The Review was announced in February 2018 by the Secretary of State for Health and Social Care, the Rt Hon Jeremy Hunt MP, 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.
The report, entitled “First Do No Harm”, calls for wide-ranging and radical improvements to the healthcare system, setting out nine recommendations to bring much-needed help and support to those whose lives have been devastated by these interventions.
Baroness Cumberlege said: “We have seen NHS staff rise to the enormous challenge posed by the Covid-19 pandemic and we applaud them for their amazing commitment. I’m afraid, however, that our report will make uncomfortable reading, including for the hard-working, compassionate people who do excellent work in our health service.
“I have conducted many reviews and enquiries over the years, but I have never encountered anything like this; the intensity of suffering by so many families and the fact that they have endured it for decades. Much of this suffering was entirely avoidable, caused and compounded by failings in the health system itself.
“The first duty of any health system is to do no harm to those in its care; but I am sorry to say that in too many cases concerning Primodos, sodium valproate and pelvic mesh, our system has failed in its responsibilities. We met with people, more often than not women, whose worlds have been turned upside down, their whole lives, and often their children’s lives, shaped by the pain, anguish and guilt they feel as the result of Primodos, sodium valproate or pelvic mesh. It has been a shocking and truly heart-rending experience. We owe it to the victims of these failings, and to thousands of future patients, to do better. “
Baroness Cumberlege stressed that the system should now do what it should have done years ago, and put in place the processes that will help all those who have suffered and enable it to learn from past mistakes and ensure other families do not have similar experiences in the future.
She continued: ““The system’s response – or lack of one – has added to the pain – both physical and mental – of those affected. The system and its leaders need to acknowledge what has gone so badly wrong.”
Ten per cent of babies exposed to sodium valproate during pregnancy are born with a birth defect, while up to 40 per cent will have a developmental delay or autism.
The Safety Review’s recommendations include:
- That the Government immediately issues a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh
- That a Patient Safety Commissioner is appointed. This person would be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, and demands action
- Separate schemes should be set up for Hormone Pregnancy Tests, valproate and pelvic mesh to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim
- A Redress Agency for those harmed by medicines and medical devices in future should be established
- The establishment of two types of specialist centres, located regionally – for mesh, and separately for those affected by medications taken during pregnancy
- The regulator of medicines and medical devices, the MHRA, needs to put patients at the heart of its activity, and to overhaul adverse event reporting and medical device regulation
- That a central database should be created by collecting key details including the patient, the implanted device, and the surgeon
- That the register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ clinical interests and specialisms
- Finally, that the Government immediately sets up a task force to implement the Review’s recommendations.
Janet Williams (left) and Emma Murphy standing either side of Baroness Cumberlege with the Review team.
Emma Murphy – Managing Director of INFACT and FACSA
“After eight years of campaigning at Parliament we are delighted with the recommendations from the Independent Medicine and Medical Devices Review. We are pleased to see that the Review not only took on board our evidence found at National Archives but most importantly acknowledged the many heart-breaking stories from families that have been affected by Sodium Valproate, which highlighted how women in particular have felt ignored and dismissed from healthcare professionals, despite them knowing something was wrong with their child. An apology has been a long time coming. We now look forward to the statement from Government and their acknowledgement and working with them as recommended by Baroness Cumberlege for prompt action.”
Cat Smith MP, Chair of the All Party Parliamentary Group for Valproate and other AEDS in Pregnancy said, “Today’s report vindicates the campaigning of so many women and families and the group fully welcomes, acknowledges and agrees with the findings of Independent Medicine and Medical Devices Review. It shouldn’t have taken this long for the victims to get the acknowledgement that this Report gives them, now we need action from Government to be speedy so not to deny these families justice any longer.”
BBC News https://youtu.be/lEIvkg03Qxk
Channel 5 https://youtu.be/nNB1vfuGKDk
Fiona Bruce MP https://www.fionabruce.org.uk/news/valproate