Population Council Researchers Say RU486 Abortions Can Be Done at Home.
Three women with ectopic pregnancies had their tubes rupture after receiving the abortion pill and a prostaglandin (misoprostol), which is used to stimulate powerful uterine contractions to expel the dead or dying child. One of those women hemorrhaged so badly she bled to death.
Two other women developed serious bacterial infections, which proved fatal in one case. The sixth woman, a 21-year-old, had a heart attack three days after taking the two-drug combination. She recovered, but questions remain about the connection of the drugs to the incident.
With this spate of bad news about RU486's users, incredibly, some researchers for the abortion pill's American patent holder are arguing that the whole process should be even looser -- that much can be handled by the woman herself at her home.
Writing in the February 2002 edition of Contraception, Population Council researchers Beverly Winikoff, Charlotte Ellertson, and University of California San Francisco researcher Cynthia Harper assert,
Evidence suggests that most women can handle most steps of the medical abortion process themselves, safely and effectively. The utility of clinic visits to ingest mifepristone [RU486] and misoprostol [the accompanying prostaglandin] is questionable. For many women, even the follow-up visit could perhaps be replaced by telephone follow-up, combined with home pregnancy tests.
This is nothing short of amazing advice. Current protocol approved by the Food and Drug Administration (FDA) calls for a minimum of three office visits spread out over a two-week period.
At the first, a woman is to be screened and counseled to make sure she is a qualified candidate for the drugs and is aware of the risks and dangers of the two-drug abortion technique. After a physical exam to confirm and date the pregnancy (as well as to rule out any physical red flags), she is given RU486 pills, which she takes in the abortionist's office.
Two days later, after the RU486 has done its work starving and/or suffocating the developing baby, the woman returns to the abortionist's office to take misoprostol that works to expel the dead or dying embryo. In U.S. trials of the drug, women spent four hours in the doctor's office for this visit waiting for the prostaglandin to do its work. About half aborted during this four-hour window.
A third visit on day 14 of the process allows the abortionist to confirm the completion of the abortion. Those women who do not abort (some 8% or more did not completely abort in the U.S. trials) are then scheduled for surgical abortions.
The recommendation for laxer medical supervision continues an unnerving pattern.
Initially recommending that women spend three to four hours in the doctor's office waiting for the misoprostol to take effect, the FDA dropped this as a requirement after the abortion drug's sponsor objected but did maintain the necessity for a second visit. Researchers for the Population Council say that now, at a minimum, this second visit should be eliminated entirely, letting the woman administer the prostaglandin to herself when and how she chooses.
With only slightly less fervor, the Population Council's researchers go on to argue for the general elimination of all required office visits. Each one of their conclusions warrant very close scrutiny, especially in light of the very serious adverse reactions reported in the Post.
Women, write Harper and her colleagues, can confirm and date their own pregnancies, administer the drugs at their proper times and dosages, and handle all but the most serious side effects.
Confirmation of the abortion could be accomplished with a home pregnancy kit and any necessary follow up could be done over the phone. Only in the rarest of circumstances would a woman need to seek direct medical care, they argue.
In making these recommendations, Harper and her associates gloss over a whole range of difficulties and dangers that would be associated with such dramatic changes.
Home pregnancy kits do help a woman to confirm pregnancy, but are not 100% accurate. They also do not tell a woman whether she is dealing with an ectopic pregnancy.
Harper and her colleagues go on to say,
"With mifepristone medical abortion, it is important to note that it does not matter much if women wrongly diagnose themselves to be pregnant and use the therapy even if they are not pregnant."
Note that even though the researchers claim that evidence shows no medical harm and few side effects when RU486 is taken by non-pregnant women, the research they cite did not involve its use in combination with a prostaglandin. This second powerful drug both enhances the effects of RU486 and has its own serious side effects.
Of ectopic pregnancy, the authors state, "The detection and treatment of ectopic pregnancy is only tangentially related to medical abortion." They admit, "Women who might use the regimen without a clinical exam would miss the opportunity to diagnose a possible ectopic pregnancy," but claim the two-drug combo "will neither hurt nor help this underlying condition." However, no research is cited to back up this assertion.
We know one woman died after doctors failed to diagnose her ectopic pregnancy and her fallopian tubes ruptured (see NRL News, May 2002). Whether misoprostol contributed to the rupture of the tubes would appear to be an open question. A doctor's visit requiring an ultrasound, just the opposite of the approach argued for by the researcher, might prevent such outcomes.
