Ethics & Medicine: To the editor

Dr. Goodnough's commentary (Ethics & Medicine 17:1) is an important addition to the current debate about the oral birth control pill's (the Pill) postfertilization effects - which would be tantamount to an abortifacient effect to those who believe that valuable human life begins at fertilization (conception). However, we are concerned about several inaccuracies about medical facts in this paper and believe your readers will find this information useful.

Dr. Goodnough states that the rate of pregnancy on the Pill ". . . in the general population is 3% per year."1 Unfortunately, the data to which he refers did not account for elective abortions. In other words, women who get pregnant on the Pill and then abort are not counted in these data. One national analysis, based upon 1992 data from the United States, that did account for the underreporting of elective abortions reported that the unintended pregnancy rates during the first year of Pill use were at least 4% for "good compliers," 8% for "poor compliers," and up to 29% for some users. We find that most Pill-users and prescribers are unaware of these facts. Dr. Goodnough discusses what we have called the "turned-on-endometrium theory." The proponents of this hypothesis feel, like Dr. Goodnough, that "One would therefore expect the endometrium in an ovulatory cycle on the OCP (oral contraceptive pill) to be more receptive than the endometrium in an anovulatory cycle on the OCP."1 We have discussed elsewhere data that may refute this hypothesis.3 Dr. Goodnough does admit that this is only a theory and as such "is somewhat speculative."1 We feel it is more accurate to report that the "turned-on-endometrium" theory is completely speculative. There is, to our knowledge, no published, peer-reviewed data that supports this theory.

Dr. Goodnough inaccurately discusses both our views and the data about the increased risk of ectopic pregnancies in women who get pregnant on the Pill.1 We feel it is unfortunate that he only used an outdated secondary source of our data (he used the 2nd instead of the current 4th edition). We feel your readers may have been better served if Goodnough had used the primary reference - a peerreviewed, systematic review that we published in the Archives of Family Medicine, an American Medical Association journal.3 Unfortunately, this oversight led to several inaccurate statements. We will cite only one example: Goodnough says that we ". . . lump the progesterone-only minipill (POP) in with the combined estrogen and progesterone OCP."1 This is not true. In our paper, we clearly stated that of the available studies, we specifically excluded any that even might have included women taking POPs mixed into the COC group. We said, "Therefore, of the five available publications, only two allow review of the association of COCs with ectopic pregnancy. These two studies from seven maternity hospitals in Paris, France, and three in Sweden involved 484 women with ectopic pregnancies and 289 pregnant controls and suggest that at least some protection against intrauterine pregnancy is provided via postfertilization preimplantation effects."3 Our evidence-based and systematic review of this topic concluded, "Therefore, COC use seems to be associated with an increased risk of ectopic implantation or unrecognized loss of (embryos). We considered this level II.2 (good to very good) evidence."

For the reader seeking objective information, the peer-reviewed, systematic review of a subject may be of more value than a commentary, which may be more affected by the bias of the authors. This bias can be amplified in singleauthor commentaries - such as Dr. Goodnough's. Likewise, we have some concerns about Dr. Goodnough's ethical conclusions: Dr. Goodnough indicates his belief that prescribing a medication with a potential postfertilization effect, such as the Pill, is acceptable under the principle that ". . . if we prescribe (OCPs) to enough patients, more patients will be helped than hurt."' Indeed, in the practice of medicine, some risks are necessary. But Pill-takers unnecessarily put pre-born children at risk. In fact, the very survival of these children is at stake. Regardless of the actual risk percentage, which is uncertain, a sexually active woman runs a new risk of aborting a child, in an unrecognized fashion, every time she takes the Pill.

Furthermore, as we discuss below, she has a non-abortifacient option for birth control, such as modern, scientific, natural family planning (NFP), that can be as or more effective than the Pill. Dr. Goodnough discusses a patient's consent to use the Pill and states, "The fact that she consents and the embryo does not in no way lessens my responsibility."1 This does not lessen his responsibility, but increases it. If Goodnough believes that the embryo is fully valuable human life, how can he allow someone else's consent to put that pre-born child at risk to control his choice to prescribe the Pill? Even if the Pill does not usually cause an abortifacient effect, whenever it does it is just as real an abortion as if that were its primary effect.

Dr. Goodnough reviews our discussion about the Principle of Double Effect. Unfortunately, his incomplete review of the topic did not address what we consider to be the most important point of this principle: The argument about a possible abortifacient effect of the Pill ". . . certainly could be considered to fall under the category of disputable matters discussed in Romans 14:1-21. Objective, knowledgeable Christian observers would in all likelihood line up on both sides of the argument based upon a variety of subjective and objective criteria. However, the fourth principle of double effect has a corollary that must be considered. That corollary relates to alternatives. In other words, the principle is now being interpreted by some authors to make the contention that there must be no other way to produce the good effect."5

Goodnough does not discuss this information with his readers. Your readers should certainly be aware that several forms of natural family planning (NFP) have been found to have effectiveness rates comparable to oral contraceptives. One method that was developed at Creighton University in the United States has been medically studied over the last 20 years and has been reported in a large meta-analysis to be 96.8% effective at preventing pregnancy, taking into account user and teacher errors. As mentioned above, the Pill is at best 94% effective in actual use. The most recent study of this scientific approach to NFP concluded that pregnancy probabilities using this form of NFP compared favorably with those of other methods of family planning and that women did not need to have regular cycles to use NFP successfully.

