The RU 486 Abortion Technique
From Discovery to Marketing, 1980-1988:

A Chronology and Bibliography

The current lull in the public controversy over the dangerous RU 486/Cytotec prostaglandin (RU 496/PG) abortion technique provides an excellent opportunity to look back and analyze the key developments in the eighteen-year history of the notorious “abortion pill.” Such a retrospective can both clarify for “old timers” what was happening behind the scenes of the major events, and offer newcomers an overview of how we got to where we are today.

This issue of The RU 486 Report covering the period from 1980 through 1988 is the first installment of that retrospective. The review of events is in the form of a chronology listing the major developments along with some background information and the sources, such as newspaper or medical journal articles. The sources are listed in the bibliography alphabetically by the name of the author and date.

In an effort to provide a rough road map to follow, here are some of the most notable trends and themes on RU 486 from the time of its discovery in 1980 until the first marketing for abortion in December, 1988:

• How the name of the drug “RU 486” has remained the same.

• How the term “abortion pill” has persisted despite a massive publicity campaign in the U.S. to change the image of RU 486 to a novel form of “contraceptive.”

• How researchers rushed to test RU 486 on women for abortion less than two years after discovery.

• How early both the World Health Organization and the key U.S. research and development organization, the Population Council, entered the picture and remained at the center of developments.

• How the French manufacturer and distributor of RU 486, Roussel Uclaf, and its German parent company, Hoechst AG, tried to distance themselves from the abortion controversy in the U.S. while pushing for marketing in Europe.

• How researchers experimented using RU 486 for abortion during three different times in pregnancy (1) “post-coital” or “morning-after pill;” (2) about the time of the expected menstrual period; and (3) 5-to-7-weeks or more into pregnancy, but found that only the third was effective enough to go on the market.

• How the concept of the two-drug RU 486/prostaglandin technique has essentially remained the same since 1984, but three different prostaglandins have been used.

• How RU 486 promoters in the U.S. persisted in describing it as a “monthly menses inducer” long after clinical research proved it ineffective.

• How from the time of the initial experiments using RU 486 for abortion, prolonged and severe bleeding has persisted as the principal and most dangerous short-term complication.

• How there have not been any studies of aborted women to determine the long-term adverse side effects.

• How RU 486 advocates claimed that the drug had non-abortion beneficial uses when research showed that it was only effective for abortion.

Chronology

(The references are listed in the bibliography in alphabetical order by the name of the author. )

April, 1980 -- Discovery of RU 486 Researchers at the French drug company, Roussel Uclaf, synthesized a new molecule, named RU 38486—later shortened to RU 486. The aim of the project was to develop new glucocorticoid antagonists, not just for abortion. The team included André Ulmann, a nephrologist and endocrinologist who was medical director; J. Georges Teutsch, a chemist; Daniel Philibert, a physicist and pharmacologist who supervised the research on RU 486's action in cells and animals; Sir Daniel H.R. Barton, an Englishman who later won the Nobel Prize in chemistry in 1990; and Etienne-Emile Baulieu, M.D., an endocrinologist at INSERM (the French equivalent of the U.S. National Institutes of Health), a university professor, and a consultant with Roussel Uclaf. (Ulmann 1990, pp. 42, 44-47; Baulieu 1990, pp. 16-17)

Early 1982. Initial abortion tests conducted.   In October 1981, Dr. Baulieu suggested using RU 486 to abort pregnant women to Dr. Walter Herrmann of the University of Geneva in Switzerland. Two experiments tested using RU 486 both before and after the woman has missed her menstrual period.

In early 1982, Herrmann used 200 milligrams of RU 486 alone to abort 11 women who were 6-to-8-weeks pregnant (measured from the time of the onset of their Last Menstrual Period (LMP)). (Ulmann 1990, p. 47) Nine of the women aborted within four days, and the drug failed in two cases. (Baulieu 1990, p. 21.) “The results achieved with this small group proved to be representative of the findings of almost all subsequent studies conducted over several years,” observed Baulieu later. (Baulieu, 1989, pp. 1811-12) The rate of complete abortion using RU 486 alone was about 80%, and the women who have either an incomplete abortion or no abortion at all had surgery to complete the abortion procedure.

