This article was published with permission from Culture of Life Foundation. To view the original publication, see their website.
By Jessica Sage
AUL Staff Counsel
Brenda Vise, a 38-year old pharmaceutical representative, died on September 12, 2001. Holly Patterson, an 18-year old student, died on September 17, 2003. Chanelle Bryant, 22-years old, died on January 14, 2004. Vivian Tran, also 22 years old, died on December 29, 2003. Orianne Shevin, a 34-year old attorney and mother of two, died on June 14, 2005.
What do these women have in common? They all took RU-486, the so-called “abortion pill,” and died, most from a C. Sordelli infection and one from a ruptured ectopic pregnancy. RU-486, a drug that its proponents claim is a “safe” and “easy” method of abortion, has killed at least 29 women worldwide including at least 8 American women.
This month marks the 21st anniversary of French approval of the controversial abortion drug. Initially, the U.S. Food and Drug Administration (FDA) considered RU-486 dangerous and banned the importation of the drug. However, later in 1993, following the wishes of then-President Bill Clinton, the FDA lifted the import ban and the Department of Health and Human Services (HHS) brokered a deal for the drug manufacturer, Roussel-Uclaf, to gratuitously donate the rights to distribute RU-486 in the U.S. to the Population Council, an organization whose mission is to research, develop and introduce birth control methods (including abortion) to control populations, “especially [for] disadvantage populations.”
Since the Population Council is a research and policy organization, not a drug company, it founded Danco Laboratories for the sole purpose of marketing and distributing RU-486 in the U.S. Unable to find a U.S. company willing to manufacture the drug, Danco Laboratories turned to China, a nation known for coerced abortions, and a manufacturer formerly cited by the FDA for tainted drugs.
In September 2000, during the final days of the Clinton Administration, the FDA approved RU-486, or Mifeprex (generic name: mifepristone), under its accelerated approval regulations designed to expedite drug approvals for HIV patients. Suddenly, the FDA deemed that the benefits of RU-486 outweighed the risks and required that it receive expedited approval. In other words, the FDA succumbed to intense political pressure from the Population Council and abortion advocates to approve the drug.
On its website and in its literature, Danco Laboratories advertises RU-486 as a “safe” and “easy” abortion option. However, the U.S. trials and subsequent market use are to the contrary. It is neither safe nor easy.
A RU-486 or chemical abortion is, in reality, a long, messy, and dangerous process. RU-486 is a synthetic steroid that requires two drugs and three doctor visits to abort an unborn child at 7 weeks of gestation or less. During the first visit, the woman takes three pills (Mifeprex) to chemically destroy the unborn child’s environment, deprive him/her of nourishment and subsequently starve the child to death. During the second visit, if the woman is still pregnant she is given a prostaglandin (misoprostol), which causes cramping to expel the child in something similar to a very heavy and painful (and, at times, deadly) menstruation cycle. The third office visit (14 days later) confirms the woman is well and the abortion complete. If the RU-486 abortion is unsuccessful, the women must consider the possibility of birth defects and typically then undergoes a surgical abortion.
The Population Council, with vested interest in the success of RU-486, conducted and reported on the results of the U.S. clinical trials. Despite the highly-controlled trials conducted from September 1994 to September 1995, the results reported in the New England Journal of Medicine remained alarming. They revealed how RU-486 creates significant risks of life-threatening complications for the healthiest of women.
The study cited excessive bleeding as the most serious risk. Excessive bleeding left 4 women needing blood transfusions, 25 women requiring hospitalization (including emergency-room visits), 56 women with “surgical interventions,” and 22 women needing intravenous fluids. To the logical observer, these “adverse events” would equate to “medical emergencies,” but the Population Council dismissed these life-threatening complications as normal and expected with a chemical abortion.
The studies also indicated that women suffered from abdominal pain, nausea, vomiting and diarrhea. Abdominal pain, referred to as “cramps,” was so significant that 68% of women received at least one pain medication and 29% received opiates. One woman was hospitalized for the intense pain and actually needed two “surgical interventions.”
Further, the study results also confirmed that a chemical abortion “procedure” must begin within 49 days of conception, otherwise the baby’s size and development are too advanced and complications are admittedly too severe and dangerous.
Inexplicably, the report paid little attention to the other adverse events women reported including headache (32%); dizziness (12%); back pain (9%); fatigue (9%); fever (4%); vaginitis (4%); viral infections (4%); rigors (3%); dyspepsia (3% ); and asthenia, leg pain, anxiety, insomnia, anemia, syncope, leukorrhea, and sinusitis (2% each). And if that is not enough, endometritis occurred in 19 women. These are not just percentages and not simply insignificant statistics, but real women experiencing real complications (some requiring timely life-saving measures) after taking RU-486.
