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.
Deaf Scientists Just Created Over 1000 New Signs to Dramatically Improve Ability to Communicate
For the deaf, talent and hard work may not be enough to succeed in the sciences. According to the National Science Foundation, deaf Americans are vastly underrepresented in the STEM fields, a discrepancy that has profound economic implications.
The problem with STEM careers for the deaf and hard-of-hearing is that there are not enough ASL signs available.
Deaf and hard-of-hearing professionals in the sciences earn 31 percent more than those employed in other careers, according to a 2010 study by the National Technical Institute for the Deaf (NTID) in Rochester, N.Y., the largest technical college for deaf and hard-of-hearing students. But at the same time, in 2017, U.S. students with hearing disabilities earned only 1.1 percent of the 39,435 doctoral degrees awarded in science and engineering.
One reason so few deaf students gravitate to science careers and may struggle to complete doctoral programs is the communication chasm between deaf and hard-of-hearing scientists and their hearing colleagues.
Lorne Farovitch is a doctoral candidate in biomedical science at the University of Rochester of New York. Born deaf and raised by two deaf parents, he communicated solely in American Sign Language (ASL) until reaching graduate school. There, he became frustrated at the large chunk of his workdays spent communicating with hearing lab mates and professors, time he would have preferred spending on his scientific work.
The problem with STEM careers for the deaf and hard-of-hearing is that there are not enough ASL signs available, says Farovitch. Names, words, or phrases that don't exist in ASL must be finger spelled — the signer must form a distinct hand shape to correspond with each letter of the English alphabet, a tedious and time-consuming process. For instance, it requires 12 hand motions to spell out the word M-I-T-O-C-H-O-N-D-R-I-A. Imagine repeating those motions countless times a day.
To bust through this linguistic quagmire, Farovitch, along with a team of deaf STEM professionals, linguists, and interpreters, have been cooking up signs for terms like Anaplasma phagocytophilum, the tick-borne bacterium Farovitch studies. The sign creators are then videotaped performing the new signs. Those videos are posted on two crowd-sourcing sites, ASLcore.org and ASL Clear.
The beauty of ASL is you can express an entire concept in a single sign, rather than by the name of a word.
"If others don't pick it up and use it, a sign goes extinct," says Farovitch. Thus far, more than 1,000 STEM terms have been developed on ASL Clear and 500 vetted and approved by the deaf STEM community, according to Jeanne Reis, project director of the ASL Clear Project, based at The Learning Center for the Deaf in Framingham, Mass.
The beauty of ASL is you can express an entire concept in a single sign, rather than by the name of a word. The signs are generally intuitive and wonderfully creative. To express "DNA" Farovitch uses two fingers of each hand touching the tips of the opposite hand; then he draws both the hands away to suggest the double helix form of the hereditary material present in most organisms.
"If you can show it, you can understand the concept better,'' says the Canadian-born scientist. "I feel I can explain science better now."
The hope is that as ASL science vocabulary expands more, deaf and hard-of-hearing students will be encouraged to pursue the STEM fields. "ASL is not just a tool; it's a language. It's a vital part of our lives," Farovitch explains through his interpreter.
The deaf community is diverse—within and beyond the sciences. Sarah Latchney, PhD, an environmental toxicologist, is among the approximately 90 percent of deaf people born to hearing parents. Hers made sure she learned ASL at an early age but they also sent Latchney to a speech therapist to learn to speak and read lips. Latchney is so adept at both that she can communicate one-on-one with a hearing person without an interpreter.
Like Favoritch, Latchney has developed "conceptually accurate" ASL signs but she has no plans to post them on the crowd-sourcing sites. "I don't want to fix [my signs]; it works for me," she explains.
Young scientists like Farovitch and Latchney stress the need for interpreters who are knowledgeable about science. "When I give a presentation I'm a nervous wreck that I'll have an interpreter who may not have a science background," Latchney explains. "Many times what I've [signed] has been misinterpreted; either my interpreter didn't understand the question or didn't frame it correctly."
To enlarge the pool of science-savvy interpreters, the University of Rochester will offer a new masters degree program: ASL Interpreting in Medicine and Science (AIMS), which will train interpreters who have a strong background in the biological sciences.