Researchers also tested RU 486 earlier in pregnancy before the women missed her menstrual period. In an extremely small sample, 50 milligrams of RU 486 was administered for four days to 3 women who were at the 22nd day of the menstrual cycle (that is, 7 days past ovulation—or 3-weeks LMP) to determine whether the drug could be used as a “menses inducer.” (Herrmann, 1982, pp. 935, 937) (The onset of the menstrual cycle would normally occur about 28th day—or 4-weeks LMP.)

April 19, 1982 -- Public announcement of RU 486 Baulieu presented the results of the abortion tests to the French Academy of Sciences. International publicity described three possible uses: (1) a monthly “menses inducer, a “morning-after pill,” and for early abortion on women about 6-to-8-weeks pregnant. The monthly technique received the biggest play in the media. (Baulieu, 1990, pp. 21-25; Lesh, 1982; Russell, 1982; Eder, 1982. The clinical results were published in Herrmann, 1982.)

The announcement established some important trends:

• For the next six years, Baulieu and others primarily promoted RU 486 as a “menses inducer” that would substitute for the current birth control pills that are taken daily for three weeks. RU 486 was supposed to be taken monthly by the woman for two-to-four days about the time she expected to start her menstrual period. The New York Times reported that “Dr. Baulieu believes that the most promising aspect of RU-486 is not to induce abortion once pregnancy is recognized, but to be used regularly to terminate any pregnancy that may have occurred.” (Eder, 1982) [In other words, if fertilization (conception) had taken place, RU 486 would be causing an abortion, but before the woman knows for sure that she is pregnant.] Baulieu also mentioned using RU 486 as a “morning after pill,” which a woman would take if she had “unprotected intercourse,” at a time when she could become pregnant.

• The media coverage confused the uses of RU 486. The news accounts stressed the the “menses inducer” use, but described the results of the test on the 11 Swiss women who were 6-to-8-weeks LMP.

• Baulieu became the principal spokesperson on RU 486 in the major U.S. media accounts, and he was even incorrectly identified as the “inventor” by the New York Times.

• The Roman Catholic Church was the only named opponent of RU 486, and was only mentioned in passing near the end of the articles—if at all. (Lesh, 1982)

• The press uncritically accepted the safety and effectiveness claims of the proponents, such as Baulieu. Opposition was based only on moral–not medical or safety–concerns.

• “RU 486" became the public name of the drug.

Sept. 1, 1982 U.S. Research-and-Development Contract Signed. Roussel Uclaf signed a then-confidential research and development agreement with the Population Council, a not-for-profit organization based in New York City, which was later revised on July 18, 1984. (Euvrard, 1993; Baulieu, 1990, p. 30) See entry for July 1984 for the initial U.S. test under the auspices of the Population Council.

1983 through 1986 Small-scale clinical trials on a total of several hundred women were conducted under the auspices of the manufacturer Roussel Uclaf, the World Health Organization, the Population Council and others to evaluate different dosages and schedules of administration, especially to increase the effectiveness for abortion.

