Editor’s Note: This article is the third in a series. Read other installments at the following links… Bad Actors #1, Bad Actors #2.
The profitable abortion industry is threatening to promote the unapproved one-drug abortion regimen (referred to as ‘Misoprostol only’) if litigation seeking to undo the FDA’s approval of the current two-drug abortion pill regimen proves successful.
Misoprostol-only abortions have a much higher failure rate than the approved two-drug (mifepristone/misoprostol) regimen, meaning women taking ‘misoprostol only’ are at greater risk of an incomplete abortion. In such cases, women may be advised to take additional doses of misoprostol or to have a surgical procedure to complete the abortion.
In 2000, the U.S. Food and Drug Administration (FDA) approved the abortion pill mifepristone (Mifeprex) for use in an abortion regimen with a second drug — misoprostol. Due to the potential for serious adverse events when using mifepristone, that drug has been under a safety system (REMS) which monitors use and regulates those certified to prescribe and dispense the drug. Because the FDA has kept the drug under stricter oversight due to the REMS, abortion industry leaders are flipping the script.
Misoprostol (Cytotec) was FDA-approved to lower the risk of stomach ulcers caused by nonsteroidal anti-inflammatory drugs (NSAIDs) like ibuprofen (Advil, Motrin) in certain people, according to GoodRx. Misoprostol is not subject to the REMS safety system, which is why bad actors in the abortion industry could be pivoting toward the unapproved one-drug versus the approved two-drug regimen. Technically, using misoprostol in the abortion pill regimen is considered off-label use.
Media has referred to mifepristone as “the sidekick, and misoprostol the superhero,” meaning that it is believed misoprostol (the second drug) contributes more to the “success” of the abortion pill regimen than mifepristone. Beverly Winikoff, president of Gynuity Health Projects (GHP), which conducted a TelAbortion clinical trial and reportedly “helped develop the World Health Organization’s guidelines for medication abortion,” agreed, saying, “If you had to choose only one, you would choose the miso — but it wouldn’t be as effective as having the two.”
Abortion industry pivots to promoting the unapproved one-drug regimen
Joan Fleischman’s MYA Network tells its clients online that in addition to the FDA-approved abortion pill regimen, “Another option is to use misoprostol only. This method is a little less effective (it works about 85% – 90% of the time) and may have more side effects, but the advantage is that the pills are very inexpensive and can be picked up at any local pharmacy.”
Fleischman recently received backlash for distributing images of purported early embryos to the Guardian, which it published, and which look nothing like actual early embryos.
The MYA Network claims to be “a network of clinicians, activists and patients who want to normalize abortion care, medically and culturally.” So it was even more shocking to discover that their own website acknowledges the high incidences of failed abortion with the one-drug misoprostol-only regimen.
MYA’s FAQ section reads, “A mifepristone/misoprostol abortion pill fails about 1-2% of the time. A misoprostol-only abortion fails about 10-15% of the time” — a vast difference, increasing clients’ failure rates anywhere from 650-1400% with ‘misoprostol-only’. Media reports confirm that the abortion industry is already utilizing the unapproved one-drug abortion regimen, outside the approved FDA two-drug regimen.
“At this point, there are still a lot of unknowns in terms of how this is going to play out,” Dr. Jamila Perritt, president and CEO of Physicians for Reproductive Health told Houston Public Media. “What we do know is that misoprostol has been used on its own for decades around the world and is effective at ending an early pregnancy.”
But the media outlet also noted that abortionist Ushma Upadhyay admitted that a ‘misoprostol-only’ protocol could produce a higher risk of side effects like nausea and cramping. “It’s so important that patients understand how long they’ll be bleeding after they take the miso alone,” Upadhyay said. “And it is longer.”
Slate Magazine recently wrote, “The medical director of Just the Pill, a nonprofit online clinic that mails abortion medication to patients in four U.S. states, said the organization is prepared to switch to a misoprostol-only protocol ‘if the Texas judge rules in the way that it’s expected.’”
She was referring to a federal lawsuit filed by the Alliance Defending Freedom on behalf of the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, the Christian Medical & Dental Associations, and doctors Shaun Jester, Regina Frost-Clark, Tyler Johnson, and George Delgado. The Plaintiffs are asking the court to hold the FDA accountable for its recklessness in approving the abortion pill two decades ago.
“A representative from Hey Jane, another site that does virtual consultations and mails abortion pills, said many of the group’s practitioners have already provided misoprostol-only abortions, and they are ready to fully pivot if mifepristone is banned. Planned Parenthood confirmed to Jezebel that its facilities are ready to offer misoprostol-only abortions, too,” Slate Magazine noted (emphasis added).
Eight abortion providers have confirmed to Jezebel that if a Texas judge rules in favor of the Plaintiffs, “they are prepared to prescribe misoprostol-only abortions as a workaround.”
“Planned Parenthood, Abortion on Demand, Aid Access, Carafem, Choix, Forward Midwifery, Hey Jane, and Just the Pill told me they’re ready with the back-up plan and that the single-drug regimen is safe and effective,” Susan Rinkunas of Jezebel wrote.
