“There’s no quick fix for pregnancy, no magic pill,” Holly Patterson’s sobbing father told reporters on September 19, two days after she died from a massive bacterial infection apparently brought on by a failed RU-486 abortion.
Two weeks earlier, Holly, who had just turned 18, “seemed happy and healthy.” But that was before she entered the Planned Parenthood clinic in Hayward, California, about seven weeks along into her pregnancy.
It’s unclear whether Holly was given a dose of Mifeprex (the knock-off brand of RU-486 made in China and distributed in the U.S.) or simply a prescription for the drug during her September 10 visit to Planned Parenthood. We do know that when taken alone, RU-486 causes a complete abortion only about 60 percent of the time, leaving a patient vulnerable to serious infection and hemorrhaging. For this reason, a second drug (Cytotec in the U.S.) must be taken about 48 hours after RU-486 to cause uterine contractions, which help expel the embryo. Holly took one of these drugs–most likely Cytotec–at home on Saturday, September 13.
Under the protocol approved by the Food and Drug Administration (FDA) Cytotec is supposed to be given orally and under medical supervision. But some Planned Parenthood clinics and abortionists, who apparently can’t be bothered with multiple visits and monitoring women onsite, tell patients like Holly to administer the drug vaginally, at home, with no medical supervision.
This laissez-faire approach markedly differs from protocols mandated in other countries where RU-486 is legal, such as France, China, Sweden, and the U.K. These countries require patients to be monitored by medical staff for four hours or longer after taking Cytotec (or a similar drug) to ensure that no cardiac complications or severe allergic reactions occur, and to determine if the embryo has been expelled.
By Sunday, Holly was “bleeding severely, in acute pain and unable to walk.” Unfortunately, these symptoms may not alert emergency-room staff to potentially life-threatening complications because heavy bleeding and painful cramping are exactly what’s expected in an RU-486 abortion. So it’s not surprising that when Holly’s boyfriend took her late Sunday to Valley Care Medical Center (VCMC), she was sent home with painkillers.
In the early hours of Wednesday, September 17, Holly returned to VCMC. That afternoon she died from septic shock, the result of a massive systemic infection. The attending physician told her father that the infection developed because she “hadn’t aborted all of the fetus, and she had fragments left in her.”
Predictably, Planned Parenthood concedes nothing beyond the established fact that a patient “who recently sought health-care services” at a Planned Parenthood “health-care center” died “at a hospital in Pleasanton.” A mere coincidence, really, and anyway she died at a hospital, not one of their “health-care centers.”
And Danco Laboratories, the U.S. distributor of mifepristone (RU-486) under the brand name Mifeprex, can be expected to deny any link between the drugs and Holly’s death. Following a similar death in September 2001, Danco insisted that RU-486 did not cause the septic shock which killed a woman taking part in Canadian drug trials. And that’s technically true, of course. The infections are caused by dead human embryos or parts thereof which are not fully expelled. So the fault lies with the embryos, not the drug that successfully killed them but proved less than successful in evacuating them.
Although Danco has sent the FDA about 400 reports of “adverse events” related to RU-486–ranging from excessive bleeding to bacterial infections and death–Danco maintains the drugs are “safe.” It seems that safety is a subjective and flexible concept. “Mifepristone Questions and Answers,” an FDA fact sheet, cautions: “Patients should also understand that safe does not mean risk free.”
Does the average patient, the average teen understand she may be risking her life taking RU-486 when she’s repeatedly exposed to statements like these: “It’s what women have wanted for years: a safe and effective way to end pregnancy–taken orally, without surgery–early on” and “It’s the first [FDA] approved pill providing women with a safe and effective non-surgical option for ending early pregnancy” (www.earlyoptionpill.com).
The FDA’s mifepristone fact sheet explains that the agency “will approve a drug if it determines that the benefits exceed the risks for the approved use.” But exactly what benefit exceeded the risks to Holly, or to a 15-year-old girl whose “adverse event” report describes a “life-threatening hospitalization” and the following symptoms: abdominal pain, adult respiratory distress syndrome, lung infiltration, pelvic pain, purulence, and septic thrombophlebitis? Where was the benefit to a dozen other girls and women described in RU-486 adverse-event reports who experienced “failed” or incomplete abortions which “required intervention to prevent permanent impairment/damage”?
These are not isolated events. A major World Health Organization (WHO) study documented the infection risk associated with RU-486 abortions: 30 percent of women who had incomplete RU-486 abortions developed pelvic/genital-tract infections. The reason for this high infection rate: One side effect of the RU-486 drug combination is immune-system suppression. For this reason, the WHO study calls for women to receive antibiotics for six weeks following an RU-486 abortion.
In April 2002, Danco sent an FDA-approved “dear doctor” letter warning of safety issues associated with prescribing RU-486, i.e., undetected ectopic pregnancies and bacterial infections which had resulted in patient deaths, and informing them of a 21-year-old woman who died of a heart attack three days after taking RU-486. But you won’t find that in the promotional materials.
The current FDA protocol requires that patients return two weeks after taking RU-486 so the physician can verify a complete termination and the absence of complications. But Holly Patterson and the Canadian patient who died from septic shock didn’t live long enough for the follow-up appointment.
The WHO study, the dozen adverse-event reports of failed/incomplete abortions, and two fatalities from septic shock should make it clear that the RU-486/Cytotec drug regimen is not safe in the hands of teenagers. Nor is it safe in the hands of abortion-facility staff who leave it up to frightened girls to determine if a life-threatening complication is developing.
And because the mode of action and side effects of RU-486/Cytotec mask the very symptoms that would alert medical personnel to life-threatening complications like ectopic pregnancy, incomplete abortion, and uncontrolled bleeding (which nearly cost an Iowa woman her life during U.S. drug trials), RU-486 abortions are unsafe even if the current FDA protocols were followed.
These risks inherent in RU-486 abortions simply do not outweigh the sole purported benefit of avoiding a surgical abortion. Last year those risks were detailed and documented in a “citizen petition” to the FDA filed by the American Association of Pro-Life Obstetricians and Gynecologists, the Christian Medical Association, and Concerned Women for America. Had the FDA acted on the petition, Holly might still be alive.
Although she was living at home, Holly’s father did not learn of her pregnancy and abortion until a few hours before she died. He wants to tell teenage girls who become pregnant that “no matter what, no matter how bad things are, talk with family and friends. We will support you. Family has the strength to pull you through anything….”
Anything, perhaps, other than a “safe and effective” RU-486 abortion.
–Susan E. Wills is associate director for education at the pro-life office of the United States Conference of Catholic Bishops.