New Options Are Emerging in the Search for Better Birth Control
A decade ago, Elizabeth Summers' options for birth control suddenly narrowed. Doctors diagnosed her with Factor V Leiden, a rare genetic disorder, after discovering blood clots in her lungs. The condition increases the risk of clotting, so physicians told Summers to stay away from the pill and other hormone-laden contraceptives. "Modern medicine has generally failed to provide me with an effective and convenient option," she says.
But new birth control options are emerging for women like Summers. These alternatives promise to provide more choices to women who can't ingest hormones or don't want to suffer their unpleasant side effects.
These new products have their own pros and cons. Still, doctors are welcoming new contraceptives following a long drought in innovation. "It's been a long time since we've had something new in the world of contraception," says Heather Irobunda, an obstetrician and gynecologist at NYC Health and Hospitals.
On social media, Irobunda often fields questions about one of these new options, a lubricating gel called Phexxi. San Diego-based Evofem, the company behind Phexxi, has been advertising the product on Hulu and Instagram after the gel was approved by the Food and Drug Administration in May 2020. The company's trendy ads target women who feel like condoms diminish the mood, but who also don't want to mess with an IUD or hormones.
Here's how it works: Phexxi is inserted via a tampon-like device up to an hour before sex. The gel regulates vaginal pH — essentially, the acidity levels — in a range that's inhospitable to sperm. It sounds a lot like spermicide, which is also placed in the vagina prior to sex to prevent pregnancy. But spermicide can damage the vagina's cell walls, which can increase the risk of contracting sexually transmitted diseases.
"Not only is innovation needed, but women want a non-hormonal option."
Phexxi isn't without side effects either. The most common one is vaginal burning, according to a late-stage trial. It's also possible to develop a urinary tract infection while using the product. That same study found that during typical use, Phexxi is about 86 percent effective at preventing pregnancy. The efficacy rate is comparable to condoms but lower than birth control pills (91 percent) and significantly lower than an IUD (99 percent).
Phexxi – which comes in a pack of 12 – represents a tiny but growing part of the birth control market. Pharmacies dispensed more than 14,800 packs from April through June this year, a 65 percent increase over the previous quarter, according to data from Evofem.
"We've been able to demonstrate that not only is innovation needed, but women want a non-hormonal option," says Saundra Pelletier, Evofem's CEO.
Beyond contraception, the company is carrying out late-stage tests to gauge Phexxi's effectiveness at preventing the sexually transmitted infections chlamydia and gonorrhea.
Phexxi is inserted via a tampon-like device up to an hour before sex.
Phexxi
A New Pill
The first birth control pill arrived in 1960, combining the hormones estrogen and progestin to stop sperm from joining with an egg, giving women control over their fertility. Subsequent formulations sought to ease side effects, by way of lower amounts of estrogen. But some women still experience headaches and nausea – or more serious complications like blood clots. On social media, women recently noted that birth control pills are much more likely to cause blood clots than Johnson & Johnson's COVID-19 vaccine that was briefly paused to evaluate the risk of clots in women under age 50. What will it take, they wondered, for safer birth control?
Mithra Pharmaceuticals of Belgium sought to create a gentler pill. In April, the FDA approved Mithra's Nextstellis, which includes a naturally occurring estrogen, the first new estrogen in the U.S. in 50 years. Nextstellis selectively acts on tissues lining the uterus, while other birth control pills have a broader target.
A Phase 3 trial showed a 98 percent efficacy rate. Andrew London, an obstetrician and gynecologist, who practices at several Maryland hospitals, says the results are in line with some other birth control pills. But, he added, early studies indicate that Nextstellis has a lower risk of blood clotting, along with other potential benefits, which additional clinical testing must confirm.
"It's not going to be worse than any other pill. We're hoping it's going to be significantly better," says London.
The estrogen in Nexstellis, called estetrol, was skipped over by the pharmaceutical industry after its discovery in the 1960s. Estetrol circulates between the mother and fetus during pregnancy. Decades later, researchers took a new look, after figuring out how to synthesize estetrol in a lab, as well as produce estetrol from plants.
"That allowed us to really start to investigate the properties and do all this stuff you have to do for any new drug," says Michele Gordon, vice president of marketing in women's health at Mayne Pharma, which licensed Nextstellis.
Bonnie Douglas, who followed the development of Nextstellis as part of a search for better birth control, recently switched to the product. "So far, it's much more tolerable," says Douglas. Previously, the Midwesterner was so desperate to find a contraceptive with fewer side effects that she turned to an online pharmacy to obtain a different birth control pill that had been approved in Canada but not in the U.S.
