Campaigning parents dismiss outcome of inquiry into drug
THE campaigning parents of a 12-year-old girl who died more than 40 years ago after being prescribed a medicine used in the treatment of epilepsy – a condition she did not have – say they are not reassured by the outcome of an inquiry into the use of the drug.
Helenor Bye, of Porthcawl, 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 concluded that Helenor died of a rare genetic metabolic disorder called hyperammonaemia, but her parents, Joan and Derek Bye, refused to accept the verdict. They spoke to a world expert in genetic hyperammonaemia 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.
Its recently published report 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 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: “These recommendations are all very well, but after all these years campaigning for justice and getting blocked time and again, I have little faith that the interests of patients will truly be to the fore in the future.”
Last month 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.
Sanofi denies the allegations and is challenging the merits of the investigation.