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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.

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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.”

Read more:
The Primodos Drug Scandal
Theresa May says victims were patted on the head and told ‘you’re imagining it’
Government accused of ‘bullying’ disabled campaigners in the courts

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.”

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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.”

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Child who died in Minehead school coach crash was 10-year-old boy, police say

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Child who died in Minehead school coach crash was 10-year-old boy, police say

The child who died in a school coach crash in Somerset on Thursday was a 10-year-old boy, Avon and Somerset Police have said.

A specially trained officer is supporting the child’s family, the force said, adding that two children taken to Bristol Royal Hospital for Children by air ambulance remain there as of Friday.

Four children and three adults also remain in hospital in Somerset.

There were between 60 to 70 people on board when the incident happened near Minehead, just before 3pm on Thursday.

The coach was heading to Minehead Middle School when it crashed on the A396 between Wheddon Cross and Timbercombe.

Flowers outside school
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Pic: PA

Police said that 21 people were taken to hospital, including two children who were taken via air ambulance.

Gavin Ellis, chief fire officer for Devon and Somerset, said the coach “overturned onto its roof and slid approximately 20ft down an embankment”.

Rachel Gilmour, MP for Tiverton and Minehead, said the road where it happened is “very difficult to manoeuvre”.

“You have a very difficult crossing at Wheddon Cross, and as you come out to dip down into Timbercombe, the road is really windy and there are very steep dips on either side,” she told Sky’s Anna Botting.

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Tearful MP reacts to coach crash

It comes after a teacher at Minehead Middle School praised the “incredibly brave” pupils for supporting each other after the coach crash.

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“You have looked after each [other] in what was a life-changing event, we will get through this together,” they wrote on Facebook.

“I feel so lucky to be your teacher. I am so grateful to my wonderful colleagues during this time who were also fighting to help as many people as we could.”

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Woman handed criminal conviction despite ‘unlawful’ strip search by police in Greater Manchester

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Woman handed criminal conviction despite 'unlawful' strip search by police in Greater Manchester

Maria’s treatment by Greater Manchester Police (GMP) was so shocking the chief constable described it as “undefendable” and yet a year after a high-profile inquiry found she had been “unlawfully” arrested and strip-searched, Maria now has a criminal conviction for the crime the inquiry said she should never have been arrested for.

Warning: This story includes graphic descriptions of strip searches and references to domestic violence.

The Baird Inquiry – named after its lead Dame Vera Baird – into GMP, published a year ago, found that the force made numerous unlawful arrests and unlawful strip searches on vulnerable women. A year on, the review has led to major changes in police processes.

Strip searches for welfare purposes, where the person is deemed at risk of harming themselves, are banned, and the mayor’s office told Sky News only one woman was intimately strip-searched to look for a concealed item by GMP last year.

Women had previously told Sky News the practice was being used by police “as a power trip” or “for the police to get their kicks”.

However, several women who gave evidence to the Baird Inquiry have told Sky News they feel let down and are still fighting for accountability and to get their complaints through the bureaucracy of a painfully slow system.

The case of Maria (not her real name) perhaps best illustrates how despite an inquiry pointing out her “terrible treatment”, she continues to face the consequences of what the police did.

'Maria' said she was treated like a piece of meat by GMP
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‘Maria’ said she was treated like a piece of meat by GMP

‘Treated like a piece of meat’

The story begins with an act of poor service. A victim of domestic violence, Maria went to the police to get keys off her arrested partner but was made to wait outside for five-and-a-half hours.

The Baird Inquiry said: “This domestic abuse victim, alone in a strange city, made 14 calls for police to help her.

“She was repeatedly told that someone would contact her, but nobody did. The pattern didn’t change, hour after hour, until eventually she rang, sobbing and angry.”

The police then arrested her for malicious communications, saying she’d sworn at staff on the phone.

Inside the police station, officers strip-searched her because they thought she was concealing a vape. Maria told Sky News she was “treated like a piece of meat”.

The Baird Inquiry says of the demeaning humiliation: “Maria describes being told to take all her clothes off and, when completely naked, to open the lips of her vagina so the police could see inside and to bend over and open her anal area similarly.”

GMP's Chief Constable Stephen Watson
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Chief Constable Stephen Watson said the actions towards Maria were ‘inexplicable’

After the inquiry found all this not only “terrible” but “unlawful”, Chief Constable Stephen Watson described the actions of his officers towards Maria as “an inexplicable and undefendable exercise of police power”.

