MANY QUESTIONS RAISED
By Randall K. O'Bannon, Ph.D.
NRL Director of Education and Research
Coming on the heels of a recently published study that called RU 486 "safe and effective," a new study now asserts that women who took the abortion pill found the dangerous, taxing procedure "acceptable." However, just as the first study, published in April, glossed over a number of significant safety concerns, so too the new study ignores a number of factors, including design, methodology, and conflict of interest, that cast doubt on the reliability and applicability of the researchers' findings.
The prior study, published April 30, 1998, in the New England Journal of Medicine, (NEJM), claimed to have determined that the two-week, three-step process involving the combination of the abortifacient RU 486 (mifepristone) and the prostaglandin (PG) misoprostol was "safe" and "effective," despite a high prevalence of painful side effects and a 2% hospitalization rate (see NRL News, 5/7/98). This latest study, appearing in the July/August 1998 edition of the Archives in Family Medicine, surveyed that same group of women in their last visit and determined that those women found the chemical abortion regimen "acceptable."
According to the study, "nearly all," or 95.7%, would recommend the method to others and 91.2% said they would choose it again. A slightly smaller percentage, 87.6%, rated the chemical abortion as "very satisfactory" (72.5%) or "moderately satisfactory" (15.1%).
Even among those 14-15% women for whom the technique "failed,"1 the technique received a 84.9% recommendation level and 69.6% of these women still said they would try it again. Much fewer, but still a majority (51.9%) of these women rated these abortions as "very satisfactory" (32.2%) or "moderately satisfactory" (19.7%).
ANALYSIS
The remarkably high acceptability numbers obtained by researchers are easier to understand once one looks closely at the design of the study and its methods. Beyond this, there is evidence, even in this study, of serious problems that may lie ahead for women who take these powerful abortion drugs.
Objective vs. subjective measures
The study was, by nature, a subjective analysis, that is, an examination of how women felt about their RU 486 abortion experience. What mattered, then, from this standpoint, was not how safe a woman was or how dangerous her side effects actually were, but how safe she felt she was and how serious she felt her side effects were. Her perceptions, not reality, are what are crucial in this sort of study, and any factor that could unduly manipulate or influence her perceptions should be carefully considered. There were many such factors.
More objective accounts we have of these women's experiences tell us of violent cramping and golf ball-sized clots of blood (TIME, 12/5/94 and Newsweek, 9/18/95). They tell us of women shaking and ashen faced and losing great quantities of blood. They tell us of a woman in Iowa who almost died after losing half her blood volume and requiring emergency surgery (Des Moines Register, 9/21/95).
The sponsor of those trials, the Population Council, the same group now publishing these survey results, wrote the Iowa woman's experience off as merely something "within the context of what happened before" in France. Interestingly enough, Gloria Feldt, president of Planned Parenthood, which managed several of the RU 486 testing sites, including the one in Iowa, tried to brush aside concerns about the Iowa woman's near- death experience raised at the July 19, 1996, Food and Drug Administration (FDA) hearing. Her explanation was that Iowa woman, too, had reported satisfaction with the procedure.
Note that those conducting the trial were able to use their proximity to the test subjects to help them frame their experiences, to help them see their extensive blood loss as "normal," to tell them everything was okay when they began to vomit and double over in pain. When the baby was aborted and the immediate danger was passed, they were able to encourage women to feel a sort of pride, a sense of accomplishment, that they had survived and accomplished some great deed for the cause of "abortion rights." (The first woman to abort in the Des Moines section of the trials talked about a celebratory atmosphere that greeted her; clinic workers there told her she was "making history," according to TIME magazine, 12/5/94.) Under such circumstances, it is hardly surprising that the sponsors of the trial got the results they wanted.
Possible selection bias
From a scientific standpoint, it is important to note that these were specially selected test subjects, not aborting women chosen at random. Researchers were able to hand pick women so that they got a group of women who were not only physically strong enough to endure the toxic effects of the drugs with the lowest risk, but were also ideologically sympathetic to the researchers' non-medical agenda.
For instance, nearly 11% specifically cited what the study's authors termed "a political commitment to abortion rights and the availability of mifepristone in the United States" as one of the reasons they chose the chemical method. This was one of the top five reasons women gave researchers for picking the RU 486/PG method.
Receiving free care, special attention
Even more women, 17.3%, or nearly 1 in 5, cited certain study features as one of their reasons for choosing the drugs - - that there were no insurance questions, that they received good medical care, or that treatment was free. No one seems to have considered that since other surgical methods cost upwards of $300, the fact that the chemical method was free may have unduly influenced the women's evaluation of their options.
The high level of care and attention given by the medical staff is itself a complicating variable. Because of the complexity of the multi-step abortion process and the serious physical risks involved, women received an inordinate amount of time and attention from the medical personnel participating in the study.
