All posts in “Birth Control”

Natural Cycles contraception app told to clarify pregnancy risks

A multi-month investigation by Sweden’s Medical Products Agency into a number of unwanted pregnancies among users of ‘digital contraception’ app Natural Cycles has been closed after the startup agreed to clarify the risk of the product failing.

But, on the self-reported data front, the agency said it was satisfied the number of unwanted pregnancies is in line with Natural Cycles’ own clinical evaluations which are included in the certification documentation for the product.

In its marketing and on its website Natural Cycles describes the app-based system as “93% effective under typical use” — a finding that’s based on a clinical study it conducted of more than 22,000 of its users.

The investigation by Sweden’s MPA began around eight months ago, after a number of users in Natural Cycle’s home market had reported unwanted pregnancies to a local hospital — which then reported the app to the regulator.

The Natural Cycles app uses an algorithm to track fertility by monitoring the user’s menstrual cycle. The process requires women take their body temperature at least several times a week, and do so first thing in the morning, inputting the data into the app which is designed to adapts its ‘fertile’ or ‘not fertile’ predictions to each user’s cycle.

Several users have reported falling pregnant while using the app. But the proportion of women who have done so (at least in Sweden) is in line with efficacy rates reported by Natural Cycles, according to the regulator’s assessment.

Earlier this year the MPA said it had received “approximately 50 complaints” related to unwanted pregnancies in users of the app. But late last week it announced it had concluded its assessment of the app — which it said focused on “product safety, instructions for use and post market surveillance documentation in order to confirm if the product is in compliance with regulations”.

As well as looking at parts of the certification documentation for Natural Cycles, the agency says it assessed monthly reports of unwanted pregnancies among active app users in Sweden, covering a six-month period — with pregnancy data supplied by the company itself on a month by month basis during the first half of 2018.

The agency found the number of reported unwanted pregnancies reported by users to be in line with Natural Cycles’ certification documents for the product, finding a failure rate in typical use of 6.9%.

But it also asked the company to clarify the risk of unwanted pregnancies in instructions for the app.

“Our conclusion is that the number of unwanted pregnancies during the assessed time period is consistent with data shown in the clinical evaluation included in the certification documentation. Since it is important that a contraception app is correctly used, we requested the manufacturer to clarify the risk of unwanted pregnancies in the instructions for use and in the app. These issues have been addressed by Natural Cycles and thereby our review is completed,” said Mats Artursson, investigator at the agency in a statement.

As we reported earlier this year, the startup has lent heavily on aggressive social media marketing of its novel ‘digital contraception’ method — which has sometimes appeared to downplay the risk of failure for what is undoubtedly a relatively complex contraception option, given it requires users to consistently self-monitor (and accurately measure their body temperature) as well as use alternative contraception on days when the app informs them they are fertile.

Natural Cycles admits that factors such as illness, disrupted sleep, drinking alcohol and having an irregular menstrual cycle can have a negative impact on the accuracy of its algorithmic fertility predictions. And says itself that the method is not a suitable contraception choice for every individual.

Nor does the app offer any protection against STDs — unless users combine it with additional barrier methods of contraception.

But despite that, until very recently on its website (and in some of its marketing) Natural Cycles has been making the misleading claim that its contraception app is “99% effective” if used “perfectly”. (Perfect use implying, well, superhuman use.)

And just last month the company was wrapped on the knuckles by the UK’s Advertising Standards Authority — which banned one of its social media ads for being misleading, also warning the company against exaggerating the efficacy of the app in preventing pregnancies.

The assessment by the Swedish MPA looks to have reached similar conclusions about certain aspects of the claims Natural Cycles’ has been making for the app.

When we covered the ASA’s ruling last month Natural Cycle’s website still included the misleading 99% ‘perfect use’ claim — within this confusingly worded paragraph: “With using the app perfectly, i.e. if you never have unprotected intercourse on red days, Natural Cycles is 99% effective, which means 1 woman out of 100 get pregnant during one year of use.”

