Latest news with #StephenDonnelly
Irish Times
12 hours ago
- Health
- Irish Times
Inquiry begins into historical use of anti-epileptic drug and effects on pregnant women
The historical licensing and use of the anti-epileptic drug sodium valproate for women of childbearing age will be examined as part of an inquiry that started its work on Tuesday. Mothers of children diagnosed with foetal valproate spectrum disorder (FVSD) have long called for a public inquiry to investigate why they were not warned about the risks of taking the drug while pregnant . FVSD is caused by exposure in the womb to valproic acid, which is the key ingredient in sodium valproate, better known in Ireland as Epilim. An Irish Medical Journal study published in 2021 said diagnosing the condition was 'difficult' due to the lack of any specific diagnostic test or biomarker. READ MORE However, it said dysmorphic facial features, neural tube defects, congenital heart disease and cleft lip were among the most commonly associated characteristics. The study noted that Irish public health data suggested 3,126 babies were potentially exposed to sodium valproate before birth between 1975 and 2015. Minister for Health Jennifer Carroll MacNeill said the inquiry would give people directly affected by sodium valproate an 'opportunity to have their voices heard'. She welcomed the commencement of the inquiry, which was announced last year by her predecessor, Stephen Donnelly. She said she recently met the Organisation Anticonvulsant Syndromes Ireland (OACS Ireland), a campaign group dedicated to supporting and advocating for families affected by foetal anticonvulsant syndrome. 'I know this is an important day for them and the families they represent,' Ms Carroll MacNeill said. 'I have every confidence that the chair will conduct an independent and fair inquiry and finally get answers for those affected and their families.' The inquiry, involving three distinct phases, is chaired by barrister Bríd O'Flaherty. The Department of Health said it envisaged she would spend 12 to 18 months conducting an 'independent, fair and rigorous process'. The first phase will establish a timeline for the use of sodium valproate in women of childbearing potential in the State, including information on regulation, prescribing, dispensing and safety information issued. The inquiry will document the evolution of the drug's regulation and practices around its control. The second phase will focus on oral statements from people diagnosed with FVSD, their mothers and other family members. The final strand will assess the health service's capacity to respond to safety issues related to the use of anti-seizure medications in women of child-bearing potential.
The Journal
16 hours ago
- Health
- The Journal
'The real work starts now': Long-awaited inquiry into drug that causes birth defects begins
A LONG-AWAITED inquiry into an antiepileptic drug that can cause serious birth defects if used during pregnancy has finally gotten underway, nearly five years after the Government committed to holding one. The non-statutory inquiry into the historical licensing and use of sodium valproate will have three strands, with statements from those affected by the drug expected to be taken from September. Health Minister Jennifer Carroll MacNeill has welcomed the commencement, saying that it 'will give those directly affected by sodium valproate an opportunity to have their voices heard'. The inquiry was approved by Cabinet in July 2023 , almost three years after the then-health minister Stephen Donnelly committed to holding a probe into the drug. Barrister and mediator Bríd Flaherty was announced as the chairperson of the non-statutory inquiry in June 2024, with Donnelly saying at the time that he intended to get it up and running ' in a matter of weeks ', but this did not take place. The delay in the commencement of the inquiry is understood to have been due to the fact that the data regulations had yet to be finalised. Sodium valproate can cause serious birth defects and developmental disorders to an infant if taken during pregnancy and women have been advised against using it unless no other treatment is possible. The drug was prescribed in Ireland and elsewhere for years after the danger was discovered and many countries are now investigating its use. Today, the Health Products Regulatory Authority (HPRA) states that the drug can cause birth defects and problems with the development and learning of the child if their mother takes it during pregnancy. Advertisement Children exposed to the drug while in the womb are at a high risk of serious developmental disorders (in up to 30-40% of cases) and congenital malformations (in approximately 10% of cases). Symptoms of fetal valproate syndrome (FVS) vary, but can include characteristic facial features, spina bifida, congenital heart defects, cleft lip and/or cleft palate, genital abnormalities, skeletal abnormalities and developmental delay. The drug's risk to infants has been made public in recent years, but campaigners in the UK found documents in the National Archives that indicated health regulators were aware of the risk as far back as 1973 but chose not to warn patients, saying it 'could give rise to fruitless anxiety'. A HSE report published in 2018 estimated that 1,250 children have been affected by valproate since 1975 in Ireland. In 2021, an investigation by The Journal Investigates found that around 3,000 Irish children were potentially harmed by exposure to the drug in the womb. Read The Journal Investigates's investigation into the valproate scandal . Last January, doctors began informing men of the potential risks that taking sodium valproate can have on their future children before prescribing it to them following precautionary measures recommended by the European Medicines Agency. Inquiry The Department of Health said the inquiry will have three strands. The first strand will be the review phase, which will establish a timeline for the use of sodium valproate in Ireland 'in women of childbearing potential including information on regulation, prescribing, dispensing and safety information issued'. The inquiry will seek to document the evolution of the regulation of the drug and the practices around the control of it. The Department said the inquiry 'will have responsibility to request documentation and submissions from a range of