Are Abortion Reversals Science Or Scam?

Are Abortion Reversals Science Or Scam?

Hundreds of children may owe their lives to a promising new medical protocol called abortion reversal, which may increase in demand due to the new ten-week abortion pill.
Margot Cleveland
By

“The light of our life.” “My little girl is the joy of my life and I truly don’t know what I would do without her.” “There is a new light in my home that brings a smile to everyone in my family and I would not change it for the world.” “Active, precocious and healthy.”

These are just a few of the ways families describe some of the hundreds of their children almost lost to abortion. Those children may well owe their lives to a promising new medical protocol called abortion reversal, which may increase in demand due to the new ten-week abortion pill.

How We Got Pill-Induced Abortions

Abortion reversal refers to halting a chemical abortion, an abortion caused by ingesting a drug. The abortion pill first made headlines when the French government approved RU-486 for sale in 1988. In September 2000, the U.S. Food and Drug Administration approved the abortion pill to terminate pregnancies up to seven weeks old. Then in 2016, the FDA expanded the label to include terminating pregnancies up to ten weeks.

Sold in the United States under the brand name Mifeprex and generically known as mifepristone, the abortion pill, as the FDA explained, “is used, together with another medication called misoprostol, to end an early pregnancy.” Mifeprex, which is taken first, binds to a woman’s progesterone receptors, blocking progesterone from the uterine lining. Progesterone deficiency causes the uterine lining to break down, depriving the embryo of the nutrients necessary to live.

Twenty-four to forty-eight hours later, the woman takes the second drug, misoprostol. This drug induces uterine contractions, which expel the now-dead embryo (or fetus, depending on the stage of human development, as Mifeprex is also used off-label for second-trimester abortions). While French pharmaceutical company Roussel-Uclaf developed Mifeprex to cause abortions, first testing its chemical actions in vitro (in labs) and later running clinical trials, the abortion reversal protocol developed by happenstance, necessity—and prayer.

‘There’s Nothing You Can Do’

The story begins in North Carolina in 2007, in the family practice of Dr. Matthew Harrison. A patient sought Harrison’s help in stopping the abortive effects of Mifeprex. Harrison said that at the abortion clinic, “they gave her no hope. They said, ‘There’s nothing you can do; you have to complete this procedure.’”

As Harrison later recounted, he stepped out of the exam room then “said a prayer and started looking through books and thinking about how RU-486 works…It essentially just blocks the progesterone receptors and starves the baby. Harrison then immediately took some progesterone he had on hand for fertility treatments and, after informing the mother that the treatment might not work, injected her with the hormone.”

The unborn baby survived, and half-a-dozen months later the first known woman treated with the abortion reversal protocol gave birth to a healthy baby girl.

Two years later, on the other side of the country, Dr. George Delgado made the same deduction after receiving an urgent request for help from a friend. The friend had fielded a desperate call on a pregnancy helpline from a woman who had begun the chemical abortion process by ingesting Mifeprex, but now wished to carry her baby to term.

As the Indianapolis Star explained: “Delgado had frequently prescribed progesterone to women at risk of miscarrying. Knowing of mifepristone’s progesterone-blocking properties, Delgado calculated that adding progesterone into the system could counteract the drug’s effect. From his southern California offices, he located a doctor in El Paso who agreed to treat the woman. Her child is now about 7 years old …Word got out, and Delgado started receiving more calls about the procedure.”

The Abortion Pill Reversal Program Is Born

With interest in the abortion reversal protocol growing, doctors Delgado, Harrison, and Mary Davenport established the Abortion Pill Reversal program in 2012, operating within the Culture of Life Family Services, a nonprofit organization in San Diego, California. The Abortion Pill Reversal program maintains a website and a 24/7 hotline. When women call, a medical professional answers and, if the caller chooses, Delgado’s team helps connect her with a local doctor for treatment.