1983 World-wide Research-and-Development Agreement Signed. Roussel Uclaf signed an confidential agreement with the United Nations' World Health Organization (WHO) for testing and marketing of RU 486 in both developed and developing countries. “If Third World public health services wanted to use it in clinics later on, the company would offer a reduced price. This agreement would not only provide research but also pave the way for RU-486's introduction into poorer countries,” observed Dr. Baulieu. (Baulieu, 1990, pp. 29-30)

A letter in 1991 from the then-president of Roussel Uclaf described the substance of the agreement: (1) Roussel must provide RU 486 for tests; (2) Roussel will provide RU 486 for “public sector” [presumably non-profit or government] distribution; (3) if Roussel cannot provide RU 486, then WHO has a license to get it elsewhere; and (4) the agreement covers the world except for Europe, Australia, Canada, Japan, New Zealand, South Africa and the U.S. (Sakiz, 1991)

Extensive world-wide testing was later conducted under the auspices of WHO's Special Program of Research, Development, and Research Training in Human Reproduction. (For example, Kovacs, 1984; Bygdeman, 1985; Diczfalusy, 1986; Kovacs, 1985; Swahn, 1985; Swahn, 1986; Radestad, 1988; Swahn, 1989; Van Look, 1989; Swahn 1990 ) One especially important development was the demonstration in 1984 that using RU 486 with a prostaglandin would increase the effectiveness of the abortion technique close to that of surgical abortion. (Diczfalusy, 1986, pp. 10-11; WHO, 1990, p. 38)

May 31, 1983 -- U.S. Patent Granted for RU 486 U.S. patent No. 4,386,085 for RU 486 was granted to a team of researchers headed by J. George Teutsch and assigned to Roussel Uclaf. The original application had been filed on Jan. 8, 1982, and the foreign application priority data from France was dated Jan. 9, 1981. (Teutsch, 1983)

July, 1984. U.S. Abortion Test Begins. The only U.S. test of RU 486 for abortion during the 1980s was conducted from July, 1984 through February, 1990 on nearly 400 women at the Women's Hospital, Los Angeles-University of Southern California Medical Center. The women were about 7-weeks-or-less LMP. The leading researchers were Drs. Daniel R. Mishell, Jr. and David A. Grimes. (Grimes, 1990; Krier, 1990) (See entry for Sept. 18, 1982 about agreement for supply of RU 486.)

1984 Prostaglandin Tested with RU 486 To Increase Effectiveness In effort to increase the effectiveness of RU 486 for abortion, researchers in Sweden tested RU 486 plus an injection of the prostaglandin Sulprostone on 16 women who were 49-days-or-less pregnant. The rate of complete abortion reportedly increased to 100%. The dose of prostaglandin (PG) was much lower than would be needed for abortion, if the PG were to be used alone. (Swahn, 1985, p. 254)

October 23-25, 1984 International Conference on RU 486 held at the Rockefeller Foundation's Conference and Study at Bellagio, Italy. (The proceedings are later published in 1985 in a book co-edited by Dr. Baulieu and Sheldon J. Segal of the Rockefeller Foundation. Roussel Uclaf funded the conference and the publication. (Baulieu, 1985, p. v) The book provided the initial comprehensive scientific description of using RU 486 for abortion and other purposes. )

December, 1984. RU 486 Proponents claim 100% abortion rate In an unpublished research paper released to the French press, researchers claim a 100% rate of abortion for the RU 486 plus prostaglandin technique, and a 70% abortion rate when used in alone.

The Associated Press news story stated (incorrectly) that RU 486 “prevents implantation of the fertilized embryo on the uterine wall.” Tests had been conducted in Sweden, Switzerland, the Netherlands, the United States, and Mexico under the auspices of WHO. Further tests were planned in India and China in 1985. The research paper also claimed “practically no secondary effects” except for “prolonged bleeding,” which was not considered life-threatening. (Ganley, 1984)

The chief media spokesperson, Dr. Baulieu, forecast that RU 486 would be used in France, India, and China in 1985. “It's main target is the 1 billion women in Third World nations who should be using birth control,” he said. (UPI, 1984)

April 1985. RU 486 named “mifepristone” As of April, 1985, 200 women who were 6-to7-weeks pregnant had been aborted using RU 486, either alone or with prostaglandin. RU 486 has been given the generic name “mifepristone.” (Baulieu, 1985, p. 347) Large-scale trials began in 1985 to determine the most effective administration schedule for the RU 486/PG combination. (Ulmann, 1990, p. 47)