stakeholders', and the chair will record 'difficulties encountered where such requests are refused as part of their reporting function'. The second strand of the inquiry will seek oral statements from anyone impacted by the use of the drug, including people diagnosed with Foetal Valproate Spectrum Disorder (FVSD), their mothers and other family members who may wish to participate. This is anticipated to begin in September. Anyone who wishes to take part in this strand of the inquiry can register their interest on its website . These sessions will be held in private, and other stakeholders may also be invited to provide oral statements in separate sessions. Related Reads Chairperson appointed to probe into drug that causes birth defects after almost a year's delay Six months on, chairperson yet to be appointed to inquiry into drug that causes birth defects Doctors to inform men taking sodium valproate of risks to unborn children The third strand will focus on assessing the health service's current capacity to respond to safety issues 'related to use of anti-seizure medications (ASMs) in women of childbearing potential'. This will involve an assessment of the current systems in place to respond, disseminate and implement measures that address these potential safety issues, the development of other recommendations regarding current control systems for sodium valproate and other ASMs, and the services and supports for those impacted by sodium valproate. The Department said the results of this assessment will inform future service development. A communications campaign will be launched in the coming weeks to raise public awareness and support engagement with the inquiry. 'The real work starts now' Last month, when the inquiry had yet to commence, the Organisation for Anticonvulsant Syndromes (OACS) Ireland group, which supports families that have been impacted by the drug, told The Journal that it was seeking a meeting with the Minister for Health to discuss the status of the inquiry. Today, Carroll MacNeill said she was 'grateful' to meet with OACS Ireland recently 'and I know this is an important day for them and the families they represent'. 'I have every confidence that the Chair will conduct an independent and fair Inquiry and finally get answers for those affected and their families,' she said. In a statement, chair of OACS Ireland Karen Keely, whose three adult sons have been affected by exposure to sodium valproate, said: 'The real work starts now. 'The Inquiry will draw a spotlight on a public health issue which, whilst life-changing, is perhaps not as well known or understood by the public as other public health issues,' Keely said. Solicitor Ciara McPhillips, who represents OACS Ireland within the inquiry process, said: 'Together with OACS, I look forward to working with all stakeholders under the stewardship of the Chair to ensure those affected understand how it arose that women and mothers were prescribed a medication, which whilst very effective in preventing seizures, was so devastatingly detrimental to their children – many of whom will never live independent lives.' Readers like you are keeping these stories free for everyone... A mix of advertising and supporting contributions helps keep paywalls away from valuable information like this article. Over 5,000 readers like you have already stepped up and support us with a monthly payment or a once-off donation. Learn More Support The Journal
Irish Independent
a day ago
- Entertainment
- Irish Independent
Suzanne Crowe: Level of churn at the top of the HSE is unsettling for all
The most fascinating aspect of the responses to quotes from Stephen Donnelly at the MacGill Summer School last week is that there was a reaction at all.
Irish Independent
4 days ago
- Health
- Irish Independent
Former Health Minister Stephen Donnelly believes public must become comfortable with use of AI in health service
Stephen Donnelly, who was Minister of Health and is a Health Consultant, was speaking during a panel discussion at the MacGill Summer School in Glenties, Co Donegal. During the discussion on 'Taboo Ideas to Transform Ireland?', Mr Donnelly said he believed Ireland could be a global leader in AI related health care. He said for the country to succeed in the field, the public would have to become comfortable sharing their data with AI platforms and algorithms. The host of the panel, Jess Majekodunmi, Design Historian & Innovation Researcher said there is a lot of anxiety and concerns about the use of AI and she questioned if the use of AI is already creeping into the health service. Mr Donnelly said the use of AI and algorithms is increasing and already present in the health service. 'In more and more GP services now, we may not know it, but there is an algorithm listening to the entire conversation, categorising what we say and when we leave, it is saying, Stephen referenced these four things, you never checked them. 'In more hospitals in Ireland now, there is a machine beside the bed and the patient is wired up to it and it is monitoring all sorts of stuff at a level of complexity that doctors and nurses will struggle to maintain consistently and flagging saying this person is going to crash in half an hour, you need to intervene. 'AI is coming in to help clinicians anyway. 'If you go into your hospital today or your GP, there is a decent chance it will already be involved in some way,' said Mr Donnelly. However, Mr Donnelly said all advances must link back to a human being and there must be transparency for it to be a success. 'Within healthcare there has to be accountability. ADVERTISEMENT 'There has to be security of data, and we probably need to have a complex conversation by being very respectful of people's anxieties, very respectful of the fact it is new and people are trying to get their head around it,' said Mr Donnelly. When asked by Ms Majekodunmi about his predictions for the timescale of the developments, Mr Donnelly said it is moving so quickly it is difficult to say. 'I would be very surprised if healthcare does not look quite different 10 years from now,' said he said. However, he said in order for the development to be introduced on a wider scale, people must get more comfortable with the use of AI. 'Most of us would have to be comfortable sharing our data and I mean data right down to the genetic level. 