Population Council Researchers Say RU486 Abortions Can Be Done at Home.
Readers of NRL Noun 1. NRL - the United States Navy's defense laboratory that conducts basic and applied research for the Navy in a variety of scientific and technical disciplines
Naval Research Laboratory News learned in May that two women who used the two-drug RU486 abortion technique are dead and others have been injured, according to an article that appeared in the Washington Post. In addition, at least six other women suffered serious "illnesses" after taking the drug.
Three women with ectopic pregnancies had their tubes rupture after receiving the abortion pill abortion pill See Contragestive, Oral contraceptive, RU-486. 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 The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). San Francisco researcher Cynthia Harper assert,
Evidence suggests that most women can handle most steps of the medical abortion medical abortion Obstetrics An elective nonoperative abortion effected in the 1st trimester by abortifacients. See Abortion. process themselves, safely and effectively. The utility of clinic visits to ingest in·gest
tr.v. in·gest·ed, in·gest·ing, in·gests
1. To take into the body by the mouth for digestion or absorption. See Synonyms at eat.
2. mifepristone Mifepristone Definition
Mifepristone is a pill that can be taken as an alternative to a surgical abortion.
This medication most often is used for ending early pregnancies. [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 FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ) 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 suf·fo·cate
v. suf·fo·cat·ed, suf·fo·cat·ing, suf·fo·cates
1. To kill or destroy by preventing access of air or oxygen.
2. To impair the respiration of; asphyxiate.
3. 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 abortionist /abor·tion·ist/ (ah-bor´shun-ist) one who performs abortions. to confirm the completion of the abortion. Those women who do not abort (1) To exit a function or application without saving any data that has been changed.
(2) To stop a transmission.
(programming) abort - To terminate a program or process abnormally and usually suddenly, with or without diagnostic information. (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 un·nerve
tr.v. un·nerved, un·nerv·ing, un·nerves
1. To deprive of fortitude, strength, or firmness of purpose.
2. To make nervous or upset. 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 adverse reactions,
n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration. 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 Side effects
Effects of a proposed project on other parts of the firm. .
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 Fallopian tubes
The narrow ducts leading from a woman's ovaries to the uterus. After an egg is released from the ovary during ovulation, fertilization (the union of sperm and egg) normally occurs in the 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 last menstrual period Gynecology The most recent time that a ♀ notes menstruation, a datum recorded in a chart during a routine gynecologic visit. See Menstruation. . 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 adnexal /ad·nex·al/ (ad-nek´sal) pertaining to adnexa.
pertaining to, or emanating from, the adnexa.
adnexal tumors mass"; current use of an IUD IUD Definition
An IUD is an intrauterine device made of plastic and/or copper that is inserted into the womb (uterus) by way of the vaginal canal. One type releases a hormone (progesterone), and is replaced each year. (intrauterine device intrauterine device (IUD), variously shaped birth control device, usually of plastic, which is inserted into the uterus by a physician. The IUD may contain copper or levonorgestrel, a progestin (a hormone with progesteronelike effects; see progesterone). ); "chronic adrenal adrenal /ad·re·nal/ (ah-dre´n'l)
2. adrenal gland.
3. pertaining to an adrenal gland.
1. failure"; "concurrent long-term corticosteroid corticosteroid /cor·ti·co·ster·oid/ (-ster´oid) any of the steroids elaborated by the adrenal cortex (excluding the sex hormones) or any synthetic equivalents; divided into two major groups, the glucocorticoids and therapy"; an allergy to RU486, misoprostol, or another prostaglandin; presence of "hemorrhagic Hemorrhagic
A condition resulting in massive, difficult-to-control bleeding.
Mentioned in: Hantavirus Infections
pertaining to or characterized by hemorrhage. disorders or concurrent anticoagulant therapy anticoagulant therapy Hematology The use of anticoagulants to prevent intravascular clot formation, or dissolve clots that have already formed Indications DVT/thrombophlebitis, CAD, TIA/stroke, dysrhythmia, prosthetic heart valve, cancer Monitoring Serial "; 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 Renal disease
Mentioned in: Glycogen Storage Diseases
hypertension High blood pressure Cardiovascular disease An abnormal ↑ systemic arterial pressure, corresponding to a systolic BP of > 160 mm Hg or thromboembolism thromboembolism /throm·bo·em·bo·lism/ (-em´bo-lizm) obstruction of a blood vessel with thrombotic material carried by the blood from the site of origin to plug another vessel.
n. . Also excluded were those who were anemic, had a suggestion of pelvic inflammatory disease pelvic inflammatory disease (PID), infection of the female reproductive organs, usually resulting from infection with the bacteria that cause chlamydia or gonorrhea. , or had insulin-dependent diabetes. Significantly, the trials also excluded anyone who had high blood pressure or some sort of cardiovascular disease Cardiovascular disease
Disease that affects the heart and blood vessels.
Mentioned in: Lipoproteins Test
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 Analgesics Definition
Analgesics are medicines that relieve pain.
Analgesics are those drugs that mainly provide pain relief. ." 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 dipstick /dip·stick/ (dip´stik) a strip of cellulose chemically impregnated to render it sensitive to protein, glucose, or other substances in the urine. 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