Data Contradicts Safety Claims made for Chemical Abortion delivered by Webcam and by Mail

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

Results from a trial in which chemical abortifacients were made available via webcam and delivered by mail have been published with the authors predictably claiming that the method is “safe, efficient, and satisfactory.” But a closer look at the study numbers reveals evidence of serious safety issues.

Study seeks to bypass clinics

Elizabeth Raymond, Beverly Winikoff, and a team from Gynuity worked with researchers and clinicians from the Guttmacher Institute, the University of Hawaii, Oregon Health & Science University, Planned Parenthood Columbia Willamette, Maine Family Planning, and the Choices Medical Center of Jamaica, New York as part of a webcam, abortion pills by mail study conducted in five states – Hawaii, Oregon, Washington, Maine, and New York* – between May 2016 and December 2018.

The study, “TelAbortion: evaluation of a direct to patient telemedicine abortion Service in the United States” is slated to appear in an upcoming issue of the journal Contraception.

The study’s aim was to see if a pregnant woman could bypass the abortion clinic altogether. In this model, she could have testing done at regular medical labs and ultrasound facilities, then contact the abortionist who interviews and screens her via a webcam connection.

The abortionist would then send her the abortions pills–mifepristone (RU-486) and misoprostol– and instructions by mail, if she qualified. After receiving the pills, women were supposed to take the pills and abort at home.

A follow up (unclear if by email, phone, or webcam) was scheduled to discuss any problems that may have occurred, to determine if the abortion was complete or whether additional care or tests were needed.

Results bear scrutiny

Gynuity reported a success rate of 94% (177 of 188 patients who were known ultimately to have aborted). However this figure requires some serious qualification.

Only 268 of the 433 who contacted the TelAbortion program actually did the “televaluation” with a clinician who did the pre-abortion counseling, explained the procedure and expected costs, and got consent. The clinician also made sure the women had gotten an ultrasound and had Rh typing done, and had a plan for evaluating the outcome.

Twenty more women dropped out at that point and were never sent the pills. Three women dropped out because they changed their minds. Seven women miscarried before the pills were sent, seven had other unspecified reasons, two wouldn’t have gotten the pills before the 70 day cutoff (after a woman’s last menstrual period), and one woman just withdrew, not providing a reason.

Of the 248 who did receive the drugs, most (193) took both the mifepristone (RU-486) and misoprostol. However six women took neither, 14 took at least one drug but it wasn’t clear whether they took the other drug. Another 35 women provided no data on whether they did or did not take the drugs.

Here’s the key fact: of the 248 women sent the abortifacient drugs, the actual abortion outcome was unknown for 58 of them. For the 190 where the outcome was known, two were known to have continued the pregnancy, 11 were known to have gone on to have a surgical abortion, and 177 “successfully” aborted with the drugs.

Considering just those women known to have aborted, you do get the 94% “success” figure for the chemical abortions. However you get a much lower percentage if you consider it as a percentage of the women to whom the TelAbortion team sent packages of pills.

Gynuity can only certify that 71% of those women aborted. While they know about the 11 others who had surgical abortions, and the two who continued their pregnancies, they’re not sure about the other 23% of patients. That’s a significant number of women—almost a quarter– about whose health and safety Gynuity can tell us precious little.

Several complications

While the TelAbortion team tried to downplay the number and significance of complications or “adverse events,” their data revealed several safety incidents. Furthermore, given all the patients for whom they lacked outcome data, their confidence in their numbers and in the safety of their method seems unsubstantiated.

Gynuity says they had “meaningful follow-up” with 217 of the participants after the package shipment. They report just two of these (1%) reporting “serious adverse events.”

However, there are a number of problems with this estimate. Given that they sent out 248 packets of pills and knew the “abortion outcome” for only 190 of these patients, it seems unwarranted to claim any sort of certainty about the extent of complications for 217 patients, let alone the procedure in general.

The two events they do mention both involved severe bleeding. One woman was hospitalized after a seizure following an “aspiration performed for bleeding.” The other a woman was hospitalized for severe anemia and received a transfusion.

There were at least 16 other “events” where patients went to the emergency room or an urgent care center: 14 for bleeding and/or pain, one for dizziness, and one to get Rh immune globulin. An additional eleven patients had clinic or office visits that were not part of the original TelAbortion program, most (eight) for “outpatient aspirations” – presumably surgical abortions when the chemical abortion failed.

Safety concerns should not be dismissed

The Gynuity team gives assurances that neither of the two “events “they deemed “serious” “would have been averted had the abortion medications been provided in person.” They fail to see how this misses the point. The claim, the safety issue involved, is not that the webcam/mail procedure introduces a new category of risk. It is that when a woman is so far removed from the doctor who is supposed to be managing her case, there is a new and special danger beyond the ordinary risks that come with any chemical abortion.

Put another way, it isn’t that pills delivered by mail cause more bleeding or severe bleeding more often. Rather it is that the webcam/mail process potentially puts more distance between the woman and her doctor at the time she needs to be most closely monitored and may need to be treated by someone familiar with her situation.

Remarkably, Gynuity says their results show “unscheduled encounter[s]” – visits to the ER, urgent care, clinic or doctor’s office – were higher among patients who lived farther away, fifty or more miles from the study site. (Gynuity says that 18% of patients living fifty miles or more away reported an “unscheduled visit” versus 6% of those living closer, but does not provide the numbers showing the numbers of visits used to calculate these percentages.)

