By Randall K. O’Bannon, Ph.D., NRL Director of Education & Research
Editor’s note. This article appeared on in the digital edition of National Right to Life News, “the pro-life newspaper of record.” You can read this story and the issue in its entirety at www.nrlc.org/uploads/NRLNews/NRLNewsFeb2015.pdf
One of Planned Parenthood’s large affiliates has just published a study that they assert shows that the abortion drugs mifepristone (RU-486) and misoprostol can be used safely and effectively following a different protocol than the one laid out by the U.S. Food and Drug Administration (FDA).
No real surprise there – Planned Parenthood has a lot of money and its reputation riding on the outcome. But facts are stubborn things. The data show that risks still remain, that follow up is lax, and that they really don’t know what happened to a lot of their patients, despite putting a lot of women through a whole lot of misery.
A different protocol
The study, “Efficacy and safety of medical abortion using mifepristone and buccal misoprostol through 63 days” was published online January 14, 2105, and is slated to appear in an upcoming issue of the journal Contraception.
Two of the three authors are from Planned Parenthood’s Los Angeles affiliate. The patients from the study were drawn from “Our large network of urban healthcare centers in the Los Angeles, California area, [which] includes 19 health centers providing approximately 15,000 abortions a year, of which about 30% are medical abortions.”
The study followed 13,373 women who came in for abortions between April 1, 2008, and May 31, 2011. The chemical abortion regimen consisted of 200 milligrams of mifepristone (RU-486) followed by an at-home dose of 800 micrograms of misoprostol taken bucally (under the cheek or gum) 24-28 hours after the mifepristone.
Two immediate contrasts. The FDA protocol involved 600 milligrams of mifepristone followed by 400 micrograms of misoprostol taken orally at a return visit to the clinic two days after the first.
And while the FDA protocol also limited use to the first 49 days after a woman’s last menstrual period (LMP), Planned Parenthood aborted women who were as many as 63 days LMP.
The authors concluded that their study reinforced the safety and efficacy of their regimen.
Why do they want to change the regimen?
Before getting into the data, let us look for a moment at why Planned Parenthood and the abortion industry have such a problem with the FDA protocol.
The official focus is allegedly on increased safety and efficacy (for the woman). However the changes just happen to have the fortuitous side effect of making things easier and much more profitable for the abortion industry. Here’s how.
Mifepristone sells for about a $90 a pill, while generic misoprostol can be purchased for less than a dollar a pill. By reducing the dose of mifepristone from the FDA’s recommended three pills to one, and doubling the dose of the cheaper misoprostol, as Planned Parenthood has done in this “study,” there’s more money to be made.
Allowing women to take the second drug (misoprostol) at home rather than return to the clinic saves the clinic the space and time of additional appointments so that they can set that aside for other customers.
Likewise, extending the cutoff date by two weeks from 49 days to 63 days LMP means a bigger pool of customers.
Whether women’s chemical abortions supposedly get safer or not, take note that industry leaders like Planned Parenthood stand to gain more customers and make more money with these changes.
As mentioned earlier, Planned Parenthood looked at the outcomes for 13,373 chemical abortion patients over a five year period. Of this number, the authors claim that 13,066, or 97.7%, were “successful.”
Seventy patients had an “aspiration for ongoing pregnancy” and 237 had “aspiration for symptoms.” There were just two cases of infections among the group and four cases requiring transfusions.
This was supposed to offer an improvement over results from the study the FDA used to justify its protocol when it approved mifepristone in September of 2000. Using the results of an April 30, 1998, study from the New England Journal of Medicine, that protocol showed diminishing “success” rates with time: 92% at 49 days LMP, 83% at 56 days LMP, and 77% at 63 days LMP. This decreased “efficacy” prompted the FDA to limit use of the drug to 49 days.
The authors here argue that by comparison, this demonstrates that their method is more effective and can be used later than the FDA limit.
“This study reinforces the safety and efficacy of the regimen for medical abortion … through 63 days estimated gestational age, and contributes to the existing evidence against restrictions requiring use of the FDA-approved regimen in the United States,” the report’s authors wrote.
Let’s see if that’s true.
The authors say that “The primary outcome of interest was successful abortion,” and the abortion was deemed “successful” if there was “expulsion of the pregnancy without the need for aspiration.”
A few things worth noting here. Abortion, not patient comfort or safety, was the criteria for success. If a woman aborted, but suffered a major injury, as long as she did not have an “aspiration,” it would, by this standard, be successful.
Also, “success” rates may have been, in some cases, boosted by extra doses of misoprostol.