The treating physician then follows the abortion reversal protocol:

In 2012, Delgado and Davenport published a paper in the Annals of Pharmacotherapy, a peer-reviewed journal. It reported the results of Delgado’s protocol, noting that four out of six women who had undergone treatment with progesterone after ingesting mifepristone successfully carried their babies to term.

With the publication of their article and establishment of the webpage, the abortion pill reversal protocol began receiving growing attention within the pro-life medical community. As the IndyStar reported, while originally a small operation, the program now connects women worldwide to a network of more than 350 physicians. These doctors have treated more than 300 women and the abortion reversal protocol boasts a 60-70 percent success rate.

From Doctors’ Offices to Legislative Chambers

Then came a presentation on the abortion pill reversal protocol at the annual conference of the American Association of Pro-Life Ob-Gyns (AAPLOG). In attendance that year was Ovide Lamontagne, the former legal head of Americans United for Life, a national pro-life public-interest law firm. As AUL spokeswoman Kristi Hamrick explained in an email interview, based on the science shared at the AAPLOG annual conference, AUL lawyers drafted an informed consent model law for abortion reversal—the Abortion Pill Reversal Act, which provides, in part:

In 2015, the AUL claimed its first legislative victories when Arkansas and Arizona passed this model legislation.

Abortion Supporters Fight Back

As AUL moved forward with its abortion reversal legislation, abortion advocates fought back in courts, legislatures, and the press. While Arkansas’ law went unchallenged, Planned Parenthood, the Center for Reproductive Health, and the American Civil Liberties Union filed suit in federal court against Arizona’s law. However, before the court reached the merits of the litigation, Arizona’s legislature amended the law. It now only requires abortion clinics to inform women that use of mifepristone alone may not terminate the pregnancy “and that she should immediately consult a physician if she would like more information.”

Shortly after Arizona’s initial abortion reversal legislation passed, the Arizona section of the pro-abortion American Congress of Obstetricians and Gynecologists issued a purported “Fact Sheet” on “Medication Abortion Reversal.” However, that “Fact Sheet” was both false and misleading. After proclaiming, “Facts Are Important,” the Arizona branch of the ACOG stated: 

With this support from the “professional” ACOG Arizona Section, abortion-rights advocates were off and woozling. Here’s abortion doctor Cheryl Chastine: “The medical literature is quite clear that mifepristone on its own is only about 50 percent effective at ending a pregnancy. That means that even if these doctors were to offer a large dose of purple Skittles, they’d appear to have ‘worked’ to ‘save’ the pregnancy about half the time. Those numbers are consistent with what these people are reporting.”

Nearly every media outlet unquestioningly accepted the 30-50 percent figure in the ACOG statement. Some writers even rounded up, as Chastine did, presenting the probability of survival at 50 percent, such as seen in this Daily Beast article: “Simply put, it would be akin to taking credit for a coin flip.”

Delgado disputes the ACOG figure, but few media outlets bothered to report that fact and those which did failed to explain the basis for the disagreement. I asked AAPLOG Executive Director Dr. Donna J. Harrison to comment on the ACOG’s assertion that in 30-50 percent of the cases the pregnancy would have continued without progesterone supplementation. She stated: “That is a claim based on studies looking at ‘complete abortion’—i.e. situations where all of the tissue has passed and the uterus is empty. That statistic is NOT the number of living unborn children after the use of a single dose of mifepristone.”

The facts back up Dr. Harrison’s claim: In 2015, in response to the abortion reversal legislation, Dr. Daniel Grossman (an often-quoted critic of the protocol) co-authored an article reviewing the scientific literature on the effectiveness of abortion reversal and the reported cases of continuing pregnancy without progesterone supplementation. As the lead author, Grossman explained that based on Delgado’s 2012 case series, “the proportion of pregnancies continuing after this [abortion reversal] therapy was 67%…” In comparison, the literature review showed a range of continuing pregnancies at a follow-up visit (one to two weeks later) at a low of 8 percent and a high of 46 percent.

