UPDATE (9 July 2020): Since the original story, the government has issued an apology to families affected by the public health scandals around the medical products sodium valproate, Primodos and pelvic mesh. You can read the full government response on the UK Parliament website.
Original story – 8 July 2020
The UK government has been urged to issue a “fulsome apology” to the families affected by sodium valproate, Primodos and pelvic mesh by the Independent Medicines and Medical Devices Safety Review.
This is one of nine “wide-ranging and radical” recommendations for improvements in the health system set out by the review team’s report, First Do No Harm, published today. Other recommendations include the appointment of a Patient Safety Commissioner to advocate for patients and the establishment of schemes to meet the cost of additional care for those affected.
Today’s report follows a two-year review, chaired by Baroness Julia Cumberlege, into three “public health scandals” around medical interventions, one of which is sodium valproate.
Sodium valproate is an effective epilepsy medicine, but it is known to cause birth defects and developmental problems in babies born to mothers taking the medicine. Knowledge of these effects had been known since the 1970s, but this information wasn’t made widely available until years later.
The review aimed to determine what was known about the effects of this medicine by manufacturers, regulators, clinicians and policy makers. It further investigated what decisions were made and actions taken in light of this knowledge.
Baroness Cumberlege said: “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.
“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 a result of Primodos, sodium valproate or pelvic mesh.
“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 can spare other families from such anguish.”
Epilepsy Action’s deputy chief executive, Simon Wigglesworth, said: “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.”
“We welcome the suggestion of a registry for all women on anti-epileptic drugs who become pregnant and are encouraged that this will not be limited to women taking sodium valproate. This is something Epilepsy Action has been calling for and is an important first step in ensuring that all women with epilepsy are fully informed of the risks of all anti-epileptic drugs.
“Today’s report is an important milestone in the journey to address the historic issues around valproate but there is still more work to be done. We will continue to put pressure on the Medicines and Healthcare products Regulatory Agency, the Department of Health and Social Care, and others, to ensure that these recommendations are fully implemented.”
Independent Fetal Anti Convulsant Trust (INFACT)’s managing director Emma Murphy and CEO Janet Williams said they are delighted with the recommendations from the 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.
“An apology has been a long time coming.”
You can find more information and read the full list of recommendations at the Independent Medicines & Medical Devices Safety Review website.
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