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.”
Google is set to invest £5bn in the UK in the next two years, to support growing demands for AI services.
The announcement, which comes as Google opens a new data centre in Waltham Cross in Hertfordshire, is expected to contribute to the creation of thousands of jobs, the US tech giant said.
Chancellor Rachel Reeves described it as a “vote of confidence” in the UK economy.
The news comes hours before Donald Trump lands in the UK for a state visit at which he and Sir Keir Starmer are widely expected to sign a new UK-US tech deal.
It also follows reports that ChatGPT parent firm OpenAI, and Nvidia, will also unveil billions of dollars’ worth of investment into UK data centres this week.
The chancellor said the investment would boost research and development, capital expenditure and engineering.
However, Liberal Democrat leader Sir Ed Davey has criticised the proposed deal as a “Silicon Valley stitch-up”, and has demanded that the government put it to a vote in parliament.
He said: “I am really concerned the government is going to agree to a Silicon Valley stitch-up that hands tax cuts to tech billionaires while undermining protections for our children online.”
Sir Ed added: “Parents want protections for children online to be kept in place, not traded away in a backroom deal with tech barons.
“We can’t let the government sign up to a deal that benefits Elon Musk at the expense of the British people.”
Sir Ed Davey
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Google has confirmed it will invest £5bn into capital expenditure, research and development, and related engineering over the next two years, which will include “pioneering” AI research in science and healthcare through its DeepMind operation.
The Silicon Valley firm said the investment will help the UK grow its AI economy and contribute to technological breakthroughs, improvements in cybersecurity and job creation.
Google predicted the investment will help to create 8,250 jobs annually at UK businesses.
DeepMind co-founder and chief executive Demis Hassabis said: “We founded DeepMind in London because we knew the UK had the potential and talent to be a global hub for pioneering AI.
“The UK has a rich history of being at the forefront of technology – from Lovelace to Babbage to Turing – so it’s fitting that we’re continuing that legacy by investing in the next wave of innovation and scientific discovery in the UK.”
There has been no expense spared for the UK’s biggest security operation since the King’s coronation.
This time the occasion is both royal and presidential. It is vast and honestly feels, well, American.
The operation has been led by Thames Valley Police, but officers from across the UK will also play a part in the visit.
Windsor is a sea of fluorescent yellow jackets and black and white flat caps. Officers are swarming the town and over the next couple of days will be sending drones into crowds, conducting boat patrols and deploying mounted units in and around the wider area.
Authorities have planned for every eventuality but would not expand on whether the fatal shooting of Charlie Kirk had led them to heighten security measures.
Officers patrolling the River Thames
Police on horses in Windsor. Pic: Reuters
The assassination of the US activist may have intensified consideration about potential threats, but authorities have had extensive security plans in the works for months.
Operational firearms commander Sergeant Dan Hatfield explained that the police presence will be heightened – and every plan has been worked on in conjunction with the Secret Service.
“The residents of Windsor and visitors to Windsor are used to seeing a fairly high police presence, including armed police,” Sgt Hatfield said.
“However, for this state visit, they will see an increase in those numbers. Fortunately, I’ve had experience working with the Americans with all the Secret Service. We have a really good working relationship and work fairly harmoniously together to ensure the safety of everyone involved.”
A member of the Blues and Royals prepares for a first ride-out ahead of rehearsals for the state visit. Pic: PA
Whether in the air, on the ground or on the water, safety is paramount.
On a visit with the Thames Valley marine unit, Sky News witnessed what their 24-hour patrol of the waterways would look like.
A section of the River Thames that borders the Castle will be closed off during the visit.
Sergeant Lyn Smith, head of the joint operations marine unit between the Thames Valley and Hampshire forces, said this is the biggest event she has worked on.
“The team is highly trained, we are ready for anything that will happen on or around the water,” she said.
“The marine support unit are going to be doing high visibility patrols, some searching, some specialist searching in and around the area, and working with our partners in the Environment Agency to deliver a safe event.
