The first and only internationally certified contraceptive app is now awaiting approval by the U.S. Food and Drug Administration. If approved, Natural Cycles would provide Americans a government-approved drug-free and therefore side-effect-free alternative in a market saturated with hormonal and abortive birth control.
It all started when 32-year-old nuclear physicist Elina Berglund Scherwitzl, who was on the Nobel Prize-winning team that discovered the Higgs-Boson particle, “was looking for a hormone-free alternative contraception and we weren’t happy with what we found on the market,” said Dr. Raoul Scherwitzl, Berglund’s husband, in an e-mail interview. “Elina…decided to apply her mathematics expertise to develop an algorithm for herself.”
Berglund then tried out her fertility algorithm on female colleagues at CERN, the European Organization for Nuclear Research. The Swedish physicist spent years modifying and perfecting the algorithm and a corresponding app, ultimately cofounding Natural Cycles with her husband.
“Once she got talking to friends and women online, it was quite apparent that there is a need for Natural Cycles, so we decided to develop an app,” Scherwitzl said. “We wanted every woman to be able to access Natural Cycles right on her phone.”
The pair hired a team of researchers and in February European regulators approved the app as a contraceptive device. Natural Cycles is not the only app available for tracking a woman’s ovulation cycle, but it is now the first internationally recognized method of non-hormonal contraception.
The U.S. Centers for Disease Control estimates that more than 60 percent of U.S. women of reproductive age currently use a contraceptive method. More than 99 percent of women aged 15-44 who have ever been sexually active have used at least one method of contraception. The two most common forms of birth control since the 1980s have been the pill and sterilization, and the use of hormonal birth control is on the rise.
Long-term use of oral contraceptives has been linked to increased risk of liver and cervical cancer in some scientific studies according to the Mayo Clinic. They may increase blood pressure, and evidently increase risk for blood clots. They also reduce a woman’s ability to plan her family naturally and all chemical contraceptives, including intrauterine devices, can end a pregnancy in its earliest stages.
Smart Tech, Pro-Woman
While Elina’s app and its underlying algorithm may be new, women have known about cycle-based methods of managing fertility for centuries. Today the approach is often called “natural family planning,” or NFP. Natural family planning may be more attractive to women with individualized tech-based support of an app that has demonstrated effectiveness, said Peter Pitts, president and co-founder of the Center for Medicine in the Public Interest: “Technically, apps are considered devices, but the device itself does not physically prevent fertilization of an egg. It’s a natural family planning app.”
“Studies have proven [natural family planning] to be quite ineffective when it comes to typical use,” Scherwitzl noted. “This is because the term covers a variety of methods, they often require extensive knowledge and learning which makes them more prone to human error. The thing is, mobile technology is revolutionising the way we live today, and we believe that monitoring your body, getting to know yourself and applying that knowledge is something that will become the norm in the future.”
The gap between “typical use” and “perfect use” exists for most forms of birth control except long-term implants such as IUDs or hormonal patches. That’s because those require little upkeep or remembering, while perfect use of, say, the pill requires daily administration and ideally at the same time each day. The difficulty behind regulating an app is the possibility for error associated with an individual’s manual input of personal data, Pitts said: “The FDA would say that nothing is ever 100 percent.”
In typical use, a peer-reviewed study of 4,000 women found Natural Cycles was 93 percent effective at preventing pregnancy, meaning of 100 women using the app to prevent pregnancy, 7 got pregnant in a given year of use and 93 did not.
For comparison, the pill is 91 percent effective, injectable birth control is 94 percent effective, and IUDs are 99 percent effective at preventing pregnancy in typical use, according to the CDC. Another well-established non-hormonal NFP method called Creighton has been rated in a federal study as 98 percent effective at preventing pregnancy. Creighton’s governing organization doesn’t currently offer an app, although it has been developing one. Instead, to keep effectiveness high, users meet quarterly or biannually with their practitioner to maintain effective fertility management habits.
“The unique algorithm behind the app takes objective scientific parameters into account to make natural contraception as effective as possible,” Scherwitzl said. “It analyzes things like cycle irregularity, ovulation and past cycles to tell you exactly whether you need to use protection.”
Fertility awareness methods are highly individualized of necessity, because each woman’s body, circumstances, and cycles are different, Scherwitzl said. This is in keeping with the avant garde in the medical industry, which is moving into personalized medicine in a plethora of areas. In that vein, Natural Cycles aims to enhance a woman’s understanding of her broader health.
“Tracking your body’s indicators like temperature could also give you vital info about your health,” Scherwitzl said. “I think that people will become a lot more informed about what is going on in their bodies, so they can make informed choices in life.”
What It Means to Empower Women
Empowering women to manage their bodies through smart technology should be a celebrated innovation, but given its typical opposition to non-hormonal birth control, it’s likely the abortion industry does not welcome these medical developments .
The Bill and Melinda Gates Foundation, the world’s largest philanthropy, has spent millions of dollars funding abortion, contraception, and pro-abortion organizations both at home and abroad. It declined comment on the app’s potential effects on women around the world despite Melinda Gates’ very public advocacy for developing new and better contraception especially for women in the developing world, where mobile phone access is often surprisingly high. Right-leaning organizations seem more willing to embrace the idea.
“Information is power,” said Penny Nance, CEO and president of Concerned Women for America, the nation’s largest public policy women’s organization. “Women deserve the best science can offer for the health of their and their babies’ bodies.”
True Access to Choice
If approved by the FDA, the app could bridge between insurance providers and organizations that oppose federally imposed birth control requirements, Pitts suggested.
“The people that argue that contraception shouldn’t be a mandatory insurance coverage probably would not feel as agitated by allowing coverage of an app,” Pitts said. “That’s not a legal answer, but it would certainly make for an interesting court case if an insurance company that refused to cover the pill did cover this app.”
Other government agencies, including those in the United Kingdom and United States, have not yet approved the app for contraceptive use, but women are not waiting. More than 150,000 users in 160 countries are already using Natural Cycles.
The app is broadly available on iPhones, iPads, Android devices or any device with a browser, but its approval as a scientifically backed birth control method was hard-won. The Swedish Medicinal Products Agency saddled the company with heavy investigatory restrictions in labeling its product as a contraceptive. It wasn’t until the German inspection and certification agency, Tuv Sud, approved the app that the company was able to reach the European market more broadly.
“At Natural Cycles we are all about broadening the choice for women. That way she can decide what works best for her,” Scherwitzl said. “We are disrupting the contraceptive market by putting the scientific knowledge behind women’s bodies back into their hands—and as our App Store reviews show, they’re absolutely loving it.”