Contraceptive Access
Even if a contraceptive lands FDA approval, access poses a barrier. Getting insurers to cover new contraceptives can be difficult. For the uninsured, state and federal programs can help, and companies should keep prices in a reasonable range, while offering assistance programs. So says Kelly Blanchard, president of the nonprofit Ibis Reproductive Health. "For innovation to have impact, you want to reach as many folks as possible," she says.
In addition, companies developing new contraceptives have struggled to attract venture capital. That's changing, though.
In 2015, Sabrina Johnson founded DARÉ Bioscience around the idea of women's health. She estimated the company would be fully funded in six months, based on her track record in biotech and the demand for novel products.
But it's been difficult to get male investors interested in backing new contraceptives. It took Johnson two and a half years to raise the needed funds, via a reverse merger that took the company public. "There was so much education that was necessary," Johnson says, adding: "The landscape has changed considerably."
Johnson says she would like to think DARÉ had something to do with the shift, along with companies like Organon, a spinout of pharma company Merck that's focused on reproductive health. In surveying the fertility landscape, DARÉ saw limited non-hormonal options. On-demand options – like condoms – can detract from the moment. Copper IUDs must be inserted by a doctor and removed if a woman wants to return to fertility, and this method can have onerous side effects.
So, DARÉ created Ovaprene, a hormone-free device that's designed to be inserted into the vagina monthly by the user. The mesh product acts as a barrier, while releasing a chemical that immobilizes sperm. In an early study, the company reported that Ovaprene prevented almost all sperm from entering the cervical canal. The results, DARÉ believes, indicate high efficacy.
A late-stage study, slated to kick off next year, will be the true judge. Should Ovaprene eventually win regulatory approval, drug giant Bayer will handle commercializing the device.
Other new forms of birth control in development are further out, and that's assuming they perform well in clinical trials. Among them: a once-a-month birth control pill, along with a male version of the birth control pill. The latter is often brought up among women who say it's high time that men take a more proactive role in birth control.
For Summers, her search for a safe and convenient birth control continues. She tried Phexxi, which caused irritation. Still, she's excited that a non-hormonal option now exists. "I'm sure it will work for others," she says.
Imagine eating a slice of cake for breakfast. It's deliciously indulgent, but instead of your blood sugar spiking, your body processes all that sweetness as a healthy high-protein meal. It may sound like sci-fi, but this scenario is not necessarily far off.
"People with diabetes could especially benefit because sweet proteins don't trigger a need for insulin."
The Lowdown
An award-winning agtech startup called Amai is developing "sweet proteins," based on the molecular structure of naturally occuring exotic fruits. These new sugar substitutes could potentially replace artificial sweeteners and help people who are trying to curb their sugar intake. People with diabetes could especially benefit because sweet proteins don't trigger a need for insulin.
While there is a sweet protein currently on the market today called thaumatin, it's expensive, has a short shelf life, and is lacking in the taste department. But Amai's proteins taste 70 to 100 percent identical to the sweet ones found in nature. Once their molecular structure is designed through a sophisticated computing platform, they are made through fermentation, which is akin to brewing beer. These non-GMO proteins are over 10,000 times sweeter than sugar, which means much less needs to be produced and used.
Diseases like diabetes and heart disease, which are often linked to sugar overconsumption, have been on a major upswing over the last few decades, especially in the United States. According to the CDC, 100 million adults in the United States are now living with diabetes or prediabetes, which if not treated, often leads to type 2 diabetes within five years. By 2030, scientists predict cases of diabetes in the U.S. will increase by 54 percent. If sugar proteins like the type Amai is creating become widely available, these numbers could begin to decrease.
Next Up
Amai's sweet proteins are still in the research and development stage, but the Israeli startup is raising significant funding that should help expedite the process. They're also substantially upping their production ability by expanding their facilities.
Will consumers be comfortable ingesting a lab-designed food product?
And in March, the USDA and FDA announced plans to regulate cell-cultured foods, the category in which these sugar proteins would fall, so Amai researchers are hopeful they'll have an easier path to approval once their product is market ready.
Open Questions
All this progress may sound promising, but Amai still has a long way to go before the reality of healthy cake becomes tangible. Some questions to consider: Will consumers be comfortable ingesting a lab-designed food product? Will it taste enough like real sugar?
And if some products and brands begin to adopt it, will it ever overtake the real thing in popularity and make a dent in diseases like diabetes and obesity? Only time, more research, and a lot more money will tell, but in the meantime, feel free to daydream about eating entire pints of ice cream without needing to hit the gym.
One of the World’s Most Famous Neuroscientists Wants You to Embrace Meditation and Spirituality
Neuroscientist, philosopher, and bestselling author Sam Harris is famous for many reasons, among them his vocal criticism of religion, his scientific approach to moral questions, and his willingness to tackle controversial topics on his popular podcast.
