Mesh, Primodos, and Valproate Failings Highlighted by Review

Peter Russell

July 08, 2020

Editor's note, 10th July 2020: This article was updated with the latest information. 

The Government minister responsible for patient safety has apologised for the harm to women and their babies over several decades caused by certain drugs and procedures.

Nadine Dorries was giving a statement to Parliament on the Cumberlege review, published on Wednesday.

The 2 year inquiry by The Independent Medicines and Medical Devices Safety Review which took evidence on three medical interventions: Primodos, sodium valproate, and pelvic mesh implants.

The review team travelled across the UK and heard "heart wrenching stories of acute suffering" from more than 700 patients and their families that dated back years, and sometimes decades.

Health System Failings

Baroness Julia Cumberlege, who chaired the review, said much of the suffering was "entirely avoidable, caused and compounded by failings in the health system itself".

She said: "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."

She said she would "take to my grave" the harrowing experiences of those affected.

The report called for a commissioner to be appointed to guard patient safety, and an overhaul of the regulator, the Medicines and Healthcare products Regulation Agency (MHRA).

In the Commons, Ms Dorries said: "On behalf of the health and care sector, I would like to make an apology to those women, their children, and their families for the time the system took to listen and respond."

While acknowledging the need "to establish a quicker and more compassionate way to address issues of patient harm", she did not commit to any immediate action, telling MPs that the Government would issue a response as soon as possible.

The review, First Do No Harm , makes a sweeping set of recommendations to help ensure failings are not repeated.

The report was commissioned in February 2018 by the then Health Secretary Jeremy Hunt, with the task of assessing how the healthcare system in England responded to reports about harmful side effects from medicines and medical devices. It was also asked to consider how to respond to them more quickly and effectively in the future.

Specifically, it was tasked with looking at what happened with:

  • Hormone pregnancy tests (HPTs) – tests, such as Primodos, which were withdrawn from the market in the late 1970s and which are thought to be associated with birth defects and miscarriages

  • Sodium valproate – an effective anti-epileptic drug which causes physical malformations, autism, and developmental delay in many children when it is taken by their mothers during pregnancy

  • Pelvic mesh implants – used in the surgical repair of pelvic organ prolapse and to manage stress urinary incontinence, the use of which has been linked to crippling, life-changing complications

'Avoidable Harm'

The review found that children were exposed to "avoidable harm" from failure to regulate Primodos.

It also called for support for affected children of mothers who used sodium valproate, and women who experienced complications after vaginal mesh surgery.

Evidence given to the review panel as they travelled the country revealed overarching themes. Patients – mostly women – described clinicians as 'defensive', 'dismissive', and 'arrogant'.

Women who reported excruciating pain, "like razors inside their body", after pelvic mesh implants, said their concerns were regularly dismissed as "all in your head", or "women's issues".

The report described an "overwhelming sense of guilt" among many patients. Mothers who took sodium valproate during pregnancy to manage their seizures, without knowing the risks this could pose for their unborn children, experienced frustration and sorrow at what had happened.

It also highlighted problems with informed consent. One woman who took a hormone pregnancy test said: "Why, I have asked myself a million times, did the doctor give me the drug? I already knew I was pregnant."

Baroness Cumberlege told a press conference: "We were astonished to find how the health system is disjointed; it is siloed, unresponsive, and defensive. It doesn't recognise that the patients are the very purpose."

Among the report's main findings:

  • That the Government immediately issues a fulsome apology on behalf of the healthcare system to affected patients and families

  • That a Patient Safety Commissioner is appointed

  • 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

  • A Redress Agency for those harmed by medicines and medical devices in future should be established

  • Establishment of a central database to collect key details for implanted devices

  • 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.

  • That the Government immediately sets up a task force to implement recommendations in the review

Report 'Must Not Be Left on the Shelf'

Baroness Cumberlege, a former Conservative health minister, criticised the MHRA for failing to work in the interests of patients. "We believe a regulator must work for patients, and with them," she said. "And this hasn't been the case in the past. 

"So, we're recommending that the MHRA is overhauled. It needs to change, and radically improve the way that concerns are detected and acted upon. It needs to engage more with patients and track how medications and devices improve, or fail to improve, their health and quality of life."

Baroness Cumberlege said she was expecting a Government response in Parliament to the report on Thursday. She urged ministers to "really take heed of what we have to say", and said she hoped her recommendations would not be "left on the shelf".
 

Reaction to the Findings

The Royal College of Surgeons of England backed calls for a database of medical implants. Its President, Prof Derek Alderson, said a major shortcoming in the health system was "a failure properly to monitor implants and medical devices, so that any problems from their use can be picked up swiftly".

He praised witnesses who had come forward during the inquiry. "It is clear from their powerful testimonies that the system, and individuals working in it, have let them down," he said.

Linda Millband, national clinical negligence lead at Thompsons Solicitors, which represents mesh patients, said clients had endured "a journey of rejection and belittlement".

She said reform "must be swift, real, and properly resourced, with 'new' money not taken from already committed funds".

Simon Wigglesworth, deputy chief executive of Epilepsy Action, commented: "Nothing can undo the avoidable harm and distress that has been caused by the decades of Government silence and inaction. However, with the publication of the report and these recommendations, we can now start to move forward.

"As well as providing support to those families already affected, it is important to ensure that all women and girls taking this medication are aware of the risks, and able to make an informed choice about whether or not to take valproate."

MHRA Response

The MHRA issued a statement saying it took the report and its findings "extremely seriously" and it was "of profound importance".

It continued: "Throughout the Review’s work we have listened intently to the many distressing experiences of women and their families. We will now carefully study the findings and recommendations of the Report.

"We recognise that patient safety must be continually protected and that many of the major changes recommended by the Review cannot wait. We are therefore making changes without delay to ensure that we listen to patients and involve them in every aspect of our work.

"We are already taking steps to strengthen our collaboration with all bodies in the healthcare system and will strive to ensure that, working with these other bodies, the safety changes we advise are embedded without delay in clinical practice.

"We wholeheartedly commit to demonstrating to those patients and families who have shared their experiences during the Review, and anyone else who has suffered, that we have learned from them and are changing and improving because of what they have told us. We are determined to put patients and the public at the heart of everything we do."

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