Valproate and Foetal Anticonvulsant Syndrome

Norman Lamb Excerpts

Thursday 19th October 2017 Commons Chamber

[Norman Lamb (North Norfolk) (LD)]

I beg to move,

That this House notes with concern that there has been a systematic failure to inform women of the dangers of taking the epilepsy drug sodium valproate during pregnancy, resulting in thousands of children being born with congenital malformations, disabilities and developmental disorders since the 1970s as a result of fetal exposure to the drug; welcomes the launch of the Valproate Toolkit by the Medicines and Healthcare Products Regulatory Agency in February 2016 to ensure that women are informed of the potential risks of the drug, but further notes with concern a recent survey which found that 68 per cent of women have still not received these safety warnings; calls on the Government to take immediate steps to ensure that the materials in the Valproate Toolkit are distributed to all prescribing clinicians, pharmacists, and women who are being prescribed the drug; calls on the Government to require all clinicians prescribing sodium valproate to women and girls of childbearing age to discuss annually with the patient, the risks during pregnancy before a prescription is renewed; and further calls on the Government to bring forward proposals for a care plan and financial assistance to the victims of sodium valproate in pregnancy and their families.

I congratulate you, Madam Deputy Speaker, on getting through this debate’s catchy title.

I start by thanking the Backbench Business Committee, on behalf of the all-party parliamentary group on valproate and other anti-epileptic drugs in pregnancy, for facilitating this debate. I also pay tribute to Janet Williams and Emma Murphy, who are present today. They have fought tirelessly on this cause over many years, and we owe them an enormous debt of gratitude.

It is fair to say that “scandal” is an overused word in political discourse, but it is appropriate in this case: a family who have suffered as a result of a mother taking valproate in pregnancy would regard it as an absolute scandal, and we need to treat it in that way. There are many similarities to the thalidomide scandal. A group of women, over many years, took a drug during pregnancy without knowing the risks, with awful consequences, and we owe them a duty—that is the important point.

[Kate Green (Stretford and Urmston) (Lab)]

I apologise to the right hon. Gentleman for not being able to stay for the whole debate.

I, too, pay tribute to Janet and Emma for the campaign they have run. This debate is a great tribute to their efforts. Does the right hon. Gentleman agree that the real scandal is that we have known about the problems with this drug since the 1960s, but, as he says, expectant women were not told? The Government and the pharmaceutical industry knew there were dangers.

[Norman Lamb]

I thank the hon. Lady for her intervention, and I completely agree with her. Interestingly, the original product licence in March 1974 stated this, way back then:

“In women of child bearing age, it should only be used in severe cases or those resistant to other treatments.”

They knew in the ’70s, yet the appalling scandal is that so many women since then have had their life turned completely upside down, with enormous consequences for their children, because they were not told.

[Tim Farron (Westmorland and Lonsdale) (LD)]

My constituent Nicola took sodium valproate through her pregnancy, and her son has chronic fatigue. The impact on her family is immense and expensive. We have fought for, and managed to secure, medical support for her through hospitals in Manchester, but does my right hon. Friend agree that there needs to be a Government fund to ensure that victims have such support, rather than having to rely on their own means?

[Norman Lamb]

I completely agree. I will make the case a little later, but it seems unanswerable and the Government need to reflect on that.

What happened was worse than just the neglect of not telling women. The minutes from the 18 July 1973 meeting of the sub-committee on adverse reactions, a sub-committee of the Committee on Safety of Medicines, have been uncovered. That document reveals a real outrage, because it talks about keeping the information from women—deliberately withholding it

“especially as it could give rise to fruitless anxiety.”

It continued:

“Nevertheless, they thought it would be best if prescribers were all made aware of the nature of the evidence and recommended that a statement similar to that proposed by ICI”—

in respect of another product—

“could be included in all relevant data sheets but not on package inserts so that there would be no danger of patients themselves seeing it.”

That is extraordinary.

[Martin Whitfield (East Lothian) (Lab)]

Would the right hon. Gentleman share my great disappointment if the original documents were to go missing from the archive while these debates and this campaign are ongoing?

[Norman Lamb]

I thank the hon. Gentleman for that intervention. Issues such as this are of enormous concern and this raises the question whether there needs to be some sort of inquiry or Hillsborough-style panel to look at exactly how it has happened. However, it is important that we focus on the top priority, which is ensuring that women get told, that this drug is not used inappropriately and that a compensation package of some sort is put in place.

[Mr Ben Bradshaw (Exeter) (Lab)]

Given what the right hon. Gentleman has said, is it not even more extraordinary that, even now, this information and these warnings are not getting through effectively to pregnant women and their families? My constituent David Tout’s son has been affected by this, as have 20,000 children across the country in every one of our constituencies. There is no sense of urgency from the MHRA—Medicines and Healthcare Products Regulatory Agency—or from the Government.

