Only now is there national publicity for a drug that has done more damage than Thalidomide.
It's heartbreaking and infuriating that 40% of women of chlld bearing age using Valproate have not been informed of the danger of EPILIM> In March 2013 I published the blog below. The blog and EDM below were published in March 2013.
New evidence has proved that the drug Epilim affects all babies when their mothers took the drug in pregnancy. In a third of the cases, brain damage occurs. The adverse effects include spina bifida, cleft palate, deformities and autism. A campaign to expose the dangers lost their legal aid in 2010 because of a lack of proof of a causal link. That link has now been established by reports from two universities and legal aid should be restored.
Again the UK has been let down by our ramshackle drugs regulatory body the MHRA. It is funded and run entirely by the Pharmaceutical Industry. It is weak, dominated by Big Pharma influence and slow to identify and condemn adverse reactions. The UK suffered 2,000 tragic birth defects in the Thalidomide scandal. The US had 20. It was the American Food and Drug Administration (FDA) that discovered that 60,000 deaths had resulted from the use of the anti-arthritis drug Vioxx. The MHRA were unconcerned by their defective system of reporting ill-effects. Glaxo Smith-Kline was fined a massive $3.5 billion by the FDA for, among things, suppressing negative results of their drugs. There was no fine in the UK for the same offences. Beyond reason and blind to the evidence, the MHRA defended the widespread use of the anti-depressant Seroxat.
The UK needs a regulator that is independently working in the public interest and divorced from commercial pressures.
One paper reported, 'The casualties of the Epilim scandal include heartbreaking cases.
When Samantha Scott wanted to have a baby, she consulted her neurologist about whether it was safe. She has epilepsy and was concerned that Epilim could be unsafe in pregnancy.
"The doctors said it was fine," said Scott, 31, from Cumbria. "In fact, they upped my dose."
But Scott's daughter Faith was born with an extra digit, a cleft palate, a hole in the heart, and no muscle tone. Now aged seven, Faith has a mental age of two and weighs only two stone (13kg). She has spent most of her life so far in hospital.
Faith is one of hundreds of children campaigners believe suffered birth defects as a result of drugs such as Epilim, which contain a controversial anti-convulsant called sodium valprorate.
"We have 624 children on our books from these drugs and 351 are from mothers who were taking Epilim," said Janet Williams, secretary of OACS, the organisation for anti-convulsant syndromes. "That is nowhere near the figure for the total number of children out there who are actually affected."
Losing legal aid proves the impossibility of funding cases such as the Epilim action is leaving pharmaceutical companies increasingly unaccountable.
Sanofi denies all liability for the birth defects that the families say are caused by Epilim, but America has a different experience. A similar class action brought against one of its affiliate companies in the US was settled, leading to calls for a review of UK law. More than 70 MPs have signed an early day motion about the case
"Four major drug companies have gone through the litigation and never gone to court," said Janet Stock-Pollard, who has two children that suffered birth defects after she took Epilim during her pregnancies. "The law appears to protect the drug company and not the consumer."
Emma Friedmann, whose son Andy is 12 years old with a mental age of three and is one of the claimants in the UK case, says that the lack of legal aid funding denies vulnerable people access to justice.
"Andy has been damaged for life, and he's not allowed his claim to be heard in court," she said. "Everyone who uses pharmaceutical products is less safe because of this. If you take a product and you or your dependants have a problem with it, you will not be successful in court."'
Session: 2012-13 Date tabled: 05.02.2013 Primary sponsor: Anderson, David Sponsors: Betts, CliveDurkan, MarkHeyes, DavidMcCartney, KarlMeale, Alan
That this House notes with concern the withdrawal of public funding from the Fetal Anti-Convulsant Litigation in November 2010; further notes that the taxpayer is now covering the additional health, education and welfare costs incurred by families affected by fetal valproate syndrome; believes the Department of Health and the Medicines and Healthcare products Regulatory Agency could have avoided the large numbers of people affected, since the drug sodium valproate came onto the market in the late 1970s, by informing patients treated with anti-convulsant medications and women of child-bearing age; and calls for an independent inquiry into why information has been withheld from the public concerning the disastrous way in which sodium valproate has affected pregnant women and their children.
Early day motion 1197
MHRA
- Date tabled: 14.03.2013
- Primary sponsor: Flynn, Paul
That this House calls for reform of the weak Medicines and Healthcare Products Regulatory Agency (MHRA) that is funded by the pharmaceutical industry and repeatedly fails the public interest; is appalled that the 20,000 victims of birth defects arising from the use of sodium valproate (Epilim) have been denied legal aid while American parents have already received compensation; recalls that there were 2,000 victims of Thalidomide in the UK and only 20 in the US; congratulates the US regulator, the Food and Drug Administration that revealed that 60,000 deaths had resulted from the use of the anti-arthritis drug Vioxx while no alarm was registered here because of the MHRA's defective system of reporting drug side-effects; commends the US' massive fine on Glaxo Smith Kline of $3.5 billion for suppressing negative results of drug trials while no action has been taken here for identical misdemeanours; and believes that the UK should be protected by a fully independent regulatory authority liberated from financial dependence on the pharmaceutical industry.
- That this House notes with concern that the medicine valproate, which is used for the treatment of epilepsy and bipolar disorder, can seriously harm an unborn child when taken during pregnancy, including increased risk of malformations and developmental disorders; welcomes the development of a valproate toolkit to aid communication of the risks of valproate in pregnancy, including a warning on package labelling, a checklist for discussion between prescribers and patients, a reminder card and information booklet for women, and a booklet for healthcare professionals; further notes that the toolkit was disseminated by the Medicines and Healthcare products Regulatory Agency (MHRA) and the valproate manufacturer, Sanofi, in February 2016; expresses concern at reports that many pharmacists and clinicians have not received the toolkit, potentially leaving many women ill-informed of the severe risks of the medicine; and urgently calls on the Government, the MHRA and NHS England to work together to ensure that the toolkit is effectively disseminated and utilised across the country so that all women being prescribed valproate are fully informed of the risks to an unborn child.
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