Update: The manufacturer of the abortion pill, RU 486, acknowledged to the Italian government in July 2009 that it was aware of 29 deaths associated with the use of its product. In 2006, Senator Jim DeMint said eight U.S. women had died after using RU 486. There were nine life-threatening situations, 120 blood transfusions and over 200 hospitalizations.
RU 486, which is also known as mifepristone, is a synthetic steroid drug made from norethindrone, the active ingredient of Norplant. Its only purpose is to induce abortions, and it has been authorized for this purpose by the Food and Drug Administration (FDA) up to 49 days gestation. It is generally considered to be ineffective unless used in combination with a powerful prostaglandin, misoprostol, which causes contractions to occur and the preborn child to be expelled from the womb. Misoprostol is marketed under the trade name Cytotec, and is also used to treat ulcers. Women who use this method of abortion must make three trips to the abortion facility to complete the abortion process.
It is inaccurate to describe RU 486 as a contraceptive. It does not prevent pregnancy. Rather, its only proven use is to terminate a pregnancy.
It is also wildly inaccurate to describe RU 486 as a “morning after pill.” Morning after pills are not consumed 49 days after the last menstrual period (LMP).
RU 486 causes a preborn child to starve to death by inhibiting the action of the female hormone, progesterone, and causing the lining of the womb to slough off.
A “Drug Cocktail,” Say Three Feminists
Three pro-abortion feminists, Professor Janice G. Raymond, Renate Klein and Lynette J. Dumble, conducted a review of the literature concerning RU 486 and indicated that a substantial number of women required analgesics to deaden pain and some were pre-medicated with antibiotics to prevent infection. They wrote that, “In light of the claims made that RU 486 is a simple, pill-popping method of abortion, we highlight the complexity, in cumulative fashion of what has now become a drug cocktail: RU 486 + prostaglandin + analgesics+ pre-medication + antibiotics.” [RU 486: Misconceptions, Myths and Morals, published September, 1991, p. 47]
These feminists have recommended the removal of RU 486 from the market because of their concerns for the health and safety of women. They asserted that “It becomes clear that complications, such as bleeding and pain, are often evaluated differently by researchers than by women themselves.” [p. 41] They pointed out that all of the studies found that women experienced pain, but they downplayed the significance of it by categorizing it as “mild to moderate.” “The inarticulated message about pain in many of these studies is that female pain is expected....pain that would be unnatural/intolerable for men is natural/tolerable for women.” [p. 43]
The authors added that “As we evaluated the literature on complications, it became clear to us that the medical (community’s) acceptance, without comment or criticism, of what have not become ‘minimal,’ ‘tolerable,’ and ‘acceptable’ side effects for women -- deserves to be highlighted for what it is -- unethical medical practice.” [p. 47]
RU 486 Risks and Complications
The immediate risks for women using RU 486 include: prolonged heavy bleeding, nausea, extreme cramping, headache, diarrhea, skin rash, allergic reaction and vomiting.
Bleeding lasts usually about ten days, but can continue for as long as 44 days. One woman, who participated in the Iowa trials, told a TIME magazine reporter in December of 1994 that, “It was like a faucet turned on. There was a steady stream of blood.” The president of Planned Parenthood of Greater Iowa offered that, “Women will be dealing with blood that in a surgical abortion, only medical professionals would see.” One woman nearly died during the Iowa trials because she lost almost half of her blood volume.. If she hadn’t been close enough to an emergency room to receive emergency care and surgery, she would have bled to death.
One to 2% of women in Europe and in the U.S. clinical trials required hospitalization because of hemorrhaging. In the U.S. trials 9% bled for over 30 days. One percent bled for more than 60 days. Four out of about 2,000 women participating required transfusions and 25 required treatment in emergency rooms or hospitalization.
During the clinical trials in the U.S., about 5% experienced an incomplete abortion. When this occurs, surgical abortion is needed as a backup. Incomplete abortions can cause infection, sterility and death.
RU 486’s sponsor and patent holder, the Population Council, reported that 1 out of every 50 women will hemorrhage and require surgical intervention to stop the bleeding. One out of every 100 women will require hospitalization. For 8% of the women who take RU 486, this method will fail.
Prostaglandins alone are known to have their own potentially deadly side effects. [Alan Riding, “Frenchwoman’s Death Is Linked to Abortion Pill and a Hormone,” New York Times, April 10, 1991.]
