Valproate and Foetal Anticonvulsant Syndrome

Debate between Cat Smith and Norman Lamb

Thursday 19th October 2017 Commons Chamber

[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.