This Friday, the Colorado Medical Board, Board of Nursing, and Board of Pharmacy is meeting again to get stakeholder feedback on their draft rule in response to SB23-190, the legislation which addresses deceptive trade practices of anti-abortion centers, particularly their use of “abortion pill reversal.”
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.”
The June stakeholder feedback meeting saw comment from medical professionals who overwhelmingly supported the practice, or at least the right of medical providers to use progesterone in cases where an abortion patient changes their mind after taking mifepristone.
Emily Heckman, a Denver-based clinical pharmacist, addressed the conflicting medical perspectives during the June meeting. “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.”
This month, Colorado regulators issued a draft rule that would not automatically consider “abortion pill reversal” to be unprofessional conduct, undermining the provisions of SB23-190 that address the practice. The organizations and advocates who endorsed SB23-190 have signed onto a letter meant to express their disappointment in the draft rules promulgated by the medical boards, which now has 21 signatories and counting, from groups like Cobalt, COLOR, New Era Colorado, Planned Parenthood, the ACLU of Colorado, the Colorado Consumer Health Initiative, Physicians for Reproductive Health, and others.
“As written, the Board’s draft rule skirts this question, ignoring the guidance of the most relevant professional organizations including the American Medical Association and the American College of Obstetricians and Gynecologists, who have both denounced medication abortion reversal, as well as people who are seeking safe, accessible, and transparent reproductive care across the West,” reads the letter. “The American Medical Association says that ‘Because there is no credible, scientific evidence that a medication abortion can be reversed, physicians cannot, without misleading them, tell their patients that it may be possible’ to do so, ‘nor can they tell their patients that information and assistance is available to reverse a medication abortion without misleading them.’ They further say that this is ‘a claim wholly unsupported by the best, most reliable scientific evidence, contravening their ethical and legal obligations as medical providers.’ Not based on science, does not meet clinical standards, no credible scientific evidence, misleading to patients, wholly unsupported — if that is not indicative of unprofessional conduct, what is?”
In a news release from New Era Colorado, Sen. Janice Marchman (D-Loveland) expressed her disapproval of the draft rule. ““The complaint process the draft rule lays out is extremely out of touch with the reality that people in Colorado deal with. Imagine you’re a twenty year old trying to process your feelings of shame, confusion, and concern after undergoing an experimental treatment. Where would you even start? Navigating the health care system is extremely difficult, and the economic barriers and social pressures young people deal with increase these hardships tenfold. The complaint process is not only impractical for patients, it’s not sustainable for providers. We call on the medical boards and our state leaders to truly advance and protect safe, accessible, and transparent reproductive care.“
The public’s deadline to submit written comment is Wednesday, Aug. 2.