Below is the debate that has just been brought up in Parliament and noted myself and colleague Janet as Government Campaign Groups for Fetal Anti Convulsant Syndrome (FACS)
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Fetal Anti-convulsant Syndrome
Anas Sarwar (Glasgow Central) (Lab): It is a pleasure to serve under your chairmanship, Mr Hollobone. I am delighted to have secured this important and topical debate after months of bad luck in the ballot. The House will adjourn for the Easter recess today, and I appreciate the effect of that on the number of participants. As hon. Members have other commitments in their constituencies, the turnout is lower than it would have been had the debate taken place at a more convenient time, so I am grateful to colleagues who have made it here.
Members who watched the recent BBC “Inside Out” programme will recognise the timeliness of this debate, because new expert medical research has highlighted the dangers of anti-convulsant medication to pregnant women and their unborn children. Before we get into the debate, I will provide a bit of background information on fetal anti-convulsant syndrome and the Independent Fetal Anti-Convulsant Trust.
Fetal anti-convulsant syndrome is a medical condition that arises among the children of mothers who suffer from epilepsy and take a type of drug known or used as an anti-convulsant medication to treat their condition during pregnancy. Not all children who are exposed to anti-convulsant drugs are affected. The level of risk is determined by known factors, such as the particular anti-convulsant medication used and the dose taken, as well as other susceptibility factors. Children suffering from fetal anti-convulsant syndrome suffer from a constellation of physical and neuro-developmental deficits, and so have to be diagnosed by a medical specialist.
The Independent Fetal Anti-Convulsant Trust was launched in November 2012 to gather information and provide support and assistance to those affected by the condition. It is run by a small, hard-working team of volunteers, a couple of whom are in the Gallery today. I would like to put on record my thanks to the entire team, and especially to Janet Williams, who has done a fantastic job in providing me and many other hon. Members with so much invaluable information. I would urge anyone who suffers from the condition, or who has a relative or friend with it, to contact the trust.
It is difficult to get an accurate picture of the number of people affected by the condition; in response to a parliamentary question to the Department of Health on the number of women receiving anti-epileptic drugs through the NHS, I was unfortunately told that the information was not available centrally. Things are made even more difficult by the fact that many children with the condition will not have been diagnosed with the syndrome because they do not have a major congenital malformation, such as a heart defect or spina bifida. Those children are less likely to be referred to a clinical geneticist.
Sodium valproate is the drug that reportedly carries the largest risk of causing fetal anti-convulsant syndrome. According to prescription records, there were more than 21,500 women taking sodium valproate in 2010 in England and Wales alone. A range of scientific studies conducted over the past couple of decades have demonstrated that some 10% of children exposed to sodium valproate will be born with a major congenital
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malformation. Their IQ is likely to be lower than it otherwise would have been, with 29% requiring additional educational support and 6% being diagnosed with significant social communication difficulties, such as autism.
More broadly, there have been numerous case reports in medical journals of children born with one or more major birth defects when the mother had been taking anti-convulsant drugs. Those children include not only those born with spina bifida and heart defects, but those born with cleft palates, limb malformations, neuro-developmental delays and learning difficulties. There are therefore likely to be tens of thousands of children affected by the condition.
Jim Shannon (Strangford) (DUP): The hon. Gentleman is making his case very well. Fetal anti-convulsant syndrome is an unknown quantity that affects children. I am aware of a family in my constituency with children who suffer from it. The hon. Gentleman has not yet mentioned that children may also suffer from autism as a result of fetal anti-convulsant syndrome. Is he aware of that? Does he feel that more research is needed to find the necessary treatment, and that the Government should respond by encouraging, and making moneys available for, a treatment to be found for those young people and their parents?
Anas Sarwar: I did in fact mention autism, but the hon. Gentleman is absolutely right that we need direct support from the Government to help families affected by this condition.
The campaign has identified 500 families, but there are likely to be thousands of families across the country who do not know that their child suffers from this condition, and who do not have support from an organisation such as the trust. We therefore need Government action to support those families at this difficult time. The Organisation for Anti-Convulsant Syndromes—of which Janet Williams, who I mentioned earlier, was a founder—has been contacted by more than 500 families, with nearly 700 individuals affected by the condition.
