By Randall K. O’Bannon, Ph.D, NRLC Director of Education & Research
Any lay person looking at recent headlines could be forgiven if they thought that new objective scientific studies had recently determined that chemical abortions, even with drugs obtained by telemedicine rather than distributed in person, are absolutely safe and effective.
However, those who know these drugs, who have used these drugs, and who know who it is behind this public relations campaign, know different.
Despite the full scale media blitz by abortion pill advocates and a corresponding push for action by pro-abortion members of congress, the fact still remains that these drugs are dangerous and come with significant risks not just for unborn children but for their mothers.
Modest government safeguards won’t protect unborn children from harm, but they could save a few women’s lives and help keep some of the thousands of them from rushing to their local emergency room to deal with incomplete abortions, uncontrolled bleeding, virulent bacterial infections, or ruptured ectopic pregnancies.
Why safety assurances from abortion pill advocates aren’t reliable or even defensible
Abortion pill advocates clearly believe that if they can call the abortion pill “safe” enough times, then people will just believe that it is so. But the reality and the record are stubborn and resistant to spin.
To begin with, you can’t call a drug safe that has been associated with the death of at least two dozen patients and has put thousands in the hospital. And those are not up to date numbers, only what has been made public.
You can’t call a drug effective that fails 2-7% of the time.
It can’t be acceptable to mail women pills that, even when they work, put women through excruciating pain and cause copious bleeding. All this and more without a woman ever even sitting down with an abortionist who can professionally date their pregnancy, screen them for red flags, tell them what to expect, and make sure they know when and where to seek emergency help.
Too high a failure rate to be safe
Those pushing unrestricted telemedical abortion give their assurances that abortion pills work up to 98% of the time. By “work,” they mean killing the baby and the baby’s body being flushed out of a woman.
Even if this were true – and, as we shall see, there are reasons to believe this may be wildly overinflated – it would still mean thousands of women dealing with the consequences of an incomplete abortion on their own, perhaps hundreds of miles from the nearest qualified medical help.
That is not safe.
The FDA says that “About 2 to 7 out of 100 women taking Mifeprex will need a surgical procedure because the pregnancy did not completely pass from the uterus or to stop bleeding.” This is, of course, a percentage generated under the ideal conditions of trial where patients were more closely screened and monitored.
What about out in the field? Prescribers have given the pills to women weeks past the recommended cutoff date, when effectiveness is known to fall. And the number of incomplete abortions is certain to rise when women ordering these pills are not professionally screened and their pregnancies are not ultrasonically dated.
Given the popularity of the abortion pill—well more than 40% of abortions are now chemically-induced—and its heavy promotion, even a 2% failure rate represents an enormous number of women. The latest figures from Guttmacher showed that 339,640 of the nation’s 862,320 total abortions were “medication abortions” in 2017.
If those represented only the successful chemical abortions and the FDA’s most optimistic effectiveness percentage held, there would have been at least 6,931 failed or incomplete abortions. That number would leap to 25,564 with the FDA’s higher estimate, though even that still assumed ideal conditions which would surely not attain in real life.
A drug that puts that many otherwise healthy women in the hospital or scrambling for emergency surgery to stop the bleeding or complete the process is neither safe nor effective. It is the last thing that should ever be shipped to a woman’s home by some anonymous, unaccountable online order processor with little or no medical training and no reliable way of screening patients or dating their pregnancies.
Too complicated of a process to be managed safely without supervision.
Used correctly, the abortion pill process involves not one, but at least two sets of pills– mifepristone and misoprostol. They are taken over a period of multiple days and the process involves women going through several stages of an extended, harrowing process and then assessing and dealing with the consequences.
Things can go wrong at any point, particularly if instructions are not followed, but the possibility of failure or serious complications is present for any woman choosing to go the chemical route.
This is why the FDA originally had a complex protocol, with multiple medical contact points. Even after years of experience and some loosening of prescribed regimen, the FDA kept in place REMS safety regulations.
Risk Evaluation and Mitigation Strategy regulations require, among other things, that mifepristone still only be dispensed in clinics, hospitals and medical offices under the supervision of specially certified prescribers who can assure that patients know and understand the conditions under which the pill can be used safely.
That means that the FDA wants patients to actually meet their prescriber or his or her designated clinician directly; that the prescriber takes responsibility for dating and locating the pregnancy in the uterus, for ensuring that the patient knows about the process and the risks, and that he or she can make sure that they patient can have access to specialized medical intervention, such as surgery or transfusion, in the case of incomplete abortion or severe bleeding.
Prescribers have to certify that they can do this and patients have to sign documents that they have been informed of these conditions and risks.
Some of that information could conceivably be shared by a phone or computer consult. However the counseling or screening might not be as thorough as it would be in an in person session. In particular, a woman consulting on line could not have her pregnancy dated or located ultrasonically, factors that could significantly her risk of complication or failure.
There are too many ways for a chemical abortion to easily go badly wrong for a “self-managed” abortion with minimal contact with a responsible physician to be “safe.”