He added: “We’ve done the wrong thing, in the wrong way and we’ve created harm where harm already existed.”

Despite all of this, the charges of malicious communication were not dropped. They hung over Maria since her arrest in May 2023. Then in March this year, magistrates convicted her of the offence, and she was fined.

Dame Vera’s report describes the arrest for malicious communications as “pointless”, “unlawful”, “not in the public interest” and questions whether the officer had taken “a dislike to Maria”. Yet, while Maria gained a criminal record, no officer has been disciplined over her treatment.

A GMP spokesperson said: “The court has tested the evidence for the matter that Maria was arrested for, and we note the outcome by the magistrate. We have a separate investigation into complaints made about the defendant’s arrest and her treatment whilst in police custody.”

The complaint was referred to the Independent Office for Police Conduct (IOPC) in August 2023 and Maria was told several months ago the report was completed, but she has not heard anything since.

Dame Vera Baird of the Baird Inquiry into GMP
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Dame Vera Baird’s report catalogues the ‘unlawful’ arrest and strip search of various individuals by GMP

‘There’s been no accountability’

Dame Vera’s report also catalogues the “unlawful” arrest and strip search of Dannika Stewart in October 2023 at the same police station. Dannika is still grinding through the police complaints service to get a formal acknowledgement of their failings.

She told Sky News: “Everyone involved in it is still in the same position. There’s been no accountability from the police. We’re still fighting the complaint system, we’re still trying to prove something which has already been proved by an independent inquiry.”

Body cam footage of Dannika Stewart being arrested in October 2023
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Body cam footage of Dannika Stewart being arrested

Asked if anyone had been disciplined, Chief Constable Watson told Sky News: “There are ongoing investigations into individual failings, but for the most part the Baird review talked about systemic failings of leadership, it talked of failings in policy and failings of systems.

“In some cases, those people who may have misconducted themselves at the level of professional standards have retired. There are no criminal proceedings in respect of any individual.”

He added: “Every single element of the Baird inquiry has been taken on board – every single one of those recommendations has been implemented – we believe ourselves to be at the forefront of practice.”

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‘It’s been three years’

Mark Dove who was also found by the inquiry to have been unlawfully arrested three times and twice unlawfully stripped-searched says he’s been in the complaints system for three years now.

He told Sky News: “There have been improvements in that I’m being informed more, but ultimately there’s no timeline. It’s been three years, and I have to keep pushing them. And I’ve not heard of anyone being suspended.”

Mark Dove was found by the Baird Inquiry to have been unlawfully arrested three times
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Mark Dove was found to have been unlawfully arrested three times and unlawfully strip-searched twice

Sophie (not her real name), a domestic violence victim who was also found by the review team to have been unlawfully arrested by GMP, told Sky News that although most of her complaints were eventually upheld they had originally been dismissed and no officer has faced any consequences.

She said: “They put on record that I’d accepted a caution when I hadn’t – and then tried to prosecute me. Why has no one been disciplined? These are people’s lives. I could have lost my job. Where is the accountability?”

Since the Baird Inquiry, every strip search by GMP is now reviewed by a compliance team. GMP also provides all female suspects in custody with dignity packs including sanitary products, and they work with the College of Policing to ensure all officers are trained to recognise and respond to the effects of domestic and sexual trauma on survivors.

Kate Green, deputy mayor for Greater Manchester for policing and crime
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Kate Green, deputy mayor for Greater Manchester for policing and crime

The deputy mayor for Greater Manchester for policing and crime, Kate Green, says the lessons of the Baird Inquiry should reach all police forces.

She said: “I would strongly recommend that other forces, if they don’t already follow GMP’s practise in not conducting so-called welfare strip searches, similarly cease to carry out those searches. It’s very difficult to see how a traumatising search can be good for anybody’s welfare, either the officers or the detainees. We’ve managed to do that now for well over a year.”

Ms Green also suggests a national review of the police complaints system.

Read more:
Inquiry prompted by Sky news’ investigation
What Baird Inquiry revealed

Deputy Chief Constable Terry Woods, of GMP, said: “Our reformed Professional Standards Directorate (PSD) has increased the quality of complaints handling and improved timeliness.