Women met with the medical personnel at least three times for extended periods of time. They went through a lengthy screening process at the beginning to determine whether they were physically suitable for the study and understood the risk involved in the complicated procedure. At the second visit, they spent at least four hours in the doctor's office cramping and bleeding and waiting to abort while medical personnel monitored their progress and gave them reassurances about the symptoms they were experiencing. Women met with clinic personnel for an extended period again to confirm their abortions and take the acceptability survey.
Contrasted to the quick, impersonal, get-them-in-and-get-them-out nature of typical surgical abortions, it is not surprising that women found the extra attention comforting. Whether women can expect that level of attention outside the confines of clinical study is questionable, however.
Under any circumstances, this high degree of familiarity is not conducive to objectivity. How likely was any woman to complain after being given free medical care and making friends with all the medical personnel involved in the studies? How much did the personnel's views of significance of the procedure and the seriousness of the side effects color the study participants' views of the experience?
Evidence of acceptability of chemical abortions or unacceptability of surgical abortions?
By far, the most common reason (37.4%) cited by women for choosing the RU 486/prostaglandin method was a fear of surgery or injections or a dislike for the invasiveness of surgical abortions. Several things are worth noting here.
First, this was a group of women already predisposed towards any proposed alternative to surgical abortion. This bias was, certainly for many of them, the very basis for their initial decision to participate in the trial. Second, it shows that much of the supposed "enthusiasm" for RU 486 and other chemical abortifacients isn't really so much actual support for chemical abortions but rather evidence of a general fear and distaste for traditional surgical abortions.
Half (49.5%) of the women in the study had previously undergone surgical abortions, and over three quarters of these women found the new chemical abortion method "more satisfactory" than the surgical method. For such women, any alternative to surgical abortion, especially one hyped by its promoters as "safe" and "simple," is likely to sound attractive. The obvious - - but unaddressed - - question in all these studies is why is there a "need" for RU 486, if surgical abortions are as safe as abortion advocates say they are?
Like a miscarriage?
Next to fears of surgery and an aversion to the "invasiveness" of surgical abortion, the next most common reason (19.4%) women gave for choosing the chemical abortion method was that they say it as more "natural," or "feminine," more akin to a miscarriage or menses. This claim is at once telling and disturbing. Unlike surgical abortions, which would, by implication, be "unnatural," women here specifically identify RU 486 abortions with natural processes over which they have little control and no responsibility. Abortion is something a woman "chooses," while miscarriage or monthly menstruation is something that "happens" to her.
Whether this is a conscious obfuscation or not is unclear, but it is a psychologically significant recasting. In surgical abortion, a woman must consciously commit to an active external intervention. Here, however, women speak and act as if, independent of her will, her body itself performs the abortion. In this sort of language game, the place of a woman's own act (taking the pills) in the process is made ambiguous, perhaps affording her a momentary evasion.
In the end, however, this evasion cannot be sustained, as there is no psychologically stable resting point anywhere on the spectrum of options ranging between outright denial and acceptance of complicity in the death of one's child. Inevitably, the truth will have to be faced or there will be some sort of breakdown.
Long-term psychological consequences not studied
In addition, the high figures of satisfaction reported here dovetail with similar studies of post-abortion reactions showing that a woman's initial emotional reaction to abortion is one of "relief." Consider: women have survived painful contractions, endured weeks of frightful bleeding, and found a solution to what they considered to be their immediate problem, i.e., gotten rid of the baby they have convinced themselves was threatening their own life plans. Relief at last, the woman tells herself.
But what this study does not show is how these women will be perceiving and dealing with their abortion experiences 3 to 10 years down the road. Will they still be in denial, telling themselves that these were just miscarriages when they know, deep in their consciences, that they participated in the killing of their children? Will they be plagued by nightmares or flashbacks of their tiny children swirling at the bottom of a toilet bowl?
Already, in the midst of all the positive spins and appraisals, nearly 1 in 25 (3.7%) specifically identified "the sight of the embryo" as one of the method's worst features.(The report does not say how many actually saw their babies; it only records the number of women who found the experience troubling enough to mention it to researchers at the time of the final survey.) As sufferers of post-abortion syndrome are aware, those images will only become more persistent and prominent as years go by, even among those for whom the initial experience did not seem particularly problematic.
BEHIND THE STUDY
The stated aim of the researchers is to determine whether the RU 486 method is acceptable to American women and whether the regimen is "feasible" in the American medical system. Revealing their vested interest in obtaining positive results, the authors - - all of whom we must remember work for the organization holding the U.S. patent rights to the abortion pill - - state early on that "For a new technology to be a viable option in a given health care system . . . people need to want to use it and demand it." If the product is going to sell, if physicians are going to buy it and offer it, they need to be convinced that their patients will want it and be happy with it.
