Analysis Law and Policy

The ‘Science’ Behind Arizona’s Mandatory ‘Abortion Reversal’ Advice

David Grimes

Arizona will soon require providers to inform patients that it is possible to reverse the effects of a medication abortion. But there is little scientific evidence supporting progesterone-based "abortion reversal."

Arizona will soon require flawed medical advice as a part of abortion counseling. Last week, Gov. Doug Ducey signed SB 1318 into law, which mandates that providers use the following language with patients: “It may be possible to reverse the effects of a medication abortion if the woman changes her mind but that time is of the essence.” Moreover, the bill continues, “Information on and assistance with reversing the effects of a medication abortion is [sic] available on the Department of Health Services website.” Public policy and medical advice should reflect the best available evidence. What is the scientific evidence supporting “abortion reversal”?

The World’s Published Literature: Six Patients

As of now, no information is available on Arizona’s Department of Health Services website suggesting what medical techniques the government recommends for “abortion reversal.” However, the doctors testifying in support of SB 1318 have claimed that the hormone progesterone can be used to stop medication abortions. A search through the 20 million citations in the National Library of Medicine’s online database, PubMed, turned up only one published report on “abortion reversal.” Rather than a formal study, the article is an incompletely documented collection of anecdotes from Catholic physicians who tried to counter the effects of mifepristone, used in medication abortion, by administering progesterone.

The report, written by Drs. George Delgado and Mary Davenport, makes numerous scientific errors. First, the article recommends a progesterone regimen developed by Dr. T.M. Hilgers of the Pope Paul VI Institute for the Study of Human Reproduction that has not been formally studied and vetted in the peer-reviewed medical literature.

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Second, no evidence supports the statement in SB 1318 that “time is of the essence.” In Delgado and Davenport’s article, the interval between mifepristone and progesterone administration ranged from seven to 72 hours for five patients and was unknown for the sixth. Thus, no inference is possible regarding any potential effect of timing. Again, the language of the bill strays far beyond any evidence.

Third, the authors inferred a causal association between the progesterone treatment and continuation of the pregnancy. This error in logic is known as post hoc ergo propter hoc (after the thing, therefore on account of the thing). In other words, the fact that a pregnancy continued after this treatment in no way implies a causal association, only a temporal one. The patients in this report received only mifepristone before their progesterone treatment. By the 1980s, the abortion success rate with mifepristone alone was recognized to be too low for general use; 7 to 40 percent of pregnancies continue after mifepristone alone. The addition of a prostaglandin (uterine stimulant) like misoprostol after mifepristone improved success rates to greater than 95 percent and began the era of medication abortion.

Fourth, no control or comparison group was used, violating the essence of the scientific method. A suitable control group here would have been women who received mifepristone, changed their minds, and did not receive progesterone. Since the article lacked a control group, one cannot say whether the progesterone treatment had any effect on the pregnancy. Even so, the article reports, “The experience of these patients suggests that medical abortion can be arrested by progesterone.” This statement is untenable.

Fifth, the tiny sample size limits any usefulness. A total of seven women underwent this therapy, but the authors were unable to follow up with one of them. This is unexplained, since all births are reportable events: All births and deaths are required by law to be reported to state governments and then to the National Center for Health Statistics. Four of six treated women (67 percent) continued their pregnancies. Any study provides only an estimate of the truth in the larger, general population; confidence intervals should be used by researchers to describe the precision of the estimate. Narrow confidence intervals indicate good precision, and vice versa. The 95 percent confidence interval around the 67 percent of continued pregnancies in this report ranges from 26 to 94 percent. If this natural experiment were repeated 100 times, the true figure for how often pregnancies would continue would fall within this 26-to-94 percent range 95 times out of 100. With this much imprecision, the article provides almost no information.

Finally, the article misuses epidemiologic terms. The report refers to two possible “confounding factors,” or potential causes for biased results: the lack of feticidal effect of mifepristone and lack of documentation of a viable pregnancy before receiving mifepristone. A confounding factor must be related to both the exposure (abortion reversal) and the outcome (pregnancy continuation), but not involved in the causal pathway. Neither “possible confounding factor” was related to the exposure and thus could not cause confounding bias. This suggests a lack of understanding of research methods.

The Alternative: No Treatment

A recent prospective study in France followed women given mifepristone for abortion and who subsequently changed their minds before receiving a prostaglandin. These women did not receive “abortion reversal” progesterone. Among the 46 women exposed to mifepristone at a mean of nine weeks’ gestation, 37 (80 percent) had a live birth. Only 17 percent had a miscarriage, and one chose an induced abortion when Down syndrome was diagnosed in her fetus. Thus, the continuation rate in France without progesterone treatment was similar to that in the Delgado and Davenport article with progesterone treatment.  

Risks of Pregnancy Continuation

Furthermore, SB 1318 does not reflect the potential dangers of interrupting an abortion in progress. Although mifepristone is not known to be associated with birth defects, methotrexate, a drug that is sometimes used instead of mifepristone, and misoprostol have been linked with fetal anomalies. Because misoprostol is used routinely with medication abortion regimens, the American Congress of Obstetricians and Gynecologists’ Practice Bulletin recommends that health-care providers counsel all women who wish to continue their pregnancies after beginning an abortion regarding potential birth defects. SB 1318 is silent about a physician’s ethical obligation to warn women about these potential harms.

