This Good Morning America/ABCNews.com story reports on the FDA’s first medical device clearance of a birth control app, called Natural Cycles, which helps women track their menstrual cycles and bodily temperatures to figure out when they are fertile. The story provided some data on the reported effectiveness of the app and cautioned it’s not foolproof. But it stumbled by not interviewing an independent source, explaining where the data came from or providing more comparisons with other birth control methods.
Birth control methods are plentiful; Planned Parenthood, for example, lists 18. Women need data to make good choices, and news stories about birth control methods should strive to offer comparisons on effectiveness, convenience, safety, and cost.
Solid news reporting is especially important given the marketing of this app, touted as offering “more sexual freedom — minus the side effects.”
As one European woman who became pregnant while using this app wrote in the Guardian: “I was sold on shiny promises, a sleek user interface and the fact that a former Cern physicist, Elina Berglund, was at the company’s helm. But four months in, it failed. Berglund helped discover the Higgs boson; but it turns out her algorithm couldn’t map my menstrual cycle.”
While her experience might or might not be the norm, her broader point is valid: Marketing can create unrealistic expectations.
The story didn’t say how much the app costs. It’s $79.99 per year, or $9.99 a month. There’s also a free one-month trial, according to the company that makes it.
There’s also no data on how it compares cost-wise with other birth control methods and whether it’s covered by insurance. According to Planned Parenthood, the annual cost of using the app is cheaper than most other forms of birth control such as IUDs and pills, but those are usually covered by insurance and forms of assistance.
And, lastly, what is the cost compared to using the old method of taking your temperature each day and charting it?
The story stated:
The app had a “perfect use” failure rate of 1.8 percent in clinical studies that involved more than 15,500 women, or a “typical use” failure rate of 6.5 percent, according to the FDA. The “typical use” failure rate took into account women who sometimes did not use the app correctly or may have had unprotected sex on a day when the app flagged that they were fertile.
That’s useful information, but the story could have been clearer about what these terms actually mean and how the numbers were calculated. Is this an annual failure rate? The idea of a “perfect use” and “typical use” failure rate is subject to interpretation and could lead to confusion. Is the “perfect use” number based on data from real women?
The story quoted an FDA official warning that the app isn’t foolproof, “so an unplanned pregnancy could still result from correct usage of this device.”
It also relayed a report that 37 out of 668 women who received an abortion at a Stockholm hospital from September 2017 to the end of December 2017 were using the app and still had an unwanted pregnancy.
The story could have also cautioned that the app doesn’t protect against sexually transmitted diseases.
Another harm: Because the “fertile window” can last nearly two weeks, it significantly limits the time that a woman can have sex (unless she uses condoms or another well-established form of protection). That can impact quality of life.
The story didn’t explain where the effectiveness data came from. Was the trial published? How was it conducted? And what types of women participated? The story didn’t address these questions.
One big limitation to the data behind this app and FDA clearance was that many of the women in the research study were “self-selecting. As explained in this BMJ piece,
Sarah Hardman, director of the Faculty of Sexual and Reproductive Healthcare’s clinical effectiveness unit in Edinburgh, has urged caution. While acknowledging the substantial size of the study, she argues it was self selecting, as it included lots of women who were specifically looking for something different for contraception, and who may have been more motivated than the “average woman on the street.”
There’s no disease mongering here.
The story attributes some statements to ABC News’ chief medical correspondent Jennifer Ashton, M.D. She is not an independent source, she is another journalist at the same company.
We have no idea who conducted the studies and what conflicts they might have, either.
This is a weak point. The story provided only one comparison, stating that “most contraception pills have a ‘typical use’ failure rate of approximately 9 percent,” which is higher than that reported for this app. But that could be because those women don’t use back-up methods during their most fertile times, as they might with the app.
There are many options for birth control, and the story could have offered more comparisons on effectiveness as well as convenience, safety, and cost. For example, IUDs and skin implants have failure rates of less than 1%.
It’s clear the app is readily available to women who have smartphones, and the story explained that the app uses daily body temperature data and menstrual cycle information.
However, the story left out details that might prevent the app from being useful for some women. For one thing, it requires consistently taking your daily temperature with a basal thermometer immediately after waking up, which might not be feasible for some women. Also, it apparently takes some time to accumulate sufficient data to make the app useful for birth control. A medical advisor to the company that makes the app told STAT: “During the first two or three or four months, you need to use two methods.”
Also, the FDA warned that the app should not be used by some women, such as those who have a medical condition in which pregnancy could present significant risk to the mother or the fetus.
The story states that the FDA “for the first time ever has green-lighted a birth control app to be marketed as a method of contraception.”
It could have made clear that other similar apps are likely to follow.
The story relies heavily on an FDA news release and other published material. However, it did not rely solely on the news release.