Regulations needed to stop dangerous telemedical “medication” abortions — Part IV

Telemedical, Mail-Order Abortions Lack Critical Safeguards

By Randall K. O’Bannon, Ph.D., NRL Director of Education & Research

Years of experience have demonstrated that the chemical abortion process inherently comes with failures, risks, and dangers to women. This is why the U.S. Food and Drug Administration (FDA), since the pill was first approved, has limited its distribution and issued multiple warnings regarding its use.

Abortion pill advocates have long fought against these regulations. They’ve argued that the pills could be ordered and safely used by women dialing in from their phones or logging on to computers from their own home. If so, this would mean they would they never have to visit a clinic, undergo screening, counseling, and a physical examination, don’t have to come in to nail down the date of their pregnancy or the precise location of the child in their womb, or confirm the completion of their abortion. 

Somehow, they argue, women can just do without Rh testing, screen themselves for ectopic pregnancy and other contraindications, date their pregnancies, and recognize signs of dangerous complications entirely on their own.

In person professional screening is essential.

Such assurances are totally unjustified and wholly irresponsible.  

Despite a clear medical record showing decreased effectiveness and increased complications with increasing gestational age, researchers advocating the “no-test” method are satisfied that most women can estimate gestational age for themselves. Admitting that this “will inevitably result in treatment of some fraction of patients whose true GAs [gestational ages] exceed 77 days” (a point after which the “effectiveness” of abortion pills is already known to have dropped considerably), they reassure (citing their own studies) that these medications will work at later gestations than those approved by the government and that serious “adverse events” will be “rare.”

Again, even if most women estimate gestational age with some accuracy, a certain percentage of errors means a higher level of risk of failure or complications for those patients. This inevitably translates to into more women with incomplete abortions or hemorrhaging trying to get to the emergency room.

Abortion pill researchers advocating the “no-test” self-managed chemical abortion method say “Rh testing is not a requirement for abortion in any setting.” They maintain that such testing is “unnecessary for patients who can report a Rh-positive blood type or who are certain that they want no future children after the planned abortion.”

It is unclear how providers of the pills would make these high stakes plain to prospective patients or what steps they might take to limit distribution to women willing to accept those dire consequences. But even if they did, it would have the effect of forcing a woman to make an important and irrevocable decision at a time when she may be most desperate and uncertain about her future.

Abortion pills won’t work on ectopic pregnancies.

As many as 2% of identified pregnancies in the U.S. are ectopic, that is, where the unborn child implants outside the womb. If not identified and addressed, they can grow and rupture, placing the mother’s life at risk. Mifepristone and misoprostol (the two drugs used in chemical abortions) do not work in the case of ectopic pregnancy. This is especially dangerous because the symptoms of a rupture – uterine pain, cramping, bleeding – are, at least initially, difficult to distinguish from the normal side effects of a chemical abortion.

Advocates of the “no-test” chemical abortion know of the abortion pill’s lack of effectiveness in such situations and the risk it poses. But they blithely advise that even if ectopic pregnancies are missed by their self-screening methods, they “can be detected and managed afterwards.”

These advocates are suggesting that these “no-test” chemical abortions can performed at gestations up to 11 weeks, or more. Given that the rupture of ectopic pregnancies can occur anywhere between the 6th and 16th week of pregnancy and produce symptoms disturbingly similar to chemical abortion side effects, assurances that they “can be detected and managed afterwards” sound  irresponsibly optimistic.

Who will handle the inevitable complications?

The medical record clearly shows that women taking mifepristone do face ruptured ectopic pregnancies, hemorrhages, and dangerous infections. There is no medical reason to believe that these will suddenly become less frequent when women begin to manage these chemical abortions at home than they were when they received their pills at an abortion clinic. 

Complications will follow chemical abortion, as they always have. The question is, how well will these be handled?

Under the current Risk Evaluation and Mitigation Strategy (REMS) limited distribution system, a woman seeking to obtain these pills at her local clinic is to be specifically warned about the risk of complications associated with mifepristone. She is supposed to be advised on how to recognize these complications and told when and where to seek treatment. She may or may not be given such counsel with drugs purchased over the internet.

The certified healthcare provider mandated by the FDA plays a critical role in making sure the woman appreciates these risks, that she is able, for example, to distinguish the kind of bleeding that is normal from the sort that requires a quick return to the clinic or to the emergency department. This is not an inconsequential responsibility. If that provider has been certified, this means they are supposed to have been adequately trained, that they should be able to treat a hemorrhaging patient or assess them and send them to someone who is prepared to halt the bleeding.

An online doctor, if there is one and if he or she is inclined, can try to make this clear when prescribing the pills. Yet how attentive will a woman will be to stranger she has just met and sees only briefly on her computer screen is a serious question. In any case, whether because of skill level or distance, that online clinician is unlikely to be available to treat the patient should problems arise. 

Even a hotline, if there is one, may only be able to direct her to the nearest hospital. There she may await treatment from staff unfamiliar with and unappreciative of the gravity of her condition, especially if this information is withheld from them.

At least with the FDA’s REMS system, there should be a certified healthcare professional to take responsibility for ensuring that women are fully briefed on risks of the drug and will make sure they can get the treatment they need if and when a complication occurs.

Incomplete abortions are not always easy to recognize.

Though they disagree about percentages, all abortion pill researchers grant that abortion pills don’t always “work.” And when they don’t, a woman must decide whether to take more medications, have a surgical abortion, or allow the pregnancy to continue. 

But how does one know whether or not one is done?  For some women, it is obvious. They see their aborted child and side effects taper off.  But it is possible for a mifepristone patient to endure painful cramps, bleed for days, pass huge clots, think one has aborted, but later find out different. 

Eric Schaff, an early pioneer in the chemical abortion campaign, noted early on that 

Even though a woman may have experienced cramping and bleeding, she cannot know for certain that her abortion is complete until a provider performs either a sonogram or a hormonal pregnancy test.

The FDA cautions that “Lack of bleeding following treatment usually indicates failure; however, prolonged or heavy bleeding is not proof of a complete abortion.”

Advocates of the “no-test” chemical abortion argue that women can confirm completion of the pregnancy with a high sensitivity urine pregnancy test (HSPT). But because these come with high “false positive” rates, women are supposed to wait four weeks after taking the misoprostol before taking their first one. Continued positive results at that time may still end up requiring a clinical visit to conclusively determine the abortion has failed and to plan a woman’s next steps.

By contrast, the follow up with a trained health care provider that the FDA recommends at 7-14 days can provide a reliable and earlier verification of completion by clinical examination, medical history, ultrasound scan, or human Chorionic Gonadotropin (hCG) testing. 

Professional screening and follow-up are essential to safety.

The screening and the follow up visits that were part of the FDA’s original protocol were not mere afterthoughts or mere procedural roadblocks.  

Pregnancy and the chemical abortion process being what they are, screening by a professional, preferably with a trained ultrasonographer, is going to be essential to ensure that women are not too far along for the pills to be effective, or to rule out an ectopic pregnancy of which the woman may not be aware. Professional follow up will be needed to determine whether or not the abortion is complete.

It is not an assertion that every chemical abortion will end in a mother’s death or severe complication, or even that most of those abortions will fail. But it is recognition that, statistically speaking, a significant number of these abortions will fail. When they do, a number of women will face serious complications. And in these cases, that there will probably be more complications if telemedical and mail-order abortion becomes the norm.

Finally, what about all those studies from abortion experts telling us that these self-managed, do-it-yourself abortions with pills ordered off the internet are absolutely safe?  More about that Monday in our final segment.