Gulf Pine Catholic

Gulf Pine Catholic • October 25, 2024 11 What is chemical abortion? Chemical abortion is a two-drug process meant to kill and expel a developing child from the womb early in a pregnancy. Proponents call it “medication abortion,” but that is misleading. “Medication” indicates something to manage a patient’s illness. The first drug -- mifepri- stone (brand name Mifeprex, originally called RU-486) -- was not developed as a treatment or cure, but to end a child’s life. Thus “chemical abortion” is the more accurate term. Misoprostol (original brand name Cytotec) is the second drug needed to complete a chemical abor- tion. In 1988 Cytotec was approved by the U.S. Food and Drug Administration ( FDA ) to prevent gastric ulcers in patients at high risk of complica- tions from long-term use of non-steroidal anti-in- flammatory drugs (NSAIDs). When the unapproved, off-label use of Cytotec for abortion and labor induc- tion led to serious complications -- including uterine rupture, birth defects and unexpected fetal deaths -- its manufacturer and the FDA warned against giving Cytotec to pregnant women. 1 How does a chemical abortion work? Mifepristone blocks progesterone, a hormone essential to maintaining pregnancy. This leads to the breakdown of the uterine lining and cuts off the child’s supply of oxygen and nutrients. Mifepristone alone will usually kill the developing child, but his or her remains may not be expelled. This can lead to infection, sepsis, and even the mother’s death. Therefore a second pill -- misoprostol -- is taken 24 to 48 hours later, to induce uterine contractions strong enough to expel the dead child and placenta. Beginning in 2012, Drs. George Delgado and Mary Davenport pioneered the Abortion Reversal Protocol ( ARP ), giving high doses of progesterone after a woman has taken mifepristone but regrets her decision and has not taken misoprostol. The ARP has a 66% success rate in saving babies’ lives. 2 What are the risks of chemical abortion? The FDA ’s record of “adverse events” cites 32 women’s deaths from September 2000 through December 2022. Although the FDA stopped requir- ing reports of non-fatal adverse events in 2016, it reports a total of 4,218 adverse events, including 1,049 hospitalizations (excluding deaths), 604 cases of blood loss requiring transfusions, 97 ectopic preg- nancies, and 418 infections (75 of them “severe”). 3 A study of almost 55,000 women receiving abortions in California’s Medicaid program found that the rate of complications requiring treatment after chemical abortions was 5.2%, four times higher than for first-trimester aspiration abortions. 4 Complications are likely underreported in the U.S., as many are treated in hospital emergency rooms where phy- sicians may not know about the abortion or not code it as such in medical records. Scandinavian countries, where national health reporting is more thorough, have found higher com- plication rates. A Finnish study found a nearly “four- fold higher” incidence of adverse events for chemical abortions compared to surgical abor- tions, reporting that incidence as 20%. Risk of hem- orrhage was nearly eight times higher, at 15.6%. 5 How has the FDA attempted to protect the lives and health of women using chemical abortion? According to a lawsuit filed in November 2022 by the Alliance for Hippocratic Medicine and others, the FDA has ignored risks to women, its own regu- lations, and federal statutes to promote chemical abortion. 6 The FDA approved mifepristone for abortion in 2000 using an “accelerated” review process that applies only to “certain new drugs that . . . treat seri- ous or life-threatening illnesses and that provide meaningful therapeutic benefit to patients over exist- ing treatments.” Even the pro-abortion Population Council, which holds the U.S. patents for the drug, had objected that pregnancy is not an “illness.” 7 And studies show that chemical abortion does not have a “meaningful therapeutic benefit” over surgical abor- tion, as its risks are higher and it may even require a follow-up surgical abortion if fetal remains are not completely expelled. The FDA also set no age restrictions, despite the absence of a study establish- ing the drugs’ safety for minor girls -- and it failed to incorporate safeguards used in the clinical trial sub- mitted to justify FDA approval, such as the require- ment for an ultrasound exam to confirm gestational age and detect a dangerous ectopic pregnancy. 8 The FDA did require some safeguards at first. The drugs could be taken only if less than 49 days (seven weeks) had elapsed since the onset of the woman’s last menstrual period. And there had to be three in-person visits to a physician: The first to be counseled on benefits and risks and to take Mifeprex; the second, about two days later, to take misoprostol; and the third, about two weeks later, to confirm a completed abortion. 9 In 2002, pro-life medical groups filed a Citizen Petition with the FDA , objecting to its inadequate protections for women. The petition was ignored for many years. In 2016, the FDA finally responded by rejecting the petition, and simultaneously weakening the safe- guards of 2000: Health professionals other than physicians could prescribe the drugs; they could do so up to 70 days instead of 49; only one in-person visit was required; the dosing regimen was changed, allowing a second dose of misoprostol if the first did not succeed; and only fatal “adverse events” needed to be reported. Studies cited by FDA to justify these changes had not evaluated chemical abortions pro- vided under these conditions. 10 In 2019, the FDA expanded the availability of mifepristone by authorizing an “abbreviated new drug application” for a generic version of the drug, under the same conditions as for Mifeprex. 11 A new Citizen Petition was filed, objecting to the latest developments. SEE UNDERSTANDING ABORTION PILLS, PAGE 20

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