Campaigners have accused the UK government of betraying them after a review of redress for victims of health scandals excluded families who may have been affected by the hormone pregnancy test Primodos.
A report published on Wednesday by the patient safety commissioner, Dr Henrietta Hughes, found a “clear case for redress” for thousands of women and children who suffered “avoidable harm” from the epilepsy treatment sodium valproate and from vaginal mesh implants.
But despite the commissioner wanting to include families affected by hormone pregnancy tests in her review, the Department of Health and Social Care (DHSC) told her they would not be included.
Primodos was an oral hormonal drug used between the 1950s and 70s for regulating menstrual cycles, and as a pregnancy test. Hormone pregnancy tests stopped being sold in the late 1970s and manufacturers have faced claims that such tests led to birth defects and miscarriages. Last year, the high court dismissed a case brought by more than 100 families to seek legal compensation owing to insufficient new evidence.
The Hughes report states: “Our terms of reference did not include the issue of hormone pregnancy tests. This was a decision taken by DHSC and should not be interpreted as representing the views of the commissioner on the avoidable harm suffered in relation to hormone pregnancy tests or the action required to address this.
“The patient safety commissioner wanted them included in the scope but, nevertheless, agreed to take on the work as defined by DHSC ministers.”
Marie Lyon, the chair of the Association for Children Damaged by Hormone Pregnancy Tests, said the families of those who took the tests felt “left out in the cold” and betrayed that they were not included in the commissioner’s review.
“I feel betrayed by the patient safety commissioner, by the IMMDS [Independent Medicines and Medical Devices Safety] review and by the secretary of state for health – all three have betrayed our families because, basically, they have just forgotten us. It’s a case of ‘it’s too difficult so we will just focus on valproate and mesh’,” Lyon said.
Prof Carl Heneghan, a professor of evidence-based medicine at the University of Oxford, who led a systematic review of Primodos in 2018, said: “It’s unclear to me how the commissioner can keep patients safe if they are blocked and don’t have the power to go to areas where patient safety matters.”
Given that the courts dismissed the legal case for compensation, “there should be no impediment to the safety commissioners undertaking a redress report for the families who suffered the harmful effects of hormone pregnancy tests”, he said. “This report should be done urgently, and if it isn’t, the safety commissioner and the DHSC need to explain why they are now blocking it.”
The Lib Dem leader, Ed Davey, said: “The victims of this horrific scandal deserve a public inquiry. It is the only way to get past the threatening and stonewalling from pharmaceutical companies and the government. Everyone who has played a part in perpetuating this misery must be finally held to account and the recommendations of the First Do No Harm report must be implemented in full. Anything less would be a shameful failure of all those who have suffered so much.”
Lyon said up to 1,200 families had contacted the charity since 1978. Many said their GP had not told them about the risk associated with Primodos, which is 40 times the strength of an oral contraceptive pill.
“Our families receive no [assistance with the care of their children] or financial support for medication or the equipment necessary to prevent physical and mental health deterioration,” she said.
The commissioner’s report estimates that at least 10,000 women’s lives were “destroyed” by pelvic mesh, and at least 14,000 children in England alone “will never be able to live independent lives” after being exposed to sodium valproate in the womb between 1973 and 2017.
Sodium valproate, used to treat epilepsy, has been linked to physical malformations, autism and developmental delay in some children when it was taken by their mothers while pregnant.
Vaginal mesh implants have been used to treat urinary and gynaecological conditions, but have caused debilitating harm to some women.
The commissioner’s report says the “systemic healthcare and regulatory failures” mean the government should create a two-stage financial redress scheme. An interim payment of £25,000 would be followed by a main scheme with payouts based on the individual needs of each patient.
Although Hughes acknowledged families across the UK were harmed by vaginal mesh and sodium valproate, she said her statutory remit meant the report only covered redress for victims in England.
Wes Streeting, the Labour health spokesperson, said he was horrified by these scandals and called for a cross-party push to sort out redress for victims.
“I think we’ve got to learn the lesson from the experience with the victims of infected blood where justice has taken too long and it’s still proceeding at too slow a pace,” he said. “On this, why don’t we put party politics to one side, work together to get the compensation that these victims desperately need?”
A Department of Health and Social Care spokesperson said: “We remain hugely sympathetic to the families who believe that they or their children have suffered following the use of hormone pregnancy tests.
“It is right that the government is led by the scientific evidence and after reviewing the available evidence, the government’s position remains that the available evidence does not support a causal association between the use of hormone pregnancy tests and adverse outcomes in pregnancy.
“We are not closing the door on those who believe they have been affected and have committed to reviewing any new scientific evidence which may come to light.”
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