The drug sodium valproate, which is manufactured under the name of Epilim by Sanofi, has been prescribed in the UK since the 1970s. Despite the drug’s efficacy in treating certain types of seizure, research has demonstrated that it carries a higher risk to the exposed foetus than other drugs. The first case reporting the effects of sodium valproate during pregnancy appeared in 1981, and it grew to be a hot topic within the medical profession in the 1980s, with numerous reports appearing in the medical journals. The report, however, was never investigated in the review of medicines from 1971 to 1990. The then Medicines Control Agency, which became the Medicines and Healthcare products Regulatory Agency in 2004, did not pursue the claims made by the medical research community. The MHRA “Current Problems in Pharmacovigilance” reports addressed the effects of sodium valproate in January 1983 and continued to do so intermittently. No action was taken, however, to convince Sanofi to recall the drug, improve it, or provide comprehensive warnings to patients and their doctors.
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Eric Ollerenshaw (Lancaster and Fleetwood) (Con): I congratulate the hon. Gentleman on securing this important debate, and I add my thanks for the tenaciousness of Janet Williams, who is one of my constituents. In a sense, her work mirrors some of my work with the hon. Member for Heywood and Middleton (Jim Dobbin) and the all-party group on tranquilliser addiction.
The hon. Member for Glasgow Central (Anas Sarwar) hits the precise point on the licensing of these drugs and their side effects. General practitioners need to have knowledge of those side effects and transfer that knowledge to the patients to whom they dish out the drugs. Has he any suggestions for how we might tighten that up, or at least tighten up the knowledge among GPs of what they are actually prescribing?
Anas Sarwar: The hon. Gentleman is very lucky to have such a fantastic constituent who has put so much fantastic effort, energy and hard work not only into her own personal circumstances but into getting justice for families across the country. That says a lot about his constituent, and he is a very luck man in that sense. There clearly needs to be better guidance for GPs, and in a second I will make some suggestions and ask direct questions of the Minister on that topic.
From the early 1990s, Sanofi continually insisted that patients consult their doctor when taking Epilim during pregnancy, which is standard for a patient information leaflet. In 2005, it added this to its patient information leaflets:
“Some babies born to mothers who took Epilim during pregnancy may develop less quickly than normal and may require additional educational support.”
In 2011, Sanofi added:
“Some babies born to mothers who took Epilim…during pregnancy may develop less quickly than normal or have autistic disorders.”
Sanofi therefore recognised in 2005 and 2011 that its drug can have a negative impact on a foetus. Why did that take so long?
Research by a group of six academics from the universities of Liverpool and Manchester was published this year, and it concludes that if sodium valproate
“is the treatment of choice, women should be provided with as much information as possible to enable them to make an informed decision. This should take place prior to conception as the evidence suggests that the neuropathology of Autism Spectrum Disorders develops early in gestation. Further, these findings have implications for the care of children with a history of prenatal exposure to Anti-Epileptic Drugs (AED). Children exposed to AEDs in utero, particularly Sodium Valproate (VPA), should be monitored closely during early childhood to allow for early intervention, diagnosis and support, should it be required.”
There are many pieces of similar medical research, but it would be difficult to go through all of them and their findings in the short time available.
The personal story of a young constituent of mine compelled me to initiate this debate. When he was born in 1997, he was immediately taken to a special baby care unit because his body was very floppy. In 1998, he was diagnosed with pneumonia and stayed in hospital for 10 days, at which point he was diagnosed with dextrocardia, which is a congenital defect affecting the heart. In 2001, he started nursery and showed signs of regression. He lacked co-ordination and was unable to handle his emotions, as a result of which he was given a
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preliminary diagnosis of fetal valproate syndrome, another name for fetal anti-convulsant syndrome. He was then given a firm diagnosis by a geneticist at Glasgow’s Yorkhill children’s hospital.
In 2002, my constituent started primary school and was given a special educational needs teacher. The same year, he was admitted to hospital for surgery on his tonsils and adenoids and had grommets inserted. In 2003, he was admitted to hospital with problems going to the bathroom that required surgery. He was diagnosed with pneumonia again, and with primary ciliary dyskinesia, a genetic disorder affecting the respiratory tract. He was put on a repeat prescription of antibiotics to prevent chest infections and given physiotherapy three times a day.