Fall, 1985 through Fall, 1986 Promotional Campaign Started in U.S. In the fall of 1985, the RU 486 “abortion pill” became a hot media issue. For example, leading TV programs such as ABC News “Nightline,” the “MacNeil/Lehrer News Hour on PBS, and the “Donohue Show” featured debates. (News Hour, 1985; ABC, 1985; Donohue, 1986). The publication in late 1985 of a book giving the results of the October 1984 conference on RU 486 also increased interest. (Baulieu, 1985). The publicity centered around the prospect of using RU 486 alone on a monthly basis before the woman experienced her menstrual period. (For example, Goodman, 1986.)

The major “news hook” was to describe how the introduction of a “once-a-month pill” that brings “down a missed menstrual period” would “knock the heart” out of the opposition to abortion, as Sharon Camp of the Population Crisis Committee claimed on the “MacNeil/Lehrer” show. She asserted that “American citizens and people around the world” would look very differently at a technique that is used about the time of implantation than “they look at a 12-week surgical abortion.” (News Hour, 1985) An article in the New Republic predicted that abortion facilities “would become a thing of the past, replaced by 24-hour clinics to treat potential complications.” (Kaye, 1986, p. 14)

Opposition to RU 486 in the U.S. also increased. For example, the National Right to Life Committee published a two-part series in February and March, 1986. (Glasow, 1986a and 1986b)

Apr. 10, 1986 U.S. Gov't Not Doing RU 486 Abortion Research Dr. Otis Bowen, Secretary of Health and Human Services, wrote a letter to Congressmen stating that the National Institutes of Health was conducting RU 486 research, but not for abortion. (Gianelli, 1987)

Oct. 7, 1986 Status Report on RU 486 Testing In Geneva, Switzerland, a top WHO official described the status of RU 486 tests and emphasized using it as a “morning-after pill” or “menses inducer” before the woman knows she is pregnant. (Sullivan, 1986)

Dec. 18, 1986 Publication of French Test in U.S. Journal The prestigious New England Journal of Medicine (NEJM) published an article on French tests using RU 486 alone on 100 women who were requesting an abortion within 10 days after their expected menstrual period (about 5-weeks LMP). The rate of effectiveness of 85% was similar in the three different dosage regimens. (Couzinet, 1986) The NEJM published an editorial in favor of RU 486 research (Crowley, 1986) Extensive U.S. media coverage resulted. (Hilts, 1986; Brody, 1986; Benanti, 1986) The Washington Post published a long flattering profile of Dr. Baulieu, who reported that RU 486 had been tested on about 4,000 women in 15 countries. (Rosenfeld, 1986)

Dec. 1986 Experts Say RU 486 Not for Monthly Use The December, 1986 issue of Contraceptive Technology Update, a family-planning-industry newsletter, explained that RU 486 was not suitable for monthly use prior to the missed menstrual period. This statement contrasted sharply with the publicity surrounding the New England Journal article which emphasized using RU 486 monthly. Quoting experts, the Update reported that researchers discovered that taking the abortion pill monthly for several months in a row interrupted the relationship between the woman's hormonal cycles in her ovary and uterus. This interruption markedly reduced RU 486's effectiveness in causing abortion. (Update, 1986)

Dec. 29, 1986 National Magazine Stresses RU 486 Not “Morning-After Pill” Virtually alone among the national U.S. media, TIME magazine accurately reported that RU 486 was not “the long-sought, safe, morning-after pill,” but “really a month-after pill.” Most of the rest of the media took months to catch on to this crucial difference. (Murphy, 1986)

1987 through summer 1988

RU 486 Publicity Campaign in U.S. Intensified

Dr. Baulieu promoted changing the terminology to remove the stigma of “abortion” from RU 486. He proposed calling RU 486 a “menses regulator” or “contragestive” (a cross between contraception and gestation). (Gianelli, 1987; Baulieu, 1990, p. 27; Rosenfeld, 1986; Ob.Gyn News, 1987a)

