What does today’s announcement mean for people affected by epilepsy?
Building on the 2020 First Do No Harm Review, The Hughes Report outlines the devastating situation 20,000 mothers with epilepsy around the UK found themselves in. These mothers had been prescribed a medication in good faith to treat their seizures, but that medication we would later learn was associated with high levels of risk to their developing child during their pregnancy. I am delighted to see the publication of the report by the Patient Safety Commissioner which outlines their recommended compensation options for the families affected by sodium valproate. The systems needed to detect the risks associated with sodium valproate were not in place quickly enough and that is why today’s announcement is so important – to see the Hughes Report outlining the next steps for the government. Change has happened, but not soon enough and we need to look at how we do better.
What led to the changes in policy and clinical practice with prescribing sodium valproate?
Patient-led campaigns have certainly been at the forefront of the changes in policy and clinical practice, although it took time for their voices to be heard. Without the campaigning from patient groups, I am unsure whether we would have seen such significant regulatory intervention. I believe it was the patient campaigners that brought the severity of the possible deficits to life, in a way the research evidence alone was failing to do.
Part of the research evidence patient groups used to argue for change was from projects funded by the Epilepsy Research Institute. As an early supporter of both the UK Epilepsy and Pregnancy Register and the Liverpool and Manchester Neurodevelopment Group, the Institute funded key initiatives including the UK contribution to the important Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) Study. They continue funding us today to maximise the safety of pregnancy for both mother and child.
The combination and collaboration of the research evidence and international patient campaigning were central to the changes we’ve seen in valproate regulation. Research was key, but the slow accumulation of evidence undoubtedly led to more children being exposed to valproate than was ultimately necessary.
You can read more about how the evidence base evolved and led to the changes in policy and clinical practice in my earlier Research Blog.
Why is more investment in research into anti-seizure medications urgently needed?
The Hughes Report also set out recommendations for future research in this area, recognising the key role of the Epilepsy Research Institute in calling for greater research investment. Recommendations included dedicated research funds for valproate and other antiseizure medications to help close knowledge gaps and enable those harmed to participate in studies. Whilst research has provided some answers for the risks associated with valproate, there are still many questions that have been left unanswered. Questions on the risk of other anti-seizure medications, questions on the potential transmission of risk via paternal exposure and questions about whether too much folate – vitamin B9 – may be associated with later childhood risks. To address these uncertainties, more research is urgently needed. But it’s not enough to just simply fund research, we need to drive a multicentre, multidisciplinary approach with people affected by epilepsy at the forefront.
What work is the Epilepsy Research Institute doing in this area?
Reproduction & Hormones is one of six key strategic themes of the Epilepsy Research Institute and is in direct response to the priorities of people affected by epilepsy, as evidenced in the UK Epilepsy Priority Setting Partnership, which was funded and led by the Institute in 2021/22. Each theme will be supported by a task force group of leading UK scientists and clinicians. The research themes are driving a programme to secure large-scale research investment which will feed into an overall roadmap for research into epilepsy.
Through the Reproduction & Hormones programme theme, the Institute will not only enable those living with epilepsy to make fully informed decisions on their treatment but also have safer treatment options available to them, in the hope that no other families will be harmed by anti-seizure medications.
Read more about the publication of The Hughes Report here.
If you are a researcher, let us know you’re interested in joining the Reproduction & Hormones task force here.
Read more about the investment we have made to date in this area.
