- 08/10/2020
- Posted by: Valerie Vaz MP
- Category: News
On 8 October 2020, the APPG on Epilepsy sent a joint letter to the Secretary of State for Health and Social Care, Matt Hancock MP, regarding the Independent Medicines and Medical Devices Safety Review. You can read the letter in full below:
Dear Secretary of State
Independent Medicines and Medical Devices Safety Review
The APPG on Epilepsy is writing to you in relation to the Independent Medicines and Medical Devices Safety (IMMDS) review, which published its report, First Do No Harm on 8 July 2020. Following the publication of the report, we would like to hear more from the Government about its plans to implement the recommendations of the Cumberlege report.
Recommendations of the Cumberlege Report
The APPG, its members, supporters and the entire epilepsy community (>600,000 people in the United Kingdom) are understandably very interested in the specific recommendations around the anti-epileptic drug, Sodium Valproate. The Cumberlege review found that while there were concerns about the risks of Sodium Valproate, doctors were advised that the risk did not justify ‘discouraging a woman who needs anticonvulsant treatment from having a child or changing a satisfactory drug regimen when the epilepsy is well controlled.’ In view of the serious possible harm to the unborn child, this was unacceptable and has led to an estimated 20,000 children being affected by the drug.
Many of the individual members of the APPG have written to you separately about this issue, and we are all concerned at the lack of any commitment from the Government to implement the Cumberlege report’s recommendations. Given the significant and increasing risk of maternal death among women with epilepsy, it is also vital Government consider how to carefully balance the risks faced by both women and their unborn child while planning this implementation process.
We would therefore ask that you confirm the Government’s commitment to implementing the recommendations and set out a clear timeline for this to happen.
Epilepsy and Covid-19
Many of the recommendations in the report will take time to fully implement and resource, such as the recommended registry for all women on antiepileptic drugs who become pregnant. It is therefore imperative that planning for these starts as soon as possible. There are also logistical challenges in implementing measures across all four nations which need to be taken into account. In addition, many families have been waiting years for help with the financial costs of caring for people affected by sodium valproate, and work to establish a redress scheme and financial support is vitally important for so many of those affected.
We are aware that the current national focus is on COVID-19, so implementation of the Cumberlege report is likely to be affected by this. However, it is important to note that research by members of the APPG has highlighted worsening outcomes for people with epilepsy as a result of the pandemic, impacting on access to health services, mental health, education and worsening of risks linked to premature mortality. Unfortunately many people with epilepsy in the UK do not have access to specialist services and adequate information, with fewer than 1 in 4 having seen an epilepsy specialist in the last year.
As a result of the current pandemic, transparency and action in addressing the recommendations of the Cumberlege report so both mother and baby are kept safe from harm is of upmost importance.
We would welcome further discussion with you and your department about the concerning impact COVID-19 is having on the wider epilepsy community and how Government can act to improve outcomes for this vulnerable group.
Epilepsy12 Report
We would also draw your attention to the Epilepsy12 report which was published on 10 September 2020. This report provides a key focus for the resumption of paediatric epilepsy services as the recovery period develops. The Epilepsy12 report also charts the prescribing of valproate in children’s first year of care.
The APPG and our members have a great deal of expertise and experience on these issues, and we would therefore welcome the opportunity to discuss these with you in more detail, in addition to discussing how we can help ensure that the recommendations are implemented fully and properly. All patient groups should be given the opportunity to be involved in the Taskforce and setting up of the Patient Safety Commissioner, to ensure fair play and that there’s no conflict of interest. It is vitally important that any task force includes patient groups and charities to ensure that the views and concerns of patients are foremost in the group’s work.
We would welcome the opportunity to be involved in a task force to monitor the implementation and progress of the recommendations.
In conclusion, while the Cumberlege report goes a long way to addressing the issues that so many women have faced, this is only the first step in addressing these problems. The Cumberlege report has provided the Government with an excellent opportunity to address decades of suffering and put measures in place to ensure such suffering does not happen again.
We would urge you to not miss this opportunity and ensure that the families who have suffered for so long finally get the support they need.
Yours sincerely
Rt Hon Valerie Vaz MP
Chair of the APPG on Epilepsy
Baroness Hussein-Ece OBE
Vice-chair of the APPG on Epilepsy
Andy McDonald MP
Vice-chair of the APPG on Epilepsy
Dame Diana Johnson MP
Member of Parliament for Hull North
Sarah Olney MP
Member of Parliament for Richmond Park
Sara Garland
The Daisy Garland
Daniel Jennings
Epilepsy Action
Annie Perez
Epilepsy Action (Member)
Trevor Hutton
Epilepsy Awareness
Torie Robinson
Epilepsy Sparks
Fiona Kettell
Epilepsy Wales
Nicola Swanborough
Epilepsy Society
Caoimhe Twohig-Bennett
Epilepsy Research UK
Rona Johnson
Epilepsy Scotland
Eve Maria Spiccelli
Emma Friedmann
FACSaware
Dr Sarah Aylett and
Professor Helen Cross
Great Ormond Street Hospital
Emma Murphy and Janet Williams
INFACT
Matthew Walker
International League Against Epilepsy
Nada Abuknesha
London Metropolitan University
Emma Williams MBE
Matthew’s Friends – Ketogenic Dietary Therapies
Dr Rhys Thomas
Newcastle University
Karen Keely
OACS Ireland
Jo Cozens
OACS Charity UK
Carol Lapidge
OACS Charity UK
Dr Arjune Sen
Oxford University Hospitals Foundation Trust
Paul Milton
Jane Hanna OBE
SUDEP Action
Sammy Ashby
SUDEP Action
Karen McLeod
South Tees Hospitals NHS Foundation Trust
Dr Sallie Baxendale
UCL Institute of Neurology
Mark Devlin
Young Epilepsy
Susan Cole
Valproate Victims
Georgina Gillard