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.”
The families of the victims of the Nottingham attacks have said the killer should face a retrial on a murder charge.
Findings from a new independent review published on Wednesday mean Valdo Calocane should be retried on the more serious charge, the families told Sarah-Jane Mee.
Valdo Calocane, who had been diagnosed with paranoid schizophrenia, was sentenced to an indefinite hospital order after killing 19-year-old students Barnaby Webber and Grace O’Malley-Kumar, and 65-year-old caretaker Ian Coates, before attempting to kill three other people in June 2023.
Grace Kumar, Barnaby Webber and Ian Coates
The report detailing his mental health treatment before his killing spree has found failings in his NHS care – including that he was allowed to avoid taking long-lasting antipsychotic medication because he did not like needles.
Prosecutors accepted a plea of manslaughter after experts agreed his schizophrenia meant he was not fully responsible for his actions.
But on Wednesday, the father of Grace, Dr Sanjoy Kumar, told The UK Tonight with Sarah-Jane Mee: “The basis of the trial was that Calocane had treatment resistant paranoid schizophrenia and that’s why he was convicted in the way he was.
“We have now got three agencies – the Care Quality Commission has said he did not have treatment resistant paranoid schizophrenia. The mental health trust has said emphatically he did not have treatment resistant paranoid schizophrenia. And now the trust report has confirmed he didn’t have treatment resistant paranoid schizophrenia.
“So if that was the basis of what the sentences were passed on, then if that basis is wrong, as families we can’t understand why that basis wouldn’t be challenged and even looked at by someone like [sentencing judge] Mr Justice Turner, who ultimately passed that sentence, because that sentence to us is not right.”
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Nottingham killer avoided medication
James Coates, the son of Ian Coates, said Calocane’s defence team portrayed him as an “upstanding citizen” in court.
He said he had been contacted by several people from Nottingham on social media “that are going through similar things that we are – they have a child in mental healthcare because of issues they are going through and they are refusing to take medication and they are refusing to get help”.
“If they then learn the same doctor that signed off my father’s killer into the streets is the one looking after their child, or friend, or partner – how are they supposed to deal with that?”
Emma Webber, Barnaby’s mother, said: “I have been engaging with a lady who messaged me to say… ‘Emma, my son’s going to be the next Valdo Calocane. Can you help?’
“This isn’t peculiar to just Nottingham, this is an entirely different part of the country.”
Asked if they would be willing to take on the challenge of seeking a murder retrial, Ms Webber said: “Yes, of course I am, because it is such a grievous wrong. Once the truth is fully uncovered, then we will cross that bridge. Absolutely, yes.”
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‘He got away with murder, didn’t he?’
Earlier, she told a news conference held by the families in London that the indefinite hospital order handed to Calocane represented an “enormous miscarriage of justice”
“He knew what he was doing,” she said. “He serves no punishment for his crimes.”
She said the evidence of failures in dealing with her son’s killer would have been “brushed under the carpet” had it not been for the campaigning by the victims’ families.
Talking about her son’s killer, she said: “He got away with murder, didn’t he? This has to be addressed. So enough is enough. It’s shameful we’ve had to fight so hard against the public agencies and institutions that should be there to protect us.”
She added: “Barnaby, Ian and Grace would be here today if those concerned across these agencies had just done their job properly.”
You can watch the full interview on The UK Tonight with Sarah-Jane Mee at 8pm
Southport killer Axel Rudakubana’s anti-terror case should have been kept open, a review into his attacks has found.
Following the killings in Southport last summer, a rapid review was launched into Rudakubana’s contact with Prevent – a government strategy aimed at stopping people from becoming terrorists.
Speaking in the House of Commons, Home Office minister Dan Jarvis repeated that Rudakubana was in contact three times before his attacks at a Taylor Swift dance class where three young girls were murdered.
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He added that the report found Rudakubana should have been referred to Channel, another anti-terror scheme.
Mr Jarvis said: “The review concluded that too much focus was placed on the absence of a distinct ideology, to the detriment of considering the perpetrator’s susceptibility, grievances, and complex needs.
“There was an under-exploration of the significance of his repeat referrals and the cumulative risk, including his history of violence.
“There were potentially incomplete lines of inquiry, that at the time the perpetrator could have fallen into a mixed, unclear or unstable category for Channel due to his potential interest in mass violence.
“Indeed, the overall conclusion of the review is that he should have been case-managed through the Channel multi-agency process, rather than closed to Prevent.”
He said the review found Rudakubana’s referral to Prevent was “closed prematurely”, and there was “sufficient concern to keep the case active while further information was collected”.
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Could the Southport killings have been prevented?
The review noted Rudakubana was referred to Prevent on three occasions: first in December 2019 when he was 13, again in February 2021 when he was 14, and finally in April 2021.