[Norman Lamb]

I thank the right hon. Gentleman for that, and he is right in what he says; I, too, feel that there is a sense of inertia. For goodness’ sake, for as long as women are not getting told about this, more such babies are being born. That is the awful horror of this.

[Dr Philippa Whitford (Central Ayrshire) (SNP)]

Many of us in the House have been approached by constituents or groups about several of these drug scandals, which represent a paternalistic time, when the patient was not part of a team in an open discussion with the doctor. I am sure there are many of these, so should they be looked at together, as the principles of them all are the same?

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[Norman Lamb]

That is a profound comment to make and it reflects a changing attitude and culture; it is thankfully now less paternalistic than it was. However, elements of it remain and we need to keep fighting against that. The hon. Lady makes a good point: this relates to other products, too.

[Cat Smith (Lancaster and Fleetwood) (Lab)]

rose—

[Norman Lamb]

I will take this intervention and then I ought to make progress.

[Cat Smith]

Is the right hon. Gentleman aware of research done by the Independent Fetal Anti Convulsant Trust—In-FACT—which found that up to 400 babies affected by valproate have been born since the toolkit was launched in February 2016?

[Norman Lamb]

I thank the hon. Lady for the intervention. I am aware of that figure and again it is shocking. It makes the point that this is a continuing scandal, not something from the dim and distant past.

Since the 1970s, more information has emerged bit by bit. In 2000, the information given to patients was changed to refer to the warning, but it took until then for anything to emerge. In 2005, Sanofi made an addition to this, and an interesting question is whether it downplayed the risk. That is one point that raises the question whether some sort of panel investigation needs to take place. In 2005, Sanofi said on its warnings to patients:

“Some babies born to mothers who took Epilim during pregnancy may develop less quickly than normal and may require additional educational support”.

That is putting it at its mildest, because the implications were far more serious. The question is, did it know then? These things need to be investigated further.

It is important to state what the risks are. Among the general population there is a 2% to 3% risk of foetal abnormality. If valproate is taken during pregnancy, that risk rises to 11%, and possible defects include spina bifida; malformations of the face, including cleft palate; malformations of the skull, limbs and organs, including the heart; and respiratory issues. It is incredibly important not to disregard the fact that when people take valproate during pregnancy there is also a 30% to 40% risk of developmental problems, including life-changing issues such as poor speech and language skills, delayed walking and talking, behavioural problems, interaction and communication issues, low intellectual abilities, memory problems, noise sensitivity, sensory issues, attention deficit hyperactivity disorder and autism spectrum disorders. The consequences are incalculable. It is estimated that 20,000 babies have been affected since the 1970s. It is also important to remember the profound impact on the mothers themselves, who too often have been treated as if they are to blame for the problems their children face and who then face years of guilt. That is a really shameful aspect of all this.

I have some case studies. Becky Parish, a mother from my own county, Norfolk, says:

“Logan is 7 and was born with a 7 mm unilateral cleft lip and palate…which the geneticist confirmed was due to Fetal Valproate Syndrome…He also has grommets and struggled with glue ear and bronchitis as a baby”.

He has needed “constant speech therapy” and suffers ear infections.

Becky describes how Logan

“has all facial features of FVS”

and is short in height and low in weight for his age. He has

“severe aggressional and destructive behaviours, including violence against others and self-injurious behaviours”

and so it goes on. This is really significant. There is sometimes a danger when we talk in general or abstract terms, but when we hear the stories of the affected families, we realise just how awful it is.

Becky says “social”—social services—“blamed me for it”. Her assertion is that in her case social services thought that the problems related to a detachment disorder, with the implication being that the mother was in some way to blame. She says:

“Social blamed me for it and so did the school—and now I feel more guilt due to it being FVS. Because no matter how much someone says I didn’t know and it wasn’t my fault, the guilt never goes away. And sadly it never will.”

That is really shocking.

Becky decided not to continue with valproate when she became pregnant with her youngest child, who is now five. She says that it was not a difficult decision, because in her view her child’s health was “far more important” than her own seizures, but that must have been a terribly difficult judgment for her to make. Nevertheless, she stopped straight away and was not put on any alternative treatment, despite conflicting messages from health professionals. Her specialist nurse told her that—wait for it—she was being selfish, and made her upset at her 12-week scan. However, her neurologist said that coming off the drug was the best thing she ever did. So she got two completely conflicting messages.

Carolyn Allen in Southampton talks about how her son requires support for a number of the effects of the condition, including deafness in his left ear, noise sensitivity, and speech and language delay. She says:

“He has been referred to portage, speech therapy, occupational therapy, ophthalmic, hearing clinic, physiotherapy, community paediatricians and has already had one operation to release his tongue tie.”

Just imagine the massive impact of this condition on that family.

