Abortion-pill reversal: The next frontier of informed-consent laws?

Indianapolis, Ind., Aug 15, 2017 / 05:04 am

Medication abortions are on their way to becoming the dominant method of abortion in the U.S. But lawmakers are starting to look at whether to change their state's informed-consent laws to let women know of an experimental treatment that could possibly reverse the effects of a progesterone-blocking abortion.

Indiana state Rep. Ronald Bacon, (R-Chandler), told the National Catholic Register that he heard about the "abortion-pill reversal" technique during a presentation by Fort Wayne obstetrician-gynecologist Christina Francis. Bacon, who is Catholic, thought that women contemplating abortion, or who have taken mifepristone – the first pill in the two-pill RU-486 abortion process – should at least know the possibility existed.

In the event they wanted to reconsider their choice for abortion, Bacon said they should know about this possibility and who they should contact from the information packet that abortion doctors are required to give their patients.

"We should at least try to give women as much information as possible," he said.

Bacon's legislation passed Indiana's House of Representatives Feb. 27 on a 54-41 vote, but never made it through the state senate. Other pro-life lawmakers balked at the law, citing the need for more studies.

Still, Bacon said the media coverage of the debate did create awareness.

"I felt at least the word got out there," he said.  

Rapidly Changing Industry

First-trimester abortion accounts for 91 percent of all abortions performed in the U.S. But RU-486 medication abortions account for nearly a third of all abortions, according to the Guttmacher Institute. That figure is rising, and in some states, RU-486 accounts for half of all abortions.

In Scandinavian countries, that future has already arrived: Medication abortions account for 96 percent of abortions in Finland, 91 percent in Sweden and 86 percent in Norway.

Mifepristone is the first drug taken in the two-step RU-486 chemical abortion regimen. The first pill (also known as Mifeprex) blocks the hormone progesterone from bonding to the uterine wall, causing it to shed, killing the embryo by literally starving it to death. Approximately 24-48 hours later, a second pill called misoprostol (commercially known as Cytotec) is ingested to expel the deceased unborn child with the other contents of the uterus.

However, Dr. George Delgado, medical director of Culture of Life Family Services in San Diego, California, that runs the AbortionPillReversal.com program and its 24/7 hotline, has developed protocols designed to block the effects of mifepristone by flooding a woman's body with progesterone, ideally within 72 hours of taking the abortion pill. The concept involves overwhelming Mifeprex with progesterone in order to save the uterine lining and allow women to exercise their choice to continue their pregnancies.

Delgado said he is in the process of submitting an article for publication to a peer-reviewed medical journal that "will describe over 200 cases of successful reversals."

The article will build on another study published in the spring 2017 edition of Issues in Law and Medicine by his colleague Dr. Mary Davenport, which reviews studies on women who took mifepristone alone for abortion. The review, he said found the embryo survival rate to be between 8 and 25 percent.

Delgado said that upper limit of 25 percent will form the "historical control group" for comparing the embryo survival rates from their best progesterone-treatment protocols, which their data puts in the range of 60-70 percent.

"It does make a difference if a woman who changes her mind undergoes our reversal protocols," he said.

Abortion-Pill Reversal

Many pro-life physicians and pro-life health centers across the country have now made abortion-pill reversal a treatment option to women.

Kathleen Eaton Bravo, founder of the Obria Medical Clinics and president of the Obria Foundation, told the National Catholic Register that Obria provides the progesterone treatment to women who request it. She said that as Obria's telemedicine platform expands in more states, it will provide another mechanism for women searching for help after taking the first abortion pill.

"We have a much better opportunity to save lives this way," she said. Bravo, who is a post-abortive mother, said when she had time to reflect on her surgical abortion decades ago, it was too late to do anything to save her child. But the woman who takes mifepristone in a doctor's office actually has time in the privacy of her home to consider whether she really wants to go through with abortion before taking the second pill. At that point, she said, a woman who changes her mind and wants to keep her baby will turn to her smartphone and start searching for help.

