Six years after the Population Council received U.S. rights to RU-486 (mifepristone) and four years after the Food and Drug Administration ("FDA") declared the drug "approvable," RU-486 has still not entered the U.S. market, except for use in clinical trials.
Approval looked like a slam-dunk on President Clinton's first day in office when he signed an Executive Order asking federal agencies, including the FDA, to expedite approval of the abortion drug. And that wasn't the end of his labors to bring chemical abortion to the U.S. He actually "wrote to Hoechst asking the company to file a new drug application with the FDA (an unprecedented situation in the pharmaceutical industry!)" which to their everlasting credit, "Hoechst intransigently refused to do" (André Ulmann, in "The Development of Mifepristone: A Pharmaceutical Drama in Three Acts," Journal of the American Medical Women's Assn. ["JAMWA"], Vol. 55, No.3, p. 117, 120).
Wanted: Manufacturer – Scruples Not Required
Immunity from Lawsuits a Plus
Dr. Ulmann, former director of RU-486 development at Roussel-Uclaf, cites the "lack of a raw material manufacturer" as the main reason for the delay. It appears major pharmaceutical companies fear costly product-liability litigation as well as boycotts.
As the September 30 deadline for FDA action looms, a manufacturer willing to supply mifepristone to U.S. women may have stepped forward. The Population Council's manufacturing licensee, Danco Laboratories, will pay $293,363 this year to "one of several Chinese manufacturing plants that currently produce RU-486" (Zimmerman,"Awaiting Green Light, Abortion-Pill Venture Keeps to the Shadows," Wall Street Journal, Sept. 5, 2000, A1). Ms. Zimmerman errs in a minor detail: Chinese plants are producing not RU-486 but a reverse-engineered copy of the pill, China being somewhat lax in observing intellectual property rights.
What exquisite irony this presents! The U.S. government excoriates China for egregious violations of copyrights and patents on CDs and videos, but stands poised to permit importation of a pill—made and sold in violation of patent rights—in order to kill America's children.
Zimmerman reports that a "second, back-up manufacturing site is in the works, though its location couldn't be established, and the documents say it is having production problems, including 'poor yields' and 'high impurities'" (WSJ, id. at A14). Please take note, FDA!
The Wall Street Journal article also shines light into the secretive Danco Laboratories operation. "There are no signs in the building's lobby or hallway pointing to the suite the company occupies." The phone is answered without mentioning Danco's name. Much of its funding comes from foundations actively supporting population control, such as those set up by Warren Buffet, David Packard and George Soros. Its medical director, abortionist Richard Hausknecht, admits "[Danco] is tiny. ... It's literally a mom and pop store" (quoted by Sharon Lerner, Village Voice, Aug. 30, 2000).
FDA Throws Up 11th Hour Roadblocks
Prior to June 2000, the FDA appeared eager to grant final approval. But in June Danco leaked new proposed restrictions on RU-486, hoping to raise a public outcry. The FDA proposed five restrictions. Only licensed doctors who perform abortions will be allowed to prescribe RU-486. In addition, prescribing abortionists would be required to comply with the following: register with the drug's distributor; be trained in RU-486 use (and so certified by a third party); be trained and certified in reading ultrasound scans to determine gestational age and to rule out life-threatening ectopic pregnancy; and maintain admitting privileges at hospitals with emergency facilities no more than one hour from their office.
Given the serious risks the RU-486 regimen poses for women—from incomplete abortion, infection and excessive bleeding—the regulations are eminently reasonable. While one can never condone using RU-486 to kill a child, the fact that the FDA may intend to contain the potential of this deadly drug for serious harm to women is a positive development.
Many, especially in the media, do not share this viewpoint. Shock, outrage and charges of betrayal characterize editorials lambasting the proposed restrictions. As their comments reveal, they are not well-informed, or women's health is far from their primary concern. They support RU-486 for its potential "to end the abortion debate" forever. As one columnist puts it, once RU-486 is approved, "this country can start putting this awful abortion fight behind us" (Mann, "We Need the Abortion Pill Now," The Washington Post, June 23, C9). Dr. Eric Schaff, a pediatrician involved in clinical trials, explained: "The whole idea of [RU-486] was to increase access. ... [The FDA proposal] kills the drug if it can't be used by primary care providers" (Stolberg, The New York Times on-line edition, June 8).