Paula Hartshorn, a mother from Leeds, says:

“The powers-that-be need to think about the devastating impact this has on families, and how these families have to just cope and instantly know how to deal with all these complex medical issue. We have been left to give up on our jobs, careers, social interactions, and everything that goes with a well-rounded life. There are no breaks for us.”

The stories are heartbreaking.

Kazzy Southam from Blackpool tells a story of not finding out about the condition until her daughter was nearly 20. Her voyage of discovery began when she met Janet and Emma in 2014. This was after her daughter had been diagnosed with learning disabilities, dyspraxia, and social anxiety disorder. She had to fight to get a geneticist to investigate and give advice. Eventually, it was confirmed that her daughter had foetal valproate syndrome. It was a shocking fight for her to get justice, and she should not have had to go through that. She says:

“To me, she is an angel and I wouldn’t change her for the world. She said to me not long ago: I wouldn’t want to be ‘normal’—I like my mad head. But it hurts me to say, she doesn’t and won’t know any different—all down to the pills I took for my seizures.”

I ask Members to imagine living with that throughout their life. The Minister really needs to reflect on this. It seems to me that the Government have an obligation to do good by these people and not just to say that they must resort to the local authority or the clinical commissioning group for whatever might be available in their locality. There is a moral duty here and we must accept it just as we did with thalidomide.

I became aware of this scandal when I was a Minister and met the campaigners in September 2013. I was horrified by what I heard, having known nothing about the condition until then. I asked the Medicines and Healthcare Products Regulatory Agency, which attended the meeting, for an urgent review of what was being done to stop more and more mothers giving birth without knowing of the risks. In October that year, the MHRA asked the European Medicines Agency to undertake a full review. That review reached the conclusion—it was very little different from what the product licence said back in 1974—that the product should be used only if all other drugs are ineffective or are not tolerated. It also advocated a strengthened warning to ensure that all mothers were aware of the issue.

In January 2015, the MHRA issued new information with stronger warnings, education materials, patient information leaflets and so on. Eventually, in February 2016, the toolkit was issued: I have it here. It may not look like a toolkit, but it is. It is of value, because it gives information to clinicians and patients about the risks involved. Again, the scandal is that the information has not been communicated to very many of the affected women.

In September this year, a survey carried out by the UK’s three leading epilepsy charities—Epilepsy Society, Epilepsy Action and Young Epilepsy—found that the warnings were not getting through. Some 68% of women of childbearing age had not had any of the materials released as part of the valproate toolkit. That is not acceptable.

[Kate Green]

I thank the right hon. Gentleman for accepting a further intervention. He is making a very powerful case. The hon. Member for Central Ayrshire (Dr Whitford) mentioned the paternalistic approach that the medical profession has perhaps taken in the past. Is he as shocked as I was to learn that that paternalistic approach was still in evidence some two years ago when I met the pharmaceutical company Sanofi to discuss getting information out to mothers? The company told me that it would be inappropriate to make the information available, as it was unsupported by detailed advice from doctors. Of course it is important that women should be able to discuss the matter with their clinician, but they are able to understand and interpret intelligence, too.

[Norman Lamb]

I thank the hon. Lady for her intervention and pay tribute to her for her work on the all-party group for valproate and other anti-epileptic drugs in pregnancy, and for her campaigning. Yes, the response she got from Sanofi two years ago was unacceptable. It had the effect of hiding from women the full extent of the risk. Women should be presented with the evidence so that they can have a full discussion with the clinician about what steps to take. The September 2017 survey also found that 18% of women did not know of the harm—it was not that they had not received the toolkit, but that they still did not know. The system is failing those women.

[Huw Merriman (Bexhill and Battle) (Con)]

I stand here as an advocate for my constituent, Ms Carol Short, who describes her son as a 26-year-old locked in a man’s body, but unable to do much more than a 10-year-old. Does the right hon. Gentleman agree that it is shocking, with the clinical commissioning groups and all the funding that comes from the public sector, that we still cannot get this message through? Might one solution be shorter length prescriptions, to increase the likelihood that women receive more regular advice?

[Norman Lamb]

That suggestion is worth exploring. There certainly should be regular reviews—discussions on the woman’s intentions about childbirth, and on the appropriateness of the treatment for that woman at that place and time.

I acknowledge an important danger. If all the focus is on the risk of valproate, there is a risk that women will simply give up and take no medication during pregnancy, and that there will be a rise in unexpected deaths through epilepsy. SUDEP Action raised that really important issue. Already, every year, 1,200 people die sudden unexpected deaths in epilepsy, and of that total SUDEP Action estimates that about 42% are avoidable. We definitely do not want any increase in that number. For me, that points to the need for all women—indeed, all people—with epilepsy to have access to specialist teams, wherever in the country they live. My worry is that access is haphazard and variable.

