"It’s time for our industry to recognize the consequences of the lack of investment in maternal health and come together to bring forward innovations," Charlotte Owens, MD, stated.
Charlotte Owens, MD, FACOG, head of Medical Affairs and Outcomes Research at Organon, addressed the imperative role of industry in mitigating the increasing maternal morbidity rate in a written interview with The American Journal of Managed Care® (AJMC®).
This transcript has been lightly edited.
AJMC: In your view, what are the key ways in which the pharmaceutical and health care industry can make a significant impact on maternal health?
Owens: The arrival of a child should be a joyous time, yet globally, maternal morbidity is at an all-time high, leading to poor outcomes and potential long-term complications for both mothers and infants. Contributing to this issue is a historic lack of awareness of the social determinants of health that play a significant role in how healthy each of us can be, and a lack of investment in solutions to help improve maternal health—these are areas that the pharmaceutical and health care industries have the power to change.
As a company that was founded on listening to women with a commitment to delivering innovation to help address therapeutic gaps in women's health, Organon is working to make childbirth safer for mothers and babies by continuing to expand access to innovative solutions for maternal health conditions.
AJMC: The CDC data indicate that 84% of pregnancy-related deaths in the US were preventable. What steps need to be taken to reduce these preventable deaths, and how can the industry contribute to these efforts?
Owens: Every day in 2020 almost 800 women died worldwide from preventable causes related to pregnancy and childbirth. Maternal mortality is unacceptably high and in some areas of the world, it reflects inequities in access to quality health services. Most of these complications develop during pregnancy and are preventable or treatable. To improve maternal health, we need to identify and address the causes of maternal deaths and invest in areas with critical unmet needs, such as postpartum hemorrhage (PPH), a leading cause of morbidity and mortality around the world.
Each year, about 14 million women experience PPH. Despite this, there hadn’t been innovation in PPH treatment for nearly 20 years before Organon’s JADA System—a novel intrauterine vacuum-induced hemorrhage control device—was cleared by the FDA for the treatment of PPH when conservative management was warranted in 2020.1 It’s time for our industry to recognize the consequences of the lack of investment in maternal health and come together to bring forward new innovations.
AJMC: What challenges do you foresee in implementing effective changes in maternal health care, and how do you propose overcoming these challenges?
Owens: A key reason that innovation has stalled in maternal health is that we are still playing “catch-up” with intentionally including women and diverse populations in research. While the industry has made inroads in recent years, pregnant and lactating women remain underrepresented in clinical trials, creating a gap in our understanding of how certain treatments may impact expectant mothers and their babies. We need to have diversity in clinical trials by design.
There are several actions we can take to overcome this gap in maternal health, such as creating new protocols for safely integrating pregnant and lactating women into clinical trials and investing in enhanced real-world data collection, which can improve our understanding of how existing drugs impact pregnant and lactating women.
AJMC: Do you see opportunities for collaboration and partnerships between industry players, governmental bodies, and nonprofit organizations to collectively address maternal health issues?
Owens: Absolutely. To address maternal health issues holistically and sustainably, you will need cross-sector partnerships and collaborations. This is a global issue too big for one entity or one sector to solve. This is especially true when you are bringing forward innovations in a space that’s been stagnant for so long, impacting the entire home and health care ecosystem. At Organon, we recognize that we can’t change the maternal health landscape alone, which is why we actively pursue collaborations with innovators who are at the forefront of leading-edge research in areas where unmet needs are high.
I can’t overemphasize the importance of providers. The pharmaceutical industry needs to work alongside doctors, nurses, and all members of the health care community to understand their needs in providing care for mothers and infants and how they can feel best equipped to swiftly and effectively respond to birth complications like PPH.
Reference
Organon receives FDA clearance for technological updates to the Jada® System, a medical device intended to control postpartum hemorrhage. News Release. Organon. October 11, 2021. Accessed January 4, 2024. https://www.organon.com/news/organon-receives-fda-clearance-for-technological-updates-to-the-jada-system-a-medical-device-intended-to-control-postpartum-hemorrhage/
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