Mothers of children diagnosed with foetal valproate syndrome (FVS) are demanding a public inquiry into why they were not warned of the risks of taking an anti-epilepsy drug while pregnant.
They cite “alarming similarities” between what happened to them and their children, and the Thalidomide scandal of the 1960s. Thalidomide was an anti-morning sickness drug that led to the birth of thousands of babies with deformities.
An estimated 400 babies have been born in Ireland with FVS – caused by exposure in the womb to valproic acid, the key ingredient in the anti-epilepsy drug sodium valproate, better known in Ireland as Epilim. Since 2017, about 40 affected families have come forward.
FVS is characterised by distinct deep-set facial features, physical malformations, developmental delay and autism, and can mean life-long care.
Despite studies since the late 1980s showing significantly increased risks of foetal malformations where pregnant women took sodium valproate, women of child-bearing age were not warned until recent years.
In February 2018, the European Medicines Agency recommended that sodium valproate not be used during pregnancy, and warnings were provided to women taking the drug here last year after a campaign by affected mothers, initiated by Karen Keely from Ratoath, Co Meath.
Ms Keely first told her story in an interview in The Irish Times in April 2017. Later that year she founded, with the support of Epilepsy Ireland, the Organisation for Anticonvulsant Syndrome (OACS) Ireland. Members of sister organisations in Britain and Frances were at a conference on the issue in Dublin on Friday.
Ms Keely, who has three sons in their 20s with FVS, said the syndrome “is and always was preventable”.
“The simple truth is the structures were not put in place to ensure women were informed and warned about the devastating consequences valproate could have on their babies.”
Calling for a public inquiry, she referenced Thalidomide, and said: “We need to understand why history has been allowed to repeat itself, not only for the valproate families but so something like this cannot happen again.”
In Britain, a review, chaired by Baroness Julia Cumberlege, is examining how the national health system responded to concerns.
About 20 mothers were among those at a conference which heard clinical experts say “certainly from 1990 women should have been offered the opportunity to switch to a treatment with a lower risk”.
Carl Heneghan, professor of evidence-based medicine at the University of Oxford, said by 1992 it was "clear with some certainty...there were increased risks of neural tube defects".
“It’s very clear to us that everybody acted too late – regulators, governments, drug companies, journal editors, prescribers...The most important issue here is that the commercial complex seems to override patient safety.”
He said doctors did not always acted in patients’ best interests, and there was often a “complete failure” in health systems to admit when patients had been misinformed and harmed.
"I think if you in Ireland can force a similar type of approach as in England where we are having a review, and ask 'why are we not having a review, an open, transparent inquiry?' that would be great."
Dr Colm Henry, HSE chief clinical officer, said the executive was "delighted" to support the conference. He said about 40 families had contacted the HSE since last year seeking support for their children.
“We were able to discuss their experience of Epilim, and if required, to refer them to a specialist team, or to HSE-funded counselling supports.”
A MOTHER’S EXPERIENCE
It was not until Aideen Pettigrew from Artane, Dublin, saw Karen Keely on Sky News 16 months ago describing her children's foetal valproate syndrome that she realised her teenage children had the same condition.
Ms Pettigrew has been prescribed sodium valproate, known in Ireland as Epilim, for epilepsy since she was 10.
“I didn’t know anything about sodium valproate. As far as I was concerned I was put on it as a child and that was my medication.”
She has had two miscarriages – due, she believes, to the Epilim - and two children – Peter born in 2001 and Sarah in 2005. As a baby Peter “used to shake a lot”. As he got older “there were problems, things weren’t adding up”. When she sought medical help she was told not to worry. He was diagnosed with Asperger’s syndrome aged seven.
Sarah was born with holes in her heart, her toes were “scrunched up”, and she had similar issues to Peter.
“When I saw Karen on the news in November 2017 I went into shock. I was just horrified to know that this was after going on for so long. I’d been thinking there’s something wrong with me, that I’d done something wrong. You want to do the best for your kids. I just felt sickened that it was Karen was on the news telling me what was wrong.
"The more I find out the angrier I am. Absolutely I want to see a national inquiry. Irish women are third-class citizens – between the Magdalene laundries, the Tuam babies, the cervical cancer scandal, the vaginal mesh scandal – we're just kept in the dark and told, 'we'll make the decisions for you'. I'm very angry."