Members of Congress are unlikely to intervene to lighten restrictions proposed by the FDA. The House has twice passed a ban on the FDA's use of taxpayer funds to approve RU-486 or other abortifacient drugs. The provision failed in the Senate and was twice dropped in conference. The latest effort failed the House on July 10, 2000, narrowly defeated by just five votes, because 66 members (many of whom support the ban) were not present for the vote. Still, pro-abortion members of Congress would be in an awkward position urging Congress to override FDA restrictions; they objected to Rep. Tom Coburn's earlier efforts on the ground that the FDA should be "left alone to reach its best scientific judgment" free of interference from Congress.
Dr. Coburn notes that even with the high level of government oversight in Europe regarding the administration of RU-486, still one in 40 women has an incomplete abortion which can lead to infection and death. In the unregulated health care environment of the U.S., he is concerned that "it might become an 'underground' drug used by frightened young women without proper medical supervision, and end up killing many of them."
Dr. Coburn has good cause for concern. A recent special issue of the Journal of the American Medical Women's Association (Vol.55, No.3)–funded by the inaptly named Open Society Institute chaired by population control enthusiast George Soros–raises numerous red flags. For example, one study compared bleeding patterns following chemical abortion and surgical abortion. Women who underwent RU-486/misoprostol abortion experienced a mean of 24 days bleeding/spotting and 20% of them bled/spotted for 35 to 42 days. In Population Council drug trials, 4 women required blood transfusions and 25 were treated in an emergency room or were hospitalized for complications.
How severe is the pain women experience during this prolonged abortion procedure? Most said it was no worse than severe menstrual cramps, but others described significant pain–including one who likened it to the pain she felt when she broke her foot. Nausea, vomiting and diarrhea are the other common side effects.
What emerges from reading the JAMWA supplement is a depressing picture of women being used as guinea pigs in a global effort to find the most effective poisons and optimal dosing to kill and expel their unborn children.
For example, Dr. Wu of the National Research Institute for Family Planning in Beijing, blandly reports: "Some recent adverse events resulting from undiagnosed ectopic pregnancies have led providers to pay more attention to ultrasound examination" (JAMWA, at 197). This means one of two things: the mother died or, but for emergency surgery, she would have died. Perhaps this is not a matter of serious concern in a country where cadres enforcing the one-child-per-family policy think nothing of using a muddy ditch to drown a newborn who miraculously had survived a forced full-term abortion. But in America?
Dr. Wu adds: "The common complications of medical [sic] abortion are profuse bleeding and allergy. ... Allergic reactions to mifepristone or misoprostol were not uncommon, manifesting in facial edema, skin rash and itching, numbness of feet and hands, and even a serious case of allergic shock. The potential for such reactions is one reason to keep clients for observation" (at 198). Other articles cite allergy to mifepristone or misoprostol as absolute contraindications for the use of chemical abortion. But how in the world can women with such allergies be identified before the allergic reaction occurs?
Even in China, chemical abortion is falling into disfavor among staff members at larger hospitals. Wu explains: "The staffs were too busy to handle the procedure (more counseling, more visits and observation), and they also have to manage the referred cases with serious side effects and complications" (at 199).
Misoprostol: Another Obstacle, Another Nightmare
Misoprostol (the second pill of the drug combination) is critical to both the approval of RU-486 and to its use. Approved as an ulcer medication designed to protect the stomach from anti-arthritis drugs, misoprostol is owned and manufactured by G.D. Searle under the brand name Cytotec. Study after study has demonstrated the substantially superior efficacy and safety (such as it is) of chemical abortion with the RU-486/Cytotec combination. Just one little problem: Searle has adamantly refused to change the labeling on Cytotec to include its use in abortion or as a labor-inducing drug to facilitate full-term delivery.