Last Friday I met a specialist team in Norwich. It is a very good team, and they explained to me how they have managed to reduce the use of valproate by women in the childbearing years to a very small number. They say it is only a very small subset, for whom there is no alternative. Thus they can focus all their attention on those women. They said that there is considerable variability around the country—that many women do not get access to a specialist team. I would like the Minister to commit to the publication by the Government of data for every CCG showing the level of prescribing of this medication, to enable us to pinpoint where over-prescribing is taking place.

The interesting and rather concerning point is, if those specialists that I spoke to are right that only a very small subset of women of childbearing age need to take valproate, why is it that still, of the 173,787 people with epilepsy taking valproate, 17,848 are women of childbearing age? That looks like substantial over-prescribing, which is completely contrary to the current guidance. If the guidance is clear that it should not be prescribed to women of childbearing age unless there is no alternative that is safe for the individual woman, why on earth are so many women still being prescribed this medication? It is a scandal, and the Government need to get to grips with it.

We need a holistic approach, so that women have access to specialist care and so that full consideration can be given to the right arrangements to ensure that no woman is on valproate who need not be during those years of childbearing age. Then we might start to see an end to this awful continuing scandal.

Finally, I shall outline the steps that the Government and others should take. First, the toolkit must reach everyone. It must surely be mandatory, not voluntary. Given the clear evidence from the survey of the number of women who are not getting the message, we cannot rely on the current system to work, because it is not working. As the hon. Member for Lancaster and Fleetwood (Cat Smith) said, 400 affected babies have been born since it was introduced. That cannot continue; the warnings must be mandatory, along with raising awareness among GPs, pharmacists, specialists, midwives and health visitors.

Secondly, people should have an annual discussion with their GP or another health professional. The Epilepsy Society has argued that that should happen, and it is very much consistent with the valproate toolkit, which highlights the need for regular review. There should be face-to-face discussion with a health professional before the prescription is renewed.

Thirdly, all women should have access to specialist units, wherever they live. We must end this haphazard, variable position around the country, and we must address fully the concerns raised by SUDEP Action. Professor Ridsdale, a consultant who has specialised in this area of policy, says:

“A useful outcome of this exercise would be that whoever prescribes Valproate agrees to identify and provide regular advice to women and girls at risk. Better still, that policy-makers and providers start exploring how ongoing structured self-management advice might be offered to everyone with epilepsy.”

That is surely the ambition we should set.

Fourthly, we should publish the prescribing rates for valproate for every CCG. The Government say they have a commitment to openness, and this would be a good demonstration of it, because we would be able to identify where the real problems exist and where women are not getting access to good enough advice.

Fifthly, we should ensure that only those women who absolutely have to take valproate do so during their child-bearing years, in accordance with the advice, and that we end what appears to be the significant over-prescribing of this medication for such women.

Sixthly—this comes back to some of the interventions that have been made, including by my hon. Friend the Member for Westmorland and Lonsdale (Tim Farron)—there must be a financial support package. In a way, that comes down to the Government’s duty to these people. This has gone on for many decades, so my point is not directed just at this Government, but they have the responsibility here and now to do right by these people. There is an overwhelming moral case for them to do that, and it is not good enough for Ministers to simply say that support is available locally through local authorities or CCGs. These families have suffered an injustice, and the Government have a moral obligation to address it. If it is right for thalidomide victims, it is right for those who have lost out severely as a result of valproate. In France, a €10 million initial fund has been established, and it could be increased. The Government need to take the same step in this country.

Seventhly, there must be a statement of regret or apology for the people who have been let down by the system so very badly.

Finally, there is a case for an inquiry or a Hillsborough-style panel so that we can understand how on earth this outrageous scandal could ever have happened, how it has gone on for so many decades, letting down so many families, and what lessons can be learned to ensure that this never, ever happens again.

[Several hon. Members rose—]

--- Later in debate ---

[Mims Davies]

I thank my hon. Friend for her intervention. Many of us have constituents, friends or family who are affected by epilepsy, which, in itself, is very serious, or by bipolar disorder. Appropriate use remains very important. For the vast majority of patients, treatment can be effective and useful if it is done right—if managed, if educated and if understood. The argument, therefore, should not be about ceasing use, but about telling the truth and looking at appropriate use during pregnancy. Men use the drug too, so we need to take a balanced approach and reflect all situations.

[Norman Lamb]

The hon. Lady is making really good points. I totally agree with her that the drug is appropriate for most people. I just want the guidance to be followed. The guidance is clear that for women of childbearing age it should not be used unless there is no alternative. We just need to stick to that guidance and make sure it is implemented everywhere.

[Mims Davies]

Absolutely. Speaking about this issue in this Chamber will empower our women constituents, before and during pregnancy, so they can be informed and make the right choices. That is the outcome we should all be hoping for.

