Claims New RU486 Protocol Helps Avoid Deadly Infections
By Randall K. O'Bannon, Ph.D.
by Planned Parenthood appearing in the July 9, 2009, issue of the
New England Journal of Medicine (NEJM) essentially claims to have
solved the problem of sometimes deadly infections associated with
the use of the two-drug RU486 abortion technique. Reading between
the lines the study offers some disturbing results, especially given
Planned Parenthood’s reported history of not following the Food and
Drug Administration’s (FDA) recommended protocol.
from the NEJM study that the rate of infections dropped
substantially once Planned Parenthood switched from the vaginal to
the buccal (placed between cheek and gum) administration of
misoprostol, the second drug in the combo, in March 2006. Before the
switch, 69 patients out of 77,182 faced serious infections. After,
there were just 25 among 166,510.
change, not publicly acknowledged when Planned Parenthood announced
a shift in how it administered the prostaglandin used to expel the
dead baby, was to begin prescribing a full course of antibiotics
prophylactically (given as a preventive measure, even if no sign of
infection is present) when the abortion drugs were given. Only a
portion of PPFA clinics did this at first, but a decision was made
in July 2007 to make this a policy organization wide. With the
prophylactic antibiotics, there were only five serious infections
among 116,082 chemical abortion patients.
Planned Parenthood is now being celebrated for cutting the infection
rate, serious questions remain.
didn’t Planned Parenthood heed the advice of the FDA when the FDA
advised doctors early on to follow the protocol, having been warned
that the safety of the vaginal administration of the misoprostol had
not been proven?
just some of the history of an organization that had been involved
in national testing of the abortion pill, which had heavily promoted
its use when FDA approval came in 2000, and which had assured
everyone that the new method was safe.
said that the drug was to be used on pregnant women no more than 49
days after their last menstrual period. Women were to take three
RU486 pills (mifepristone) there at the clinic and then return to
the clinic two days later to swallow two tablets of misoprostol.
(Misoprostol is a prostaglandin that stimulates powerful uterine
contractions to expel the dead baby.) A third visit at two weeks was
to confirm the completion of the abortion.
Planned Parenthood, following the lead of the National Abortion
Federation, reportedly ignored the FDA instructions and reduced the
dosage of the RU486 pills from three to one, doubled the dose of the
prostaglandin, and gave those pills to women to take at home, rather
than at the clinic.
rather than advising women to take the prostaglandin orally, women
were reportedly told to insert the pills vaginally. This was
supposed to reduce the severity of side effects (nausea, diarrhea,
etc.) associated with the drugs. They also reportedly extended the
limit on RU486’s use by two weeks, from 49 days to 63 days.
reported here and elsewhere, between September 2001 and November
2005, five North American chemical abortion patients died of rare
infections, four in the U.S., one in Canada. At least two of them
were known to have involved patients who received their abortion
pills at Planned Parenthood clinics.
more deaths were announced in March 2006, both at Planned
Parenthood, the organization announced that it was changing its
procedures. It would no longer ask patients to administer the
prostaglandin vaginally (New York Times, 3/18/06). (One of these
deaths was later determined not to be related to abortion or
brings us back to the 2009 NEJM study. If its findings are
legitimate, women may have lost their lives, and others dealt with
serious infections, because Planned Parenthood chose to go its own
Furthermore, in prescribing the prophylactic antibiotics, is Planned
Parenthood at risk of solving one problem and creating another?
Vicki Saporta, president of the National Abortion Federation, and
Beverly Winikoff, a Columbia University professor who worked for the
Population Council for 25 years, were interviewed by Newsday.
a full course of antibiotics would prevent all but a relatively few
infections, but “could trigger rare allergic reactions, add to the
problem of antibiotic resistance, and raise the cost of the
procedure, making it unaffordable in developing countries.”
in “Mifeprex Questions and Answers,” issued by the FDA in August
2007, the agency hesitates to endorse the idea of prophylactic
antibiotics to prevent infections among those taking the abortion
drug. While suggesting that any patient suspected of having an
infection should be given antibiotics immediately, it warns that
“preventive use of antibiotics can stimulate the growth of
‘superbugs,’ bacteria resistant to everyday antibiotics.”
could end up much worse off, although it would no longer appear to
be Planned Parenthood’s problem.
also questions about the rosy conclusions of the study. How well was
Planned Parenthood able to keep track of patients who took RU486 and
received the prostaglandin at their clinics? The authors of the
study admitted, “We do not have data available on the rates of
follow up of women after medical abortion, and it is possible that
the reporting of serious infections is incomplete.”
Infections happen after the abortions, and if women do not call or
return to the clinic, there may be no record of it. They also note
that there was a lot of close attention and scrutiny among health
professionals when the deaths were in the news, but admit that may
have later waned.
even clear how well Planned Parenthood tracked the most serious
infections. The pathogen that killed several abortion patients was
Clostridium sordellii, a common bacterium that can prove deadly when
it gets into the bloodstream.
unusual feature about C. sordellii infections, however, is that they
often come without fevers. Study authors said that they identified
serious infection cases as those “in which the patient had fever
accompanied by pelvic pain and was treated with intravenous
antibiotics either in an emergency department or inpatient unit, or
cases in which sepsis or death caused by infection was documented.”
else we find out is that “the rate of serious infection [before
PPFA’s protocol change] was substantially higher than the rates
previously published.” In other words, infection was a much bigger
issue than the abortion lobby let on.
people appeared to have ignored the government protocol, did things
their own way, didn’t admit or recognize how serious the problems
were with infections, saw women die, adopted a controversial new
protocol, and then did a study in which a significant number of
women and amount of data may be missing.
women should trust them?
Dr. O’Bannon is director of NRLC’s Education Department.