Legislating Junk Science

The State of Arizona has effectively based public health policy on six informal clinical anecdotes. A descriptive study without a control group allows no conclusions about potential benefit or harm of treatment. Moreover, the experience of similar women in France suggests that using progesterone for “abortion reversal” has no benefit. Junk science has no place in courts of law, but it continues to prevail in many state legislatures, including the one in Phoenix. When politicians play doctor, everyone suffers. Citizens deserve better.

News Contraception

New Hawaii Law Requires Insurers to Cover a Year’s Supply of Birth Control

Nicole Knight Shine

Insurance companies typically cover only a 30-to-90-day supply of birth control, posing a logistical hurdle for individuals who may live miles away from the nearest pharmacy, and potentially causing some using oral contraceptives to skip pills.

Private and public health insurance must cover up to a year’s supply of birth control under a new Hawaii law that advocates called the nation’s “strongest.”

The measuresigned by state Gov. David Ige (D) on Tuesday, applies to all FDA-approved contraceptive medications and devices.

Hawaii joins Washington, D.C., which also requires public and private insurers to cover up to 12 months of birth control at a time.

Oregon passed a similar measure in 2015, but that law requires patients to obtain an initial three-month supply of contraception before individuals can receive the full 12-month supply—which the Hawaii policy does not.

“At a time when politicians nationwide are chipping away at reproductive health care access, Hawaii is bucking the trend and setting a confident example of what states can do to actually improve access,” Laurie Field, Hawaii legislative director for Planned Parenthood Votes Northwest and Hawaii, said in a statement.

Insurance companies typically cover only a 30-to-90-day supply of birth control, posing a logistical hurdle for individuals who may live miles away from the nearest pharmacy, and potentially causing some using oral contraceptives to skip pills. Both the American Congress of Obstetricians and Gynecologists (ACOG) and the U.S. Centers for Disease Control and Prevention recommend supplying up to one year of oral contraceptives at a time, as the Hawaii Senate Committee on Commerce, Consumer Protection, and Health noted in a 2016 conference report.

Fifty-sex percent of pregnancies in Hawaii are unintended, compared to the national average of 45 percent, according to figures from the Guttmacher Institute.

Women who received a year’s supply of birth control were about a third less likely to experience an unplanned pregnancy and were 46 percent less likely to have an abortion, compared to those receiving a one- or three-month supply, according to a 2011 study of 84,401 California women published in Obstetrics and Gynecology.

Reproductive rights advocates had championed the legislation, which was also backed by ACOG–Hawaii Section, the Hawaii Medical Association, and the Hawaii Public Health Association, among other medical groups.

“Everyone deserves affordable and accessible birth control that works for us, regardless of income or type of insurance,” Planned Parenthood’s Field said in her statement.

Roundups Law and Policy

Gavel Drop: Welcome to the New World After ‘Whole Woman’s Health’

Imani Gandy & Jessica Mason Pieklo

With the recent U.S. Supreme Court ruling, change may be afoot—even in some of the reddest red states. But anti-choice laws are still wreaking havoc around the world, like in Northern Ireland where women living under an abortion ban are turning to drones for medication abortion pills.

Welcome to Gavel Drop, our roundup of legal news, headlines, and head-shaking moments in the courts.

The New York Times published a map explaining how the U.S. Supreme Court’s ruling in Whole Woman’s Health v. Hellerstedt could affect abortion nationwide.

The Supreme Court vacated the corruption conviction of “Governor Ultrasound:” Former Virginia Gov. Bob McDonnell, who signed a 2012 bill requiring women get unnecessary transvaginal ultrasounds before abortion.

Ian Millhiser argues in ThinkProgress that Justice Sonia Sotomayor is the true heir to Thurgood Marshall’s legacy.

The legal fight over HB 2 cost Texas taxpayers $1 million. What a waste.

The Washington Post has an article from Amanda Hollis-Brusky and Rachel VanSickle-Ward detailing how Whole Woman’s Health may have altered abortion politics for good.

A federal court delayed implementation of a Florida law that would have slashed Planned Parenthood’s funding, but the law has already done a lot of damage in Palm Beach County.

After the Whole Woman’s Health Supreme Court ruling in favor of science and pregnant people, Planned Parenthood is gearing up to fight abortion restrictions in eight states. And we are here for it.

Drones aren’t just flying death machines: They’re actually helping women in Northern Ireland who need to get their hands on some medication abortion pills.

Abortion fever has gone international: In New Zealand, there are calls to re-examine decades-old abortion laws that don’t address 21st-century needs.

Had Justice Antonin Scalia been alive, explains Emma Green for the Atlantic, there would have been the necessary fourth vote for the Supreme Court to take a case about pharmacists who have religious objections to doing their job when it comes to providing emergency contraception.