In Europe there have been two heart attacks and one death. [Dr. Y.M. Kervran, “RU 486: Rousell addresse une lettre aux gynecologues des centres d’IVG (RU 486: Rousell Addresses A Letter to Abortion Center Gynecologists),” Le Quotidien DuMedicin (Medical Daily), April 30, 1990, p. 11; Martine Laronche, “Les contre-indications de 1’IVG par voie medicamenteuse pourraient etre elargies (Contraindications for abortion by medication could be expanded),” Le Monde, April 10, 1991].
If RU 486 were a life-saving drug, such risks might be acceptable, but abortion is an overwhelmingly elective procedure.
Cytotec Manufacturer Objects to Drug’s Use for Pregnant Women
The manufacturer of Cytotec, a drug used to treat ulcers, wrote a letter to health care practitioners on August 23, 2000 cautioning that the drug is not meant to be used by pregnant women. The manufacturer warned, “Serious adverse events were reported following off-label use of Cytotec in pregnant women include maternal or fetal death, uterine hyperstimulation, rupture or perforation requiring....surgical repair, hysterectomy or [other treatment]...severe vaginal bleeding...and shock.” RU 486 has a low rate of success unless it is used in combination with the prostaglandin, Cytotec.
Former Abortionist Warns of Dangers to Women and Their Surviving Offspring
Dr. Bernard Nathanson, a prominent former abortionist who co-founded the National Abortion Rights Action League (NARAL) and past director of the world’s largest abortion clinic located in New York City, the Center for Reproductive and Sexual Health, warned that RU 486 poses serious health risks to women who use it.
Dr. Nathanson claims that he performed 60,000 abortions during his career as an abortionist. After having made the video, “Silent Scream,” a video in which he reveals on an ultrasound machine an unborn child’s reaction as he was being surgically aborted, Dr. Nathanson renounced his profession and later became a Christian convert.
Dr. Nathanson opined that the approval of RU 486 was influenced more by the politics of the Food and Drug Administration (FDA) than by concerns for public health. Nathanson expressed concerns that disorders would be inherited by the surviving offspring of women who take this drug because “RU 486 is the drug which acts on the female reproductive system, and anything that does that we have to be keenly aware of what are called transgenerational effects.”
Potentially a chemical time-bomb, RU 486 has chemical properties similar to DES, which was given to women several decades ago to bring a halt to excessive bleeding and to prevent miscarriages. Some of the offspring of these women ultimately developed deformities of the reproductive tract or developed cancer.
Another possibility is that some women who start taking RU 486, but don’t complete the process because they decide continue their pregnancies to term, could find that their offspring have serious skull deformities.
“RU 486 in itself is not potentially dangerous to women, but (Cytotec) is, and you have to give them together,” said Dr. Nathanson. He warned that the prostaglandin, Cytotec, could cause asthma or exacerbate it.
Dr. Nathanson indicated that Cytotec’s purpose is to expel the baby from the womb, but because it is frequently ineffective, the pregnancy often only partially detaches itself from the womb and excessive bleeding can occur. “Many of these women bleed for hours at home, having terrible cramps, and end up in emergency rooms,” he declared.
Nathanson said that even if a woman does not expel the preborn child until she gets home, she still has to show the remains of her child to the abortion provider. He asked, “Now the question is how is a young girl of 17 going to go plowing through a toilet bowl full of blood clots and other nasty things to try to find this tiny little fetus and bring it to the doctor?”
He added, “They’ll pass this out (in school) too, and many kids probably, will be using this for contraception and adults too.” [Source: NewsMax; October 9, 2000].
European RU 486 Results
The New England Journal of Medicine published a study in May, 1993 which reviewed European RU 486 results. Four hours after being administered the second drug, a prostaglandin, at the clinic only 59% had aborted before leaving the clinic’s premises. One-fourth aborted during the next 24 hours. Nearly 2% had incomplete abortions, which meant that their physicians had to do a surgical procedure as a backup called dilation and curettage (d & c). Nearly 1% never aborted after taking RU 486, and one patient’s abortion did not take place until 12 days after she left the clinic.
