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 vaginal mesh implants.
But despite wanting to include families affected by hormone pregnancy tests in her review, the Department of Health and Social Care (DHSC) told the commissioner 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 due 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 hormone pregnancy tests felt “left out in the cold” and “betrayed” that they were not included in the patient safety commissioner’s review.
“I feel betrayed by the patient safety commissioner, by the IMMDS review [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’.”
Prof Carl Heneghan, a professor of evidence based medicine at the University of Oxford, who led a systematic review into 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.
And given 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 added.
“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.”
Up to 1,200 families had contacted the charity since 1978, Lyon added. 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” due to pelvic mesh, and at least 14,000 thousand 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” means 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.
But although Hughes acknowledged families across the UK were harmed by vaginal mesh and 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?”
