On 8th July, the Independent Medicines and Medical Devices Safety Review released its “First Do No Harm” report. The report was based on a two year review of testimonies from patients and evidence regarding three medical interventions/procedures:
- Primodos – a pregnancy test used in the 1960s and 1970s that consisted of two pills that contained norethisterone (as acetate) and ethinylestradiol.
- Sodium valproate – a medication used to treat epilepsy and bipolar disorder.
- Pelvic mesh – a woven synthetic netting implanted into the pelvis for a number of conditions, such as pelvic organ prolapse and stress urinary incontinence.
“First Do No Harm” report
The overall aim of the report is to provide help and support to those who have suffered as a result of the above medical treatments/procedures, and to also provide recommendations to healthcare systems to reduce the risk of avoidable harm from medical treatments and devices going forwards.
The report surveyed the views and received written evidence from hundreds of impacted patients, plus their families, whose lives have been severely impacted. The Independent Medicines and Medical Devices Safety Review team also took into consideration evidence from the healthcare system, including the NHS, private healthcare providers, policymakers, regulators and professional bodies, and manufacturers.
Chair of the Independent Medicines and Medical Devices Safety Review, Baroness Julia Cumberlege, commented:
“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.
“That is why, having spent two years listening to these stories of acute suffering, “First Do No Harm” is an appropriate title and a necessary reminder not just to doctors but to the whole healthcare system. We are urging the system to do what it should have done years ago, to help those who have suffered and put in place the processes that will enable it to learn from past mistakes so that we spare other families from such anguish.
“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.”
Recommendations of the “First Do No Harm” report:
- An immediate apology from the Government on behalf of the healthcare system to those impacted by the medical treatments and procedures.
- The appointment of a Patient Safety Commissioner who would hold the healthcare system to account, monitors trends, and demand action on behalf of patients.
- For those who have suffered harm, additional schemes should be created for hormone pregnancy tests, valproate and pelvic mesh to provide extra support.
- The establishment of a Redress Agency and two types of specialist centres (one for pelvic mesh implants, and another for those impacted by medications taken during pregnancy) to support those affected.
- That the Medicines & Healthcare products Regulatory Agency (MHRA), who is the regulator of medicines and medical devices, must put patients at the heart of its activity. Additionally, the MHRA needs to overhaul adverse event reporting and the regulations in relation to medical devices.
- The creation of a central database which collates important details and information, such as the details of the patient, surgeon and the implanted device/treatment.
- The register managed by the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all medical practitioners, plus their clinical interests and specialisms.
- The creation of a Government task force to implement the above recommendations from the report.
This long awaited and welcome report is hard hitting and wide ranging. One of the most difficult things to hear is how people’s suffering was ignored or played down for so long. Specialist claimant clinical negligence solicitors will be all too familiar with the story of people’s voices going unheard. That is one of the reasons why it is so important there is an effective system of legal redress in the health sector.