Sign up to get Today’s Best Articles in your inbox
Join 350,000+ subscribers and keep yourself informed with a selection of
The Week’s most interesting, enlightening and entertaining stories - plus daily puzzles.
You are now subscribed
Your newsletter sign-up was successful
Want to add more newsletters?
An account already exists for this email address, please log in.
A new BBC documentary has reignited the outcry over the sodium valproate scandal – a catalogue of pregnancy harms that England’s Patient Safety Commissioner has called “bigger than thalidomide”.
The drug at the centre of the scandal was prescribed to pregnant women, despite its known risks to foetuses. Over the past 50 years, it is thought to have caused an estimated 20,000 babies in the UK to develop serious disabilities or autism in the womb. The documentary, narrated by two campaigning mothers from northwest England, tells “an appalling tale of regulatory failure”, said The Telegraph.
What is the scandal?
In 1962, sodium valproate was found to be an effective anti-seizure drug, as well as a treatment for bipolar disorder. The scientists who created it knew that it had caused foetal malformations when tested on pregnant rats. Yet in 1972, the drug, often distributed as Epilim, was licensed in the UK to treat epilepsy without official contra-indications for pregnant women. By the 1990s, it was one of the most widely prescribed treatments for epilepsy in the UK.
The Week
Escape your echo chamber. Get the facts behind the news, plus analysis from multiple perspectives.
Join more than 350,000 subscribers and keep yourself informed with a selection of The Week’s most interesting, enlightening and entertaining stories - plus daily puzzles.
Join more than 350,000 subscribers and keep yourself informed with a selection of The Week’s most interesting, enlightening and entertaining stories - plus daily puzzles.
In the 1990s, Jill Clayton-Smith, a Manchester-based clinical geneticist, began to notice “a recurring cluster of features” among children of epileptic women, said The Guardian. She unearthed a 1984 US study describing “foetal valproate syndrome” and presented it, along with her own findings, at a conference. “The male-dominated audience essentially scoffed at her ‘anecdotal’ data and ignored it.”
She then began a formal study that eventually helped determine that babies exposed to sodium valproate in the womb have a 10% risk of developing physical malformations (way above the 2% norm), and a 30% to 40% risk of developing serious neurodevelopmental disorders. Yet warnings were not added to some packaging until as late as 2016.
Who are the mums?
Janet Williams gave birth to two sons with developmental delays in the 1990s but was told for years that nothing was wrong. Then, in 2009, a specialist mentioned that their condition had probably been caused by her epilepsy medication, Epilim. She started telling her story to families in and around her home town of Pilling, Lancashire, and asking other potentially affected parents to get in touch. One of those was Emma Murphy from nearby Bury. Five of Emma’s six children had similar developmental difficulties and she, too, had taken Epilim during pregnancy. Together, they “doggedly pursued answers” in the face of “institutional resistance and, in some cases, patronising dismissal”, said The Times.
By 2013, they had begun investigating why UK regulators had allowed the drug to be prescribed without warnings, despite knowing the risks. In 2015, they found “the smoking gun”, said The Guardian, in meeting notes from the Committee on Safety of Medicines: putting warnings on packaging about drug manufacturer Sanofi Aventis’ statement that sodium valproate was harmful to foetuses “could give rise to fruitless anxiety”.
Sign up to get Today’s Best Articles in your inbox
A free daily email with the day’s biggest news and analysis – and the best features from TheWeek.com
What has the government done?
In 2018, then health secretary Jeremy Hunt announced an independent review into sodium valproate. The resulting report, published in 2020, highlighted affected families’ “struggle to be believed” and recommended financial redress for the “life-changing consequences” they had suffered. In 2024, England’s Patient Safety Commissioner set out options for a compensation scheme.
The government has still not responded to that, although, in October, health minister Diana Johnson spoke of a commitment to “making meaningful progress” by the end of this Parliament. Affected families have yet to receive any payouts.
Harriet Marsden is a senior staff writer and podcast panellist for The Week, covering world news and writing the weekly Global Digest newsletter. Before joining the site in 2023, she was a freelance journalist for seven years, working for The Guardian, The Times and The Independent among others, and regularly appearing on radio shows. In 2021, she was awarded the “journalist-at-large” fellowship by the Local Trust charity, and spent a year travelling independently to some of England’s most deprived areas to write about community activism. She has a master’s in international journalism from City University, and has also worked in Bolivia, Colombia and Spain.
