By Randall K. O’Bannon, Ph.D., NRL Director of Education & Research
Editor’s note. This appeared on in the current 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 Please pass this and other stories along using your social networks.
One
of Planned Parenthood 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.
Study Results
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.
Measuring “Efficacy”
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.
Counting Complications
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.
Missing Patients
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 service.
Hasty Conclusions
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.
Source: NRLC News
The 
Over
the years—indeed over the decades—pro-abortionists have offered up
painfully arcane explanations to convince the public that the unborn
does not deserve legal protection at [fill in the blank]. Many/most
insist that abortion ought to be legal up until birth—and, for some,
beyond, depending on the parent[s] whim and/or the child’s
“imperfections.”
One
of the sweetest, kindest men I have ever known passed away today. I
can’t imagine that it was his time but God knows these things, not me.
Brother Paul was only 55 years old. He was the Superior at the
Franciscan Brothers of Peace, a stalwart advocate for life throughout
its spectrum, and he was my friend – for well over 25 years. He was also
one of my heroes.
This
week, my colleagues and volunteers and I are at the University of
Central Florida, debating university students on abortion and making the
case, through conversational apologetics and abortion victim
photography, that abortion is a human rights violation. As the
inevitable pro-abortion protestors began to show up with their hand-made
signs, I noticed that one argument was surfacing more often than most:
“Reproductive rights are human rights.”
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