“Where officers have been found to breach our standards then we have not hesitated to remove them from GMP, with more than 100 officers being dismissed on the chief constable’s watch.

“Out of 14 complaints relating to Dame Vera’s report, four have been completed. Our PSD continues to review and investigate the other complaints.

“We’re committed to being held to account for our use of arrests and our performance in custody.

“By its nature, custody has – and always will be – a challenging environment.

“However, basic provisions and processes must always be met and, while we’re confident our progress is being recognised across policing, we stand ready to act on feedback.”

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One child dies after coach crashes in Somerset on way back from school trip

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One child dies after coach crashes in Somerset on way back from school trip

One child has died after a coach bringing children back from a school trip crashed and overturned near Minehead, Somerset, police have said.

A major incident was declared after the vehicle, which had 60-70 people on board, crashed on the A396 Cutcombe Hill, between Wheddon Cross and Timbercombe, shortly before 3pm on Thursday afternoon.

The coach was heading to Minehead Middle School at the time.

At a news conference on Thursday night, officials confirmed one child died at the scene.

A further 21 patients were taken to hospital, including two children who were transported via air ambulance. “Several” other people were treated at the scene, they added.

A police officer near the scene of a coach crash in Somerset. Pic: PA
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A police officer near the scene of the coach crash in Somerset. Pic: PA

“This has been an incredibly challenging scene for all emergency services,” Chief Superintendent Mark Edgington said.

“Today’s events are truly tragic, we know the whole community and wider area will be utterly devastated to learn of this news.”

An investigation into what caused the crash will be carried out, he added.

Gavin Ellis, the chief fire officer for Devon and Somerset Fire & Rescue Service, said the coach “overturned onto its roof and slid approximately 20ft down an embankment”.

He praised an off-duty firefighter who was travelling behind the vehicle for helping at the scene, before crews then arrived to carry out rescues “in extremely difficult circumstances”.

“I’m grateful for the tireless effort and actions of the crews in doing everything they could for those who were trapped and as quickly as safely as possible,” he said.

“I’m extremely proud of the efforts that my firefighters took today at this tragic event.”

Eight fire engines were sent to the scene, with two specialist rescue appliances and around 60 fire personnel, Mr Ellis said.

A total of 20 double-crewed ambulances, three air ambulances and two hazardous area response teams were also sent to the scene, a representative for the South Western Ambulance Service said.

Emergency services near the scene in Minehead
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Pic: PA

Ch Supt Mark Edgington said: “Many passengers either sustained minor injuries or were physically unharmed and were transferred to a rest centre.

“Work to help them return to Minehead has been taking place throughout the evening.

“An investigation into the cause of this incident will be carried out.”

Minehead Middle School has pupils aged between nine and 14, and is five days away from the end of term.

‘I don’t have words,’ says local MP

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‘From one mother to another, I feel your pain’

Rachel Gilmour, MP for Tiverton and Minehead, has said the road where the coach crashed is “very difficult to manoeuvre”.

Speaking to Sky News chief presenter Anna Botting, Ms Gilmour said she visited Minehead Middle School recently, where she “met the children and they were full of joy, enthusiasm and were very positive”.

“I know many of their parents,” she said. “I don’t have words.”

Describing the scene, Gilmour continued: “You have a very difficult crossing at Wheddon Cross, and as you come out to dip down into Timbercombe, the road is really windy and there are very steep dips on either side.

“If the coach, as the police are saying, went 20ft off the road, you are literally on a really, really steep bank.”

The MP, whose constituency is partly in Devon and partly in Somerset, said there is a “really, really close community”.

“We will pull together, but it would be crass of me to say to a parent who’s just lost their child that I could make things better, I can’t,” she said.

“All I can say is that from one mother to another, I feel your pain.”

Cutcombe Hill near Minehead, where the accident took place. Pic: Google Maps
Image:
Cutcombe Hill near Minehead, where the accident took place. Pic: Google Maps

Sir Keir Starmer said in a post on X: “There are no adequate words to acknowledge the death of a child. All my thoughts are with their parents, family and friends, and all those affected.

“Thank you to the emergency workers who are responding at pace – I’m being kept up to date on this situation.”

Education Secretary Bridget Phillipson wrote: “It is heartbreaking to hear that a child has died and others are seriously injured following the incident in Minehead earlier today.

“My thoughts are with their friends and families, and all those affected by this tragic event.”

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