The use of hormone pregnancy tests “should have been stopped” more than a decade before they were eventually withdrawn from the UK, a review has concluded.
“Opportunities were missed” to withdraw controversial hormone pregnancy tests, including Primodos, from the market, according to the Independent Medicines and Medical Devices Safety Review.
The review concludes: “It is our view that from 1967, hormone pregnancy tests should no longer have been available.
“We are of the view that their use as pregnancy tests should have been stopped in 1967 due to the suggestion of increased risk.”
But the tests were not fully withdrawn from the UK until 1978.
A bitter row lasting half a century has ensued, with families desperate for answers.
The review concluded that alternative pregnancy tests had become available and that “the expression of any concern about risk should have led to action by the regulator. Failure to act meant that women were exposed unnecessarily to a potential risk”.
Today’s announcement by @Jeremy_Hunt will strengthen this Government’s commitment to patient safety – @JuliaCumberlege will lead a review looking at Primodos, sodium valproate and vaginal mesh pic.twitter.com/JfJnUrQYZ4
— DHSC Media Centre (@DHSCmedia) February 21, 2018
Even today, the healthcare system does not know how many people took a hormone pregnancy test (HPT) such as Primodos.
“The system does not know, so neither do we, how many miscarriages may have occurred after taking this medication, how many of the children born to mothers who took Primodos may have suffered physical malformations or died before reaching adulthood, or how many of those children, now adults, may still be alive and in need of extensive care and support,” the report states.
But the Association For Children Damaged by Hormone Pregnancy Tests, estimates that 1.25 million took the drugs and thousands of families have been affected, though some may be unaware.
Patients and their families who gave evidence to the review also showed “psychological suffering”.
“The sorrow and anger arising from a conviction that lives had been needlessly, and often irreparably, damaged, both physically and mentally; the impact of carrying a relentless sense of burning injustice for decades without resolution; parents of the affected children, deeply anxious about what will happen to their adult child when they are no longer there for them; mothers burdened by guilt at having taken the tablets. The extent of the suffering, endured over decades, must not be underestimated,” the report adds.
During the 1950s and early 1960s, pregnancy tests were provided by the NHS, but only for women with a pressing medical need for a diagnosis.
HPTs were used from 1950 onwards in Britain.
The tests contained a synthetic versions of two hormones found naturally in the body – progesterone and estrogen.
Varying combinations of progestogens and estrogens are used daily by many millions of women for contraception – the oral contraceptive pill.
Campaigners said that Primodos tablets were 40 times the strength of the pill.
One tablet was taken on each of two consecutive days – if women had a “withdrawal bleed” a few days later this meant they were not pregnant.
Campaigners have claimed that the use of the medicine in early pregnancy has caused a range of devastating and life-long impacts such as limb defects, spina bifida, congenital heart defects or developmental and learning problems.
It has been claimed that the use of the drug also led to miscarriages or still births.
When hormone pregnancy tests first became available, the regulatory framework which guides medicines was not in place.
Pharmaceutical companies were not required by law to ensure that marketed medicines met appropriate standards of safety and efficacy.
It was not until the thalidomide tragedy in 1961 that the regulation was put in place.
Campaigners have faced a series of blows when trying to get their voices heard.
The latest review stressed that the scope of the inquiry was not to determine a causal association between HPT use and physical malformations.
It instead examined the UK’s decision making around the drugs in the healthcare system.
It examined the role of the Committee on Safety of Drugs – a UK body established in 1964.
The review team said this body “should have recommended the withdrawal of the indication for use as a pregnancy test in 1967”.
Their report added: “We also consider that further opportunities for action were missed in 1970, 1973 and 1974 when the preliminary results from the CSD/CSM study, which indicated an association between HPT use and malformations, became known.”
“An apology is due, and support is required for those who have suffered avoidable harm,” the authors recommended.
Marie Lyon, chairwoman of the Association For Children Damaged by Hormone Pregnancy Tests, said: “I am just so overwhelmed that after a 53 year battle to expose the truth about oral hormone pregnancy tests, Baroness Cumberlege and her team have concluded that the first substantive scientific report on Primodos in 1967, was sufficient to justify the withdrawal of Primodos and other HPT’s from the market.
“It has been concluded there was sufficient evidence of adverse effects to justify the withdrawal of HPT’s and both the UK regulator and the drug company failed in their duty of care to our families.
“This is a result we could only dream of, after years of campaigning to expose the truth about the life changing and heart breaking effect of these drugs.”
MP Yasmin Qureshi, who has been campaigning over the issue for the last eight years, said: “This is the most comprehensive assessment of this tragedy to date and a significant moment in the long struggle for recognition.
“Although the findings will not go all the way towards giving families closure – because nothing can compensate them for their past losses and struggles – I do believe that this report contains detailed recommendations on practical ways in which the lives of those affected by Primodos, their families and their carers can be improved and how they can finally achieve something like the justice they have been denied for over 50 years.”