Snapshots of the Sodium Valproate Story
Independent Medicines and Medical Devices Safety Review
Sometimes change begins because people keep asking questions.
For many years, patients and families affected by sodium valproate had been raising concerns about the harm caused by exposure to the medicine during pregnancy.
They were not alone.
Women affected by pelvic mesh and families affected by hormone pregnancy tests were also asking questions about what had happened to them and why their concerns had not been heard.
These were three very different stories, involving different medical interventions and different types of harm.
But there was something that connected them.
Women had tried to raise concerns.
Too often, they felt that nobody was listening.
These were people and families traumatised by their experiences, many of whom had spent years trying to be heard. Their stories were different, but there was a recurring feeling that their voices had somehow been lost to the wind.[1]
Three different stories:
Hormone pregnancy tests - Primodos
Hormone pregnancy tests, including Primodos, had been given to women as pregnancy tests. Families subsequently campaigned for decades about possible harm following their use.[1]
Sodium valproate
Sodium valproate is an important medicine for some people with epilepsy and other conditions, but exposure during pregnancy can cause physical malformations and neurodevelopmental harm in children.[1]
Families affected by sodium valproate had also spent many years fighting for recognition of what had happened to their children and for support for those living with the consequences.
Pelvic mesh
Pelvic mesh had been used to treat conditions including stress urinary incontinence and pelvic organ prolapse. Women reported serious and sometimes life-changing complications and described enormous difficulties getting their experiences recognised.[1]
By 2018, these three very different stories had come together in one independent Review.[2]
This did not come from nowhere
For some families, the fight for recognition had already lasted many years.
My own journey was slightly different.
I had not spoken about sodium valproate for years. Then, in 2013, I became involved again, just before a period when much began to happen.
I attended meetings and became involved in discussions as regulatory reviews took place, warnings changed and patients and families became increasingly involved. Sodium valproate was also being discussed in Parliament, alongside wider questions about whether common lessons could be learned from valproate, Primodos and mesh.[3]
But by the time of the IMMDS Review, my own circumstances had changed.
I was very unwell with what I would later discover was undiagnosed Graves' disease and the effects this was having on my other health problems.
I was not part of the patient groups taking an active role in the Review, although I attended a couple of meetings.
Branwen did take part.
Her involvement in the Review was her own, and her experience belongs in this part of the story.
Tlhe Independent Medicine and Medical Devicies Safety Review was announced
in 2018 and chaired by Baroness Julia Cumberlege.
ts work covered three interventions: hormone pregnancy tests, sodium valproate and pelvic mesh.[1][2]
But its remit went further than simply examining three individual medical interventions.
The Review was also asked to consider broader lessons, including how problems with medicines and medical devices could be identified more effectively and how the voices of patients and families could be strengthened so that concerns were heard.[2]
That distinction matters.
As the Review listened to patients and families, recurring problems emerged around the way concerns had been heard, risks communicated and the healthcare system had responded when people reported harm.[1]
What had begun as three separate stories was exposing wider systemic problems.
Listening to those affected
One of the most important aspects of the IMMDS Review was that it listened directly to people affected by the three interventions.
For sodium valproate, this included not only parents but young people who were themselves living with the consequences of exposure during pregnancy.
My daughter, Branwen Mann, was one of them.
The Review's oral-hearing archive records a session specifically entitled “Young people affected by valproate”, held on 20 November 2018. Branwen gave evidence alongside Josephine “Josie” Coyle and introduced herself as someone living with fetal valproate syndrome who had come to speak for those exposed to sodium valproate in the womb.[4]
Branwen had also gathered anonymous statements from other young people with fetal valproate syndrome so that their experiences could be brought into the discussion.[4]
This mattered.
For many years, much of the sodium valproate story had necessarily been told by parents. We had explained our children's diagnoses, disabilities, difficulties and needs.
But those children were growing up.
They were no longer simply the children being talked about in reports, research and meetings.
They were young people with experiences and opinions of their own.
They could talk about what it was actually like to live with the consequences.
They could say what mattered to them.
And they could describe things that perhaps we, as parents, could never fully describe for them.
Their voices belonged in the Review too.
Those voices made it into First Do No Harm. The final report drew directly on the experiences of young people affected by valproate, including Branwen's evidence about living with FVSD, caring responsibilities and concerns about the future.[1][4]
But there were boundaries
The IMMDS Review was extensive, but it was not an investigation into every question surrounding sodium valproate.
I had raised the issue of over-prescribing when I attended a couple of meetings connected with the Review.
