Primodos: New study claims to find link between the pregnancy test drug and malformations

Published

2 years ago

December 6, 2023

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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.

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.

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.”

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.”

UK

Inquiry launched to ‘uncover truth’ behind bloody clashes at Orgreave miners’ strike

Published

2 hours ago

July 21, 2025

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Inquiry launched to 'uncover truth' behind bloody clashes at Orgreave miners' strike

A new public inquiry will “uncover the truth” behind the so-called “Battle of Orgreave”, a bloody fight between striking miners and police officers in the 1980s.

One hundred and twenty people were injured in the violent confrontation on 18 June 1984, outside a coal processing factory in Orgreave, South Yorkshire.

Five thousand miners clashed with an equal number of armed and mounted police during a day of fighting.

Police used horse charges, riot shields and batons against the picketers, even as some were retreating.

In the aftermath, miners were blamed for the violence in what campaigners believe was an institutional “frame-up”.

“There were so many lies,” says Chris Peace, from campaign group Orgreave Truth and Justice, “and it’s a real historic moment to get to this stage.”

“There’s a lot of information already in the public domain,” she adds, “but there’s still some papers that are embargoed, which will hopefully now be brought to light.”

Although dozens of miners were arrested, trials against them all collapsed due to allegations of unreliable police evidence.

Campaigners say some involved have been left with “physical and psychological damage”, but until now, previous governments have refused calls for a public inquiry.

Launching the inquiry today, Home Secretary Yvette Cooper told Sky Newsi that she wanted to “make sure” campaigners now got “proper answers”.

“We’ve obviously had unanswered questions about what happened at Orgreave for over 40 years,” Ms Cooper says, “and when we were elected to government, we determined to take this forward.”

The inquiry will be a statutory one, meaning that witnesses will be compelled to come and give evidence, and chaired by the Bishop of Sheffield, Pete Wilcox.

“I’m really happy,” says Carl Parkinson, a former miner who was at Orgreave on the day of the clash, “but why has it took so long?”

“A lot of those colleagues and close friends have passed away, and they’ll never get to see any outcome.”

Mr Parkinson and Chris Skidmore, who was also there that day, were among the group of campaigners informed first-hand by Ms Cooper about the public inquiry at the Orgreave site.

“It wasn’t frightening to start off with,” Mr Skidmore remembers of the day itself, “but then what I noticed was the amount of police officers who had no identification numbers on. It all felt planned.”

“And it wasn’t just one truncheon,” says Mr Parkinson, “there were about 30, or 40. And it was simultaneous, like it was orchestrated – just boom, boom, boom, boom.

“And there’s lads with a split down their heads for no good reason, they’d done nothing wrong. We were just there to peacefully picket.”

In the intervening years, South Yorkshire Police have paid more than £400,000 in compensation to affected miners and their families.

But no official inquiry has ever looked at the documents surrounding the day’s events, the lead-up to it and the aftermath.

“We need to have trust and confidence restored in the police,” says South Yorkshire Mayor Oliver Coppard, “and part of that is about people, like this campaign, getting the justice that they deserve.

“Obviously, we’ve had things like Hillsborough, CSE [Child Sexual Exploitation] in Rotherham, and we want to turn the page.”

UK

New water ombudsman to give public stronger protections, government pledges

Published

5 hours ago

July 21, 2025

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New water ombudsman to give public stronger protections, government pledges

Consumers will get stronger protections with a new water watchdog – as trust in water companies takes a record dive.

Environment Secretary Steve Reed will announce on Monday that the government will set up the new water ombudsman with legal powers to resolve disputes, rather than the current voluntary system.

The watchdog will mean an expansion of the Consumer Council for Water’s (CCW) role and will bring the water sector into line with other utilities that have legally binding consumer watchdogs.

Consumers will then have a single point of contact for complaints.

Politics latest: Labour should let water companies ‘go bust’, Farage says

The Department for the Environment, Food and Rural Affairs (Defra) said the new watchdog would help “re-establish partnership” between water companies and consumers.

A survey by the CCW in May found trust in water companies had reached a new low, with fewer than two-thirds of people saying they provided value for money.

Just 35% said they thought charges from water companies were fair – even before the impact could be felt from a 26% increase in bills in April.