Planned Parenthood even seemed to endorse the ‘misoprostol-only’ protocol in a recent press release. In a Twitter thread, the abortion corporation claimed that if the previously mentioned federal lawsuit prevailed, “… medication abortion with only one drug – misoprostol – will still be accessible in states where abortion is not banned. And misoprostol has safely been used by millions of people for decades…”
The industry seems poised to go off the approved FDA protocol regardless of the risk to women.
According to one OBGYN, a ‘misoprostol-only’ abortion has a higher failure rate than the approved FDA regimen, can lead to a born-alive infant, and has the potential to produce birth defects. In addition, Live Action News has documented at least one death related to ‘misoprostol-only’ abortion.
Leah Coplon, director of clinical operations for the online abortion pill dispensary Abortion on Demand, told Houston Public Media they are also preparing to switch to the unapproved method. “Obviously we hope that we can continue to use mifepristone and misoprostol, but we’re ready if necessary,” she stated.
“Carafem, an organization that provides medication abortion through telehealth as well as at clinics in Chicago, Atlanta and outside Washington, D.C., began offering the single-drug protocol in 2020 amidst growing threats to abortion access in general and mifepristone in particular,” Houston Public Media reported.
“It made sense to us to better understand how to use it and make it available,” Carafem’s Chief Operating Officer Melissa Grant told Houston Public Media.
Other abortion promoters are also openly advocating that women seek misoprostol from veterinary sources, and one has published a recipe to make the drug online — it should go without saying that both of these options put women at risk.
‘Misoprostol-only’ abortion regimen fails more often
In a September 2022 issue of Charlotte Lozier Institute’s (CLI) On Science Series, OBGYN Dr. Ingrid Skop suggested that the likelihood of a preborn baby surviving an abortion increases with a ‘misoprostol-only’ regimen.
Skop, the Senior Fellow and Director of Medical Affairs for CLI, wrote, “… [A] 2010 study comparing standard mifepristone/misoprostol with misoprostol alone documented that using misoprostol only to induce an abortion led to a 23.8% failure rate requiring surgery. The embryo/fetus continued to survive in 16.6% of the pregnancies, and misoprostol is known to produce birth defects such as Moebius Sequence, associated with craniofacial and limb abnormalities…. In contrast, there were 3.5% failures and 1.5% continuing pregnancies in the mifepristone/misoprostol group.”
The high failure rate of a misoprostol-only regimen was acknowledged in a report written by a Kaiser Health News author who claimed, “a medication abortion is completed 92% of the time when misoprostol and mifepristone are taken together. That rate drops to around 60% with only misoprostol.”
But the data is mixed; a 2011 study reported, “The number of ongoing pregnancies documented with misoprostol-only warranted an early end of the trial after unblinding of the study at interim analysis.”
“The success rate of both FDA-approved pills taken together is 98%, but misoprostol taken alone is successful around 80% of the time,” claimed Jezebel.
That 20% failure rate matches a report published by the American Academy of Family Physicians as well as a February 2023 report published by the Society of Family Planning, which stated, “Evidence from studies across a range of settings demonstrates that misoprostol alone successfully terminates ~80-100% of pregnancies without the need for procedural intervention, with variations within that range based on regimen and pregnancy duration.”
A report published by Ibis Reproductive Health claimed that the failure rate was as high as 22%: “Studies of self-managed use of misoprostol-alone regimens have found high levels of effectiveness, with 93-99% of participants reporting complete abortions without the need for surgical intervention. By comparison, a recent meta-analysis of all available clinical trial data on outcomes following clinically-managed use of misoprostol alone found that 78% of study participants across 13 clinical studies had a complete abortion without need for surgical intervention, though the studies varied widely in the misoprostol-only regimens used and time period under observation.”
Meanwhile, Dr. Daniel Grossman claimed in a continuing education class for pharmacists that the efficacy rate for misoprostol (before 10 weeks of pregnancy) is about 85% — a 15% failure rate.
“Ongoing pregnancy is more likely after the misoprostol-only regimen than after mifepristone and misoprostol,” wrote the pro-abortion authors of a ‘misoprostol-only’ sample protocol in a 2023 Journal Contraception article: “Some studies reported that the effectiveness of the misoprostol-only treatment declined with gestational duration within the first trimester whereas others did not observe this trend.”
“The risk of treatment failure requiring additional medications or a procedure (about 10%) is higher after misoprostol-only than after regimens containing mifepristone. About 3-6% of patients using misoprostol-only may have an ongoing pregnancy. Patients should be informed that misoprostol can be teratogenic if the pregnancy is not terminated; prospective studies have suggested that exposure in early pregnancy may double the risk of cranial nerve anomalies, limb defects, and other major birth defects,” they added.
It seems the data on ‘misoprostol-only’ abortions varies widely. The higher failure rates of this unapproved one-drug abortion regimen is further evidence that the abortion industry is seldom concerned with women’s safety and instead is focused on profits, regardless of the lives lost and the cost to women’s health.