NRL News

RU-486 at 15: An Infamous Anniversary

by | Sep 22, 2015

By Randall K. O’Bannon, Ph.D., NRL Director of Education & Research

RU486Come September 28, it will 15 years since the Food and Drug Administration (FDA) announced official approval for the abortifacient RU-486 to be sold in the United States. For millions of American women and their aborted children, it is not an anniversary to celebrate.

Before approval, RU-486 was heralded as an innovation that would “change the industry” and offer women a safe alternative to surgical abortion. Experience has shown that while the packaging and presentation are different, the end product is still the same – the loss of an innocent human life – and women have been exposed to a whole new set of physical dangers, risks that have also taken their own lives.

From the Abortion Industry’s point of view, all that matters is that percentage of chemically-induced abortions has increased. Though it started slowly, the numbers of chemical abortions has grown steadily increased, from about 70,500 in 2001, the first full year these were available, to 239,400 in 2011.

Thus chemical abortions represent nearly a quarter (22.6%) of all abortions performed in the United States.

For the rest of us, there are many other major concerns.

A “new” chemical abortion method

The RU-486 chemical abortion is actually a two-drug technique, one to kill the baby, the other to induce contractions to expel the dead baby. There are multiple steps involved, occurring over several days. It is bloody and painful.

In the FDA approved protocol, which the abortion industry has striven to avoid from day one, a pregnant woman, no more than 49 days past her last menstrual period (LMP), comes to the clinic. She is screened for possible red flags that would disqualify her (e.g., allergies to the drugs, chronic adrenal failure, bleeding disorders), receives counseling about what to expect. If all is clear, she takes three RU-486 pills (also known as mifepristone) there in the doctor’s office under the supervision of the physician.

This drug blocks progesterone and thus shuts down the baby’s life support system providing nutrition and hydration for the quickly developing child.

Under the FDA protocol, the woman then would come back two days later and take two tablets of misoprostol, a prostaglandin which, over the next few hours, stimulates powerful uterine contractions to expel the now emaciated baby. This part of the process can be exceedingly bloody and painful, in addition to being psychologically difficult as the mother encounters her aborted child.

This does not always happen right away. While about half of the women expel their dead baby within the first four hours, some women take a day, or even several days to abort. A certain percentage do not abort at all.

A third visit 14 days after the first confirms whether or not the abortion has occurred. If not, clinics seek to have the woman undergo a surgical abortion to complete the process.

The industry alters the protocol

Bowing to pressure from the industry, the FDA scrapped more stringent requirements that might have mandated ultrasounds and surgical training to handle complications, requiring only that a prescribing physician/abortionist be able to date pregnancies and refer a woman to qualified surgical backup.

Despite the hype and all the promises of new, simple, safe abortions, doctors found the new process complex and cumbersome. The abortion industry’s early dream of using the drug to make abortion more mainstream went largely unrealized. Few doctors added the drug to their practices, with most the business coming from abortion clinics merely adding the chemical method to their practices.

Sensitive to the resistance, the abortion industry tinkered with the protocol, trying to make the process less onerous, not for the mother, but for the clinic. First, they reduced the dose of mifepristone from three pills ($90 a pill) to one, doubled the dose of the cheaper misoprostol (a dollar or so a pill). This saved abortion clinics a lot of money and increased their profit margin.

Second, they eliminated the second visit entirely. The woman took the misoprostol at home and administered it to herself vaginally, rather than by mouth.

The industry claimed this was to help reduce painful side effects like nausea and diarrhea, but it was hard to miss that this freed up office space and time for the clinics as well.

The industry found the FDA’s 49 day cutoff date too restricting as well. It advised prescribers that the drugs could be used at 8 or 9 weeks LMP, or more.

Clinics also interpreted the FDA’s mandate that the drug be offered under a physician’s supervision rather loosely, so that pills dispensed under the authority of a regional abortionist might qualify. This enabled abortion giant Planned Parenthood to begin offering chemical abortions at many of its smaller, more lightly staffed clinics without surgical facilities.

Death plays no favorites

It was not long before reports of problems began to surface. Danco, the U.S. distributor of the drug (made in China), was forced to send out a letter in April of 2002 informing doctors that the FDA had learned of six women developing serious complications after taking the drugs, including two who died.

Three women suffered ruptured ectopic pregnancies and one of these women died. Two women suffered serious bacterial infections. One of those women died. One of the six–a 21 years old woman–had a non-fatal heart attack three days after taking her pills.

Doctors were cautioned to watch out for ectopic pregnancy. The abortifacient drugs do not abort ectopic pregnancies.

These turned out to be only the tip of the iceberg. Over the next few years, thousands of “adverse event reports” flooded the FDA, with news of hundreds of women hemorrhaging, dealing with serious infections, suffering from ruptured ectopic pregnancies. More than a dozen women died, and there were more deaths associated with use of the drug outside the United States. And that was of 2011!

