Loving mother Karen Buck knows every cuddle with her 14-year-old daughter Bridget could be the last.
In a few weeks, the frail dark-haired teenager is expected to die and her family have signed an instruction that she must not be resuscitated. (pictured are Karen Buck and daughter Bridget)
If that sounds harsh, the facts are stark. Bridget has not been able to swallow solid food for months and can only be fed from a baby’s bottle.
Her brain is so damaged she has the comprehension of a toddler and has never uttered a word.
Her twisted legs are shrunken, her back is bent, and every day she gets weaker still. She sometimes stops breathing for a minute at a time.
In fact, it is a miracle that 6st Bridget is still alive at all.
For she was born with a catastrophic array of medical ailments, including brain damage and spina bifida — where part of the spinal cord is exposed.
In March 1998 Karen took a drug called Epilim to combat her epileptic fits during the pregnancy. Her daughter has needed 24-hour care every day since.
What has happened to this family from Stanmore, Middlesex, is not a rarity.
Earlier this month, the Daily Mail printed Carol Sarler’s heartbreaking account of her battle to get help for her three-year-old granddaughter Milly, born brain-damaged after Carol’s daughter took Epilim when pregnant.
In fact, campaigners and researchers say that of the 48,000 children born to mothers in the UK who have taken the drug since it was introduced in 1973, 40 per cent — a massive 19,200 — have developed physical or mental problems. Some, like Bridget, suffer both.
They claim that up to 800 new babies are affected every year and will need a lifetime of care at a cost of hundreds of millions to the state.
Their allegations chime with a groundbreaking new report from Liverpool University, which monitored the development over six years of 243 babies born to mothers with epilepsy between 2000 and 2004.
Published in the respected Journal of Neurology, Neurosurgery and Psychiatry, it says children exposed to Epilim are six times more likely to have a neurodevelopment disorder than pregnant mothers who took other types of anti-seizure drugs or none at all.
The researchers concluded that one in three of the children born to mothers taking Epilim has learning difficulties, low IQ and types of autism.
‘It is a huge medical dilemma,’ said Professor Gus Baker, an eminent neuropsychologist who conducted the research.
It also has huge social implications, says Dr Peter Turnpenny, a consultant geneticist at the Royal Exeter and Devon Hospital who has advised mothers with children damaged by Epilim.
‘It is really tough on the families who devote their whole lives to these children, some of whom never really grow up.
‘The parents are worried what will happen when they, themselves, die.
‘It is a big financial burden for the country to care for them, and we know that hundreds more babies with the same neurodevelopment problems are being born each year.’
Epilim, one of the registered trade names for sodium valproate which controls electrical activity in the brain to halt seizures, is now being blamed for a medical disaster worse than the Thalidomide scandal of the Sixties — when around 2,000 babies were tragically born with missing or shortened limbs after their mothers took the drug Thalidomide to control morning sickness.
For Emma Murphy, a 32-year-old Manchester-based mother with epilepsy and a founder of the Independent Fetal Anti-Convulsant Trust (FACT), there is no doubt about the scale of the problem:
‘This is bigger than Thalidomide and it will not just be epileptic mothers whose babies are harmed.
‘Epilim is prescribed to pregnant mothers with depression, bi-polar disorders and even for pain relief.
‘Women must be told by doctors before they start a family that there is a danger in using this drug when they are expecting.’
Emma has five children who have all been affected.
‘Every day I deal with autism, slow learning, incontinence, deafness, and a host of other problems that they suffer.
‘I was not warned about Epilim by my doctor, even after my fourth child and when I voiced my suspicions.
‘I was nursery nurse and I believed the medical team when I was told there were no dangers using the drug in pregnancy.
‘Now I, my husband Joe and the children are paying a high price.’
Suspicions that sodium valproate caused physical defects, particularly spina bifida and cleft palates, in children first emerged in 1980.
Then came the realisation that some of the Epilim babies had distinctive facial abnormalities, such as high brows, broadened noses and downturned mouths.
More research in 2005 found rates of autism among babies exposed to sodium valproate were far higher than in the general population.
But still the drug was handed out without, the campaigners claim, warnings to mothers.
Janet Williams, 47, another founder of FACT, explains: ‘We know there are mothers having babies today who have not been told of the dangers.