It’s since scrubbed the paragraph from its website, focusing solely on the 93% effective stat — on which it now writes: “Natural Cycles is 93% effective under typical use, which means that 7 women out of 100 get pregnant during 1 year of use. Typical use effectiveness takes into account all possible reasons for becoming pregnant while using the app: from having unprotected sex on a red day, to the app wrongly attributing a green day or the chosen method of contraception on a red day having failed.”

It’s not clear whether Natural Cycles removed the 99% ‘perfect use’ claim as a result of the ASA ruling — or following the Swedish MPA’s assessment. (We’ve asked the company to clarify the exact changes it made related to the MPA’s findings, which the regulator also says relate to software versioning, and will update this story with any response.)

Its app gained certification as a contraception in the EU in February 2017, and went on to gain FDA clearance (via a De Novo classification request) this summer — giving the product a major credibility boost, even as regulatory clearances still come with plenty of caveats. (In the FDA‘s case it warns that: “Users must be aware that even with consistent use of the device, there is still a possibility of unintended pregnancy.”)

It’s also worth noting that it’s still the case that Natural Cycles has not carried out a randomized control trial to more robustly prove out the efficacy of the product, i.e. by using standard scientific methods.

Instead, users must rely on the findings of its self-selecting clinical study of its own users — which may have its own weaknesses, given that, for example, any user who fails to report an unwanted pregnancy to Natural Cycles would not be reflected in the data it’s providing to regulators.

Commenting on the conclusion of the Swedish MPA’s investigation in a statement, Natural Cycles CEO Raoul Scherwitzl said: “We are pleased that the MPA has concluded its investigation, following a review of our real-world effectiveness data. There has been a lot of discussion about this investigation, and we hope that it will provide some reassurance to women to see eminent bodies like the Swedish MPA and the US FDA in alignment based on the strength of our clinical evidence. We never doubted the effectiveness of our product since the number of reported pregnancies is monitored closely on a monthly basis — this is an ongoing responsibility that we commit to as part of operating in a regulated environment.”

The FDA OK’d an app as a form of birth control

Don’t want to get pregnant? There’s a Food and Drug Administration approved app for that. The FDA has just given the go ahead for Swedish app Natural Cycles to market itself as a form of birth control in the U.S.

Natural Cycles was already in use as a way to prevent pregnancy in certain European countries. However, this is the first time a so-called ‘digital contraceptive’ has been approved in America.

The app works using an algorithm based on data given by women using the app such as daily body temperature and monthly menstrual cycles. It then calculates the exact window of days each month a woman is most fertile and therefore likely to conceive. Women can then see which days the app recommends they should avoid having sex or use protection to avoid getting pregnant.

Tracking your cycle to determine a fertile window has long been used to either become pregnant or avoid conceiving. However, Natural Cycles put a scientific spin on the age-old method by evaluating over 15,000 women to determine its algorithm had an effectiveness rate with a margin of error of 1.8 percent for “perfect use” and a 6 percent failure rate for “typical use.”

What that means is almost two in every 100 women could likely conceive on a different date than the calculated fertile window. That’s not exactly fool-proof but it is higher than many other contraceptive methods. A condom, for instance, has an 18 percent margin of error rate, according to the Centers for Disease Control (CDC).

And though the app makers were able to convince the FDA of its effectiveness, at least one hospital in Stockholm has opened an investigation with Sweden’s Medical Products Agency (MPA) after it recorded 37 unwanted pregnancies among women who said they had been using the app as their contraception method.

“Consumers are increasingly using digital health technologies to inform their everyday health decisions, and this new app can provide an effective method of contraception if it’s used carefully and correctly,” assistant director for the health of women in the FDA’s Center for Devices and Radiological Health Terri Cornelison said in a statement.

However, she also acknowledged there was a margin of error in the app’s algorithm and other contraceptive methods. “Women should know that no form of contraception works perfectly, so an unplanned pregnancy could still result from correct usage of this device,” she said.

Nurx raises $36 million and adds Chelsea Clinton to its board of directors

Telemedicine startup Nurx recently closed a $36 million funding round led by Kleiner Perkins. As part of the investment, Kleiner Perkins General Partner Noah Knauf is joining the startup’s board of directors, along with and Chelsea Clinton .

With this new funding, CEO and co-founder Hans Gangeskar told TechCrunch that the startup plans to scale its clinical teams, pharmacies and geographic reach in the coming year.

