by Susan E. Wills
September 15, 2000
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. The "lack of a raw material manufacturer" is the most plausible 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!
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.
A recent special issue of the Journal of the American Medical Women's Association (Vol.55, No.3) touting chemical abortion, nevertheless raises numerous red flags. In Population Council drug trials, for example, 4 women required blood transfusions and 25 were treated in an emergency room or were hospitalized for complications.
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. Dr. Wu of the National Research Institute for Family Planning in Beijing, for example, 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 (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 hyperstimulation, 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.
If the FDA approves this drug combination, only Danco investors and Chinese manufacturers will be the winners. American women and their unborn children will be the big losers.
Mrs. Wills is assistant director for program development, NCCB Secretariat for Pro-Life Activities.