Primodos: New study claims to find link between the pregnancy test drug and malformations
A new study claims to reveal how the hormone pregnancy test drug Primodos damages the foetus in some pregnant women.
The report comes after alleged victims of the drug had their legal challenge against the manufacturer and the Department of Health struck out by a judge in May this year.
Primodos was a hormone-packed pill and, in the 1960s and 70s, GPs gave it to women to test whether they were pregnant.
This new report produced by a Swedish professor of pharmacology and toxicology claims the drug could cause damage to the foetus in similar ways to abortion drugs.
Bengt Danielsson, who has worked in the field of drug safety and teratology for 35 years, spent two years analysing data from studies on Hormone Pregnancy Tests (HPTs), concluding the drug had the potential to cause a range of congenital problems, such as shortened limbs, skeletal malformations, and cardiovascular defects.
Professor Bengt Danielsson Consultant in Early Drug Development on non-clinical and clinical safety
Campaigners plan to raise the findings in a meeting on Wednesday with the minister for patient safety, who agreed to look again at the issue following a heated debate in parliament in September.
Previously, the government had apologised for letting down the alleged victims of Primodos, before siding with the manufacturer to block their legal claim.
HPTs were sold under different trademarks, the most prevalent in the UK was called Primodos.
Unlike the urine pregnancy test that was developed later, these were two pills that were handed out by GPs to be taken 12 hours apart.
This would give the woman a rise in hormones, followed by a rapid decline, mimicking the end of the menstrual cycle, which in non-pregnant women would trigger a menstruation bleed.
If a pregnant woman used HPTs, she would generally have high levels of pregnancy-induced progesterone, which maintains pregnancy normally and there is no bleed – and this is how the woman knows she is pregnant.
However, Professor Danielsson’s study suggests that HPTs have potential for a third outcome – to initiate a failed abortion process, resulting in uterine contractions and bleeding in some pregnant women – most likely those women with naturally lower progesterone levels when pregnant.
He argues the hormone spike from the pregnancy test could give women with low progesterone levels uterine cramping, resulting in the womb attempting to expel the uterine lining with the living embryo.
His paper suggests this also decreases blood flow to the embryo, starving tissues of oxygen (hypoxia) and when the oxygen returns, this can also impact recently formed blood vessels within the embryo (so called “vascular disruption”) which can damage whatever is developing at the time.
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Pregnancy testing drugs ‘did cause defects’
This could range from shortened limbs to hand defects – to damaged internal organs such as the heart and brain.
Professor Danielsson argues this “vascular disruption” is the same mechanism that can occur with the morning-after pill, Misoprostol, if it somehow fails to abort the embryo.
He says his hypothesis is supported by numerous factors, not least results in a human clinical trial in Australia, where a proportion of women who used HPTs showed “spotting” and signs similar to an early threatened miscarriage.
He also notes that the types of malformations seen in alleged HPT victims are near identical to those associated with Misoprostol.
He told Sky News: “Depending when in pregnancy of having this hypoxia, the oxygen deficiency event, that also tells you what type of malformations you would get.
“So, if it’s early on, it would be more severe, for example an amputation of the arm. Later, it might be the branches of the latest developed vessels such as the fingers.”
Professor Danielsson is also critical of an expert working group EWG commissioned by the British government, which concluded in 2017 that they could not find evidence to prove a causal association between hormone pregnancy tests and malformations in the embryo.
He argues that the datasets within the annexes of their report show the association exists.
He said: “One of the annexes to the EWG report, highlighted that HPTs may cause embryonic hypoxia by a similar mechanism as Misoprostol and that several types of malformations associated with HPTs were of the same ‘vascular disruption’ type as shown for Misoprostol.”
He added: “Two extensive epidemiogical investigations on HPT-associated malformations, based on totally different populations and different methods, were presented in annexes to the EWG report.
“Both showed consistency in increases of several specific defects, however this important aspect was neglected.”
