The Effectiveness Of Natural Family Planning

by John Kippley

Part 4 —The Ethics of FDA and ACOG Regarding NFP

Part 1: Introduction: The Effectiveness of NFP
Part 2: Method Effectiveness
Part 3: User Effectiveness
Part 4: The Ethics of FDA and ACOG Regarding NFP
Part 5: References

In the light of this demonstrated effectiveness, the ethical propriety of certain allegations about natural family planning must be questioned. For example, the FDA Consumer for May, 1985 ran an article that listed "Natural Family Planning or Rhythm" as having an estimated effectiveness of "very variable, perhaps 53-86%.¹³ Correspondence with the editors and U.S. Department of Health and Human Services medical advisors to the FDA Consumer revealed that the basis for that very low figure were two Latin American studies. One was almost entirely a calendar rhythm study in Colombia.¹⁴ and the other was a comparison between the Ovulation Method (OM) and the Sympto-Thermal Method (STM) also done in Colombia by some of the same people involved in a somewhat similar study in Los Angeles.¹⁵

The Colombian calendar rhythm study was conducted in six birth control centers and had many problems. The overall Pearl rate was 47.0 pregnancies per 100 woman years which translates to a 53% effectiveness rate.

The rhythm investigators also studied the effectiveness of the Pill in those same Colombian birth control center and reported a Pearl unplanned pregnancy rate of 10.5 or an 89.5% effectiveness rate.

Thus, the FDA authorities used a study that reported a 89.5% effectiveness rate for the Pill and a 53% effectiveness rate for calendar rhythm. However, they ignored the Colombian 89.5% figure for the Pill and reported only a 99% figure, supposedly from other sources. In fact, they did not even report an 89.5 to 99% range in effectiveness for the Pill; they reported on the single highest figure. Can that be called ethical and fair?

The Colombian OM-STM comparison study used by the FDA to allege low effectiveness for NFP failed to report on "method failures," concentrating entirely on user effectiveness. With the life-table method of statistics there was a net pregnancy rate of 24.2% for OM users and 19.8% for STM users. In terms of the older Pearl formula, the pregnancy rates were 33.8 per 100 woman years for OM users and 26.0 for STM users during the one year of the follow-up phase.

As the authors reported, "The results of this study indicate that these two methods of NFP cannot be considered as simple methods of family planning but as a new way of life which requires changes in sexual behavior cannot be achieved in a short period of time.. The degree of motivation toward following periodic abstinence is related to cultural factors that make abstinence difficult to practice in Colombia."

Precisely. This was also demonstrated in the previously cited five-nation STM study in which the results from Colombia were so markedly different from the North American, European, and Asian figures that they were treated separately.¹⁶ However, when the rates of 94.5% overall use effectiveness and 85% spacer use effectiveness are cited from that study, such figures include the Colombian results (and would be higher if they did not).

Thus it is well known among birth control professionals that if you want to quote very low effectiveness rates for any form of NFP, you go to Colombia. However, is it ethical to write for a North American audience and quote only the Colombian studies and ignore the North American and European studies which are far more relevant?

It should also be noted that the 86% figured quoted as the high end of the range for NFP is actually almost the low end of the range in the only federally funded American STM study.¹⁷ As mentioned previously, the authors found a 100% method effectiveness rate and an 85% user effectiveness rate for the Sympto Thermal Method.

In the introduction to the FDA article, the author noted that the range of effectiveness could vary as couples either followed or did not follow the rules. It is no excuse to say the FDA wanted to report only the figures for groups containing chance-takers; if that were the case, a range would have been reported for the Pill.

To recapitulate, in an article purporting to compare birth control options in a publication designed for the American consumer, the FDA:

Withheld a relatively low effectiveness figure for the Pill, a figure reported in study used by the FDA.
Withheld the STM 99% effectiveness figures available to anyone writing in the field of birth control. The difference in treatment is unethical and unfair.
Distinguished between different unnatural methods of birth control.
Mixed up and confused the different methods of natural family planning. The difference in treatment is unfair and unprofessional.
Failed to report any sort of range of user effectiveness for the Pill.
Reported only the highest possible figure for the Pill.
Reported what may be the lowest figure ever reported for calendar rhythm.
That's unethical and the difference in treatment is unfair.

Such a combination of unfairness, unethical reporting, and unprofessional writing is simply intolerable among those employed as our "public servants."

* * *

Another unethical treatment of NFP is the work of the American College of Obstetricians and Gynecologists (ACOG). This organization has unfortunately adopted a pro-abortion stance, and thus its orientation towards contraceptive, abortifacient, and surgical methods of birth control is understandable. Nevertheless, if an organization is going to treat of NFP at all, it has an ethical responsibility to treat it fairly and accurately.

In 1985 ACOG produced a slide-rule form of birth control effectiveness comparison which listed Natural Family Planning as producing 24 unplanned pregnancies for every 100 couples who used it.¹⁸ Their "Natural Family Planning" figure is identified as meaning "periodic abstinence, symptothermal, temperature, mucus."

