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.
Neil deGrasse Tyson Wants Celebrities to Promote Scientists
"President Kennedy was the first president to not wear a hat. Have you seen men wearing hats since then?" Neil deGrasse Tyson, one of the world's few astrophysicists with a household name, asks on the phone from his car. Well, no. "If I wear some cowboy hats, it's because it's the outfit, it's not because that's my standard equipment when I leave the home."
"We have classes on 100 things and none of them are on the ability to distinguish what is true and what is not."
But Tyson, who speaks in methodically reasoned paragraphs with lots of semi-rhetorical questions to make sure we're all still listening, isn't really making a point about Mad Men-era men's clothing trends. "Should a president influence fashion?" he says. "I think people sometimes don't know the full power they have over other people. So, that's the first prong in this comment. My second prong is, why would anyone take medical advice from a politician?"
Days before our conversation, news broke that President Trump said he was taking hydroxychloroquine, which he had hyped for months as a surefire magical cure for COVID-19 — the science just hadn't caught up to his predictions. But the science never did catch up; instead, it went the opposite direction, showing that hydroxychloroquine, when used to treat COVID-19 patients, actually led to an increased risk of death.
Alarm spread swiftly around the globe as experts cast the president's professed self-medicating as illogical and dangerous. However, it was just one of a series of wild pieces of medical advice espoused by Trump from his mighty pulpit, like that, hey, maybe disinfectants could cure people when injected into their bodies. (That also leads to death.)
But people do take medical advice from politicians. An Arizona man afraid of COVID-19 died after consuming chloroquine phosphate, which he and his wife had sitting on the back of a shelf after using it to treat koi fish for parasites. The pandemic has exposed many weaknesses in the feedback loop of society, government, the media, and science, including the difficulty of seeding accurate medical information with the masses. Many on the left and right decry a broken political and news media system, but Tyson believes the problem isn't mega-influencers like Trump. Rather it's the general public's desire to take their advice on complex topics – like the science of virology – that such influencers know nothing about.
Tyson's not upset with the public, who follow Trump's advice. "As an educator, I can't get angry with you," he says. Or even Trump himself. "Trump was elected by 60 million people, right? So, you could say all you want about Trump, kick him out of office, whatever. [There's] still the 60 million fellow Americans who walk among us who voted for him. So, what are you going to do with them?"
Tyson also isn't upset with Facebook, Twitter, and other social platforms that serve as today's biggest conduits for misinformation. After all, in the realm of modern media's history, these networks are tadpoles. "As an educator and as a scientist, I'm leaning towards, let's figure out a way to train people in school to not fall victim to false information, and how to judge what is likely to be false relative to what is likely to be true. And that's hard, but you and I have never had a class in that, have we? We've had biology classes, we've had English lit, we've had classes on Shakespeare — we have classes on 100 things and none of them are on the ability to distinguish what is true and what is not."
This is why Tyson himself doesn't engage in Trump bashing on his social feeds, but does try to get people to differentiate factual science from fake news. "I feel responsibility to participate in the enlightenment of culture and of civilization, because I have that access," says Tyson, who has 13.9M followers on Twitter, 1.2M on Instagram, and 4.2M on Facebook. He doesn't tell his followers not to inject themselves with Clorox ("no one likes being told what to do"), but tries to get them to visualize a pandemic's impact by comparing it to, say, a throng of rabbits.
"Left unchecked, 1,000 rabbits in 5 years, become 7-billion, the human population of the World. After 15 years, a 'land-ocean' of rabbits fills to one-kilometer depth across all of Earth's continents. Viruses can reproduce waaaay faster than Rabbits," he tweeted on April 6, after much of the nation had locked down to slow the pandemic's spread. For added viral impact, he attached a photo of an adorable, perhaps appropriately scared-looking, white bunny.
Of course, not all celebrities message responsibly.
Tyson is a rare scientist-turned-celebrity. His appeal isn't acting in movies or singing dance-pop anthems (if only). Rather, his life's work is making science fun and interesting to as many people as possible through his best-selling books on astrophysics and his directorship of the planetarium at the American Museum of Natural History in New York. His longstanding place in popular culture is an exception, not the rule.
And he believes his fellow celebrities, actors and pop music stars and internet influencers, should aid the public's quest for accurate scientific information. And in order to do that, they must point their followers to experts and organizations who know what they're talking about. "It could be to a website, it could be to a talk that was given. I would say that that's where the responsibility lies if you control the interests of a million people," he says.