This also explains the efforts of researchers to get patients and physicians to support the idea of home administration of either one or both of the drugs. One of the chief complaints against the chemical method, voiced by 21.9% of the 2,015 women who participated in the study all the way to the end (106 of the original women never returned for their third visit and were lost to follow-up), was the difficulty involved in scheduling the three required visits. Allowing women to self-administer either one or both of the drugs at home would supposedly eliminate the need for one or more of these visits or at least shorten these visits and the amount of time a doctor or his staff must spend with the patient.
Not surprisingly, majorities of these highly motivated women and abortionists endorsed the idea of home administration of these drugs, though they were more comfortable with RU 486 being used at home than the prostaglandin misoprostol. While 91.7% of women felt that using RU 486 at home would have been comfortable and wise, 99% of abortionists would have considered it comfortable and wise for a given patient. Only 65.2% of women were comfortable with the idea of home use of misoprostol, while clinicians would have supported home misoprostol use in 85.5% of cases.
Women had an obvious reason for preferring home administration - - to avoid the hassle of three extended visits to the doctor's office. And having survived the process seemingly unscathed (long-term physical and psychological consequences were not explored in these studies), they had reason to think home administration would not necessarily present any insurmountable challenges. But this ignores the fact that these women were probably made much more comfortable by the constant presence of medical personnel identifying which side effects were normal and which were truly serious. That sort of expert access and evaluation would not necessarily be readily available in home use, raising the likelihood of serious, untreated side effects like hemorrhage.
Putting aside the vested interest the abortion clinic personnel had in promoting the abortion pill and shortening their contact time with patients, the issue of how a doctor would be able to determine, prior to writing a prescription, who would and who would not be a suitable candidate for home administration of the drug is completely unexplained. The only way, it seems, of identifying who might be likely to hemorrhage and require surgical intervention to stop the bleeding is to give a woman the drugs and see what happens. It is clear how this might increase sales and use of the drugs, but not clear how this would increase safety.
It seems painfully obvious that sales, rather than safety, is a controlling concern here. The study is a not-too-well-disguised effort to convince American women and American doctors that the product is something that women want and like. Yet whatever the language games, whatever the subjective reports of satisfaction, nothing can disguise the fact that this is simply a new way to kill innocent, defenseless, human beings, and nothing can render that "acceptable."
RU 486 PRODUCTION DIFFICULTIES CONTINUE
Efforts to prove RU 486 safe, effective, and acceptable are part of the Population Council's campaign to stimulate demand for the two-drug abortion technique, gain final government approval, and get it out on the market. Yet the council has faced a number of obstacles - - unfavorable publicity, contentious court cases among investors, etc. - - that have repeatedly delayed the process. Chief among them is difficulty in finding a manufacturer willing to take on the controversial product.
Hemant Shaw, an independent pharmaceutical industry analyst, told the Associated Press that "The question is whether the financial gain is worth the political headache. . . . [F]or most pharmaceutical companies, the answer is no."
The Population Council got U.S. rights to the abortion pill from Roussel Uclaf, the French company that developed it, in 1994. Neither Roussel nor its parent company Hoechst A.G. wanted to be involved in U.S. production, though it apparently continued to produce the pill in France through at least 1997. Since that time, the Population Council has tried, with little success, to find a manufacturer. A Hungarian pharmaceutical maker that was supposed to have agreed to manufacture the raw product pulled out of its deal with the Population Council in 1997, setting back the council's plans yet again. Though the FDA issued a letter in 1996 saying the drug was "safe" and "effective" and thus "approvable," it withheld final clearance pending a manufacturing inspection. As long as there is no manufacturer, there can be no manufacturing inspection.
The Population Council has recently dropped hints of having found a possible replacement manufacturer and forecast a 1999 launch date for the product, but precisely where negotiations stand and just how long it will take a new manufacturer to get FDA approval and get production going is unknown. The council has declined to release further details.
Both the NEJM and the Archives in Family Medicine studies employ data drawn from the American trials of RU 486 conducted between September 1994 and September 1995 that involved some 2,121 women in 17 locations across the United States. The trial was conducted at the behest of the New York City-based Population Council, the group holding U.S. patent rights to RU 486. Authors of the studies were Population Council employees.
In the procedure employed in the trial, women took the RU 486 pills, which chemically block the progesterone essential to the nourishment and growth of their unborn children, in their first visit. They returned two days later to take the prostaglandin misoprostol to initiate powerful uterine contractions to expel the starved, shriveled babies.
Two weeks after taking the RU 486, the women returned to undergo medical examinations to determine whether the abortions were complete. It was during this third visit that the women were questioned about their experience and the acceptability of the procedure, the subject of the Archives in Family Medicine article.