In 2004, my constituent was seen by occupational, educational and speech therapists due to his communication problems and inability to mix with peers. In 2006, he was sent back to occupational therapy and sent for a CT scan on his chest that showed fibrosis on the lower left lobe of his left lung, which was found to be smaller than his right. Between 2007 and 2009, he was diagnosed several times with pneumonia and severe chest infections requiring intense physiotherapy and antibiotics. In 2010, he was diagnosed with pneumonia again and, after admission to hospital, with hypoplasia of the left pulmonary artery, which had failed to develop.
As shocking as that story is, it is only one case, and there are many worse. I was informed of a family in which two children have been on disability living allowance since the ages of five and eight. Anyone hearing those stories can only be saddened by the personal circumstances. It is incumbent on Members from all political parties, whether in government or opposition, to ensure that we work together to get justice for those families and provide them with any necessary support.
The anti-convulsant that my constituent’s mother was given during her pregnancy was sodium valproate, otherwise known as Epilim, taken twice daily. It is clear that both the Government and the pharmaceutical companies, particularly Sanofi, could have done more and taken further action to protect the public. It was Sanofi’s duty to keep up to date with known medical knowledge, conduct further research and pass on that information to patients via the patient information leaflet. It was the MHRA’s duty to ensure that Sanofi investigated the medical research claims of birth defects caused by their products. Delays by both have resulted in thousands of women becoming pregnant without being given the necessary information on the levels of risk associated with the treatment.
Is the Minister aware that an estimated 40% of children exposed to sodium valproate during pregnancy are affected by neuro-developmental problems, autistic spectrum disorders and physical malformations, and that approximately 20,000 have been so affected since 1973? Does she think that that is acceptable? I know that her answer will be, “Of course not.” Is she also aware that this year, sodium valproate will have been licensed for 40 years, and that it is now being prescribed for other conditions, such as bipolar disorder and migraine headaches, and as pain relief? Does she think that that is appropriate, given the significant concerns raised by medical research about the drug’s use?
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Mr Hollobone, you will be shocked to hear that 80 families claiming damages against Sanofi-Aventis lost their legal aid in 2010 after six years of pre-trial preparation. Their legal aid was withdrawn after assessments ruled that the group’s prospects of winning had fallen and a judicial review failed. It was a devastating blow to families who had been struggling to deal with the condition without knowing what the problem was, and without any proper support. Their lawyer, David Body, summed up the tragedy when he said that
“our case against the manufacturers of Epilim must be discontinued, not because we have lost our fight in court but because continuing without legal aid funding would place our clients at too great a financial risk.”
I know that the Minister cannot reinstate the legal aid funding, but there are other things that she can do. As an aside, we should never allow thousands of families to be affected by the malpractice of a medical company and a failure of the state, and then not give them the support that they need to find justice for their families. We should never allow a situation in which people, through no fault of their own, cannot pursue justice due to the barriers put in their way by the system. No one who believes in the principle of fairness would think that that was just. We all have a responsibility to ensure that we support those families in bringing their action, so they can get some justice. It will not be the justice that they want, which is to have fit, healthy children, but it will be some kind of justice.
Given that successive Governments and regulators have failed to address the issue, will the Minister consider launching a public inquiry to investigate why sodium valproate and other anti-convulsants have been allowed to cause so much damage over such a long period? At the moment, there are pregnant women taking sodium valproate who are unaware of the dangers, because they did not receive pre-conception counselling. Can she confirm that she will ensure that that is corrected in future? Will she commit to working with the Independent Fetal Anti-Convulsant Trust to raise awareness of the condition? As a minimum, will she assure me that new guidelines will be issued to ensure that children exposed to anti-convulsant drugs in utero, particularly sodium valproate, are monitored closely during early childhood to allow for early intervention, diagnosis and support, should it be required? Lastly, is she or one of her colleagues prepared to meet me, my constituent and representatives of the Independent Fetal Anti-Convulsant Trust to discuss how we can support people affected by the condition, and help protect others from it in the future?
Inaction is not an option. These families have suffered for long enough, and it is incumbent on all of us to work together to find a fair deal for them, so they can get the necessary compensation, and so that we can ensure that not a single family suffers in future.
