Valproate and Foetal Anticonvulsant Syndrome

Debate between Liz McInnes and Fiona Bruce

Thursday 19th October 2017 Commons Chamber

[Liz McInnes]

The hon. Lady is absolutely right. She and I are well aware of the yellow card system, because we have both worked in the NHS, but how many people out there know that they can report side-effects of drugs, or even suspected side-effects? We really have a job to do in conveying that message to the general public, and we also need people to collate the information and act on it.

A definitive paper stating that there was a clear link between valproate taken during pregnancy and birth defects was published in 1995. It was entitled “Foetal Valproate Syndrome”, and was written by geneticists at St Mary’s Hospital, Manchester. It is clear that the evidence has been building up for a long time, so why does it appear that women were not warned about the potential dangers of taking the drug in pregnancy?

[Fiona Bruce]

That 1995 report concluded that the “risk” of foetal valproate syndrome when babies were exposed to valproate was “significant”.

[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.

Human Fertilisation and Embryology

Debate between Liz McInnes and Fiona Bruce

Tuesday 3rd February 2015 Commons Chamber

[Fiona Bruce]

I want to pick up on the point the hon. Lady makes about mitochondria not affecting characteristics. The Government’s own consultation document acknowledged that diverse characteristics are associated with mitochondria, including learning disabilities, neurological problems and dementia, and that every person’s symptoms are different. Is there not an insurmountable contradiction in saying that this is just like changing a battery if on the one hand one is saying that the aim is to prevent damage to those characteristics, but on the other hand one is saying that the techniques will not affect them at all?

[Liz McInnes]

I did not say it was just like changing a battery. In fact, I try to avoid using that terminology. The hon. Lady mentions learning disabilities, but as I just said, the organs affected the most by mitochondrial disorders are organs that require a large amount of energy, such as the brain, so that comes as no surprise to me.

Allegations have been made that the techniques are not safe.

[Liz McInnes]

No, I will not, because I need to make progress and let other people speak.

Last night, it was my privilege to attend the debate on the safety and ethics of this technique and to hear Professor Doug Turnbull, who leads the research team at Newcastle university, talk about the 15 years of work done by his team and the extensive safety checks that have taken place during those years. In the Chinese case to which my hon. Friend the Member for Stoke-on-Trent South (Robert Flello) referred, the treatment was carried out by an American clinician on a single patient in China. The patient became pregnant with triplets, one of whom was aborted and the other two were born prematurely and died. Importantly, the clinician attributed the outcome entirely to multiple pregnancy and obstetric complications, not to the method of conception. I do not accept that that one case represents a proper clinical trial.

What we have to remember is that mitochondrial disease is a life-limiting debilitating disease, causing severe distress to parents and their affected children. We have here a technique with the ability to alleviate their suffering and to allow affected parents the chance to have a healthy child who is genetically related to them in all aspects apart from a tiny proportion of mitochondrial DNA. The spectre of designer babies can be dismissed. There is no possibility of using this technique to select certain characteristics. It will simply allow mitochondria to function normally and for the child to be free of mitochondrial disease.

[Fiona Bruce]

Will the hon. Lady give way?

[Liz McInnes]

I will not, no.

In safety, the UK has a robust regulatory framework. A vote in favour of the motion will not in itself open the way for mitochondrial donation to be used in clinics. It will simply enable the HFEA to consider each individual family’s request for treatment on a case-by-case basis, taking expert scientific and medical advice and licensing the procedure only if the evidence shows that that is appropriate.

I am lucky enough to have worked at the Royal Oldham hospital, where the first IVF baby, Louise Brown, was born. When IVF was first introduced, there was no certainty that it was completely safe. Only after the first babies were born using the technique could scientists be completely reassured that their detailed research had led to the birth of healthy babies, but to this day research continues on IVF, just as more research must be done on mitochondrial transfer. That is the nature of science: it is a continuous process; it does not stand still.

For families affected by mitochondrial disease, this research has given them new hope that they may at last have the chance to bear a healthy child of their own. Last night I heard from a woman who suffered from mitochondrial disease, which had also affected her mother. That young woman had taken a considered decision not to have her own children, for fear of passing on the condition. The opportunity to have this treatment presents her and many other women in that situation with new hope. The science is there to alleviate the suffering of affected families, and in my opinion it would be unethical to withhold this treatment. I urge the House to approve the regulations.