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Charles Feeny, the barrister who represented the alleged victims of Primodos, said: “It was like they (the EWG) had the pieces of a jigsaw on the table – and it’s a complicated jigsaw and you’ve got to put the pieces together carefully and they just weren’t able to do that.
“What Bengt Danielsson’s done is put all the pieces together – and there you can see that clear picture.
“Hormone Pregnancy tests did cause malformations, but they caused them in a small group of women, the women who were susceptible to it, probably because they had low progesterone levels, even though they were pregnant.”
Barrister Charles Feeny
Mr Feeny also believes the drug would have caused some women to have abortions.
The High Court judgment in May dismissed the legal case in the UK. Previous litigation against Schering, which is now owned by German manufacturer Bayer, also failed in 1982 when the claimants’ legal team decided to discontinue on the grounds that there was no realistic possibility of success.
Bayer told Sky News: “Since the discontinuation of the legal action in 1982, Bayer maintains that no significant new scientific knowledge has been produced which would call into question the validity of the previous assessment of there being no link between the use of Primodos and the occurrence of such congenital anomalies.
“In 2017, the Expert Working Group of the UK’s Commission on Human Medicines published a detailed report concluding that the available scientific data from a variety of scientific disciplines did not support the existence of a causal relationship between the use of sex hormones in pregnancy and an increased incidence of congenital anomalies in the new-born or of other adverse outcomes such as miscarriage.
“The Committee for Medicinal Products for Human Use of the European Medicines Agency supported that conclusion.”
There’s been a huge increase in animal neglect and abandonment in England and Wales and the RSPCA’s rescue centres are “absolutely full”, according to the charity.
New figures show there were 38,977 incidents of neglect reported to the RSPCA’s emergency cruelty line between January and September 2023.
But for the same period in 2024, there were 48,814 – a 25% increase.
The number of animals dumped in winter has also doubled.
“Our centres up and down the country are absolutely full, and we’re also taking animals into private boarding,” said RSPCA spokesperson Suzanne Norbury.
“So when our teams are out there, they rescue animals and we haven’t got space.
“We’re spending money on private boarding facilities at the moment on top of running centres like this one. It’s costing us £26,000 each and every week.”
It means the charity is trying to absorb extra costs of £1,352,000 a year for emergency boarding.
RSPCA spokesperson Suzanne Norbury said centres are full
At their rescue centre at Frankley near Birmingham, Damon is one of many cats looking for a new home.
He was a stray found on a building site with a broken jaw and has had to have it wired back together at the animal hospital here.
Damon had his jaw wired back together
‘The first thing they cut back on is their animals’
Ian Briggs, a chief inspector for the charity, said: “He must have been in considerable pain, and it was only due to a member of the public letting us know that we were able to intervene and give him the treatment he needed.”
“During COVID, people sought to own pets because they were looking to have companionship.
“Then after lockdown was released and everyone got back to normal, we were then hit by the cost of living crisis. Then year on year we’re seeing finances stretched for everybody, so we believe we’ve got all these extra people who have pets and now some are feeling the financial strain.”
He added: “Because of the Christmas period, we’re in the middle of winter, heating goes up, electricity costs even more, that adds an additional financial burden to people who are already struggling, and often the first thing they cut back on is their animals.”
Damon the cat
Animals found in appalling conditions
Last year, the charity rescued 34 animals from a house in Walsall, including 24 dogs, who’d been kept in appalling conditions.
They were found surrounded by hundreds of empty dog food cans, and faeces.
Following an RSPCA prosecution, two people were disqualified from keeping all animals for life.
They also received suspended 20-week custodial sentences after pleading guilty to offences including failing to provide the animals with veterinary care, a suitable living environment or taking reasonable steps to protect them from pain, suffering, injury and disease.
The animals were rehabilitated at various RSPCA rehoming centres, including the centre at Frankley.