It mattered to me because I already had questions about my own treatment and the doses of sodium valproate I had been prescribed.
I was told that over-prescribing did not fall within the terms of reference of the Review.
The specific sodium valproate Terms of Reference concentrated on the treatment of women and girls of childbearing age in relation to teratogenicity, how developing scientific knowledge had been communicated and acted upon, and the diagnosis and lifetime needs of those affected by fetal valproate spectrum disorder.[2]
But the wider Review also had a systemic remit. It was asked to consider broader lessons about how problems with medicines and devices were identified, how patients and families were heard and how safeguards could be strengthened.[2]
At the time, I did not pursue the over-prescribing question much further.
I was ill and simply was not in a position to follow everything that was happening.
It was later, during lockdown, when I began looking properly at the Review and the wider sodium valproate story, that I started to see things differently.
I went back over the history, the evidence and the questions that had been asked.
I also began noticing questions that had not been asked.
One of those concerned over-prescribing.
The question never entirely went away.
If over-prescribing occurs within a healthcare system, when does it become a systemic patient-safety issue?
That question did not disappear.
It became one of the questions I continued to follow.
First Do No Harm
On 8 July 2020, the Review published its report:
First Do No Harm.[1]
Its overriding message was difficult to ignore.
The healthcare system had failed to listen.
The Review made nine strategic recommendations and 50 Actions for Improvement.[1][5]
It is worth looking briefly at all nine recommendations, because together they show the scale of the systemic change the Review believed was necessary.
Recommendation 1 - An apology
The Review called for the Government to issue a full apology on behalf of the healthcare system to the families affected by hormone pregnancy tests, sodium valproate and pelvic mesh.[1]
An unreserved government apology followed on 9 July 2020.[5]
But there is something about those days in July 2020 that has always stayed with me.
First Do No Harm was published on 8 July.
On that same day, Chancellor Rishi Sunak delivered the Government's major Summer Economic Update - its Plan for Jobs - as the country dealt with the economic consequences of the COVID-19 pandemic.[6]
It inevitably became a major news story.
I remember giving a television interview around this time.
For years, families had fought to have their voices heard. A major independent review had finally listened to them. Their experiences had been documented. Systemic problems had been identified and recommendations for change had been made.
Yet even at that moment, it seemed remarkably easy for their story to disappear beneath something bigger.
I have no evidence that this was a deliberate attempt to suppress the Review.
But the irony has never been lost on me.
It raises a question that reaches much further than that particular day:
How can something be known, documented and placed in the public domain — and still struggle to be heard?
Recommendation 2 - A Patient Safety Commissioner
The Review recommended the appointment of an independent Patient Safety Commissioner with statutory responsibility, championing the importance of listening to patients and bringing their perspective into the safety of medicines and medical devices.[1][5]
The recommendation was accepted. The role was established through the Medicines and Medical Devices Act 2021, and England's first Patient Safety Commissioner was appointed in 2022.[5]
That was significant systemic change.
But what happened next - and what the Patient Safety Commissioner has subsequently done - deserves a snapshot of its own.
Recommendation 3 - An independent Redress Agency
The Review proposed a new independent Redress Agency for people harmed by medicines and medical devices, using a non-adversarial approach centred on avoidable harm and systemic failings rather than individual blame.[1][7]
The proposal raised a much bigger question.
What should happen when people have experienced avoidable harm from healthcare?
The Government did not establish the independent Redress Agency proposed by the Review.[7]
Recommendation 4 - Redress schemes
The Review also recommended separate schemes for hormone pregnancy tests, sodium valproate and pelvic mesh to meet the costs of additional care and support for eligible people who had experienced avoidable harm.[1][7]
Redress has subsequently become an important continuing part of the story.
But what does redress actually mean?
Is it simply financial compensation?
What about health, care, education, support and the lifelong consequences experienced by families?
Redress - and particularly non-financial redress - deserves to be looked at separately.
Recommendation 5 - Specialist centres
The Review recommended networks of specialist centres providing comprehensive treatment, care and advice for those affected by implanted mesh and, separately, people adversely affected by medicines taken during pregnancy.[1][5]
The subsequent response was different for the two groups.
Specialist mesh centres were established in England. The Government did not accept the recommendation to establish an equivalent network of new specialist centres for those affected by medicines taken during pregnancy, instead pursuing work on care pathways.[5]
That difference deserves closer examination in another snapshot.
