Foetal Valproate Spectrum Disorder: Fatalities
Debate between Caroline Nokes and Christian Wakeford(1 year, 4 months ago)
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Caroline Nokes (Romsey and Southampton North) (Con)
I start by expressing my thanks to Mr Speaker for granting this Adjournment debate. It is not the first time we have debated the issue of foetal valproate spectrum disorder in this House or in Westminster Hall, but this time we have added fatalities to the title of the debate. It is stark, and deliberately so, because this year for the first time a coroner has listed it as a contributing factor to a death.
Jake Aldcroft was just 21 when he died in April this year after an infection triggered by problems with his kidneys. The coroner listed foetal valproate syndrome as a contributing factor to his death because of the physical damage done to Jake as an exposed baby, which meant that his bowel and bladder did not work properly and he relied on urostomy and colostomy bags. He had also suffered brain swelling that needed a drain. Jake did not experience pain in the normal way, which would have triggered the alarm sooner. That meant that when he arrived at hospital he collapsed and deteriorated quickly. His mum, Sharon Aldcroft, has been clear that she was never warned about the dangers of valproate when she took it while pregnant with Jake, who was diagnosed with FVSD as a baby.
Christian Wakeford (Bury South) (Lab)
I thank the right hon. Lady for raising this important topic. The fact that the warnings are still not being displayed on pharmacy prescriptions is truly shocking and needs to be corrected. Does she agree that if there is one clear message we can send from this House, it is that doctors and chemists need to be doing what they should be doing and warning any patient of the risks of this drug?
Caroline Nokes
Of course, the hon. Gentleman is right. One of the serious issues to do with sodium valproate has been the lack of warning and information provided to women of child-bearing age.
I have highlighted Jake’s case, with the permission of his mum, because it gives a stark description of some of the very severe problems FVSD can cause for affected babies, and because, as far as I know, it is the first time that it has been listed as a contributory factor to a death. But the horror for many families is that they have to do everything they can to avoid infection and to manage really complex and difficult conditions because they know that, like Jake, their children are vulnerable and could, ultimately, also lose their lives to this totally avoidable syndrome.
Caroline Nokes
I thank the hon. Member for that intervention. I remember being in this Chamber when a predecessor of my hon. Friend the Minister made a full apology in line with the recommendations of the Cumberlege report. Unfortunately, not all of that report’s recommendations have been implemented for some issues, which I will move on to shortly.
I know that I do not have to rehearse this with the Minister because she has been there—and indeed in Westminster Hall—when we have debated this issue before. There have been many debates, statements and urgent questions on this issue and on the related matters of vaginal mesh and hormone pregnancy testing, but this is the first time the syndrome has been found by a coroner to have contributed to a young person’s death—a child’s death.
As the Minister will know, foetal anti-convulsant syndrome is a serious condition in which a baby suffers physical and/or developmental disability from his or her mother taking sodium valproate. Those disabilities can vary and will include minor and major malformations ranging from deformities just of fingers and toes to major physical disabilities such as spina bifida, malformed limbs, skull and facial malformations and malformations of the internal organs.
Christian Wakeford
I thank the right hon. Lady for giving way a second time. We have also recently heard that foetal valproate syndrome can be passed down the generations, so the very unfortunate victim of that awful illness can pass it on to their children as well. Although that has been confirmed only recently, we need to ensure that people are warned about the knock-on effects. Up until probably a couple of weeks ago, no one really knew about that.
Caroline Nokes
The hon. Gentleman makes an important point. The illness can continue down the generations, and that is not yet well understood but it is causing real fear for the families who have been affected so far.
Additionally, problems can include learning disabilities, autism spectrum disorder, delayed walking and talking, speech and language difficulties, and memory problems. It is a long list, and it has now been listed as directly attributing to the death of a young person.
Way back in 2018, the Government commissioned the independent medicines and medical devices review, chaired by the noble Baroness Cumberlege, and its “First Do No Harm” report was published in 2020. That excellent piece of work had nine significant recommendations, some of which have been implemented, some of which have not—or not effectively. As the noble Baroness pointed out, many thousands of women of child-bearing age who suffer from epilepsy are still being prescribed sodium valproate.
Since 2018, when the pregnancy prevention programme was introduced, only 7,900 women are believed to have switched from valproate, which means that today approximately 20,000 women taking valproate are at risk of becoming pregnant. Information from the Medicines and Healthcare products Regulatory Agency indicates that of those 20,000 women, roughly one in three will have a pregnancy. That means that about 400 pregnant women a year have been exposed to valproate and that, of those 400 pregnancies, about one in two will have a child affected to some extent by foetal valproate syndrome.
Caroline Nokes
I will go on to say how important valproate is and how it is imperative that women keep taking the medication, but they need to do so in collaboration with their GP and in discussion with consultants —they need to do so being aware of the risks.
According to the MHRA’s chief safety officer, around three babies are being born every month having been exposed to valproate in pregnancy, although The Sunday Times has estimated the numbers to be double that, at six per month. I pay particular tribute to The Sunday Times, which has worked alongside families and campaigners, such as the Independent Fetal Anti-Convulsant Trust, or INFACT, to make sure that this scandal does not get brushed to one side and forgotten about.
As the hon. Member for Bury South (Christian Wakeford) indicated, new information suggests that valproate will affect their children too. Those mothers who already feel a sense of guilt that their medication has harmed their children now live in fear that it will impact their grandchildren too. Put simply, it is a health disaster that is not going to go away.
