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

Published

12 months 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

Five people guilty in case of mistaken-identity double murder of teenage boys

Published

13 hours ago

November 15, 2024

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Five people guilty in case of mistaken-identity double murder of teenage boys

Four teenagers and a 45-year-old man have been found guilty of murdering two boys, aged 15 and 16, who were attacked with machetes in a case of mistaken identity.

The convictions follow a five-week trial at Bristol Crown Court.

The jury heard how Max Dixon and Mason Rist were killed in a case of mistaken identity on 27 January, after being wrongly identified as being responsible for a house attack in the Hartcliffe area of the city earlier that evening.

Antony Snook, 45, Riley Tolliver, 18, and three boys aged 15, 16 and 17 were all on trial each charged with two counts of murder.

As the jury foreman returned the guilty verdicts, none of the defendants showed any reaction from the dock, as they sat impassively and stared straight ahead.

The fatal stabbings in Knowle West lasted just 33 seconds – with both boys suffering what the court heard were “unsurvivable” injuries and “instant severe blood loss”.

Both died in hospital in the early hours of 28 January.

Detective Superintendent Gary Haskins, the case’s senior investigating officer from Avon and Somerset Police, told Sky News that Max and Mason had nothing to do with the house attack.

“Those boys were not known to their attackers, they were best friends, two beautiful children just going about their lives and attacked for no reason whatsoever,” he said.

Much of the prosecution’s case was based on CCTV and doorbell videos, including a camera on Mason’s own house which captured footage of the knife attack against him.

The pair were seen leaving Mason’s home at around 11.15pm and were going for a pizza.

Prosecutor Ray Tully KC told the jury that the boys were set upon by the group who had been travelling in Snook’s Audi Q2.

He said the group were “out for revenge”, “acting as a pack” to hunt down those responsible and “tooled up” with fearsome weapons.

After the attackers fled, Max and Mason were left bleeding in the street.

The investigation involved more than 230 police officers and staff – with thousands of pieces of evidence analysed.

Hundreds mourned victims at school

The teenage victims were in year 11 together at the Oasis Academy John Williams secondary school and were preparing to sit their GCSEs this summer.

The school’s headteacher Victoria Boomer-Clark told Sky News that everyone rallied to support fellow pupils and staff.

She said: “After the boys were tragically murdered, for us first and foremost we were thinking about the families and how they were coping with the absolute tragedy and shock of that.

“I can remember trying to prepare for that Monday morning and my memories now are how exceptionally strong our young people are and how we have a real sense of community.

“Unbeknownst to us the young people had arranged to hold a vigil on the playground during breaktime on that first Monday. We had hundreds of young people and staff coming together in silence.”

Ms Boomer-Clark said the boys would have attended school prom this summer.

“We had a wall that was lit up in red for Mason and Liverpool football club and a wall in blue for Park Knowle Football Club,” she said. “The year group came together and supported each other through it.”

Detective had never seen ‘horrific’ weapons before

The murders came before a new law was introduced banning ownership of zombie-style knives and machetes.

Detective Superintendent Gary Haskins said: “The weapons used in the attack on Mason and Max were simply horrific.

“I’ve been a detective for many, many years and I’ve had the misfortune of investigating some serious offences.

“In all my service I’ve not seen a weapon like the one we saw used on those two boys.

“There is no place for a weapon of that type in society for any reason whatsoever.”

The detective praised the boy’s families, who attended court throughout the trial.

He added: “I’m humbled by the families involved in this investigation. They’ve been at court every day, they’ve seen things at court that no parent should ever be exposed to. They saw the attacks on their children, but they maintain their dignity, their courage and their love for their family.

“How can you replace what they’ve lost? They’ve lost two beautiful sons, and I can only hope that the verdicts will bring some form of closure. It will never close completely.”

Snook will be sentenced on 19 November at Bristol Crown Court.

The other four defendants will be sentenced on 16 December following the preparation of pre-sentence reports.

Police are continuing to investigate the Hartcliffe house attack and search for those responsible.

UK

UK economy grows by 0.1% between July and September – slower than expected

Published

16 hours ago

November 15, 2024

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UK economy grows by 0.1% between July and September - slower than expected

The UK economy grew by 0.1% between July and September, according to the Office for National Statistics (ONS).

However, despite the small positive GDP growth recorded in the third quarter, the economy shrank by 0.1% in September, dragging down overall growth for the quarter.

The growth was also slower than what had been expected by experts and a drop from the 0.5% growth between April and June, the ONS said.

Economists polled by Reuters and the Bank of England had forecast an expansion of 0.2%, slowing from the rapid growth seen over the first half of 2024 when the economy was rebounding from last year’s shallow recession.

And the metric that Labour has said it is most focused on – the GDP per capita, or the economic output divided by the number of people in the country – also fell by 0.1%.

Reacting to the figures, Chancellor of the Exchequer Rachel Reeves said: “Improving economic growth is at the heart of everything I am seeking to achieve, which is why I am not satisfied with these numbers.

“At my budget, I took the difficult choices to fix the foundations and stabilise our public finances.

“Now we are going to deliver growth through investment and reform to create more jobs and more money in people’s pockets, get the NHS back on its feet, rebuild Britain and secure our borders in a decade of national renewal,” Ms Reeves added.

The sluggish services sector – which makes up the bulk of the British economy – was a particular drag on growth over the past three months. It expanded by 0.1%, cancelling out the 0.8% growth in the construction sector.

The UK’s GDP for the most recent quarter is lower than the 0.7% growth in the US and 0.4% in the Eurozone.

The figures have pushed the UK towards the bottom of the G7 growth table for the third quarter of the year.

