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.
GOOD10: The Pandemic Issue explores big-picture ways that science innovation and communication can usher in a more equitable, more progress-oriented, and safer world.
This issue is a collaboration among GOOD, leapsmag, and the Aspen Institute Science & Society Program.
The GOOD10 format explores fundamental issues facing humanity through the lenses of ten forces pushing the needle toward progress: Places, Philanthropists, Celebrities, Whistleblowers, Companies, Media, Products, Politicians, Scientists, and Actions. Across these categories, we seek to present unexpected and encouraging paradigms emerging from this historic crisis.
This special issue is available as an e-reader version for both desktop and mobile. It is also available as a free downloadable PDF.
TABLE OF CONTENTS:
- PLACES:
55 Lessons Learned About Science Communication Around the World; Quarantining Our Way Into Outer Space - PLACES:
Quarantining Our Way Into Outer Space - PHILANTHROPISTS:
An Exclusive Interview with Wendy Schmidt about Science in the Pandemic Era - CELEBRITIES:
Neil deGrasse Tyson Wants Celebrities to Promote Scientists - WHISTLEBLOWERS:
The Science Sleuths Holding Fraudulent Research Accountable - COMPANIES:
The Biggest Challenge for a COVID-19 Vaccine: Making It Accessible and Affordable - MEDIA:
Isaac Asimov on the History of Infectious Disease—And How Humanity Learned To Fight Back - PRODUCTS:
Will COVID-19 Pave the Way For DIY Precision Medicine? - POLITICIANS:
Will the Pandemic Propel STEM Experts to Political Power? - SCIENTISTS:
Would a Broad-Spectrum Antiviral Drug Stop the Pandemic? - ACTIONS:
Pseudoscience is Rampant: How Not to Fall For It - ACTIONS:
How COVID-19 Could Usher In a New Age of Collective Drug Discovery
THE EVENT:
"The Pandemic Science Summit" focused on how science innovation is key to society's future stability as we emerge from the pandemic, featuring:
Christopher Bailey – Arts and Health Lead, World Health Organization
Elisabeth Bik, Ph.D. – Microbiologist and scientific integrity consultant
Margaret Hamburg, M.D. – Foreign Secretary, National Academy of Medicine; former Commissioner, U.S. Food and Drug Administration
Peggy Oti-Boateng, Ph.D. – Director, Division of Science Policy and Capacity- Building, UNESCO
George Yancopoulos, M.D., Ph.D. – President and Chief Scientific Officer, Regeneron Pharmaceuticals
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.
Two Conservative Icons Gave Opposite Advice on COVID-19. Those Misinformed Died in Higher Numbers, New Study Reports.
The news sources that you consume can kill you - or save you. That's the fundamental insight of a powerful new study about the impact of watching either Sean Hannity's news show Hannity or Tucker Carlson's Tucker Carlson Tonight. One saved lives and the other resulted in more deaths, due to how each host covered COVID-19.
Carlson took the threat of COVID-19 seriously early on, more so than most media figures on the right or left.
This research illustrates the danger of falling for health-related misinformation due to judgment errors known as cognitive biases. These dangerous mental blindspots stem from the fact that our gut reactions evolved for the ancient savanna environment, not the modern world; yet the vast majority of advice on decision making is to "go with your gut," despite the fact that doing so leads to so many disastrous outcomes. These mental blind spots impact all areas of our life, from health to politics and even shopping, as a survey by a comparison purchasing website reveals. We need to be wary of cognitive biases in order to survive and thrive during this pandemic.
Sean Hannity vs. Tucker Carlson Coverage of COVID-19
Hannity and Tucker Carlson Tonight are the top two U.S. cable news shows, both on Fox News. Hannity and Carlson share very similar ideological profiles and have similar viewership demographics: older adults who lean conservative.
One notable difference, however, relates to how both approached coverage of COVID-19, especially in February and early March 2020. Researchers at the Becker Friedman Institute for Economics at the University of Chicago decided to study the health consequences of this difference.
