Pregnancy and Postpartum Healthcare is Underfunded, Under-researched, and Undervalued.
Pregnancy and Postpartum Healthcare is Underfunded, Under-researched, and Undervalued.
by Katie Black
Things need to change around here. For too long the U.S. has underfunded and undervalued research on women’s health. And the results can be grim.
For women with pre-existing conditions, or those that develop health conditions while pregnant or lactating, there often isn’t enough research for reliable, evidence-based treatment.
So we’re taking a long, hard look at:
- The history of women’s reproductive healthcare in the U.S.
- The current roadblocks and the effects on moms’ and babies’ health
- How things can and should change in 2024 and beyond
Note: Healthcare for women and people born female needs to be better across the board. In this post we’re talking about issues with pregnancy and postpartum research and care.
A brief history
The history of women’s healthcare is filled with racism, misogyny, and class division.
One of the craziest examples is the so-called “father of gynecology,” Dr. J. Marion Sims, who did experiments without anesthesia on enslaved women. The statue in Central Park celebrating his achievements was only taken down in 2018.
Plus, women were often left out of research because it was thought their changing hormones would mess up results. All this led to male data making up the majority of information on disease and treatment. Even today, women’s pain is not taken as seriously as men’s, and their symptoms are more likely to be pushed aside as psychological.
And it wasn’t just a general bias towards women and female biology that left them out of trials–it became policy.
From the 1950s to 60s the drug Thalidomide was given to pregnant women for nausea. The problem: it caused severe birth defects.
The FDA banned Thalidomide and in order to avoid something like that happening again, they set up a policy to leave out premenopausal women from phase I and early phase II of clinical trials–even if a woman was on birth control or her partner had a vasectomy.
But this had outcomes they didn’t see coming. By only using data from male or animal studies, it became clear that this wasn’t good enough for treating women since symptoms of disease and the effectiveness and safety of drugs are different for them. Plus researchers were afraid to include women in any trial phases–not just the ones the policy banned.
It wasn’t until 1993 that the FDA got rid of the policy with the NIH Revitalization Act. They basically said that women and minorities have to be included in all human subject research. Specifically, they have to be in Phase 3 of clinical trials in enough numbers for a valid analysis. Cost couldn’t be used as a reason for leaving them out. The NIH needed to review proposals for funding to make sure they followed this guideline, and they could deny them if the criteria wasn’t met.
While things got better for women’s health overall, the most sensitive issue was still up in the air: how should pregnant women be included in clinical trials? Protecting the fetus is a priority, and it’s something policy makers and researchers are still wrestling with. There are major gaps in the data for treating pregnant and breastfeeding women, but since they’re still listed as a vulnerable population it’s difficult to get approval or volunteers for clinical trials.
The FDA came up with a way to categorize drugs based on how safe they are and how much they’ve been tested. But because so few products have been tested in pregnant women, almost none are ranked as Category A. Most of the time they’re either in Category B or Category C.
Category A: Controlled studies show no risk
Adequate, well-controlled studies in pregnant women have failed to demonstrate risk to the fetus.
Category B: No evidence of risk to human fetus
Either animal findings show risk but human findings do not, or if no adequate human studies have been done, animal findings are negative.
Category C: Risk cannot be ruled out
Human studies are lacking, and animal studies are either positive for fetal risk or lacking. However, potential benefits may justify the potential risk.
Category D: Positive evidence of risk
Investigational or postmarketing data show risk to the fetus. Nevertheless, potential benefits may outweigh the potential risk.
Category X: Contraindicated in pregnancy
Studies in animals or humans, or investigational or postmarketing reports have shown fetal risk that clearly outweighs any possible benefits to the patient.
This leads to a catch-22: pregnant and breastfeeding women are left out of clinical trials to protect them and their children, but then can’t get proper care which puts both at higher risk.
It’s very important that they’re studied specifically when it comes to drug therapies. Pharmacokinetics (PK) is how the body interacts with a drug. Being pregnant or postpartum has been shown to have major changes in a person’s physiology that can alter the PK of drugs. This can change how safe and effective those drugs are, and what the right dosage is.
Some of those physiological changes and their effects on the PK are:
Pregnancy can really mess up how well your meds are absorbed because of things like there being less stomach acid inside you, delays in stomach emptying, digested things hanging around in the small intestine, nausea, and vomiting.
There’s also a change in how much of a drug is free floating in the body when pregnant. The volume of distribution (Vd) is a drug’s tendency to stick to plasma protein or move to tissue. There’s more water in your body when you’re pregnant, plus a certain protein in your blood drops (serum albumin). Because of these changes, drugs that usually bind to protein tend to become more unbound.
Pregnant bodies also change in how they get rid of drugs. Enzymes in the liver that metabolize drugs can be affected by hormonal changes, boosting activity in some and bringing it down in others. These genetic factors have a big influence on the PK of drugs, and cause a lot of variation in metabolism.