While the study used by the FDA tallied “success” or failure after a single course of the drugs and an assessment at the end of two weeks, the Planned Parenthood study “allowed for repeat doses of misoprostol for patients who had an incomplete abortion.” This means what would have been counted as a “failure” in the original study could have been listed as a “success” in the latest from Planned Parenthood. This would inflate the study’s “success” rate.
The precise number receiving this extra dose is unclear, though 87 in a subgroup of about half (7,335) did receive a repeat of misoprostol. Without this modification, efficacy rates would have been lower.
A different process?
Some may argue that modification of the protocol doesn’t matter as long as efficacy was increased. However when misoprostol becomes the primary drug, this moves towards becoming a different procedure entirely.
And this does matter. Misoprostol, developed and FDA approved as an anti-ulcer drug, has been found to function as a stand-alone abortifacient. But it has never been tested by the manufacturer or approved by the FDA for that purpose. That means that there is no standard protocol or any official guidelines about contraindications, over dosages, or side effects.
Lacking government approval, the drug is sold on the black market in the U.S. and elsewhere, but those who use it may have limited information on its risks for mother and child. Off-label use in Brazil, for example, has been associated with the birth of children with hydrocephaly, partial facial paralysis, clubfeet, or fused or missing fingers and toes. A February 2007 report from Obstetrics & Gynecology tells of a death associated with what appeared to be a misoprostol overdose during an attempted abortion in Portugal.
Even with the repeated doses of misoprostol, there was still a drop-off in efficacy the farther along the pregnancy. It was not as dramatic as in the study from the U.S. trials of the drug, but it was clear nonetheless. Measured in terms of requiring “aspiration for ongoing pregnancy” or “aspiration for symptoms,” rates for women 57-63 days LMP (4.12%) were more than twice what they were for women 43-49 days (1.7%), the FDA’s original limit.
The criteria the study uses to measure significant complications is whether or not the woman was hospitalized, reporting those only in situations where there was an infection or a transfusion was required. By this measure, there were two patients with infections and four who needed transfusions.
Four otherwise healthy women having to go to the hospital for transfusions simply after taking a drug is a big deal in itself. But it isn’t clear that these were the only ones dealing with excessive bleeding.
Remember that 237 women taking the drugs ended up having “aspiration for symptoms.” The examples of symptoms given are “pain or bleeding.” That would make bleeding a bigger issue.
Lower rates of infection may be due to an addition of a prophylactic antibiotic to the protocol, but this may come at a price. The FDA says on its “Postmarket Drug Safety Information for Patients and Providers” webpage that the “FDA does not have sufficient information to recommend the use of prophylactic antibiotics for women having a medical abortion… Prophylactic antibiotic use carries its own risk of serious adverse events such as severe or fatal allergic reactions. Also, prophylactic use of antibiotics can stimulate the growth of ‘superbugs,’ bacteria resistant to everyday antibiotics.”
The published data does not reveal whether this means there were no further instances of infection, excessive bleeding, no ectopic pregnancies, no episodes of diarrhea, vomiting (that were themselves serious enough in other trials to warrant some hospitalizations), or other significant adverse events.
This of course, tells us nothing about the outcome for the 2,517 chemical abortion patients of whom Planned Parenthood lost track.
The original number of chemical abortion patients was not 13,373, but 15,890. This means that there were 2,517 patients (15.8%) missing from the data set, who were excluded from the analysis.
Most of these were patients who never returned for their follow up visits (2,470), but there were also 20 excluded for missing data on gestational age. Twenty-seven were left off because they changed their minds and did not complete the chemical abortion process
Some of those 27 who changed their minds may have opted for a surgical abortion or were past the gestational limit. But others simply “began the regimen but did not take all of the medications.” The authors do not seem to want to admit that some women may have changed their minds about aborting entirely, hoping their babies would survive.
The researchers from Planned Parenthood look at these study results and conclude that “This study adds to the growing literature supporting provision of medical abortions using evidence-based regimens, and supports the conclusion that legislative efforts to restrict medical abortion to the FDA regimen are based on political goals to restrict abortions services, not efficacy or patient safety.”
While on paper, they are reporting higher efficacy and safety rates, high numbers of missing patients from this study (and from similar ones) make one wonder if these are legitimate conclusions. Women with serious problems may have simply skipped the clinic and gone on to the emergency room, where they may or may not have told the attending physician they had taken the abortion drugs. Other women may have changed their minds once the abortion did not occur, deciding to give birth.
In any case, even in this self-serving study, the risk of failure and safety issues still remain, as does the physical and psychological ordeal of every chemical abortion. A baby still dies, a mother still goes through great pain and agony, and an abortion clinic figures out how to make more money out of the whole deal.