By Randall K. O’Bannon, Ph.D. NRL Director of Education & Research
The constant refrain of abortion advocates is that mifepristone (the first of the two-drug chemical regimen) ought to be available by telemedicine and mail because it has been shown to be “safe and effective,” poses no real harm to women and allows them the convenience of aborting at home without ever having to visit the doctor or the clinic.
We have addressed the industry’s tenuous claims of telemedicine abortion safety before. (See here “Women Must Not be Misled by Orchestrated Campaign Declaring Abortion Pills ‘Safe’” NRL News Today, 9/7/21; and here). While we have hinted at the problem posed by incomplete efficacy, with the U.S. Food and Drug Administration (FDA) on the verge of permanently dropping regulations that could make nationwide telemedical abortion or “abortion by mail” a reality, direct examination of some of these claims and assumptions about abortion pill efficacy and its public health implications is now critical.
A significant percentage of chemical abortions fail.
Everyone admits that these drugs sometimes fail. The FDA says that 2-7% of the time, women taking mifepristone “will need a surgical procedure because the pregnancy did not completely pass from the uterus or to stop bleeding.”
Gynuity, the promoter of the national “TelAbortion” program, claims “Medical abortion is highly effective.” However they go to explains that “ Research has shown that the pill regimen completely terminates pregnancy in about 95% of patients,” so that “About 5% of patients may need to have a uterine aspiration (a surgical abortion) because of a continuing pregnancy, incomplete abortion, or persistent bleeding.”
AidAccess, a promoter and seller of mifepristone/misoprostol abortions trying for dominate the world’s online abortion market, reports a higher general effectiveness for chemical abortion – 98%. But they admit in a 2010 World Health Organization study that the rate of complete abortion for women who took the pills at home was closer to 90%, which they called “comparable to those who took the pills under the supervision of a medical authority.” (“Is it safe to do a medical abortion by yourself with pills bought online?” aidaccess.org, accessed 9/30/21.)
This represents thousands of chemical abortion failures.
Whether the failure rate is 2%, 5%, 10%, or, as seems likely, something much higher, the important thing to remember is that any percentage other than 0% or zero-point-something represents a LOT of women.
There were, according to the Guttmacher Institute, 339,640 chemical or “medication” abortions performed in the U.S. in 2017 (the last year for which they have published comprehensive national data). This was 39% of all abortions Guttmacher recorded for America that year. That figure itself represented a 25% increase over the numbers of chemical abortions performed just three years earlier.
If trends continued as they were, a figure approaching 50% of all abortions for 2021 is not out of the question.
Even with 2017 numbers, though, the failure rates that abortion pill advocates have reported represent a lot of women. If 339,640 represented the 98% of mifepristone-misoprostol abortions that advocates say were “successful,” then 2% would mean failures for 6,931 women. It jumps to 17,876 failed chemical abortions with a 5% failure rate. A 10% failure rate means 37,378 women dealing with incomplete chemical abortions in just one year’s time.
If promotion of this chemical method continues to be successful and reaches the point where half of all abortions are done this way, expect the number of failed abortions in each of those scenarios to rise by at least a quarter.
Whether use increases or stays the same, this means, even under the most optimistic projections, thousands of women each year taking the pills going through a great deal of stress and pain, perhaps a copious amount of bleeding, but failing to abort.
Something more serious than the inconvenience of a failed abortion is at stake.
Failure for those women is more than simply an added expense or an inconvenience. For them, this could be a life or death matter if something is not be done to address the bleeding or, if the baby has passed, to deal with any other retained tissue left in the uterus.
This means women scrambling to get to the nearest clinic or emergency room to have someone surgically complete the abortion, to stanch the flow of blood before one of these moms bleed to death. Or, if the ordeal has caused her to reconsider, to find somewhere where the chemical process may be reversed and her child perhaps saved.
This is bad enough under circumstances where a woman originally got her pills at a clinic with a trained surgeon on staff or when she lives in a city or suburban area with a well equipped emergency department. But abortion pill advocates have specifically promoted these pills for use by women in areas where there are few if any abortion clinics, particularly none with trained surgeons, and for remote areas where medical care is generally not readily accessible.
For these women, failure can mean disaster – bleeding that doesn’t stop, retained tissue that doesn’t pass, anxiety and uncertainty about what may or may not have happened, fear that a surgical abortion may be required to finish the job if she intends to go forward.
Studies have reported unrealistic efficacy rates.
Studies developing these efficacy rates were often done under ideal conditions, with careful screening, monitoring and adherence to protocol, conditions that are unlikely to obtain in the real world. Worse yet, the rates they report are probably exaggerated because of data missing on a number of patients.
Screening is important not simply because it gives prescribers the chance to identify and deselect would-be patients who might have conditions that could make taking the drugs dangerous, but also because it eliminates candidates for whom the drugs will not work. If this is not done, or done poorly, safety will be compromised and efficacy rates will drop.
The more careful screening done during the studies meant that women with disqualifying conditions such as ectopic pregnancy, allergies to the drugs, adrenal issues, taking blood thinners or corticosteroids, etc., or who were too far along in their pregnancies (which lowers efficacy and increases the risk of complications) were not offered the drugs. And those women, who would have had more complications and more failures, were not included in safety and efficacy assessments.
