Posted on 03/15/2017 5:12:46 PM PDT by Mrs. Don-o
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.
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.”
There are lots of apps or related devices that just measure and track BBT. I had one 25 years ago, for heaven’s sake.
But this gizmo seems to be a good deal more comprehensive -— if it were just BBT, like what’s been out there for decades, I can’t see how they could get a patent.
As you no doubt know, there are four major hormones which interact rather complexly, with feedback loops and all, to bring you to the verge of ovulation. If this app tracks them via saliva, urine, or even vaginal secretions, it would be a huge improvement over just BBT, or subjective impressions about how how or firm or slip-slidey your cervix may be.
The article didn’t specify what-all goes into these new, improved algorithms, but it seems it’s truly not the equivalent of a sun-dial. If they’re trying to get away with fraud, I’m betting savvy NFPers would catch them early on.
I say hooray for the lady physicist and her great new gizmo.
There are lots of apps or related devices that just measure and track BBT. I had one 25 years ago, for heaven’s sake.
But this gizmo seems to be a good deal more comprehensive -— if it were just BBT, like what’s been out there for decades, I can’t see how they could get a patent.
As you no doubt know, there are four major hormones which interact rather complexly, with feedback loops and all, to bring you to the verge of ovulation. If this app tracks them via saliva, urine, or even vaginal secretions, it would be a huge improvement over just BBT, or subjective impressions about how how or firm or slip-slidey your cervix may be.
The article didn’t specify what-all goes into these new, improved algorithms, but it seems it’s truly not the equivalent of a sun-dial. If they’re trying to get away with fraud, I’m betting savvy NFPers would catch them early on.
I say hooray for the lady physicist and her great new gizmo.
True to some extent. Depends on circumstances.
There are cases of need for tub-ligation. My mom would have died if she got pregnant again age was more the issue for her as she was nearly 45, I’m the one who found her bleeding out in the bathroom and had to call the ambulance and clean up the blood, I was just a teenager then, I’m 68 now.
For me I couldn’t take the Pill to many side effects, and 2 C-Sections were all you were allowed back then. This was my 4th child, and I didn’t want more nor could afford more.
Tub-ligation is a necessity for some of us. Not a wholesale method of population control, but should be an option with full disclosure if issues. Don’t know about any issues with it, had none nor did my mom. Endometriosis which is the most common issue can happen even with C-Sections and that is the most common issue with any abdominal surgery. Mine was done at the same time as the 2nd C-Section.
I don’t know what the C-Section rule is now, I’m well beyond that stage. But 2 were all that the medical community felt was safe then. I couldn’t even take HRT’s. Nasty stuff.
True DAT. I’m amazed that “aware,” “progressive” females who won’t tolerate hormones in their beef or chicken, will meekly pour them straight into their own livers.
It’s great that there are more holistic and womanistic options now. I can imagine how a woman in your mother’s situation 50 years ago would have felt totally trapped.
Isn’t that funny?
Like the libs who want to save every wild animal and their babies but are ok with any woman killing any unborn child ever.
I don’t have a problem with her profiting from it, but yes, the next step would be something you insert that gives a serious chemical / hormonal read.
I did temps for over 6 years, no preg. Infertile. Temps alone would not have cut it. Thank Gd (and I do) that I kicked infertility in the butt. Only one of my four was conceived without a lot of help.
If you feel so inclined, would you like to explain briefly how you kicked infertility in the butt? It sounds inspirational!
Not just 50 years ago, to many women died in child birth for hundreds of years before the C-Section was invented.
I was only 33 when I had mine 2nd C-Section, and was told NO more even if I would have liked to try for a girl, all mine were boys. The OB/GYN medical field had set 2 C-Sections as a limit for safety.
They may be different today.
Now I battle Chronic Pain, OA/OP/Spinal degeneration/Gastropresis/Barrett’s Esophagus/Diverticulosis/Peripheral Neuropathy/bursitis and currently a skin yeast infection nothing works on, not meds or natural. Getting old is not for the faint of heart.
I agree about tubal being a good solution, but will add this one caveat because most people reading may not be aware of it. Because of the way that the ovarian blood supply is tampered with, it can trigger early menopause in sensitive women. My hormone doc who deals mostly with menopausal issues says she sees it quite often in her practice and wishes that more ob/gyn doctors would mention it to patients before the surgery.
So I feel it for ya, honey. R.A. here and etcetera etcetera.
Not to mention mental fading. Geez I hate it when that happens.
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When what happens?
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Duh....
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Do you know where I put my glasses? Did I pay the electric bill?
Have you heard a bunch of old Navy Salts in a monthly meeting, all they talk about are every ache, pain and pills they have to take. Hubby gets a new partial knee Tue. Guess who gets to wait on him? Let the dogs in/out, get his cup of coffee, or his snack...me who can barely get up myself.
I only hit the high lights, there are lesser issues. And finding a doc that will take Medicare/Tricare Life is a pain in the rear. Our PCP is DUMB AS A BOX OF ROCKS! No chance of changing, as fewer docs take us. To complicate it I have to have Valium for Meniere’s and the Peripheral Neuropathy. DUMBOCARE mandated a 75% reduction in it and all pain meds. Less than I take and I take the max the FDA allows I go into painful attacks of both. Meclizine which is the usual Meniere’s drug doesn’t work, only Valium does.
Me I sleep a lot, my complaints are bad do noting drugs or the side effects, I’ve a full typed sheet of those, and NO I don’t want to go to the ER we have had some rows over that one. If I go into A-Fib I’ll give in. Last trip they blew 5 veins, I have very fair skin, you can see my veins, they are the size of a child’s. You don’t use big IV Cath Pics on me, you will blow a vein every time. Or the fact meds are not delivered on my time schedule, some are critical I take when I first get up as they are taken on empty stomach and timed apart. Not at 8 AM all at once. I’m up at 6AM. First ting I want is coffee and my Synthyroid. Have to wait an hr before any thing else. And my food best be low sodium and Gastropresis friendly. Dietary does NOT know what those 2 things are.
How long have women been having kids, they have yet to find a cure for diaper rash. Part of the blame is disposable diapers. Not a lot of difference in diaper rash and yeast skin infection, I’ve tried all your pills, creams and powders, they stink and don’t work, the side effects are horrible. I didn’t ask for a 40 D, at 130 lbs, those women who pay big $$ to buy, they can keep them, I’d be happy with a B that didn’t develop yeast infections under the saggy, sweaty things because idiots don’t know how to make bras any more. And at 68 they do sag. Nor do they make bras that lift. I have to use a Mastectomy shop to buy mine to get a proper fit and those suckers aren’t cheap.
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