BBC Two documentary Mums v Big Pharma has detailed how pharmaceutical bosses and National Health Service (NHS) regulators ignored warnings that the epilepsy drug sodium valproate harmed unborn babies.
Around 20,000 children are believed to have been born with birth defects after their mothers were prescribed the medication, which is also sold under the brand name Epilim, starting in the 1970s. Rather than acting on concerns, drug company executives and doctors deflected blame for decades and accused the mothers of disabled children of being ignorant, "hysterical" or bad parents.
Reviewing the programme, television critic Christopher Stevens noted that the documentary laid out a start-to-finish timeline of how the medical establishment ignored affected families. Broadcast on BBC Two, the British public service television channel, the film combined stylised silent animations with testimony from mothers and their children as they took on the government, the health service, social services, the courts and multinational businesses.
While authorities have now admitted that taking the medicine during pregnancy carries major risks, the affected children and their families have still not been awarded financial compensation. Stevens wrote that even that partial victory only happened because of the determination of two campaigning mothers, Janet Williams and Emma Murphy, who between them have eight children, seven of whom live with disabilities attributed to sodium valproate.
Janet Williams and the effects of Epilim in pregnancy
Janet Williams took Epilim to treat her epilepsy, a neurological condition that causes recurring seizures. She and her husband Steve first grew concerned about their sons, Lee and Phil, when the boys began missing early childhood developmental milestones such as sitting up and crawling.
Both babies were constantly drowsy, with Steve recalling that Lee could "sleep on a washing line". Years passed before a medical specialist sent the couple a cold, off-hand note stating that "the most likely explanation for the problems" was "the effect of Epilim during pregnancy". Janet and Steve remarked heavily that it was "a bit too late to tell us now."
Birth defects linked to sodium valproate
Women who were prescribed the anti-epilepsy pill received it in a plain white box without any warnings about pregnancy risks. However, the medication had been linked to serious physical conditions in newborns, including limb defects, spina bifida and cleft palates, alongside autism and other developmental issues.
Sodium valproate is an anticonvulsant medication prescribed to control seizures by stabilising electrical activity in the brain. Spina bifida is a birth defect in which a developing baby's spine fails to form properly in the womb, while a cleft palate leaves an opening in the roof of the mouth, and autism is a developmental condition affecting communication and interaction.
Sanofi court battle and National Archives files
While campaigning to warn other parents about the dangers of the drug, Janet Williams met mother-of-six Emma Murphy. Together, the two women spent years spearheading a court battle to hold Epilim's manufacturer, the multinational pharmaceutical company Sanofi, to account.
"We were referred to as hysterical housewives," Emma said of their treatment during the campaign. The mothers were eventually forced to back down when their legal aid, the public funding that helps people in the United Kingdom afford legal representation in court, was withdrawn. By 2004, Sanofi had an annual turnover of £200million from sodium valproate.
Undeterred by the collapse of the court action, Janet Williams and Emma Murphy continued amassing evidence themselves and uncovered crucial proof at the National Archives in Kew, south-west London, which holds official UK government records. Documents buried in the archive showed that regulators had been informed of sodium valproate's appalling side effects in pregnancy back in 1974, but suppressed the information on the grounds that it would "give rise to fruitless anxiety".