The first report was due to concerns he was carrying a knife and searching for school shootings online.
The second was for online activity relating to Libya and Colonel Gaddafi, and the third for searching for London bombings, the IRA and the Israel-Palestine conflict.
“On each of these occasions, the decision at the time was that the perpetrator should not progress to the Channel multi-agency process,” Mr Jarvis said.
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The report highlighted that in the second referral, Rudakubana’s name was spelt differently from the first.
It then says a Prevent supervisor was unable to find the previous referral and “this may have caused the case to be closed quickly on minimal information”.
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As part of the review, 14 recommendations were made on how to improve Prevent, which Mr Jarvis said they had accepted and would be implementing.
Mr Jarvis said the government is working to set up an inquiry into what happened as soon as possible, although confirmed it would not initially be on a statutory footing.
Kay Burley has announced she is retiring from Sky News after 36 years at the broadcaster.
Burley, 64, was part of the team that launched Sky News in 1989 and has been the face of the channel ever since, covering royal events, general elections and other major stories.
Closing her final show on the Sky News Breakfast programme, she said: “From a standing start to one of the most recognised and valued brands in global news, it’s been an honour and privilege to work with some of the best and hardest working teams in the business.
“News by its very nature is often devastating and together we’ve covered so many life-changing events – from the tragic death of Diana, the shocking terror attack of 9/11; the Asian Tsunami; the Concorde air disaster.
“But we’ve also enjoyed some wonderful high notes too, haven’t we – the thrill of London winning the chance to host the 2012 Olympics; a plethora of royal weddings; jubilees and who can forget days and days and DAYS waiting for royal babies to arrive at the Lindo Wing.
“But after over a million minutes of live TV news – more than anyone else in the world – it’s time for me to indulge in some of my other passions – including my love for travel.
“So, after covering 12 separate general elections – including Sir Keir Starmer’s victory last year – I am retiring from Sky News – let politicians of every party just rejoice at that news!
“Thank you for waking up and tuning in every morning. I can’t tell you how much I have appreciated your support over the last three and a half decades: You’re awesome.
“I will post more on my social media and hope to see you around. Please keep in touch.”
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Most memorable moments of Kay Burley’s Sky News career
The Breakfast team applauded at the end of the announcement
‘Unmatched legacy’
Raised in Wigan, Lancashire, Burley took her first steps into journalism at 17, reporting for the Wigan Evening Post and Chronicle.
She secured a job with the BBC on its local radio stations and then on a local TV before being recruited by Scottish broadcaster Andrew Neil and moved to the fledgling Sky News in the 1980s as one of its founding presenters.
Her live coverage of 9/11 won Sky News a BAFTA award.
David Rhodes, executive chairman of Sky News, said: “With millions of minutes presenting live rolling news, Kay’s legacy in television journalism is unmatched, as is her commitment to Sky’s legacy. And I’m sure some MPs in Westminster will sleep easy knowing they won’t face her indomitable questioning in the mornings.”
He added: “We thank Kay for her huge contribution to Sky, to the art of the interview and to British journalism. And we wish her the best of luck.”
Former Sky News editor-at-large Adam Boulton posted on X: “The one and only Kay Burley announces she is leaving Sky News.
“Kay is unique, there are no other women of her background who have had such an impact on British News and current affairs. We have been friends and colleagues for forty years. Onward Kay I know it’s going to be exciting!”
Sky News’s political editor Beth Rigby said: “No one does live telly like Kay Burley. Our anchor woman for decades, Kay’s has been THE face of Sky News for as long as I can remember.”
Rigby added: “She’s been a trailblazer & inspiration to a whole generation of women. You’re one of a kind.”
Former Sky News journalist Simon McCoy shared an image on X from when he worked with Burley and wrote: “That’s how long she worked at Sky News!
“Wishing Kay Burley all the best for whatever comes next.”
Sky News business presenter Ian King posted on X: “It is impossible to overstate the achievements of my brilliant and supportive friend @KayBurley.
“No one in the world has clocked up as many hours of live television. No doubt politicians will be glad she is leaving – her loyal viewers will not.”
Good Morning Britain presenter Susanna Reid called Burley “a fierce advocate for viewers, a powerful interviewer and a supporter of women in television”.
Reid wrote on X: “That she gets her own #BreakingNews announcement is testament to @KayBurley impact on news journalism… She is going to be hugely missed from our screens. Good luck Kay.”
Former BBC Newsnight producer Sam McAlister said she was “devastated” by the “absolute icon” retiring from Sky News.
McAlister wrote on X: “Genuinely devastated to hear about @KayBurley leaving @SkyNews.
“An absolute icon. Smart as hell, sharp as they come, bloody amazing company.
“Always a total inspiration to me as a single parent and woman from a different background.
“A sad day.”
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