Ethics Articles
Articles: Birth Control (Contraception)
>> = Important Articles; ** = Major Articles
FDA Approval For RU-486 Ought To Be Aborted (Free Congress Foundation, 020902)
“No Magic Pill”: Holly Patterson, R.I.P (NRO, 030926)
Dangerous Medicine (Free Congress Foundation, 030925)
Good Money for Bad Advice: Same old “safe sax.” (NRO, 040116)
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Concerned Women for America, the nation’s largest women’s group, the American Association of Pro-Life Obstetricians and Gynecologists, and the Christian Medical Association have done the Bush Administration and the nation a great favor. They have filed a petition with the Food and Drug Administration requesting that the FDA immediately revoke its approval of RU486, the abortion pill. The petition, some 186 pages of carefully crafted legal arguments, demonstrates that the Clinton Administration pressured the FDA to approve RU486 without the safeguards, which even the FDA itself wanted to promulgate. The CWA et al. petition identifies at least one woman, perhaps two known to be dead as the result of the lack of safeguards associated with RU486. Others have been physically harmed.
The Clinton Administration was known for having broken promises to almost every group that supported it in 1992. The one exception was the pro-abortionists. Bill Clinton never disappointed them and they insisted that RU486 be approved and approved with no restrictions.
President George W. Bush was asked about RU486 during the campaign. He said he would take a look at it, and if the drug was a danger to women he would see about possibly rescinding the FDA action.
The petition says that the FDA failed to carry out its mission of ensuring that only drugs shown to be safe and effective are approved for marketing. The petition is the culmination of a 22-month investigation. Among other things, some 8,000 documents released by the FDA were reviewed. The petition, according to CWA, “details numerous violations of the agency’s standards and rules.” The petition also reports on medical complications suffered by women who took the completely unregulated RU486.
“Concerned Women for America is dedicated to seeing that the previously high standards of the FDA are restored and that the American public is once again safe from politically driven bureaucrats whose irresponsible actions have unnecessarily cost the lives and health of trusting and otherwise healthy women. This is a shameful episode for a once trusted institution.”
Dr. David Hager, a spokesman for the Christian Medical Association, said, “As an obstetrician/gynecologist, I have a passion for the health and well being of women and their unborn/newborn offspring. The use of any medication that puts the life and health of either of these individuals at risk implores me to call for a thorough and exhaustive evaluation, in an evidence-based manner, on such drugs. RU486 is such an agent, posing risks to women and their unborn babies, pressing me to call upon the FDA to reconsider its ‘fast track’ approval of Mifeprex [RU486].”
Dr. Donna Harrison, of the American Association of Pro Life Obstetricians and Gynecologists calls RU486 dangerous. “The recent deaths in Canada and the United States during RU486 abortions support our findings. To safeguard the health of American women, this drug must be removed from the market.”
Paul M. Weyrich is President of the Free Congress Foundation
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“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.”
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.
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Holly Marie Patterson of Livermore, California died at the age of 18. Her premature death came as a result of her visit to a Planned Parenthood clinic where she was given the drug RU-486 to abort her child. She died due to an infection resulting from her use of RU-486.
Sadly, only moments before his daughter’s death, her father learned that she had chosen to “terminate her pregnancy.”
There will be plenty of scrutiny paid to RU-486 after a tragic incident like this, particularly given the rushed approval that it received from the Clinton era Federal Drug Administration, in large part due to pressure applied by the pro-abortion lobby. Concerned Women for America has been at the forefront of raising public awareness about the quicker-than-normal approval of the RU-486 pill and the questions that exist about its safety.
An even more unfortunate lesson in the wake of the loss of this young woman is the fact that her father and other family members had been shut out of Holly’s troubles. The father’s grief and anguish are all too clear in the statements he has made to the news media.
The news media and the entertainment industry like to pretend that because teenagers - and in Holly’s case - those on the verge of being young adults, know about the facts of life and all of their consequences. Among American teens, peers are often considered wiser than parents, impulsive behavior rules, and the values associated with maturity take a back seat to being “cool.”
The authority of parents is steadily undermined in movies and advertising, through popular music, fashion magazines and on television. All too often, this message serves to drive a wedge between parents and children, particularly in the case of families where there is only one parent or in families that have been ripped apart by divorce.
