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Foetal Valproate Spectrum Disorder: Fatalities

Volume 724: debated on Wednesday 7 December 2022

Motion made, and Question proposed, That this House do now adjourn.—(Robert Largan.)

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.

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?

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.

I congratulate the right hon. Lady. She takes part in many of the same debates as me, when we often stand together, and we stand together in this one as well. Does she not agree that the fact that up to 20,000 births have been affected by the drug means that we have waited an awfully long time to react to the dangers in pregnancy? That is the terrible lesson that so many have suffered, and it reinforces the fact that we must act on the side of caution and, what is more, admit our mistakes and appropriately compensate those living with the effects of that negligence.

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.

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.

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.

I congratulate the right hon. Member on securing this debate on such an important issue. She is touching on the issue of women currently taking sodium valproate when they are of child-bearing age and the number of pregnancies we are still seeing. While more needs to be done with GPs to ensure that these women understand the risks and that there are pregnancy prevention plans, does she agree that it is important to say that any women listening to our debate this evening should keep taking their medication until they have had that conversation with a GP, because sodium valproate is also a lifesaving drug?

The hon. Lady is absolutely right, and I will come on to say that none of us is advocating that valproate be banned.

Motion lapsed (Standing Order No. 9(3)).

Motion made, and Question proposed, That this House do now adjourn.—(Robert Largan.)

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.

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.

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.

I congratulate my right hon. Friend the Member for Romsey and Southampton North (Caroline Nokes) on securing this important debate on fatalities relating to foetal valproate spectrum disorder. We all know the devastating effect that the drug can have during pregnancy, which is why we took seriously the recommendation in Baroness Cumberlege’s report. I have met the campaigners, Janet and Emma, when I was previously a Minister and since being reappointed—I can confirm that they are definitely not blacklisted by the Department. I look forward to meeting them again shortly to hear the concerns that they still have, which my right hon. Friend set out well this evening.

To reaffirm what the hon. Member for Lancaster and Fleetwood (Cat Smith) said, we all know that sodium valproate can be a highly effective drug that is used to manage and treat epilepsy as well as other disorders, such as bipolar disorder and migraines, often when many other medications do not work or have stopped working. It is absolutely right to say that if a woman is on sodium valproate, it is crucial that they do not stop that medication suddenly but discuss it with their GP.

We know that there are teratogenic side effects that mean that, if taken during pregnancy, sodium valproate can have harmful effects on a foetus and increase the risk of a child being born with physical defects and neurodevelopmental disorders. In relation to the point made by my right hon. Friend the Member for Romsey and Southampton North about possible death, I do not know about that specific case but I am happy to ask officials to go away and look at it, because that would be an important development.

The risk of birth defects following the use of sodium valproate is about 11%, but with a high maternal dose, the risk can increase to 24%. There are significant risks of taking that drug and effects on babies once they are born.

I thank the Minister for the time that she makes available for the subject, which is much appreciated. While she is on the topic of the percentage risk of harm to the unborn baby, at that stage in pregnancy, many women and couples have a very much wanted pregnancy, which is perhaps planned for and longed for, but are suddenly advised by a doctor to terminate it. Does she agree that that tragedy needs to end? We need to come together to ensure that pregnancy prevention plans really work.

I absolutely agree with the hon. Lady, and I will come on to some of the changes that are being made on that point. When I have met Janet and Emma, they have very much represented women who feel that those risks were not explained and that if they had known, they would have been on contraception or spoken to their team about stopping the medication before getting pregnant. Often, those are women with complex epilepsy for whom pregnancy is a difficult enough decision in the first place.

We have known for a long time that the drug should not be used by any woman or girl who can have children, unless they are in the proper pregnancy prevention programme. That is why, in 2018, the programme was introduced to reduce and prevent the number of pregnancies, which was high at the time, in women taking the drug. Being part of the programme means that women are supposed to have an annual review by a specialist, but I have concerns and have heard from campaigners that that does not always happen and is not always the case. There is also the valproate registry, which has now been created so that we can track every woman who is taking that medicine and ensure that the records of when they are prescribed it, when it is dispensed and what is happening to them are followed through, which has never happened before.

The programme is designed to make sure that, each year, those women have a discussion with their health team, so should they wish to become pregnant, they can get that advice there and then. When I was in this post previously, I had concerns about the overview of the register, the annual checks and some of the other safeguards around the dispensing and packaging of the drug, which have been touched on. That is why we have reviewed the programme.

I have met the MHRA, which has taken both campaigners’ and my concerns very seriously. It is looking at the programme, and it will be making an announcement shortly on stronger advice to GPs, but also to pharmacists, about some of the technical issues with dispensing medication, and on some safeguards we need in place so that women—once again, whether they mean to get pregnant or happen to get pregnant—have the advice they need and the reminder on the packaging when they pick up their medication.