Potentially as serious are difficulties involved in having women self-date their pregnancies. The "effectiveness" of the RU486/prostaglandin abortion method diminishes with the length of pregnancy, while the severity of side effects is said to increase. The FDA put the cutoff for its use at 49 days after a woman's last menstrual period. U.S. trial data showed failure rates increasing from 8% at seven weeks to 23% at nine weeks.
The Population Council's researchers write that "data suggests that dating pregnancies may not be much more difficult for women than it is for clinicians." But even in the data cited by Harper and the rest, women did underestimate the length of their pregnancies, one in 50 by more than two weeks. Trained medical personnel should be able (especially with the right equipment) to determine whether or not medical evidence confirms a woman's memory and experience.
Perhaps one of the more ludicrous suggestions put forward by the Population Council researchers is that women screen themselves for possible contraindications. "All contraindications to mifepristone-misoprostol," write the authors, "are uncommon and based on medical history and therefore should already be known to women."
Official contraindications for RU486 are swathed in medical jargon. For example, contradictions include a "confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass"; current use of an IUD (intrauterine device); "chronic adrenal failure"; "concurrent long-term corticosteroid therapy"; an allergy to RU486, misoprostol, or another prostaglandin; presence of "hemorrhagic disorders or concurrent anticoagulant therapy"; or "inherited porphyrias."
Even supposing these are translated into terms more familiar to the non-professional, it isn't clear how women are supposed to be able to ask the follow-up questions that would rule out the yet undiagnosed presence of such conditions. Harper, Ellertson, and Winikoff write, "No physical examination is necessary, and brochures or telephone help lines could help resolve doubts where they exist." Little good this would do, however, in a situation of ectopic pregnancy.
Even if women were able to somehow screen themselves for the above conditions, there is no way this could substitute for the skill and experience a trained physician would bring in a face-to-face exam. This could be crucial.
The RU486 trials excluded anyone who had a history of severe liver, respiratory, or renal disease or thromboembolism. Also excluded were those who were anemic, had a suggestion of pelvic inflammatory disease, or had insulin-dependent diabetes. Significantly, the trials also excluded anyone who had high blood pressure or some sort of cardiovascular disease.
While these were not included in the final list of contraindications, any doctor familiar with the drugs and their properties would understand the need for a more comprehensive interview and physical examination to avoid potentially serious adverse reactions. A doctor understanding the properties of prostaglandins on heart muscle, for example, might be more reluctant to prescribe the medication to a 21-year-old with a family history of heart disease.
Of the pain, nausea, vomiting, and diarrhea that often accompany chemical abortions, Harper, Ellertson, and Winikoff write, "For the most part, women could manage these side effects with over-the-counter analgesics." Some women, they admit, may need stronger medicine to fight the pain and other side effects, which "might constitute a reason for physician involvement."
The researchers admit that excessive bleeding put a certain number of women in the hospital during the trials of the drug, but said that those women "were able to follow the appropriate rules of thumb for seeking care when they needed it." Women in the trials, however, were rigorously screened and given extensive counseling and explicit instructions in person about when and how to contact their physicians.
Even the authors admit it is unclear how well women will follow instructions in the absence of an initial doctor-patient contact. The risks -- hemorrhage or death -- are considerable.
Even while granting that "the consequences of missing an ongoing pregnancy are serious enough to perhaps warrant a clinical role if women are not able to assess completion accurately," the authors do not seem to able to bring themselves to admit that there is any one stage where the presence or expertise of a doctor ought to be required. It will be "obvious" to many women when the abortion has occurred, they say, but "a follow-up clinic visit should always be an option for women who are in doubt."
The researchers suggest that "an extremely useful tool to develop for all women would be a dipstick urine pregnancy test to diagnose completion of abortion. Telephone consultation could also provide assistance at this stage in interpreting test results." How someone on the other end of a telephone is supposed to be able to read the results of a dipstick, analyze the baby's remains, or determine what fetal tissue remains in the uterus, the authors do not say.
In closing, the authors write, "Although clinician assistance might be useful, it is clear from our study that routine physician involvement is not essential. Physicians may be necessary for back-up, but mid-level providers, such as nurse-midwives or nurses themselves, have the skills needed to help women with those steps they could not manage or chose not to undertake alone."
However, many women have abortions precisely because they feel abandoned -- by their boyfriends, parents, and society in general. Now the promoters of the abortion pill want to add another level of abandonment to the burden borne by the pregnant woman -- abandonment by the medical profession.
They say the issue is control and convenience. What this means is that a woman may endure the most painful and dangerous parts of her abortion, and face the most horrific consequences of her actions, all alone. That's a recipe not just for soul-crushing loneliness, but for a public health nightmare.>EN