Carlson took the threat of COVID-19 seriously early on, more so than most media figures on the right or left. Already on January 28, way earlier than most, Carlson spent a significant part of his show highlighting the serious dangers of a global pandemic. He continued his warnings throughout February. On February 25, Carlson told his viewers: "In this country, more than a million would die."
By contrast, Hannity was one of the Fox News hosts who took a more extreme position in downplaying COVID-19, frequently comparing it to the flu. On February 27, he said "And today, thankfully, zero people in the United States of America have died from the coronavirus. Zero. Now, let's put this in perspective. In 2017, 61,000 people in this country died from influenza, the flu. Common flu." Moreover, Hannity explicitly politicized COVID-19, claiming that "[Democrats] are now using the natural fear of a virus as a political weapon. And we have all the evidence to prove it, a shameful politicizing, weaponizing of, yes, the coronavirus."
However, after President Donald Trump declared COVID-19 a national emergency in mid-March, Hannity -- and other Fox News hosts -- changed their tune to align more with Carlson's, acknowledging the serious dangers of the virus.
The Behavior and Health Consequences
The Becker Friedman Institute researchers investigated whether the difference in coverage impacted behaviors. They conducted a nationally representative survey of over 1,000 people who watch Fox News at least once a week, evaluating both viewership and behavior changes in response to the pandemic, such as social distancing and improving hygiene.
Next, the study compared people's behavior changes to viewing patterns. The researchers found that "viewers of Hannity changed their behavior five days later than viewers of other shows, while viewers of Tucker Carlson Tonight changed their behavior three days earlier than viewers of other shows." The statistical difference was more than enough to demonstrate significance; in other words, it was extremely unlikely to occur by chance -- so unlikely as to be negligible.
Did these behavior changes lead to grave consequences? Indeed.
The paper compared the popularity of each show in specific counties to data on COVID-19 infections and deaths. Controlling for a wide variety of potential confounding variables, the study found that areas of the country where Hannity is more popular had more cases and deaths two weeks later, the time that it would take for the virus to start manifesting itself. By March 21st, the researchers found, there were 11 percent more deaths among Hannity's viewership than among Carlson's, again with a high degree of statistical significance.
The study's authors concluded: "Our findings indicate that provision of misinformation in the early stages of a pandemic can have important consequences for health outcomes."
Such outcomes stem from excessive trust that our minds tend to give those we see as having authority, even if they don't possess expertise in the relevant subject era.
Cognitive Biases and COVID-19 Misinformation
It's critically important to recognize that the study's authors did not seek to score any ideological points, given the broadly similar ideological profiles of the two hosts. The researchers simply explored the impact of accurate and inaccurate information about COVID-19 on the viewership. Clearly, the false information had deadly consequences.
Such outcomes stem from excessive trust that our minds tend to give those we see as having authority, even if they don't possess expertise in the relevant subject era -- such as media figures that we follow. This excessive trust - and consequent obedience - is called the "authority bias."
A related mental pattern is called "emotional contagion," in which we are unwittingly infected with the emotions of those we see as leaders. Emotions can motivate action even in the absence of formal authority, and are particularly important for those with informal authority, including thought leaders like Carlson and Hannity.
Thus, Hannity telling his audience that Democrats used anxiety about the virus as a political weapon led his audience to reject fears of COVID-19, even though such a reaction and consequent behavioral changes were the right response. Carlson's emphasis on the deadly nature of this illness motivated his audience to take appropriate precautions.
Authority bias and emotional contagion facilitate the spread of misinformation and its dangers, at least when we don't take the steps necessary to figure out the facts. Such steps can range from following best fact-checking practices to getting your information from news sources that commit publicly to being held accountable for truthfulness. Remember, the more important and impactful such information may be for your life, the more important it is to take the time to evaluate it accurately to help you make the best decisions.