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RU 486 Conference, Frankfurt, Germany


Bernadette Marx, M.M.M.J., is a resident of Breda, The Netherlands. She is a scholar, researcher and author with a doctorate in geography.

A conference titled “Medical Abortion Services” occurred on 5 and 6 December 1992 in Frankfurt am Main, Germany. The official subject was “European perspectives on anti-progestins,” but the hidden agenda was the promotion and acceptance of RU-486, the abortion pill.

The conference was organized by International Planned Parenthood Federation (IPPF) Europe region, Birth Control Trust (United Kingdom) and Pro Familia (Germany). The majority of those attending came from Western Europe and the United States. An additional 149 people were present from Sudan, Bangladesh, Indonesia and Eastern Europe.

The major theme of the speakers was the widening of the range of choices in abortion methods through the development of RU-486. It was promoted by all as advancing “reproductive rights, freedom and health.” Although some discussion of problems associated with the drug were discussed there were no objections raised to distribution. Every argument was favorable to the aggressive promotion and acceptance of RU-486.

Presenters spoke openly on the thousands of deaths, complications, and perforations resulting from surgical abortion. The arguments assumed a strange ideological tilt as bitter complaints were registered that in “rich countries,” where the abortion is paid for by a health service, the more tedious abortion job is very often the work of a part-time female gynecologist, married and with children. The more sophisticated abortion surgeries were performed by her male colleagues.

The drug RU-486

RU-486 is a product of the pharmaceutical company Roussel Uclaf, Paris, France. This company is the property of the pharmaceutical industry Hoechst, Frankfurt am Main, Germany. Hoechst is the owner of the world patent for RU-486. The pill has been produced in China without permission.

It is not exported from there, because of the illegality. With this pill early abortion is possible from the fifth till the ninth week. It was reported that IPPF concluded an agreement with Roussel Uclaf for the promotion of RU-486 for commercial production. The World Health Organization (WHO) has been deeply involved in directing research toward the development of an abortion-pill. As a public organization WHO received donations from IPPF, and others, who emphasized the “need” for a drug which causes “safe termination?

WHO conducted extensive trials on women in over 30 countries in the process of searching for the minimum effective dose of RU-486. One research report states: “In an unpublished WHO trial involving l,188 women in 11 centers, 300, 400 and 600 mg of RU-486 in combination with 1 mg Gemeprost was shown to be equally effective.” The report continued, “Although the minimum effective dose of sulprostone (Gemeprost), which is effective in combination with RU-486 is unknown, the current data suggests that the recommended dose is too high.” One must wonder about the long-term effects of the drug-testing on the health of women subjects when the following statement was made: “In a randomized trial it was shown that 0.5 mg Gemeprost was as effective as I mg, while there were fewer side-effects associated with the lower dose” (Dr. David Baird).

RU-486 (generic name is mifepristone, trade name in France, UK and Sweden is Mifegyne) is a synthetic drug with anti-steroid hormone properties, synthesized by the Roussel-Uclaf Company. The drug is based on anti-progesterone action. Progesterone is a steroid hormone, indispensable for the beginning and the continuation of pregnancy.

RU-486 was registered in France by September 1988. Approximately 120,000 women are reported to have used it since then. It is currently given, in registered centers in France, to women with less than 50 days amenorrhoea, in combination with misoprostil (Cytotec), an orally active prostaglandin taken 48 hours later. RU-486 is used for pregnancy termination in the United Kingdom, Sweden and China. It has been tested in the United States for five years. Professor E. Baulieu claims that there are six “contraceptive” methods which utilize RU-486 administration.

The use of mifepristone requires four visits to an abortion center. Elisabeth Aubeny described the procedure: “On the first day, 3 cups of RU-486, that is, 600 mg, are taken at an authorized center, after which patients immediately return home.” On the third day, “48 hours later, 2 cups of oral prostaglandin, that is, 400 mg of misoprostil, are given at the center with a follow-up surveillance of 4 hours. Patients are allowed to wait in armchairs with the possibility of lying down or receiving painkillers if required. After a period of time, the patients return home, whether expulsion has taken place or not (expulsion occurs in 6l% of the women at the center).” By the eighth and tenth day, “A controlled examination is given. An ultrasonic examination or a dosage of human chorionic gonadotrophin (hCG) hormone is used if the ovum was not expelled at the hospital, to ensure that the uterus is empty.” Although the differentiation was not made by Aubeny, the term “ovum” refers to a fertilized egg.

According to Dr. David Baird: “It is unclear as to how widely medical termination will be used when it is more generally available. Experience in France suggests that up to 25% of women will opt for medical termination. Preliminary studies suggest that the majority of women who have had a medical termination are satisfied with the method.”

United Kingdom

In the United Kingdom (UK), RU-486 was licensed for medical “termination of pregnancy” up to nine weeks gestation in July 1991. The introduction of the drug met some barriers. Wendy Smith of the United Kingdom described the experience, “As these forces interact on many levels, I am going to suggest we look at the barriers under the headings of intolerance, inertia and ignorance. Arguably the most entrenched and pernicious of these three is intolerance.”