Recommendation 6 - The regulator
The Review said the Medicines and Healthcare products Regulatory Agency (MHRA) needed substantial revision, particularly around adverse-event reporting and medical-device regulation. It also called for greater engagement with patients and for patients to have an integral role in its work.[1][7]
This raises another important question:
How does a medicines regulator recognise a pattern of harm?
Recommendation 7 - Medical-device data
Recommendation 7 concerned medical devices specifically.
The Review recommended a central patient-identifiable database recording key details when devices were implanted, which could then be linked to registers used to research and audit device safety and patient outcomes.[1][5]
The Government accepted this recommendation and legislated for powers to establish a UK-wide medical-device information system through the Medicines and Medical Devices Act 2021.[5]
Although this recommendation was directed at medical devices rather than sodium valproate, the underlying importance of good data is difficult to miss.
Without good data, how do we recognise patterns?
How do we follow what happens to people over time?
For sodium valproate, those questions would continue in other forms.
Recommendation 8 - Transparency
The Review addressed transparency around financial and other interests involving clinicians and the pharmaceutical and medical-device industries.
It recommended expanding information about doctors' financial and non-financial interests and improving transparency around payments made by industry to healthcare organisations and clinicians.[1][8]
At its heart was another fundamental issue:-
trust.
Patients need to be able to trust that decisions about their treatment are being made in their interests and that relevant relationships and interests are transparent.
Recommendation 9 - Making change happen
Finally, the Review recommended that the Government immediately establish a taskforce to implement the recommendations and set out a timetable for doing so.[1][5]
The independent taskforce proposed by the Review was not established. A Patient Reference Group was established instead to help inform the Government's response.[5][7]
And perhaps this demonstrates one of the most important distinctions when looking at the outcome of First Do No Harm:
Making a recommendation is not the same as implementing it.
What happened next?
The IMMDS Review did not finish the story.
It changed it.
The Government subsequently reported that it had accepted four of the nine strategic recommendations in full, one in principle and one in part. It also reported accepting 46 of the 50 Actions for Improvement in full or in principle.[5]
Some recommendations resulted in significant systemic change.
England gained its first Patient Safety Commissioner.
Specialist mesh centres were established.
Changes were made within the MHRA
Patient involvement became a much more explicit part of discussions about medicines and medical-device safety.[5]
Other recommendations were not implemented in the form proposed by the Review.
Some questions; including questions I had already begun asking about the treatment of the person taking sodium valproate - remained outside its specific remit.
So First Do No Harm left us with more stories to follow.
The Patient Safety Commissioner.
Redress.
Non-financial redress.
Regulation.
Data.
Research.
And the questions that were not answered at all.
Those deserve snapshots of their own.
First Do No Harm looked back at what had happened and asked the healthcare system to learn from it.
Its recommendations looked towards what needed to change.
What happened next is another story.
References
1. Independent Medicines and Medical Devices Safety Review (2020). First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review. Chaired by Baroness Julia Cumberlege.
2. Independent Medicines and Medical Devices Safety Review. Terms of Reference. Includes the intervention-specific remit for sodium valproate and the Review's wider remit concerning systemic learning, identification of problems and strengthening the patient voice.
3. UK Parliament, House of Commons (19 October 2017). Valproate and Foetal Anticonvulsant Syndrome. Hansard. Parliamentary debate discussing sodium valproate, pregnancy risks and common themes involving valproate, Primodos and mesh.
4. Independent Medicines and Medical Devices Safety Review (20 November 2018). Annex K: Oral Hearing Transcripts — Session 2: Young People Affected by Valproate. Evidence from Branwen Mann and Josephine Coyle and statements gathered from young people affected by fetal valproate syndrome.
5. Department of Health and Social Care (2022). Independent Medicines and Medical Devices Safety Review: Update report on government implementation. Includes the nine strategic recommendations, the Government's response, implementation progress, the Patient Safety Commissioner, specialist services, medical-device data and the Government's summary of recommendations and Actions for Improvement accepted.
6. HM Treasury (8 July 2020). A Plan for Jobs 2020. Chancellor Rishi Sunak's Summer Economic Update, delivered on the same day that First Do No Harm was published.
7. Department of Health and Social Care (11 January 2021). Update on the Government's response to the Independent Medicines and Medical Devices Safety Review. Covers the Patient Safety Commissioner, proposed Redress Agency, separate redress schemes, specialist services, MHRA reform and implementation arrangements.
8. Department of Health and Social Care. Disclosure of industry payments to the healthcare sector. Government consultation and subsequent work addressing the transparency issues raised by Recommendation 8 of the IMMDS Review.