Words by Cheyenne Eugene
Over recent decades, there has been a deficit of drug development within maternal health, as well as a lack of pregnant participants in clinical trials. What are the reasons behind these shortfalls and how can the industry prioritise maternal health going forward?
Motherhood’ is a globally symbolic concept that crosses continents, language, and cultures; one firmly entrenched into our everyday language in expressions such as ‘mother earth’ and ‘mother tongue’. Despite this, statistics suggest that innovation within maternal health is not being sufficiently nurtured; in the last 30 years there has only been one new drug developed for preterm birth and the past 50 have laid witness to zero new therapies to prevent miscarriages. The phrase ‘drug drought’ has been gestating and calls to action are being heard within research and development throughout the pharmaceutical industry.
Describing the industry as “ripe for disruption”, Keren Leshem, CEO, OCON Healthcare says: “Women’s health has been under-invested in and overlooked for many decades… the overarching work for women’s health companies is breaking down taboo and stigma around women’s bodies.” She acknowledges that challenges stand in the way of this essential progress: “Building a pharmaceutical or drug delivery device targeted at a specific population is incredibly expensive and long.”
An industry ripe for disruption
Professor Arri Coomarasamy, Joint Director, WHO Collaborating Centre for Global Women’s Health, details this further: “The poor economic return from pregnancy drugs, as pregnancies last for a limited period, creates fear that there will be no long-term usage and financial accrual. However, as pregnancy is common, the economic return can make a viable business case, so these factors need not be deterrents to new drug development.”
There is a notable absence of certain demographics within clinical trials, a fact that has been highlighted by the COVID-19 pandemic in all therapy areas. Women have been historically excluded from drug trials, often owed to their hormonal cycles, metabolism rates, and difference in disease manifestation which may skew results. Leshem explains: “Women, along with people who are transgender and gender-nonconforming, have been excluded and underrepresented with consequences for their health.” Leshem recognises that there are “dilemmas for the drug developers to include [pregnant participants] due to high-risk and ethical questions.” This is a concern also noted by Coomarasamy: “I believe the shortfall in new drugs relate to a fear of litigation, particularly if a new drug is found to cause harm to a newborn baby. However, there are robust mechanisms for managing risks.”
Exclusion of pregnant participants in research, due to both industry and participant hesitancy, leads to a lack of knowledge about how medications and dosing for chronic conditions should be managed during pregnancy. “There is limited data regarding how certain conditions, therapies, and dietary supplements affect pregnant and lactating women. This lack of research is to the detriment of women’s health and safety.” Coomarasamy seconds this: “Unless pregnant participants are included in clinical trials, we would not know if the result of a treatment applies to them. Guessing is not good enough.”
Considering the future and a solution-based focus, Coomarasamy explains: “The pharma industry needs to have a nuanced approach to the risks of medicines in pregnancy and be willing to make investments in the healthcare needs of women who are pregnant.” He insists: “Involving women who are pregnant and patient representative groups in the prioritisation of research questions and the development and trial of new medicines, would allow progress to be made.”
In relation to R&D, Coomarasamy comments: “The priorities will be to study the major pregnancy complications including miscarriages, ectopic pregnancies, preterm birth, and more. We need to study the aetiology and mechanisms of these conditions and explore novel therapies.” Referring to where the research is most relevant, he highlights a salient point: “As most of these complications in pregnancy occur in low-income countries, we will need to find affordable solutions.”
This is undoubtedly a lively and opportune time for women’s health. Leshem says: “With a true focus on women’s health, more money circulating into this field, and large pharma making bold acquisitions in this space, I’m sure that the next decade will be unrivalled in terms of innovation, investments, products, and services for women’s health to increase our quality of life.” She places emphasis on investment and how funding drives innovation: “Investing in and getting more women involved in investing is the way to cultivate more successful, innovative, and profitable companies.”
Getting more women involved in investing is the way to cultivate more successful, innovative, and profitable companies
Maternal health is a vast landscape of fruitful and fertile ground. Addressing risk concern, diversifying investment, and improving inclusion within clinical trials are tangible solutions to this currently under-served area. These are the seeds that need to be sown in order to transform this drug drought, and beckon in a boundless and flourishing future for mothers and the communities that treasure them.