In an August 23 letter, Searle warned doctors not to prescribe Cytotec to pregnant women for the "unapproved use of ... induction of labor or abortion." The company's letter, reportedly drafted jointly with the FDA, states that Searle will not conduct trials to test Cytotec as an abortifacient and lists among the possible side effects the following:"maternal death, fetal death, uterine hyper-stimulation, rupture or perforation requiring uterine surgical repair, hysterectomy ... amniotic fluid embolism, severe vaginal bleeding, retained placenta, [and] shock ..." (Kaiser Daily Reproductive Health Report, Aug. 28, 2000).
Searle's letter also stated that it may oppose any effort by the FDA to approve the use of misoprostol in conjunction with mifepristone for chemical abortion.
Just how dangerous is Cytotec when used for labor induction? Ina May Gaskin, a certified professional midwife and president of Midwives Alliance of North America, presents findings of her investigation into Cytotec in an article posted on the Salon.com website (See "Cytotec: Dangerous experiment or panacea," July 11, 2000). She makes a strong case that the burgeoning use of Cytotec to induce labor is extremely dangerous. It can cause a full-term uterus to rupture (described by one doctor as "totally exploding") leading to both maternal and fetal death. She describes in detail a case where the baby and the mother barely survived, and the mother required emergency surgical removal of her uterus, one ovary and fallopian tube, as well as thirty-seven units of blood, plasma and platelets to replace what she lost.
Most Cytotec-induced labors work extremely well. Because the drug is very cheap, easy to administer and works effectively most of the time, it is becoming a popular alternative to pitocin for inducing or speeding up labor contractions. Gaskin reviewed twenty studies of Cytotec-induced labor published in peer-reviewed medical journals and papers presented at professional meetings. Among the total of 1,958 births in the combined studies, she found two maternal deaths, 16 baby deaths, 19 uterine ruptures and two life-threatening hysterectomies. Thus, approximately 1 birth out of 100 in the studies resulted in uterine rupture. Half occurred among women who had previous Caesarean deliveries, but others occurred to women who had no prior uterine surgery.
A 1999 article in the American Journal of Obstetrics and Gynecology reported uterine rupture (and one baby death) in 5 of 89 women with previous Caesarean delivery whose labors were induced by Cytotec. This 1 in 18 rate is 28 times higher than that of women with previous Caesarean delivery who had a vaginal delivery without Cytotec. Gaskin quotes Marsden Wagner, a perinatal epidemiologist: "It can be reliably estimated that between 1990 and 1999, as a result of widespread off-label use of Cytotec for vaginal birth after Caesarean section, well over 3,000 women in the United States suffered a ruptured uterus, resulting in at least 100 dead newborn babies."
Cytotec also increases the risk of amniotic fluid embolism ("AFE") which occurs when amniotic fluid enters the mother's bloodstream. AFE is "one of the most dangerous complications that can happen at birth," according to Gaskin. More than 60% of women and their babies die when AFE occurs and survivors often suffer neurological impairments. AFE is now one of the leading causes of maternal death in the U.S. Already, two cases in the medical literature have been associated with Cytotec use.
If the FDA approves this drug combination, only Danco investors (like the David and Lucile Packard Foundation, the Buffett Foundation and Soros, all heavy investors in population control) and Chinese manufacturers will be the winners. American women and their unborn children will be the big losers.
Some pop psychologists have tried to explain the female psyche by suggesting "women are from Venus." Until now, there was little support for the theory that women originate anywhere other than Earth. But how does one explain the bizarre thinking that went into stickers plastered around Washington, D.C. this week? They read: "BILL CLINTON: YOU OWE US! RU486 TODAY! Keep our hopes and dreams alive. Call 1-202-456-1414 and tell them you want RU486 with no restrictions." Along the outside edge of the circle-shaped sticker runs the following message: "Allow women the freedom to pursue their hopes and dreams."
Does destroying a child by chemical abortion figure into any girl's hopes and dreams? Is the lack of an abortion pill what's standing between young women and a lifetime of happiness? Where do they get this stuff? The phone number is the White House comments line. Give them a call and let them know how you feel about RU-486.