One example of this is Lady Gaga's March 14 Instagram of herself on her couch with her three dogs with the caption, "So I talked to some doctors and scientists. It's not the easiest for everyone right now but the kindest/healthiest thing we can do is self-quarantine and not hang out with people over 65 and in large groups. I wish I could see my parents and grandmas right now but it's much safer to not so I don't get them sick in case I have it. I'm hanging at home with my dogs." (All the celebrities here in this article are my references, not Tyson's, who does not call out specific people.)
Of course, not all celebrities message responsibly. Jessica Biel and Jenny McCarthy have faced scorn for public stances against vaccines. Gwyneth Paltrow and her media brand GOOP have faced backlash for promoting homeopathic treatments with no basis in science.
"The New Age Movement is a cultural idea, it has nothing to do with religion, has nothing to do with politics, and it's people who were rejecting objectively established science in part or in total because they have a belief system that they want to attach to it, okay? This is how you get the homeopathic remedies," says Tyson. "That's why science exists, so that we don't have to base decisions on belief systems."
[Editor's Note: This article was originally published on June 8th, 2020 as part of a standalone magazine called GOOD10: The Pandemic Issue. Produced as a partnership among LeapsMag, The Aspen Institute, and GOOD, the magazine is available for free online.]
Masks and Distancing Won't Be Enough to Prevent School Outbreaks, Latest Science Suggests
Never has the prospect of "back to school" seemed so ominous as it does in 2020. As the number of COVID-19 cases climb steadily in nearly every state, the prospect of in-person classes are filling students, parents, and faculty alike with a corresponding sense of dread.
The notion that children are immune or resistant to SARS-CoV-2 is demonstrably untrue.
The decision to resume classes at primary, secondary, and collegiate levels is not one that should be regarded lightly, particularly as coronavirus cases skyrocket across the United States.
What should be a measured, data-driven discussion that weighs risks and benefits has been derailed by political talking points. President Trump has been steadily advocating for an unfettered return to the classroom, often through imperative "OPEN THE SCHOOLS!!!" tweets. In July, Secretary of Education Betsy DeVos threatened to withhold funding from schools that did not reopen for full-time, in-person classes, despite not having the authority to do so. Like so many public health issues, opening schools in the midst of a generational pandemic has been politicized to the point that the question of whether it is safe to do so has been obscured and confounded. However, this question still deserves to be examined based on evidence.
What We Know About Kids and COVID-19
Some arguments for returning to in-person education have focused on the fact that children and young adults are less susceptible to severe disease. In some cases, people have stated that children cannot be infected, pointing to countries that have resumed in-person education with no associated outbreaks. However, those countries had extremely low community transmission and robust testing and surveillance.
The notion that children are immune or resistant to SARS-CoV-2 is demonstrably untrue: children can be infected, they can become sick, and, in rare cases, they can die. Children can also transmit the virus to others, especially if they are in prolonged proximity to them. A Georgia sleepaway camp was the site of at least 260 cases among mostly children and teenagers, some as young as 6 years old. Children have been shown to shed infectious virus in their nasal secretions and have viral loads comparable to adults. Children can unquestionably be infected with SARS-CoV-2 and spread it to others.
The more data emerges, the more it appears that both primary and secondary schools and universities alike are conducive environments for super-spreading. Mitigating these risks depends heavily on individual schools' ability to enforce reduction measures. So far, the evidence demonstrates that in most cases, schools are unable to adequately protect students or staff. A school superintendent from a small district in Arizona recently described an outbreak that occurred among staff prior to in-person classes resuming. Schools that have opened so far have almost immediately reported new clusters of cases among students or staff.
This is because it is impossible to completely eliminate risk even with the most thoughtful mitigation measures when community transmission is high. Risk can be reduced, but the greater the likelihood that someone will be exposed in the community, the greater the risk they might pass the virus to others on campus or in the classroom.
There are still many unknowns about SARS-CoV-2 transmission, but some environments are known risks for virus transmission: enclosed spaces with crowds of people in close proximity over extended durations. Transmission is thought to occur predominantly through inhaled aerosols or droplets containing SARS-CoV-2, which are produced through common school activities such as breathing, speaking, or singing. Masks reduce but do not eliminate the production of these aerosols. Implementing universal mask-wearing and physical distancing guidelines will furthermore be extraordinarily challenging for very young children.
Smaller particle aerosols can remain suspended in the air and accumulate over time. In an enclosed space where people are gathering, such as a classroom, this renders risk mitigation measures such as physical distancing and masks ineffective. Many classrooms at all levels of education are not conducive to improving ventilation through low-cost measures such as opening windows, much less installing costly air filtration systems.
