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.
Image: 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.
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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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3:46
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.”
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.”
Image: 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.”
An asylum seeker has been found guilty of murdering a hotel worker at a train station in the West Midlands.
Deng Chol Majek was caught on CCTV following Rhiannon Skye Whyte from the Park Inn hotel, in Walsall, where he lived and she worked, to the nearby Bescot Stadium station.
She was stabbed in the head with a screwdriver 19 times, and 23 times in total, on 20 October last year.
Image: Deng Chol Majek. Pic: PA
Mr Majek, who is from Sudan and claims to be 19 years old, had told Wolverhampton Crown Court he was at the hotel for asylum seekers at the time the 27-year-old was attacked.
A two-week trial heard that Mr Majek had previously been reported to security at the hotel after “spookily” staring at three female staff members for prolonged periods.
Ms Skye died in hospital three days after the attack, having been found injured in a shelter on the platform by the driver and guard of a train which pulled in about five minutes later.
Image: Rhiannon Skye Whyte. Pic: Family handout/PA
Mr Majek, who is about ten inches taller than Ms Whyte, walked to the Caldmore Green area of Walsall after the attack to buy beer, and was recorded on CCTV apparently wiping blood from his trousers.
He returned to the hotel at 12.13am, changed his bloodstained flip-flops for trainers, and was seen dancing with other residents in the car park, within sight of emergency vehicles called to the station.
Asked by defence KC Gurdeep Garcha if he was at the train station when Ms Whyte was stabbed, Mr Majek replied: “No.”
He also denied being “responsible for that fatal assault” on the platform.
Image: CCTV from the reception area of the hotel alleged to show Deng Chol Majek staring at Rhiannon Whyte, left. Pic: PA
Prosecutor Michelle Heeley KC said of Mr Majek’s behaviour after the murder: “He is celebrating, his mood has changed from that prolonged scowl before the murder to dancing and joy after the murder. It is utterly callous.”
Mr Majek said he had spent time in Libya, Italy and Germany before arriving in the UK to claim asylum in July last year.
He will be sentenced at a later date.
‘She was always happy’
Rhiannon’s sister, Alex Whyte, said her sibling “always wanted to make everyone else around her happy”.
She said: “Rhiannon had such a quirky personality. You would hear her before you’d see her.
“No matter what her day had been, she always wanted to make everyone else around her happy. She always prioritised family. That was the most important thing to Rhiannon. Obviously, she has a brother and three sisters. And my mum, who was her best friend.”
She added: “Rhiannon is the second youngest. But our baby sister would always say ‘I’m your big little sister’, because Rhiannon was very soft.
“So, no matter what, we always wanted to protect her. That was our priority most of our life, because Rhiannon never saw danger – Rhiannon never understood how scary the world really could be.
“But no matter what Rhiannon was just happy, always.”
Plaid Cymru have won the by-election in the Senedd seat of Caerphilly for the first time.
The Welsh nationalist party secured 15,960 votes – and candidate Lindsay Whittle cried as the result was announced.
Mr Whittle is 72 years old and had stood as a Plaidcandidate 13 times since 1983. He will now hold the seat until the Welsh Assembly’s national elections next year.
This by-election was widely regarded as a two-horse race between Plaid Cymru and Reform UK, and the result marks a considerable blow for Nigel Farage.
His candidate Llyr Powell received 12,113 votes – denying a victory that would have strengthened claims that Reform can convert a large lead in opinion polls into election wins.
Nonetheless, the party’s performance is a marked improvement on 2021, when it received just 495 votes.
More than anything, the result is a humiliating and historic defeat for Labour, who had held Caerphilly at every Senedd election since it was created in 1999 – as well as the Westminster seat for over a century.
Its candidate Richard Tunnicliffe secured 3,713 votes and finished in third place, with Welsh Labour describing it as a “by-election in the toughest of circumstances, and in the midst of difficult headwinds nationally”.
Turnout overall stood at 50.43% – considerably higher than during the last ballot back in 2021.
Giving his acceptance speech after the result was confirmed, Mr Whittle began by paying tribute to Hefin David – who was Welsh Labour’s Member of the Senedd for Caerphilly until his death in August.
“He will be a hard act to follow,” Mr Whittle said. “I will never fill his shoes – but I promise you, I will walk the same path that he did.”
The Plaid politician described how he had been “absolutely heartened” by how many young people were involved in the by-election – and said the result sends a clear message.