Alongside other Members, I recognise the importance of sodium valproate as a drug to control epilepsy. It is crucial for some patients where other drugs have proven ineffective. At no point have I, or the APPG that I co-chair with the hon. Member for Lancaster and Fleetwood (Cat Smith), or INFACT called for it to be withdrawn, but the controls have to be more effective. We have to do better with the pregnancy prevention programme, and we have to do better at providing the necessary information to women of child-bearing age.
The pregnancy prevention programme is just not working adequately. Information to women is not getting through. Drugs are still being dispensed in plain packaging, without the required warning notices. Many women are still highlighting through the media, through campaign groups and to their Members of Parliament that they were not warned, that they have become pregnant and then, only at that point, have they been told of the possible danger to their baby and advised to have an abortion. First-time mums excited at finding they are pregnant are advised to have an abortion. I know that the Minister, my hon. Friend the Member for Lewes (Maria Caulfield), will find that abhorrent.
There are drugs for other conditions where I have seen far more radical and determined pregnancy prevention programmes. I have previously identified Roaccutane, where women prescribed it have to have long-acting contraception and produce a negative pregnancy test before they can collect a monthly prescription, not to mention sit with a consultant and go through a very detailed explanation of foetal abnormalities and be given a form to sign stating they will have a termination if they get pregnant. That might sound draconian in the case of valproate, but it would at least mean that every woman prescribed the drug would have had the risks spelled out very clearly.
For thousands of families, the damage has been done. At this point, I pay tribute to Emma Murphy and Janet Williams of the INFACT campaign group, who are the women who have kept up the pressure on Government. They are the ones who have kept digging for information on what was known by the authorities and how long ago. They are the ones who persuaded my right hon. Friend the Chancellor of the Exchequer, when he was Chair of the Health and Social Care Committee, to launch an inquiry into the use of sodium valproate, which The Sunday Times has described as a scandal bigger than thalidomide. Why is it a scandal bigger than thalidomide? Because it is still happening. Those babies are still being born to parents who have simply not had the level of warning and practical prevention measures that they need.
That brings me to redress and recommendation 4 of “First Do No Harm”. I know that successive Ministers have decided that redress should come via the courts and medical negligence claims, but I would like us all to reflect a little on that and the added strain it puts on families already caring for a disabled child or, in some cases, children—children who we now know can have their death caused by foetal valproate syndrome.
We know that the costs of caring for a disabled child are high. We know that in this cost of living crisis the energy costs for any family living with a disabled child will be higher. We know that in terms of physical effort and mental anxiety it is simply harder to look after a disabled child. We also know, unequivocally, that the dangers of valproate were known the best part of 50 years ago, so it is especially tough and insensitive to suggest to those same families that redress should be via a courts system that is itself under immense strain and subject to delays.
The noble Baroness recommended in her review not only that an independent redress agency be set up, but that there be separate schemes for the three medicines or devices covered. Specifically, recommendation 4 states:
“Separate schemes should be set up for each intervention—HPTs, valproate and pelvic mesh—to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.”
To my mind, the specific relevance here is around the additional care needed, which we all acknowledge, and the bare fact of avoidable harm.
I have three asks of the Minister, and I look forward to her response. The first is for an acknowledgement that sodium valproate has contributed to a death. A young person has died avoidably, and we need the Government to reflect on the very serious conditions that too many babies were exposed to the risk of. What additional controls does she think should be put in place in the light of the knowledge that valproate has caused a young man to lose his life?
Secondly, the pregnancy prevention programme needs to be more effective. Some 200 babies are at risk every year. Is the Minister satisfied that the programme is adequately effective and that the information is properly communicated to women of child-bearing age? If not, what more is she planning to do?
Finally, we need redress. Back in 2019, the disability equality charity Scope reported that a family with disabled children faces average extra costs of £581 a month. That was three years ago. Fuel inflation and food price inflation have increased since then, and the stark reality is that families with disabled children are struggling. These children were, in the words of the “First Do No Harm” report, “avoidably harmed”. It is no sort of redress to suggest that those struggling families resort to the courts.
My suggestion to the Minister, who I believe is dedicated to her job, works extremely hard and can be very persuasive, is the following.
Christian Wakeford
I thank the right hon. Member for giving way a third time. As we know, both Emma and Janet have unfortunately been blacklisted by the Department of Health and Social Care, so if I could be so bold as to suggest another recommendation, it would be that they are never blacklisted again, to ensure that their voices are listened to, and the voices of those children and mothers are constantly heard.
Caroline Nokes
The hon. Gentleman makes an important point, but I am absolutely confident that the Minister will be very pleased to meet both Janet and Emma. I look forward to her agreeing to do so from the Dispatch Box.
My final point to the Minister is this: the Chancellor of the Exchequer, when he was Chair of the Health and Social Care Committee, was incredibly active on this issue. He launched the inquiry when he was still the Chair. His successor, my hon. Friend the Member for Winchester (Steve Brine), is equally committed and is continuing with the inquiry, and both Janet Williams and Emma Murphy will give evidence to the Committee next week. I would like the Minister to use her powers of persuasion and ability to convince the Chancellor of the Exchequer that he needs to keep going on this issue. He is now in a position where he could put in place the finances to allow a redress scheme to be set up. I urge her to persuade him to do just that.