Valproate and Foetal Anticonvulsant Syndrome

Lindsay Hoyle Excerpts

Thursday 19th October 2017 Commons Chamber

[Dr Whitford]

Will the hon. Gentleman give way?

[Mr Deputy Speaker (Mr Lindsay Hoyle)]

He has finished.

--- Later in debate ---

[Jim Shannon (Strangford) (DUP)]

It is always a privilege to speak in these debates. I give special mention to the hon. Member for Bury North (James Frith), whose powerful and personal summary of his life has greatly added to the debate. Everyone who heard his contribution will appreciate it and thank him for it. The right hon. Member for North Norfolk (Norman Lamb) set the scene so capably, outlining the case for addressing valproate and foetal anticonvulsant syndrome. I pay tribute to him for the summary at the end of his speech, about which I will speak later, and his eight recommendations. If there are any recommendations to follow, those are they, as everyone in the House will agree. I thank all the other hon. and right hon. Members who have spoken, because their contributions were equally as important, and I also thank those who made interventions. The House shines better whenever we discuss issues on which we can have an input both personally and on behalf of our constituents, and this is one such issue.

There is no greater gift from God than a little baby. I have two wee granddaughters, and I adore them. We maybe do not spend as much time with them and our children as we should, but we try. They are both perfect in my opinion, even if they have some tantrums. As girls, perhaps they have different tantrums to boys—I only had boys, so I do not know. We live on coffee in my office—I suspect everyone else is the same—and I have watched my parliamentary aide as she refused her normal 10 cups of coffee and drank only caffeine-free beverages for nine months during her pregnancies. Indeed, her not drinking coffee was the first indication that she was expecting again. She had had two miscarriages but now had one baby and was expecting her second, so she was going to take every step that she could to ensure that the baby was perfect. She said that the reason for not drinking caffeine was that it can make the baby’s heart beat a little fast. Mothers everywhere will do almost anything to ensure that they protect that little life when they know of its existence. Unfortunately, as this debate has clearly shown, some mothers did not know what was happening, which is why I feel strongly that more research must be done for the mothers who have long-term health problems and do not know how the medication they need may affect their children. Every Member who has spoken has made that point.

I want to throw another point into the equation. People with ulcerative colitis, Crohn’s disease and other conditions who have infusions such as infliximab have to come off them if they want to get pregnant. Some people are made aware of such things, but does everyone know that? I suspect not, but they should. The hon. Member for Central Ayrshire (Dr Whitford) and others referred to the yellow card scheme, and people need to be made aware of when incidents happen. More needs to be done to ease families’ minds, and that is why I join with colleagues today to ask for more to be done not only in the case of this epilepsy medication, but with more long-term medications in general. We must look beyond this debate and encapsulate what other people are saying.

Sodium valproate is an anti-epileptic drug that is associated with greater risks in pregnancy than other AEDs. Other valproate medicines include valproic acid and valproate semisodium. The Medicines and Healthcare Products Regulatory Agency reports that, although the general risk of foetal abnormality is 2% to 3%, the risk for women taking sodium valproate is around 10%. Did those women know? This debate illustrates that they did not, but they should have known. We have to address the issue now.

The birth defects can include spina bifida and limb, facial and skull malformations. The use of sodium valproate in pregnancy can also affect a child’s development. Many Members, including the hon. Member for Bury North in his powerful speech, have told us exactly what valproate does. Children have delays in learning to walk and talk. The drug can lower intelligence, and affected children have poor speech and language skills compared with children of the same age.

There have unfortunately been many scandals over the years, and my constituents made me aware of the thalidomide scandal, to which I can relate. The hon. Member for Eastleigh (Mims Davies), like me, spoke in yesterday’s Westminster Hall debate on mesh implants: I have been contacted by many affected women, and they did not know what the risks were, either. They have lived with the repercussions for years. One Member mentioned a lady who had to go in three times in six years to have operations before she was cured.

The same is true of Primodos. A Member who is not here told me about his involvement with that issue. There many such scandals and, as other Members have said, we need to bring them all together under one headline.

I am not a doctor, and I have no medical skills, but I can read about symptoms. I have no medical training, but it appears that the risks are significant enough that people should be fully informed of them before they are prescribed such medication. The massive risks in taking these drugs during pregnancy will then be embedded in their minds.

Many of us were supplied with the Epilepsy Action briefing. The statistics are hard to read, but they are very clear. I also thank the Library for the in-depth information it has provided so we can prepare for this debate. The surveys to which hon. Members have referred go back to 1995-96, when a possible problem was first mooted, but no action was taken. The Library briefing says:

“This survey has been repeated in 2017, when it was found that 18% of women taking the epilepsy medicine sodium valproate didn’t know the risks this medicine can pose during pregnancy and 28% of women said that they had not been informed of the risks of this medicine in pregnancy.”

How can it be that lessons have not been learned?

Dr Rhys Thomas, an honorary consultant in epilepsy at the Royal Victoria Infirmary, Newcastle, says:

“This is a dramatic and important survey focusing on a crucial area for women with epilepsy. As a medical community, we clearly could be doing more, and should be doing more. Even if women are being told of the risks, this may be at the wrong time for them—or in the wrong way.”

Sometimes the risks are not explained in a way that people understand, which is wrong. We need to have the conversation, and it has to be repeated. People need to be aware of the risks, and I am not sure that that has happened in the way it should.

The Medicines and Healthcare Products Regulatory Agency figures suggest that up to four in 10 babies are at risk of developing disorders if valproate medicine is taken during pregnancy—that is massive. How can it be ignored? Approximately one in 10 babies is at risk of physical birth defects. Babies affected by sodium valproate can have severe problems that require lifelong care and support. Are we looking at prevention? Are we looking to the future? Are we looking at what the long-term care will be? I suspect not.

It is estimated that 20,000 babies have been affected and 400 babies a year are born to women taking sodium valproate. Epilepsy Action, the Epilepsy Society and Young Epilepsy have surveyed more than 2,000 women with epilepsy, and they found that some women are still not aware of the risks of taking epilepsy medicine in pregnancy. More than a quarter, 28%, of women who have taken an epilepsy drug have not been given information. That would indicate to me that a knowledgeable medical professional should have taken the time to go through the risks of being pregnant with people on the drug. After someone has become pregnant, it may well be too late, so those discussions with the GP are very important. It is not a matter of someone simply stopping a drug when their pregnancy test is positive, as that is not the safe way to do things.

In conclusion, I urge that the eight points are followed, but that we should put in place the compensation fund that everyone in this House wants to see, because that will at least help the families affected to deal with the financial positions they are in.

[Mr Deputy Speaker (Mr Lindsay Hoyle)]

I call Cat Smith. If she could finish at half past, I would be grateful. In addition, if the wind-ups could be about nine and a half minutes long, that would allow us to bring in Norman Lamb.