This week, one year after the Cumberlege review was published, the government has shared their full response to the recommendations outlined in the report. The Cumberlege review (Report of the Independent Medicines and Medical Devices Safety Review), was published in July 2020 in response to patient concerns about harmful side effects from three NHS treatments, including the antiepileptic drug sodium valproate.
In January, the government set up a Patient Reference Group, which MP Nadine Dories credited for strengthening the government response to the Cumberlege Review: “We are extremely grateful to the Group for their insight and honesty. The government response has undoubtedly been strengthened through listening to and learning from group members’ experiences, knowledge and expertise.”
Led by Baroness Julia Cumberlege, the review outlined strategic recommendations and Actions for Improvement for how the health system responds to patient reports about side effects from treatments. Of the nine strategic recommendations made, four have been accepted in full, one in principle and two in part and forty-six of the fifty Actions for Improvement were accepted in full or in principle.
The accepted recommendations include the government issuing a “fulsome apology” on behalf of the healthcare system to the families affected, with MP Nadie Dories saluting “…[the families] courage and persistence in coming forward to make these concerns heard; without their bravery, the review would not have been possible.” Other accepted recommendations include the appointment of a Patient Safety Commissioner and substantial revision of the Medicines and Healthcare products Regulatory Agency (MHRA), particularly in relation to reporting of an adverse event.
The rejected recommendations include implementing an independent Redress Agency for families affected and setting up schemes to cover the cost of providing additional care and support to those who have experienced avoidable harm. Rejected in part was the recommendation for specialist centres to be set up for those affected by taking sodium valproate during pregnancy. The government response stated, ‘our view is that a network of new specialist centres is not the most effective way forward. We will instead take forward work to improve the care pathways for children and families affected by medicines in pregnancy, within existing services.’
Research funded by Epilepsy Research UK was one of several important initial studies that led to the understanding that taking sodium valproate during pregnancy carries a 4 in 10 risk of developmental disorders and roughly a 1 in 10 risk of birth defects for the baby. Alongside the efforts of campaigners, this work carried out by Dr Rebecca Bromley provided the evidence needed to drive this change. We must continue to put pressure on the government to ensure all women with epilepsy who are planning a family are made aware of the risks associated with sodium valproate.
You can read Dr Rebecca Bromley’s blog on how patient campaigning and research brought about this vital change here.