Recent FDA News That’s Great For Fertility Awareness (Even If There’s Still A Long Way To Go)

posted on August 29, 2018 by Mary Rose Somarriba, Editor Mary Rose Somarriba

Did you hear the recent triumph for Fertility Awareness-Based Methods (FABM) to be taken more seriously in mainstream American medicine? As Time Magazine reported, “fertility awareness gained more legitimacy in the U.S. when a popular fertility-tracking app, Natural Cycles, was cleared for marketing as a contraceptive by the U.S. Food and Drug Administration (FDA).

Natural Womanhood Fertility Awareness Based Methods FABM FAM Natural Family Planning NFP Natural Cycles App FDA News Cleared Charting Effectiveness Rates Pregnancy Prevention Natural Birth Control

Considering how quickly the FDA approved pharmaceutical forms of birth control, it’s nice to see a natural method to avoid and space pregnancies getting greater attention—and a method that’s unequivocally safe, at that. Unlike the Pill, which was fast-tracked to approval in the 1950s, despite reports of deaths and blood clots for women who took the oral contraceptives. Also unlike the permanent birth-control device Essure, which was prescribed to women for 16 years until recently when, upon new FDA requirements and a film scrutinizing its side effects, Bayer announced it will take it off the shelves at the end of this year. In Essure’s case, Bayer had rushed to FDA approval and long ignored the health risks to female patients that came after.

We applaud the FDA clearing Natural Cycles, a sign of progress for fertility awareness to get a seat at the table of women’s health.

Further To Go

Still, there’s a ways to go before FABMs are fully understood and applied in the American medical community. For instance, researchers recently attempted to analyze FABMs effectiveness in a medical-journal article published August 6, 2018 in Obstetrics and Gynecology, the official publication of the American College of Obstetricians and Gynecologists also known as the Green Journal. Researchers at the University of North Carolina (UNC) led by Rachel Peragallo Urrutia, MD, reviewed studies that followed FABM-using women to rate their effectiveness at avoiding pregnancy.

UNC’s newswire reported that Urrutia’s team “identified all available studies on 14 different FABMs and rigorously evaluated the quality of each study based on a 13-point list of criteria. Based on that list, each study was rated high, moderate or low quality. Estimates from high-quality studies would be considered the most valid. Of the 53 studies identified, the investigators ranked 0 as high quality, 21 as moderate quality, and 32 as low quality.”

Urrutia, an OB-GYN and assistant professor at UNC School of Medicine, explained her motivation for the review: “Many women think they are using an effective FABM to avoid pregnancy, when in fact the method they are using has not undergone robust effectiveness testing.”

Since the review was published, the Fertility Appreciation Collaborative to Teach the Science (FACTS) issued a response on August 21, 2018, critiquing the review’s rating methods. FACTS, a collaborative project of the Family Medicine Education Consortium, notes on its website its goal to educate medical students, physicians, and health professionals in the basic principles of Fertility Awareness-Based Methods and the supporting science behind their medical applications.

In its response to the UNC review, FACTS noted a quality standard applied in their rating process that is used nowhere else in rating birth-control effectiveness. Urrutia excluded from her analysis cycles when FABM-users did not document intercourse. “Couples may choose not to have intercourse in any given cycle for many reasons,” FACTS noted, “such as the variability in the woman’s cycles, comfort level of couples with interpretation of their fertility signs, and/or personal or professional obligations that may not allow them the time or opportunity to have sexual relations. Since abstaining from sexual relations during potential days of fertility is among the guidelines for using FABMs, it seems unfair to downgrade studies in which couples may simply have followed the rules.” Still, in one swoop, the UNC study gave low-quality ratings to a number of solid studies that showed high effectiveness rates for FABMs, for the reason that some cycles did not document intercourse.

“While one can understand the logic of excluding these cycles (based on an assumption that pregnancy would not be possible without intercourse), the approach seems contrary to the underlying principles of FABMs where informed, shared-decision making and development of self-control are integral to the use of the methods,” FACTS stated. “Furthermore, it is not at all clear whether ANY contraceptive method, be it hormonal, a device or surgical, has ever been evaluated with this criterion and would meet this definition of high quality. While this may be an ideal criterion to include, it is uncertain this standard has ever been required before now.”

Quality By Any Other Name

Dr. Marguerite Duane, FACTS executive director, told Natural Womanhood, “in the Urrutia study, to be considered a ‘high-quality’ study . . . a study had to be ranked a ‘1’ on all 13 criteria, essentially receiving a perfect score. As such, they did not identify any high-quality studies of FABM effectiveness.”

Duane contrasted this with a 2013 study led by Michael D. Manhart, PhD, that she participated in and that was published in Osteopathic Family Physician. Duane notes, the Manhart study “also identified 12 critical criteria, but studies had to have a positive score on each criteria and not necessarily a perfect score. Based on our review, we identified 10 high-quality studies, including at least one for each of the major modern methods, with typical effectiveness rates ranging from 2 to 14 unintended pregnancies per year.”

According to the Manhart review, the FABM known as the SymptoThermal method, for instance, demonstrated a perfect use rate of 1 percent, and a typical use rate of 2 percent probability of unintended pregnancy over one year. Readers of Urrutia’s review would miss this highly effective and science-based natural method due to a technical reason.

Natural Cycles, the app recently cleared by the FDA, cites research that women who use the app to avoid pregnancy have a 1 percent perfect-use rate of unintended pregnancy, and 7 percent for typical use. Despite it also not being highlighted as quality in the UNC research, the Natural Cycles website states more than 900,000 women worldwide are using it.

What both the UNC researchers and FACTS seem to agree on, however, is the need for more research on Fertility Awareness-Based Methods, so women can be equipped make informed reproductive choices. While the medical community in the United States is working on that, it would appear women themselves are doing their own research. And many are finding natural methods of birth control to better fit with their health and goals.

Posted by Mary Rose Somarriba, Editor Mary Rose Somarriba