“We have a new site in Miami where we have a team of nurses being on-boarded, [we’re] building out our engineering and design teams and really just [working to] increase the pace of everything that we’re doing” Gangeskar said.

The startup launched in 2014 with the goal to make reliable access to contraceptives as easy as opening your web browser. After plugging your information into its online app, users are connected with physicians, given a prescription and Nurx prepares their product for delivery.

Since its launch, this California-based startup now operates in 17 states, and has expanded its products to include not only contraceptives (such as pills, patches, injectables and products like Nuva Ring) but the anti-HIV medication PrEP as well. Gangesker says the company is also preparing to launch an at-home lab kit soon for HIV testing.

For Gangeskar, creating affordable access to contraceptives is a first step to changing how patients interact and receive medication from their physicians.

“Birth control is one of the fundamental functions of any health care system [so] for us its a natural place to start,” said Gangeskar.

To help advance its plans to redefine this space, Gangeskar says Nurx is excited to welcome public health veteran Chelsea Clinton to its board.

“Her experience in public health and global health from the Clinton Global Initiative has been really valuable, [particularly learning about] rolling out preventative services in large scales, because really that’s the potential of our platform — [to reach] populations that can’t be reached by the conventional medical system.”

While Washington looks to make cuts to American’s health care access, startups like Nurx offer a fresh perspective on this critical space.

When the trolls come at you over birth control coverage, here’s what to say

If you’re a woman who, on the internet, has tried to defend widely accessible and affordable birth control, you probably know all the counterarguments by heart: “Why should my tax dollars make it easy for you to have sex?” “I don’t want to pay for what you do in the bedroom”. “Don’t have sex if you can’t afford to get pregnant”

Such comments conveniently gloss over the complexities of real life. But it’s also easy to trot out similarly simplistic responses when arguing for birth control. Women and their allies are tired of having to defend something that seems basic, but the important thing to remember is that you’re not trying to convince the troll. Instead you want to sway the social media audience watching your exchange. You’re playing to the crowd. 

“Most of these claims or moral arguments don’t take women’s interests very seriously.”

That matters because informed public debate of birth control is critical right now. The Affordable Care Act, commonly known as Obamacare, requires insurers to provide federally-approved methods of contraception without a copay. Republicans, who plan to repeal Obamacare but haven’t introduced a replacement yet, have indicated their bill won’t have the same requirement. Millions of women could lose access to affordable contraception as a result.

Public polling shows that a majority of Americans support full birth control coverage, but Republicans aren’t in that camp, and trolling comments on social media can amplify a much different narrative. Some critics will never be convinced, but if you choose to take on their talking points for all to see, here are six things to keep in mind: 

1. It’s not “free” birth control. 

First, the government doesn’t send bureaucrats out to roam the streets with bags of free pills and IUDs, tossing them to the nearest random woman. Instead, insurance companies and clinics work with doctors and pharmacies to provide them to patients at no additional cost. 

People who receive copay-free contraception typically put their own money into the health care system by paying taxes and private-market premiums. Last year, people with employer-sponsored health insurance paid on average $5,277 toward their family coverage. Low-income Medicaid recipients may also pay premiums for their insurance. 

While eliminating the birth control copay saved women a lot of money, they continue to finance their own health care while also subsidizing services for fellow Americans. 

2. Birth control is for planning pregnancy. 

People who oppose copay-free contraception often associate it with promiscuity or irresponsible sexual behavior. The simple truth is that birth control helps women prevent and plan pregnancy. (It can also alleviate symptoms of medical conditions like Polycystic Ovary Syndrome.) That’s pretty thoughtful decision-making, and yet, critics get stuck on sex, a nearly universal expression of human desire and intimacy.

Arguing about why people are having sex, or under what circumstances, is ultimately a distraction from legitimate practical concerns about not getting pregnant. Demanding that people wait to have sex until they’re ready to conceive just isn’t realistic, says Lawrence Nelson, an associate professor of philosophy at Santa Clara University. That logic would make even the most committed married couples chaste. 

“Most of these claims or moral arguments don’t take women’s interests very seriously,” Nelson says. 

