Dr. George Delgado says he has the statistics that prove otherwise.
(NCR) In a lawsuit against New York pro-life pregnancy centers earlier this month, Attorney General Letitia James took aim at the abortion-pill-reversal method, claiming that there is “no credible evidence” to prove that it is either safe or effective.
But her claims don’t reflect the available data and literature on abortion-pill reversal (APR), Dr. George Delgado, who famously established the first protocol for APR, contends.
“There have been over 5,000 documented cases of successful births after successful reversal. It is fallacious to say that there’s no proof and no evidence,” Delgado, who is board certified in family medicine and hospice and palliative medicine, told the Register this month.
That 5,000 number is a statistic taken from Heartbeat International, ironically one of the pro-life organizations being sued by New York. The organization oversees a network of health-care professionals who administer APR when a woman seeks help after abortion regret.
Abortion-pill reversal is a method that uses a regimen of progesterone to compete with the first of the two abortion pills, mifepristone, in order to save the life of the unborn child. APR is only used before the second pill, misoprostol, is taken.
Some physicians and pro-life organizations, including Heartbeat International, have said that APR is a method that has saved thousands of unborn lives.
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Others, like the pro-abortion group the American College of Obstetricians and Gynecologists, have said APR is “not supported by science” and it’s misleading to claim otherwise.
Pro-abortion and pro-life organizations stand on opposite sides of the debate, so who’s right about the science?
Can a mother who regrets taking the abortion pill really save her baby with a directed regimen of progesterone?
Science says
“Using the word ‘proven’ is always difficult from a scientific standpoint, because, in science, there’s always a doubt, and that’s why you keep searching. I wouldn’t say it’s proven, but I would say that there is proof and there is scientific evidence,” Delgado, who practices family medicine, said.
Delgado first referenced the research of the abortion-pill inventor, French biochemist and endocrinologist Étienne-Émile Baulieu, as evidence of progesterone’s efficacy for APR.
“The reason they developed mifepristone as the chemical abortion pill was because it directly competes with progesterone,” an essential hormone for a pregnancy, he said.
Early studies by Baulieu in test tubes “clearly demonstrate” that if there is an increase in progesterone after mifepristone, then the hormone will outcompete mifepristone, Delgado said.
Lab-rat study
In addition, Delgado pointed to a 2023 peer-reviewed study by a neuroscientist and psychology professor at Franciscan University of Steubenville that examined APR in rats, showing an 81% effectiveness rate.
The study examined three groups of pregnant female rats: One group received no medication; another group received mifepristone; and a third received mifepristone and then progesterone after.
“Our results indicate that progesterone administration following initiation of mifepristone-induced pregnancy termination (indicated by weight loss and uterine bleeding) reversed the process in 81% of rats in the [mifepristone and progesterone] group,” the study’s authors, professor Stephen Sammut and Christina Camilleri, wrote in the abstract.
For the group of rats who took mifepristone alone, none of the offspring survived, according to the study.
A similar abortion-pill study on pregnant rats was done in Japan in the 1980s. In the experiment, one group was given mifepristone, and the other group was given mifepristone and progesterone, according to the American Association of Pro-Life Obstetricians and Gynecologists.
In the mifepristone-alone group, only 33% of the pups survived, while in the progesterone group, 100% of the pups survived, according to the organization.
According to Delgado, in the Japanese study, progesterone was given at the same time as mifepristone. In Sammut’s study, the progesterone was given after mifepristone, more likened to the APR protocol used in humans, Delgado said.
A debated case series
In both 2012 and 2018, Delgado co-authored a case series studying APR, which New York Attorney General James takes direct aim at in her lawsuit.
The 2012 case series tracked six women who each took mifepristone for abortion and then progesterone to try and reverse the effect of the pill.
Four of the six women successfully carried their pregnancies to term.
James cited a review article from the pro-abortion medical journal Contraception that criticized the 2012 report as “anecdotal.”
The lawsuit says, “The review characterized the 2012 Case Series as ‘of poor quality with few details,’ making it impossible to compare its results to the rates of continuing pregnancy after taking mifepristone alone, ‘which was as high as 46% in one of the clinical trials.’”
“The authors therefore concluded that the ‘evidence is insufficient to determine whether treatment with progesterone after mifepristone,’ i.e., following the APR protocol, ‘results in a higher proportion of continuing pregnancies compared to expectant treatment,’ i.e., doing nothing but monitoring the patient,” the suit says.