"Until you have some capacity to be mindful, you have no choice but to be lost in every next thought that arises."
He is also a passionate advocate of mindfulness meditation, having spent formative time as a young adult learning from teachers in India and Tibet before returning to the West.
Now his new app called Waking Up aims to teach the principles of meditation to anyone who is willing to slow down, turn away from everyday distractions, and pay attention to their own mind. Harris recently chatted with leapsmag about the science of mindfulness, the surprising way he discovered it, and the fundamental—but under-appreciated—reason to do it. This conversation has been lightly edited and condensed.
One of the biggest struggles that so many people face today is how to stay present in the moment. Is this the default state for human beings, or is this a more recent phenomenon brought on by our collective addiction to screens?
Sam: No, it certainly predates our technology. This is something that yogis have been talking about and struggling with for thousands of years. Just imagine you're on a beach on vacation where you vowed not to pick up your smart phone for 24 hours. You haven't looked at a screen, you're just enjoying the sound of the waves and the sunset, or trying to. What you're competing with there is this incessant white noise of discursive thinking. And that's something that follows you everywhere. It's something that people tend to only become truly sensitive to once they try to learn to meditate.
You've mentioned in one of your lessons that the more you train in mindful meditation, the more freedom you will have. What do you mean?
Sam: Well, until you have some capacity to be mindful, you have no choice but to be lost in every next thought that arises. You can't notice thought as thought, it just feels like you. So therefore, you're hostage to whatever the emotional or behavioral consequences of those thoughts are. If they're angry thoughts, you're angry. If they're desire thoughts, you're filled with desire. There is very little understanding in Western psychology around an alternative to that. And it's only by importing mindfulness into our thinking that we have begun to dimly see an alternative.
You've said that even if there were no demonstrable health benefits, it would still be valuable to meditate. Why?
Sam: Yeah, people are putting a lot of weight on the demonstrated health and efficiency benefits of mindfulness. I don't doubt that they exist, I think some of the research attesting to them is pretty thin, but it just may in fact be the case that meditation improves your immune system, and staves off dementia, or the thinning of the cortex as we age and many other benefits.
"What was Jesus talking about? Well, he certainly seemed to be talking about a state of mind that I first discovered on MDMA."
[But] it trivializes the real power of the practice. The power of the practice is to discover something fundamental about the nature of consciousness that can liberate you from psychological suffering in each moment that you can be aware of it. And that's a fairly esoteric goal and concern, it's an ancient one. It is something more than a narrow focus on physical health or even the ordinary expectations of well-being.
Yet many scientists in the West and intellectuals, like Richard Dawkins, are skeptical of it. Would you support a double-blind placebo-controlled study of meditation or does that miss the deeper point?
Sam: No, I see value in studying it any way we can. It's a little hard to pick a control condition that really makes sense. But yeah, that's research that I'm actually collaborating in now. There's a team just beginning a study of my app and we're having to pick a control condition. You can't do a true double-blind placebo control because meditation is not a pill, it's a practice. You know what you're being told to do. And if you're being told that you're in the control condition, you might be told to just keep a journal, say, of everything that happened to you yesterday.
One way to look at it is just to take people who haven't done any significant practice and to have them start and compare them to themselves over time using each person as his own control. But there are limitations with that as well. So, it's a little hard to study, but it's certainly not impossible.
And again, the purpose of meditation is not merely to reduce stress or to improve a person's health. And there are certain aspects to it which don't in any linear way reduce stress. You can have stressful experiences as you begin to learn to be mindful. You become more aware of your own neuroses certainly in the beginning, and you become more aware of your capacity to be petty and deceptive and self-deceptive. There are unflattering things to be realized about the character of your own mind. And the question is, "Is there a benefit ultimately to realizing those things?" I think there clearly is.
I'm curious about your background. You left Stanford to practice meditation after an experience with the drug MDMA. How did that lead you to meditation?
Sam: The experience there was that I had a feeling -- what I would consider unconditional love -- for the first time. Whether I ever had the concept of unconditional love in my head at that point, I don't know, I was 18 and not at all religious. But it was an experience that certainly made sense of the kind of language you find in many spiritual traditions, not just what it's like to be fully actualized by those, by, let's say, Christian values. Like, what was Jesus talking about? Well, he certainly seemed to be talking about a state of mind that I first discovered on MDMA. So that led me to religious literature, spiritual or new age literature, and Eastern philosophy.
Looking to make sense of this and put into a larger context that wasn't just synonymous with taking drugs, it was a sketching a path of practice and growth that could lead further across this landscape of mind, which I just had no idea existed. I basically thought you have whatever mind you have, and the prospect of having a radically different experience of consciousness, that would just be a fool's errand, and anyone who claimed to have such an experience would probably be lying.