The registry tracks all women in England who are taking the prescribed valproate, and it identifies if they become pregnant are accessing care for pregnancy. We can track pretty accurately when pregnancy happens, so we have a handle on how many women are getting pregnant while on the medication. I can reassure the House that the numbers are falling. They are still too high in my view, but they are falling. In the six-month period from April to September 2018 68 women prescribed valproate became pregnant, and from October 2021 to March 2022 that number fell to 17 women. That is still 17 women too many, although we are making progress in reducing that number of pregnancies, but that is why the MHRA is looking at further safeguards for prescribing and dispensing such medicine. It will be making that announcement fairly soon.

A national clinical audit is being undertaken by all community pharmacy contractors, as agreed with NHS England and the Pharmaceutical Services Negotiating Committee, which will measure adherence to current MHRA regulations. The audit will look at whether all patients are provided with a patient card and a patient guide every time the medicine is dispensed. It will also look at whether patients who are supposed to be getting a review every 12 months actually are, and what then happens to them if they are being signposted for additional advice.

I am appearing before the Health and Social Care Committee next week to go through the Cumberlege review on its anniversary and follow up on the progress that has been made. This week, I have met the new patient safety commissioner, Henrietta Hughes, who has also met Janet and Emma, and the issue of valproate is one of her key priorities in her first few weeks in post. I have discussed with her my concerns about its dispensing and packaging, and about the monitoring of women, including whether they are getting the advice they need for a planned pregnancy or, if they are not planning to get pregnant, whether they have had reliable advice and discussion about contraception. I plan to meet the patient safety commissioner on a regular basis to make sure that the measures in place are actually reducing the number of those pregnancies and providing women with the support and information they need.

The Department and the MHRA are consulting on a proposal that medicines containing sodium valproate should always be dispensed in the original manufacturer’s packaging. This would ensure that patients, particularly women and girls of child-bearing age, always receive the patient information leaflet about the medicine they are taking. We will shortly publish a response to that consultation, and we will keep Members updated.

To touch on the issue of redress, it was not one of the recommendations accepted in the original response to Baroness Cumberlege’s report. However, last year I was concerned about the issues, which my right hon. Friend the Member for Romsey and Southampton North raised, for women seeking legal advice and taking on the huge challenge of getting compensation. What we have done as an interim measure is to work with NHS Resolution to launch a claims gateway, so that individual women can go to NHS Resolution and get their individual case looked at and be provided with support if they want to make a claim, without having to go independently to solicitors and lawyers. That has only just started, and we are looking at how effective it is in helping women get access to some of the compensation they feel they need. However, in my conversations with the patient safety commissioner I have asked her to look at what a potential redress scheme could look like. I am not going to make commitments on that from the Dispatch Box because it is not necessarily my decision to make—that would have to be in discussion with the Chancellor—but I am keen to look at what a redress scheme would look like, and I will follow up on that with the patient safety commissioner and see what is possible. I hope I have been able to reassure colleagues.

Will the Minister commit on the Floor of the House this evening that after she has had conversations with the commissioner about the possibilities of the scheme she will talk to the Chancellor or someone from his team about the recommendations and how they might be implemented?

I have had those discussions about what a scheme could look like with the patient safety commissioner only this week. I will need to see the details, but I hope that reassures the House that I am listening to the concerns of parliamentarians and campaigners such as Emma and Janet, who represent a huge number of affected women. I understand the situation they are facing: they have lifetime costs for their children through no fault of the women or the children. They took that medication not realising the effect it could have. We now have that information, but we did not know it at the time. My commitment is that I am exploring options and will update the House on that later.

I want to reassure the House once again that we take very seriously the safety issues around this drug. It is an important drug in the management of epilepsy, and for some women it is the only way of managing their condition, but we need to make sure that women are aware of the implications of taking such a drug during pregnancy, that they are monitored annually to make sure those discussions are ongoing, and that every time their medicine is prescribed and dispensed that message is reinforced. We are reducing the numbers involved, which is great news, but we need to make sure they go even lower, and we need to look at how we support women who have been affected through no fault of their own.

We will be giving evidence at the Health and Social Care Committee next week. I think I am also meeting the hon. Member for Lancaster and Fleetwood shortly, and I am sure other parliamentary colleagues too. I just want to say that I want to support women who have been affected by taking sodium valproate and that we are in listening mode on what more we can do to support them and make sure the help they need and the support for their children are at the forefront of our minds.

Question put and agreed to.

House adjourned.