On 19th October 2017, BLB partner and leading sodium valproate solicitor David Gazzard, attended the House of Commons for the debate on Valproate and Fetal Anti-Convulsant Syndrome. The full transcript of the debate can be found here.
The debate, which was well attended, was initiated by Liberal Democrat MP, Norman Lamb. The motion proposed was:
“That the 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 Valporate 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% of women have still not received the safety warnings; calls on the Government to take immediate steps to ensure that the materials in the Valporate 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 child bearing age to discuss annually with the patient, the risks during pregnancy before 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.”
In his opening speech Mr Lamb highlighted examples showing that the risks posed by Sodium Valproate have been known for well over 40 years. He described the issue as scandalous and referred the House to the 1974 Licence Agreement for the commercial use of Epilim with the emphasis being on it being used only in extreme cases where there were no other practicable alternatives. Mention was also made of the minutes of a subcommittee meeting on the safety of medicines in 1973, from which it was clear that the risks of prescribing the drug were known but were not to be mentioned in the data sheets in order to avoid “fruitless anxiety” amongst patients.
Concern was also expressed about original documentation going missing and the need for a Hillsborough type enquiry to be held.
Mr Lamb informed the House that unfortunately warnings were often still not being given and that it was estimated that another 400 babies had been affected by fetal valproate syndrome since the Toolkit was issued to the medical profession in February 2016. In conclusion, he made the following proposals:
1. that the use of the Toolkit must be made mandatory;
2. that all women suffering from epilepsy and of a child bearing age should have an annual face to face discussion with their GP about the risks of taking Epilim;
3. that all women should have access to specialist units;
4. that the prescription rates for every CCG should be published;
5. that Sodium Valproate should only be prescribed to women if there was no other alternative;
6. that there should be a financial support package put in place for affected families (similar to the €10,000,000 fund in France);
7. that the Government should issue a statement of regret or an apology; and
8. there should be a public inquiry held.
Shadow Health Minister, Sharon Hodgson MP, called for a mandatory discussion to take place prior to the first prescription of Epilim, followed by annual reviews. She also called for a public inquiry.
The Minister attending for the Department of Health, Philip Dunne MP, made reference to the findings of the Association of British Neurologists and the NICE guidelines, both of which concluded that Sodium Valproate was the most effective drug for the treatment of epilepsy. He also made reference to the testing carried out on animals in 1974 which proved positive for birth defects etc. and the decision taken by health professionals not to warn patients. He made it clear that that sort of “paternalistic attitude” was no longer acceptable.
The Minister said that advice leaflets had been available since 1999 and that warnings of birth defects were published in 2003 with the risks of autism becoming clear in 2010. He said that by 2013 the full extent of the risks were well known and that in January 2015 the MHRA issued a letter to all doctors. Mr Dunne said that in July of this year the Toolkit was redistributed to doctors and that the statistics were now showing that the use of Epilim was declining, but he accepted that more needed to be done. He assured the House that the Government was taking the situation seriously and he mentioned that Local Authority funding was now available to help affected families.
During the debate sincere gratitude was expressed by a number of the Members of Parliament to Janet Williams and Emma Murphy (both of whom were present) for their tireless campaigning through the Fetal Anti Convulsant Syndrome Association (FACS).
In closing the debate, Norman Lamb informed the House that on 7th December 2017 he would be attending a meeting with Lord O’Shaughnessy, a junior minister at the Department of Health, to discuss further the possibility of additional help for families and perhaps a Government backed compensation scheme.