A provision in a new Arizona law requiring doctors to tell women that their abortion may be reversible has made national headlines, incited outrage from abortion-rights groups, and sparked heated criticism from the medical community.
An almost identical provision in an Arkansas law signed this week by Gov. Asa Hutchinson has not seen much media coverage. Even the man who has pioneered the idea of abortion reversals—Dr. George Delgado—said he hadn't heard of the Arkansas law until National Journal informed him of it during a phone interview.
Delgado, medical director of Culture of Life Family Services in San Diego, has seen his share of media coverage recently, but says he has yet to speak to lawmakers about the Arizona and Arkansas requirements. He was informed of the Arizona bill just before it went to a vote in the state legislature there, and endorses the idea of the legislation.
"I think that abortion pill reversal, in our experience, has been shown to be a safe and effective treatment," Delgado said. "I think in different states, the best way to make women aware might be different, and so I think the most important thing is they be aware of this option."
But is it real? Can abortions be reversed?
"This has happened over and over again where we have seen abortion counseling take a turn to the absurd and provide information that is inaccurate and misleading. We see it in a variety of ways; this is one more," said Elizabeth Nash, senior state issues associate at the Guttmacher Institute.
Medical abortions, done during the first seven weeks of pregnancy, are typically performed by giving a woman two medications. First, a woman takes mifepristone tablets orally. Misoprostol tablets are then taken two days later to complete the abortion, according to the FDA.
Delgado says the pregnancy may continue if another medication, progesterone, is taken after the first tablet.
A 2012 report about using the treatment, written by Delgado and published in the peer-reviewed Annals of Pharmacotherapy, is a case report of seven women. One didn't give her results, and four of the other six women continued their pregnancies. The study was published without the oversight of an institutional review board or an ethical review committee.
Dr. Dan Grossman, vice president for research of Ibis Reproductive Health, said the method is "not at all proven. It's really kind of a skeletal report."
Grossman said that as a physician, he finds it "shocking" that a legislature "would be mandating this kind of legislation," as it requires doctors to tell patients that there's an option that is "medically false."
These appear to be the first two instances of abortion reversal making its way into public policy.
The sponsor of the Arkansas bill, Republican state Rep. Robin Lundstrum, said the provision was added "to nail everything down so that a woman has as much information as possible."
"Now maybe this is overkill, but you have to be completely upfront with all the information," she said. "That's a critical time, and no matter what you're going to do when it comes to your physical person, you need to get information."
When National Journal spoke to her before Hutchinson signed it into law, she said there had been no debate over the provision during discussion of the bill.
Given the response to the Arkansas and Arizona laws this month, it will likely be impossible for the next state that considers such language to fly under the radar.
Dan McConchie, vice president of government affairs for Americans United for Life, which provides abortion policy expertise to legislators, said he expects the debate to continue in statehouses.
"There are legislators in other states who are very interested in wanting to make sure that women have as much information as possible if they are going to go through an abortion procedure," said. This interest has been expressed through other laws, such as those requiring informed consent, and he expects it to extend to policy requiring women to be informed of the possibility of abortion reversal.
"I certainly see it coming back next year," he said.
The abortion reversal debate appears to take a sharp turn away from the strict follow of FDA protocol abortion opponents have advocated for in the past. Laws in North Dakota, Ohio, and Texas require medical abortions to follow FDA-approved protocol for using mifepristone, although scientific studies show other practices are just as effective while using less medication, according to Guttmacher.
Arizona has a court order enforcing medical abortion must be provided under FDA-approved protocol, and Arkansas has passed a law requiring the same that will go into effect later this year.
Progesterone is a hormone and has several FDA-approved uses, including the treatment of hormone imbalances; abortion reversal is not one of them.
"Progestational agents have been used beginning with the first trimester of pregnancy in attempts to prevent abortion but there is no evidence such use is effective," reads one FDA-approved progesterone drug label.
Although not uncommon to use medication other than its FDA-approved labeled use, this usually happens after there's been published research documenting the safety and effectiveness of the alternative use, Grossman said.
"As far as I can tell, this is an unusual way to be using medicines off-label," he said.
However, Delgado said that medical abortions themselves use mifepristone off-label by using 200 mg of the drug instead of the FDA-approved 600 mg dosage.
Using progesterone off-label "should not at all be a criticism of our protocol," he said.
The Delgado case study results also are not entirely attributable to the progesterone. Grossman said either of the two medications used in medical abortions are not as effective if taken alone.
"It's very likely that women just take the mifepristone, and in the very rare case she changes her mind, doing nothing and waiting to see what happens might be just as effective as doing treatment," he said.
Pregnancies continue in 30-50 percent of women who take mifepristone alone, according to The American Congress of Obstetricians and Gynecologists, although Delgado says he believes the rate is 20-40 percent.
Since his report, Delgado says progesterone has about a 60 percent success rate in reversing abortions. The method has resulted in 89 live births and more than 75 current continued pregnancies, Delgado said, although these figures have not been documented.
"We have a couple of layers of scientific inquiry there showing that this is safe and effective," he said.
The Culture of Life Family Services runs the Abortion Pill Reversal website that features a hotline women can call if they change their mind after taking the first tablet. The program now has more than 270 doctors in its national network and the hotline has received calls from women in 45 states and 13 other countries, Delgado said.
Delgado says he's planning on publishing another paper, acknowledging of the 2012 study, "it's a small case series, there's no doubt about that." The study will be funded by small donations from benefactors interested in the research, although no political donors, he said, adding that he expects the recent attention to abortion reversals will make the publishing date sooner than originally anticipated.