The year “gaslighting” of women with hard-to-diagnose maladies was finally given the kabosh? - The year we found the hormone causing acute morning sickness?
- Impressive and large funding rounds despite a bleak funding environment?
- “Birth control for men” makes it to the clinical trial stage?
By Anna Zornosa - In the shadow of one very bad, no-good horrible development setting women’s health back decades (the overturning of Roe V. Wade), I spent the year taking note of some amazing advances happening in the pursuit of health solutions for women. Curious if others were also seeing bright spots, I asked some of the smartest women I know if they’d also seen events signaling notable progress.
My timing was bad: with the holidays upon us I knew some could not answer. But to my delight I got observations Barbara Levy, MD, FACOG, FACS : from CEO/Founders Somer Baburek, MBA (Hera Biotech), Melody Roberts (Liv Labs), and Melissa Bowley (Flourish Care); from author Susan Salenger; medtech designer and diversity driver Nada (Osman) Hanafi ; investors Jessica Karr and Susan Solinsky; and Ayse McCracken, Founder of the Ignite Accelerator for women leading life science companies.
What did we miss? A lot, certainly. Please add your own “brightspots of note” to comments. This will create something we can all turn to if (when) bad developments happen in 2024.
BRIGHTSPOTS IN WOMEN'S HEALTH FROM THE YEAR 2023
Gaslighting no more? Attention, Support, and validity
“I think one of the most compelling things has been the publicity around gaslighting women - dismissing and refusing to treat our symptoms of menopause, endometriosis and highlighting the embarrassing inequities in maternal health outcomes” Said Dr. Levy, OB/GYN, former head of research for ACOG (the American College of Obstetrics and Gynecology), currently co-chair of the AMA CPT board and Medical Director for Visana Health and SoLá Pelvic Therapy. Contributors Roberts and Salenger also called out the sea change in tone, with Salenger adding: “While Gaslighting is still a huge issue, the publicity the subject has attracted has helped create awareness.”
Also in this category: The White House Initiative on Women’s Health Research (nominated by Hanafi, Baburek, McCracken and others); The first comprehensive review of investment in women’s health by Silicon Valley Bank highlighting that funding into companies innovating in women’s health has “flourished in the past five years” (also noted by Solinsky, Karr and others); and the work of the NIH to put a focus on the causes of the maternal mortality in the US (noted by Hanafi and myself.)
Hanafi, in particular, pointed out that these efforts often highlighted “the health crises disproportionately disadvantageing black and brown and LatinX women in the US '' while noting the need to address systemic racism to enact change.
The first OTC birth control pill; a path towards contraception for men
In a year where developments in government policy often ran counter to women’s reproductive rights, the FDA’s decision in July to allow for some birth control pills to be sold over the counter was a significant move to get contraception into the hands of all women, and earned Karr’s nomination. Now the fight is happening to make sure that pills bought this way will still get insurance reimbursed with no out of pocket, as specified for contraception under the Affordable Care Act.
And this just in: in December, YourChoice Therapeutics began clinical trials in the UK of the first hormone-free reversible male birth control pill, creating a new path for men to take part in reproductive decisions.
Funding yes. But with some significant improvements.
The year 2023 was a car wreck for private investment in general but in contrast, according to the SVB report, “women's health is seeing more of a speed bump.” Looking at the five year trends in funding of this sector, in 2023 there were some differences. Somer Baburek noted that big later stage raises are happening (I.e. Maven Clinic ’s $90 M raise.) And while the early funding focus was on digital health innovations particularly in fertility and maternity, now companies born of solid advances in life science research are breaking through.
AOA DX’s $17 M 2023 seed raise, for instance, will bring its liquid biopsy-based diagnostic for ovarian cancer closer to market. With this raise, AOA Dx has received a total of $24 M in seed funding. This may, in itself, be a record for a company innovating in women’s health. Another breakthrough diagnostic is coming: Hera Biotech, the company founded by Barburek, is completing its first round of clinical trials for a tissue-based diagnostic for endometriosis. With a tool that diagnoses with more certainty than saliva or blood-based attempts to test for endo, pharma companies will be better able to look for therapies and fertility clinics can identify the 50% of their patients for whom endo may be the root cause of their infertility.
And YAY for Science!
This one’s from my list: In 2023, we learned that the HPV vaccine may be lowering rates of cervical cancer by as much as 65%. In fact, the vaccine has been so effective that the lower incidence of cervical cancer brought down the overall US cancer rate. We can give the vaccine the credit because 2023 was the year the first cohort who got vaccinated could be looked at from a 10-year perspective.
This bodes very well for other advances that are just now coming to market.
“The approval of an oral, at-home treatment for severe postpartum depression, zuranolone (despite its $15,000+ price tag) is a brightspot. (It) allows a woman to remain home with her newborn and family,” said Dr. Levy, who noted the only other therapy requires that the patient be in the hospital. Karr also named this as one of her “brightspots.”
And when funding is there for science, it turns out that “mystery ailments” have a cause. In another win for 2023, in December the journal Nature reported that the cause of acute morning sickness turns out to be a hormone -- GDF15. With the cause known, the therapies can be developed.
The Embrace of Doulas
Maternal mortality in the US tops that of any developed economy and the rates are greatest among disadvantaged populations including black, brown, Indian, and low-income women particularly living in a rural area. Sadly, 2023 was not a year that saw any movement in that statistic.
But, as noted by Melissa Bowley, CEO and Founder of Flourish Care, 2023 IS the year that both government and private insurers began paying for one of the things - Doulas - that can make a difference. Evidence shows that when a Doula is involved, NICU rates, C-section rates, and postpartum depression rates go down - dramatically - and breast-feeding rates go up among other benefits.
Just in November, the nation's largest private employer, Walmart, said it would reimburse employees who use a doula up to $1K per birth, joining companies like Microsoft and CVS who have similar policies. On the Medicaid side - which covers 42% of the country’s births - the US Department of Health and Human Services announced in December the Transforming Maternal Health (TMAH) initiative which includes doula care as a component of programs of personalized care for mothers it will help fund in 15 states. Turning to Medicaid in the states, 2023 was the year we hit the half-way mark in terms of states either having doula reimbursement in their plans, or on the path to doing so.
At the root of progress: Better definitions
The brightest spot in 2023 may be that the common understanding of what constitutes “Women’s Health” is changing, a development nominated by Solinsky. It can be argued that all advances - diagnosis, funding, the development of therapies - depend on solid data collection that shows the breadth of problems (and the opportunity inherent in addressing them) as well as provides the quantitative understanding that can lead to therapies.
So the broadening of "women's health" beyond a focus on women's reproductive and "women only" diseases to include the fast panarama of "mostly women" or "different in women" makes a difference. In April, McKinsey issued this report (brought to my attention by Salenger) documented just how big a difference this change makes, and also doocumenting the data gaps, their consequences, and where progress can be made.
A Solid and Collaborative Community
Each accomplishment noted above - and others that I know will be added in comments - was born of a community of scientists, private and governmental funders, start-up founders, authors and policy makers who have spent the last few years (and sometimes the last decades, looking at you, WHAM) fighting for improveents in women’s health. So I’ll end this list of “Bright spots” in 2023 with a profound thank you to this community. It’s been hard and frustrating. But take a moment to note what happened this year and take a bow.