As you probably know, there's a resurgence of research in psychedelics now, which again I also fully support, and I've had many useful experiences since that first one, on LSD and psilocybin. I don't tend to take those drugs now; it's been many years since I've done anything significant in that area, but the utility is that they work for everyone, more or less, which is to say that they prove beyond any doubt to everyone that it's possible to have a very different experience of consciousness moment to moment. Now, you can have scary experiences on some of these drugs, and I don't recommend them for everybody, but the one thing you can't have is the experience of boredom. [chuckle]
Very true. Going back to your experiences, you've done silent meditation for 18 hours a day with monks abroad. Do you think that kind of immersive commitment is an ideal goal, or is there a point where too much meditation is counter-productive to a full life?
Sam: I think all of those possibilities are true, depending on the person. There are people who can't figure out how to live a satisfying life in the world, and they retreat as a way of trying to untie the knot of their unhappiness directly through practice.
But the flip side is also true, that in order to really learn this skill deeply, most people need some kind of full immersion experience, at least at some point, to break through to a level of familiarity with it that would be very hard to get for most people practicing for 10 minutes a day, or an hour a day. But ultimately, I think it is a matter of practicing for short periods, frequently, more than it's a matter of long hours in one's daily life. If you could practice for one minute, 100 times a day, that would be an extraordinarily positive way to punctuate your habitual distraction. And I think probably better than 100 minutes all in one go first thing in the morning.
"It's amazing to me to walk into a classroom where you see 15 or 20 six-year-olds sitting in silence for 10 or 15 minutes."
What's your daily meditation practice like today? How does it fit into your routine?
Sam: It's super variable. There are days where I don't find any time to practice formally, there are days where it's very brief, and there are days where I'll set aside a half hour. I have young kids who I don't feel like leaving to go on retreat just yet, but I'm sure retreat will be a part of my future as well. It's definitely useful to just drop everything and give yourself permission to not think about anything for a certain period. And you're left with this extraordinarily vivid confrontation with your default state, which is your thoughts are incessantly appearing and capturing your attention and deluding you.
Every time you're lost in thought, you're very likely telling yourself a story for the 15th time that you don't even have the decency to find boring, right? Just imagine what it would sound like if you could broadcast your thoughts on a loud speaker, it would be mortifying. These are desperately boring, repetitive rehearsals of past conversations and anxieties about the future and meaningless judgments and observations. And in each moment that we don't notice a thought as a thought, we are deluded about what has happened. It's created this feeling of self that is a misconstrual of what consciousness is actually like, and it's created in most cases a kind of emotional emergency, which is our lives and all of the things we're worrying about. But our worry adds absolutely nothing to our capacity to deal with the problems when they actually arise.
Right. You mentioned you're a parent of a young kid, and so am I. Is there anything we as parents can do to encourage a mindfulness habit when our kids are young?
Sam: Actually, we just added meditations for kids in the app. My wife, Annaka, teaches meditation to kids as young as five in school. And they can absolutely learn to be mindful, even at that age. And it's amazing to me to walk into a classroom where you see 15 or 20 six-year-olds sitting in silence for 10 or 15 minutes, it's just amazing. And that's not what happens on the first day, but after five or six classes that is what happens. For a six-year-old to become aware of their emotional life in a clear way and to recognize that he was sad, or angry…that's a kind of super power. And it becomes a basis of any further capacity to regulate emotion and behavior.
It can be something that they're explicitly taught early and it can be something that they get modeled by us. They can know that we practice. You can just sit with your kid when your kid is playing. Just a few minutes goes a long way. You model this behavior and punctuate your own distraction for a short period of time, and it can be incredibly positive.
Lastly, a bonus question that is definitely tongue-in-cheek. Who would win in a fight, you or Ben Affleck?
Sam: That's funny. That question was almost resolved in the green room after that encounter. That was an unpleasant meeting…I spend some amount of time training in the martial arts. This is one area where knowledge does count for a lot, but I don't think we'll have to resolve that uncertainty any time soon. We're both getting old.
Kira Peikoff was the editor-in-chief of Leaps.org from 2017 to 2021. As a journalist, her work has appeared in The New York Times, Newsweek, Nautilus, Popular Mechanics, The New York Academy of Sciences, and other outlets. She is also the author of four suspense novels that explore controversial issues arising from scientific innovation: Living Proof, No Time to Die, Die Again Tomorrow, and Mother Knows Best. Peikoff holds a B.A. in Journalism from New York University and an M.S. in Bioethics from Columbia University. She lives in New Jersey with her husband and two young sons. Follow her on Twitter @KiraPeikoff.