Fetal Anti-convulsant Syndrome

Eric Ollerenshaw Excerpts

Tuesday 26th March 2013 Westminster Hall

[Eric Ollerenshaw (Lancaster and Fleetwood) (Con)]

I congratulate the hon. Gentleman on securing this important debate, and I add my thanks for the tenaciousness of Janet Williams, who is one of my constituents. In a sense, her work mirrors some of my work with the hon. Member for Heywood and Middleton (Jim Dobbin) and the all-party group on tranquilliser addiction.

The hon. Member for Glasgow Central (Anas Sarwar) hits the precise point on the licensing of these drugs and their side effects. General practitioners need to have knowledge of those side effects and transfer that knowledge to the patients to whom they dish out the drugs. Has he any suggestions for how we might tighten that up, or at least tighten up the knowledge among GPs of what they are actually prescribing?

[Anas Sarwar]

The hon. Gentleman is very lucky to have such a fantastic constituent who has put so much fantastic effort, energy and hard work not only into her own personal circumstances but into getting justice for families across the country. That says a lot about his constituent, and he is a very luck man in that sense. There clearly needs to be better guidance for GPs, and in a second I will make some suggestions and ask direct questions of the Minister on that topic.

From the early 1990s, Sanofi continually insisted that patients consult their doctor when taking Epilim during pregnancy, which is standard for a patient information leaflet. In 2005, it added this to its patient information leaflets:

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

In 2011, Sanofi added:

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

Sanofi therefore recognised in 2005 and 2011 that its drug can have a negative impact on a foetus. Why did that take so long?

Research by a group of six academics from the universities of Liverpool and Manchester was published this year, and it concludes that if sodium valproate

“is the treatment of choice, women should be provided with as much information as possible to enable them to make an informed decision. This should take place prior to conception as the evidence suggests that the neuropathology of Autism Spectrum Disorders develops early in gestation. Further, these findings have implications for the care of children with a history of prenatal exposure to Anti-Epileptic Drugs (AED). Children exposed to AEDs in utero, particularly Sodium Valproate (VPA), should be monitored closely during early childhood to allow for early intervention, diagnosis and support, should it be required.”

There are many pieces of similar medical research, but it would be difficult to go through all of them and their findings in the short time available.

The personal story of a young constituent of mine compelled me to initiate this debate. When he was born in 1997, he was immediately taken to a special baby care unit because his body was very floppy. In 1998, he was diagnosed with pneumonia and stayed in hospital for 10 days, at which point he was diagnosed with dextrocardia, which is a congenital defect affecting the heart. In 2001, he started nursery and showed signs of regression. He lacked co-ordination and was unable to handle his emotions, as a result of which he was given a preliminary diagnosis of fetal valproate syndrome, another name for fetal anti-convulsant syndrome. He was then given a firm diagnosis by a geneticist at Glasgow’s Yorkhill children’s hospital.

In 2002, my constituent started primary school and was given a special educational needs teacher. The same year, he was admitted to hospital for surgery on his tonsils and adenoids and had grommets inserted. In 2003, he was admitted to hospital with problems going to the bathroom that required surgery. He was diagnosed with pneumonia again, and with primary ciliary dyskinesia, a genetic disorder affecting the respiratory tract. He was put on a repeat prescription of antibiotics to prevent chest infections and given physiotherapy three times a day.

In 2004, my constituent was seen by occupational, educational and speech therapists owing to his communication problems and inability to mix with peers. In 2006, he was sent back to occupational therapy and sent for a CT scan on his chest that showed fibrosis on the lower left lobe of his left lung, which was found to be smaller than his right. Between 2007 and 2009, he was diagnosed several times with pneumonia and severe chest infections requiring intense physiotherapy and antibiotics. In 2010, he was diagnosed with pneumonia again and, after admission to hospital, with hypoplasia of the left pulmonary artery, which had failed to develop.

As shocking as that story is, it is only one case, and there are many worse. I was informed of a family in which two children have been on disability living allowance since the ages of five and eight. Anyone hearing those stories can only be saddened by the personal circumstances. It is incumbent on Members from all political parties, whether in government or opposition, to ensure that we work together to get justice for those families and provide them with any necessary support.

The anti-convulsant that my constituent’s mother was given during her pregnancy was sodium valproate, otherwise known as Epilim, taken twice daily. It is clear that both the Government and the pharmaceutical companies, particularly Sanofi, could have done more and taken further action to protect the public. It was Sanofi’s duty to keep up to date with known medical knowledge, conduct further research and pass on that information to patients via the patient information leaflet. It was the MHRA’s duty to ensure that Sanofi investigated the medical research claims of birth defects caused by their products. Delays by both have resulted in thousands of women becoming pregnant without being given the necessary information on the levels of risk associated with the treatment.

Is the Minister aware that an estimated 40% of children exposed to sodium valproate during pregnancy are affected by neuro-developmental problems, autistic spectrum disorders and physical malformations, and that approximately 20,000 have been so affected since 1973? Does she think that that is acceptable? I know that her answer will be, “Of course not.” Is she also aware that this year, sodium valproate will have been licensed for 40 years, and that it is now being prescribed for other conditions, such as bipolar disorder and migraine headaches, and as pain relief? Does she think that that is appropriate, given the significant concerns raised by medical research about the drug’s use?

Mr Hollobone, you will be shocked to hear that 80 families claiming damages against Sanofi-Aventis lost their legal aid in 2010 after six years of pre-trial preparation. Their legal aid was withdrawn after assessments ruled that the group’s prospects of winning had fallen and a judicial review failed. It was a devastating blow to families who had been struggling to deal with the condition without knowing what the problem was, and without any proper support. Their lawyer, David Body, summed up the tragedy when he said that

“our case against the manufacturers of Epilim must be discontinued, not because we have lost our fight in court but because continuing without legal aid funding would place our clients at too great a financial risk.”

I know that the Minister cannot reinstate the legal aid funding, but there are other things that she can do. As an aside, we should never allow thousands of families to be affected by the malpractice of a medical company and a failure of the state, and then not give them the support that they need to find justice for their families. We should never allow a situation in which people, through no fault of their own, cannot pursue justice owing to the barriers put in their way by the system. No one who believes in the principle of fairness would think that that was just. We all have a responsibility to ensure that we support those families in bringing their action, so they can get some justice. It will not be the justice that they want, which is to have fit, healthy children, but it will be some kind of justice.

Given that successive Governments and regulators have failed to address the issue, will the Minister consider launching a public inquiry to investigate why sodium valproate and other anti-convulsants have been allowed to cause so much damage over such a long period? At the moment, there are pregnant women taking sodium valproate who are unaware of the dangers, because they did not receive pre-conception counselling. Will she confirm that she will ensure that that is corrected in future? Will she commit to working with the Independent Fetal Anti-Convulsant Trust to raise awareness of the condition? As a minimum, will she assure me that new guidelines will be issued to ensure that children exposed to anti-convulsant drugs in utero, particularly sodium valproate, are monitored closely during early childhood to allow for early intervention, diagnosis and support, should they be required? Lastly, is she or one of her colleagues prepared to meet me, my constituent and representatives of the Independent Fetal Anti-Convulsant Trust to discuss how we can support people affected by the condition, and help protect others from it in the future?

Inaction is not an option. These families have suffered for long enough, and it is incumbent on all of us to work together to find a fair deal for them, so they can get the necessary compensation, and so that we can ensure that not a single family suffers in future.