Mr Reed is planning a “root and branch reform” of the water industry – which he branded “absolutely broken” – that he will reveal alongside a major review of the sector on Monday.

The review is expected to recommend the scrapping of water regulator Ofwat and the creation of a new one, to incorporate the work of the CCW.

Campaigners and MPs have accused Ofwat of failing to hold water operators to account, while the companies complain a focus on keeping bills down has prevented appropriate infrastructure investment.

On Sunday, Mr Reed avoided answering whether he would get rid of Ofwat or not when asked on Sunday Morning with Trevor Phillips.

He pledged to halve sewage pollution by water companies by 2030 and said Labour would eliminate unauthorised sewage spillages in a decade.

Mr Reed announced £104 billion of private investment to help the government do that.

Victoria Atkins MP, Shadow Secretary of State for Environment, Food and Rural Affairs, said: “While stronger consumer protections are welcome in principle, they are only one part of the serious long-term reforms the water sector needs.

“We all want the water system to improve, and honesty about the scale of the challenge is essential. Steve Reed must explain that bill payers are paying for the £104 billion investment plan. Ministers must also explain how replacing one quango with another is going to clean up our rivers and lakes.

“Public confidence in the water system will only be rebuilt through transparency, resilience, and delivery.”

UK

England star Jess Carter targeted by racist abuse during Euros

Published

8 hours ago

July 20, 2025

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England star Jess Carter targeted by racist abuse during Euros

England star Jess Carter says she has been the victim of racist abuse online during the UEFA Women’s Euros in Switzerland.

The Lionesses defender, who has 49 England caps, said she will be “taking a step back from social media and leaving it to a team to deal with”.

In an Instagram post, the 27-year-old player said: “From the start of the tournament, I have experienced a lot of racial abuse. Whilst I feel every fan is entitled to their opinion on performance and result, I don’t agree or think it’s ok to target someone’s appearance or race.”

Carter said she was stepping back from social media to “protect myself in a bid to keep my focus on helping the team anyway I can”.

She added: “Hopefully speaking out will make the people writing this abuse think twice so that others won’t have to deal with it.”

Carter also said that England have made some “historic changes with the Lionesses squad” that she was “so proud” of, and she hopes that by speaking out about racial abuse “it will make another positive change for all”.

‘Abhorrent abuse’

The Football Association leadership has condemned the “abhorrent abuse” against Carter and has contacted UK police about it.

FA chief executive Mark Bullingham said in a statement: “Our priority is Jess and giving her all the support she needs. We strongly condemn those responsible for this disgusting racism.

“As soon as we were made aware of the racist abuse Jess received, we immediately contacted UK police. They are in touch with the relevant social media platform, and we are working with police to ensure those responsible for this hate crime are brought to justice.”

The Lionesses said in a statement: “We stand with Jess and all Lionesses players past and present who have suffered racism.

“No one should have to endure such vile abuse, be that in football or any walk of life.”

They added: “Those behind this online poison must be held accountable.”

Anger and sadness

England teammate Lucy Bronze said there was “anger” and “sadness” among the squad following the abuse.

Bronze said: “I think we all know that any player of colour that’s played for England has probably gone through racist abuse. That’s a sad fact.”

She told Sky News’ sports correspondent Rob Harris that social media platforms need to be held more accountable.

Bronze added: “People need to be held accountable for their actions, whether it’s in-person or online. The abuse is not okay. Racism is not okay.”

The prime minister said on X that there was “no place for racism in football or anywhere in society”.

Sir Keir Starmer added: “I stand with Jess, the Lionesses, and any players who have suffered racism, on and off the pitch.”

Carter has started all four of England’s games at the tournament.

The defending champions face Italy on Tuesday night in Geneva in the Euros semi-finals. If they win and reach the final, they will play either Germany or Spain, who face each other on Wednesday.

The Lionesses also said that until now, they have chosen to take the knee before matches.

“It is clear we and football need to find another way to tackle racism,” they said.

England won’t be taking the knee before semi-final

The Lionesses said they have agreed as a squad to remain standing before kick-off in the match against Italy.

“We hope the game can come together to see what more can be done.”

Kneeling, a symbolic anti-racism gesture, came to prominence in 2016 when NFL player Colin Kaepernick knelt in protest during the United States national anthem and became more widespread during the Black Lives Matter movement.