Ms. Smith saw the “stringent rules laid down for the employment of anti-progestins” as appearing to be “designed to militate against women’s electing to use this method.” These rules would limit the use of mifepristone “to women who live within one hour’s traveling time of the clinic,” A further obstacle was the requirement that a woman must agree “to have her own doctor notified.” And in contrast with expectations the clinic was required to “provide a given number of beds for treatment.” It had been Ms. Smith’s understanding that the drug was, “essentially, designed for well women, not for sick patients.” Without considering that the drug is capable of transforming “well women” into “sick patients,” Smith persisted in viewing the medical requirements as “more petty regulations” which would increase the cost of early medical abortion to the consumer, “making a mockery of the concept of ‘Choice’.”

“[A]nti-progestins,” she insisted, “are new” (emphasis added), Therefore there must also be a new system of use, “They do not fit into old systems, old hierarchies, old divisions of labour.” The “new drug” should be treated as a “consumer” product rather than being “geared to the convenience of a surgeon’s schedules.” She viewed the regulations as “resistance,” based on professional standing, “overseeing a pill and pessary regime does not command the same professional standing as wielding a scalpel.”

Dr. Anna Glasier complained, “referrals [can] take so long to arrange that many patients will arrive too late to have the choice between medical and surgical abortion.” Further, there is a “reluctance of National Health Service (NHS) managers” to provide funding for a “new” drug. Gynecologists also tend to believe (mistakenly, of course) “that existing services meet the needs of the population” Dr. Glasier believed that NHS executives were apparently fearful of “becoming involved with a matter so obviously ‘political’.” As a result, “medical abortion is not yet widely available” in the UK. As of August 1992, 74 private clinics are licensed to perform abortions, of which 16 have applied for approval for ‘medical terminations’ while only 12 were actually “providing the service.” In the 265 National Health Service hospitals doing abortions, 74 were using RU-486.

Sweden

The Karolinska Hospital in Sweden has been involved in the development of the clinical use of RU-486 within the WHO Human Reproduction Program (HRP) since 1983. The combined treatment of RU-486 with prostaglandins was developed there. RU 486 alone has a success rate in inducing early pregnancy termination of approximately 60%. In combination with prostaglandins this rate increases to about 98%. On 4 September 1992 RU-486 was licensed in Sweden.

Kerstin Hagenfeldt described the effect of public resistance to mifepristone in Sweden, “’The public appearance of pro-life activists and the appearance of a new Christian Democratic Party in the Parliament (September 1991) has only resulted in a strong reconfirmation by a great part of the population including most members of Parliament on the right of the woman to make her own decision irrespective of what kind of method is used for the interruption of pregnancy.”

United States

The speaker from the United States, Marie Bass, expressed great pleasure at the outcome of the 1992 elections. Ms. Bass stated, “This election carries a profound impact for those of us who work in the area of reproductive rights, family planning, women’s health and women’s rights.” Ms. Bass expounded on her theme, ““The long era of right-wing tyranny is oven” She described the “policies and program” of the Clinton Administration as “saner, more humane, more pro-woman and, may I say, pro-family.” Along with his “pro-choice” ideology, she viewed President Clinton as “progressive,” a man who “will have more women and minorities in his Administration.”

“You would be amused by some of the publicity on this subject [the introduction of RU- 486] since his election,” Bass smiled ironically. “It goes something like this: Since pro-choice people are for the introduction of RU-486 into the United States, and since President-elect Clinton is pro-choice, then surely this means that we will have RU-486 in the United States in no time. Isn’t that what happened just a few days ago in January l993?” In tones which showed her patronizing attitude toward such simplistic views, Bass went on, “Of course, a pharmaceutical company is needed to apply to the Food and Drug Administration.”

Bass also explained some of the complexities of the application process as it related to Roussel Uclaf. “Roussel Uclaf requires three conditions to be met before it submits an application: First, the country in question must have legislation permitting free access to abortion; Second, there must be a direct request from national authorities that RU-486 should be licensed; Third, there must be a reliable method of distributing RU-486.”

International Planned Parenthood Federation

The keynote address by Dr. Halfdan Mahler of the International Planned Parenthood Federation, was titled, “Obstacles to improving reproductive choice.” Mahler has been Secretary General of the International Planned Parenthood Federation since 1989 after a long career with the WHO. From 1973 until 1988 he was Director—General, and on his retirement the World Health Assembly declared him Director-General Emeritus of VVHO.

Mahler stated his position, “The right to choose is the right from which other rights flow.” He described women as “members of society who suffer the worst consequences of unplanned reproduction — those consequences which affect adversely their possibilities of development, which put upon them tremendous emotional pressure, and which represent a risk to their health and even their life.”

