outh Dakota will soon require doctors to tell women that they can change their minds after taking the abortion pill and potentially halt an abortion in progress. Arizona and Arkansas passed similar laws last year. And an antiabortion group is promoting model legislation to inform women they can “reverse” medication abortions.
Yet that claim has no solid science behind it — just an anecdotal case report written by a physician who invented a protocol and arranged to have it tested on a half-dozen patients who regretted swallowing the abortion pill.
That’s raised alarms among mainstream medical groups.
“As physicians, we can’t just experiment on patients willy-nilly,” said Dr. Daniel Grossman, a professor of obstetrics and gynecology at the University of California, San Francisco. Doctors offering to undo medical abortions are “essentially testing an unproven, experimental protocol on pregnant women,” he said.
The new laws target the growing popularity of the abortion pill at a time when states have forced many surgical abortion clinics out of business with tight regulation.
About 2 million women have taken the pill since it was approved by the Food and Drug Administration in 2000; it is now responsible for 40 to 50 percent of pregnancy terminations in some states. The FDA recently took steps to expand access to medication abortions by approving their use through 10 weeks of pregnancy, up from the previous limit of seven weeks.
To push back, antiabortion groups have been urging states to restrict access to abortion pills — for instance, by mandating that they be dispensed only after a face-to-face examination by a doctor, rather than a video consultation. More recently, Americans United for Life has been circulating a model bill which would require doctors to advise all women taking the pill that they might be able to reverse the abortion, “but that time is of the essence.”
One supporting study
The abortion pill actually consists of two medications. First, a woman takes mifepristone, which causes her uterus to shed its lining and her cervix to begin to dilate. Then, a few days later, she takes misoprostol, which causes sustained uterine contractions.
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When women try to undo an abortion, another medication is administered after the first pill. Yet both the American Medical Association and the American College of Obstetricians and Gynecologists say “there is no credible, medical evidence” it works.
The sole study suggesting that “abortion reversal” might be possible was published in December of 2012, in the Annals of Pharmacotherapy.
It was a case report of seven women, all of whom were pregnant and had taken mifepristone hours or days before. All, reportedly, immediately regretted that decision and asked physicians for help.
Doctors provided injections of progesterone, a hormone that thickens the lining of the uterus, priming it for pregnancy. Two women aborted in short order. One dropped out of touch and couldn’t be located. Four gave birth to healthy infants months later.
Despite the study’s limitations — including a tiny sample size, incomplete data, and no controls — the authors suggested their therapy could become a “standard of care” for physicians attempting “mifepristone reversal.”
The regimen is the brainchild of Dr. George Delgado, who speculated that sufficient doses of progesterone might stop mifepristone from interfering with the uterine lining. After all, both drugs bind to the same molecular receptors.
Delgado reasoned that safety wouldn’t be an issue because progesterone was already used widely in pregnancy, both in the first trimester for women who’ve undergone fertility treatments and later on, to forestall premature birth.
“I devised a protocol, the patient was treated, and the baby survived,” said Delgado, who serves as medical director of Culture of Life Services, a family health clinic in San Diego, which follows Catholic teachings in opposing abortion and contraception.
That clinic now offers abortion reversal services through 300 physicians across the country. Delgado says the network has managed to halt abortions in process for some 270 women who have either given birth or are currently pregnant.
Protocols vary, but the most common calls for injecting a pregnant woman with 200 milligrams of progesterone 24 to 72 hours after she’s taken mifepristone and again on the two following days. Progesterone injections continue every other day, then twice a week through the end of the first trimester. At that point, some doctors keep administering injections, while others stop.
“It makes complete sense biologically to use progesterone in this fashion,” said Dr. Donna Harrison, executive director of the American Association of Pro-Life Obstetricians and Gynecologists, which represents nearly 3,000 doctors who oppose abortion.
“We endorse abortion pill reversal because it saves lives and permits women who have regrets about their pregnancies to have a meaningful choice — the choice to change their minds,” Harrison said.
Concern about side effects
But critics say there isn’t any reliable evidence proving that Delgado’s protocol works.
Some patients, no doubt, go on to carry a pregnancy to term, but that’s a possibility for any woman who takes just mifepristone — the first pill in the medication abortion regimen.
Grossman and colleagues reviewed the research last year in a paper published in the journal Contraception. They found that mifepristone alone resulted in a completed abortion 53 to 88 percent of the time. The second pill, misoprostol, is often needed to finish the job.
In other words, it’s not clear that progesterone injections make any real difference.
“It looks like progesterone may not do anything, but we can’t really know because we’d need to compare women who got mifepristone alone with women who got mifepristone and progesterone, and that study hasn’t been done,” said Dr. Beverly Winikoff, president of Gynuity Health Projects, which promotes reproductive health technologies.
Side effects of progesterone are uncommon but can include maternal depression, hypertension, and pain when injections are given, according to Dr. Courtney Schreiber, an associate professor of obstetrics and gynecology at the University of Pennsylvania’s Perelman School of Medicine, who testified in a legal case against Arizona’s abortion reversal law.
The combined effect of mifepristone and progesterone on fetal development has never been studied, she noted.
The lawsuit in Arizona was brought by several local physicians, the American Civil Liberties Union and Planned Parenthood of America. They won an injunction preventing the state from enforcing the law for now.
No such litigation is in the works in South Dakota. That state’s law is due to take effect July 1.
Given a paucity of scientific evidence, inserting statements about “abortion reversal” or “abortion discontinuation” violates a fundamental principle of informed consent: that women should get sound medical information to guide them in decision-making, said Sarah Stoesz, president of Planned Parenthood Minnesota, North Dakota, South Dakota.
State Rep. Leslie Heinemann, a Republican who was the lead sponsor of that state’s legislation, doesn’t see it that way.
“Our intent is get as much information as possible to women,” he said. “If there’s a chance that a fetus could be viable after a woman takes an abortion pill and that their pregnancy could go to term, that’s something they should know.”