complications.)

• Dr. Suzanne Poppema, a Seattle abortionist, explained in the April 12, 1993, American Medical News that even though U.S. surgical abortion facilities routinely include a follow-up visit in the price of an abortion "we're lucky if 30% to 40% of these patients ever return."

• FDA Advisory Committee member Dr. Cassandra Henderson was especially worried about the follow up with women who do not return for the second and third visits to the abortionist: "Most of the women that I am concerned about, no one is going to go and get them. No one is going to call them because a lot of them do not have a phone."

Source: Dr. Cassandra Henderson, FDA Hearing on “RU 486” (1996), p. 292.

• The women in the U.S. trial were a "highly selected and motivated group," observed Dr. Cassandra Henderson at the FDA Advisory Committee hearing in 1996. She and other committee members raised questions about whether women in the "real world" will be less likely to return for repeat visits to the abortionist. Henderson stated that she believed that “RU 486” is a "very valuable tool for taking care of women and increasing reproductive rights and options, but I also believe that there is a great risk for harming a very large, vulnerable population if we do not study them and make sure that once this (“RU 486”) is available that they are not irreparably harmed."

Source: FDA Hearing on “RU 486” (1996), pp. 267-271, 280.

• Three feminists who strongly support unrestricted abortion raised concerns in 1991 about the drop-out rate even among white, middle-class women who participated in trials." Those who have administered RU 486/PG report compliance and follow-up problems in the white, middle-class, western world. When asked whether there was any succeeding supervision to ascertain the future fertility of women who underwent RU 486/PG abortions in the Southern California trials, Daniel Mishell responded:" ...we cannot even get the patients to return to have their blood drawn."

Source: Janice G. Raymond, Renate Klein, Lynette J. Dumble, RU 486 Misconceptions, Myths and Morals (Cambridge, MA: Institute on Women and Technology, 1991), pp. 31-32. (Janice Raymond is Professor of Women's Studies and Medical Ethics at the University of Mass., Amherst.)

Contacting teenagers at home

Q. How will the abortionist follow up with teenagers who do not want to be called at home?

Secret manufacturer to limit liability?

Q. Will the manufacturer of RU 486 be kept secret? If so, how would women and their children who are harmed by “RU 486” be able to get compensation?

Background:

• Heather O'Neill, a representative of the company handling the distribution of RU 486, "won't reveal the names or the locations of the manufacturers or even whether they are start-ups or established companies," said the New York Times in July, 1999. O'Neill said that the company will try to maintain this secrecy throughout the manufacturing process.

•The New York Times article said that once the FDA has inspected the manufacturer, keeping the company's name "out of the public's hands becomes a much dicier matter." In fact, reported the article, "I can't think of any precedent for that kind of secrecy," says Lars Noah, a law professor at the University of Florida whose expertise is food and drug law.

Source: Margaret Talbot, "The Little White Bombshell," New York Times Magazine (July 11, 1999), pp. 42, 43.

Comment: Abortion supporters have long sought a way to minimize or eliminate the potential for product liability lawsuits.

• In 1991, the leading advocate of “RU 486, Dr. E.-E. Baulieu, wrote in his book, The Abortion Pill, that the best way to avoid lawsuits is to have" a single-product company." Baulieu explained that "A carefully designed corporate structure could limit the liability, discouraging nuisance lawsuits and offering no other product to be boycotted."

Source: Etienne-Emile Baulieu with Mort Rosenblum, "The Abortion Pill: RU-486 A Woman's Choice" (New York: Simon & Schuster, 1991), p. 153.

• According to the Reproductive Health Technologies Project, one of the key organizations promoting RU 486, the leading U.S. drug companies stayed away from the controversial abortion drug because of the risk that a "healthy" woman would use it and be injured or "have a child born with abnormalities."

Source: Reproductive Health Technologies Project, booklet, "The Case for Antiprogestins. RU 486: The first in a new generation of birth control." (1992), p. 15. The two consultants who operated the Project were formerly employees of the Planned Parenthood Federation of America and the National Abortion Rights Action League (NARAL).

• In a chapter-length study of "The Political History of RU-486" published by the National Academy Press in 1991, R. Alta Charo described how drug companies viewed RU 486 warily because of the recent lawsuits over IUDs. "We never even got to a serious examination of the [RU-486] pill's properties," said one pharmaceutical company executive." As soon as our attorneys learned that it is only 95% effect, they began to scream. The other five percent could involved defective childrenCand that, in terms of liability suits, could blow us out of the water."

Source: R. Alta Charo, The Political History of RU-486,in Biomedical Politics edited by Kathi E. Hanna (Washington, D.C.: National Academy Press, 1991), p. 84.