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The mothers fighting a scandal bigger than thalidomide: ‘We were told the medication was safe’

<span>Janet Williams <em>(left)</em> and Emma Murphy, who founded In-Fact to support other parents of children affected by sodium valproate.</span><span>Photograph: Annie Challenger/The Guardian</span>
Janet Williams (left) and Emma Murphy, who founded In-Fact to support other parents of children affected by sodium valproate.Photograph: Annie Challenger/The Guardian

In 2009, Emma Murphy took a phone call from her sister that changed her life. “At first, I couldn’t make out what she was saying; she was crying so much,” Murphy says. “All I could hear was ‘Epilim’.” This was a brand name for sodium valproate, the medication Murphy had been taking since she was 12 to manage her epilepsy.

Her sister explained that a woman on the local news had claimed that taking the drug during her pregnancies had harmed her children. She was appealing for other women who might have experienced this to come forward.

Murphy found the news segment that evening and watched it. “I was just stunned,” she says. “Watching that, I knew. I knew there and then that my children had been affected.”

At that point, Murphy was a mother to five children, all under six, and married to Joe, a taxi driver in Manchester. “My kids are fabulous, all of them, but I’d known for years that something was wrong,” she says. “They weren’t meeting milestones. There was delayed speech, slowness to crawl, not walking. There was a lot of drooling – that was really apparent. They were poorly, with constant infections. I was always at the doctors with one of them.

Janet answered the phone and we talked for two hours. She saved my life

Emma Murphy

“I knew there was something wrong and I’d say it to doctors, to friends, to family, but no one was listening. I was told: ‘It’s a phase.’ ‘You’re reading too much into things.’ ‘You’re depressed.’” At times, she had wondered if her medication was to blame. “Everyone knows about thalidomide, but then I’d think: there’s no way. It can’t be. I’ve been told so many times – by midwives, by doctors, by consultants – over so many years that it was safe to keep taking.” By the time Murphy saw the news item, one of her children, Lauren, had been diagnosed with cerebral palsy.

“It was 10 at night, but I called the news station straight away and asked for this woman’s number,” says Murphy. “I knew I should wait until morning, but I couldn’t. Janet answered the phone and we talked for two hours.” At this point, Murphy wells up and has to pause. Then she says simply: “She saved my life.”

This call between Murphy and Janet Williams was the start of an incredible partnership. It led to the report published this month by England’s patient safety commissioner, Dr Henrietta Hughes, which recommended a compensation scheme for families of children harmed by valproate taken in pregnancy. Hughes has suggested initial payments of £100,000 and described the damage caused by the drug as “a bigger scandal than thalidomide”. It is estimated that 20,000 British children have been exposed to the drug while in the womb.

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Williams and Murphy have campaigned relentlessly to reach this point. It is by no means the endpoint – even now, an estimated three babies are born each month having been exposed to the drug. Together, the women formed In-Fact (the Independent Fetal Anti Convulsant Trust) to find and support families like theirs. They were instrumental in the creation of an all-party parliamentary group to raise awareness in government. They went to Geneva to get foetal valproate spectrum disorder (FVSD) included in the latest version of the World Health Organization’s International Classification of Diseases.

Perhaps most crucially, they uncovered papers from the early 1970s that revealed the key decisions that informed how the drug would be prescribed. They found notes from the manufacturer, Sanofi, that stated that valproate could be teratogenic – harmful to foetuses. They also found the response from the Committee on Safety of Medicines (CSM), then the main decision-making body on new medicines, which concluded that the risk was low and that patients should not be informed, in order to avoid “fruitless anxiety”.

All this has taken 15 years, but Williams has been battling for a lot longer. “Both my boys are now in their 30s,” she says. “We realised what had happened when our youngest was just 12 months.”

Williams, who lives in Pilling, Lancashire, was diagnosed with epilepsy at 16 and prescribed valproate. She had gone on to marry Steve, a bus driver, and have two sons, Lee and Philip. Both spent time in a neonatal intensive care unit (NICU). “Within 12 hours of being born, Lee was very jittery, shaky, refusing his feeds, and they rushed him off to NICU,” she says. “They explained that it was withdrawal from the valproate. He was there for seven days, but they said absolutely nothing about how it would affect him in later life. I gave birth to his brother, Philip, 16 months later and went through exactly the same thing.”

For the next year, many problems worried her. The boys were slow to reach for toys, roll over, crawl or attempt to talk or walk. When they were two and one respectively, they were given an appointment with a geneticist at St Mary’s hospital in Manchester. “The whole family went,” says Williams. “The geneticist told me both boys had been diagnosed with FVSD within 24 hours of being born. She said she’d looked at the research papers and couldn’t find any reason for the problems they were having other than valproate. At first, I was speechless. ‘So the medications caused this?’ was my first question. She said: ‘I’m afraid so.’ There was so little research; there wasn’t much she could tell us about what to expect. “I’d harmed my children. That’s how I felt. The guilt is enormous and it never leaves you.”

I’ve been told so many times – by midwives, by doctors, by consultants – that it was safe to keep taking

Emma Murphy

Immediately, Williams began trying to make sense of it. She contacted a medical negligence lawyer, who pointed her to a group of families with children harmed by valproate during pregnancy who were already seeking legal redress. They joined together for a clinical negligence case against the NHS, which stretched from the early 90s to 2003. “The NHS was saying they didn’t have that information and there was insufficient research,” says Williams. “Eventually, the case collapsed, as the legal aid funding was withdrawn.”

Next, they filed a lawsuit against Sanofi: “The drug company’s defence was that it had passed on all the relevant information. That case collapsed in 2010. More than 15 years of litigation for nothing.”

