Campaign Questions Deepen as Government Hovers Over Proposal


Tuesday 29th October INFACT attended a meeting at the Department of Health with Health and Social Care Minister Norman Lamb. This meeting resulted from our Westminster Hall Debate which was held back in March and arranged via Glasgow MP Anas Sawar who was present at the meeting. Also in attendance was Head of the All Party Political Group (APPG) for Thalidomide, Alec Shellbrooke MP.
This was a very highly anticipated meeting, as INFACT are calling for a PUBLIC ENQUIRY into why since 1973 approximately 20,000 children have been harmed by the Anti Convulsant medication Epilim, which is made by Sanofi. Epilim (Sodium Valproate) was licenced by The Medicines Control Agency (MCA) in 1973 and was primarily used for controlling Epilepsy, but now it is used for a number of conditions including Migraine and Bipolar Disorder. Sanofi were aware of the teratogenic (fetal malformation) effects of Epilim on animals in 1973.
A few months ago INFACT had a meeting with Medicines Health Regulatory Agency (MHRA), a Government led agency. The agency’s job is to make sure medicines are fit for purpose and to protect the public. It was in this meeting that Dr June Raines Pharmacoviligence Director for the MHRA, stated that our figures of approximately 20,000 affected persons was correct. She also stated the MHRA had been watching Epilim.



What good is just watching Epilim now? When it has been proven in a medical journal published in February 2013, that if a woman takes Epilim during and to some extent prior to pregnancy the risk of their child being damaged with Neurodevelopmental Disorders (Autistic Spectrum) is atleast 40%. Is a 4 in 10 chance not deemed to be worthy of, at the very least a public warning from the MHRA? Something we at INFACT have been insisting has to be carried out with the upmost urgency.
Mr Lamb showed great empathy. He asked lots of questions but as we all had agreed prior to the meeting, the reason of this meeting was to ask for a public enquiry. It was to also state that a PUBLIC HEALTH WARNING needs to be released as there are thousands of ladies currently on this medication. An estimated 500 affected babies are born each year, it is NOT ACCEPTABLE that up to now 20,000 children many who are now adults have been harmed but that also babies continue to be born and ladies are not being given the adequate information with regards to the risks of Epilim.

Epilim is a very effective drug for controlling epilepsy especially and Sanofi the third largest Pharma company in Europe made approx. 410m (Euro) Net Sales on it alone in 2012. However, currently, it’s the state (taxpayers) who foot the welfare bill for these disabled children and their families, whilst Sanofi and their shareholders continue to grow richer regardless of the cost to you, me and the children.
Personally I wonder if we will ever get a public enquiry. With the NHS being in such a crisis at the moment, how can another government controlled issue which is potentially bigger than the Thalidomide disaster, that will possibly cost millions be allowed to become mainstream and cause such scandal?
Representing the approx. 20,000 affected persons INFACT have to insist on a public enquiry being granted. And continue to push for it. We are now awaiting to hear from Mr Lamb and what the next steps will be with regards to Epilim. The human costs continues!


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