Another effective form of NFP, the Billings Ovulation Method, is taught around the world in all sociocultural situations, and used successfully even by people who cannot read or write. NFP is noted by its users and advocates to promote love, romance, communication, prayer, spirituality and learning about natural, God-created reproductive mechanisms. Other advantages of NFP are that it is fosters communication and understanding between the man and the woman, develops co-operation between them and a sharing of the responsibility in this important matter of their children.11

In all these ways it improves a couple's relationship and helping them to grow in love and fidelity to each other. There is no evidence that the Pill provides these same benefits. Since there is a viable, safe and effective, non-abortifacient alternative to the Pill, this fact would appear to dissolve most arguments that the Pill, until scientifically proven to be non-abortifacient, should be or can morally be used by Christians for birth control. In fact, assuming that NFP is only as effective as the Pill (and not more effective), it would appear that most arguments to use the Pill, in view of the fact that it may have an abortifacient effect, would be reduced to arguments of convenience (for the Pill-user or prescriber) at the potential expense of pre-born human life.

Lastly, Goodnough indicates that the intent one has in prescribing or using Pill is an important consideration. He contends, "If the desired effect is prevention of conception by preventing ovulation, it is not accomplished by a bad effect and there are no alternatives that are safer." Indeed, most Pill prescribers don't intend to cause an unrecognized abortion. Nevertheless, while the intentions of those taking or prescribing the Pill may be harmless, the results can be just as fatal. In this sense, taking the Pill is analogous to playing Russian roulette, but with more chambers and therefore less risk per episode. In Russian roulette, participants usually do not intend to shoot themselves. Their intention is irrelevant, however, because if they play the game long enough they cannot beat the odds eventually someone dies. However, with Pill roulette, it is another person who may die. The fact that a woman will not know when a child has been aborted in no way changes whether or not it happens. The more Pills she takes, the greater her chance of having a silent abortion. The more a physician prescribes the Pill, the more likely he is to cause an unrecognized abortion.

Goodnough J.E. "Redux: Is the oral contraceptive pill an abortifacient? Ethics and Medicine 2001;17:37-51. Potter L.S. "How effective are contraceptives? The determination and measurement of pregnancy rates." Obstet Gynecol 1996;88(suppl 3):13S-235.

Larimore W.L., Stanford J.B. "Postfertilization effects of oral contraceptives and their relationship to informed consent." Arch Fam Med 2000;9:126-133. (http://archfami.ama-assn.org/issues/v9n2 /ffull/fsa8035.htI - last accessed 9/6/01)

Alcorn R. Does the Birth Control Pill Cause Abortions? (2nd Ed.) (Gresham, OR: Eternal Perspective Ministries, 1998). (http://www.epm.org/bcp.html - last accessed 9/6/01).

Larimore W.L. "The abortifacient effect of the birth control pill and the principle of 'double effect'. Ethics and Medicine 2000;16(1):23-30.

Prospective European Multi-Center Study of Natural Family Planning (1989-1992): interim results. "The European Natural Family Planning Study Groups." Adv Contracept 1993 Dec; 9(4):269-83.

Hilgers T.W., Stanford J.B. "Creighton Model NaProEducation Technology for Avoiding Pregnancy. Use effectiveness: a meta-analysis." J Reprod Med 1998;43:495-502.

Howard M.P., Stanford J.B. "Pregnancy Probabilities During the Use of Creighton Model Fertility Care System. Arch Fam Med 1999 Sep-Oct.;8(S):391-402. (http://archfami.ama-assn.org/issues/v8nS/ ffull/foc6083.htmI - last accessed 9/6/01)

Klaus H., Goebel J.M., Muraski, B., Egizio M.T., Weitzel D., Taylor R.S., Fagan M.U., Ek K., Hobday K. "Use-effectiveness and client satisfaction in six centers teaching the Billings Ovulation Method." Contraception 1979;19(6):613-29.

11 Bhargava H., Bhatia J.C., Ramachandran L., Rohatgi P., Sinha A., "Field trial of Billings Ovulation Method of natural family planning." Contraception 1996 Feb;53(2):69-74).

11 Stanford, J.B. "Sex, Naturally." First Things. November, 1999; 28-33. (http://www.firstings.com/ftissues/ft9911/articles/stanford.html - last accessed 9/6/01).

Fleischmann R. The Christian and Birth Control: The Pill. (Milwaukee, WI: WELS Lutherans for Life, 1999). (http://www.wels.net/wlfl/bible/biblstdy/pill.htm - last accessed 9/6/01)

Walter L. Larimore, MD, is Associate Professor of Community and Family Medicine, University of South Florida, Tampa, Florida, 8605 Explorer Drive, Colorado Springs, Colorado 80920, USA Larimowl@fotf.org

Joseph D. Stanford, MD, MSPH, is Associate Professor of Family and Preventive Medicine, University of Utah Health Research Center, 375 Chipeta Way, Suite A, Room 216, Salt Lake City, Utah 84108, USA jstanford@dfpm.utah.edu