Maternal mortality in the U.S. has been on the rise, increasing 144% from the first decade of the 2000s to the second. And experts are asking: What can the pharma industry do to protect mothers across the board?
Health equity remains a major piece of the puzzle — as of 2022, Black women were more than twice as likely to die from a pregnancy-related condition than women in other demographics. This challenge highlights shortcomings in access to care, but also points to a general lack of research in the field, said A. Metin Gülmezoglu, executive director at the nonprofit Concept Foundation, which heads up the Accelerating Innovation for Mothers project.
“There have been very few new medicines being registered for these pregnancy conditions in the last 30 to 40 years,” Gülmezoglu said. “If you compare this to innovations in other areas like chronic diseases, it's really tiny in terms of the number of solutions we have.”
The slow pace of innovation can be traced back to two major mid-20th century healthcare tragedies related to prescription drugs — the nausea medicine thalidomide for pregnant women led to severe birth defects in thousands of children in the 1950s and 1960s, and not long after that, the hormone diethylstilbestrol was found to cause cancer in women who had been exposed to it in utero.
“All of these combine for a perfect storm where nobody's investing in this field."
A. Metin Gülmezoglu
Executive director, Concept Foundation
These calamities had a chilling effect on drug research involving pregnant women. But ironically, what is meant to protect women and their children has made it difficult to find new drugs through normal clinical routes, Gülmezoglu said, driving up mortality rates as innovation is stifled.
“These tragedies created this enormous fear and risk averseness in this area … because those two drugs were not actually researched properly without a rigorous evaluation before,” Gülmezoglu said. “That created this mindset that pregnant women are vulnerable and we have to protect the fetus, even if it means we have to withhold medication a woman might need.”
The lack of research is global, but it hits harder for women in low- and middle-income countries, where studies are almost nonexistent, Gülmezoglu said.
Other market drivers include the limited time period of pregnancy, which “doesn’t lend itself to the drug solutions that take many years of treatment or preventive interventions like statins or diabetes medicines,” Gülmezoglu said.
“All of these combine for a perfect storm where nobody's investing in this field,” he added.
In developing countries, women are often susceptible to conditions like preeclampsia, hemorrhage and obstructed labor, but they also face comorbidities like communicable disease, obesity, diabetes and mental health issues.
“Prevention, prediction and management all require new innovations that are doable when you look at the progress in other areas of healthcare and morbidities,” Gülmezoglu said.
A gendered problem
Beyond the pharmaceutical challenge, a lack of solutions for pregnancy-related conditions comes from gender disparity, Gülmezoglu said. When women take part in clinical research and become pregnant, they are often taken out of that trial, adding to this disparity.
“All of these differences tend to push evaluation to male bodies, male cell cultures and so on, which in the short term may be helpful because you can find solutions easier, but it doesn't help because you are not developing solutions for the other 50% of the population,” Gülmezoglu said.
This was made clear during the COVID-19 pandemic, when vaccine trials deliberately excluded pregnant women, even though they were at higher risk of mortality and morbidity from the virus. That shifted the responsibility to healthcare providers and patients to decide whether to receive a shot despite a lack of evidence.
Gaining traction for a widespread push to study more women's health issues could partly hinge on winning political and public support.
“Inclusion of women and inclusion of pregnant and lactating women in trials has for many years been a secondary concern,” Gülmezoglu said. “Any political process that does not support inclusivity and equality is likely to have an adverse effect on women's inclusion in research as a general concern.”
Merck’s efforts
One pharma success story came out of pharma giant Merck & Co. in 2018, which through its Merck for Mothers initiative studied the use of heat-stable carbetocin, finding it was not inferior to the standard of care oxytocin at preventing excessive bleeding after birth. The heat-stable nature of the new compound makes it easier to use in countries where refrigeration is difficult to come by.
Merck for Mothers has been building evidence for maternal mortality trends since 2011 and providing women with education and health solutions in the U.S., India, Kenya and Nigeria. The initiative has reached more than 30 million women in that time, said Jacquelyn Caglia, director of learning, communications and U.S. programs at Merck for Mothers.
Caglia’s vision is to see a healthcare system with a plan in place to treat mothers in the same way it treats newborns.
“What are our opportunities to think about mom and baby receiving care together? Our system across the U.S. is not quite set up that way,” Caglia said. “We have a very clear schedule for the types of care and visits and the timing of those visits that newborns need to have — but what's our opportunity to think about mom and the care that they should be receiving alongside the newborn at those same points in time?”
Through programs like the Safer Childbirth Cities — which supports community organizations in cities with high maternal mortality rates — Merck for Mothers looks to meet mothers where they are, cutting down on the basic geographic disparities that cause gaps in outcomes.
“We're still seeing in our national trends across the U.S. and globally, that most of the deaths, most of the complications, are preventable, which points us in the direction of where we need to intervene,” Caglia said. “We also see across the U.S. that there are continued patterns of disparities and differences based on race and ethnicity, as well as based on geography and how close or how proximate folks are to services and their access to health, and those disparities demand our attention.”
