Brainstorm Health: Digital Birth Control Controversy, Nestle Wants Your DNA, Coffee Cancer Warning

August 30, 2018, 7:52 PM UTC

Happy Thursday, readers. This is Sy.

Earlier this month, the Food and Drug Administration (FDA) green lit a digital birth control app called Natural Cycles. It’s meant to be a more natural, if tech-fueled, option for women who might not want to take hormones to prevent (or plan out) pregnancy. But the app is reportedly under fire over a Facebook ad that claims Natural Cycles is a “highly accurate” birth control method—adding to criticism that a number of women using the app had unintended pregnancies and eventually had to get abortions.

The U.K.’s Advertising Standards Authority (ASA), the nation’s ad watchdog, concluded that a Facebook ad claiming the app was “clinically tested” and “highly accurate” was, well, not necessarily accurate, according to The Verge, since it could mislead consumers into thinking that Natural Cycles suffices as an unimpeachable alternative to hormonal birth control. Given existing user complaints—including claims that more than three dozen women had to get abortions after using the app—those claims have drawn some pushback.

Natural Cycles had not responded to a Fortune request for comment as of press time. We’ll update this post if it does. UPDATE: Natural Cycles issued the following response: “We respect the outcome of the investigation by the UK Advertising Standards Authority (ASA) into one Facebook advertisement, which ran for approximately 4 weeks in mid-2017. The investigation was initiated nearly 12 months ago and the advertisement was removed as soon as we were notified of the complaint. This investigation triggered an internal review of all our advertisements and the way that we communicate more broadly, to ensure our message is clear and provides women with the information they need to determine if Natural Cycles is right for them.”

The company’s tech relies on women taking daily temperature readings and recording menstrual cycle data in the app, which then uses a program to estimate days of fertility. Or, as the FDA put it a few weeks ago: “Natural Cycles contains an algorithm that calculates the days of the month a woman is likely to be fertile based on daily body temperature readings and menstrual cycle information, a method of contraception called fertility awareness. Designed for mobile devices, it is intended for use in pre-menopausal women aged 18 and older.”

The agency went on to note that “no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device.”

That latter caveat is what makes the issue more complicated. Natural Cycles’ studies show that just 1% of women who use the app correctly become pregnant; but many typical consumers, at least to date, haven’t been using the technology perfectly. And yet—in another twist—its effectiveness for a “typical” rather than “perfect” user may still be comparable to hormonal birth control (though not as effective as an IUD).

The early studies on birth control apps have painted a bit of a mixed picture, which can make assessing them difficult (especially on such a personal health care issue). The question is whether longer-term data will vindicate the technology and foster a market for less invasive birth control and family planning.

Read on for the day’s news.


Nestle wants your DNA. Add another company to the slew of upstarts seeking your genetic information: Food giant Nestle. In a project launched in Japan, Nestle is aiming to blend every buzzword in the digital health zeitgeist (DNA testing... artificial intelligence... and, uh, Instagram) in an effort to offer personalized nutrition information. This is, to be clear, a limited initiative for now. But the inner-workings are fascinating: "[Users] send pictures of their food via the popular Line app that then recommends lifestyle changes and specially formulated supplements," according to Bloomberg. "The program can cost $600 a year for capsules that make nutrient-rich teas, smoothies and other products such as vitamin-fortified snacks. A home kit to provide samples for blood and DNA testing helps identify susceptibility to common ailments like high cholesterol or diabetes." (Fortune)


Bayer's hemophilia A drug wins FDA nod. The Food and Drug Administration (FDA) on Thursday approved Bayer's long-acting treatment for the rare blood clotting disorder hemophilia A, setting up a battle with fellow European biopharma firm Roche's competing Hemlibra. A number of bigger drug makers have homed in on this rare disease space, including Shire and Sanofi.

Filed under "oh, the horror": Rare side effect of diabetes drugs is serious genital infection. Here's something you don't hear every day: The FDA on Wednesday issued a safety warning over certain kinds of type 2 diabetes drugs that (in very rare occasions, it must be said) could cause a serious genital infection called Fournier's gangrene. So-called SGLT2 inhibitors, a relatively new class of diabetes treatments, were associated with a dozen cases of the horrifying infection in patients between 2013 and 2018, according to the agency. These popular drugs are manufactured by companies like Eli Lilly, AstraZeneca, and Johnson & Johnson. Let us repeat that these are very rare occurrences—but if you experience any potential symptoms (like tenderness, swelling, or redness of the genitals, or a high fever), as the FDA says, contact a medical professional.


FDA: Coffee doesn't need a cancer warning, California. Yes, there was a lot of FDA news this week. The agency waded into the controversial issue of California's cancer warnings for coffee on Wednesday. Commissioner Scott Gottlieb's assessment (which centers on the chemical acrylamide)? "[R]equiring a cancer warning on coffee, based on the presence of acrylamide, would be more likely to mislead consumers than to inform them... Although acrylamide at high doses has been linked to cancer in animals, and coffee contains acrylamide, current science indicates that consuming coffee poses no significant risk of cancer. This finding was reflected in a comprehensive report by the World Health Organization’s International Agency for Research on Cancer." The agency is strongly supporting California officials' proposal to exempt coffee from the cancer warning law that's brought about the debate in the first place.


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