Aware that their higher rates of “unscheduled visits” to hospitals, the ER and urgent care might undercut their argument of the webcam/mail abortions being as safe as those at a clinic **, Gynuity argues that many of these visits turned out to be unnecessary because they did not end up receiving any medical treatment. Raymond, Winikoff, and colleagues argue that “incidence could possibly be reduced by stronger encouragement to contact the TelAbortion provider for advice before seeking unplanned in-person care.”

Ignoring display of the self-serving impulse to produce better statistics for their study, this statement betrays a number of troubling and revealing tendencies on the part of the researchers.

Having denied the need for direct patient management, Gynuity nevertheless seems to be arguing they would have gotten better results with more patient contact!

Furthermore, after saying that the method is simple and safe enough to be managed by the patient herself, they are here saying that either their instructions are not clear enough or the patients not capable enough to accurately assess the severity of their condition.

Alternatively, they are admitting that the chemical abortion process is much more harrowing than has been advertised (by folks like them) prompting bleeding, cramping women to rush to the ER for professional medical assurance something has not gone badly wrong.

These concerns are not trivial and hardly safe to ignore. Though not something that Gynuity and other abortion pill promoters seem anxious to advertise, two dozen chemical abortion patients have died in the U.S., and thousands of others have ended up, like women in this study, hemorrhaging, or hospitalized with severe infections, suffering from ruptured ectopic pregnancies, or other “serious adverse events.”

Given that hard reality, it is only prudent for women with persistent or heavy bleeding, severe pain and gastrointestinal distress, or other troubling symptoms to have a doctor physically examine them and give a professional evaluation of their condition. And one might argue irresponsible, if not dangerous, to suggest otherwise.

Better to be safe than sorry. Unless something other than safety is your priority.

Too much left unknown

Considered separately from the spin, the numbers do not present a good picture for the hands-off webcam/mail method. While touting a 94% success rate, this simply set aside 58 patients where the researchers did not know the outcome. Whether these women aborted, went on to have surgical abortions, whether they had serious complications, whether they changed their minds – all outcomes encountered by other women in the study – Gynuity simply doesn’t know.

Not only does Gynuity not know what happened with these 58 patients, they also do not know what happened with the drugs sent to most of them, whether the women took them, flushed them, or re-sold them on the black market. It was because of potential safety issues that the U.S. Food & Drug Administration (FDA) restricted distribution of mifepristone and refused to let it be sold by pharmacies. Gynuity is one of the groups fighting that restriction, but, ironically, their data reinforces the need for it.

As noted, Gynuity and the TelAbortion team try to minimize the danger of the drugs, saying that they only identified two cases of “serious adverse events.” But their data actually showed that 29 of their patients visited a hospital, emergency room, urgent care, or visited a clinic or doctor’s office for some form of treatment or to address some concern.

Whether this represents 15.3% or 13.4% of patients is difficult to tell (because of conflicting numbers the study gives of the patient base), either percentage is considerably higher than those advertised for the standard in-person clinic managed chemical abortion.

Gynuity knows this and tries to say many of these visits were not warranted, but that shows a troubling lack of concern for or consideration of their patients’ medical distress and uncertainty, factors which seem to frequently accompany this method and circumstances.

The truth is, women do hemorrhage and bleed, and they need qualified and informed medical help when they do. Gynuity’s own data confirm this. The women are also at risk of infection or ruptured ectopic pregnancy, we know from years of other data. Gynuity tries to argue that this method is particularly needed by and useful for those who live far from an abortion clinic, but that may also mean that they are far from any help they might need in a medical emergency, help for which many women in their study went searching.

Another small but important tidbit the study revealed but Gynuity underplayed is that women seeking these chemical abortions do indeed change their minds. The number was small, but Gynuity tells us that three of the women who had the webcam consultation ultimately “decided against the abortion.”

Of the 248 sent the packages of pills, only 193 were known to have taken both drugs–the mifepristone and misoprostol. We are told that 14 patients took one of the drugs but not the other and that six patients took neither the mifepristone nor the misoprostol.

Because mifepristone without misoprostol is a less effective abortifacient, there is the possibility of a continuing pregnancy if only the first drug is taken. That is the premise of the Abortion Pill Reversal technique—the second drug is not taken and a woman’s body is flooded with progesterone to counteract the mifepristone.

For some of these women, the method clearly failed, either because the drugs were not effective or they chose not to take the full regimen. Eleven of the 190 women known to abort ultimately had a surgical procedure. But we are also told that at least two of those who received the drug package did not take the mifepristone and “decided to continue their pregnancies.”

How many of the 58 others for whom their abortion outcome was not recorded skipped the full regimen and decided to have their babies is unknown. It is clear from the data, however, that there are women who may go through the full screening process, consider their options, obtain the abortion pills, and still change their minds.

Gynuity, Guttmacher , and the TelAbortion team clearly want people to believe that their study has shown the webcam/mail abortion process they have set up to be a safe, feasible option. But their own data show a process with a lot of problems and unresolved issues – too many missing patients, too many missing pills, too many safety concerns.

*It appears from the website that these abortions are now also being offered in Colorado, Georgia, and New Mexico.

**Without giving their actual numbers, Gynuity says that 8% of their patients made such visits, twice the percentage reported in a 2015 study of over 11,000 chemical abortion patients in California.