Catholic: Ectopic Pregnancy

On February 8th I said the following on Facebook:

Many Catholics use birth control. I suspect that even though doctrine commands that a woman should die rather than terminate her ectopic pregnancy, most Catholic doctors and most Catholic women choose to terminate the pregnancy. Does anyone know a Tebow like testimony where a woman chose to die from her ectopic pregnancy? 

I misunderstood the following section of the Catholic Encyclopedia.

After these and other similar decisions had been given, some moralists thought they saw reasons to doubt whether an exception might not be allowed in the case of ectopic gestations. Therefore the question was submitted: "Is it ever allowed to extract from the body of the mother ectopic embryos still immature, before the sixth month after conception is completed?" The answer given, 20 March, 1902, was: "No; according to thedecree of 4 May, 1898; according to which, as far as possible, earnest and opportune provision is to be made to safeguard the lifeof the child and of the mother. As to the time, let the questioner remember that no acceleration of birth is licit unless it be done at a time, and in ways in which, according to the usual course of things, the life of the mother and the child be provided for". Ethics, then, and the Church agree in teaching that no action is lawful which directly destroys fetal life. It is also clear that extracting the living fetus before it is viable, is destroying its life as directly as it would be killing a grown man directly to plunge him into a medium in which he cannot live, and hold him there till he expires.

However, if medical treatment or surgical operation, necessary to save a mother's life, is applied to her organism (though the child's death would, or at least might, follow as a regretted but unavoidable consequence), it should not be maintained that the fetal life is thereby directly attacked. Moralists agree that we are not always prohibited from doing what is lawful in itself, though evilconsequences may follow which we do not desire. The good effects of our acts are then directly intended, and the regretted evilconsequences are reluctantly permitted to follow because we cannot avoid them. The evil thus permitted is said to be indirectly intended[1]

I misinterpreted the Catholic Encyclopedia which never should be taken as a modern source anyways. This is lazy research on my part.  The position in the Catholic Encyclopedia and the modern position is that a mother can be saved by removing the tissue around the ectopic pregnancy thereby indirectly killing the embryo.

ABC: Baby Born Deformed After Misdiagnosed Ectopic Pregnancy

Rachel Schoger of Caldwell, Idaho, had been trying to have a baby for two years and eight months -- a grueling wait interrupted by three positive pregnancy tests and three unexplained miscarriages.

After a fourth positive test, she went to her doctor for answers. The news was devastating. "It's ectopic," Schoger recalled the doctor saying after a hormone test and an ultrasound. "I was so upset because we'd been trying for so long."

An ectopic pregnancy is one that occurs outside the womb, usually in one of the fallopian tubes. Because the fetus cannot survive and the mom could suffer life-threatening internal bleeding, ectopic pregnancies, which may account for as many as one in 40 pregnancies, are terminated at the earliest sign. Schoger's doctor recommended using methotrexate -- a chemotherapy drug that would save her and her fallopian tube, and kill the doomed fetus.

"I have three other kids at home," said Schoger, who was 29 at the time. "I couldn't take the risk."

Schoger was given two high-dose shots of methotrexate in the fatty tissue above her hips to abort her pregnancy, which was four weeks and five days along. Days later, she started having nightmares about a baby crying out in pain inside her. So when she returned to the doctor for a second round of shots a week later, she insisted on a follow-up ultrasound for peace of mind.

"I needed it to calm me down, to know I was doing the right thing," she said.

As the ultrasound technician rolled the probe over Schoger's pelvis, her jaw suddenly dropped. Schoger was still pregnant, and the fetus was in her uterus where it belonged.

Despite advances in medical imaging, roughly 40 percent of pregnancies diagnosed as ectopic are later revealed to be normal, intrauterine pregnancies, according to a 2002 study published in the journal Obstetrics and Gynecology.

And for women treated with methotrexate, the lapse can be catastrophic.

"Those fetuses that are misdiagnosed as ectopic and were actually in the uterus receive high doses of a teratogenic drug during early stage of development, and that causes malformations," said Dr. Yaron Finkelstein, an emergency physician at Sick Kids Hospital and associate professor of pharmacology and toxicology at the University of Toronto. "This is a serious problem, and one that's probably overlooked."