A cornerstone of the pro-family movement has been the belief that parents are the principle educators of their children and responsible both for and to their youngsters’ lives.
Holly’s untimely death should serve as a reminder that your children are an irreplaceable blessing. Our children are a sacred gift from God. Parents must pray for wisdom and trust in God in order to provide their children with proper guidance.
Paul M. Weyrich is Chairman and CEO of the Free Congress Foundation.
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The dangers of early sexual activity are well documented. It leads to higher levels of child and maternal poverty, elevates the risk of sexually transmitted diseases, and often leaves teenage girls depressed, even suicidal. It contributes to marriage failure in adulthood.
So why is the government spending 12 times more promoting so-called “safe sex” than it does encouraging people to wait?
That’s the finding of a new, in-depth survey of government spending by the Heritage Foundation. In 2002 (the most recent year for which complete information is available), the federal and state governments spent at least $1.73 billion on programs that, in various ways, encourage “safe sex.”
At the same time, we invested only $144.1 million in programs that encourage people, primarily teens, to abstain.
Of course, some of the “safe sex” spending was used to provide contraception and AIDS-prevention information to people in their 20s and 30s, and all of the abstinence funding was spent on teens, the group that most needs to hear the abstinence message. Still, governments spent $4.50 on “safe sex” programs aimed at teens for every $1 invested in abstinence.
These spending priorities are the exact opposite of what parents want. In a recent Zogby poll, 85 percent of parents said the government’s emphasis on abstinence for teens should be equal or greater than the emphasis placed on contraception. Only eight percent said teaching teens to use condoms is more important than teaching them abstinence.
Abstinence-education programs work. Many evaluations show they can substantially reduce teen sexual activity. That’s all to the good, as many social science studies link beginning sexual activity at an older age to higher levels of personal happiness in adulthood.
Unfortunately, that won’t stop many lawmakers from ignoring the evidence and pushing for even more “safe sex” funding when Congress considers reauthorization of the 1996 welfare reform bill later this year.
Rep. Henry Waxman (D., Calif.), has already tried to abolish some $50 million in abstinence-education funding and replace it with sex-education money states could use for either safe sex or abstinence programs. Waxman’s bid failed, but others are in the works.
Rep. Barbara Lee (D., Calif.), wants $100 million per year for “comprehensive sexuality education.” Sens. Evan Bayh (D., Ind.), and Tom Carper (D., Del.), are pushing for $50 million more to fund states’ contraceptive programs. Sen. Max Baucus (D., Mont.), is also pressing for $50 million in new “safe sex” funding.
Let’s not forget that all of this would come atop the $1.73 billion we’re already spending on this type of sex education.
Worse, all of these programs, and many others, play off the popularity of abstinence education by claiming to be “abstinence plus.” But in reality, they focus on the “plus” and almost entirely ignore abstinence. While more than 90 percent of parents want teens to wait until they are at least out of high school before having sex, safe sex or “abstinence plus” programs don’t give that message. Many contain sexually explicit material that shocks many parents.
For example, in the government-sponsored program “Focus on Kids,” middle- and high school students are told about the joys of bathing together, watching sexually explicit movies together and reading erotic books and magazines. The “Be Proud! Be Responsible!” program promoted by the Centers for Disease Control asks teens to “think up a fantasy using condoms” then “use condoms as a method of foreplay.” Kids as young as 13 are taught to “act sexy/sensual” while putting on condoms.
“Becoming A Responsible Teen,” also pushed by the CDC, ironically gives students instructions that are likely to make them behave irresponsibly. The program has teens practice putting a condom on a plastic phallus and encourages them to scrounge around the house for a sexual lubricant. “B.A.R.T.” helpfully suggests grape jelly, maple syrup, and honey.
Clearly, any abstinence message children might happen to hear in these programs is overwhelmed by their real message: “We expect you to have sex, but please use a condom when you do.”
We’re putting our money in the wrong place. Instead of investing heavily in contraception and sexual-education programs that send the wrong message to teens, we ought to spend more encouraging those teens to wait until they’re older to have sex. After all, when they do, the news is better for them — and for us.
— Melissa Pardue is Weinberg Fellow in social-welfare policy and Robert Rector is a senior research fellow in domestic policy at the Heritage Foundation.
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