Thursday, October 29, 2009

Does the birth control pill cause abortions? "PART 3"

What do the Pill manufacturers say?


I asked an excellent pro-life physician, and a good friend, to call a birth control manufacturer concerning the statements in their inserts. He contacted Searle, whose package insert for their pill Demulen, says "alterations in the . . . endometrium (which may reduce the likelihood of implantation) may also contribute to the contraceptive effectiveness." (Note that Searle twice uses the term "may," in contrast to Ortho and Wyeth, which in their information in The PDR state the same effect as a fact rather than a possibility.)

Here is part of a letter dated February 13, 1997, written by Barbara Struthers, Searle's Director of Healthcare Information Services, to my pro-life physician friend:

Thank you for your recent request for information regarding whether oral contraceptives are abortifacients . . . . One of the possible mechanisms listed in the labeling is "changes in the endometrium which may reduce the likelihood of implantation." This is a theoretical mechanism only and is not based upon experimental evidence, but upon the histologic appearance of the endometrium. However, as noted by Goldzieher, the altered endometrium is still capable of sustaining nidation, as shown by pregnancies occurring in cycles with only a few or no tablet omissions.

Dr. Struthers (PhD) makes a valid point that the Pill's effects on the endometrium do not always make implantation impossible. But in my research I never found anyone who claimed they always do. The issue is whether they sometimes do. To be an abortifacient does not require that something always cause an abortion, only that it sometimes does. In fact, whether it's RU-486, Norplant, the mini-pill or the Pill, there is no chemical that always causes an abortion. There are only those that do so never, sometimes, often and usually. Thus, the point that the Pill doesn't always prevent implantation is true, but has no bearing on the question of whether it sometimes prevents implantation, which Searle's own literature indicates. (Children who play on the freeway, climb on the roof or are left alone by swimming pools don't always get killed, but this hardly proves these practices are safe and do not result in fatalities.)

Dr. Struthers goes on to say, "It is unlikely that OCs would decrease the likelihood of endometrial implantation, particularly when one appreciates that the blastocyst is perfectly capable of implanting in various 'hostile' sites, e.g. the Fallopian tube, the ovary, the peritoneum."

Her point is that the child sometimes implants in the wrong place. True enough -- but, again, no one is saying this doesn't happen. The question is whether the Pill sometimes hinders the child's ability to implant in the right place. (Whether the child implants in the wrong place or fails to implant in the right one, the result is the same -- death. But while in the first case the death is not caused by a human agent, in the second case -- by taking the Pill -- it can be.)

Dr. Struthers then says, "Used as directed, the hormone level in modern OCs is simply too low to cause interception, that is, failure of the blastocyst to implant."

If this is true, then why does the company's own literature -- produced by their researchers and submitted to the FDA, the medical community, and the public -- suggest the contrary? And why do dozens and dozens of scientific and medical sources I am drawing from in this article definitively state the contrary? If Dr. Struthers is right, not just some but all of these other sources have to be wrong.

Dr. Struthers further states, "Until the blastocyst implants . . . there would be no loss of an embryo and, therefore, no abortion. Thus, the theoretical mechanism of reduced likelihood of implantation by whatever means would not be considered an abortion by any biological definition."

Now we cut to the heart of her presuppositions. Having said implantation won't be pevented, she then says even if it is (why add this if it never happens?), the result isn't really an abortion. This statement is profound both in its breadth and its inaccuracy. It's a classic logic-class-illustration of faulty reasoning. It's like saying "Sudden Infant Death Syndrome does not affect toddlers; therefore, it does not involve the deaths of human beings." Such a statement assumes facts not in evidence -- that infants are not people because they are pre-toddlers. In exactly the same way Dr. Struthers begs the question by assuming -- without bothering to provide any evidence (there is none) for this assumption -- that pre-embryo human beings are not really human beings.

But if human life does begin at conception, which is the overwhelming biological (not to mention biblical) consensus, then causing the death of a "blastocyst" is just as much an abortion as causing the death (or she puts it, "loss") of an "embryo." The days-old individual is a smaller and younger person than the embryo, but he or she is no less a person in the sight of God who created him. (People do not get more human as they get older and bigger -- if they did, toddlers would be more human than infants, adolescents more human than toddlers, adults more human than adolescents and professional basketball players more human than anyone.)

