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NRL News
Page 22
September 2009
Volume 36
Issue 9

PPFA Claims New RU486 Protocol Helps Avoid Deadly Infections
By Randall K. O'Bannon, Ph.D.

A study 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.

We learn 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.

Another 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.

Though Planned Parenthood is now being celebrated for cutting the infection rate, serious questions remain.

Why 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?

Consider 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.           

The FDA 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.

However, 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.

And, 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.

As 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.

When two 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 infection.)

Which 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 way.

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.

They said 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.”

Moreover, 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.”

Women could end up much worse off, although it would no longer appear to be Planned Parenthood’s problem.

There are 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.

It isn’t 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.

One 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.”

Something 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.

These 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.

So now women should trust them?

Dr. O’Bannon is director of NRLC’s Education Department.