One, a Staffordshire bull terrier cross, was rehomed in the summer.
Sarah Potter with her new cats
‘We needed to give two homeless cats a home’
Cats Peter and Paul are the lucky ones being picked up to be taken to a new home while Sky News was filming at the centre.
Sarah and Martin Potter are taking them back to Worcestershire.
“We recently lost a cat,” said Sarah, “and the house is just completely empty”.
“We’ve just got so much love to give, that we needed to give two homeless cats a home ready for Christmas”.
It can, though, take years for other animals to be re-homed and there are now more than ever needing a new start.
UK
King praises response to ‘lawless’ UK riots in Christmas message – as he gives ‘personal’ thanks to medics
The King has praised the community response to the “anger and lawlessness” of this summer’s riots in towns and cities around the UK in his annual Christmas message.
Charles, 76, also used the message, filmed by Sky News at the chapel of the former Middlesex Hospital in central London, to thank doctors and nurses who cared for him and his daughter-in-law the Princess of Wales through their cancer treatment this year.
Drawing on the Nativity story’s theme of listening to others, the King said: “Through listening, we learn to respect our differences, to defeat prejudice, and to open up new possibilities.
“I felt a deep sense of pride here in the United Kingdom when, in response to anger and lawlessness in several towns this summer, communities came together, not to repeat these behaviours, but to repair.
“To repair not just buildings, but relationships. And, most importantly, to repair trust; by listening and, through understanding, deciding how to act for the good of all.”
King Charles and Queen Camilla attend church at Sandringham on Christmas morning. Pic: PA
Read more:
Sky News behind the scenes of King’s message
King jokes he’s ‘still alive’
Almost 1,000 people were arrested during the summer riots, which came in response to misinformation around the deadly stabbing of three children at a Taylor Swift-themed holiday club in Southport in July.
The King visited the Merseyside town after the killings and the ensuing disorder, during which rioters attacked hotels housing migrants.
His final public engagement of the year was in Walthamstow, east London, where thousands gathered in a counter-protest to condemn the rioting this summer.
The King’s Christmas message spoke of the need to support one another, as “all of us go through some form of suffering at some stage in our life – be it mental or physical”.
“The degree to which we help one another – and draw support from each other, be we people of faith or of none – is a measure of our civilisation as nations,” he said.
He added that “those who dedicate their lives to helping others… continually impress me” and he is “thinking especially of the many thousands of professionals and volunteers here in the United Kingdom and across the Commonwealth who, with their skills and out of the goodness of their heart, care for others – often at some cost to themselves”.
The Prince and Princess of Wales with their children Louis, Charlotte and George on Christmas Day. Pic: PA
Reflecting on his cancer treatment, which will continue into next year, he gave his “special, heartfelt thanks to the selfless doctors and nurses who, this year, have supported me and other members of my family through the uncertainties and anxieties of illness, and have helped provide the strength, care and comfort we have needed”.
He also thanked members of the public for their well-wishes after he and the Princess of Wales, 42, returned to public duties in April and September respectively – following courses of cancer treatment.
They and other members of the Royal Family attended church near the Sandringham estate in Norfolk on Christmas morning.
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How Sky News filmed the King’s message
Thoughts with people in ‘Middle East, central Europe and Africa’
The King began his message by recalling his visit to 80th anniversary D-Day commemorations with the Queen in June.
He described meeting “remarkable veterans” and noted that “during previous commemorations we were able to console ourselves with the thought that these tragic events seldom happen in the modern era”.
But he said: “On this Christmas Day, we cannot help but think of those for whom the devastating effects of conflict – in the Middle East, in central Europe, in Africa and elsewhere – pose a daily threat to so many people’s lives and livelihoods.”
He thanked humanitarian organisations working in conflict zones and referenced the gospels’ references to conflict and the “values with which we can overcome” them.
Signing off, he wished “you and all those you love a most joyful and peaceful Christmas”.
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