Dr. Struthers says the "reduced likelihood of implantation by whatever means would not be considered an abortion by any biological definition." This statement is unscientific in the extreme. The biological definition she ignores is not just some obscure definition of life, but the precise definition which the vast majority of scientists, including biologists, actually hold to -- that life begins at conception. (See Appendix B: When Does Human Life Begin? The Answer of Science. An early abortion is still an abortion, and no semantics change this reality. (Though for some they do manage to obscure it.)

The letter from Dr. Struthers certainly contains some valid information along with the invalid. But how seriously can we take its bottom-line conclusions that the Pill is not an abortifacient? One physician I showed it to said a "healthcare information services director" is a public relations position with a primary job of minimizing controversy, denying blame, putting out fires, and avoiding any bad publicity for products with both with physicians and the general public. Perhaps this assessment was unfair -- I don't know. But on reading her letter I determined to personally call the research or medical information departments of all the major birth control manufacturers and hear for myself what each of them had to say.

When I called Syntex, they informed me that all their "feminine products," including the Pill, have recently been purchased by Searle. So I called Searle's customer service line, identified myself by name, and was asked to explain my question. When I said that it related to the Pill's mechanism of preventing implantation, the person helping me (who didn't identify herself) became discernibly uneasy. She asked me who I was (I gave her my name again) and then asked me to wait while she conferred with her colleagues. After several minutes she got back on the line and said "Dr. Struthers will have to talk to you about this, and she's not in."

Since Dr. Struthers was unavailable, I asked the woman if she could offer me any guidance. She said, uneasiness very evident, "By any chance are you asking about this for religious reasons?" I said, "Yes, that's part of it." She said, "Well, I can tell you that our pills are not abortifacients." I asked "then why does your professional labeling talk about the Pill reducing the likelihood of implantation?" She said, "I can't answer that question. You'll have to talk to Dr. Struthers." I left my number, but Dr. Struthers didn't call me back. Since I already had her position, as stated in her fax to my physician friend, I didn't call her back either.


Next I called Organon, the maker of the birth control pill Desogen. After explaining my question about their literature that says the Pill sometimes prevents implantation, I was handed over to Erin in medical services. She informed me "the primary mechanism is preventing ovulation." After my follow-up question, she said, "The other mechanisms also happen, but they're secondary." When I asked how often the primary mechanism fails and the secondary mechanisms kick in, she said "there's no way to determine the number of times which happens and doesn't happen."

Reading between the lines, Erin said, "If you're asking if it's an abortifacient . . . [pause]" I interjected, "Yes, I am." She continued, ". . . that's difficult to ever say that." She added, "What happens is, if ovulation occurs, the Pill will thicken the mucus and thin the endometrium so that it doesn't allow that pregnancy." She quickly added, "but it's not like the IUD." (Meaning, I took it, that preventing implantation is the primary function of the IUD, whereas it is only a secondary function of the Pill.)


Wyeth-Ayerst Labs is the maker of six combination Pills. I called and spoke with a medical information coordinator named Adrianne. I read to her the professional labeling of their Pills that says "other alterations include changes . . . in the endometrium (which reduce the likelihood of implantation)." I asked if she knew how often the Pill prevents implantation.

Once again it became obvious that I was pro-life, presumably because no one but a pro-lifer would care about this issue. Adrianne read to me a printed statement that said "these mechanisms are not abortifacient in nature." She carefully explained that inhibiting ovulation and thickening the cervical mucus were contraceptive, not abortive. Of course, I agreed 100%. She then said, reading from the statement in front of her, "while it is true that progestins do alter the uterine lining, this is not considered a contraceptive action of these methods. The fact that these methods are not 100% effective and successful pregnancies have occurred clearly demonstrate that successful implantations can occur."

