Valproate and Foetal Anticonvulsant Syndrome

Teresa Pearce Excerpts

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.

--- Later in debate ---

[Mims Davies]

Absolutely. Speaking about this issue in this Chamber will empower our women constituents, before and during pregnancy, so they can be informed and make the right choices. That is the outcome we should all be hoping for.

Similar issues were raised yesterday during a debate in Westminster Hall on mesh implants. New mothers in particular had taken the advice they were given without hesitation. A woman’s first pregnancy can be an unsettling time with all the changes their body goes through. I would imagine that for people suffering from epilepsy or bipolar disorder that time is even more nerve wracking. It is absolutely right that we are measured when we talk about these issues.

It is important that our specialists ensure that women are given the correct and proper guidance. Patients need knowledge and they need it more than anyone. They live with the consequences if things go wrong and they will always look back on their decisions. If they have not been given the right information, how can they truly know they have made the right decision for themselves and their family? Siblings are often impacted as well.

The Government and MPs have a really important role to play in raising awareness of medical issues during pregnancy, including those concerning sodium valproate. I recognise the efforts that have been made, with labelling on packages. I am sure the Minister will agree, however, that more needs to be done. This drug, introduced in 1974, has been crucial, but support for families affected is also crucial. I welcome the fact that young people who have been affected are to be included in the new framework for health and social care for children and young people. It has been a real battle, but clinical commissioning groups and local authorities are getting to grips with it. It is really important that they receive support on a local level. I welcome the Minister’s forthcoming meeting with the all-party group, and I know that Ministers are taking this matter seriously, but I ask the Department for assurances on similar health issues affecting women, such as those relating to Primodos and mesh implants. We have moved to an incredible place on blood contamination—some of my constituents were affected by that—and constituents have written asking me to raise this issue too. We want more action, and there is a common denominator.

[Teresa Pearce]

Two years ago, I asked the Minister to extend the Primodos inquiry to include valproate, but my request was declined because, I was told, the two issues were very different, yet they seem to be quite similar. Does the hon. Lady think that that was a missed opportunity?

[Mims Davies]

As a woman in Parliament, I think that any opportunity not taken to raise women’s issues is a missed opportunity, and I know the Minister is listening intently.

The hon. Member for Newport West (Paul Flynn) raised a point about the seemingly cosy relationship the MHRA has with the drugs companies, when it suits it, and sometimes the laissez-faire attitude it adopts, when it suits it. It is incomprehensible that greater independence cannot be injected into this area. We need openness and reform. I would like the Minister to take a look at the position in France and consider setting aside some funding for compensation for medical accidents.

Few in the Chamber can imagine the hardship, guilt and heartbreak of the impact of taking a simple prescription drug during pregnancy and finding out later that it might have had an effect on one’s child. I am lucky to have two healthy beautiful daughters. We are all at the mercy of decisions we take during our pregnancy and the professional guidance we receive. We are fortunate to have the opportunity to raise awareness among people in this situation, but there are those not lucky enough to be sufficiently informed. This is an important debate, therefore, and I urge the Department to work with the MHRA to give patients full confidence in it on all pregnancy matters.