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.
A patient getting examined at health startup Forward.
What if going to the doctor's office could be … nice?
If you didn't have to wait for your appointment, but were ushered right in; if your medical data was all collated and easily searchable on an iPhone app; if a remote scribe took notes while you spoke with your doctor so you could make eye contact with them; if your doctor didn't seem horribly rushed.
Would you go to the doctor to get help staying healthy, rather than just to stop being sick?
Would that change the way you thought about your health? Would you go to the doctor to get help staying healthy, rather than just to stop being sick? And would that, in the long run, be much better for you?
Those are the animating questions for Forward, a healthcare startup devoted to preventive care. Led by founder Adrian Aoun, formerly of Google/Sidewalk labs, Forward opened its first office in San Francisco in 2016 and has since expanded to Los Angeles, Orange County, New York, and Washington, D.C., with a San Diego location opening soon.
It's been described as the "Apple Store of doctor's offices," which in some ways is a reaction to Forward's vibe: Patients have described the offices as having blonde wood, minimalist design, sparkling water on tap — and lots of high-tech gadgets, like the full-body scanner that replaces the standard scale and stethoscope.
The interior of a Forward office.
(Courtesy Forward)
The more crucial difference, though, is its model of care. Forward doesn't take insurance. Instead, patients, or "members," pay a flat $149 per month, along the lines of a subscription service like Netflix or a gym membership. That fee covers visits, messaging with medical staff through the Forward app, the use of a wearable (like a Fitbit or a sleep tracker) if the physician recommends it, plus any bloodwork or diagnostic tests run in the on-site labs. (The company declined to disclose how many people have signed up for memberships.)
Predictability is Forward's other significant, distinguishing feature: No surprise co-pays, or extra charges showing up on a billing statement months later. Everything is wrapped up in the $149 membership fee, unless the physician recommends visiting an outside specialist.
That caveat isn't a small one. It's important to note that Forward is in no way meant to replace standard health insurance. The service is strictly focused on preventive care, so it wouldn't be much use in case of an emergency; it's meant to help people, as far as is possible, avoid that emergency at all.
Ani Okkasian's family recently went through such an emergency. Her 62-year-old father, an active and seemingly healthy man living with diabetes, had been feeling unwell for a while, but struggled to receive constructive follow-up or tests from his doctor. It finally emerged that his liver was severely damaged, and he suffered a stroke — the risk of which can be elevated by liver disease. He seemed to deteriorate completely within mere weeks, Okkasian said, and in January he passed away.
"He was someone who'd go to the doctor regularly and listen to what they said and follow it," Okkasian said. "I shouldn't have had to bury my father at 62. I still believe to my core that his death could have been avoided if the primary care was adequate."
"I could tell that the people who designed [Forward] had lost someone to the legacy system; it was so streamlined and so much clearer."
Okkasian began researching, looking for a better alternative, and discovered Forward. Founder Aoun lost his grandfather to a heart attack; his brother's heart attack at age 31 was the impetus to start Forward.
"I could tell that that was the genesis," Okkasian said. "Having just lost someone, and having had to deal with different aspects of the healthcare industry — how complicated and convoluted that all is — I could tell that the people who designed [Forward] had lost someone to the legacy system; it was so streamlined and so much clearer."
So Who Is Forward For?
The Affordable Care Act mandates that evidence-based preventive care must be covered by insurers without any cost to the patient. Today, 30 million Americans are still living without health insurance; but for most of the population, cost shouldn't prevent access to standard, preventive care, says Benjamin Sommers, a physician and professor at the Harvard T.H. Chan School of Public Health who has studied the effect of the ACA on preventive care access.
For Okkasian and her family, it wasn't a lack of access to primary care that was at issue; it was the quality of that primary care. In 2019, that's probably true for a lot of people.
"How come all other industries have been disturbed except the medical industry?" Okkasian asked. "It's disturbing the most people. We're so advanced in so many ways, but when it comes to the healthcare system, we're not prioritizing the wellness of a person."
Is Forward the answer? Well, probably not for everyone. Its office are only in a handful of cities, and there are limits to how scalable it would be; it's unavoidable that the $149 per month charge restricts access for a lot of people. Those who have insurance through their employer might have a flexible spending account (FSA) that would cover some or all of the membership fee, and Forward has said that 15 percent of their early members came from underserved communities and were offered free plans; but for many others, that's just an unworkable extra cost.
Sommers also sounded a dubious note about a maximalist attitude toward data collection.
"Even though some patients may think that 'more is always better' — more testing, more screening, etc. — this isn't true," he said. "Some types of cancer screening, ovarian cancer screening for instance, are actually harmful or of no benefit, because studies have shown that they don't improve survival or health outcomes, but can lead to unnecessary testing, pain, false positives, anxiety, and other side effects.
"It's really great for people who are in good health, looking to make it better."
"I'm generally skeptical of efforts to charge people more to get 'extra testing' that isn't currently supported by the medical evidence," he added.
But relatively healthy people who want to take a more active approach to their health — or people who have frequent testing needs, like those using the HIV-prevention drug PrEP, and want to avoid co-pays — might benefit from the on-demand, low-friction experience that Forward offers.
"It's really great for people who are in good health, looking to make it better," Okkasian said. "Your experience is simplified to a point where you feel empowered, not scared."
