Analyzing Pro-Life Headlines: “NEW peer-reviewed study confirms that the abortion pill CAN be reversed!”

Since September of 2000, Mifepristone, also known as the abortion pill, has been approved for use in chemical abortion. Mifepristone works by blocking progesterone, a hormone that helps maintain the uterine lining during pregnancy. San Diego physician George Delgado argues that by flooding the body with progesterone, the effects of Mifepristone can be negated and therefore “reverse” a chemical abortion. Though the process has been largely unproven, several states have passed laws requiring abortion providers to inform women of progesterone therapy, also called “Abortion Pill Reversal”, and many crisis pregnancy centers state that they can connect women that do change their minds to a network of doctors that can reverse the effects of Mifepristone in some cases.

Early last year, the results of a study regarding the effects of progesterone therapy were released and pro-life groups were quick to praise the results. The Wisconsin Right to Life posted on their Facebook page, “NEW peer-reviewed study confirms that the abortion pill CAN be reversed!” along with an article stating that “Yes, women can stop in-progress chemical abortion with life-saving protocol”. WRTL also posted a petition supporting additional legislature that would require abortion providers to tell women of Abortion Pill Reversal.

Some pro-life articles were boasting a 68% success rate, but this is only partially true. There was a 68% success rate with women that had taken 400 mg of progesterone orally twice a day for three days followed by 400 mg progesterone orally once a day until the end of the first trimester—the “High Dose Oral” group. However, there were only 31 women in this group, which may not be enough to truly determine if this type of progesterone therapy is successful.

The study concluded that Abortion Pill Reversal had an overall 48% success rate, which may sound impressive to pro-life supporters. However, there appears to be more to this 48% success rate than it lets on.

754 women had started progesterone therapy, but only 547 women were eligible for study analysis. Included among those that were excluded were 112 women that were lost to follow up before 20 weeks gestation. An additional four women had been lost to follow up after 20 weeks gestation, but were considered reversal successes “since any pregnancy loss after 20 weeks would be unlikely to be attributable to the early mifepristone exposure”.

The study acknowledges the women lost to follow-up as a study limitation. “Furthermore, although the number of women lost to follow-up was small, it could have affected the results.” Could have affected the results? Try WOULD have affected the results. Those four women that were assumed to be successes affected the reversal rate and raised it by 1%. Imagine having 28x as many women included in the study! If the remaining 112 women hadn’t been lost to follow up and had known outcomes that could be included in the study, the overall success rate could have been anywhere between 40%-56%.

If the 116 women that were lost to follow up had been included in the study as “Unknown”—meaning their outcomes were unknown—the results would have been:

39% Reversal (257)

43% Failure (286)

18% Unknown (116)

By excluding most of the women lost to follow-up and assuming some were successes, it raised the Reversal rate by almost ten percent. Additionally, as stated by a Slate article, “Critics point out that some of the women who attempted reversal may have received ultrasounds to confirm their pregnancies were still viable, which could skew the results since some pregnancies that would not have been helped by reversal would be excluded.” This was pointed out in the study’s limitations section, noting that the number of women who had received ultrasounds exams prior to initiating therapy were not available to researchers.

There were 57 women that decided to go through with an abortion, indicating that the decision to have an abortion is not always simple. The remaining 38 women excluded from the study didn’t meet criteria. In order to be included in the study, women had to start progesterone therapy within 72 hours of taking Mifepristone and before taking any doses of Misoprostol, a drug that causes the uterus to contract and expel its contents.

The reality is what we would consider “the abortion pill” is actually two pills taken a few days apart. Progesterone therapy/Abortion Pill Reversal is about reversing the first pill in the regimen rather than a complete chemical abortion. This piece of information about Abortion Pill Reversal is vital when you consider why there’s a second pill in the regimen in the first place.

Mifepristone was developed during the early 1980s by French pharmaceutical company Roussel Uclaf. The results from the clinical trials of the drug showed that Mifepristone by itself failed to induce a complete abortion in 40% of women with pregnancies up to 49 days gestation. It was then discovered adding small doses of a prostaglandin analog on the last day of Mifepristone treatment increased the complete abortion rate from 60% to 95%. Thus, Misoprostol, a synthetic analog of prostaglandin E1, was added to chemical abortions.

Dr. Daniel Grossman’s, one of Delgado’s biggest critics, own research found a 25% chance of a pregnancy continuing after taking Mifepristone alone. “Mifepristone by itself is not a very effective abortion-causing agent,” Grossman said. “If you use it just by itself there’s a good chance the pregnancy will continue on its own.”

What Delgado calls the success rate of progesterone therapy may actually be the failure rate of Mifepristone. A good way to rule out the possibility that Abortion Pill Reversal is taking credit for Mifepristone being a poor abortion pill on its own would be to conduct placebo-controlled clinical trials, but this would be unethical if the subjects were women wanting to save their pregnancies after partially going through with a chemical abortion.

If all the original subjects that started progesterone therapy had been included in the study, the percentages would be:

34% Reversal (257)

38% Failure (286)

15% Unknown, lost to follow-up (116)

8% Decided to complete abortion after starting therapy and progesterone therapy had zero impact on the outcome (57)

5% Likely failure—therapy likely wouldn’t have worked as 72 hours had passed after taking Mifepristone or had taken misoprostol before starting progesterone therapy (38)

From the results of this study, progesterone therapy is either a crap shot or riding on the coat tails of Mifepristone not being that great at terminating pregnancies.

What’s worse is that Abortion Pill Reversal may be unsafe. Progesterone comes with a list of side effects: drowsiness, dizziness, breast pain, mood changes, headache, constipation, diarrhea, heartburn, bloating, swelling of hands and feet, joint pain, hot flashes, or vaginal discharge. Using progesterone can increase your risk of blood clots, stroke, heart attack, or breast cancer. While the study concluded that progesterone therapy was safe and effective, this appears in reference to the low number of birth defects as it provided no information on what side effects or medical issues women experienced during or after progesterone therapy. We don’t know if taking progesterone through the rest of the first trimester to reverse a chemical abortion is safe, especially for women that end up continuing their pregnancies and produce their own progesterone naturally.

The extra cherry on top of all this is that the study ended up being withdrawn due to ethical concerns as its wording suggests the University of San Diego had reviewed and approved the study. They had only approved to analyze existing data, not collect new data. Grossman had other ethical concerns about the paper as it’s unclear if the subjects underwent informed consent and if they knew the treatment was experimental.

Wisconsin Right to Life and other pro-life groups may believe that Abortion Pill Reversal works based on this study, but looking at the data and considering the other factors suggests otherwise. Should abortion providers be required by law to tell their patients of an unproven experimental treatment that may not actually work and may be dangerous to a woman’s health? Absolutely not! The American Congress of Obstetricians and Gynecologists had this to say regarding legislators making anti-abortion laws requiring women to be informed about Abortion Pill Reversal based on a much smaller study Delgado did in 2012, which wasn’t approved by any institutional review board:  “Legislative mandates based on unproven, unethical research are dangerous to women’s health. Politicians should never mandate treatments or require that physicians tell patients inaccurate information.”