Grieving dad fought for truth
GRIEVING father Derek Bye, who spent more than 40 years campaigning for medical negligence victims after the tragic death of his own daughter has passed away after a long period of ill-health.
A GRIEVING father who spent more than 40 years campaigning for medical negligence victims after the tragic death of his own 12-year-old daughter has passed away after a long period of ill-health at the age of 82.
Together with his wife Joan, Derek Bye devoted his life to exposing the failures like those that robbed them of 12-yearold Helenor.
The schoolgirl, who lived in Porthcawl with her parents, was prescribed a medicine used in the treatment of epilepsy – a condition she did not have.
Helenor died in 1978 after taking epilim, a brand name for the generic drug sodium valproate.
She suffered severe side effects before being admitted to hospital as an emergency case and abruptly taken off the drug.
She went into a long seizure and sank into a coma. After three-and-ahalf days, her life support was switched off.
An inquest two years later concluded that Helenor died of a rare genetic metabolic disorder called hyperammonaemia, but Mr and Mrs Bye, refused to accept the verdict.
They spoke to a world expert in the condition and discovered it was impossible for Helenor to have had it.
They found cases where other patients taking sodium valproate had developed the disorder and persuaded the manufacturers to alter the drug’s data sheet.
The couple formed a support group to help others searching for answers over the deaths of children.
In 2018, Tory peer Baroness Cumberlege was appointed by the then
Health Secretary Jeremy Hunt to chair the Independent Medicines and Medical Devices Security Review, investigating reports from women patients about harmful side effects from medicines and medical devices, and how the health service had responded.
The review included an examination of the use of sodium valproate.
It concluded that “[the] system does not know, so neither do we, just how many women over four decades took sodium valproate, a highly effective treatment for managing epilepsy but a known teratogenic medication [one that causes malformations in babies].”
The review found that the healthcare system, which included NHS, private providers, regulators, professional bodies, pharmaceutical and device manufacturers, is “disjointed, siloed, unresponsive and defensive.
It does not adequately recognise that patients are its raison d’etre.
It has failed to listen to their concerns and when, belatedly, it has decided to act it has too often moved glacially”.
Baroness Cumberlege said the system “is not good enough at spotting trends in practice and outcomes that give rise to safety concerns. Listening to patients is pivotal to that”.
The review made a series of recommendations, one of which was for “an immediate and fulsome apology on behalf of the healthcare system to families affected by sodium valproate”.
It also recommended the appointment of an independent patient safety commissioner, as well as the creation of a new independent Redress Agency for those harmed by medicines and medical devices, administered on a non-adversarial basis.
Mrs Bye said: “Derek was a wonderful husband who was determined to expose what had gone wrong in Helenor’s case and what needed to change so that tragedies like it could never happen again.
“We were emotionally devastated after Helenor’s death. Derek gave up his career as an area organiser for the mentally handicapped, and we have spent all this time fighting against a massive cover-up.”
Last October French prosecutors placed Sanofi, the pharmaceutical manufacturers of sodium valproate, under formal investigation for manslaughter after the deaths of four babies whose mothers took the drug.
In France, being put under formal investigation means that a dedicated investigative judge considers the case is serious enough to warrant an investigation.
Sanofi denies the allegations and is challenging the merits of the investigation.
Meanwhile, the French medical safety regulator faces prosecution for injuries and manslaughter by negligence caused by sodium valproate.
Mr Bye’s funeral was due to take place in Porthcawl on Monday.
A funeral for Helenor will be held at the same time, laying to rest body parts that were removed from her without her parents’ knowledge or permission.