Correspondence with ACOG revealed two sources used for their "NFP" numbers. The first was an article in a Planned Parenthood publication.¹⁹ The authors attempted a generalized approach to all methods of birth control employing information from two retrospective surveys in 1973 and 1976. Their figure for the Pill was a 2.4% failure rate in the first year; their figure for "rhythm" was 23.7. "Rhythm" was unspecified, and in 1973 and 1976 retrospective surveys, the term in all probability includes every imaginable sort of makeshift "wrong way" rhythm.

The second source was the 1984-1985 edition of Robert A. Hatcher's Contraceptive Technology.²⁰ Table 10:2, "Efficacy rates: fertility awareness of birth control" lists figures for ten different systems of NFP from calendar-only to temperature-only, mucus-only, and sympto-thermal, and the effectiveness rates ranged from 70% (calendar-only) to 99.7% (Phase III only, temperature-only). The 1985 ACOG birth control calculator apparently settled for the Schirm-Planned Parenthood figure of 24 (above) which is also quoted by Hatcher.²¹

This is unethical and unprofessional. The "24" figure is derived from two retrospective studies about a completely unspecified and catch-all "rhythm," and it is a serious misrepresentation to state that it represents "periodic abstinence, sympto-thermal, temperature, mucus." Proponents of natural family planning would be ridiculed if they relied upon a 1968 Colombian study to state that the Pill had an unplanned pregnancy rate of 10.5% or if they averaged all the unnatural methods listed by Hatcher and said that unnatural methods had an average unplanned pregnancy rate of 11.4%--true but quite irrelevant. The same standards need to be applied to the so-called professionals in ACOG and the FDA.

Fairness Needed

The FDA and ACOG treatments of Natural Family Planning are misleading and unfair. It is not only unethical for knowledgeable people to mislead the general public, but it is unfair both to the general public and to the many thousands of ordinary couples who are successfully using modern methods of natural family planning and who deserve knowledgeable support, not ridicule, from their physicians.

Fairness dictates that ACOG and all branches of HHS inform the public about method and user effectiveness rates that have been reported in European and North American studies. No matter how effective NFP is, there will be many who will not choose it simply because they will not accept even the idea of periodic abstinence; but such people at least deserve to know the real facts about NFP if for no other reason than that they can then deal more honestly with their own reasons for choosing one method or another.

With regard to the FDA, a division of the U.S. Department of Health and Human Services, it should be noted that another branch of HHS, the Bureau of Community Health Services, published a brochure, "Natural Family Planning" in which it listed the Sympto-Thermal Method as having a "Method Effectiveness" of 98% and a "User Failure Rate of 10-15" pregnancies per 100 woman years.²²

That's not entirely accurate since the demonstrated method effectiveness is 99% and user-effectiveness has been demonstrated to range from 1 to 15 pregnancies per 100 woman years in European and North American populations, but it represents a much fairer treatment than that given by the FDA.

Fairness also dictates that ACOG and all branches of HHS distinguish between the various forms of natural family planning. The above mentioned HHS brochure on NFP distinguished four different systems: Temperature-Only, Mucus-Only, Sympto-Thermal, and Calendar Rhythm. The HEW (now HHS) Los Angeles study reported statistically significant differences in the use of the Ovulation Method and the Sympto-Thermal Method, and interested health care providers and prospective user couples deserve to know these facts.²³

Fairness requires that the range of STM user effectiveness be attributed primarily to choices of the user couples, themselves, not some trick or fault in the method.

For Birth Control Comparisons

The birth control comparison charts and graphs that appear in popular magazines devote much space to the Pill: more space needs to be given to the different methods of natural family planning.

In the style of such birth control comparison charts, the following would be a fair treatment of the Sympto-Thermal Method:

Effectiveness

Effectiveness depends on how correctly the ST Method is used. Of 100 couples using the STM correctly for one year, one or less will become pregnant. Of 100 couples using the STM but with some not following the rules, anywhere from 3 to 15 will become pregnant depending upon the frequency of "taking chances", i.e., intercourse during the fertile time.

Advantages

All natural; no drugs or devices are needed. Inexpensive. No continuing cost after initial training, thermometer and charts. Acceptable to all religions. A scientific method based on systematic observation and recording of the signs of fertility and infertility.

Disadvantages

Requires systematic charting. Requires mutual decisions about abstinence.

Side Effects

No physical effects. Most couples report improved marriages and sex lives. Some couples do not accept periodic abstinence.

Health Factors to Consider

No health risks. Increased body-awareness can lead to early detection of physical disorders. Increased fertility awareness can help couples of marginal fertility to conceive.

Proponents of natural family planning can find much more to say about the advantages of NFP, but the above was written in the style of a birth control comparison chart published some years ago by the FDA and adopted or adapted by many popular magazines in recent years.

The time has come for ACOG, the government and the media to be fair in their treatment of natural family planning. It is not a panacea for anything, but the STM is a highly effective, healthy and inexpensive form of family planning that enables most married user-couples to state they enjoy improved sex lives and better marriages. It's a story that deserves both attention and fair treatment.