By Randall K. O’Bannon, Ph.D., NRL-ETF Director of Education & Research
It caused a bit of a stir in 1991 when three “pro-choice” feminists came out with a book warning of the dangers of the chemical abortifacient RU-486. “RU486: Misconception, Myths and Morals,” written by Renate Klein, a biologist and social scientist from Deakin University in Melbourne, Australia, Janice Raymond, a professor of women’s studies from the University of Amherst (Massachusetts), and Lynette Dumble, a member of the University of Melbourne’s Department of Surgery, won awards and received some momentary coverage in the press. But ultimately, the pro-abortion establishment pushed back and plowed ahead, ignoring the warnings.
Approved in the U.S., the chemical abortion method is now legally on the market in at least 50 countries. The U.S. Food and Drug Administration (FDA), which approved RU-486 in September of 2000, says that 1.5 million women had used the drug as of April 2011. In Europe, one international group promoting chemical abortifacients says that as of 2009, RU486 had already been used by two million (womenonweb.org, accessed 11/19/13, at www.womenonweb.org/en/page/561/is-a-medical-abortion-dangerous).
The notorious chemical abortion method is, of course, actually a two-drug combination. RU-486 (known as mifepristone) blocks the hormone that creates and sustains the safe, nurturing environment in the womb where the young baby grows. Misoprostol, the prostaglandin given a day or so later, initiates powerful uterine contractions to dislodge the now starved child.
Over the past several years, there have been modifications of dosages, the addition of antibiotics to some regimens, new warnings have been added to the label.
Does any of this satisfy Renate Klein, one of the original feminist critics?
Writing in a ninety-page preface to a new edition of RU486: Misconceptions, Myths and Morals published earlier this year, far from taking anything back, after seeing twenty plus years of RU-486 on the market, Klein is as convinced as ever that “a down-to-earth rational best practice approach that truly respects women’s health and well being could not, in good faith, endorse this fraught abortion method.”
Klein repeats here what she has published elsewhere–that she sees a ”RU 486/PG abortion as an unsafe, second-rate abortion method with significant problems”
Unapologetically “pro-choice,” Klein explicitly favors surgical abortion as a safer, easier option. But her honest, clear eyed appraisal of chemical methods and the significant risks they pose for women is rare among those who champion abortion as essential to women’s rights.
Ignoring their own evidence
In the new preface, Klein notes a troubling tendency among researchers to catalogue a long list of serious “adverse reactions” (or complications) and then to go on to declare the two-drug combination “safe and effective,” against their own evidence.
One researcher Klein cites is Régine Sitruk-Ware. In a 2006 review of large postmarketing studies in the U.S. and France, Sitruk-Ware found 10% of women suffering from excessive bleeding, 1.4% requiring curettage to control bleeding, and 0.25% requiring blood transfusions.
Though Klein says these sound like low percentages and cites another study that makes these look like underestimates, she points out that for the 1.5 million said to have undergone such abortions in the U.S., this would mean 150,000 women experiencing excessive bleeding, 21,000 requiring curettage, and 3,750 needing transfusions. These are hardly inconsequential numbers.
Sitruk-Ware said, according to Klein, that “Women living in areas where no medical facilities are available should not be included in the medical [chemical] protocol of TOP [termination of pregnancy] unless referrals, and possible transportation are available for emergencies.” Obviously, this is not a statement you heard quoted a lot by the pro-abortionists or their allies in the media during discussions over the Texas law that requires abortionists to have admitting privileges to a hospital within 30 miles of the abortion clinic.
Sitruk-Ware also notes the higher risk of infection, potentially serious drug interaction issues, special risks for asthma sufferers, and risk of “malformations” to the “fetus” should the pregnancy continue. Yet then, Klein notes, Sitruk-Ware, like so many chemical abortion researchers before and after her, goes on to declare that the safety and the efficacy of the method has been confirmed.
While Sitruk-Ware does issue some cautions, Klein says her warnings never show up in the mainstream promotional literature for the drugs.
While “study after study” shows a high rate of adverse effects, Klein says that these are ignored or downplayed in most popular discussions of the drug.
Recounting information that may be familiar to regular readers of National Right to Life News Today, Klein shares data from the April 30, 2011, “Postmarketing Events Summary” put out by the U.S. Food and Drug Administration (FDA). That summary reported 2,207 adverse events, 14 U.S. deaths, 58 ectopic pregnancies, 256 infections, and 339 women requiring transfusions. Klein notes that only 1% to 10% of complications are typically reported to the FDA, meaning the numbers could be 10 or even 100 times higher.” And remember that this was as only of early 2011.
Klein notes that several of these deaths involved the rare bacteria Clostridium sordellii, which prompted a joint investigation by the FDA and Centers for Disease Control in May of 2006. Experts presented evidence that RU 486 might suppress immunity , but the conference ultimately came to no official conclusion on the reason behind the sudden rash of incidents specifically among the population of chemically aborting women and RU-486 remained on the market.
The FDA made it sound as if pregnancy itself [!] was the culprit and simply let stand special warnings added to the label in November of 2004.
Klein says that because RU-486 increases women’s susceptibility to infection, “this means that RU-486 is a drug unsuited for abortion purposes.”
A drug safety information update issued by the FDA in July of 2011 tells patients to contact a health practitioner right away if they “develop stomach pain or discomfort, or have weakness, nausea, vomiting or diarrhea with or without fever, more than 24 hours after taking misoprostol” (the second drug in the process) as it could be an indicator of infection.
Klein says “this advice comes close to being nonsensical,” given the pain, diarrhea, vomiting and cramping that normally accompany these abortions, along with the heavy bleeding. If patients took that advice, Klein guesses that “close to 100%” would be contacting the abortionist, who she expects would simply give the woman reassurance.
Editor’s note. On Friday we will pick up Dr. O’Bannon’s research where he discusses Klein’s observations on the deaths of two women who had ingested the two-drugs that make up RU-486 regimen and another significant side effect of the method that hasn’t been addressed much in the literature.
 In the 1991 edition of their book, Klein and her co-authors had warned about similar issues with the accompanying prostaglandin.