RxISK Stories – Facts about FACS

Janet’s Story

I was diagnosed with epilepsy at the age of 14. After trying different drugs my seizures were controlled by a combination of Phenytoin (Epanutin) and Sodium Valproate (Epilim). What they didn’t tell me was that Sodium Valproate carried the highest incidence of birth defects to the unborn baby. In my ignorance I continued to take the drugs in all of my pregnancies thinking I was doing the best thing for my child.

Fetal AntiConvulsant Syndrome (FACS) has been known about since about 1968 and Fetal Valproate Syndrome specifically was first talked about in a 1980 journal paper. Latest figures conclude that up to 40% of babies exposed to sodium valproate will develop neurological defects.

I had the first of my four children in 1988. I was told about risks like hare lip and cleft palate and spina bifida, but I was also told that it would be safer for me to remain on my medication. I was scanned more often than normal throughout the pregnancy to check for these risks. All of my children seemed normal. I had my last child in 1999, and not once in all that time was I told of the potential risks to my children. I believed them to have been unaffected by my drugs because they didn’t show any of the classic problems – like spina bifida.

My younger two had health and behavioural problems from birth. It was as they grew that their problems with social interaction and communication brought their many other problems to light and showed me that my older children had in fact also been affected but not so obviously. My two youngest have been diagnosed with Autism as part of FACS and are both statemented into specialist schools in different areas. The problems with social interaction left them isolated and depressed in main stream primary education.  They lead lonely lives with few friends. They also have asthma, bowel problems, joint pain, problems with memory, attention and concentration, sleep problems, sensory issues and more.

One of the hardest things for them has been the fact that they can communicate verbally and look like any other child but their cognitive ability and comprehension is poor and this leads them to get stressed and confused. They don’t show their emotions facially and don’t say when things are too much for them – instead they have a melt down or get very upset. This has led them, and us as a family, to become socially ostracised in the neighbourhood. There is a lack of knowledge and understanding that makes other people judge you poorly as parents.  It leads to bullying also. I remember one time when our son came home saying his friend couldn’t come to tea as her mum thought our family were ‘weird’!

I heard about the condition from an Article by Janet Williams from OACs (the Organisation for AntiConvulsant Syndrome – http://www.oacs-uk.co.uk/) and from FACT (http://www.fact-uk.co.uk/) about the litigation. I heard nothing from the medical profession. It was through OACS that we were seen by top geneticist Peter Turnpenny who diagnosed my youngest two with FVS (Fetal Valproate Syndrome).

As a mother you feel guilty beyond belief, but also so angry and you don’t know how to deal with those emotions which can be so destructive. I decided to join OACs  to meet and help others in the same situation. Last year we founded FACT in the hopes that we can raise awareness and get the government and drug companies to accept responsibility for the fact that the warnings were not given and 1000’s of children will need lifelong support as a result. The numbers continue to grow as the drug is still being prescribed not just for epilepsy but many other conditions also like bipolar disorder, depression, blood pressure, headaches etc. Latest figures estimate that the numbers of children affected are potentially growing by 1354 each year (these are calculated by our medical researchers based on latest available data).

Because of the lack of awareness and knowledge many children are being wrongly diagnosed with Autistic Spectrum conditions or they are classed as naughty children caused by bad parenting. There are incidences of Social services accusing families of child abuse because of their lack of awareness of the condition which then adds to the pressure already felt by the parent. Many families exist on benefits as the mother already has a disability of her own and because of the lack of warnings many families have more than one child affected and the parents become full time carers. We as a family have been criticised and questioned by the authorities so much and had such little support that it has resulted in my husband also becoming ill due to the stress. Many couples don’t survive.

We are working to increase awareness within the government, health and social care, and education. By doing so we hope that the children affected can then receive the lifelong support that so many will need. We have parents and parent groups across the globe and have several MP’s supporting us as we set up an All Party Parliamentary Group to lobby about the Syndrome within Parliament. We have already attended and are due to attend meetings in Whitehall to bring the Syndrome to the attention of the relevant people and we are being guided by the Thalidomide Trust on our journey.

Janet Stockley-Pollard

RxISK Response

Just this week Chemie-Gruenenthal, the makers of Thalidomide have been in the news. They have asked for forgiveness. All the indications are that Thalidomiders would be prepared to forgive but believe that the asking is hollow if the company are not prepared to say what happened in the first instance. And they aren’t. There is still a veil of secrecy over the origins of the drug, and the extent to which the company both hid problems they became aware of and marketed the drug despite growing evidence of a problem.

Just this week, the Lancet has run a self-congratulatory editorial whose primary author appears to be A Breckenridge, now head of the MHRA (Britain’s FDA), who previously had links to many of the major pharmaceutical companies including GlaxoSmithKline and who has been a vocal defender of drugs like Seroxat-Paxil in the public domain right up to the moment when it became illegal for the company to defend certain issues further. The editorial gives the impression that nothing like Thalidomide could happen again. Janet’s story gives the lie to this.

Just a few weeks ago, Martha Rosenberg posted an interview with Ronald Kavanagh, a former scientist at FDA, who makes a strong case that if Thalidomide were ever to happen again, the FDA would not act. And many drug company personnel are on record stating that if disasters like Opren-Oraflex were to happen again that companies have gotten so good at “managing”  problems, they could keep the drug on the market for ever.

Meanwhile, in the United States GlaxoSmithKline have resolved a series of birth defect cases linked to Paxil-Seroxat apparently to the tune of over $1 billion. Other SSRI companies face the same. There is clear evidence that these drugs also lead to substantially increased miscarriage and voluntary termination rates and growing evidence that they lead to behavioral delay and other abnormalties just as anticonvulsants do, but FDA and MHRA do nothing.