'In order for these things to work you have to have a big pool of data and it is much better if it is national data rather than international data. 'If we could get our heads around becoming comfortable with AI and the idea that this is a public good and our data is a public good with the right protections around it, we could become one of the handful of countries in the world that does something truly mind blowing and extraordinary and flips our entire concept of what a public health service is, into one that keeps us well. 'It is very important to me anyway that it is a public service. It cannot be something that only wealthy people can afford.' Mr Donnelly. He said the introduction of AI and new technologies would see a major move towards preventative healthcare. Mr Donnelly used the example of who fells unwell and visits their GP who carries out a number of tests. The patient is then diagnosed with Type Two Diabetes. However, with the new technology, the patient would get an alert notifying the patient of changes in their cells which if left untreated, could result in Type 2 Diabetes in five years. 'All over the world, the health service says if you get sick, we will fix you. 'There is a wave off innovation coming. 'AI is the glue that holds a lot of it together, but it is geo typing, robotics, genetics, bio printing, printing replacement organs in hospitals rather than having to use donors. 'There is a vast wave coming. 'The entire purpose of a health service shifts from one that tries to fix you when you get sick to one that keeps you well for as long as possible. 'And then inevitably, if something bad happens, can fix you,' said Mr Donnelly. Mr Donnelly said he believes Ireland is 'incredibly placed' to be a world leader in innovative healthcare. 'I would love to see us make a stand on this and say look we have a healthcare service that is getting better at an incredible rate. 'We are rolling out a new health strategy, so we are going to have the digital infrastructure in place soon enough. 'We have a pharma hub, a health tech hub, a digital hub so we have brains to burn around the country in terms of some of the things that can happen. 'We have a very attractive country for these things. 'It is big enough that you can really roll these things out but small and integrated enough that you can get your head around doing it at the population level,' said Mr Donnelly.
Irish Times
5 days ago
- Health
- Irish Times
Public opinion is now toxic, warns former minister for health
People in Northern Ireland must wait 11 times longer than people in the Republic for urgent operations, yet the HSE gets no credit, a former minister for health has said. Stephen Donnelly said waiting lists in the Republic have fallen by 60 per cent over the last three years, yet few in the public know anything about it, or want to know anything about it. 'It is improving rapidly. They're doing incredible work. It's not all the way there, but it's moving really quickly,' the former minister told the Patrick MacGill Summer School in Glenties, Co Donegal. 'It's hard to find another country in Europe that has achieved anything like that. Emergency department pressures are falling. Women's healthcare is being transformed. There's a lot of really good things happening now,' he said. READ MORE 'Don't get me wrong. Not for a moment am I suggesting that it's fixed, or that everything is right. It's not. I know it's not. But it's moving in the right direction so quickly that we are on track to have achieved universal healthcare within the next five years.' Despite the improvements, the public narrative about the Republic's health system is 'a black hole', said Mr Donnelly, who served as served as health minister from June 2020 to January 2025. 'Contrary to the national view on this, we have a public health service that is improving at an extraordinary rate,' he said. The negativity surrounding public attitudes towards the health service is typical of the attitudes towards nearly every other element of Irish public life, which is increasingly corrosive and destructive, said Mr Donnelly, who lost the seat he held for Fianna Fáil in Wicklow at the last general election. 'If we are to be serious about navigating what is an increasingly fractured and turbulent world, we're going to have to have a different conversation about who we are. We need to balance the conversation,' he told the summer school. [ Warning labels on alcohol an idea from 'different time', Minister warned Cabinet colleague Opens in new window ] 'It's not that we shouldn't shine a light on the challenges that exist. Of course we should, we do and we must always do that, but we've got to start bringing some balance.' Six months after he stepped down as minister for health, Mr Donnelly said: 'What strikes me is that the political debate has become harsher and harsher. You would be forgiven if you were watching a lot of TV for believing we live in a failed state. 'And we really, really don't. Social media has just gone completely off the reservation. Fourteen years ago when I was first in politics, it was fairly all right. People used it to put out their ideas and have chats. Now, it's just poison. 'There's lies and misinformation and hatred and racism and poison, and ... but it is being consumed all the time,' said Mr Donnelly, who was a Social Democrat TD before he joined Fianna Fáil. Social media would have us believe that Ireland is in 'a state of perpetual crisis', he said. 'That the doctors and the nurses are all leaving. The teachers are all leaving. The young people are all leaving, or the Government is uncaring, incompetent and corrupt.' [ Brother of Veronica Guerin criticises Catherine Connolly over nomination of Gemma O'Doherty for 2018 election Opens in new window ] Foreign friends who have visited Ireland say they have heard nothing but complaints when they have travelled around the country for a week, he said. 'You meet them, and they just say, 'What is wrong with you people?'' Ireland does face some 'immense, some deadly serious challenges', but so does every other country, he said. 'The level of negativity that we see here is not normal. It does feel like there is something particular going on in Ireland at the moment.' Ireland is 'incredibly well placed' to become a world leader in the use of artificial intelligence in healthcare, he said. 'There's a wave of innovation coming. Some of it's already here.'