Similar issues were raised yesterday during a debate in Westminster Hall on mesh implants. New mothers in particular had taken the advice they were given without hesitation. A woman’s first pregnancy can be an unsettling time with all the changes their body goes through. I would imagine that for people suffering from epilepsy or bipolar disorder that time is even more nerve wracking. It is absolutely right that we are measured when we talk about these issues.

It is important that our specialists ensure that women are given the correct and proper guidance. Patients need knowledge and they need it more than anyone. They live with the consequences if things go wrong and they will always look back on their decisions. If they have not been given the right information, how can they truly know they have made the right decision for themselves and their family? Siblings are often impacted as well.

The Government and MPs have a really important role to play in raising awareness of medical issues during pregnancy, including those concerning sodium valproate. I recognise the efforts that have been made, with labelling on packages. I am sure the Minister will agree, however, that more needs to be done. This drug, introduced in 1974, has been crucial, but support for families affected is also crucial. I welcome the fact that young people who have been affected are to be included in the new framework for health and social care for children and young people. It has been a real battle, but clinical commissioning groups and local authorities are getting to grips with it. It is really important that they receive support on a local level. I welcome the Minister’s forthcoming meeting with the all-party group, and I know that Ministers are taking this matter seriously, but I ask the Department for assurances on similar health issues affecting women, such as those relating to Primodos and mesh implants. We have moved to an incredible place on blood contamination—some of my constituents were affected by that—and constituents have written asking me to raise this issue too. We want more action, and there is a common denominator.

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[Liz McInnes]

That was probably the first research paper to suggest that it was not just coincidence and that there was a causal relationship, which is why it is seen as definitive.

The pharmaceutical company Sanofi, which many Members have mentioned, has stated that it has kept in line with scientific knowledge when reporting side-effects in a foetus. However, from as early as 1983 the CSM and the MHRA reported the problems caused by taking sodium valproate in pregnancy, but did not insist that Sanofi issue warnings in the form of a patient information leaflet.

Even now, to this day, epilepsy charities report that women are not aware of the potential risks when taking the drug in pregnancy. A survey has shown—I know it has already been mentioned, but it does no harm to reinforce these findings—that 18% of women taking sodium valproate were not aware of the risks during pregnancy, and 28% said that they had not been informed of any risks. That is despite the production by the MHRA of a valproate toolkit designed to help healthcare professionals to talk to women with epilepsy about the risks of taking valproate during pregnancy.

[Norman Lamb]

The hon. Lady is making an incredibly valuable contribution to the debate. Does she agree that if it is clear during a period of time that the amount of a drug that is being prescribed is significantly more than the guidance suggests is appropriate, it is not acceptable for the drug company, the regulator and the Government simply to be passive and to allow that to continue? If we knew that this drug was being over-prescribed, which appears to be the case, why on earth was action not taken?

[Liz McInnes]

That is a very good point, and if we manage to establish an inquiry, it should look into the issue of over-prescribing.

I want to mention other agencies. The European Medicines Agency has also recommended a strengthening of measures to reduce the risk of harm to babies born to mothers taking valproate. Information from the House of Commons Library outlines a situation in France, which has already been referred to, with an estimate that between 425 and 450 children were affected by birth defects attributable to valproate from 2006 to 2014. The French Parliament this year voted to set aside €10 million for claims related to valproate. The Health Minister, Marisol Touraine, described this as a “starting point” and stated that compensation would ultimately be paid by those deemed responsible:

“I regret that Sanofi didn’t seek an amicable settlement as a matter of principle. I hope Sanofi will change its position.”

Sanofi had no comment to make on the Minister’s remark. A class action has also been brought by the French association for people affected by sodium valproate against Sanofi.

In the UK, in 2004 a class action was brought by a group of families under the Consumer Protection Act 1987, which was expected to go to trial in 2011, but the litigation was discontinued prior to this after the Legal Services Commission withdrew funding. It is disappointing that this Government have said that there are no current plans to introduce a compensation fund similar to that in France, and I urge them to reconsider.

I fully support the remedial steps outlined in the motion, including the call for an inquiry, and this Government must bring forward a care plan and financial assistance for the victims of this national scandal.

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[Dr Philippa Whitford (Central Ayrshire) (SNP)]

I, too, pay tribute to the right hon. Member for North Norfolk (Norman Lamb) for securing this debate and trying to air this issue again. Epilepsy affects 1% of the population—600,000 people—and it is not a trivial condition. It is dangerous. As we have heard, 1,200 people a year die due to epilepsy, and we must not diminish that fact. At the lowest level, someone who has a fit after being well controlled suddenly cannot drive again, which can have quite a big impact, but at the other end of it there is death. We therefore must be careful not to send out a message that anti-epileptic drugs are bad, or even that Epilim is. It works really well, and it is one of the drugs that often can control the most dangerous seizure—the tonic-clonic or grand mal, as it used to be called—without the use of other drugs.