This range differs greatly from the 30-50 percent figure. A closer reading of the journal article provides the explanation—the same one Dr. Donna Harrison provided: There is a difference between a “medical abortion failure” and a “continuing pregnancy.” Grossman’s literature review also “excluded studies that only reported medical abortion failure after mifepristone alone and did not specify the number of continuing pregnancies.”

Slandering the Science

Arizona’s ACOG also asserted in its “Fact Statement” that “[c]laims of medication abortion reversal are not supported by the body of scientific evidence.” This statement is not wrong, but it is misleading. It leads the public to believe that abortion reversal is “fake science,” whereas the “body” of scientific evidence develops over time and the abortion reversal protocol is emerging science, so there isn’t a “body” of evidence—yet.

But this language gave abortion advocates room to run and claim, as Jodi Liggett, the public policy director of Planned Parenthood Arizona, did in an interview with The Guardian, that no science supports the procedure: “Women in their most vulnerable moment are going potentially to be given information that has no science to back it up.”

It is Liggett, however, who is pushing an anti-science agenda by ignoring the scientific basis for the protocol. After all, that is what the abortion reversal protocol rests on—a fundamental understanding of the science underlying the reproductive system. A snippet from a 2015 New England Journal of Medicine article explains the basics:

Progesterone is essential to achieve and maintain a healthy pregnancy. It is secreted naturally by the corpus luteum during the second half of the menstrual cycle and by the corpus luteum and placenta during early pregnancy. . . .The physiological importance of progesterone in early pregnancy has prompted the performance of several trials to evaluate the effect of progesterone supplementation in the first trimester of pregnancy among women with a history of recurrent miscarriages.

This scientific knowledge led to the development of RU-486, with researchers “envisioning” a new method of abortion based on a chemical interruption of progesterone. All Delgado and Matthew Harrison did was apply the same logic in reverse. As Dr. Donna Harrison (no relation to Matthew Harrison) explained, it’s also the same standard of care that “has been used for over 40 years in the treatment of women who are likely to miscarry from progesterone deficiency called Luteal Phase defect.”

Staff counsel for AUL Mailee Smith explained these concepts in more detail, adding that the protocol replicates “a well-established medical regimen that is used in other areas of health care — in particular, methotrexate and ‘leucovorin rescue” that physicians use to treat cancer patients.

But It’s Not FDA Approved!

Opponents of the abortion reversal protocol are also exploiting the public’s ignorance about the FDA approval process and the proper use of off-label prescriptions. You saw this misdirection in House Democrats’ press release criticizing Colorado’s abortion-reversal informed consent law: “The reversal method referred to in the bill, which consists of administering a large dose of the hormone progesterone after the abortion process has been initiated, hasn’t undergone clinical trials or been approved by the FDA.”

Abortion advocates have painted the abortion-reversal protocol as dangerous and doctors prescribing progesterone as conducting unethical studies on human subjects.

But, as the FDA explains, a drug approved for one purpose can be prescribed for any purpose. This practice, known as “off-label” use, is not just legal, but in many cases the standard of care. Further, clinical trials are but one form of scientific evidence that supports off-label use.

While a large randomized placebo-controlled trial provides the best evidence, it is well-established that “[o]ff-label uses can be supported by different levels of evidence,” including “case reports” and the “logical extension of an approved use, [such] as when a drug approved for one condition is prescribed for another condition that has genetic or physiologic similarities to the first.” Off-label applications may emerge “through ‘field discovery,’ in which clinicians identify new applications as they care for patients.”

That is what happened here. Yet abortion advocates have painted the abortion-reversal protocol as dangerous and doctors prescribing progesterone as conducting unethical studies on human subjects with no oversight. Wrong. “The ethical justification for off-label prescribing is that it can provide the best available therapy for a particular patient. This contrasts with the ethical justification for conducting clinical trials, which is to develop new therapies or clarify the best use of existing treatments for future patients…But clinical off-label prescribing has a therapeutic purpose and individual patient interests should guide such use.”

