Real Story Far Different Than Painted By Authors
American RU 486 Study Results Released
Results of a U.S. trial of RU 486, conducted in 1994 and 1995, have just been published in the April 30, 1998, issue of the New England Journal of Medicine (NEJM). Not surprisingly, the authors of the study, employees of the Population Council, the New York City-based group which sponsored the trial and holds the U.S. marketing rights to RU 486 (mifepristone), gave the drug a positive review. They described the two-drug abortion technique as "safe and effective for women seeking medical abortions of 49 days' duration or less."
The authors' declaration that the combination is a "safe" abortion option should be considered in light of this basic fact: even though this was a carefully controlled and monitored clinical trial with hand-picked test subjects, women still had some serious problems.
Heavy bleeding, intense pain, women "lost" (that is, those who did not come back for follow up appointments), the possiblity of serious injury to babies who survive the chemical assault are only some of the dangers routinely associated with RU486. This two-drug abortion technique will result not only in the deaths of thousands of unborn babies, but will also threaten the lives and health of women drawn in by the false promise of "easy" abortions.
Study Results
The study was conducted between September 1994 and September 1995 and involving 2,121 women in 17 locations scattered across the United States. According to the NEJM article, there was a " successful" abortion rate of 92% for women pregnant for 49 days or less, slightly lower than the 95%-96% rate found in similar European studies. "Success" was defined as an abortion with the complete expulsion of the baby without the need for a follow up surgical procedure. Included in the 8% who did not completely abort were 5% who had incomplete abortions and 1% whose babies survived the attempted chemical abortion.
The "success" rates dropped substantially and the rate of ongoing pregnancies increased dramatically for women who were more than 49 days pregnant. Only 83% of women who were 50-56 days pregnant had complete abortions; 4% of their babies survived. For women 57-63 days pregnant, only 77% experienced a complete abortion; 7% of these babies survived. (The numbers do not add up to 100% Some of the remaining women had incomplete abortions while the experience of other women was simply not clear from the article.)
Forty-nine percent of women aborted at the clinic within four hours after receiving misoprostol, a powerful prostaglandin, administered to them on their second visit. The remaining women aborted elsewhere - - at home, at work, maybe on the bus, etc. Seventy-five percent aborted within 24 hours after taking the prostaglandin, but others took longer.
Women taking the drugs typically bled for 13-15 days, most heavily on day three, and many on day four, when most of them were aborting their babies. Other "adverse events," such as abdominal pain (96%), nausea (61%), vomiting (26%), and diarrhea (20%) were common among the group 49 days pregnant or less. Numbers were even higher for women over 49 days.
Reading Between the Lines
These results were generally presented as up beat by the group writing the study. However, there were other aspects of the study listed, but not discussed at any real length, that indicate there could be serious problems ahead if and when the drug hits the open marketplace.
"Adverse Events" or Medical Emergencies?
The authors dismiss the heavy bleeding, abdominal pain, and other side effects as just a normal, expected part of the RU 486 process. Ann Robbins, one of the Population Council doctors who authored the study, told the Associated Press (4/30/98), "The side effects we saw were what are expected for the drug to work.... You need to bleed, and you have to have cramps, and that's what we saw." What isn't mentioned in the AP article, however, is that many of these "adverse events" were so bad that women ended up in the hospital.
Four women, including the woman who nearly bled to death in Iowa (see NRL News, 8/21/96), bled so badly they needed transfusions. According to the study, excessive bleeding was the cause of 25 hospitalizations, 56 "surgical interventions," and 22 women requiring intravenous fluids. The bleeding is so substantial that Robbins actually told the Los Angeles Times (4/30/98) that the Population Council's lower "success" rate was due to the early surgical intervention of U.S. doctors that were, as the Times put it, "not yet comfortable with the amount of bleeding caused by the medication." Bleeding was so bad in the 49 days or less group that 5% were given some drug to manage the bleeding. Overall, nearly 1 woman in 10 (9%) bled for over 30 days.
Abdominal pain, dismissed as "cramps" in the AP article, was actually so severe that 68% of the women received at least one medication for pain, with 29% receiving opiates. The pain was so intense that one woman had to be hospitalized for it; this was the reason given for at least two "surgical interventions." Severe vomiting was also responsible for one hospitalization, and was the reason for one "medically indicated" surgical intervention.
Safe - - But Only for Women in Top Physical Condition?
Because its study was limited, the Population Council was able to carefully select the doctors and the facilities which would be participating, give them extensive training, and set some rather strict procedures. They were also able to carefully screen potential test subjects, take extensive medical histories and reject anyone who might engage in any behavior (e.g., smoking) or have any condition (e.g., high blood pressure) that might put the life or health of a woman taking the drug at risk (see sidebar, this page). Yet, even with all these safeguards, women experienced severe bleeding.
In the real world, outside this artificially controlled environment, the situation would be much more grim. Instead of choosing the best facilities with the most experienced abortionists, the drug will be put in the hands of physicians who have little or no hands-on experience with pregnancy, abortion, or any of its complications. At one point, family practitioners and pediatricians were discussed as possible dispensers of the pills.
Questions abound. How carefully those doctors will screen for serious contra-indications? (How many of these will actually be listed on the labeling authorized by the Food and Drug Administration [FDA], is not known.) How much time and effort a doctor's office will be willing or able to spend tracking down a woman who has not returned for her second or third appointment?