“Similar to President Macron’s state visit, we are still providing capability on the water, it’s just on a larger scale for us.”
Police dog Jack, from Thames Valley Police, has been carrying out security searches. Pic: PA
Security fences along the Long Walk near Windsor Castle. Pic: Reuters
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Notably, for the first time in any state visit or royal occasion, the section of the Long Walk leading up to the castle has been cordoned off with large white barricades erected to shield the residence from view.
Airspace over the town is also restricted for the duration of the visit, enforced using police drones and helicopters.
Vehicles will be standing by close to patrol officers on the ground, holding their ballistic helmets, ballistic vests and shields if an incident occurs.
Thousands of protesters plan to descend on Windsor and central London during the visit to demonstrate against the president’s trip.
A rally in central London on Wednesday is expected to draw the largest crowd, but protesters from the Stop Trump Coalition have now confirmed plans for a Tuesday event too.
A royal welcome may not be extended by all – but many will be hoping they won’t drown out the pomp for the president.
An emergency debate will take place in parliament today over Sir Keir Starmer’s controversial appointment of Peter Mandelson as his ambassador to the US.
Speaker Lindsay Hoyle has agreed to allot three hours for questions about what the government, and particular the prime minister, knew and didn’t know about the depth of Lord Mandelson’s relationship with billionaire paedophile Jeffrey Epstein.
Lord Mandelson was appointed in January 2025 to the UK’s most senior overseas diplomatic position – the ambassador to the US.
He had always admitted to having known Epstein, but last week the US Congress unveiled the contents of a 50th “birthday book” which revealed a much closer relationship.
Among the tributes to Epstein in it, Lord Mandelson had described him as “my best pal”.
A picture of Epstein and Mandelson together in the ‘birthday book’ released by the US Congress. Pics: US House Oversight Committee
Then, emails published by The Sun and Bloomberg were even more damning, showing the former Labour minister sympathising with the convicted sex trafficker, saying: “I think the world of you and I feel hopeless and furious about what has happened.”
Lord Mandelson was removed from his ambassadorial post on Thursday, but not before Sir Keir had defended him at PMQs the day before. He has come under fire over his handling of the issue.
I’m ‘angry’, says PM
On Monday, in his first remarks about the sacking, the embattled prime minister – who earlier this month lost his deputy Angela Rayner to a tax affairs scandal – insisted he would have “never appointed” Lord Mandelson if he’d known then what he knows now.
He told Channel 4 News he was “angry” to have ended up in a situation where he pivoted from defending him to sacking him within 24 hours, suggesting he was unaware of the “detailed allegations” before PMQs.
But questions remain about what exactly the PM – or the vetting team – knew, and the government has declined to release the details of the procedure Lord Mandelson underwent before he was appointed.
The Conservatives hope to use today’s emergency debate to increase pressure on the government to publish all the information – just hours before Donald Trump lands in the UK for a state visit.
The US president is himself embroiled in questions about his own relationship with the disgraced billionaire.
Analysis: No state visit has had a backdrop quite like this
Commons Speaker Sir Lindsay Hoyle has granted the emergency debate. Pic: PA
Sir Keir was also hit by the resignation of Number 10’s director of strategy, Paul Ovenden, on Monday. He quit after it emerged he’d sent sexually explicit messages about independent MP Diane Abbott.
It’s all added up to a rotten start to the new parliamentary term for the prime minister, who just two weeks ago confidently declared “phase two” of his government was now under way.
He’s ruled out resigning, despite discontent on his backbenches and Reform UK’s sustained lead in the polls.
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Former PM Gordon Brown rallied to Sir Keir’s defence
But former prime minister Gordon Brown has come to Sir Keir’s defence.
Speaking to Sky News, he said he expected the PM to be “completely exonerated” over the Mandelson scandal.
Mr Brown, the last Labour PM before Sir Keir, said he didn’t want to criticise his judgement because he faces “very difficult decisions”.
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