Independent Medicines and Medical Devices Safety Review – The Cumberlege Review

 

The Review was announced in February 2018 by the Secretary of State for Health and Social Care, the Rt Hon Jeremy Hunt , in the House of Commons. He stated that it would examine how the healthcare system has responded to concerns raised by patients and families about three medical interventions:

  • the hormone pregnancy test Primodos
  • the anti-epileptic drug sodium valproate
  • surgical mesh

The Secretary of State said that the system’s response to these concerns was “not good enough”.  He announced that the Review, to be chaired by Baroness Julia Cumberlege, would consider a range of matters, including:

  • whether any further action is needed relating to the complaints around Primodos, sodium valproate and surgical mesh
  • the processes followed by the NHS and its regulators when patients report a problem
  • how to make sure communication between the different groups involved is good

The Review may make recommendations regarding the three specific interventions but also about how the healthcare system can improve its response to concerns raised about other medicines and medical devices in the future.

INFACT have been very involved with the Review providing fact based knowledge and evidence based on our 7 year Parliamentary Campaign, and also 20 years dedication to the topic of Fetal Valproate Syndrome

Below is the evidence sessions in which we gave evidence over 3 sessions.

Session 1 we were accompanied by Warren Matthews, who is a father to 3 beautiful girls diagnosed with Fetal Valproate Syndrome.  We felt it was important that the Review team heard a fathers perspective and how living with the syndrome affects dad, and the family as a whole.

We also provided and quoted the archive documents in which we discovered in 2015, during our research at National Archives, Kew , in which we worked and liased with Sky News to expose the Government documents  Jason Farrell at Sky News      

Sky-News-Pictures-300x300

 

Session 2 we were accompanied by Norman Lamb MP in his capacity as Chair of All Party Parliamentary Group for Valproate and other AEDs in Pregnancy.

Evidence Session 1 

Evidence Session 2 – APPG for Valproate and other AEDs in Pregnancy

Evidence Session 3

We now patiently await the recommendations from Baroness Cumberlege and her colleagues and hope that the 45 year scandal with Sodium Valproate is finally addressed.