Since the Americans with Disabilities Act was enacted in 1990, opportunities in higher education for deaf and hard-of-hearing students have opened up in the form of federally funded financial aid and the creation of student disability services on many college campuses. Still, only 18 percent of deaf adults have graduated from college, compared to 33 percent of the general population, according to a survey by the U.S. Census Bureau in 2015.
The University of Rochester and the Rochester Institute of Technology, home to NTID, have jointly created two programs to increase the representation of deaf and hard-of-hearing professionals in the sciences. The Rochester Bridges to the Doctorate Program, which Farovitch is enrolled in, prepares deaf scholars for biomedical PhD programs. The Rochester Postdoctoral Partnership readies deaf postdoctoral scientists to successfully attain academic research and teaching careers. Both programs are funded by the National Institutes of Science. In the last five years, the University of Rochester has gone from zero deaf postdoctoral and graduate students to nine.
"Deafness is not a problem, it's just a difference."
It makes sense for these two private universities to support strong programs for the deaf: Rochester has the highest per capita population of deaf or hard-of-hearing adults younger than 65 in the nation, according to the U.S. Census. According to the U.S. Department of Education, there are about 136,000 post-secondary level students who are deaf or hard of hearing.
"Deafness is not a problem, it's just a difference," says Farovitch. "We just need a different way to communicate. It doesn't mean we require more work."
Pregnant and Breastfeeding Women Might Have a New Reason to Ditch Artificial Sweeteners
Women considering pregnancy might have another reason to drop artificial sweeteners from their diet, if a new study of mice proves to apply to humans as well. It highlights "yet another potential health impact of zero-calorie sweeteners," according to lead author Stephanie Olivier-Van Stichelen.
The discovery was serendipitous, not part of the original study.
It found that commonly used artificial sweeteners consumed by female mice transfer to pups in the womb and later through milk, harming their development. The sweeteners affected the composition of bacteria in the gut of the pups, making them more vulnerable to developing diabetes, and greatly reduced the liver's capacity to neutralize toxins.
The discovery was serendipitous, not part of the original study, says John Hanover, the senior author and a cell biologist at the NIH National Institute of Diabetes and Digestive and Kidney Diseases. The main study looked at how a high sugar diet in the mother turns genes on and off in the developing offspring.
It compared them with mothers fed a low sugar diet, replacing sugar with a mix of sucralose and acesulfame-K (AK), two non-nutrient artificial sugars that are already used extensively in our food products and thought to be safe.
While the artificial sweeteners had little effect on the mothers, the trace amounts that were transferred through the placenta and milk had a profound effect on the pups. Hanover believes the molecules are changing gene expression during a crucial, short period of development.
"Somewhat to our surprise, we saw in the pups a really dramatic change in the microbiome" of those whose mothers were fed the artificial sweeteners, Hanover told leapsmag. "It looked like the neonates were much, much more sensitive than their mothers to the sucralose and AK." The unexpected discovery led them to publish a separate paper.
"The protective microbe Akkermansia was largely missing, and we saw a pretty dramatic shift in the ratio of two bacteria that are normally associated with metabolic disease," a precursor to diabetes, he explains. Akkermansia is a bacteria that feeds on mucus in the gut and helps remodel the tissue to an adult state over the first several months of life in a mouse. A similar process takes several years in humans, as the infant is weaned off of breast milk as the primary food source.
The good news is the body seems to remove these artificial sweeteners fairly quickly, probably within a week.
Another problem the researchers saw in the animals was "a particularly striking change in the metabolism of the detoxification systems" in the liver, says Hanover. A healthy liver is dark red, but a high dose of the artificial sweeteners turned it white, "which is a sign of massive problems."
The study was conducted in mice and Hanover cautions the findings may not apply to humans. "But in general, the microbiome changes that one sees in the rodent model mimics what we see in humans...[and] the genes that are turned on in the mouse and the human are very similar."
Hanover acknowledges the quantity of artificial sweeteners used in the study is on the high end of human consumption, roughly the equivalent of 20 cans of diet soda a day. But the sweeteners are so ubiquitous in consumer products, from foods to lipstick, and often not even mentioned on the label, that it is difficult to measure just how much a person consumes every day.
The good news is the body seems to remove these artificial sweeteners fairly quickly, probably within a week. Until further studies provide a clearer picture, women who want to err on the side of caution can choose to reduce if not eliminate their exposure to artificial sweeteners during pregnancy and breastfeeding.