The Government has a moral duty to provide financial assistance to the thousands of families affected by the epilepsy drug sodium valproate, Norman Lamb argued in the House of Commons today.
Since the 1970s, around 20,000 children have been born with severe congenital defects and developmental problems after medical regulators deliberately withheld information about the risks of taking the drug during pregnancy. Leading a debate in Parliament, the North Norfolk MP called for an inquiry or a Hillsborough-style panel to find out “how on earth this outrageous scandal could ever have happened”, in addition to financial support for the victims.
He urged the Government to ensure that women are given mandatory warnings about the risks of taking valproate during pregnancy, after a recent survey found that more than two-thirds (68%) of women have still not received a set educational materials that were released in February 2016 to make sure that all those of childbearing age are fully informed of the dangers before being prescribed the medicine.
During the debate, Norman highlighted the experiences of Becky Parish in Norfolk, whose seven year-old son was born with several abnormalities and developmental disorders due to ‘Fetal Valproate Syndrome’ – including a prominent cleft lip and palate, speech difficulties, low height and weight, and aggressional and destructive behavioural problems. Becky was originally blamed for her son’s behaviour by social services, who thought that the problems related to a detachment disorder until he was eventually diagnosed with Fetal Valproate Syndrome by a geneticist.
Closing his speech, the MP argued that there is “an overwhelming moral case” for a financial package for those affected, similar to the support provided to victims of thalidomide. He pointed to a €10 million fund that was recently established for valproate victims in France, and urged the Government to consider similar proposals in the UK.
Responding to the debate, Health Minister Philip Dunne said that the Government is “taking the matter seriously”. He declined to directly address the question of compensation or an inquiry. However, Norman Lamb – Chair of the All Party Parliamentary Group on Valproate – is scheduled to meet with the health minister Lord O’Shaughnessy in December to discuss these issues further.
Commenting afterwards, Norman Lamb said:
“This is a massive and continuing scandal. It beggars belief that women have been kept in the dark for decades about the risks of taking Valproate during pregnancy. Now it has emerged that the regulator took a decision to hide the risks from women when Valproate was first licensed in the 1970s.
“Now there is a moral imperative that the Government do right by all those affected. It is estimated that 20,000 babies have been born with birth defects or developmental problems. Mothers have been left distraught and suffering guilt when they themselves are the victims. They deserve an apology and a financial support package. There also needs to be an Inquiry or Hillsborough-style Panel to get to the bottom of how this massive failure can have happened.
“I am meeting the Health Minister in December to discuss these demands along with other members of the cross-party group, and I hope that he will accept the case we are making.”
The full debate, including Norman Lamb’s speech, can be read here.
Studies have shown that children exposed to the drug during pregnancy are at an approx. 11% risk of congenital malformations at birth, compared with a 2% to 3% risk in the general population. These include spina bifida, facial defects (e.g. cleft palate) and neural tube defects. Studies show a 30-40% risk of developmental problems, including delayed walking and talking, memory problems, difficulty with speech and language, lower intellectual ability. Children exposed to valproate in the womb are also at an increased risk of attention deficit hyperactivity disorder (ADHD) and autistic spectrum disorders (link).
Medicines regulators were aware of the dangers of the drug as far back as 1973. However, meeting minutes recently uncovered by campaigners reveal that a decision was made to keep the information from women “as it may give rise to fruitless anxiety”. Although the Committee on Safety of Medicines recommended that prescribers should be informed of the risks, it advised that these warnings should not be included in packaging leaflets “so that there would be no danger of patients themselves seeing it.”
Following a Europe-wide review of the safety of the medicine in 2013-14, the Medicines and Healthcare Products Regulatory Agency (MHRA) released a toolkit of educational materials in February 2016 to ensure that healthcare professionals and all women taking sodium valproate are aware of these dangers. However, a survey in September 2017 by three epilepsy charities revealed that more than two-thirds (68%) of women of childbearing age had still not received any of the materials – putting hundreds of unborn children at continued risk.
The following motion was debated, and passed without a vote.
That this House notes with concern that there has been a systematic failure to inform women of the dangers of taking the epilepsy drug sodium valproate during pregnancy, resulting in thousands of children being born with congenital malformations, disabilities and developmental disorders since the 1970s as a result of fetal exposure to the drug; welcomes the launch of the Valproate Toolkit by the Medicines and Healthcare Products Regulatory Agency in February 2016 to ensure that women are informed of the potential risks of the drug, but further notes with concern a recent survey which found that 68 per cent of women have still not received these safety warnings; calls on the Government to take immediate steps to ensure that the materials in the Valproate Toolkit are distributed to all prescribing clinicians, pharmacists, and women who are being prescribed the drug; calls on the Government to require all clinicians prescribing sodium valproate to women and girls of childbearing age to discuss annually with the patient the risks during pregnancy before a prescription is renewed; and further calls on the Government to bring forward proposals for a care plan and financial assistance to the victims of sodium valproate in pregnancy and their families.