Through all this, Williams had been on a one-woman publicity campaign, contacting local newspapers across the UK, appearing on local news. On her wall, she had a map of Britain covered in pins that marked the location, names and details of people who had called her. “We’d have meetings and ask people to give us photos of their children as babies, then we’d put them on a noticeboard. It was amazing how all these children looked alike.”

Shortly after Murphy’s first call to Williams, she and her husband drove to Pilling to attend one of those meetings, held in a pub. “I’ll never forget looking at the pictures,” says Murphy. “The medication in pregnancy changes the features. For years, people had commented on my children’s facial features: very thin lips, broad noses. I could never understand it – were they implying my children were ugly? Every picture on Janet’s noticeboard looked the same. I must have done her head in, as I had so many questions.”

Murphy learned that symptoms of FVSD vary, which was why her children had been affected in such different ways. Neurodevelopmental disorders are the most common. Between 30% and 40% of children exposed to valproate during pregnancy have delays in development, lower intellectual abilities, poor language skills and memory problems. Children with a history of valproate exposure in pregnancy have a threefold risk of autistic spectrum disorder compared with the general population. There is also an 11% risk of congenital malformations, including heart and kidney defects, spina bifida, cleft palate and limb defects.

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Murphy and Williams established two goals when they set up In-Fact. The first was to warn women of the dangers of taking this drug while pregnant. The other was to seek compensation. The families that found them all had similar stories. “The common theme was: ‘I knew something was wrong, but no one would believe me,’ and then it’s the guilt. Every single mother blames herself. Some women are so, so depressed. Panic attacks are really common. They just feel they’ve failed their children.”

When it came to compensation, they needed to establish blame. “After the second litigation collapsed, you ask yourself a question,” says Williams. “If it’s not the NHS’s fault and it’s not the drug company’s fault, then why has it happened? By now, the thalidomide campaign team were giving us advice and they suggested we go to the National Archives in Kew to look for the meeting notes from the Committee on Safety of Medicines around 1973, when the drug came on the market.” The CSM had been established three years earlier in response to the thalidomide scandal.

In January 2015, Williams and Murphy made several trips. “We’d be given these huge piles of documents to read through,” says Williams. “Then we had what we call ‘the eureka moment’.”

All the time, nagging away at you, is the question: ‘What will happen to the children when we’re no longer there?’

Janet Williams

As well as a data sheet that noted the potential danger of the drug to unborn babies were the CSM meeting notes. They stated that although anti-seizure drugs were “liable to produce abnormalities”, “the risk appears to be low” and “not sufficient to justify stopping” its use. It was decided that the packaging should contain no warnings, “so that there would be no danger of patients themselves seeing it”. The CSM failed to order any further detailed research.

Evidence of valproate’s effects grew slowly through the decades. By the mid-90s, geneticists and paediatricians recognised what would become known as FVSD. Still, the drug continued to be prescribed to pregnant women.

“We now had all the evidence we could possibly need that this was a government issue,” says Williams of their discoveries at the National Archives. In 2017, the women took the documents to the health secretary, Jeremy Hunt. In 2018, the Medicines and Healthcare Products Regulatory Agency established a valproate pregnancy prevention plan and Hunt announced an independent review into complaints around valproate (as well as vaginal mesh implants and the hormonal pregnancy test Primodos).

Related: Sodium valproate: what are dangers of epilepsy drug for unborn babies?

In 2020, the review, titled First Do No Harm, supported the case for compensation and called for the creation of an independent redress agency for victims – but this was rejected by the government. “It was heartbreaking,” says Williams. “We were really hoping the end was in sight. Instead, it meant more campaigning and endless meetings.”

This led, finally, to the redress scheme proposals set out this month by the patient safety commissioner. “It’s very encouraging, but we’re waiting with bated breath to see what comes next,” says Williams.

In France, where Sanofi is facing a class-action lawsuit, the government has already established a dedicated compensation fund for victims. A recent statement on Sanofi’s website said: “It should be remembered that drug companies cannot unilaterally decide to change the information documents relating to their medicines without the approval of the health authorities in each country where the product is marketed. Sanofi continues to update information on its medicines for both healthcare professionals and patients, in line with developments in scientific knowledge and under the supervision of the Health Authorities.”

We know it’s the government that chose not to warn women of the risks. But the guilt remains with every single mother

Emma Murphy

Williams’ elder son, Lee, has Asperger syndrome and attention deficit hyperactivity disorder. “Everything has to be organised, on time and methodical for him,” says Williams. He has passed his driving test – he has always loved anything mechanical – although when it comes to finding a legal place to park, he is less reliable.

Lee keeps his brother, Philip, safe when they are out. “Philip has no road sense at all, no sense of direction, no understanding of money,” says Williams. Music is his passion. “A few years ago, he told me that he didn’t want his life to be wasted,” says Williams. “It was very upsetting.” They found a drumming tutor and he took to it quickly. He is now in a band. “They’re both lovely kids, they help each other, they get each other’s humour,” says Williams. “All the time, though, nagging away at you, is the question: ‘What will happen to them when we’re no longer there?’ They’ll need help and support – and that can be costly.”

Murphy’s children are now between 14 and 20. “There have been so many diagnoses,” says Murphy. “Cerebral palsy, autism, deafness, hypermobility, sensory processing disorder – they’ve all got different, unique challenges. Lauren is at uni now and she came back the other day and was so giddy. She said: ‘I’ve found a friend!’ She’s 19, but people have always seen her wheelchair, or her splints, or her frame, before they see Lauren. The emotional damage this has done to the children is just horrific.”

“We know it’s not our fault,” she says. “We know it’s the government that chose not to warn women of the risks. But the guilt remains with every single mother this has happened to. That’s why we have to fight.”

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