Over the following ten minutes, Adrianne kept talking about the first two mechanisms. I kept asking about the third. Finally she said, "That occurs, but it doesn't prevent a pregnancy." I thought, that's true, it doesn't prevent a pregnancy, it actually ends a pregnancy, but I knew that wasn't what she meant. I then referred her back to Wyeth's professional labeling and pointed out once more the third mechanism. She followed along with her copy and said, "That third effect happens, but it's not considered a contraceptive action, because sometimes it fails to prevent pregnancy."

(Of course, she had already acknowledged that sometimes the Pill fails to prevent ovulation and sometimes the thickened cervical mucus fails to prevent the sperm from impregnating the egg. In the same way a visible pregnancy proves the third mechanism has failed, it proves the other two mechanisms have also failed. Yet they are still considered to be real mechanisms of the Pill, despite the fact they sometimes fail. Why shouldn't the third effect be treated the same way?)

I said, "According to your professional labeling, sometimes your Pills do prevent a fertilized egg from implanting -- is that correct or incorrect?" She paused for a very long time and I heard papers shuffling. Finally she said, "Yes, that's correct, but not always . . . that's why we can't say contraceptives are 100% effective."

I said, "Okay, let me try to summarize, and please correct me if I'm wrong. There are three different ways the Pill operates. #1 usually works. When #1 fails, #2 may work. When #1 and #2 fail, #3 may work. And sometimes all three fail."

She said "Yes, that's correct." She offered to send me information by mail and I gladly accepted the offer. (I had asked Searle and Ortho to do this but they said they didn't have anything they could send me.) She warmly invited me to call back if I needed any more information.

When I received the information in the mail, it contained three things. The first was a cover letter written by Robin Boyle, , R.Ph., Wyeth's Manager of Drug Information. It was clearly a form letter designed for those expressing concerns about abortion, and contained the precise contents that Adrianne quoted to me. Also enclosed was a colorful booklet entitled Birth Control with the Pill, which is designed "to be distributed only with Triphasil sample." In the section "How the Pill Works," it states "The pill mainly prevents pregnancy in two ways." It then speaks of only the first two mechanisms and makes no reference whatsoever to the third, which prevents implantation. (This booklet does not fall under the same FDA requirements of full disclosure that the professional labeling does.)

The detailed, fine print "professional labeling" was also enclosed, and, as reflected in The PDR, it does in fact speak about "alterations include changes in . . the endometrium (which reduce the likelihood of implantation)." It struck me as obvious that virtually everyone receiving this information would read the large print, attractive, colorful, easy-to-understand booklet (which makes no mention of the abortive mechanism), and almost no one would read the extremely small print, black and white, technically worded, and completely unattractive sheet -- the one that acknowledges in the fine print that the Pill sometimes causes abortions by preventing implantation.

It is safe to say that virtually none of Wyeth's consumers will read the highly technical study printed in a 1988 International Journal of Fertility article, by none other than Wyeth's own Regional Director of Clinical Research, who stated one way oral contraceptives work is "by causing endometrial changes that will not support implantation." (Dr. G. Virginia Upton, "The Phasic Approach to Oral Contraception," The International Journal of Fertility, volume 28, 1988, page 129.)


On March 24, 1997, I had a lengthy and enlightening talk with Richard Hill, a pharmacist who works for Ortho-McNeil's product information department. (Ortho-McNeil and Searle are the largest birth control pill manufacturers.) I took detailed notes. Hill was not guarded, was most helpful, and never asked me about my religious views or my beliefs about abortion. He informed me "I can't give you solid numbers, because there's no way to tell which of these three functions is actually preventing the pregnancy; but I can tell you the great majority of the time it's the first one [preventing ovulation]."

I asked him, "Does the Pill sometimes fail to prevent ovulation?" He said "yes." I asked, "What happens then?" He said, "The cervical mucus slows down the sperm. And if that doesn't work, if you end up with a fertilized egg, it won't implant and grow because of the less hospitable endometrium."

I asked him how many of the contraceptives available on the market are low dose. He said, "I don't have statistics, but I also work in a pharmacy and I can tell you the vast majority of the time people get low dose pills." He confirmed that there are some "higher dose" pills available, with 50 micrograms of estrogen instead of 20-35 micrograms, but said these were not commonly used. (Remember, even 50 micrograms is only 1/3 of the average estrogen dosage in pills of the 1960's, and is still low dose by those standards.)