Almost all anti-epileptic drugs carry risk. Sodium valproate is the worst by far, but all the ones we have heard of in the past—phenytoin, phenobarbital, primidone and carbamazepine—carry some risk. We therefore have to recognise that it is not just as though the doctors prescribed the wrong drug. This condition is really hard to deal with, and we need people to have specialist input. We are really asking that from when girls reach puberty until they reach menopause or get into their 50s—when there is no risk of them having children—decisions are made with them by specialists.

As we have heard, there was obviously a recognition right back in the ’70s that sodium valproate could bring about congenital abnormalities, but what appears to have changed is the scale. If we look back, we see that people used to discuss a 2% risk of malformation and “some possibility” of developmental delay. We are now talking about 10% of children having a birth defect, which might be something like a minor cleft palate that can be dealt with, right through to spina bifida, meaning the child faces major physical disability. On a much worse scale, some 40%—almost half—of children face some form of developmental delay, which might mean an autistic spectrum disorder, learning difficulty or ADHD. That is a big change.

We heard earlier about the 1995 paper that started to bring these cases together. Before that, there were predominantly case reports—someone saying, “Oh, this is odd; I’ll write it up”—but we needed someone to bring things together. When we hear that 400 affected babies have been born in the year since the recent attempt to deal with this issue, we realise that had the yellow-card reporting system been working when we had perhaps 500, 600 or 700 cases a year, the situation would have been spotted much more quickly.

The system utterly failed to recognise a pattern and has to be reformed. If a woman gives birth to a child with a birth defect, or there is in the very early years recognition of some kind of major developmental delay, and she is on a drug, that should be reported, and I do not care what the drug is. Her GP may never have seen such a thing before and might not recognise that there could be an association, but someone sitting in the MHRA who is receiving 400 or 500 reports certainly ought to.

The obvious question is how to tackle this issue. The toolkit was put out in February 2016, because we have recently recognised the huge scale of the problem—the change is the recognition of the scale. It is therefore shocking and incredibly disappointing to hear that more than two thirds of women have not received any part of it. It is great that there is now some marking on packaging, but perhaps more of that needs to be combined, because we then do not have to depend on people remembering to hand something out or to pick something up. We would be empowering women to say, “Oh, what’s that? You’ve never talked to me about that,” and both sides would have the chance to have a discussion.

We have predominantly focused on the results of using sodium valproate during pregnancy but, as the hon. Member for—

[Norman Lamb]

Strangford.

[Dr Whitford]

Sorry. I am not doing very well today. Six hundred and fifty names is hard enough; adding another 650 constituencies just does my head in!

As the hon. Member for Strangford (Jim Shannon) mentioned, by the time a women is pregnant—crucially, by the time she knows she is pregnant—it is too late, because these abnormalities happen in the first trimester: those first two months when the brain and spinal cord are forming and the arches of the face are combining. That is why we particularly see neural tube defects, brain function abnormalities and cleft palate. Many women who lead hectic lives may already be two months pregnant by the time they finally know, and that means it is too late. That is why the annual review is important.

Epilim is perfectly fine for a girl to use if it gives good control for grand mal seizures, but we need to flag up the fact that when she is expected to be approaching puberty, discussions need to start with her and her family. Family planning is important for all women, but for women on these kinds of drugs, which must be stopped in pregnancy, it is crucial. We need to have that discussion so that the alternatives can be considered. I echo the comment that if a woman is pregnant and did not plan for that, she should not stop the drug on her own. She should have emergency access to a specialist who is able to look at her type of epilepsy and discuss the options with her, such as whether it would be safe to take nothing or if it would be better to change to something else. It should be recognised that uncontrolled seizures in pregnancy can cause the loss of the mother and the baby. We must not have any kind of irresponsibility by not flagging that up.

We had a debate in this Chamber last week on baby loss. It was a very powerful cross-party debate on the anguish that people face, whether it is due to early miscarriage, stillbirth or neonatal loss. We talked about that loss and bereavement, but any of us—male and female—who have had children know of the expectation and joy that comes from waiting for a child. There is still exactly that bereavement when we know that our child will face a life of physical and mental difficulties, and of learning disabilities. We know that a child with a marked learning disability has only a 7% chance of working. For the parents, there is the stress of knowing that there will come a point when they are not there, and of wondering how their child—perhaps now a young adult—will actually survive facing a harsh world.

Financial support is absolutely crucial to give families peace of mind. We need an inquiry, but rather than holding multiple inquiries, we should recognise that bringing some of these common themes together into one would be a much more powerful way to get people to understand that we are talking about relentlessly repeating patterns. Let us try to reform the things that allowed this to happen and to ensure that we support the families and the children to whom, sadly, it has happened.

