Advocates Nervous About Deaths Associated with RU486

Part One

Editor's note. When this three-part series originally ran, we had a number of computer snafus. The information is extremely important, so the author, NRLC Education Director Dr. Randall K. O'Bannon, has put the three parts all together in one edition. I promise, you will enjoy and learn a great deal.

So much evidence has surfaced that RU486 is dangerous to women that even the New York Times wrote an editorial this week conceding that recent deaths make "the regimen based on RU-486 looks a lot less attractive than once thought."

Long recognized as the media arm of the pro-abortion movement, the Times' April 10 editorial said that deaths associated with the two-drug abortion technique have "alarming and puzzling characteristics." The editorial writer even suggests that "health authorities" need to investigate to find out the precise cause of these deaths and infections.

The Times says "women seeking an abortion will need to weigh the risk and benefits carefully before deciding which method [chemically-induced versus surgical abortion] to choose." It argues that the danger is relatively "slight," but warns that "for a few women" the abortion pill could prove "catastrophic."

However, the Times still says that calls to pull the drug off the market are "premature."

Yet the change in tone is a remarkable turnaround from the days when the Times was bashing pro-life opposition to RU486 and declaring the pill "a breakthrough for better access to safe, legal abortions" (editorial, 9/30/00). Why the change? Has the Times had second thoughts about its aggressive abortion advocacy?

Hardly. What the Times is doing fits into a larger strategy. Pro-abortion advocates are trying to buy time for the now embattled drug and to refocus attention on another drug which is part of the process and how that drug has been administered.

If successful, changes already made by Planned Parenthood, the nation's largest abortion chain, and clinics that follow PPFA's lead in how the drug is administered (the protocol) would let RU486 stay on the market. (The changes bring the protocol closer to what the FDA originally recommended.) If the FDA doesn't buy the feint, then the agency could consider yanking the drug's approval.

Tinkering with the Protocol

When the FDA first approved RU486, it specified a certain time frame and set a particular protocol for how it was to be used. As to timing, use was limited to pregnant women who were no more than 49 after their last menstrual period (LMP). Though tested at later dates, "effectiveness" was shown to drop off considerably after 49 days.

Used alone, RU486 only "worked" about three or four times out of five. Abortionists began using it in tandem with another drug, a prostaglandin, taken two days later which stimulated powerful uterine contractions to expel the now emaciated child. This increased "effectiveness to over 90%.

The protocol approved by the FDA in 2000 had women receiving three RU486 pills the first day and coming back on day three to take two tablets of Misoprostol, a prostaglandin. Both drugs were to be taken orally in the doctor's office.

A third visit two weeks after the first was part of the FDA protocol to make sure there had been a complete abortion.

Almost immediately after approval was granted by the FDA in September of 2000, the abortion industry began to tinker with the protocol, making things cheaper and more convenient for the clinics.

In October of 2000, the National Abortion Federation (NAF) published its own protocol, which included "alternatives to the FDA-approved regimen" it said were "supported by scientific studies." Many clinics, including some run by Planned Parenthood, began to adopt elements of the alternative protocol pushed by the NAF.

Instead of three RU486 pills, which ran about $90 a piece, many of the clinics began giving out just one pill. They doubled the dose of the prostaglandin (called Misoprostol), which was only a couple of dollars a pill. To spare women (and clinics) the inconvenience of a return visit, women were given the misoprostol to take at home.

They were instructed to administer it to themselves vaginally, rather than orally, at any time from 1-3 days after taking the RU486. This recommendation was supposedly based on scientific studies showing that vaginal administration (with the altered dosages) was more effective and had fewer troubling side effects.

Finally, in what can hardly be imagined to be anything but a crass ploy to expand the customer base, many in the abortion industry began offering chemically induced abortions to women up to 63 days LMP (or in some cases, more).

Everything's Fine, Until Women Start Dying

Early on, the abortion industry talked about how many women had used the two-drug abortion technique "safely," and bragged about how "satisfied" women were with the new method. They celebrated the "expanded choice" RU486 gave women and openly expressed hopes that the drug would help the industry expand the pool of abortion "providers."

Then women began to die.

First, in September 2001 a woman in Canada participating in trials of the drug died of a rare infection. Then, days later, a woman taking RU486 in Tennessee died when her undetected ectopic pregnancy ruptured. The industry dismissed these as uncharacteristic aberrations and the press gave them little or no attention.

The death of a teen, Holly Patterson, in California in September of 2003, finally garnered some national attention. Predictably, the abortion industry tried to pass this off as rare, insisting the death be put in the context of what they claimed were hundreds of thousands of safe uses. The distributor, in its communications with doctors and the press, tried to emphasize that "no causal relationship" between the deaths and RU486 had been established.

Questions began to be raised, however. The FDA was on the case, investigating the causes.