He maintained that the “right to reproductive choice is a right which is particularly susceptible to obstruction and neglect.” Mahler described the obstacles to reproductive choice as “based on a chain of inequities and social injustice” This chain of negative circumstances results “in acute poverty and powerlessness” for the women. Overwhelmingly, the entire “micro-universe of the individual, the family, local communities, nations and the entire world” are bound by these inequities and injustices. They invade and link the “cultural, medical, legal, economic and political” aspects of existence. Exacerbating these problem are the “organized anti-choice groups which use, in combination, any type of obstacle to prevent people from making their own reproductive choices.”

Of the cultural obstacles he said, “Very often the opposition to reproductive choices comes from people who use religious arguments.” And, “in many circumstances, people, and particularly women, will be in the situation of having to make decisions which may not be acceptable to their families or communities.” Women who must make decisions of this kind “should be supported as part of the quality of family planning services.”

Mahler then went on to describe the medical obstacles confronting women. “With respect to medical obstacles,” he continued, “[o]ften, members of the medical profession join others who oppose reproductive choice based on moral grounds. That actually represents an abuse of their power as recipients of scientific knowledge which should not give them the right to exert their influence to impose their personal moral values upon those who trust them.”

Economic obstacles also loom before the woman. “An important obstacle to reproductive choice is the lack of enough investment on research for new methods of fertility regulation.” With respect to the United States, “It is scandalous for example that at the present time only one pharmaceutical company in the USA is involved in this type of research.” Due to the “low interest among the pharmaceutical industry” the WHO had to “become the major research organization on methods of fertility regulation.”

Politically, opposition came from fringe groups, he said. “We can’t let fundamentalists deprive poor women of the less developed nations of their lives and well-being, just as we can’t let them deprive any women of their right to choose” Abortion must be a part of family planning programs. “The separation of abortion from family planning is a negation of basic human rights as recognized by the United Nations? “Further,”` he stormed, “The UN General Assembly declared in 1968 that it is the basic right of couples to ‘decide freely and responsibly on the number and spacing of their children.” Without “access to abortion as a backup to contraceptive failure or to end an unwanted pregnancy” women are unable to exercise their proper rights.

“After all,” Mahler insisted, including all women in the sweep of his embrace, “when the French Minister of Health in 1938 declared that RU-486 was the moral property of women, he was referring to all women in the world, wasn’t he?”

Draft recommendations for action

IPPF Europe must raise the subject of early medical abortion services in the context of safe abortion with the Council of Europe, the European Commission and the European Parliament.

Scientific, medical and women’s groups were encouraged to urge Roussel and Hoechst to apply for the product license in appropriate countries, and to distribute RU-486. They are to be urged to delete all criteria for release of RU-486 except those for medical indications.

Delegations of medical, scientific and women’s groups must be sent to Roussel and Hoechst to challenge them to allow another company to take up the product if they are unwilling to distribute and allow development of all uses, those attending the conference were told.

New independent organizations must be founded to develop RU-486 if Roussel/Hoechst gives up the product. Other pharmaceutical companies must be pressured to conduct research and development projects on other anti-progestins.

Further, where the medical profession is interested in providing anti-progestin abortion within a country, appropriate medical groups could approach Roussel to set a pre-market acceptability trial. If this approach has favorable results, it could be used to support an application for a product license.

Conclusions

The issue was described as “freedom, choice and reproductive rights” but multiple questions remained unanswered and unspoken at the end of the conference. Objections to the regulation of mifepristone avoided the hard questions of drug safety and accountability for the woman’s health. The dangers of urging pharmaceutical companies who are hungry for profit to experiment further on women’s bodies remained unquestioned. Liability for possible drug side effects was not mentioned (Third World women have particular difficulty in holding pharmaceutical companies accountable for their physical health damages due to a lack of medical records). The woman’s loss of a child was not mentioned. The ideological argumentation of the participants failed to reach the substance of the human problems faced by women and minors who take these powerful drugs (Judith Senderowitz of the U.S.-based Center for Population Options argued for the use of RU-486 as a morning-after pill for adolescents at a London anti-progestin conference).

Within Islamic countries, where abortion surgeries are restricted, RU-486 is to be promoted as a drug for “menstrual regulation” Is this disingenuous approach an answer to women’s well-being and health?

One was tempted to ask, “Is there anyone here who really cares about women or their health? Or is this simply a public opportunity for arguing on behalf of technologies which offer the illusion of ‘scientific solutions’ to human problems?” Perhaps these solutions even pose life-threatening dangers. The practitioners and promoters of this ‘scientism’ for women appear frenzied in their determination to keep hard questions from being asked and the dark side of science from being revealed. Is it possible, after all, that the answers to true ‘freedom and justice’ lie in the interrelationships of men and women with their Creator rather than in the controlling elements of pharmaceutical formulas? Such answers are obviously very far beyond the abilities of IPPF, WHO or the pharmaceutical companies to answer — no matter how loud and furiously they thunder.

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