Text of Oral Testimony given before the Reproductive Health Drugs Advisory Committee of the Food and Drug Administration at its Public Meeting of July 19, 1996
by Joel Brind, Ph.D., Professor of Endocrinology, Department of Natural Sciences, Baruch College of the City University of New York, New York, NY 10010
In the 3-1/2 years since I sent Commissioner Kessler a detailed letter summarizing the research literature on abortion and breast cancer, considerable additional data have been gathered, bringing the issue into much sharper focus. To date, a total of 30 published reports describe 24 separate epidemiological studies which give specific data on induced abortion and breast cancer incidence. Nineteen of the 24 report overall increased breast cancer risk, 12 with statistical significance. Several important conclusions can be clearly drawn based on this substantial body of worldwide knowledge dating back to 1957:
1) Only induced abortion -- not spontaneous abortion -- is consistently linked to the incidence of breast cancer. The biological basis of this difference is also clear: Most spontaneous abortions are characterized by subnormal ovarian estradiol secretion. It is the surge of estradiol early in a normal pregnancy which provides an estrogen overexposure by which most known risk factors increase breast cancer risk.
2) Induced abortion increases breast cancer risk independently of its effect in delaying first full term pregnancy. An early full-term pregnancy decreases breast cancer risk. Since induced abortion also abrogates this protective effect, it raises breast cancer risk in two ways for young nulliparous women.
3) The increased breast cancer risk attributable to induced abortion cannot be explained by response bias in case-control studies. The only study claiming to provide direct evidence of response bias relies on the specious conclusion that breast cancer patients report having had abortions that never took place, and the only other study using prospective data found a statistically significant 90% risk increase.
4) There is now evidence of a particularly strong interaction between induced abortion and family history of breast cancer, shown by two studies published in 1994.
5) There is no basis for assuming that the somewhat younger average gestational age of medically induced abortions will confer any less of a breast cancer risk increase than surgical abortion: Neither of the two studies which looked at the timing of first trimester induced abortions found a significant difference between abortions before versus after 9 weeks. Endocrinological evidence backs this up: Estradiol begins to surge measurably within a few days after conception. Unfortunately, the short time allotted today does not permit me to report specific data. However, along with colleagues at the Penn State Hershey Medical Center, I have completed a “Comprehensive review and meta-analysis” on the subject, which is now in press for this October’s Journal of Epidemiology and Community Health. Although subject to embargo, I can provide the FDA a copy if you are interested.
In the drug approval process to date for mifepristone/misoprostol, has breast cancer, even as a potential risk factor, ever come up? Indeed, the overall, highly significant positive association between induced abortion and breast cancer, which we have documented in the meta-analysis, demands that women be warned at the very least. Such warnings are already mandated to be given to any women considering induced abortion by law in Louisiana, Montana and Mississippi, with more such laws in the pipeline.
Finally, we are not speaking here about any concern for the life of any fetuses: only about the life and health of the women who may be able to take these abortifacient drugs. However safe this drug regimen may appear in short term testing, there is too much hard evidence that in the long term, many thousands of women will get breast cancer because they took these drugs. If this agency can simply approve as the Population Council has requested, the legitimate use of such drugs by healthy women in order to achieve elective medical results, then we will have witnessed, in effect, the end of the Food and Drug Administration as we know it, for this agency will have abandoned its function to protect American women from purveyors of harmful medicine.
“An Appalling Psychological Ordeal”
Edward Sakiz, president of Roussel Uclaf, the former manufacturer and distributor of RU 486, said in an interview on August 1, 1990 that, “As abortifacient procedures go, RU 486 is not at all easy to use. In fact it is much more complex to use than the technique of vacuum aspiration . . . . But a woman who wants to end her pregnancy has to ‘live’ with her abortion for at least a week using this technique. It’s an appalling psychological ordeal..” [Interview, Le Monde (August 1), reprinted in Guardian Weekly (United Kingdom, August 19, 1990)].
It is apparent that this kind of abortion is not the “safe, easy, and private” method claimed by abortion supporters. These abortions can happen publicly. RU 486 abortions frequently do not take place in the clinics after the second drug is administered. Therefore, many of these abortions are taking place elsewhere, whether at home, at work, in public restrooms or in the grocery store. This clearly has psychological and physical ramifications for women using the drug cocktail, who now must see the remains of their unborn children.
Ironically, Roussel-Uclaf, which markets Allegra, has an unfortunate, but appropriate, connection to the Nazi Holocaust. The firm was once a part of a conglomerate which manufactured the chemical used in German gas chambers during World War II.
