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Government urged to issue apology over sodium valproate, Primodos and pelvic mesh ‘public health scandals’ by safety review

8 Jul 2020

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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UK Government launches review after three “public health scandals”, including sodium valproate

The UK government has launched a review following three “public health scandals”.

Comments: read the 4 comments or add yours

Comments

Matt Hancock's apology on yesterday's news bulletin was about as sincere as a spoilt brat. No number of apologies will put right the wrongs caused by this drug.

Submitted by Pete on

How about a register of all women who became pregnant while taking an type of epilepsy medicine and had babies with birth defects or developmental problems? I'd be happy to carry that out. Michele

Submitted by Michele Eckford on

What good does any apology do? Surely it is more important to find a suitable alternative to Valporate. My daughter has tried about 6 meds over the last 14 years and Valporate is the only one that works. Let's have more constructive help rather than pointless words.

Submitted by Geoff on

My daughter has Lennox Gastaut syndrome and complex learning disabilities. It is widely accepted she does not have mental capacity. She has Depo Provera injections every 10 weeks, as she has very catamenial epilepsy. She has been on Epilim since she was 14 - she has gone from 50 seizures a day to 5 - 10 on it. She used to be permanently confused with 50 seizures a day. Yet every time, a new GP has to do her prescription, they talk to me about the dangers of sodium valproate. My daughter cannot give meaningful consent to sex; and even if she could, what are the chances of getting pregnant on 10 weekly Depo injections? In my lay opinion, a pregnancy would be extremely dangerous to her, given her severe epilepsy. She is under 1:1 supervision all her waking hours, and video/auditory monitoring at night.

Why can’t there be a red flag on medical records about learning disabilities, no mental capacity, whatever so that families don’t have to endure these painful conversations - when in her case, the real question is more likely to revolve around if it was rape by a care worker?

Submitted by Susan Lyons on
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