Dear Editor,

In reference to the recent articles and letters on the cancer drug trial for "Tarceva" several critical points need to be acknowledged in the debate.

If patients enrolled in the upcoming trials are in a sexual relationship they have a right to know the scientific reality that IT IS IMPOSSIBLE TO AVOID PREGNANCY with one hundred percent reliability. Every single method of contraception has a pregnancy rate WITHOUT EXCEPTION.

True contraceptive failure rates are extremely misleading as two different sets of figures can be quoted regarding contraceptive efficiency. The figures that are generally quoted by drug companies, doctors and pharmacists are the "Theoretical use effectiveness" which always overstates contraceptive efficacy. The figures that people need to understand and accept are the imperfect, Real Life or "Actual use effectiveness" which lets you know in practice how many pregnancies will occur in a population that use contraceptives. This figure is much higher, but it is real, not theoretical.

A study by The Alan Guttmacher Institute in New York has shown that 8% of women using the Oral Contraceptive Pill will become pregnant each year despite taking the pill and wanting to avoid pregnancy. (Ref 1) In direct quotation from the referenced study "When contraceptive methods are ranked by effectiveness over the first 12 months of use (corrected for abortion under-reporting), the implant and injectables have the lowest failure rates (2-3%), followed by the pill (8%), the diaphragm and the cervical cap (12%),the male condom (14%)."

It is certain that some of the patients in the proposed study will conceive if they continue in a sexual relationship, despite using contraception to avoid pregnancy. The question is how many will conceive and what do you do at that point? Is the woman advised to have an abortion so that the drug company will not be held responsible for the harm to the baby if it is brought to full term? If the pregnant woman brings the baby to term and it is handicapped in some way, how can she be compensated?

According to International Planned Parenthood and the Irish Family Planning Association, the failure rate of contraception makes ABORTION NECESSARY as a means of dealing with unwanted and unplanned pregnancies. In 1994 in the USA there were 2.1 million pregnancies which occurred as a result of "contraceptive failure"....25% of these pregnancies were aborted. (Ref 1)

In the light of this information the BEST option for the women involved in this study is to ABSTAIN from intercourse completely during the study (and possibly for 3 months after the drug is discontinued) to avoid pregnancy and potential harm to the unborn child. If a couple feel they would be prepared to take a risk and continue their sexual relationship during the trial period, then that is up to them, but the drug company would be wise to advise against this, considering they may be potentially liable for damage to the unborn child for those who conceive and do not abort the pregnancy.

Finally, the couples have a right to know what their Family Planning Choices are and what their "True Actual use effectiveness" is. A new system of family planning called "The Creighton Model FertilityCare system" is widely available in Ireland and is consistent with a Catholic ethos. The "Actual use effectiveness" rate of 96.4% has been published in a scientific peer reviewed medical journal (Ref 2) and is superior to most reversible contraceptives, including the oral contraceptive pill.

Dr Phil Boyle,
Director of the FertilityCare Centres of Europe,
Suite 11, The Galway Clinic,
Doughiska, Co. Galway.


1.) Contraceptive failure rates: new estimates from the 1995 National Survey
of Family Growth. Fam Plann Perspect. 1999 MarApr?31(2): 5663.
Fu H, Darroch JE, Haas T, Ranjit N. Alan Guttmacher Institute (AGI), New York, USA.

2.) Creighton Model NaProEducation Technology for Avoiding Pregnancy: Use Effectiveness. Thomas W. Hilgers, M.D., and Joseph B. Stanford, M.D., M.S.P.H. (J Reprod Med 1998;43:495-50)


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