Another thing to note, the increase in kidney function during pregnancy can really up the rate of drugs your body gets rid of, meaning you might need a higher dose or shorter gaps in between taking them.
Despite all this clear evidence that pregnant and breastfeeding women have different physiologies making medication affect them differently, studies are not being done with them and they “remain therapeutic orphans”.
Chronic disease in mothers has gone way up in the last decades in the developed world, from 4% in 1989 to 16% in 2013. There are a few explanations for this like:
- A rise in disease rates in general.
- The average age women have kids is going up.
- Progress in medicine gives women with a preexisting health condition more options and support to have kids.
Studies have shown a correlation between moms with chronic conditions and worse birth outcomes, including:
- Higher risk of preeclampsia (a serious blood pressure condition that can develop during pregnancy or postpartum)
- Cesarean section
- Preterm birth
- Newborns being admitted to the NICU
These issues are even worse for Black women and other people of color in the U.S.
Big medical decisions with lots of risks to weigh are left up to individual healthcare professionals and their patients instead of having solid, reliable data to inform them.
Another issue that simply isn’t researched enough: the risks of possibly passing on medication to a baby through breast milk versus not breastfeeding at all.
There are many risks when it comes to not breastfeeding. Infants who have been breastfed for less than two months or are partially breastfed have a higher mortality risk compared to infants who are exclusively breastfed. Not breastfeeding is also associated with higher chances of later developing obesity, diabetes, asthma, and cardiac conditions. And there may be a higher risk of childhood cancer, including leukemia and lymphomas. It also impacts cognitive, emotional, and social development.
While breastfeeding lowers the risk of mortality and disease in newborns (especially for preemie babies), breastfeeding seems to worsen some chronic diseases in moms. For example, prolactin, a hormone that helps with lactation, can make lupus and rheumatoid arthritis worse. Many moms who want to exclusively breastfeed are forced to stop earlier than planned, either because their symptoms get worse, or because they need to start taking drugs that may harm their child.
Note: If you’re breastfeeding and want to know about the quality of your breast milk due to a health condition or otherwise, consider testing it to find out exactly what’s inside it. Plus get personalized recommendations for optimizing your milk from a doctor!
It’s unfair that women are forced to choose between breastfeeding or receiving treatment.
But it’s not just worries about the ethics of it all or liability that’s led to where we are today. Those who give out grants and make investment decisions systematically undervalue this area of healthcare too.
One 2021 article from the Journal of Women’s Health found that
“Gender bias has been an ongoing issue in healthcare, examples being underrepresentation of women in health studies, trivialization of women's physical complaints, and discrimination in the awarding of research grants.”
They went on to say that in nearly ¾ of cases where a disease affects mostly one gender, the pattern of NIH funding favors men. Meaning either the disease affects more women in terms of the number of years lost and is underfunded or the disease affects more men and is overfunded.
Oliver Wyman, a management consulting firm, in their Women in Healthcare Leadership 2019 report found that while women make up 80% of consumer decisions and 65% of the workforce in healthcare, they’re underrepresented in leadership. In the industry, 30% of C-suite roles are held by women, while only 13% are CEOs.
Women’s health issues are traditionally seen as a “niche market.” Over 91% of venture capitalists are men, and this (actually bursting with potential) market is often overlooked by them. Many investors don’t feel there are any incentives to invest in women’s health because of personal bias or a lack of education and awareness around these issues.
Looking to the future
Despite all these barriers, things are still changing for the better.
There’s growing public awareness around the shortcomings of women’s health research and people are putting pressure on fixing them.
Private equity firms are also starting to pay attention to this gap in the market. One big example is how investment in women’s healthcare companies in the U.S. jumped from 0.8 billion in 2021 to 3.3 billion in 2022.
In 2016 the 21st Century Cures Act started the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) to advise the Secretary of the U.S. Department of Health and Human Services about the gaps in research on safe and effective therapies for pregnant and breastfeeding women. They created a 388-page report talking about these gaps and made special recommendations for including pregnant and breastfeeding women in research studies, and how to motivate researchers and companies to take part.
In 2023, the PRGLAC Implementation Working Group of Council was made to track and report how the recommendations are actually used. In other words, the first PRGLAC group focused on making recommendations, and the second on putting them into practice.
Things are certainly far from perfect, but there is noteworthy progress. And that’s something to celebrate.
If you are pregnant and taking any medications, consider joining a pregnancy exposure registry to share your experience and help close the gap in research.
You can also go to www.mothertobaby.org to find the most up-to-date information on specific drugs and vaccines.
Photo by Pixabay: https://www.pexels.com/photo/grey-ceramic-landmark-during-daytime-62318/
MART PRODUCTION: https://www.pexels.com/photo/people-woman-sitting-technology-7088531/