New Insights from Abortion-Pill Test

The results of the U.S. trial on 2,100 women of the dangerous two-drug RU 486/Cytotec prostaglandin (RU 486/PG) abortion technique conducted by the Population Council have not been formally published. Our only sources about the U.S. experience have been anecdotal information in newspaper and magazine articles and summary data in the Council’s presentation in July 1996 before a U.S. Food and Drug Administration (FDA) Advisory Committee.

Nevertheless, analysis of recent medical journal articles summarizing the results of other experiments of RU 486/PG provides valuable new insights about the effectiveness, safety, and acceptability that can be useful in the public-policy debate. Here is one example.

RU 486/PG in Developing Countries

Beverly Winikoff, et al., "Safety, efficacy, and acceptability of medical abortion in China, Cuba, and India: A comparative trial of mifepristone-misoprostol versus surgical abortion," American Journal of Obstetrics and Gynecology (February 1997), pp. 431-437.

Since the first announcement of the existence of RU 486 in 1982, proponents such as French physician Dr. E.E. Baulieu have frequently described their hope to use the abortion technique in the so-called "Third-World" or "developing" countries. According to media reports, one of the major stumbling blocks to the introduction of RU 486/PG into such countries has been the well-documented necessity for women using the technique to have rapid access to follow-up medical care to handle the short-term adverse side effects. In particular, women who are anemic or malnourished would be especially in danger from the excessive bleeding that is an integral part of every RU 486/PG abortion.

In an article published in February 1997, Beverly Winikoff from the Population Council and her nine co-authors described the first test comparing surgical abortion with the French regimen for using RU 486/PG on a total of 1,373 women in three "developing countries"—China, Cuba, and India. This study conducted under the auspices of the Population Council is very significant in the following ways:

• first test in developing countries of the RU 486 and prostaglandin abortion method employed in France (and tested in the U.S.),

• first test in developing countries comparing RU 486/PG and surgical abortion,

• first test in developing countries of "acceptability" of RU 486/PG by women,

• publication in a leading U.S. medical journal, and

• assertion that RU 486/PG abortion "is safe, efficacious, and highly desired by and acceptable to women in developing countries."

This article will probably be cited as demonstrating the safety, efficacy, and acceptability by women of RU 486/PG in developing countries. But a close reading of the study reveals major deficiencies in the methodology and findings that invalidate its conclusions.

• As in all of the published work on RU 486/PG, the researchers lack objectivity because of their strong ideological commitment to abortion in general and their interest in promoting wider use of chemical abortion.

Unfortunately, the media has largely ignored this bias.

• No follow up of women after 2 weeks to identify long-term adverse side effects, such as the physical and psychological complications of the two powerful synthetic hormones.

• The study was conducted only in urban abortion facilities. The facilities were selected for the trial because they had a "proven capacity to endure patient follow-up" and were able to "provide emergency care." These arrangements are not typical of many developing countries with heavily rural populations.

• The procedure for selecting women for the test was much more extensive than could be expected in most "developing" countries. Participation criteria included a bimanual examination, "typically, ultrasonography" and a hemoglobin-level test. The researchers also rejected women over 35-years-old or who smoked over 10 cigarettes a day.

• The total number of women tested was not large enough to draw the sweeping conclusions that Winikoff and her co-authors make.

• The abortion facilities went to extraordinary lengths to guarantee that women returned to take the prostaglandin Cytotec and the subsequent follow-up visit. The article stated that "[s]taff visited the home of any woman who did not return at the required time after either the mifepristone [RU 486] or misoprostol [Cytotec prostaglandin] administration." As shown in the enclosed table, few women were "lost to follow up," but a very sizable percentage were late for their three-day follow-up visit (6% in China, 5.9% in India, and 22.1% in Cuba). In fact, in Cuba, the researchers reported that "[w]ithin 4 weeks after the prostaglandin 8.8% still had not reported for exit interviews," which was attributed to transportation problems resulting from "severe gasoline shortages."

If RU 486/PG were to go into widespread use, it is unlikely that abortion facilities would be able to commit such heavy resources to follow up, and the problems with transportation in Cuba would be replicated many times over. What happens to the aborted women then?

• As shown in the enclosed table, RU 486/PG has an even lower effectiveness rate in this study than in previous tests in Europe or the United States. For example, the "failure" rate in Cuba was 16%, which translates into an effectiveness of 84%, much lower than the 90%-to-95% rate claimed in developed countries. The researchers defined "failure" with RU 486/PG as any time surgery was required.

A detailed analysis of the reasons for the "failures" indicated that (1) almost half of the "failures" were incomplete abortions or continuing pregnancy; (2) almost half were attributable to either the women or the abortion provider using surgery to intervene before the abortion drugs had time to act; and (3) a small percentage of the "failures" in Cuba were due to the medical personnel’s misdiagnosis of either incomplete abortion or continuing pregnancy.

Apparently, much of the "failure" rate depends on women and abortionists not following the procedure in what was supposed to be a carefully run trial. This raises questions about how this technique would be mishandled if it were to be used in much less tightly supervised conditions.

• A final point worthy of note is the rate of "repeat" abortions of women in this study. "Repeat" abortion means a woman who has had at least one prior abortion. As shown in the accompanying table, the rates of previous abortion for women who chose RU 486/PG were 20% in India, 57.2% in Cuba, and an astounding 70.6% in China.

Actions Needed To Stop RU 486 Abortion

There is still need for action:

• Write Gedeon Richter company officials to urge them to stay out of the abortion business. 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 control the use of RU 486 worldwide. The boycott is aimed at pressuring them to withdraw the abortion drug from the market.

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

The dangerous "RU 486" abortion method which kills an unborn baby whose heart has started to beat actually uses two drugs: First, the powerful synthetic steroid RU 486 (generic name "mifepristone") starves the unborn baby to death by causing the lining of the uterus to disintegrate. Second, another powerful synthetic hormone, a prostaglandin known as Cytotec (generic name: "misoprostol"), causes contractions of the womb which expel the dead baby and bloody contents.

Some key facts form the "core message" that pro-life and pro-family advocates need to keep repeating at every opportunity. Contrary to what the general media has usually been saying, the RU 486/PG abortion technique

• is not a "contraceptive" because it causes an abortion by killing an unborn baby whose heart has started to beat;

• is not "safe" and "easy;"

• will injure, and possibly kill, women;

• will possibly deform babies who survive;

• is being rushed on to the market by President Clinton to appease the abortion lobby; and

• will increase the number of abortions beyond the already appalling 1.5 million per year.