That review, which examined 13 articles of pregnancies continuing after only mifepristone, said, “The proportion of pregnancies continuing 1-2 weeks after mifepristone alone varied from 8% … to 46%. ... Continuing pregnancy was more common with lower mifepristone doses and advanced gestational age.”
Delgado told the Register that the review from Contraception conflates both surviving human embryos and deceased human embryos still remaining in the uterus after abortion as a continued pregnancy and is therefore unreliable.
In his own co-authored 2017 review of past literature of fetal survival after a pregnant woman took mifepristone and nothing else was done, Delgado said the highest rate of survival was 25%.
The lawsuit also cited a commentary published in the abortion-friendly American Journal of Obstetrics & Gynecology that criticized the 2012 case series for its “small sample size, lack of long-term follow-up, as well as no review or oversight by an institutional review board or ethics committee.”
Responding to the criticisms, Delgado told the Register, “The 2012 case series was just six patients, so of course it’s going to have limitations. So what’s new? Any small case series is going to have limitations. That’s why we did the larger case series in 2018.”
He said that in the 2012 case series, no institutional review board oversaw the study because all it entailed was a review of medical records, with the patients giving permission for examination.
In 2018, Delgado co-wrote another case series report analyzing existing data of 754 patients who attempted APR. Only 547 were ultimately able to be analyzed because of exclusions for different reasons, not limited to some of the women’s choice to complete their abortions and loss of communication.
A variety of progesterone regimens were given to the pregnant women by more than 300 medical professionals.
Although the overall reversal rate was 48%, the report found, “Intramuscular progesterone and high dose oral progesterone were the most effective, with reversal rates of 64% … and 68% …, respectively.”
That case series, too, is criticized by James in her lawsuit. She cites a commentary in The New England Journal of Medicine, which criticizes the case series for its “failure to account for confounding variables such as gestational age, minimal safety data, and lack of clarity as to whether institutional review board approval was obtained prior to administering the ‘experimental treatment protocol’ to patients,” the suit says.
Delgado said, “It was clear that we had institutional review board approval for the 2018 paper.”
“We had good birth defect and preterm birth data, the most important adverse reactions. It was novel, but not experimental,” he added.
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Placebo studies ‘unethical’
Delgado told the Register he plans to undertake a randomized control trial (RCT) of two treatment groups for APR within the next year.
An RCT is a study that assigns participants into either an experimental group, which undergoes treatment, or a “control” group, not undergoing the treatment, according to George Washington University.
Although APR has been studied for a number of years, it may never undergo a double-blind, placebo-controlled trial, often referred to as the “gold standard” of clinical trials.
In this type of trial, placebo is used in one of two or more groups, and neither the participants nor the researchers know who received the real medicine until after the trial is finished.
“From our standpoint, it would be unethical to have a placebo-controlled trial because those babies would be doomed to death,” Delgado said.
Only one double-blind placebo controlled trial on APR has been attempted by a pro-abortion OB-GYN, but had to be halted due to women hemorrhaging during testing. The three patients who hemorrhaged consisted of two who took mifepristone alone and one who took mifepristone and progesterone, according to the study. The two women who took mifepristone alone had emergency abortions at the emergency room, according to the study. The woman who took progesterone had her bleeding stop and “no intervention was needed,” the study said.
Delgado drew an analogy to CPR (cardiopulmonary resuscitation): “We never had a placebo-controlled trial before we started using it. We discovered it would work in animals, and we saw that it worked in people.”
“It would be absurd to have a placebo control trial where someone would go down with a heart attack and you look on the list and say, ‘Oh, sorry, he’s in the placebo group. We have to watch and see if he comes back to life on his own,’” Delgado said. “That would be absurd. [Using placebo trials for APR] is equally absurd because this is analogous to CPR for the preborn baby.”
Delgado said that while his RCT is in its planning stages, “we go by the evidence that we have, which is good evidence.”
He added, “And whenever you have a treatment that’s been shown to be safe and effective and there’s no alternative treatment, then you go with it, even if you don’t have randomized control trials.”
Editor's note: Reprinted with permission from the National Catholic Register – www.ncregister.com. Heartbeat International manages the Abortion Pill Rescue® Network (APRN) and Pregnancy Help News, and is a party to the lawsuit initiated by the New York attorney general.