The Parliamentary Under-Secretary of State for Health (Anna Soubry): It is, as ever, a pleasure to serve under your chairmanship, Mr Hollobone. I thank the hon. Member for Glasgow Central (Anas Sarwar) for bringing this matter to the House and for his speech, which was clearly based on careful consideration of a number of matters that have, properly, been brought to his attention by his constituents and by the action group to which he has referred.
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I concede that it is never attractive for a Minister to begin opening remarks by saying, “This particular issue is not within my brief.” Immediately, it sounds like trying to pass the buck to somebody else. However, notwithstanding that the issue is not within my brief—I am standing in for the Minister with responsibility, who is unfortunately unable to attend this debate—I assure the hon. Gentleman that on my return to the Department of Health, I will speak to the Minister’s officials and ensure that they are fully aware of all the matters that he has raised and the many questions that he has rightly posed, some of which I will be able to answer. I will ensure that all the answers are given, if not by me today then certainly in a letter.
I will speak directly with the Minister of State, Department of Health, my hon. Friend the Member for North Norfolk (Norman Lamb). Knowing him as I do, I am sure that he will be keen to meet the hon. Gentleman. It might take a little time—our diaries, as one might imagine, are fiendishly full—but I can see no good reason why my hon. Friend would not want to know more about the issue. Anybody hearing the hon. Gentleman’s speech, the arguments advanced and the stories behind this unfortunate condition would want to know more and to see whether anything can be done.
What we do know is that fetal anti-convulsant syndrome can occur when a mother must take anti-epilepsy drugs, as the hon. Gentleman has explained better than I can. We know that it can result—although, it is important to say, not always—in delays in developing speech and language skills in the babies born, difficulties with social interaction, memory and attention and physical defects such as spina bifida, heart defects, ocular abnormalities and characteristic facial features.
It is important to say that most women with epilepsy will have successful pregnancies and healthy children. However, epilepsy during pregnancy can pose challenges. Epilepsy is associated with the risk of giving birth to a disabled child, and for women on anti-epilepsy drugs, the risk is greater. Pregnancy may also increase the frequency of seizures in about one third of women, and it can alter their metabolism of AEDs. Prolonged fits can be dangerous for the baby as well as the mother, so ideally, pregnant women should be seizure-free.
The hon. Member for Glasgow Central rightly made the point that women have been diagnosed and prescribed this treatment, and he argued that they have not had sufficient explanation of the risks involved in continuing to take that form of medication, which many epilepsy sufferers take without any difficulty, for the sake of their health because of its positive effect.
I commend my hon. Friend the Member for Lancaster and Fleetwood (Eric Ollerenshaw) for the important point he made about the role of general practitioners in ensuring that National Institute for Health and Clinical Excellence guidelines are followed. I have those guidelines in front of me and what they say is important. It is all well and good that the pros and cons of the medication are set down, but it is also imperative for GPs and everyone else involved in the treatment of a woman with epilepsy who is thinking of becoming pregnant or is of childbearing age to understand the potentially bad consequences of taking AEDs throughout a pregnancy. Such women need proper information and a full and
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frank discussion so that they can make an informed choice—I emphasise that it should be an informed choice—before and during pregnancy.
The NICE guidelines are clear:
“In women of childbearing age, the risk of the drugs causing harm to an unborn child should be discussed and an assessment made as to the risks and benefits of treatment with individual drugs…In girls of childbearing age, the risk of the drugs causing harm to an unborn child should be discussed between the girl and/or her carer”—
in most cases, a parent—
“and an assessment…made as to the risks and benefits of treatment with individual drugs…Prescribers should be aware of the latest data on the risks to the unborn child associated with AED therapy when prescribing for women and girls of childbearing potential…Specific caution is advised in the use of sodium valproate because of the risk of harm to the unborn child”.
The NICE guidelines could not be more clear, but proper information sharing and full and frank discussion are critical to informed choices.
Anas Sarwar: I thank the Minister for reading out the NICE guidelines, which I have also read. When that system fails, however, as it clearly has for so many years, affecting thousands of families, what happens then?
