Um, OK, so, let’s talk NFP: Persona, anyone?

Last updated on: May 21, 2015 at 3:23 pm by Jane the Actuary

Um, OK, so, let’s talk NFP: Persona, anyone? 2015-05-21T15:23:49-06:00 Jane the Actuary

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Hey, readers!

Look, I know that many of you aren’t Catholic. But I also know that most of you are pretty thoughtful and like to think about things rather than just pounding out knee-jerk bashing-type responses.

So I’m going to wade into the issue of contraception, and ask my readers to put on their thinking caps here. I am not going to get onto a soapbox, much less talk about my own family life.

Here are two paragraphs of context:

Yesterday I landed on a lengthy article (which I X’ed out of and forgot where it came from) that got me thinking about the topic. The article, seeming to think that Pope Paul VI invented opposition to contraception out of whole cloth, suggested that Pope Francis just announce that Humanae Vitae was a mistake and undo it, whereas in reality, the teaching against contraception goes way back to the earliest non-Biblical documents.

And this author, and many of the commenters took the position that Natural Family Planning is not really distinguishable from the pill in any meaningful way so there’s no logic to this teaching. Here is the distinction between NFP and other forms of family planning: there is no specific act within the practice of NFP in which one actively does something to prevent pregnancy. Taking one’s temperature and monitoring other fertility signs: there’s nothing inherently “contraceptive” about this, as the many people who monitor their fertility signs to achieve pregnancy will tell you. Not having sex? Well, that’s not an act, is it? By definition, it’s something you’re not doing. Seem a bit legalistic? Maybe so, but that’s not what I’m interested in talking about.

What is interesting is that there are new, high-tech ways of practicing NFP — the “Marquette Model” uses the ClearBlue Fertility Monitor to identify fertile days, although, in the United States, its manufacturer doesn’t appear to support this. This is not so in Germany, and elsewhere in Europe where it’s sold as a 94%-effective NFP device under the name Persona, for not just Catholics but in line with a general German distrust of chemicals; the difference appears to be that any company selling such a device in the U.S. would have to get FDA approval, which they’ve never found it worth seeking (yeah, I asked them, via their “ask a question” link). There’s also a device called “Ovacue,” which has a sensor to detect fertility of cervical fluid, which, again, as sold in the U.S. necessarily states that it’s not approved for pregnancy avoidance (I can’t find a non-U.S. site), and in the UK, there’s a device called “LadyComp,” which is less sophisticated (temperature/charting only) but, again, is able to promote its use for natural birth control because it’s marketed in the UK rather than the US.

What if the FDA approved these devices, or a similar device that measures a woman’s hormones/chemistry to determine periods of fertility and infertility? Per the HHS mandate, these would now be provided at no out-of-pocket cost as a part of health insurance, and the hormone measurement would mean that even women for whom traditional NFP is difficult due to irregular cycles and confusing fertility signs, could use these methods with ease (though the German Persona website says it’s not to be used by women with cycles shorter than 24 or longer than 35 days, or women with premenopausal symptoms).

So — to an extent this is a regulatory question: are the FDA approval requirements so much more burdensome than those in the EU that it simply is unreasonable for the ClearBlue maker to put for the effort for approval? Is the potential market in the EU simply larger, not on account of Catholics but women looking for natural, non-chemical methods, in the same way as they favor organic foods?

And, in practice, if ClearBlue were able to market Persona without additional regulatory hoops, would they? Would there be enough market to make even the necessary additional programming and packaging worthwhile?

And how many takers would there be?

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