December 10, 2010

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Expanding Use, Eliminating Safeguards

By Randall K. O'Bannon, Ph.D.

Editor's note. Yesterday we wrote about a report arguing that it is unnecessary for pregnant women to have an ultrasound if they are undergoing "medical abortions"--abortions that use chemical abortifacients, such as RU-486. (www.nrlc.org/News_and_Views/Dec10/nv120910part3.html).

For some time Gynuity has been a major player in the not-so-quiet campaign to eliminate the use of ultrasound.

As I wrote, "The study doesn't make sense unless you understand that the mega-objective is to continue the abortion industry's relentless campaign to expand the use of abortifacients later and later in pregnancy and to introduce its use into areas outside metropolises."

The following is written by NRLC Director of Education Dr. Randall K. O'Bannon, an expert on chemically-induced abortions.

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In the U.S. those dispensing the two-drug RU-486 abortion regimen--mifepristone [RU-486] and misoprostol-- have already modified the protocol approved by the government in four major ways. They have extended the cutoff date for its use from 49 to at least 63 days LMP [last menstrual period], reduced the dosage of mifepristone while increasing the dose of misoprostol, allowed women to take the misoprostol at home, and administer the misosoprostol vaginally instead of orally.

Not surprisingly this has had a measurable impact on women's health and safety.

In its "Program Brief" on "Medical Abortion," Gynuity spells out its research program and its vision for chemical abortions. Among the "improvements" it is studying to the regimen are the reduced dosage of mifepristone and the home administration of misoprostol, but also having the woman take the mifepristone at home as well. According to their webpage. Gynuity is pushing beyond even the 63-day limit loosely observed in the west. It is is experimenting with extending use of the either misoprostol (or mifepristone and misoprostol) to later in the first trimester and even the second trimester (gynuity.org).

Though it was not made a formal requirement in the U.S. protocol, the use of ultrasound has been common to aid in the dating of pregnancy and the detection of extra-uterine or ectopic pregnancies. This potentially helps avoid some safety and efficacy issues (the drugs do not "work" in situations of ectopic pregnancy and the drugs' effectiveness declines with the length of pregnancy). But it adds significant expense to the abortion with the clinic having to have an ultrasound machine and technician, neither of which are readily available in poorer countries. "Reducing reliance on ultrasonography," as Gynuity puts it, reduces cost and makes the method exportable to less developed regions.

While each of these modifications expands the possible use and lowers the cost of these chemical abortifacients, it is important to note what they do not do: they do not increase the safety or efficacy of the drugs.

In U.S. trials of the mifepristone/misoprostol combination, the "effectiveness" dropped with each additional week of gestation. While at 92% for 7 weeks (or 49 days LMP), it was 83% at 56 days LMP, and 77% at 63 days LMP (New England Journal of Medicine, 4/30/98). When the combination "fails," a woman faces new risks. If she is determined to abort, she then faces all the risks that surgery brings, all the worse if she is in an area where facilities are sparse and unsanitary and trained specialists are few. If she changes her mind and chooses to continue the pregnancy, she needs to be prepared to possibly care for a child disabled by the violent drugs.

Efforts to boost effectiveness (and lower the price) by increasing the dose of misoprostol (and cutting back the dose of mifepristone) may be problematic as well. Misoprostol has the potential to affect not only the smooth muscle of the uterus, but that of other systems as well, to the point that breathing or heart beat may be affected.

When the first deaths and injuries associated with the mifepristone/misoprostol combination after its approval were reported, among those was a heart attack in a 21-year old young woman (see NRL News, May 2002). In Brazil, an adolescent died of an overdose of misoprostol in an apparent abortion attempt.

Doctors treating her encountered "multiorgan failure" unstable blood pressure, "upper gastrointestinal bleeding," and "several episodes of cardiac arrest" (Obstetrics & Gynecology, February 2007). In later pregnancies, even smaller doses of misoprostol can lead to uterine rupture or even death.

Having a woman take these drugs at home, particularly vaginal self-administration of misoprostol, may be a way to introduce deadly bacteria into a woman's reproductive tract, especially during times of extended bleeding. There are articles in medical journals speculating that either mifepristone or misoprostol may suppress a woman's immune system. (For example, R. Miech, Annals of Pharmacotherapy, 9/05; D. Aronoff, et al, Journal of Immunology, 6/08.)

Doctors who use ultrasound do so because of the drop off in effectiveness in aborting older babies, and because the pills will have no effect on an ectopic pregnancy, which if untreated, can lead to death. The danger is increased with the symptoms of a ruptured ectopic pregnancy being so similar to the side effects of chemical abortion – significant bleeding, cramping, and pain. A woman experiencing those events may think that she is aborting while her fallopian tube is rupturing. (See the story of Brenda Vise in NRL Factsheet "Deaths Associated with RU-486" at www.nrlc.org.)

The chemical abortion industry's supposed aim of the altered protocols and dosages is to decrease cost and increase convenience. In fact it is unclear whose pocketbook and whose convenience – the patient's or the industry's – takes precedence. But the ultimate effect of all these changes may be increased risk for women, particularly poor women in areas lacking adequate medical care.

As a result, though the intention of these drugs' promoters may be one death – that of the child – the real consequence, in many cases, may be two deaths – the mother and the child.

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