Valproate and Foetal Anticonvulsant Syndrome

Debate between Fiona Bruce and Teresa Pearce

Thursday 19th October 2017 Commons Chamber

[Fiona Bruce (Congleton) (Con)]

I pay tribute to the right hon. Member for North Norfolk (Norman Lamb) for so eloquently articulating the concerns that many of us share about the taking of sodium valproate by expectant mothers.

I am speaking today because I believe there is a case for Ministers to answer on the grounds of compassion and justice as to how and why pregnant women were allowed to take sodium valproate for so many years without being better advised and informed, and without their unborn children being better protected from the risks. That is particularly the case since professionals became increasingly aware of those risks over the years—as early as 1973. As we have heard, the risks are huge. At the end of the day, the people who should have been able to weigh them up and choose whether to take valproate while pregnant were the mothers. I appreciate that in 1973 we were, as has been said by a practitioner in medicine, in a more paternalistic era, but that was not the case as the years went by, and certainly not in 2016, when the valproate toolkit—the patient guide that I have here in my hand—was published.

Mothers were not given the relevant information and, sadly, far too many still are not. It is absolutely critical that they are given it, because the toolkit is stark, stating:

“If you take valproate when you are pregnant it can harm your unborn child…Taking valproate…can cause birth defects and problems with development and learning…In women who take valproate while pregnant, around 10 babies in every 100 will have a birth defect”,

such as

“spina bifida…facial and skull malformations…malformations of the limbs, heart, kidney”

and other organs. It goes on to say that

“about 30-40 children in every 100 may have developmental problems”

such as

“learning to walk and talk…lower intelligence…poor speech and language skills”

and “memory problems.” It states that

“it is…important that you…know about these risks”.

But for years women did not know about the risks when medical professionals did. They might not have known, and probably did not know, all those details. However, I have with me a copy of a letter from the Committee on Safety of Medicines—the precursor to the MHRA—from 1973. It refers to a number of studies and says:

“it is now clear from other studies…that the use of anticonvulsants during pregnancy…is liable to produce other abnormalities as well as hare-lip and cleft palate. The risk appears to be low and not sufficient to justify stopping the use of anticonvulsants when they are necessary for the control of epilepsy.”

There we have it—the Committee on Safety of Medicines was aware of this in 1973. The documentation relating to the licensing application in 1974, which the right hon. Gentleman mentioned, says that the product is licensed

“for use in general, focal or other epilepsy. In women of child bearing age, it should only be used in severe cases or those resistant to other treatment”.

So we now know that the dangers were being raised as long ago as 1973 and 1974.

In response to these concerns, the CSM instructed that an alert must

“not go on the package inserts”

so that patients would be protected from “fruitless anxiety”. Because patients did not see anything, they were denied the information and therefore the choice to abstain from this drug. Yet very much more anxiety was caused for many of them when the reality was that thousands of babies were born with life-changing disabilities and deformities that could have resulted from taking this drug during pregnancy.

[Teresa Pearce (Erith and Thamesmead) (Lab)]

Does the hon. Lady find it even more shocking that it was decided to keep this information from women in 1973-74, in the wake of the thalidomide scandal, when it should have been uppermost in people’s minds that pregnant women needed warning about the drugs they took? That should have made it more likely that women were informed about the risks.

[Fiona Bruce]

The hon. Lady makes a very good point.

Further warnings were issued. In 2000, a patient information leaflet from the producer, Sanofi, said:

“It is known that women who have epilepsy have a slightly higher risk of having a child with an abnormality than other women. Women who have to take Epilim in the first 3 months of pregnancy to control their epilepsy have about a 1-2% chance of having a baby with Spina Bifida.”

In 2005, Sanofi added:

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

and that some

“babies born to mothers who took Epilim…during pregnancy may develop less quickly than normal or have autistic disorders.”

Warnings were emerging over the years, but nothing was done to ensure that patients were told. Why did patients have to wait almost 30 years to be warned of the risks?

Janet Williams and Emma Murphy, whom the right hon. Member for North Norfolk (Norman Lamb) mentioned and whom I have had the privilege of meeting, are tenacious and brave women who have campaigned for years and set up a support group for affected families. I pay tribute to them, and I want to tell the House a little bit about their family situations. Janet has two sons aged 26 and 28: Lee and Philip. Janet took Epilim, but nothing else, during both pregnancies. She told me:

“I wasn’t offered anything else—and no one told me of the risks.”

Lee, at 26, has curvature of the spine, Asperger’s, learning difficulties and memory problems, and he cannot hold down a job. Philip, at 28, has even more problems. He has problems with hearing, vision, speech, language and walking, as well as floppy joints. He is still fully dependent on Janet.

Emma had her children a generation later. She has five children, aged eight to 14: Chloe, Lauren, Luke, Erin and Kian. They have all been diagnosed with a number of symptoms. All have varied problems, including autism, incontinence, deafness, cerebral palsy and curvature of the spine, and all are slow to develop. Emma took the same dose of Epilim during each pregnancy. She told me that she questioned that, but was told that it was the best drug to control her seizures and that her baby would be fine. She took no other drugs during her pregnancies. No one warned her of the risks.

The tragedy is that those two women represent more than 1,000 others in their support group, the Fetal Anti Convulsant Syndrome Association. Together, they founded the Independent Fetal Anti Convulsant Trust, a registered charity, to campaign for better awareness of the risks of taking valproate, to prevent further such difficulties occurring, and to challenge the Government. There is, as I say, a case to answer, and I do not believe that we would be here today were it not for these two women.