The Population Council acknowledged that the study showed that RU-486 had a low success rate and attempted to rationalize the discrepancy as merely “a lack of experience with [chemical] abortion in the United States as well as the design of [the] study.” If this is true, then how much lower would the success rate and higher the complication rate be once approved by the FDA and introduced to the uncontrolled and unmonitored marketplace? Unfortunately, U.S. women are finding out first-hand.
Since its September 2000 FDA approval, RU-486 has caused at least 8 deaths, 9 life-threatening incidents, 116 blood transfusions, and 232 hospitalizations for more than 1,100 women in the U.S. who experienced significant medical complications. These numbers are only the incidents reported to and by the FDA and are likely an inadequate reflection of actual incidences.
The futile efforts by the FDA to make an unsafe drug acceptably safe by detailing certain limitations on who can prescribe the drug and the protocols to be followed are obviously insufficient. On November 15, 2004, the FDA issued “important new safety changes” to the labeling of RU-486. The FDA and drug manufacturer Danco Laboratories had received reports of serious bacterial infection, bleeding, ruptured ectopic pregnancies, and death. The FDA’s response: Change the black box labeling and nothing more. The new label warns health care professionals and consumers about the “risk of serious bacterial infection, bleeding, sepsis, and death,” but does nothing to protect women from these risks actually occurring.
If past care is indicative of future care by abortion providers, none of these warnings will protect women. Planned Parenthood and other abortion providers have notoriously failed to adhere to the labeling instructions or given appropriate medical attention to women who notify them of these dangerous complications after taking RU-486. Since its approval, RU-486’s promoters have ignored the minimal FDA guidelines by recommending lower dosages, suggesting clinics drop follow-on visits to allow patients to self administer at home, promoting vaginal versus oral administration, and extending the usage deadline past the seven weeks prescribed by the FDA””all harming women who are entrusting their lives to these “reproductive care” providers.
States can and must act to regulate and ““ in the case of minors ““ limit the use of RU-486. Current FDA guidelines do nothing to restrict minors from obtaining RU-486 or restrict physicians from implementing the drug in “off-label” uses. It does require the drug to be provided by or under the supervision of a physician who meets certain qualifications, but most abortion providers meet these requirements and have clearly shown their willingness to prescribe RU-486 in “off-label” and life-threatening ways.
In 2004, the Ohio General Assembly enacted a law requiring abortion providers to comply with the FDA-approval letter and the uses, dosages, and administration protocols contained in the drug label. In July 2009, after five years of legal battles with Planned Parenthood, the Ohio Supreme Court answered that the plain language of the law mandates that abortion providers follow the instructions contained in the medication guide and drug labeling when administering or prescribing RU-486. Subsequently, the Sixth Circuit removed an injunction against the law’s enforcement and remanded the case to the district court. In light of the dangers associated with RU-486 and its American track record, it is astounding that Planned Parenthood would even argue that it need not follow the approved and “safe” method of administrating RU-486.
States can and should further protect women from RU-486 by imposing administrative regulations on its administration by requiring that abortion providers follow the FDA-approved drug labeling. Second, to prevent “satellite” prescriptions, states could consider physician-only limits on RU-486 explicitly requiring physicians to be physically present at the abortion facility when they prescribe and administer the drug and clearly prohibiting the delegation of actual administration duties to nurses, physician assistants, or others. It would also be prudent to require the facilities to be able to provide or be proximate to emergency care and to mandate ultrasounds before prescribing RU-486 to accurately determine the gestational age of the unborn child and to rule out ectopic pregnancy.
Another necessary consideration is for states to review existing””and enact, if nonexistent””parental involvement laws requiring abortion providers to involve parents when a minor girl seeks a RU-486 or other chemical abortion.
Despite the real and evidenced dangers of RU-486, the FDA, the drug manufacturer, and prescribing abortion providers continue to believe the “adverse effects” are not statistically significant. They continue to profess its safety and ease as more and more women are sacrificed at the altar of “reproductive choice.” At what point will the harm to women be significant enough for the FDA to pull this deadly drug from the market? The answer is unclear. In the meantime, it is imperative to regulate and, when appropriate, restrict the use of RU-486 to protect women and to limit the “collateral damage” abortion advocates are clearly willing to accept.