In 2005, the FDA announced that it had determined that Holly Patterson, along with three other women from California, had died of Clostridium sordellii infections after their RU486 abortions. In March of 2006, the FDA announced that another two patients who had taken RU486 had died (the death of one was later determined to be unrelated to her abortion). By this juncture even long-time stalwarts in the abortion industry began to publicly question the safety of the chemical method (New York Times,4/1/06

Inherent problems with the process

What is so often ignored is that the process itself was and is highly problematic. Virtually every chemical abortion comes with substantial pain and bleeding. Many are accompanied by gastrointestinal side effects such as nausea, diarrhea, and vomiting. To the callous these can be labeled inconveniences for some women, but these sometimes turn into risky complications for others.

These symptoms, however, are nearly identical to signs of other more serious problems such as infection or ruptured ectopic pregnancy. With both patients and doctors expecting these as typical side effects of the chemical abortion process, they easily might fail to consider or check for other causes like infection or ectopic pregnancy until dangerously late. It is clear that this happened in many of the cases mentioned above.

Pro-lifers had argued from the beginning that the RU486 was dangerous. Beyond the fact that RU486 is an artificial steroid, it was only a matter of common sense that a drug designed to take the life of the innocent child in a mother's womb might also have negative effects on the woman who took it as well.

Add to this the effect of multiple drugs on a woman's body, affecting multiple body systems, the complicated, multi-step, drawn out process, and you have the ingredients for problematic side effects complicated by the inability or unwillingness of women to comply with a complicated regimen.

RU486 abortions are bloody and painful. When it became known in September of 1995 that a woman in the U.S. trials lost half her blood volume in November 1994, pro-lifers warned that it was only a matter of time before American women began to lose their own lives. Sadly, it was the pro-lifer's warnings, not the glib assurances of the abortion industry and their media cheerleaders that proved prescient.

The abortion industry's spin on the number of "safe uses"

As pressure on the abortion industry has mounted, along with fears that the FDA or Congress might act to withdraw the drug, the abortion industry scrambled to defend the drug's safety and to divert attention away from RU486 and onto misoprostol, the prostaglandin used in the second stage.

With each new revelation of another chemical abortion patient's death, Danco, RU486's U.S. distributor, issued statements about how many women had used the drug safely, putting the number at over a half a million in its latest public statement. But Danco bases its usage figures on the number of doses it has sold and shipped to clinics, not on the number of women who have actually taken the drug.

At the same time, deaths and injuries may be vastly undercounted. Though women typically receive their pills at the abortion clinic, when they start to have problems they are likely to go to their local emergency room rather than return to the abortion clinic.

They may tell the attending physician that they've taken the abortion pill, or they may not. Some may not be in a condition to tell the doctor anything. If the woman dies, or suffers some sort of serious complication, it may never be reported to the coroner or to the FDA as abortion-related.

The upshot of all this is that there may have been substantially more than the six American deaths and at least 850 "adverse events" (complications ranging from mild or moderate to severe or life threatening or death). One of the FDA's own experts has estimated that, generally, only one to ten percent of adverse events is ever reported to the FDA (Claudia Karowski, FDA Hearing on "Safety Issues Related to Acetaminophen," 9/19/02).

Shifting blame to misoprostol

Realizing that claims of all the safe uses of the drug rang hollow against the backdrop of the faces and stories of real women who had died after taking the drug (and facing lawsuits from some of their families), the abortion industry had to act quickly to give the appearance of doing something to address the problem before the government stepped in and pulled the drug altogether.

Danco, the distributor, sent out letters to doctors after the earlier deaths telling them to watch out for infections and reminding them of the FDA protocol. However, Danco still claimed that "no causal relationship" between the use of the drugs or the variation in the protocol and the deaths had been established.

Planned Parenthood, the nation's largest abortion provider and one of the organizations taking the lead in promoting RU486, went further. PPFA announced that its clinics would no longer be recommending the vaginal self-administration of misoprostol, the prostaglandin used in the second step.

Oft quoted abortion researcher Philip Darney chimed in. Darney said he suspected that vaginal self administration of the prostaglandin was the culprit. This would seem to be transparent effort to heap all the blame on the change in the misoprostol protocol which had women both taking more of the prostaglandin and self-administering it vaginally.

While there is reason to think the irresponsible deviations from the FDA protocol may have contributed to the danger of the method, and that vaginal self administration could be a factor in how germs were introduced into the reproductive tract, RU-486 itself has properties which may reduce a woman's immune system and make her body more susceptible to infections.

Serious concerns about RU-486 itself are not new. Nor are they confined to pro-lifers. As far back as 1991, in a book titled RU-486: Misconceptions, Myths, and Morals, a team of pro-abortion feminists passionately opposed its use. The team included noted Australian medical researcher Lynette Dumble, a specialist on immunosupression.