Also, RU 486 advocates stressed the importance of U.S. research on RU 486 within the context of the “lack of progress” in research and development in contraceptive choices for women. (USA Today, 1987; Ob.Gyn. News, 1987b; Connell, 1987; Cooke, 1987; Thomas, 1988; Gladwell, 1988; Goodman, 1988; Fraser, 1988; Ballard, 1988)

The “women's” magazines such as MS, Savvy gave the issue special attention. (Costigan, 1987; Sweet, 1988; Glamour, 1988; Halpern, 1987; Vogue, 1988)

Jan. 22, 1987 Publication of U.S. Test as “Contraceptive” A group of researchers at the U.S. National Institutes of Health (NIH), the Population Council, and Roussel Uclaf published results of test to “induce menses” in 18 women who were in “midluteal phase” (about 3-weeks LMP or about the time of implantation) and not at “risk of pregnancy.” (Nieman, 1987) RU 486 would be “contraceptive” because “the drug is given at a time prior to when pregnancy is clearly established,” claimed Dr. Lynnette K. Nieman of NIH. (AP, 1987)

Sept. 15, 1987 Key U.S. Drug Companies Won't Test RU 486 Neither Hoechst Roussel, the U.S. arm of the French abortion pill company Roussel Uclaf, nor Sterling Drug, which controlled a similar drug to RU 486 named Epostane, will test or market the drugs in the U.S., reported the Wall Street Journal. The companies feared a consumer boycott. (Gapen, 1987)

Oct. 9, 1987 French Application to Market Abortion Technique Roussel Uclaf filed an application to use RU 486 for abortion in France. The National Ethics Council issued a favorable opinion in Dec. 1987. (Baulieu, 1990, p. 36)

Oct. 9, 1987 Large-scale Abortion Trial Started in UK Roussel Uclaf announced the beginning of a trial of RU 486 with prostaglandin for abortion in the United Kingdom on 1,000 women who were 7-or-less-weeks pregnant. (Scrip, 1987)

Jan. 15, 1988 Delay in French Approval

A French Ministry of Health commission requested more information about the prostaglandin before approving Roussel Uclaf's application to market RU 486. This development received little notice in the U.S. Roussel Uclaf refiled its application in mid-March, 1988. (Baulieu, 1990, p. 38)

Feb. 22, 1988 Pro-Life Pressure Barring RU 486 from U.S. The headline on the front page of the New York Times proclaimed “Influence of Abortion Critics Barring Sale of Drug in U.S.” (Kolata, 1988a)

June 23, 1988 Protests at the Roussel Uclaf Stockholders' Meeting French pro-life protesters at the annual Roussel Uclaf stockholders' meeting called for the withdrawal of RU 486. (Scrip, 1988; Baulieu, 1990, p. 38-39)

Sept. 15, 1988 U.S. Drug Advisory Committee Recommends Marketing of Cytotec Prostaglandin to Prevent Ulcers An panel of outside experts on the Gastrointestinal Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) recommended approval of the prostaglandin Cytotec (generic name “misoprostol) for prevention of gastric ulcers. At the committee hearing, the manufacturer, G.D. Searle of Skokie, Illinois, presented research studies showing that when taken alone Cytotec could cause abortion or malformations of the unborn child. Dr. J.C. Willke, president of the National Right to Life Committee, spoke against approval because of the potential for abuse for abortion. (See Dec. 27, 1988 entry below)

Sept. 23, 1988 French and Chinese Approve Marketing of RU 486/prostaglandin for Abortion French Health Minister Claude Evin announced the government's approval of licensing the two-drug RU 486/Sulprostone prostaglandin technique to abort women who are 5-to-7-weeks pregnant. (Haydon, 1988; Kolata, 1988b; UPI, 1988) China's approval was announced at the same time. (Kolata, 1988b; Wilhelm, 1988) World-wide publicity resulted.