As a risk reduction measure, ventilation greatly depends on factors like window placement, window type, room size, room occupancy, building HVAC systems, and overall airflow. There isn't much hard data on the specific effects of ventilation on virus transmission, and the models that support ventilation rely on assumptions based on scant experimental evidence that doesn't account for virologic parameters.
There is also no data about how effective air filtration or UV systems would be for SARS-CoV-2 transmission risk reduction, so it's hard to say if this would result in a meaningful risk reduction or not. We don't have enough data outside of a hospital setting to support that ventilation and/or filtration would significantly reduce risk, and it's impractical (and most likely impossible in most schools) to implement hospital ventilation systems, which would likely require massive remodeling of existing HVAC infrastructure. In a close contact situation, the risk reduction might be minimal anyway since it's difficult to avoid exposure to respiratory aerosols and droplets a person is exhaling.
You'd need to get very low rates in the local community to open safely in person regardless of other risk reduction measures, and this would need to be complemented by robust testing and contact tracing capacity.
Efforts to resume in-person education depend heavily on school health and safety plans, which often rely on self-reporting of symptoms due to insufficient testing capacity. Self-reporting is notoriously unreliable, and furthermore, SARS-CoV-2 can be readily transmitted by pre-symptomatic individuals who may be unaware that they are sick, making testing an essential component of any such plan. Primary and secondary schools are faced with limited access to testing and no funds to support it. Even in institutions that include a testing component in their reopening plans, this is still too infrequent to support the full student body returning to campus.
Economic Conflicts of Interest
Rebecca Harrison, a PhD candidate at Cornell University serving on the campus reopening committee, is concerned that her institution's plan places too much faith in testing capacity and is over-reliant on untested models. Harrison says that, as a result, students are being implicitly encouraged to return to campus and "very little has been done to actively encourage students who are safe and able to stay home, to actually stay home."
Harrison also is concerned that her institution "presumably hopes to draw students back from the safety of their parents' basements to (re)join the residential campus experience ... and drive revenue." This is a legitimate concern. Some schools may be actively thwarting safety plans in place to protect students based on financial incentives. Student athletes at Colorado State have alleged that football coaches told them not to report COVID-19 symptoms and are manipulating contact tracing reports.
Public primary and secondary schools are not dependent on student athletics for revenue, but nonetheless are susceptible to state and federal policies that tie reopening to budgets. If schools are forced to make decisions based on a balance sheet, rather than the health and safety of students, teachers, and staff, they will implement health and safety plans that are inadequate. Schools will become ground zero for new clusters of cases.
Looking Ahead: When Will Schools Be Able to Open Again?
One crucial measure is the percent positivity rate in the local community, the number of positive tests based on all the tests that are done. Some states, like California, have implemented policies guiding the reopening of schools that depend in part on a local community's percent positivity rate falling under 8 percent, among other benchmarks including the rate of new daily cases. Currently, statewide, test positivity is below 7%, with an average of 3 new daily cases per 1000 people per day. However, the California department of health acknowledges that new cases per day are underreported. There are 6.3 million students in the California public school system, suggesting that at any given time, there could be nearly 20,000 students who might be contagious, without accounting for presymptomatic teachers and staff. In the classroom environment, just one of those positive cases could spread the virus to many people in one day despite masks, distancing, and ventilation.
You'd need to get very low rates in the local community to open safely in person regardless of other risk reduction measures, and this would need to be complemented by robust testing and contact tracing capacity. Only with rapid identification and isolation of new cases, followed by contact tracing and quarantine, can we break chains of transmission and prevent further spread in the school and the larger community.
None of these safety concerns diminish the many harms associated with the sudden and haphazard way remote learning has been implemented. Online education has not been effective in many cases and is difficult to implement equitably. Young children, in particular, are deprived of the essential social and intellectual development they would normally get in a classroom with teachers and their peers. Parents of young children are equally unprepared and unable to provide full-time instruction. Our federal leadership's catastrophic failure to contain the pandemic like other countries has put us in this terrible position, where we must choose between learning or spreading a deadly pathogen.
Blame aside, parents, educators, and administrators must decide whether to resume in-person classes this fall. Those decisions should be based on evidence, not on politics or economics. The data clearly shows that community transmission is out of control throughout most of the country. Thus, we ignore the risk of school outbreaks at our peril.
[Editor's Note: Here's the other essay in the Back to School series: 5 Key Questions to Consider Before Sending Your Child Back to School.]