Britain‘s Independent Medicines and Medical Devices Safety Review has published a two-year review of “harrowing” evidence three medical interventions: a pregnancy testing drug, an epilepsy drug, and pelvic mesh, writes MedicalBrief. The Review calls for a government apology, the appointment of an independent patient safety commissioner, an overhaul of the Medicines and Healthcare Products Regulatory Agency and the expansion of the General Medical Council register to include a list of financial interests for all doctors.
The Review looked at three treatments:
Primodos – hormonal pregnancy test, withdrawn from the market in the 1978, which is thought to be associated with birth defects and miscarriages. The manufacturer, Schering, now part of Bayer, has always denied a link between the drug and deformities in babies.
Sodium valproate – an epilepsy drug which, while effective for preventing seizures, can be harmful if taken during pregnancy, causing physical abnormalities to the baby in the womb as well as developmental delay and autism in children whose mothers took it.
Pelvic mesh implants – used as a surgical option to treat prolapse and incontinence, some women say they have been left with internal damage and agonising chronic pain. In the last few years, the procedure has only been offered on the National Health Service (NHS) under exceptional circumstances and high vigilance.
The report, titled First Do No Harm sets out nine major recommendations to bring much-needed help and support to those who have suffered as a result of these interventions, and to reduce the risk of avoidable harm from medicines and medical devices in the future.
The Review team, led by Baroness Cumberlege, travelled across the UK to listen to hundreds of affected patients and their families, and received written evidence from many more over its two-year investigation. The team heard from people, mainly women, whose lives had been catastrophically affected and whose families had suffered terribly as a consequence.
The Review team also took evidence from the healthcare system, including the NHS, private healthcare providers, regulators and professional bodies, manufacturers, and policymakers.
Baroness Julia Cumberlege, Chair of the Independent Medicines and Medical Devices Safety Review, said:
“We have seen NHS staff rise to the enormous challenge posted by the Covid-19 pandemic and we applaud them for their amazing commitment. I’m afraid, however, that our report makes for uncomfortable reading, including for the hard-working, compassionate people who do excellent work in our health service.
“I have conducted many reviews and inquiries over the years, but I have never encountered anything like this; the intensity of suffering experienced 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.
“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. Our major recommendations, together with a number of actions for improvement we call for in our report, are wide ranging and radical. Given what we have witnessed, we are clear that is what is needed now.
I want to express my heartfelt thanks to my exceptional team. Their dedication, wisdom and sheer hard work has been absolutely invaluable. This has been a team effort.”
The Review’s major 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.
BBC reports that in total, 700 women and their families shared “harrowing” details about the procedure, as well as a hormonal pregnancy test and an epilepsy drug. The review describes complaints and worries often being dismissed as “women’s problems”, leaving many traumatised, intimidated and confused.
The Guardian reports that she added: “As women, we know when things are not right with our bodies,” she said. “We are the first to know. When that information is ignored, it is simply belittling and adds to the suffering.”
The review stops short of recommending a ban on the use of pelvic mesh, but says that such surgery should take place within specialist centres, and only in rare circumstances, after other conservative treatments have been tried.
Kath Sansom, who founded the Sling the Mesh campaign in 2015, welcomed the recommendations, saying: “The report is hard-hitting, harrowing and recognises the total failure in patient safety, regulation and oversight in the UK. It also makes it very clear that our medical establishment is deeply entrenched in institutional denial and misogyny.”
The Independent Medicines and Medical Devices Safety Report in full
Full BBC News report
Full report in The Guardian