It was expected to meet the same 0.2% growth figures reported in Germany and Japan – but fell below that after a slow September.

The pound remained stable following the news, hovering around $1.267. The FTSE 100, meanwhile, opened the day down by 0.4%.

The Bank of England last week predicted that Ms Reeves’s first budget as chancellor will increase inflation by up to half a percentage point over the next two years, contributing to a slower decline in interest rates than previously thought.

Announcing a widely anticipated 0.25 percentage point cut in the base rate to 4.75%, the Bank’s Monetary Policy Committee (MPC) forecast that inflation will return “sustainably” to its target of 2% in the first half of 2027, a year later than at its last meeting.

The Bank’s quarterly report found Ms Reeves’s £70bn package of tax and borrowing measures will place upward pressure on prices, as well as delivering a three-quarter point increase to GDP next year.

UK

Meeting the deeply radical anti-tax group that is ‘growing in popularity’

Published

16 hours ago

November 15, 2024

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Meeting the deeply radical anti-tax group that is 'growing in popularity'

“If you are a member of something, it means you’ve accepted membership. Anything with ‘ship’ on the end, it’s giving you a clue: it’s telling you that’s maritime law. That means you’ve entered into a contract.”

This isn’t your standard legal argument and it is becoming clear that I am dealing with an unusual way of looking at the world.

I’m in the library of a hotel in Leicestershire, a wood-panelled room with warm lighting, and Pete Stone, better known as Sovereign Pete, is explaining how “the system” works. Mr Stone is in his mid-50, bald with a goatee beard and wearing, as he always does for public appearances, a black T-shirt and black jeans.

With us are six other people, mainly dressed in neat jumpers. They’re members of the Sovereign Project (SP), an organisation Mr Stone founded in 2020, which, he says, now has more than 20,000 paying members.

As arcane as this may sound, it represents a worldview that is becoming more influential – and causing problems for authorities. Loosely, they’re defined as “sovereign citizens” or “freemen on the land”.

Their fundamental point is that nobody is required to obey laws they have not specifically consented to – especially when it comes to tax. They have hundreds of thousands of followers in the UK across platforms including YouTube, Facebook and Telegram.

Increasingly, they are coming into conflict with governments and the law. Sovereign citizens have ended up in the High Court in recent months, challenging the legalities of tax bills and losing on both occasions.

In October, four people were sentenced to prison for the attempted kidnapping of an Essex coroner, who they saw as acting unlawfully. The self-appointed “sheriffs” attempted to force entry to the court, one of them demanding: “You guys have been practising fraud!”

The Sovereign Project is not connected to any of those cases, nor does it promote any sort of political action, let alone violence.

Instead, they are focused on issues like questioning the obligation to pay taxes, as Mr Stone explains, referencing the feudal system that operated in the Middle Ages.

“Do you know about the feudal system when people were slaves and were forced to pay tax?” he asks.

“Now, unless the feudal system still operates today, and we still have serfs and slaves, then the only way that you can pay taxes is to have a contract, you have to agree to it and consent to it.”

Another member, Karl Deans, a 43-year-old property developer who runs the SP’s social media, says: “We’re not here to dodge tax.”

Local government tends to be a target beyond just demands for tax. Mr Stone speaks of “council employee crimes”.

I ask whether, considering the attempted kidnapping in Essex, there is a danger that people will listen to these accusations of crimes by councils and act on them.

“Well that’s proved,” Mr Stone says. “We only deal with facts.”

Evidence suggests this approach is becoming an issue for councils across the UK, as people search online for ways to avoid paying tax.

Sky News analysis shows that out of 374 council websites covering Great Britain, at least 172 (46%) have pages responding to sovereign citizen arguments around avoiding paying council tax. They point out that liability for council tax is not dependent on consent, or a contract, and instead relies on the Local Government Finance Act 1992, voted on by Parliament.

But the Sovereign Project’s worldview extends beyond council tax. It is deeply anti-establishment, at times conspiratorial. Stone suggests the summer riots may have been organised by the government.

“The sovereign fraternity operates above all of this,” he says. “We look down at the world like a chessboard. We see what’s going on.”

He explains that, really, the UK government isn’t actually in control: there is a shadow government above them.

“These are the people who control government,” he explains.

“A lot of people say this could be the crown council of 13, this could be a series of Italian families.”

Professor Christine Sarteschi, an expert in sovereign citizens at Chatham University, Pittsburgh, says she’s worried about the threat sovereign citizens may pose to the rule of law, especially in the US where guns are readily available.

“The movement is growing and that’s evidenced by seeing it in different countries and hearing about different cases. The concern is that they will become emboldened and commit acts of violence,” she says.

“Because sovereigns truly believe in their ideas and if they feel very aggrieved by, you know, the government or whomever they think is oppressing them or controlling them… they can become emotionally involved.

“That emotional involvement sometimes leads to violence in some cases, or the belief that they have the power to attempt to overthrow a government in some capacity.”

Much of this seems to be based on an underlying and familiar frustration at the state of this country and of the world.

Mr Stone echoes some of the characteristic arguments also made by the right, that there is “two-tier policing”, that refugees arriving in the UK are “young men of fighting age”, that the government is using “forced immigration to destroy the country”.

Another SP member, retired investment banker David Hopgood, 61, says: “I firmly believe it is the true Englishman – and woman – of this country – that has the power to unlock this madness that’s happening in the West.

“We’ve got the Magna Carta – all these checks and balances. We just need to pack up, go down to Parliament and say: It’s time to dismiss you. You’re not fit for purpose.”

The members of the Sovereign Project are unfailingly patient and polite in explaining their understanding of the world.

But there is no doubt they hold a deeply radical view, one that is apparently growing in popularity.