--- Later in debate ---

[The Minister of State, Department of Health (Mr Philip Dunne)]

I congratulate the right hon. Member for North Norfolk (Norman Lamb) on securing this debate through the good offices of the Backbench Business Committee. He has, as he indicated, taken a particular interest in this issue since it was brought to his attention during his time as a Minister in the Department of Health, and all tribute to him for being so persistent in that endeavour.

This is a very important issue. Members on both sides of the House have come together once again—for two weeks in a row, as the hon. Member for Central Ayrshire (Dr Whitford) pointed out—to demonstrate their concerns. Those are not party political; these issues affect all our constituents, irrespective of any party political alliance.

We have had some very constructive suggestions on both sides of the House, and we have heard a number of the personal cases that constituents have brought to the attention of Members, which has been very moving. Rather than rehearse them, I will just point to my hon. Friend the Member for Congleton (Fiona Bruce), who went into some detail, as the hon. Member for Washington and Sunderland West (Mrs Hodgson) said, about the particular circumstances of the two outstanding campaigners—I am pleased they are here to witness this debate—who have spoken so powerfully about the effects that valproate has had on their lives and those of their children. Like other hon. Members, I have very great sympathy for those families who have been affected by valproate use in pregnancy.

The Association of British Neurologists advises that valproate remains the most effective treatment for generalised epilepsy, and this is reflected in NICE guidelines. For some women with epilepsy, it may be the only effective treatment—the only thing that prevents a potentially life-threatening seizure. However, because of its risks, valproate should be used to treat women of child-bearing age only if other drugs are ineffective or not tolerated. This is not a clear case of use or no use, as was clearly pointed out by the hon. Member for Central Ayrshire, who speaks with authority on these matters.

The key challenge for clinicians is to ensure that the drug is used only by those who really need it, that they are fully informed about the risks and that their treatment is closely monitored.

[Norman Lamb]

Does the Minister share my aspiration that we should be aiming to ensure that every woman, wherever they live, has access to a specialist unit?

[Mr Dunne]

I will come on to how access—and monitoring—needs to be improved.

As my hon. Friend the Member for Eastleigh (Mims Davies) acknowledged, it is vital that no woman stops taking valproate, or any other anti-epileptic, without first discussing it with their doctor and, if necessary, with the relevant specialist. The Medicines and Healthcare Products Regulatory Agency is currently working with European regulators, and with experts and healthcare bodies, to decide what further action should be taken. Like many anti-epileptics, valproate has always been known to carry a risk if taken during pregnancy. However, as hon. Members have pointed out, important questions have been raised, here in the Chamber and elsewhere, about the extent to which women have been informed over the decades about the risks.

At the time that valproate was first marketed in 1974 for the treatment of epilepsy, animal studies had shown that there might be a risk of birth defects. Health professionals were made aware of this and were expected to weigh the benefits against the risks. Difficult prescribing decisions had to be made. Campaigners have highlighted, as did the right hon. Member for North Norfolk in his opening remarks, the minutes of a meeting of the Committee on Safety of Medicines in 1973 where the Committee concluded that it would be best not to mention the risk of birth defects in package inserts. As has been said today, this paternalistic attitude has no place in the NHS of today. Now, patients and doctors are expected to make decisions based on open communication on the risks and benefits of a treatment, which is underpinned by legislation. However, that was not always the case, and the views expressed by the CSM in 1973 were not unusual at that time, particularly in relation to life-saving medicines such as anti-epileptics.

I am pleased to say that medical practice has changed considerably since then. Comprehensive patient information leaflets have been a legal requirement since 1999, and warnings have been issued when new evidence on risks has become available. The MHRA issued bulletins in 1983 and 1993 to update prescribers on the risk of birth defects, and in 2003 warned about a possible risk of developmental delay in children exposed to valproate during pregnancy. Warnings were extended to include a risk of autism in 2010, and a reminder bulletin was issued in 2013. Information on the full magnitude and nature of the risks with valproate first became available in 2013, following a long term follow-up of children whose mothers had taken valproate and other anti-epileptics.

Given those concerns, the MHRA initiated and led a Europe-wide review which completed in November 2014. The review found that there was still a clinical need for valproate despite the significant risks to the child if taken in pregnancy, and that it should remain an option for women of childbearing potential only where other treatments had failed or were not tolerated. To mitigate the risks, the recommendation was that women should use effective contraception and treatment should be supervised by a specialist. In January 2015, the MHRA sent a letter to doctors and pharmacists about the strengthened restrictions. As well as updating statutory information, the MHRA has developed the valproate toolkit referred to by hon. Members.

Although I am not allowed, quite properly, to use props while I am at the Dispatch Box, I cannot resist pointing out to hon. Members that the warnings now on valproate packaging include the following very specific warning:

“Warning for women and girls: This medicine can seriously harm an unborn baby. Always use effective contraception during treatment. If you are thinking of becoming pregnant or you become pregnant, talk to your doctor straight away.”