In September 2005, retired Brown University professor of molecular pharmacology Ralph Miech wrote an extremely important article in the Annals of Pharmacotherapy that outlined the possible mechanisms involved in RU-486's suppression of the immune system. As explained in the December 2005, edition of Life Insights, "Dr. Miech describes two ways RU-486 may interfere with the innate immune system, contributing to the development of an infection and disrupting the innate immune system's ability to fight the infection successfully."

By dropping the vaginal administration of the prostaglandin, misoprostol, proponents are trying to sidestep the whole issue of RU-486's impact. In so doing the abortion lobby hopes that this will buy time for the RU-486 method, convince the FDA that steps have been taken and that it need not do anything further, and hope that no one else happens to die in the meantime.

If what the pro-abortion feminists and the Ivy League professor say is accurate, however, then changes in the protocol will not protect women from the dangers posed by the abortion drug combination. Women will continue to die.

Two different drugs, two different backgrounds

RU-486 and misoprostol are parts of the process approved by the FDA in 2000, but there are important differences in how the government, the market, and hence, the abortion lobby sees the drugs.

RU-486 is produced in China, imported to the U.S., and distributed by a one-product company, Danco Laboratories. Danco was set up the Population Council, a longstanding international population control lobby that holds the U.S. license to the drug.

RU-486 is sold under the brand name "Mifeprex" in the U.S. A standard dose of three pills runs about $270. This alone is nearly what it costs for a standard first-trimester suction aspiration abortion (about $372). This figure for the pills does not include the added costs of multiple doctor visits.

Misoprostol, on the other hand, is a prostaglandin produced and marketed by a pharmaceutical giant named Pharmacia, which has a lot of other drugs on the U.S. market. It is marketed under the brand name "Cytotec" as an anti-ulcer medication for those taking a lot of non-steroidal anti-inflammatory drugs, such as patients with arthritis.

It has never been marketed by its parent company as an abortifacient or as an aid to chemical abortions. The company has never submitted an application to the FDA for that sort of use. Misoprostol pills cost only a couple of dollars each versus $90 per RU-486 pill.

Misoprostol has been sold on the black market and used as a stand alone abortifacient in South American countries. But its "success" rate is far from perfect and studies have found its use associated with sometimes severe developmental malformations in the babies who survive the attempted abortion.

Because misoprostol has other safe, legitimate uses, the FDA is not likely to pull the drug off the market. Despite occasional studies trumpeting RU-486's other possible uses, neither Danco nor the Population Council has ever sought FDA approval for any use besides abortion.

If RU-486 is implicated, or the whole two-drug method in the deaths of women, the FDA could pull approval. RU-486 would be withdrawn from the market.

However, if the blame could be shifted to the prostaglandin, and particularly to its vaginal administration (which is "off label"), then clinics could simply drop that element of the protocol and RU-486 could continue to be sold. Furthermore, lawsuits could then be borne by a company with deep pockets such as Pharmacia, rather than a single product company such as Danco, which has little to lose financially.

If worse comes to worse, and the FDA were to decide that problems with misoprostol were serious enough to withdraw approval for the chemical abortion method, RU-486's licensors could simply offer to switch to a new prostaglandin without a record of safety problems. Whether this would allow the distributor to avoid a new, full FDA review of the new combo is unknown, but Danco could argue that the record of its own drug was clean.

Other prostaglandins have been used in tandem with RU-486 in Europe, although most prescribers there have since switched to the milder misoprostol. Several new prostaglandins have been introduced to the market since misoprostol debuted in 1988.

Will the diversion succeed?

The abortion industry has a lot invested in RU-486 and has already gone to great lengths to protect the drug's (and the industry's) image. It has no such allegiance to misoprostol or its manufacturer, although it needs some prostaglandin to boost RU-486's abortifacient "effectiveness."

Investigations, warning letters to doctors, a partial return to FDA protocols all help to buy the industry time and give the impression that the industry is taking steps to resolve the safety problems. If the deaths (or more accurately, reports of deaths), which have been sporadic, temporarily abate, the abortion industry can declare the problem solved. They would switch topics--talk about all the "hundreds of thousands" more who have used the drug safely, look for a better chemical combo, and just hope that Americans will accept an occasional death as part of the cost of the convenience of the chemical option.

It isn't that far of a stretch. After all, the abortion industry and its accomplices in government, academia, the arts and the media have had some success in selling the culture of death in America in the last thirty years. Forty seven million abortions are proof of that.

In the end, however, the truth will win out. Abortions have decreased as women have learned more about the development of their unborn babies and heard about life preserving alternatives to abortion.

Support for abortion has fallen once people understood the horrors of partial-birth abortion. Likewise, the image of and demand for this "new and improved" chemical abortion method will fall once word gets out of the nightmare every woman who takes the dangerous drug combination suffers, and the all too real risk of injury and death many of these patients will face.

Spin and stalling and misdirection may work for a while, but may prove insufficient the next time the death of a new RU-486 patient hits the headlines.

Part One