Knowing that progesterone injections safely prevent women from miscarrying, Delgado explained “we think that a control trial where we deny some women treatment and give it to others would be unethical.”

But What About Safety?

The lack of clinical trials has prompted others, such as Dr. Leah Torres, an OB-GYN and abortion rights activist, to argue you “have to amass significant evidence until they can make it part of standard practice, . . . . They need to be able to answer the questions of: ‘What are the risks of stopping a medical abortion? What are the risks to the baby? What are the risks to the mom?’”

The ‘fact statement’ acknowledged that ‘mifepristone is not known to cause birth defects,’ so not proceeding with the abortion does not present a risk to the baby.

But even the Arizona ACOG “Fact” statement acknowledged that “mifepristone is not known to cause birth defects,” so not proceeding with the abortion does not present a risk to the baby. (Whereas proceeding definitely does!) As Dr. Donna Harrison explained, “[p]rogesterone has been demonstrated in the extensive infertility literature to be safe for both the mother and the fetus.”

Grossman, a critic of abortion reversal legislation, also candidly admitted to Slate that “progesterone probably won’t hurt a woman if she’s under medical supervision…” Grossman’s real concern is “that the advertising of this procedure could mislead the public about the prevalence of abortion regret.”

Seeking to push back against “junk science” and other false and misleading narratives, the AAPLOG joined a press conference and issued a statement supporting the abortion reversal protocol. It also later it issued its own Fact Sheet detailing the safety of progesterone supplementation, the scientific theory behind the abortion reversal protocol, and the most current evidence supporting its effectiveness.

Legislators Adopt a More Circumspect Approach

With the popular press’s consistent (and unquestioning) reporting of preferred pro-choice narrative, pro-life politicians have backed away from AUL’s model legislation. Rather than requiring abortion clinics to provide information on the possibility of reversing the abortive effects of Mifeprex, states are following Arizona’s lead and instead merely mandating that women be told that mifepristone alone may not terminate the pregnancy. South Dakota and Utah took this approach, while legislation in Colorado and Indiana has been sidelined.

How abortion activists respond to further scientific evidence supporting the reversal protocol will be telling.

The Louisiana legislature took yet another approach: It directed the state Department of Health to study whether the effects of a chemically induced abortion could be reversed. The agency recently issued its report and conclusion: “There is neither sufficient evidence nor a scientific basis to conclude that the effects of an abortion induced with drugs or chemicals can be reversed.”

Look for abortion-rights activists to cling to this conclusion, even though the report ignored the scientific theory behind the protocol and included this glaring error: “The only professional association that has expressly stated a position on the procedure is the Arizona Section of the American Congress of Obstetricians and Gynecologists.” This completely ignored the position of the national professional association—AACLOG—that supports the abortion reversal protocol.

The battle over abortion-reversal is far from over. The sponsor of Louisiana’s bill has promised to push forward. Legislation has been proposed in several other states, including California, Georgia, Idaho, and North Carolina. AUL representatives told me they intend to continue the organization’s legislative push. With chemical abortions on the rise—they increased from 6 percent of all abortions in 2001 to 31 percent in 2014—the fight over abortion reversal legislation is here to stay.

While state lawmakers continue to grapple with the issue, scientific knowledge will continue to advance. A follow-up journal article by Delgado detailing the continued success of the abortion reversal protocol is expected soon. While critics denounced his initial case study, given the limited number of patients treated off-label with progesterone, this article will include more than 300 patients and report a success rate in the 60-70 percent range.

How abortion activists respond to further scientific evidence supporting the reversal protocol will be telling. Will they continue to deprive women who choose no longer to abort of information indicating that progesterone improves the chance their babies will survive? If so, it will continue to show the Left is not just anti-science but anti-choice and anti-life.

Correction: The U.S. FDA approved the abortion pill in 2000, not 1990.

Margot Cleveland is a lawyer, CPA, and adjunct professor for the University of Notre Dame. Cleveland can be reached via email at [email protected] or on Twitter at @ProfMJCleveland.

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