There are some inherent reasons for pharma R&D in pregnancy-specific conditions. Teratogenicity risk and physiological changes in pregnancy are the main challenges although they are not enough in themselves to exclude pregnant women from research. In fact, several organizations and researchers published position statements for inclusion of pregnant women in research judiciously. Lack of inclusion of pregnant women in research leads to lack of knowledge about how medications for chronic conditions should be used during pregnancy. While physiological changes are significant, their impact on managing the condition and whether there is need for dosing changes is unknown.
We know that there are some innovator companies that have developed pregnancy-specific medicines for postpartum haemorrhage prevention and preterm labour treatment. It is doable and it can be done for women in settings where access to medicines and technologies is challenging. The 2018 Access to Medicine Index states that most of the R&D projects (63%) for diseases listed as global priorities are being conducted by five companies: GSK, Johnson & Johnson, Merck KGaA, Novartis and Sanofi. Maternal and newborn health is one of the listed global priorities. However, since the 2016 report, no new maternal health product has entered the market from the 20 companies evaluated in the report. And, it is not because overall R&D efforts decreased. There were more projects for many diseases but not for maternal and newborn health where there were fewer new medicines and fewer new projects. The 2018 Index identified nine projects for MNH conditions. This is three fewer projects than in 2016. One third (4/12) of the projects for maternal and neonatal health were in pre-clinical development in 2016, with none in discovery. The same proportion (3/9) of MNH projects are in discovery or pre-clinical development in 2018. If we look at public sector funding US NIH funding for maternal health is approximately 300-350 million USD for the years 2017 to 2019. Over those three years I could identify not more than five novel treatments all of which concerned pre-eclampsia prevention or treatment.
Perhaps, one of the reasons for the lack of new development research in maternal health is the lack of a collective will and commitment. Maternal mortality reduction was an MDG target and it still is one of the SDG targets. Improving maternal health is clearly a global public health priority. The scale of the burden is well-quantified. There is a belief that we have interventions that work to deal with maternal health conditions and the main challenge is getting them implemented.
Why, for example, in an era of unprecedented advances in science of developing medicines, bioassays, artificial intelligence aided individualized treatments there seems to be nothing significant in terms of a new chemical entity or a new delivery system that can become a game-changer to prevent or treat , impaired fetal growth, preterm labour and birth, and pre-eclampsia? It could be argued that pregnancy and childbirth is a complex period and the pathological conditions are multifactorial making it difficult to focus on a single therapeutic agent. Even then, there are subgroups within those conditions that may render themselves to the development of new interventions such as spontaneous preterm labour and birth.
Fisk and Atun noted in 2008 that most new modalities for managing conditions during pregnancy and childbirth were either different (or new) prostaglandins and oxytocin antagonists or analogues. Since then, except for heat-stable carbetocin and inhaled oxytocin (in development) can we talk about another new medicine or technology? Placental growth factor-based tests are slowly finding a place in the pre-eclampsia space but there still is some way to go.
For many maternal health conditions, the treatments are ‘borrowed’ from other areas of medicine. While there is nothing technically wrong with this approach if the other field is not using the product anymore the availability and access disappears for the maternal health condition. This is the case for ‘nifedipine’ which is the recommended medication for tocolysis but, because the manufacturer does not see a need for it in cardiovascular medicine anymore, nifedipine, despite being recommended by WHO and being on WHO EML, is not available for obstetric use. For emergency obstetric kits there is no tocolytic agent to include.
The global maternal health community could come together and prioritize new medicines and technologies for improving maternal health in a similar way it is being done -relatively successfully- for neglected tropical diseases among other global public health priorities.