Sept. 26, 1988 Prohibition of Entry of RU 486 into U.S. The U.S. Food and Drug Administration (FDA) issued an “Import Bulletin” prohibiting entry of RU 486 for personal use.

Oct. 26, 1988 Marketing Postponed in France Roussel Uclaf officials announced they were postponing marketing of RU 486, but left open the possibility of changing their minds. The reason given was the public controversy against the drug, especially the threat of a boycott. (Foreman, 1988; Greenhouse, 1988a; Tempest, 1988a; Cody, 1988a)

Extensive publicity resulted. An immediate outcry from pro-abortion activists, including physicians at a world conference of ob/gyn's in Rio de Janeiro, dominated the headlines. (Tempest, 1988b; Greenhouse, 1988b; Baulieu, 1990, pp. 46-49)

Oct. 28, 1988 RU 486/PG Put Back on Market Roussel Uclaf officials put RU 486/PG back on the market, ostensibly at the “order” of the French Health Minister Claude Evin who declared that it was the “moral property of women.” Roussel officials claim that Evin's decision relieved them of responsibility. (Cody, 1988b; Greenhouse, 1988c; Waldholz, 1988)

Recognizing that the three-day withdrawal was only a ruse, pro-life activists still held Roussel Uclaf and its German parent company, Hoechst AG, responsible for the abortion pill. (Greenhouse, 1988c; Andrusko, 1988; Glasow, 1988)

Subsequent events demonstrated that the “order” was a carefully orchestrated attempt to shift the blame off of Roussel Uclaf. French pro-life activists challenged Evin's action in court. And in January, 1991, the Council of State, the equivalent of the U.S. Supreme Court, decided in their favor that Evin did not have the authority to issue such an “order.” At that point, Evin disclosed that he had never issued an “order” but merely held a discussion with Roussel Uclaf officials. (Le Figaro, 1991) Even Dr. Baulieu admitted in his book in 1990 that “[t] ministerial stand was not an order.” (Baulieu, 1990, p. 50) This “order” has become one of the most persistent myths about RU 486.

Dec. 27, 1988 U.S. Government Approved Cytotec for Market The U.S. FDA approved the prostaglandin Cytotec for market for the prevention of potentially life-threatening ulcers caused by arthritis medicine. The FDA required extensive labeling to indicate that the drug is not for use “in women of childbearing potential.” (Stevens, 1988; Estill, 1988) (In 1991, Cytotec replaced Sulprostone as the prostaglandin used with RU 486 to cause abortion in France.)

Dec. 28, 1988 Formal Authorization for Marketing of RU 486 in France The French government formally authorized the sale of RU 486 for abortion. (Evin, 1988) Some notable requirements were the following:

• Extremely tight requirements for record keeping.

• The pregnant woman had to be informed that if the method failed, then the fetus would be “exposed to a risk of malformation” if she did not have a surgical abortion and carried the pregnancy to term.

• A prostaglandin must be used in association with RU 486.

• The RU 486/PG method should not be used beyond 49-days LMP.

Summary

By the end of 1988, abortion-pill advocates had arranged for the French government's approval for marketing of the RU 486/Sulprostone prostaglandin abortion technique. Tests were underway in countries around the world under the auspices of the WHO using RU 486 to abort women at three different times in pregnancy: as a “post-coital” or “morning-after pill;” about the time of menstruation; and in the first few weeks after the woman missed her menstrual period. Other researchers were conducting small and preliminary tests using RU 486 for a variety of non-abortion purposes. Now that RU 486 has been approved in France, leading U.S. abortion proponents were gearing up to begin testing here with the goal of getting it on the market as soon as possible. But press reports indicated that pharmaceutical companies were unwilling to get involved in a “death pill” that would trigger consumer boycotts and hurt their other drug business.

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