Finkelstein and colleagues described the effects of methotrexate on eight misdiagnosed ectopic pregnancies in a study published in the January issue of the American Journal of Obstetrics and Gynecology. Three of the pregnancies ended in miscarriage within two weeks after the injection; three were terminated surgically after the mothers were warned of the potential birth defects; and the remaining two were born -- one stillborn at 30 weeks, the other born with severe malformations at 37 weeks... [1]

Mifepristone and Ectopic Pregnancy

Mifepristone involves one or two doctor visits.  During the initial visit the doctor will conduct a physical exam to determine whether or not that you are pregnant.  During this exam the doctor is supposed to be looking for signs of an ectopic pregnancy.[1]  A pregnancy test can tell that you are pregnant, but not where you are pregnant.[2] 

1.5% to 2% of pregnancies are ectopic.  Ectopic pregnancies are fatal 0.5 out of 1000 pregnancies. These account for 6% of all maternal deaths.  Most of these deaths could be prevented through early diagnosis and treatment.[3]  This diagnosis is supposed to be near the top of the doctor's priorities.  The FDA report notes the following.

Administration of mifepristone and misoprostol is contraindicated in patients with confirmed or suspected ectopic pregnancy (a pregnancy outside the uterus).[4]

A "contraindication" literally means "against an indication".[5] The FDA forbids use of mifepristone to be prescribed to a woman with a confirmed or suspected ectopic pregnancy.  The mifepristone will only work on uterine pregnancies.

The FDA documents several cases among the 1,520,000 women where the ectopic pregnancy was not found by the doctor.  Two women died when their ectopic pregnancies ruptured.  Another 58 women had their ectopic pregnancies missed and some of these women had to be hospitalized.

These could have been avoided if the recommended ultrasound had been used.

Flashback to Gardasil

With all the reading that I have been doing about Mifepristone, I thought that it would be interesting to compare the adverse events to Gardasil, one of the HPV vaccines.

According to the April 2011 FDA report. Since September 2000 there were a total of[1]

• About 1,520,000 women had taken mifepristone
• 2207 Adverse Events including
• 14 Deaths
• 8 deaths from sepsis
• 2 deaths from ruptured ectopic pregnancy
• 1 case each of substance abuse/drug overdose, methadone overdose, 
• 1 suspected homicide, 
• 1 delayed onset of toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and fibroid cultures were positive for Prevotella)
• 58 ectopic pregnancies
• 339 cases of blood loss so severe that they required transfusions
• 256 Infections
• 48 cases of serious infections

Gardasil was approved June 2006 and as of June 2011[2],

• 35,000,000 doses have been dispensed meaning that about half of girls 13 to 17 have received at least one dose of their three doses.[3] 
• 18,727 Adverse Events including
• 92% included fainting, pain, and swelling at the injection site (the arm), headache, nausea, and fever.Syncope (fainting) is common after injections and vaccinations, especially in adolescents.
• 8% were severe adverse events that included hospitalization, permanent disability, life-threatening illness, congenital anomaly or death
• 68 deaths
• 54 females 
• 3 males
• 11 unknown gender
• 32 deaths have been confirmed while 34 have not been confirmed, because of lack information in the report.

The Mifepristone adverse events would easily qualify as severe adverse events in the CDC research.  As with the Gardasil severe adverse events, the Mifepristone adverse events cannot be proven to have a casual relationship to the drug.  Also they are both extremely rare.  99.92% of those that take Gardasil and 99.85% of those that take Mifepristone will not have these events.  Both of these are exceptionally safe medications.  

A Brief look at Mifepristone 2004 & 2011

In 2004 the FDA updated it's warning label to mention that women had died of rare fatal infections after taking mifepristone.  Though no causal relationship could be established for the two women who had died from sepsis, the FDA thought that patients and doctors should be warned.[FDA]


In 2004 360,000 women had taken mifepristone since it came on the market in 2000. There were some adverse events.[1]

• The F.D.A. has received 676 reports of problems with the drug, including
• 3 Deaths  
• 2 deaths from sepsis 
• 1 death from a ruptured ectopic pregnancy
• 17 ectopic pregnancies 
• 72 cases of blood loss so severe that they required transfusions 
• 7 cases of serious infections

Again there were no causal relationships.  Now let us fast forward to the April 2011 FDA report.  Since September 2000 there were a total of[2]

• About 1,520,000 women had taken mifepristone
• 2207 Adverse Events including
• 14 Deaths
• 8 deaths from sepsis
• 2 deaths from ruptured ectopic pregnancy
• 1 case each of substance abuse/drug overdose, methadone overdose, 
• 1 suspected homicide, 
• 1 delayed onset of toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and fibroid cultures were positive for Prevotella)
• 58 ectopic pregnancies
• 339 cases of blood loss so severe that they required transfusions
• 256 Infections
• 48 cases of serious infections

In the last six years,

• The number of women who have taken mifepristone has quadrupled 360,000::1,520,000
• The Adverse Events have tripled 676::2207
• The deaths from sepsis have quadrupled 2::8
• The deaths from ectopic pregnancy double 1::2
• Ectopic Pregnancies increased 341% 17::58
• The cases of blood loss requiring a transfusion increased by 470% 72::339
• The serious infections increased by 685% 7::48

About 0.15% of the women who have taken the drug experience adverse events.  Remember this is all cumulative.