Far worse yet, when the pandemic hit, abortion advocates sought to use the crisis as an opportunity to push for telemedical abortion. They took the FDA to court to suspend regulations on abortion pills that required clinicians to dispense pills directly only from hospitals, clinics, or medical offices.
The Supreme Court backed the FDA’s authority to regulate the drug while President Trump was still in office. However when the pro-abortion Biden administration took over, the FDA changed its tune, suspending those regulations for the duration of the pandemic and promising to review the policy for the longer term.
Too many lost patients to be safe
Outcomes from recent studies claiming to demonstrate the safety and efficacy of telemedical abortions suffer from deficits similar to those of earlier studies. While there may not be enormously high numbers of failures or complications among the patients they track, along the way they lose track of too many women and unjustifiably assume that these missing women’s experiences are comparable.
For example, in the August 24, 2021 JAMA Network Open study of “Telehealth Medication Abortions” touted by Ms. Magazine (8/26/21), Ushma Updhyay and other colleagues from the University of California San Francisco (UCSF) reported that 95% of the patients with “outcome data” had complete abortions “without intervention.”
But this was of the 110 patients whose outcome was known. Researchers did not know what the outcome was for 18 other patients, and had actually lost track of another 13 patients who received “abortion care” from the telemedical abortion service. Considered as part of the entire group of women who received abortion pills by mail, researchers could only document 71% “successfully” aborting. Only some of these were confirmed by testing and others required additional “medical intervention” to complete their abortions.
Upadhyay and the UCSF team recorded no “major adverse events” (complications) and no cases of ectopic pregnancy. However, like the efficacy results, this was only among women for whom they knew the outcome. This offers little assurance of the chemical method’s efficacy or safety. It seems more likely that women who received their pills by mail and never visited the prescriber’s office would take their problems to their local emergency room or their own personal doctor rather than calling back the telemedicine service.
Claims that chemical abortions come without risks are inconsistent with years of experience to the contrary. In addition to dozens of deaths associated with the drug, there are thousands of cases of hemorrhage, infection, and ruptured ectopic pregnancies. These may just the tip of the iceberg, those “adverse events” that clinics were not able to manage and got reported to the FDA.
A 2015 study of emergency room admissions by Upadhyay found mifepristone had a complication rate of 5.19%, considerably higher than what is generally reported and higher than that reported for surgical abortions.
Pills that provoke complications in at least one out of every twenty women who use them are hardly safe and certainly not safe enough to send to women who have not been adequately screened or counseled as to their risks.
A drug directly responsible for hundreds of thousands of deaths each year can’t be “safe”
The deaths and injuries suffered by women taking mifepristone are no small matter, yet it cannot be overlooked that we are discussing the safety of a drug which is responsible for the death of human being every time it works.
A drug that kills hundreds of thousands of otherwise healthy babies can hardly be called safe. In fact, a drug that cures no disease, saves no person, but kills so many and endangers so many other lives, shouldn’t really be considered “medicine” or “medication” at all.
The FDA’s job is to test and approve drugs which heal, which cure, which treat debilitating conditions, or somehow ease or enhance human functioning. But pregnancy is not an injury, not an illness, but a natural healthy stage of adult female life and human reproduction.
Drugs that kill more lives than they save are inherently unsafe.
Drugs that kill babies and harm women aren’t “safe.”
Given what we know about mifepristone and its pitiful record, those who try to convince us this drug is “safe” and can be ordered by women over the internet and used in their homes clearly have something different in mind than the rest of us.
Even when it “works,” this drug puts women through a harrowing ordeal of painful cramping and gushing blood than may last days. That isn’t safe.
These pills don’t work for a large number of women, leaving them stranded, bleeding, in some sort of torturous medical limbo (is her child still alive and still savable? Is the abortion partially complete? Is she still bleeding?), maybe a hundred miles or more from the nearest emergency room. That isn’t safe.
The chemical abortion process is tedious and complex, involving multiple drugs, at different dosages, taken over a period of several days, taking as many as two weeks to work, coming with a host of side effects that must be managed and monitored to ensure things don’t get out of hand. That isn’t safe.
Trials and studies claiming high efficacy and safety rates notoriously lose track of high numbers of patients who take the first drug and disappear before taking the second drug or confirming the abortion’s completion. Researchers assume most of these women safely abort or simply leave them out of their calculations, but it seems more likely those women go where they believe they’ll get the best and most immediate treatment rather than the distant clinic or online pharmacy which sold her the pills. That isn’t safe.
When researchers who have spent years promoting abortion tell us these abortion pills are “safe,” they obviously mean something different than what the rest of us mean. They mean only that they’re able to kill most of the babies they mean to kill without doing any immediate visible harm to most of their mothers.
The trauma of a mother encountering her own aborted child, forever seared into her memory, does not concern them.
A certain number of maternal losses is acceptable to them, as are thousands of serious complications. It’s okay with them if women endure horrible cramps, or bleed for days, so long as they successfully abort those babies. It’s okay if they lose track of thousands of women, not knowing if they ended up in the ER or the morgue, so long as it isn’t traced back to them.
Trying to pass off a pill that destroys so many lives and puts so many others at risk as “safe” is not just irresponsible. It is dangerous.