He said: “Listen now Cardiff and listen Westminster – this is Caerphilly and Wales telling you we want a better deal for every corner of Wales. The big parties need to sit up and take notice.
“Wales, we are at the dawn of new leadership, we are at the dawn of a new beginning – and I look forward to playing my part for a new Wales, and in particular, for the people of the Caerphilly constituency. I thank you with all my heart.”
Mr Whittle quipped Plaid’s victory “was better than scoring the winning try for Wales in the Rugby World Cup”.
And looking ahead to the next year’s elections, he added: “[This] result shows what’s possible when people come together to back practical solutions and protect what matters most.
“We’ve beaten billionaire-backed Reform and, with the same determination, we can do it again in May 2026. Caerphilly has shown the way – now Wales must follow.”
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0:49
How tactical voting helped Plaid Cymru
Speaking to Sky’s chief political correspondent Jon Craig just before the declaration, Plaid Cymru leader Rhun ap Iorwerth said: “There’s clearly a real significance to the result – we are seeing the disillusionment with Labour writ large. I’ve heard it on hundreds of doorsteps, we’ve seen it in opinion polls.”
He conceded there was tactical voting in this by-election – with Labour and Conservative supporters alike backing Lindsay Whittle to keep out Reform.
However, Mr ap Iorwerth added: “I’ve spoken to literally hundreds and hundreds of people who told me – time and time again – ‘I’ve been a Labour supporter all my life, and we’re backing you this time.’
“Not begrudgingly, but because they see that’s the direction we’re going in – not just in this by-election, but as a nation. I’m calling on people to get behind that positive change – not just today, but ahead of next May.”
First Minister Eluned Morgan congratulated Mr Whittle on his return to the Senedd and said: “Welsh Labour has heard the frustration on doorsteps in Caerphilly that the need to feel change in people’s lives has not been quick enough.
“We take our share of the responsibility for this result. We are listening, we are learning the lessons, and we will be come back stronger.”
The Conservatives and the Liberal Democrats were among the parties who lost their deposits.
It was a welcome designed to catch our attention, for a visit that meant everything to the King.
The Swiss guard, standing to attention as the UK’s national anthem played out in the courtyard outside the Apostolic Palace.
Queen Camilla, wearing a distinctive black mantilla as a mark of respect to the Pope, as they made their way inside to meet Pope Leo XIV for the first time.
We know King Charles had built a relationship with Pope Francis before his death, now it appeared he was building a friendly rapport with his predecessor, as Pope Leo and the King happily talked away, both in English, meaning their conversation flowed more naturally.
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Will King and Pope distract from Andrew?
But while friendships between heads of state do matter diplomatically, this was also about making history.
Inside the Sistine Chapel, they prayed alongside each other. The first time a monarch and a pontiff have done that for 500 years, since Henry VIII broke away from the Catholic Church.
Image: Pope Leo greets King Charles and Queen Camilla at the Vatican. Pic: AP
Image: Pope Leo and Archbishop of York are joined by the King and Queen during an act of worship in the Sistine Chapel. Pic: Vatican Media/Reuters
With King Charles also the supreme governor of the Church of England, the optics could not have been more significant for relations between the two faiths.
If you wanted to see how much King Charles’s interfaith work is appreciated, it came at the basilica of St Paul’s outside the walls.
An abbey with long-held links with English monarchs, where he was given the ceremonial title of royal confrater, and a special seat was made just for him and his heirs.
Alongside religious matters, the two men talked publicly about their shared passion for the environment ahead of the UN’s climate conference COP, taking place in just over a week’s time.
With the King sent here on behalf of the government, and the foreign office emphasising how the Holy See is a vital global partner, we really saw brought into focus the soft power of the royals and the church, and how influential both can be.
Image: King Charles’s visit brings into focus the soft power of the royals. Pic PA
Image: King Charles at a garden reception at the Pontifical Beda College, where men prepare for the priesthood. Pic: PA
The interactions between the King and Pope showed a shared interest in a range of global issues.
But as the head of the Catholic Church for England and Wales, Cardinal Vincent Nichols pointed out to me, here are also two heads of state who sadly have issues around allegations of historical sexual abuse hanging over their institutions, and the decision on how to address that publicly.
There will be relief that there were no updates on the Prince Andrew problem today.
But despite Andrew vehemently denying that he has done anything wrong, revelations have kept coming.
And that is where the jeopardy lies for the royal family as they try to draw our attention back to important moments like this.