FDA reports 2,207 Adverse Events from the 1.52 million women who have taken RU-486

Steven Ertelt of Life News is claiming the following about a FDA report released last April entitled, Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2011:

The report indicates 14 women in the United States alone have died from using the mifepristone abortion drug and 2,207 women have been injured by it.[1]

If Steven had said 14 women in the United States alone have died using the mifepristone abortion drug, he would be correct.  However he said, "14 women in the United States alone have died from using the mifepristone abortion drug".  By adding from he implies that the FDA report established a causal link.  Steven may indicate this, but the report itself does not.  Here is what the FDA said in their report.

These events cannot with certainty be causally attributed to mifepristone because of information gaps about patient health status, clinical management of the patient, concurrent drug use and other possible medical or surgical treatments.[2]

Steven can say that these events happened from "the mifepristone abortion drug", but the FDA was very clear in the report that they cannot establish this.  I would not necessarily say that Steven is lying, but he is saying the report said something that it did not.

Why can the FDA not say these events were caused by the drug?  They did not run the study.  In a study, you formulate a hypothesis and test it via an experiment.  In a drug study, you need a placebo and a control group among other things.  This document is not a study, it is a report.  The FDA simply compiled a list of adverse events that happened to women who took the drug.  They did not run a study to see if these adverse events were caused by the drug.  As we go through the report I think you will see what I mean.

First let us look at the 14 deaths. Remember this data was collected from September 2000 to April 2011.  An estimated 1.52 million women took mifepristone over this period of almost eleven years. About 0.15% of the women who have taken the drug experience adverse events. These 14 amount to about 0.0009% that died after taking the drug.

"Deaths were associated with sepsis in eight of the 14 reported fatalities "

• "7 cases tested positive for Clostridium sordellii, 
• "1 case tested positive for Clostridium perfringens."

According to the CDC, Clostridium sordellii sepsis is rare and occurs most of the time in patients with underlying conditions.[3]  Women are at their highest risk of infection following the end of pregnancy.

Women are at highest risk of infection from C. sordellii following the end of pregnancy, whether that pregnancy ended in a live birth, induced abortion (medical or surgical), or spontaneous abortion (miscarriage). Fatal infections with C. sordellii and C. perfringens have occurred after medical abortion. In some cases, women can carry the bacteria, but not be infected (known as colonization). The rate of vaginal colonization (when bacteria are present, but not causing an infection) with Clostridium species in the period after abortion has been reported to be as high as 29%, whereas these bacteria have been isolated in the vaginal secretions of 5%-10% of non-pregnant women. Researchers continue to study what percentage of women carries vaginal or rectal C. sordellii and C. perfringens before and after abortion, as well as during pregnancy.

These seven women had just ended their pregnancy through a medical abortion and likely are some of the reported fatal infections. Still, there is no definite causal link.  Perhaps their deaths were from mifepristone.  Perhaps they died simply from an infection attained from ending their pregnancy. Medically it is very hard to prove that seven deaths were a result of a medication.  These seven deaths were spaced out over almost eleven years.  

One woman died of  Clostridium perfringens sepsis.  According to the Louisiana's Department of Health & Hospitals, 

Clostridial sepsis is an uncommon but almost invariably fatal illness following clostridial infection primarily that of the uterus, colon, or biliary tract. This entity must be differentiated from transient clostridial bacteremia, which is much more common. C. perfringens causes the majority of cases of both sepsis and transient bacteremia.[4]

 This fatal infection was probably included in the CDC quote above.  Again, causality has not been proven and it is hard to prove causality with one death over almost eleven years.

The six remaining U.S. deaths involved unique events;

• there was one case each of substance abuse/drug overdose, methadone overdose, 
• suspected homicide, 
• and a delayed onset of toxic shock-like syndrome (uterine cultures were positive for Peptostreptococcus and fibroid cultures were positive for Prevotella), 
• and there were two cases of ruptured ectopic pregnancy.  

This is what I mean about these adverse events happened when they took the drug, not necessarily because they took the drug.  One of these women was most likely not a victim of a suspected homicide, because she took mifepristone.  Some of these events seemingly have nothing to do with mifepristone.