3. Preventing unplanned pregnancy is good for women, families and taxpayers. 

Under Obamacare, birth control is considered preventive health care, just like vaccinations, routine checkups and breast pumps for new mothers. That may seem odd but making it easy for women to prevent a medical condition — pregnancy in this case — saves the government and taxpayers a lot of money. 

In 2010, the federal government spent $21 billion on births, abortions and miscarriages related to pregnancies that weren’t planned. Studies suggest that unintended pregnancy leads to worse economic, health and academic outcomes among children. When women avoid getting pregnant at the wrong time, research indicates they’re able to get more education and increase their earnings. 

Adam Thomas, an associate teaching professor at Georgetown University’s McCourt School of Public Policy, says that increased spending on family-planning services like expanded access to contraception is a wise investment. His research shows that for every dollar the government spends, it saves nearly $6. Another study indicated that savings could be as high as $7.

“Unintended pregnancy is a major public health problem,” says Thomas. “Expanding access can address that problem.” 

4. Birth control can be too expensive with a copay. 

Some people love to insist that every woman can afford contraceptive copays if she tries hard enough. But before Obamacare birth control frequently cost women hundreds of dollars a year, depending on the method. 

The most effective forms, like the IUD and hormonal implants, had an upfront cost of several hundred dollars. As a result, some low-income women, constantly making hard choices about which basic need to prioritize on a limited budget, used less effective but relatively cheap contraception (i.e. condoms).    

“We already know who’s going to suffer the most if and when they roll this back.”

Understanding that dynamic is key to tackling the problem of unplanned pregnancy, but there’s almost no point in arguing further with someone who refuses to believe birth control with a copay is out of reach for many women. If they’re not willing to believe and trust women’s personal experiences, they won’t defer to you. And if that person starts mocking a hypothetical woman’s grocery store purchases or cell phone bill, for example, in order to attack her reproductive health choices, the conversation has lost its perspective — and arguably its sense of decency.   

“We already know who’s going to suffer the most if and when they roll this back,” says Alexis Cole, policy manager for the reproductive justice organization Urge. “It’s those that had the hardest time affording birth control before — young people, immigrants, women of color and low-income families.” 

5. Yes, some sexually active women don’t use birth control. Talk about why.

One stereotype tends to throw the birth control debate into chaos, and it’s the notion that many women gleefully have sex without protection, consequences be damned. The opposition to affordable birth control is then built around the idea that women can’t be trusted with their own sexuality, so why give them a means to prevent pregnancy. In other words, they just shouldn’t have sex. 

While it is true that some sexually active women don’t use contraception, they make up less than one-fifth of women at risk for unintended pregnancies. That’s a small group, but instead of pretending they don’t exist, people who support birth control access should talk about the bigger picture. 

Studies suggest that disadvantaged women, in particular, are ambivalent about unwed motherhood. The possibility of an accidental pregnancy doesn’t constrain their risky behavior because they don’t feel like they have much to lose, says Thomas.  

Ensuring they have access to sex education and affordable birth control is important, but it might actually be more effective to improve their economic prospects. To hold those women up as a rationale for denying everyone affordable birth control fundamentally misunderstands their predicament. 

6. Beware the slippery slope of refusing to “pay” for someone else’s medical intervention. 

If someone refuses to subsidize no-copay birth control on principle, do others then have the right to withhold their taxpayer dollars from financing medical interventions they find objectionable? The natural birthing mom might insist that her premium doesn’t go toward medically unnecessary cesarean sections. Or Scientologists could demand their money never pay for psychiatric services because it violates their belief system. 

Nelson says people can’t plead a special exemption for their objections to birth control. Everyone who pays into the private or public health care system might have very specific wishes for how that money is spent, but that’s not the bargain we’ve made to ensure people are healthy and have access to preventive care and essential medical treatment. 

“To say this is different strikes me as not taking women’s lives as they’re really lived seriously, and what it means to a woman to get pregnant when she doesn’t want to get pregnant,” says Nelson. 

What it comes down to, he adds, is making birth control accessible and affordable so women are tied to the future they create for themselves, not their fertility. 

“For women to really be able to live in the world as equals to men,” Nelson says, “they need control over their sexual reproductive lives.”