RU 486 to Be Manufactured in Red China
The marketer of RU 486, Danco, which is located in New York, has contracted with a manufacturing plant in China to manufacture RU 486, known as mifepristone. The drug will be marketed under the brand name Mifeprex. Until recently, Danco has chosen to keep confidential the identity of the RU 486 manufacturer. It has been revealed that the Hua Lian Pharmaceutical Co., which produces RU 486 for Chinese women for population control purposes, will produce the drug for the United States.
The Rockefeller Foundation and Concept Foundation, which is located in Bangkok, have helped the Chinese pharmaceutical company to upgrade its equipment and to train its staff so that international standards can be met for the purpose of exporting the drug.
China is a leading source of tainted drugs, and there are concerns that the FDA will not be able to control the quality of the drug. How could injured American women possibly hope sue a Chinese firm for any negligence in the manufacturing process? The arrangement worked out by Danco, the Population Council and the FDA is diabolical.
China is the land of forced abortions and sterilizations. It is fitting that the Population Council, which holds the rights to the drug, should arrange for it to be manufactured there. It was reported that Danco expects sales of 34.2 million by 2004. [Wall Street Journal, September 5, 2000].
Food and Drug Administration Jettisoned Proposed Safeguards
Only four months before the Food and Drug Administration (FDA) authorized the use of RU 486 in the United States on September 30, 2000, the agency was considering a number of safeguards in order to protect the health of women. The safeguards have since been jettisoned. The fact that these safeguards had been under consideration at one time demonstrates that the FDA had concerns about the risks to the women taking RU 486. The abortion industry objected that these safeguards would be too onerous and that fewer women would have access to RU 486. In other words, protecting women’s health is bad for business.
In 1996 members of the FDA advisory panel, which was considering authorization of RU 486 for use in the U.S., were horrified to learn that the sponsor, the Population Council, planned to train non-surgeons to administer the drug cocktail and to perform backup surgical abortions in cases where incomplete abortions have taken place.
Some of the jettisoned safeguards once considered by the FDA include:
1) A national registry of doctors authorized to administer the drug cocktail;
2) Overseeing the distribution of the RU 486 pills;
3) Restricting the utilization of this method to physicians qualified to:
a) perform surgical abortions as a backup in case of incomplete abortions,
b) read ultrasounds in order to date pregnancies and to avoid using the procedure on women carrying ectopic pregnancies,
c) practice within an hour of an emergency room in order to handle medical emergencies;
4) Long-term tracking of the health of women taking RU 486.
Physician/Congressman Plans Legislation to Protect Women’s Health
Rep. Tom Coburn (R-OK), an obstetrician-gynecologist, and Senator Tim Hutchinson (R-AR) announced that legislation was critical because the Food and Drug Administration (FDA) had “caved in” to the abortion industry’s desire for easy access to abortion in rural areas by authorizing the use of RU 486 without establishing adequate regulatory oversight. “The FDA will allow non-physicians to dispense the drug and will not require additional training or certification to administer the drug,” said Coburn. He asked the FDA to explain how it would warn pregnant mothers that Cytotec, the prostaglandin used in the abortion process, could cause death or severe damage to a woman’s uterus.
The legislation’s purpose is “to protect women who will be endangered by the FDA’s inadequate projections for women who will use RU 486.” The RU 486 Patient Health and Safety Act will “codify and strengthen the patient health and safety projections proposed by the FDA when it approved RU 486,” said Coburn.
As a physician who has delivered 3,500 babies and performed abortions to save the lives of mothers, Dr. Coburn explained that the bill’s purpose is to protect mothers from the irresponsible and politically correct behavior of the FDA, which approved the drug with inadequate safeguards prior to the 2000 presidential elections. The bill would impose requirements that the abortion practitioner be trained to perform surgical abortions, to administer the drug cocktail properly and to have admitting privileges at a nearby hospital. He or she would be required to:
1) Handle complication of an incomplete abortion and be able to do a dilation and curettage (d & c). (During clinical trials in the U.S., about 5% of the women who had taken RU 486 before seven weeks LMP experienced an incomplete abortion.)
2) Be legally authorized and trained to perform abortions.
3) Be competent to read a sonogram to date a pregnancy and diagnose an ectopic pregnancy. It is highly dangerous for a woman with an ectopic pregnancy to take RU 486.
4) Be qualified to administer the drug cocktail.
5) Have admitting privileges at a nearby hospital in order to treat complications, such as heavy bleeding. [Source: Associated Press; October 4, 2000].