On January 28, Dr. Ralph Miech presented an explanation of how the RU-486 abortion pill kills women to a Florida conference of the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG). RU-486, he said, has an anti-glucocorticoid effect, which promotes unhealthy inflammation in the body since glucocorticoid is naturally needed to suppress inflammation. This pro-inflammatory effect of RU-486 can lead to septic shock as the bacterium Clostridium sordellii multiplies in the body, sometimes causing death. And the funny thing is, the anti-glucocorticoid effect of RU-486 was known before the FDA approved the drug. Now, women by the hundreds are having potentially life-threatening complications, and at least a few have died.
RU-486 is the drug that won't die, no matter how many women who take it do. A recent article in the New England Journal of Medicine (see PRI's Weekly Briefing, Dec. 2, 2005, "Time for a RU-486 Rollback") suggested that an RU-486 abortion was an astonishing ten times more likely to be fatal for the mother than a surgical abortion performed at the same point in pregnancy (RU-486 is not used for late-term abortions). The abortion pill, which has been used to kill over 500,000 unborn children in this country since the FDA officially rushed its approval in September 2000, has the advantage of promoting the abortionists' goal of making abortion a humdrum, everyday affair, available from any doctor or pharmacist in the world instead of segregated into abortion slaughterhouses. As in America's days of old, when folk tolerated slavery but didn't like to see slave-trading going on in respectable parts of town or associate with slave-traders, we don't like to think the clinics we visit or the doctors we know perform abortions. So abortion is largely shunted off into clinics located in poor minority neighborhoods.
Mifepristone, the scientific name for RU-486, promises to change all that. It's a simple pill that can be taken at home. It requires no pricey vacuum cutterage equipment, no bloody surgical table in the doctor's office. No dead fetuses in the health clinic's medical wastebaskets to explain to any queasy souls. All it requires is the doctor to write a few words on a little square of white paper and hand it to his expectant patientsomething he does many times a day as it is. A woman seeking to abort her child need not risk been seen entering or leaving an abortuary. Abortion easy, abortion everywhere, without any clinics to be picketed by pesky child-huggers.
The one flaw in this inhuman and anti-human dream drug: It not only kills the baby, it sometimes harms or even kills the mother. Surgical abortion is safer for the mother, which is why even pro-abortion activists should favor the withdrawal of RU-486but safety is not their No. 1 priority.
"RU-38486 was initially developed as an anti-glucocorticoid to treat Cushing's Disease and in the course of routine toxicology studies it was found to be an abortifacient," Miech told PRI. "Under the name RU-486, it was developed as a medical abortifacient and its toxic effect on the innate immune system was not studied or was ignored."
Two female physicians, Margaret M. Gary and Donna J. Harrison, just published a study in the February 2006 The Annals of Pharmacotherapy. Harrison is chairwoman of AAPLOG's Subcommittee on Mifeprex. "The choice of mifepristone termination over surgical termination is based mainly on patient perceptions of safety, convenience, and privacy, but these perceptions do not accurately reflect the realities of the regimen," they concluded.
The two doctors examined 637 mifepristone adverse event reports (AERs) filed by health care practitioners after mifepristone (brand name Mifeprex) was used by patients. It's taken years to get these reports released, and they are incompleteand many adverse events are never reported at all under America's lax reporting system. Miech noted, "The way the FDA has set up the AER process is that it is voluntary, and physicians and nurses are too busy to take the time to fill out the simple paper work. Furthermore, most physicians and nurses do not know what an AER is."
Wrote Gary and Harrison, "AERs relied upon by the FDA to monitor mifepristone's post-marketing safety are grossly deficient due to extremely poor quality." They do contain a lot of gruesome detail, however. The AERs included those on the four American women known to have died from RU-486 plus the death of a Swedish teenager.
Hemorrhage (237 reported) and infection (66) were the most frequent complications among the AERs. Among the hemorrhages, 168 were serious cases, 42 life-threatening, and one was fatal. Seven cases of septic shock were reported, four life-threatening and three fatal. Emergency surgery was required in 513 cases.
The inflammations resulting from taking RU-486 reported in the AERs may be due to mifepristone's quality of suppressing anti-inflammatories, not allergic reactions as some believe, suggest the two. "These pro-inflammatory reactions reported as allergic reactions in AERs may be due to the action of mifepristone's blockade of cortisol receptors," they wrote.
The Subcommittee on Criminal Justice, Drug Policy, and Human Resources of the House Committee on Government Reform, chaired by Rep. Mark Souder (R.-Ind.), is already investigating RU-486's safety. In the meantime, Rep. Roscoe Bartlett (R.-Md.) is trying to get Holly's Law passed. Named after 18-year-old California girl Holly Patterson, a healthy young woman killed by RU-486, Holly's Law (HR 1079) would revoke government approval of RU-486. South Carolina Sen. Jim DeMint (R.) has a companion bill, S 511. "In his State of the Union Address last night, President Bush said, 'A hopeful society has institutions of science and medicine that do not cut ethical corners, and that recognize the matchless value of every life,'" said Bartlett on February 1. "The President's words and this research add more compelling justification for Holly's Law because the FDA slashed ethical and procedural corners when it approved RU-486 under a special 'restricted distribution' approval process."
Meanwhile, the manufacturer of misoprostol, which is oftenmaybe usuallyused in conjunction with mifepristone to perform abortions, has again warned that such a use is not safe. And the Australian Senate is expected to vote next week on whether to override the Health minister's decision to keep RU-486 illegal. In a submission to the Australian parliament, Harrison and the Family Research Council's Chris Gacek warned that rural Australians would suffer most. "Finally, many of the women who underwent emergency procedures are alive because they had rapid access to surgical and hospital services. In a rural area, where medical and surgical access is limited, these women would likely have died. Women in rural areas are the most vulnerable to lethal complications from a mifepristone abortion," they said.
The growing number of professional articles questioning RU-486's safety haven't slowed the drug's well-funded and globally-aware advocates one bit.