"We have a much larger window of opportunity to save this child's life if we can reach them through their smartphones," Bravo said. "This is a much bigger opportunity to save lives than we've ever had through surgical abortions."

Bravo said the best prevention against medication abortion is building relationships with abortion-vulnerable women so they never end up taking the abortion pill in the first place. She pointed out that Planned Parenthood's abortion business model today is based on pre-existing relationships with clients: It utilizes telemedicine to connect with women and men and is providing them with health services. She noted that in California, Planned Parenthood is expanding into primary care and is starting to rebrand as "Melody Women's Health."

Bravo said that Obria is seeking to build those pre-existing relationships with women and men by connecting to them through Obria's telemedicine platform and providing them with medical care and social support so that if they are in a crisis situation, they will turn to Obria first for help.

Model Legislation

(Story continues below)

So far, just three states have enacted changes to informed-consent laws related to informing women about abortion reversal.

Arkansas explicitly requires women to be told that it might be possible to reverse a mifepristone abortion. South Dakota's legislation states that a woman does not have to continue the two-step abortion regimen if she changes her mind, and to look to the state health department's website for information on reversal – none of which can be found there. Arizona passed and then repealed legislation requiring women to be informed that medication abortion could be reversed after a court challenge.

Lawmakers in a handful of other states have attempted to bring similar bills to their statehouses for consideration based on model legislation developed by Americans United for Life (AUL).

Denise Burke, AUL's vice president of legal affairs, told the National Catholic Register that the organization believes women should know there's a "possibility" that they could increase their chances of keeping their children with this treatment.

"This is empowering women to make the best decision for them and their families," she said.

Burke said AUL has been in contact with a number of legislators that are contemplating bills for 2018. She hopes that the results of Delgado's forthcoming study will bolster the case for lawmakers for making this knowledge part of the informed-consent process for abortion.

ACOG Opposed

The American Congress of Obstetricians and Gynecologists (ACOG), however, has weighed against states changing their informed-consent laws. An ACOG spokesman referred to a position paper noting abortion-pill reversal has not been substantiated by the body of scientific evidence and is not recommended in ACOG's clinical guidance on medication abortion.

ACOG's paper noted that pregnancy will continue in 30-50 percent of women who take mifepristone alone and do not take misoprostol.

"Available research seems to indicate that in the rare situation where a woman takes mifepristone and then changes her mind, doing nothing and waiting to see what happens is just as effective as intervening with a course of progesterone," it stated.

Dr. Gretchen Stuart, director of the University of North Carolina School of Medicine's Department of Obstetrics and Gynecology's family-planning division, told the National Catholic Register that "laws that affect medical practice should be based on scientific evidence."

"The American College of Obstetricians and Gynecologists states that medication abortion reversal is not supported by scientific evidence, and, therefore, this approach is not recommended," she said.

Stuart also noted that Delgado's previous report in the literature of women receiving progesterone injections was "too small a sample size to make scientific conclusions."

In contrast, the American Association of Pro-Life Obstetricians and Gynecologists has lent its support to Delgado's work.

Studies on the Way

Delgado told the National Catholic Register his latest findings will be published over the next several months. However, he stated the ACOG position paper cited figures for incomplete abortion, which are not the same figures as embryo survival. In the studies where doctors checked for the embryo's survival with ultrasound, the embryo was already dead, even though the woman's body had not begun the process of expelling the uterine contents.

In principle, he said women should know that reversal is an option "in case they change their minds" and be assured no scientific data indicates either mifepristone or progesterone treatments cause birth defects.

"We have evidence that using progesterone to reverse the effects of a mifepristone abortion is both safe and effective," Delgado said.

Further studies demonstrating the effectiveness of Delgado's technique will likely be needed before more legislators act on it. Rep. Bacon said he intends to bring his bill back to the statehouse once he can approach his fellow Indiana lawmakers with "more clinical proof."

"I definitely will bring it back then."

This article was originally published by the National Catholic Register.