‘GPs and even some experts on epilepsy are prescribing Epilim without telling them what could happen.
‘We know that it is a good drug for controlling seizures, which can be dangerous for a pregnant mother especially if she falls, but too many children are being harmed by it.’
Janet, who lives in Preston, Lancashire, has two sons, Lee, 23, and Philip, 21 affected by the drug which she’s taken since girlhood to stop epileptic seizures — Lee has learning difficulties, Philip is autistic.
Remarkably, both boys continued at school until 18 and have been to college, but Janet worries about the future.
‘I don’t know how they will cope away from home without help.
‘I think Epilim is a fantastic drug to control seizures.
‘For years it has been the drug of choice by the medical world for treating epileptics and women like it.
‘I don’t want it off the market. But there must be alternatives for mothers. They need counselling if they are even thinking of starting a family.’
Emma Friedmann, mother of Andy, 14, who lives in Leicester, feels the same. She was first prescribed Epilim at 14 and had heard about the dangers it could pose to pregnant women.
She later went to her neurologist and said one day she’d like to have a baby and thought she should change medication.
The neurologist at first refused and suggested counselling. But two years later, when Emma had met Andy’s father, she demanded to go on a different drug.
She had to continue on Epilim and the new drug was gradually introduced.
‘But I became pregnant very quickly. The neurologist said because I had stopped using contraception I was stupid and that, perhaps, should have been a warning.’
Because there is an increased danger of birth defects in children if Epilim is taken in conjunction with another drug, the neurologist advised her to soldier on with Epilim alone.
Andy was born three weeks early and was not breathing. He was in intensive care for three weeks. He did not cry. He did not follow his mother with his eyes. He had no sucking reflex and it took him days to learn to feed from a bottle.
Andy has since been diagnosed as autistic; he is also short-sighted, has floppy limbs, a speech impediment and no awareness of danger.
As a baby, his facial features had the classic sign of valproate damage — the broad nose, the large forehead, the downturned mouth.
‘Because his hands don’t work properly he can’t even use a flannel to wash his face or do up buttons,’ says Emma, who is separated from Andy’s father.
Emma successfully sent Andy to a local primary school and taught him to read, but she first realised how very damaged her son was when she visited a secondary special school when he was 11.
‘I saw pictures drawn by 15-year-olds that looked like the work of a three-year-old. It was the kind of painting Andy would manage. I went home and cried,’ she says sadly.
Emma, who now runs the Organisation for Anti-Convulsant Syndrome, a charity raising awareness about the problem, has estimated that the cost of Andy’s care to the state — including social services, special education and carers — over his lifetime will be more than £6 million.
‘There must be a public inquiry into why mothers were not warned of the dangers of the drug when it was known about years ago,’ she says.
‘It should happen for the sake of Andy and all the other children.’
Six years ago, the law firm Irwin Mitchell began a claim for compensation against Sanofi Aventis, the drug’s manufacturer, on behalf of 100 children whose mothers say suffered birth defects because the drug was taken during pregnancy.
The case was publicly funded by legal aid through the Legal Services Commission (LSC).
But in November 2010, six weeks before the trial was due to start, the LSC withdrew funding.
‘The LSC can only spend taxpayers’ money where we believe there is a reasonable prospect of success,’ it said.
At the time, Sanofi Aventis expressed sympathy with the families but insisted it always issued appropriate warnings in its literature on Epilim ‘in line with developing scientific knowledge’.
The company has since said that for some women of child-bearing age, valproate may be the only effective seizure control medication.
It has warned that the decision to take it must be made after careful evaluation, between the patient and the treating physician, to decide whether the benefits outweigh the risks to the unborn child.
One of the mothers hoping to have her day in court was Karen Buck.
Under the deal struck when the court case failed, the families promised not to sue Sanofi Aventis in the future, if their £3.5 million legal costs for preparing the trial were paid for by the pharmaceutical company.
Today Karen Buck is still angry about the outcome.
As she nurses Bridget in her pink bedroom with a picture of the Teddy Bears’ Picnic on the wall, she says: ‘I am losing my little girl. It could happen any day and every moment is precious.
‘There are other babies being born as we speak whose future lives will already have been wrecked by this drug.
‘I took Bridget, in her wheelchair, to court so the drug company lawyers could see her.
‘They wouldn’t even look us in the eye, and is it any wonder?’