Even though researchers never claimed that these drugs were 100% safe and effective, the rates they reported were still higher in the trials and studies than would have been expected in the field.
Without researchers monitoring every step of the process, women visiting their local clinic under ordinary circumstances may have received less rigorous screening (e.g., no ultrasound to date pregnancies) and faced looser selection criteria (e.g., accepting women 11 or 12 weeks after their LMP, or last menstrual period), sure to increase the number of failures.
Absent that more rigorous screening, there will be more patients with contraindications, with gestations past the cutoff date, or with ectopic pregnancies are going to get through. This means “success” rates are going to fall and complication rates will go up. Unless the government intends to enforce the more rigorous protocol, such as the one found in the FDA’s current Risk Evaluation and Mitigation Strategy (REMS) regulations, the efficacy rates reported by these studies are going turn out to be artificially high and unattainable.
Study efficacy estimates fail to account for many lost patients.
Even under the ideal conditions of a study, there were high numbers of patients lost to followup. These patients came in, received the drugs, but never returned to confirm the completion of their abortions. Whether these lost patients were added to “success” totals, assumed to have aborted at similar rates as patients who returned or, more likely, simply not counted in overall efficacy assessments, the net effect was an ideal, rather than a realistic efficacy rate.
Given the nature of the chemical abortion process, one cannot assume that those who did not return for follow up visits (to take the second drug misoprostol to expel the child or to be checked for completeness) completed their abortions successfully. Some may have perhaps already aborted, but others may have decided to go to the E.R. or gone back to their regular physician when the miscarriage “stalled” or the side effects got too intense.
Perhaps they may have been reluctant to return to the place they believe gave them “defective” pills that didn’t work or to trust their care to folks they felt failed to adequately warn them about the pills’ limitations, its side effects, or the possibility of reversing an incomplete process.
Telemedical or mail-order abortions are likely to be less efficacious.
Assurances of the safety and efficacy of “self-managed” abortions with pills purchased over the internet assume that the safety and efficacy rates reported in controlled trials and studies could be readily translated to telemedical and mail-order abortions. This is very unlikely.
Previous experience demonstrates that abortion “providers” often ignored FDA protocol and offered abortion pills to women weeks past the FDA recommended guideline. Though the FDA extended the official cutoff from seven to ten weeks after a woman’s last menstrual period (LMP) in 2016, it did so with it common knowledge that efficacy dropped as gestation rose. Even before the FDA revised the protocol, prescribers were giving abortion pills to women at eleven weeks LMP, twelve weeks, or even later.
With telemedical or especially abortion pills ordered online and delivered by mail, there is little reason for confidence that even these later deadlines will be honored.
In the imagined, ideal telemedical model, a woman will be screened by a health care representative on a webcam who will directly ask for and attempt to gain assurance that the woman is not past the specified cutoff date. While he might have been able, had the woman had visited the office, to do an ultrasound to determine the baby’s age and location (to ensure the child was located in the uterus, not ectopic in the fallopian tube), now the prescriber must rely on the woman’s accuracy and honesty regarding her last full menstrual period and whatever symptoms she may be experiencing.
This is a high enough hurdle with the full, live interaction of a webcam. Yet some internet and mail order abortion services only ask that a woman type a date as that of her last period, give an age, and go through a checklist of possible medical conditions without any direct, in-person interview. Anyone can give a name, an address, check the “right” boxes, and pay to have the pills mailed to that location without any real confirmation of her identity, physical condition, or medical details.
If telemedicine means pills being sold to women that are not fully screened for disqualifying medical conditions, taking pills far past the recommended deadline, effectiveness will most certainly decline further. As consequence at least hundreds, probably thousands more women will be left stranded, desperate for help, and maybe scrambling for emergency surgery.
Abortion pill promoters are not being forthcoming about efficacy issues with telemedicine
As pointed out earlier, most of the efficacy rates reported by abortion pill advocates were those obtained under the ideal conditions of a clinical trial or study, where there was more careful screening and monitoring. Those conditions do not obtain in the field. And whatever the real efficacy rate turns out to be, it will surely drop even further if and when more women start ordering these abortion pills online or obtaining these by telemedicine and having them delivered to their homes.
These pills are less likely to work if the woman is past the gestational cutoff date, has certain physical conditions, or if she fails to follow the recommended protocol. They will not work at all if she has an undetected ectopic pregnancy.
A failed or incomplete abortion means much more than additional cost or inconvenience. It could mean a woman scrambling to find the nearest emergency room to stop the bleeding or some place to surgically complete her abortion.
It may leave her wondering whether her child is still alive and whether she can do anything to halt or reverse the abortion process.
In admitting that a certain percentage of chemical or medication abortions fail, the industry is granting that such circumstances will occur, that a number of women taking their pills will face such ordeals and dangers. But as long as just enough of their customers successfully abort and are satisfied with their product, they’re willing to write the rest of these women’s experiences, their losses off, to cynically accept thousands of these failures as the cost of doing business.
Those women just have to be prepared to shoulder the costs, the pain, the risk, the injuries, the trauma for the sake of the chemical abortion cause.
Editor’s note. For more on this topic, please see here.