"Lost" Women and Chemically Damaged Babies
The authors indicate that 106 women never returned for their third visit to confirm the completion of their abortions. They say that they have "evidence suggesting a successful outcome" for 92 of these women and "evidence suggesting failure" for 1. The remaining 13 women were "lost to follow up," five of whom were know to have "continuing pregnancies" at visit two.
The consequences of having women "lost to follow up" in the real world is enormous, especially if extrapolated to the enormous number of American women of child-bearing age. With more than half of the women in the test leaving the abortionist's office after the second visit still not having aborted, it means women bleeding heavily, and possibly having incomplete abortions, without any medical management, at the very least.
Some of these women may lose a lot of blood and fluid. They will assume they have aborted when they haven't. Months later they discover they are still pregnant. What will they do then? They can either have a much riskier surgical abortion when the baby is larger and much more developed, or wait and possibly give birth to child who has been injured by the chemicals.
According to the authors, studies on baby rats and monkeys born after their mothers took RU 486 have not shown any increased incidence of developmental anomalies. However, skull deformities were noticed in rabbits. The authors do not mention it, but it was reported at the FDA's hearing on RU 486 conducted in 1996 that out of 21 human babies born after RU 486 "failures," three (14%) were born with developmental disabilities, including one born with an immune deficiency which subsequently proved fatal.
How many of these were directly attributable to the use of mifepristone or misoprostol is not known. But it only makes sense that if a child is deprived of food and oxygen just when he or she is undergoing a crucial stage of development, it might cause problems. Few babies survive anyway, since women are told they should have surgical abortions if the RU 486 technique " fails."
There are many ominous, unanswered questions. Who takes care of the woman after she goes home, begins bleeding, and aborts on her bathroom floor? Who takes care of the child born with disabilities, born seven to eight months after the drugs "fail"? Members of the FDA panel that studied the drug in 1996 asked precisely these sorts of questions and never got adequate answers from the Population Council.
Two years later, this study by Population Council researchers shows that this may be an even greater problem than first thought - - and that it still has no effective strategy to address the problem. When moved out into the less controlled circumstances of the marketplace, the problem of "lost women and chemically damaged babies" will only loom even larger.
The American Future
of RU 486 When the Population Council received notice from the FDA in September 1996 that its marketing application for RU 486 was " approvable," it said that it would only be a matter of months before it answered the FDA's remaining questions regarding the labeling and manufacture of the drug.
The Population Council's efforts to get the drug on the market suffered a serious setback when the Hungarian firm it had lined up to manufacture the drug pulled out of the deal in late February 1997. Already reeling from a series of lawsuits brought by would-be investors in RU 486 questioning the character and financial dealings of the man it had hired to handle the financing and marketing of the drug in the U.S., the council had to set out in search of a new manufacturer.
Danco is the newly created pharmaceutical firm granted a license by the Population Council to set up U.S. distribution of RU 486. According to its spokeswoman, a new manufacturer, or a possible manufacturer, has been found and Danco is working out the details with the FDA and hope to get the drug on the market sometime in 1999. Danco declined to identify the company.
Pro-Life Efforts Have Made a Difference
While the battle against RU 486 continues, pro-lifers can take heart that their efforts have already helped delay for nearly five years the day that RU486 may go on the market. Meanwhile, they have saved the lives of countless unborn children over that period of time whose mothers might have succumbed to the false promises of new, improved, easy, and safe abortions by pill. We have put forward the righteous cause of the unborn child so that no respectable pharmaceutical firm wants to be associated with the negative image and impact of abortion. We have persuaded the media, and through them, many women, to take a more careful look at the dangers these pills pose to unborn children and their mothers.
The abortion industry will, of course, continue to try to come up with new ways to "improve" and repackage the killing of unborn children. RU 486 is just its latest attempt. But, in the end, the truth will come out. Even this latest study by the pill's promoters, with its admission of lost patients, women ending up in hospitals, and its long list of contra-indications, proves that pro-lifers were right all along.
The RU 486/Prostagladin Technique
RU 486, often called by its generic name "mifepristone," is an artificial steroid developed in France in the early 1980s that counteracts the action of progesterone in a normal pregnancy. Progesterone relays the signal to the body that there is a growing baby implanted in the uterine wall the woman's needing food and nourishment. RU 486 blocks that signal by taking over progesterone's chemical binding sites, so that the body no longer gets the signal that the woman is still pregnant. RU 486 shuts down the process, so that the developing baby does not get the food or oxygen she needs and eventually starves or suffocates to death.
The RU 486 procedure actually typically involves two drugs and at least three doctor's visits. On the first visit, the woman is screened for any conditions that make the drug especially dangerous to her (see below) and then is given the RU 486 pills. She returns two days later to take misoprostol, a powerful prostaglandin that acts on her body to produce (usually painful) contractions to expel the now-shriveled, emaciated corpse. A third visit two weeks after her first determines whether the chemical abortion has been successful. If not she will be asked to undergo a surgical abortion or dilation and curettage.
Women with any of the following conditions were excluded from the U.S.
trial of RU 486:
* liver, respiratory, renal, adrenal, or cardiovascular disease
* thromboembolism
* hypertension
* anemia
* insulin-dependent diabetes mellitus
* women under 18 or those over 35 years of age
who smoked more than 10 cigarettes a day and another cardiovascular risk
factor* using IUDs
* breastfeeding
* receiving anticoagulation or long-term glucocorticoid therapy
* adnexal masses
* ectopic pregnancy
* signs or symptoms suggesting possible spontaneous abortion.