The Minister for Health is being called on to begin a long-promised inquiry into the historic prescription of an anti-epileptic drug to pregnant women, reports RTE.
Sodium valproate, linked to serious birth defects and developmental issues, was prescribed to expectant mothers for decades. Families affected by the drug were informed last year that an inquiry would begin “within weeks”.
Yet, despite a chairperson being appointed in June, the inquiry has not yet commenced, reports RTE.
Karen Keely, from the Organisation for Anticonvulsant Syndromes Ireland, said she is “dumbfounded and absolutely shocked” at the lack of progress.
All three of Ms Keely’s sons – Harry (38), Lee (29), and Lorcan (26) – have been affected and need 24-hour care, reports RTE.
Speaking from her home in Ratoath, Co Meath, she shared how she’s been campaigning for nearly ten years and expected the inquiry would be well underway by now.
“I’m gutted… there’s no words for how I feel, because you know you’re living with a guilt knowing what you know, and you’re still fighting for something,” she said, reports RTE.
The Department of Health says that before the inquiry can formally begin, “it is necessary to have in place regulations made under the Data Protection Act 2018”.
These regulations are needed to provide a “robust legal basis” and ensure compliance with data protection standards, it said, reports RTE.
However, Ms Keely said this explanation doesn’t justify the hold-up.
“The only thing that’s holding up in this inquiry is the data regulations. And it does not take a year to put data regulations in place. It doesn’t take a year,” she said, reports RTE.
“I hope that the data regulations are put in place as soon as possible. I hope the inquiry is started, like yesterday. It needs to start. The Irish voices literally need to be heard. They’re the only voices that have not been heard,” reports RTE.
According to the Department, the non-statutory inquiry is intended to trace the history of sodium valproate regulation, prescribing practices and controls, and the timeline of scientific findings on the drug’s impact on foetal development.
It also stressed that sodium valproate remains an effective medicine and should not be altered or stopped without a doctor’s advice, reports RTE.
TheLiberal.ie won’t quit
Please support us with a small donation on PayPal!
Nevertheless, it’s believed that more than 1,000 children have been affected by the drug since the 1970s, with some of the latest cases occurring in the 2010s.
Ciara McPhillips, a solicitor representing many of the families, said the prolonged wait has been deeply upsetting.
“We understand the reason for that is that data protection regulations, which are obviously important to the inquiry, which will deal with personal data, have not been finalised. Families are very frustrated and feel that last year was a false dawn,” reports RTE.
She said the timeline proposed by then-health minister Stephen Donnelly in June was “overly optimistic”, but regardless, “it’s incredibly frustrating for families who have campaigned for this for years and who have children who are very much affected by this in a life-altering way”.
“Behind all of that is a deep concern for what will happen to their children when they’re no longer here and perhaps no longer able to continue the fight on their behalf,” she added, reports RTE.
Ms Keely stressed that getting the data regulations finalised and the inquiry underway is crucial.
“I want to know who knew what and when. I want people accountable for their actions, and be responsible for their actions,” she said, reports RTE.
But she’s not only seeking answers.
“Redress and an apology. I should have got the apology years ago,” she said, before explaining the level of care her sons require and the burden it places on her.
“I’ve been doing this since I’m 18 years of age. I’ve been going to medical appointments, physios, speech, surgeries for every single thing you can think of, reports RTE.
“When they come home for the surgeries, you have to really look after them. Then you have the incontinence you have to look after … and I have one child also who’s going through his own issues and he’s been put on antidepressants for them,” reports RTE.
“It’s so draining they need constant care. You know, it’s 24 hours. There’s no stop. There’s no stop button on this,” she said, reports RTE.
Any spare time she has, she devotes to campaigning to get the inquiry moving.
In a statement, the Department of Health said that since Bríd O’Flaherty was appointed chair, “significant work has been carried out to put in place the necessary arrangements to operationalise and establish the inquiry”, reports RTE.
It said that data regulations are still being drafted and, once finalised, “the public facing elements of the inquiry will commence shortly thereafter”.
Ms Keely’s message to the Minister is straightforward: “You need to get this inquiry up and running, you need to get this sorted,” reports RTE.
Tell us your thoughts in the Facebook post and share this with your friends.
