The Colorado Department of Regulatory Agencies (DORA) heard from stakeholders yesterday as part of the legislative implementation process for recently passed Senate Bill 190, which targets “deceptive trade practices” of anti-abortion centers, particularly their marketing of abortion pill reversal, a practice the American College of Obstetricians and Gynecologists argues is “not supported by science.”
SB190 has been legally challenged by Catholic health care provider Bella Health and Wellness, who argues that the legislation is a violation of their First Amendment rights and religious liberty. The Colorado Sun reported that recent filings in the case show that Colorado Attorney General Phil Weiser’s office is not planning on enforcing the provisions of SB190 until after state medical boards are able to convene for a rulemaking session to determine whether abortion reversal meets the threshold of being a “generally accepted standard of practice.”
Medication abortions consist of two medications — mifepristone, which blocks the body’s production of progesterone, stopping the pregnancy from progressing, and misoprostol, which causes the uterus to expel the aborted material. Abortion pill reversal is essentially doses of progesterone to counteract the effects of mifepristone for patients who have not yet taken misoprostol.
Democrats and abortion advocates argue that abortion pill reversal is not supported by medical science. According to the American College of Obstetricians and Gynecologists, “A 2012 case series reported on six women who took mifepristone and were then administered varying progesterone doses. Four continued their pregnancies. This is not scientific evidence that progesterone resulted in the continuation of those pregnancies. This study was not supervised by an institutional review board (IRB) or an ethical review committee, required to protect human research subjects, raising serious questions regarding the ethics and scientific validity of the results. Case series with no control groups are among the weakest forms of medical evidence. Subsequent case series used to support use of medication abortion reversal have had similar limitations, including no ethics approval, no control group, under-reporting of data, and no reported safety outcomes. A 2020 study intending to evaluate medication abortion reversal in a controlled, IRB-approved setting was ended early due to safety concerns among the participants.”
The safety concerns in the 2020 study involved three women who experienced vaginal hemorrhaging and needed to be taken to the emergency room. One woman needed a blood transfusion.
“We don’t have any evidence that disproves the possibility that abortion reversal exists,” said Mitchell Creinin, the study’s lead researcher, to Vice in 2019. “But I do have evidence that not completing the regimen as it’s designed is dangerous.”
Despite the concerns about abortion pill reversal, the majority of the stakeholders who spoke at yesterday’s virtual joint stakeholder meeting supported the practice. “I’ve used it many times for patients and we’ve seen some successful pregnancies result after mifepristone was administered in many of my patients,” said Dr. Marcus Button, a family physician in Cañon City. “The questions that have come up is whether or not this is a generally accepted standard of care. I would ask the board, what is the standard of care for reversal if [Dr. George] Delgado and other researchers’ information is incorrect about progesterone? I think it is correct. And I think it leads us to one conclusion that that’s the only remedy that women who don’t want to have abortion go through after they’ve taken mifepristone.”
Emily Heckman, a Denver-based clinical pharmacist, addressed the conflicting medical perspectives. “The evidence for both sides is weak,” she said. “I feel that Creinin and colleagues out of UC Davis had his study. Delgado has his, as others have mentioned, and there’s not a lot of evidence either way. However, this is a toxicology treatment, and that’s very common in the toxicology world not to have great evidence. I feel that calling for a huge swath of evidence for abortion pill reversal is kind of unheard of and unusual. However, the Creinin and colleagues study, I feel, really highlights what could happen if we remove progesterone, because in those patients they had a lot of bleeding out, and specifically the patients that only got the mifepristone and not the misoprostol. I’m afraid of what might happen if we remove the progesterone option and patients decide, ‘Hey, I took the first pill, I changed my mind, I’m just going to stop.’ There’s a lot of risk with that.”
Rich Bennett, the president and CEO of LifeNetwork, which has three anti-abortion centers in Colorado Springs, expressed concerns about SB190’s ban on abortion pill reversal during Saturday’s Walk For Life event in Colorado Springs. “I would say that’s the more tragic piece of the legislation and the piece that, if it were to be sustained, would mean that Colorado would be the one and only state that regulates APR in that way,” he said. “When a similar effort was undertaken last year in the United Kingdom, it was quickly thrown out and it was thrown out on a medical basis because progesterone is proven safe. It’s been used in women’s health care for over 60 years. Why would Colorado be any different in that scenario? I just don’t see it. That would be tragic piece, if APR were to be banned. Hopefully the Pharmacy Board, the Medical Board, and the Nursing Board will make a decision that says we want to be aligned with the other 49 states, and really with the international community, when it comes to the medical decision to allow progesterone in the case of abortion pill reversal.”
Bennett also shared anecdotal evidence about abortion pill reversal. “Last year we got the privilege to come alongside seven women who were choosing to reverse the effects of that first pill,” he said. They came to us and they said, ‘I regret this.’ … Why not give her the choice to potentially undo that decision? Six of those seven last year were successful. We actually had a woman testify a year ago. Her pregnancy was saved, and actually they just did a birthday party for her one year old little girl. To me, it’s tragic that her daughter might not be here if a law like this were in place two years ago.”
In March, 23 national reproductive health, rights, and justice organizations called on the Colorado legislature to pass and Gov. Jared Polis to sign the Safe Access to Protected Health Care Package, which included SB190, in an open letter. The letter noted, “A well-known problem in Colorado is the proliferation of anti-abortion centers (AACs). They are the on-the-ground presence of the national anti-abortion movement and outnumber abortion providing centers 51 to 20. Anti-abortion centers use deceptive advertising to lure people in and to steer people away from abortion and other time-sensitive reproductive healthcare procedures. Modeled after Connecticut’s recent and successful bill, deceptive commercial speech is not protected under the First Amendment and therefore subject to regulation. Not only will this bill combat harmful disinformation, but it will also address inequities in reproductive health care because AACs specifically target Spanish-speaking communities, students, people in rural areas, and uninsured or underinsured populations. Additionally, some centers purport to offer so-called “abortion pill reversal,” an experimental practice denounced by respected medical associations, like the American Medical Association and the American College of Obstetrics and Gynecologists. SB190 will prohibit the use of deceptive advertising by AACs and will give the Department of Regulatory Affairs the ability to discipline healthcare professionals who perform ‘abortion pill reversal.’ Transparency, truth in advertising, and peer-reviewed medical procedures are essential to informed consent in medical decision-making, particularly related to time-sensitive services like abortion and emergency contraception.”