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Families living with the legacy of a prescription epilepsy drug dubbed ‘the new Thalidomide’ have been crushed to discover they may never get compensation
Ayear ago, the Cumberledge Report ruled epilepsy patients given the medication sodium valproate – who went on to have children with mental and physical disorders – were harmed by their medical care.
It called for a new, independent redress agency to deal with compensation. But last month, patient safety minister Nadine Dorries dashed victims’ hopes of some kind of justice.
She said the Government had no plans for such an agency, adding: “We do not believe it is necessary.”
The announcement has devastated mothers like Janet Stockley-Pollard, who has three sons diagnosed with mental and physical disorders caused by the epilepsy drug she relies on to control her seizures.
Janet, 53, of Bognor Regis, West Sussex, says: “Families battled for years to expose this scandal. When the report came out, it felt like a victory. Now that victory feels hollow.
“Parents lie awake at night, worrying about what will happen to their children once we’re gone. Compensation is vital to secure their future.”
Accountant Janet was a teenager when she started taking sodium valproate – marketed as Epilim – after being diagnosed with grand mal and petit mal epilepsy. “It allowed me to live a normal life, get a job and drive a car. I’ve taken it ever since,” she said.
Married and wishing to start a family, she asked her GP if Epilim was dangerous to unborn children.
She was told there was a minimal risk of spina bifida – screened for during pregnancy – or cleft palate which can be cured with surgery.
She had two children without initial problems. Later she divorced before marrying second husband, Steve. But when her third child Kyle was born, Janet realised there was something different.
“Kyle cried constantly,” she says. “As a toddler he showed behaviour problems, finding it hard to play or share toys, lashing out at other kids and having extreme meltdowns.
“Cameron arrived 17 months later, showing similar physical and behavioural symptoms.” Over time Kyle, now 23, was diagnosed with atypical autism, speech and language difficulties, sleep apnoea and joint problems. He also suffers phobias. Cameron, now 21, has Asperger’s Syndrome, ADHD, speech and language difficulties as well as asthma, sleep apnoea and joint pains.
But it wasn’t until he was six that Janet saw a newspaper report linking Epilim to neurodevelopmental problems in children. By then a court case had been launched against the manufacturers.
Janet contacted a solicitor, and joined the class action. In 2006, she became a member of the family support group Organisation for Anti-Convulsant Syndrome (OACS). Her youngest two boys were both diagnosed with Fetel Valproate Syndrome in 2007, and later used as test cases in the court proceedings. But in 2010, the case collapsed after legal aid changes stopped families getting help with costs. In 2012, Janet and Steve helped found
etal Anti-Convulsant Trust to seek ce. By then, Epilim was being ribed by investigative journalists as new Thalidomide” – a drug banned e 1960s after it was found it caused defects . But Janet says it’s been ult to establish a direct link een sodium valproate and children ted, because developmental ems aren’t apparent at birth. hese children initially look like r babies. Problems only show up as grow and develop differently to peers. Years may pass and can be several children affected in a family, before the connection is made.”
In 2013, the EU’s European Medicines Agency recommended restrictions to the prescribing of sodium valproate, which is also used to treat bipolar disorder and severe migraine.
But it became apparent many medics were unaware of the advice, continuing to prescribe the drug to women who might become pregnant.
In July 2020 Baroness Cumberlege published her report First Do No Harm. Families, including Janet’s, shared their stories during her investigations.
Presenting her findings in the House of Lords, the Baroness said: “Their testimony haunts me and impels me to right their wrongs.” But according to Nadine Dorries, only some of the report’s recommendations on the impact of sodium valproate and two other now-discredited treatments (vaginal mesh and Primodos hormone pregnancy tests), will be adopted.
Ministers have publicly apologised, but the Government has ruled out the report’s recommendations for compensating young people whose lives are ruined.
Janet says: “The government position appears to be if our children need help, they can seek benefits. But the benefit system is complicated, and often impossible for people with developmental problems to navigate.
“Many children affected by Epilim are going to need support their whole lives. Steve and I are terribly worried about what will happen when we’re no longer here to help our youngest boys.”
Meanwhile, sodium valproate’s legacy continues to ripple through families. Janet’s oldest son Dale, 33, was recently diagnosed with Fetal Valproate Syndrome after experiencing mental health problems.
Janet says: “I’ve never argued Epilim should come off the market, as it’s effective at controlling epilepsy seizures. But ever since it was first licensed in the 1970s, this drug was known to be a high risk to unborn babies.
“Yet doctors failed to fully inform women with epilepsy. I live with the guilt of knowing my medication took a terrible toll on my kids. Parents like us need concrete action and compensation.
“By refusing to pay for the damage that has been caused, the Government is robbing many of the chance of a fulfilling and purposeful life. Financial support is crucial for these children’s futures. An apology is meaningless without the action to back it up.”
If you’re taking Epilim do not stop without seeking medical advice. Contact the Epilepsy Society (epilepsysociety.org.uk)
When the report came out it felt like a victory. Now that victory feels hollow