I then asked Hill if he was certain the Pill made implantation less likely. "Oh, yes," he replied. I said, "So you don't think this is just a theoretical effect of the Pill?" He said the following, as I took detailed notes:

Oh, no, it's not theoretical. It's observable. We know what an endometrium looks like when it's richest and most receptive to the fertilized egg. When a woman is taking the Pill you can clearly see the difference, based both on gross appearance -- as seen with the naked eye -- and under a microscope. At the time when the endometrium would normally accept a fertilized egg, if a woman is taking the Pill it is much less likely to do so.

I asked Hill one more time, "So you're saying this is an actual effect that happens, not just a theoretical one?" He said, "Sure -- you can actually see what it does to the endometrium and it's obvious it makes implantation less likely. The only thing that's theoretical is the numbers, because we just don't know that."

The pills produced by Searle, Ortho, Wyeth and Organon are essentially the same thing, with only slightly different combinations of chemicals. The professional labeling is essentially the same. The medical experts at Searle, Wyeth and Organon were all quick to pick up my abortion-related concerns and attempted to defuse them. Despite this, the pharmacist at Ortho and the medical services people at Organon and Wyeth all three acknowledged as an established fact what their literature says, that the Pill sometimes prevents implantation. Dr. Struthers of Searle appears to deny this, but then explains that if it happens it isn't really an abortion. When I stack up these responses to the wealth of information I've found in my research, I am forced to believe the people at Ortho, Wyeth, and Organon, not Dr. Struthers at Searle.

While I know that some of what she said is wrong (including the notion that preventing implantation is not a real abortion), I hope and pray that Dr. Struthers is correct and that her position is more than just a careful public relations ploy to placate known pro-lifers and religious people. The totality of my research, however, convinces me her position is simply not based on the facts.

I think the key issue is whether the Pill's prevention of implantation is "theoretical" or actual. None of the other three manufacturers spoke of it as anything other than actual except Dr. Struthers at Searle, who said it is "a theoretical mechanism only." Pharmacist Hill at Ortho stated it was "not theoretical," but based on direct, measurable observation of the endometrium. Who is correct?

Imagine a farmer who has two places where he might plant seed. One is rich, brown soil that has been tilled, fertilized and watered. The other is on hard, thin, dry and rocky soil. If the farmer's wants as much seed as possible to take hold and grow, where will he plant the seed? The answer is self-evident. On the fertile ground.

Now, you could say to the farmer that his preference for the rich, tilled, moist soil is based on the "theoretical," because he has probably never seen a scientific study that proves this soil is more hospitable to seed than the thin, hard, dry soil. The farmer might reply, based on years of observation, "I know good soil when I see it -- sure, I've seen some plants grow in the hard, thin soil too, but the chances of survival are much less there than in the good soil. Call it theoretical if you want to, but we all know it's true!"

When Dr. Struthers points out some newly conceived children manage to grow in hostile places, this in no way changes the obvious fact that many more children will survive in a richer, thicker, more hospitable endometrium than in a thinner, more hostile one. In this sense, the issue isn't theoretical at all.

Several articles I read spoke of the mucus's ability to block sperm migration and presented as evidence the fact that the thickness of the mucus is visually observable. Of course, this appearance is not incontrovertible proof that it slows down sperm migration, but it is still considered valid evidence. Why would we question the validity of the endometrium's appearance?

Obviously, when the Pill thins the endometrium, and it certainly does, a fertilized egg has a lesser chance of survival. This means a greater chance of death. Hence, without question a woman's taking the Pill puts any conceived child at greater risk of being aborted than if the Pill wasn't being taken. Other than for reasons of wishful thinking, can anyone seriously argue against this?

We may try to take some consolation in believing that abortions happen only in theory. But we must ask, if this is a theory, how strong and credible is the theory? Once it was only a theory that plant life grows better in rich fertile soil than in thin eroded soil. But it was certainly a theory all good farmers believed in and acted upon, having every reason to believe it was true.

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