Anna Soubry: Indeed. I was about to move on to that very point, which was also made by the hon. Member for Strangford (Jim Shannon), and to discuss support for children who have such an affliction, obviously through no fault of their own or of their mother. Before I do so, let me add that data related to the safety and use of AEDs during pregnancy remain under scrutiny; the information and the advice are updated and issued as appropriate. The MHRA regularly reviews both the evidence on AED use in women of childbearing age and the information provided in the product information and in patient information leaflets—although many people think that we are lucky if anyone reads leaflets in boxes, and that they are not the way to convey information to a patient; they are no substitute for sitting people down and telling them face to face, going through everything in the manner I have described. The important fact is that we are continually scrutinising the information and advice so that it is regularly updated.
On the specific point about children with this unfortunate condition, better care and outcomes for disabled children are a priority of the Government. The mandate to the NHS Commissioning Board sets out our ambition to give children the best start in life and to promote their physical and mental health and their resilience as they grow up. At national level, the new Children And Young People’s Health Outcomes Board will bring together what my brief describes as key system leaders in child health to provide a sustained focus on improving outcomes throughout the child health system. The Children and Young People’s Health Outcomes Forum will provide continuing expertise in child health and offer constructive challenge as we take forward plans to improve the system.
Those are fine words, though the brief was not written by me—it is not in the nice, clear, plain English that I would like. When I return to the Department of Health, however, I will make the point that, given the structures and our good, strong ambitions, it is imperative for us
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to ensure that the case of children who suffer from the syndrome is advanced within such forums, and today’s debate will help with that.
Anas Sarwar: The Minister says that she likes plain language, and I, too, like plain language. With due respect, any family with a child suffering from such a condition will not want to hear strategy documents; they want to hear what specific action is to be taken to help such families, what compensation they might get, what action is to be taken against the medical companies, or what change of structure will take place in the health service to ensure against such failures happening again. They do not need strategy documents; they need plain language and action. What will they get?
Anna Soubry: I am trying to assist the hon. Gentleman by explaining that women with epilepsy should, from the very outset, get proper, sound information and should have a full and frank discussion with their medical practitioner so that they can make an informed choice based on everything put forward and knowing the pros and cons. There are many pros—[Interruption.] I prefer not to be heckled. I am happy to give way, and I will in a moment, because I do not have a difficulty with doing so.
I was absolutely clear in my explanation. I then discussed a series of organisations and structures—call them what you will—that also make it clear that the health and well-being of all children, including those who suffer from this syndrome, must be considered, and they must be looked after and cared for as we all wish them to be. The hon. Gentleman now seeks for the spotlight to be turned on this particular syndrome as it has perhaps not been before, and he is achieving that through the debate and by bringing me to this Chamber so that I can assure him that I will take the matter back to the responsible Minister. The hon. Gentleman has already pushed the syndrome up the list of priorities by casting the spotlight on to it, as should be the case.
Furthermore, services for children with special educational needs—some of the children we are discussing will need such services—will be enhanced by the provisions in the
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Children and Families Bill. From 2014, local authorities and clinical commissioning groups—this is an important provision to understand—will commission services jointly to meet the educational, health and care needs of young people with SEN through a single, integrated assessment process. In other words, we are now beginning for the first time ever to integrate all the specific needs of a particular child, right across all the various departments and people involved, in a way that has not been done before. If we do that, we will undoubtedly see an improvement in the lives of those children.
Anas Sarwar: I assure the Minister that I was not heckling her; I am too much of a gentlemen to do that. I was trying to say yes to action on proper advice for potential mothers with epilepsy and to future guidance to stop the condition happening, but my direct question was about the support to be given to the families for whom that is too late. They already have the condition and the difficult circumstances. What specific support will they get?
Anna Soubry: Those families are already receiving support; no one is saying that the children have been completely abandoned and are not getting any support at all. Perhaps much more can be done but, as the hon. Gentleman knows, in a debate of this length and given the constraints placed on me or any Minister, he will not get an instant answer, especially without notice of such questions. If I cannot answer all his questions in the short time that we have, and the clock is against me, he will get a letter with all his questions answered. Furthermore, when I go back to the responsible Minister, the hon. Gentleman will no doubt get a meeting to follow.
I thank the hon. Gentleman again for securing the debate. He has cast the spotlight as it needed to be done, and I am sure that there will be positive outcomes as a result.