In addition to that warning on the packaging, there are other elements in the toolkit. I will not trouble the House to read them out, but they include patient cards, information for patients, and information for prescribers and clinicians. The toolkit was distributed to doctors and pharmacists in February 2016. Messages sent through different channels then and subsequently have reinforced the recommendation of its use to support discussions with patients.

In view of the importance of the issue, in the autumn of 2015 the former Minister for Life Sciences brought together healthcare bodies to support the promotion of the toolkit and ensure that there was co-ordinated messaging to health professionals and patients. The MHRA further developed that group into a 39-strong stakeholder network of health system organisations, health professional bodies, charities and campaign groups, which include In-FACT, FACS-Aware, the Organisation for Anti-Convulsant Syndrome, Epilepsy Action, the Epilepsy Society, the Royal College of General Practitioners and the Royal Pharmaceutical Society.

Our communications strategy has been informed at every step by the valproate stakeholder network, including NHS England. In response to concerns about gaps in awareness that have been identified by several Members in today’s debate, in July of this year the toolkit was redistributed to GPs and specialist prescribers, and additional materials were distributed to pharmacies. More than 100,000 healthcare professionals received the toolkit this year.

What are we doing beyond that? We are tracking changes in prescribing. Data show that between 2012 and 2017, there has been a decline of approximately 26% in the number of women of childbearing age treated with valproate. The decline is sharper among 10 to 17-year-olds. Although usage is declining, there has not been the step change that we would want, and, as has been mentioned today, the results of surveys of patient awareness of the risk clearly indicate that more needs to be done.

I am aware that campaigners have called for the use of the toolkit to be made mandatory. The MHRA and NHS Improvement sent out a patient safety alert in April 2017, which directs organisations systematically to identify women and girls taking valproate and to support them to make informed choices. MHRA and NHS Improvement are monitoring the implementation of the alert and are following up directly with relevant organisations. That action has been taken consistently across the UK and through the devolved Administrations.

The MHRA is fully involved in the new Europe-wide review to look into whether further restrictions are needed. An expert working group of the Commission on Human Medicines, a committee of the MHRA, has been convened to inform the UK’s position during the EU review, which is expected to conclude early in the new year. This review is also looking carefully at whether there is any evidence of adverse effects in babies whose father took valproate. I am sure the whole House was moved by the personal testimony of the hon. Member for Bury North (James Frith) about the consequences of childhood meningitis and his six years on valproate to control epilepsy.

I hope I have made it clear that we are taking the matter seriously. I have enormous sympathy for those families who have been affected by valproate use in pregnancy. In the short time that I have available, I want to touch on a couple of the issues raised by the right hon. Member for North Norfolk. He talked about support, and we have an established system, reinforced by the Children and Families Act 2014, to establish a new framework for local authorities and CCGs to secure services for children and young people who have special educational needs or disabilities.

I will not get into the question of compensation or an inquiry here. What I will say to the right hon. Gentleman is that a meeting has been arranged for the chair of the all-party group with my Lords colleague the Under-Secretary of State for Health, and the issues that the right hon. Gentleman has raised should be brought up at that meeting. I encourage other members of the all-party group to join him in that meeting at the Department.

I will look at the feasibility of extending the yellow card system, as hon. Members have described. I think it is right that we shine the spotlight of transparency to improve patient safety. No Government have done more than we have to make that happen in other areas, and the victims of valproate deserve nothing less.

[Norman Lamb]

I sincerely thank all right hon. and right hon. Members for participating in today’s incredibly well-informed, responsible and powerful debate. This is a fight for justice. The Minister is right that we have a meeting planned for 7 December with his colleague the noble Lord O’Shaughnessy, and I hope very much that by then, the Government will have reached a view on the case for compensation. The Government have a choice: they can either deny the unanswerable moral case for treating these people properly, or they can take the moral lead and accept that the state has a responsibility to these families. I hope very much that they do the latter.

Question put and agreed to.

Resolved,

That this House notes with concern that there has been a systematic failure to inform women of the dangers of taking the epilepsy drug sodium valproate during pregnancy, resulting in thousands of children being born with congenital malformations, disabilities and developmental disorders since the 1970s as a result of fetal exposure to the drug; welcomes the launch of the Valproate Toolkit by the Medicines and Healthcare Products Regulatory Agency in February 2016 to ensure that women are informed of the potential risks of the drug, but further notes with concern a recent survey which found that 68 per cent of women have still not received these safety warnings; calls on the Government to take immediate steps to ensure that the materials in the Valproate Toolkit are distributed to all prescribing clinicians, pharmacists, and women who are being prescribed the drug; calls on the Government to require all clinicians prescribing sodium valproate to women and girls of childbearing age to discuss annually with the patient, the risks during pregnancy before a prescription is renewed; and further calls on the Government to bring forward proposals for a care plan and financial assistance to the victims of sodium valproate in pregnancy and their families.