In 2002 when a beautiful young teenager from California named Holly Patterson died of C. sordellii, what was supposed to an exceeding rare infection, the media took notice and questions began to be raised. The FDA and the U.S. Centers for Disease Control (CDC) convened a meeting in May of 2006 to investigate a sudden rash of such infections.

An inadequate government response

Evidence from researchers clearly showed a link between the drug-induced abortion process and the infections, and a sudden jump in the number of fatal C. sordellii infections since the abortion pill’s introduction in 2000. The government chose to look away, identifying pregnancy, not chemical abortion, as the risk factor!

The government demanded no immediate changes. It allowed previous modifications made to the label before the meeting, with additional warnings, and earlier advisory letters sent out to doctors by the distributor, to stand. Those letters gave cautions but denied any causal link, and the drug remained on the market.

Some prescribers (Planned Parenthood) modified their protocol to add antibiotics prophylactically (before the abortion) or to stop recommending vaginal self-administration (theorized as one way the bacteria was introduced). However, for the most part, the industry took this as vindication that they were not at fault.

Details are sketchy with the government and media largely losing interest with the “problem solved,” but injuries and deaths have continued to be associated with use of the drugs here in the U.S. and elsewhere.

An April 2011 FDA report requested by a U.S. Senator found more that 2,200 “adverse events” associated with use of the mifepristone/misoprostol combo with 14 known deaths in the U.S. and at least five more in other countries. Deadly infections killed eight of the 14 in the U.S.

Doctors keep their distance with web-cam abortions

The industry has responded by trying to expand use of the drug further. Planned Parenthood’s monster Midwest affiliate, Planned Parenthood of the Heartland, pioneered the “web-cam” abortion in Iowa. The abortionist is linked via a computer to would-be abortion patients at small storefront clinics that might be a hundred miles away or more.

After looking at her record and asking a few questions, the abortionist clicks a button that releases a locked drawer containing the pills at the woman’s location. She takes the mifepristone there and then takes the misoprostol home to administer to herself later.

She can call a hotline if she has any problems and go to her local Emergency Room for treatment if needed. She is never in the same room as her abortionist and he never actually physically examines her.

Abortion clinics in other states have sought to follow Iowa’s lead. But pro-lifers have pushed back, passing laws that reinstituted the original FDA protocol or mandated the doctor’s physical presence. These have met with mixed success so far, with some operational, others under some stage of judicial review. An effort by the Iowa Medical Board to put in place rules to protect patient safety and prohibit web-cam abortions were thwarted by the state supreme court earlier this year.

Increasing numbers in a declining market

The promotion of web-cam abortions and chemical abortions in general is just one prong of the abortion industry’s wider effort to expand the pool of abortion “providers” in a down market. Abortions have fallen from a peak of 1.6 million a year in 1990 to just over one million as recently as 2011. The number of practicing abortionists has also fallen, from a high of 2,818 in 1982 to 1,720 in 2011.

It is expected that the drop-off in “providers” would have been more significant if not for the new abortionists added with the introduction of RU-486 after 2000. The industry has made up for some of its losses not just with web-cams that allow one abortionist to “practice” in several locations at once, but by persuading states such as California to authorize nurses, midwives, and physician assistants to perform surgical or chemical procedures.

The less space, equipment, training, or responsibility required to perform a chemical abortion, the easier it for the industry to establish new abortion centers and find someone to facilitate these abortions.

As noted at the beginning, a lot of women have bought the sales pitch and have taken the drug. One reporter put the number of American women who have used it at 2 million (U.S. News & World Report, 9/15/15). Their experience, however, has not always matched the hype.

Making abortion more abundant, but not safer

A young mom named Angie “live tweeted” her RU-486 abortion in February 2010, hoping to “demystify” the process for others. As her arduous nightmare played out over the course of the next 11 days (she had originally expected the process to take 4-8 hours) – “Stupid cramps. Aren’t we done #livetweetingabortion yet?” – Angie showed no remorse. But, inadvertently, her example served as more of a negative than positive advertisement.

The industry will keep pushing these drugs, though. One international group, Women on Waves–unsuccessful in getting Irish and Polish women to motorboat out to its “Abortion Ship” anchored in international waters to have chemical abortions–has taken to stunts like flying “abortion drones” across the border and having non-pregnant women take the pills to protest the laws there.

The international abortion lobby has always seen chemical abortion as one of the ways to bring abortion into less developed countries where abortion may not be legal, just as they’ve seen RU-486 as a way to bring abortion to communities in the U.S. where it is not wanted and no respectable doctor wants to do them.

In 15 years, millions of babies have lost their lives due to this medical “innovation,” and so have too many of their mothers. It is an anniversary to mourn.

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