Victims of three medical products that caused ‘avoidable harm’ still awaiting redress
The dark granite block in a children’s cemetery in Bristol tells an incomplete story: “Trelissa Whitbread, born 3rd of Feb 1988. She lived 2 hours.”
Deborah Mann has not returned to the grave of her firstborn for 30 years but today has come with her daughter, Branwen, to tell her the story. “It shouldn’t have happened,” she says quietly.
Ms Mann had four pregnancies. Her first two children, Trelissa and Kaverne, died shortly after birth. Ms Mann believes their deaths were caused by an epilepsy drug she was taking called sodium valproate, prescribed by her GP.
After a long gap she would go on to have two more children, both girls, who were diagnosed with what is now recognised as foetal valproate syndrome, which has left them with life-long physical and neurological problems.
Ms Mann tells Sky News: “I asked so many questions and was told ‘this is just the way things are.’ It can’t be the way things are when you lose two babies. How can it be the way things are?”
Deborah Mann
Five years ago, valproate was among three medical products including the pregnancy test drug Primodos and medical device pelvic mesh, that were found to have caused “avoidable harm” to patients.
The report was clear that valproate could cause lifelong disabilities to the children of mothers taking the drug when pregnant.
The independent review, chaired by Baroness Julia Cumberlege, strongly criticised the industry and regulators and made a series of recommendations, including the creation of a redress scheme for victims in all three groups.
On valproate, it stated: “Nothing can undo the harm that has been done to these individuals, but steps can be taken to make their lives easier.”
Deborah Mann and her daughter Branwen visit Trelissa’s grave
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20,000 children exposed to drug while in womb
Five years on there is still no such scheme for any of the campaign groups. In the week of developments in the Post Office scandal and infected blood, here is another scandal no less significant.
An estimated 20,000 children were exposed to sodium valproate while in the womb.
UK regulator the MHRA says an increased risk of neonatal loss is not currently a recognised adverse reaction, but it does warn of a range of congenital problems caused by the drug that are increasingly likely the higher the dose.
Sky News has also seen a study from 1972 which shows high doses of sodium valproate could be embryo-lethal in rats. At times Ms Mann was being prescribed 5,000mg, which is double the highest recommended dose.
Ms Mann worries about the future of her surviving children. She says of the government: “It’s financially better to pretend they don’t even exist. So many children are harmed, so many children that will not have their needs addressed as they grow older.”
At the time of birth her eldest daughter Rhonwen’s medical records state “valproate levels caused foetal and patient damage,” which included deafness.
Branwen, 29
Daughter worries about being a mother as she can pass condition on
Ms Mann wasn’t initially told about the cause of her daughter’s problems, even when she was pregnant with her next child Branwen.
The 29-year-old told Sky News: “I have tight ankles, tight legs, tight hips and I have a weak lower back. I have to wear splints every day to be sure I can keep walking, and I have to do exercises every day. I have autism, Asperger’s syndrome.”
She goes on to list a series of brain problems that must be scanned every two years, “to make sure nothing’s grown or moved.”
She was bullied at school for her appearance, and she worries about being a mother as she can pass the condition on to her children.
She said: “I feel very let down by the government. I feel let down by the people who promised they would help us, that they will help ensure that we have a better quality of life.”
‘Somebody at last had listened’
Others the Cumberlege review wanted to get redress for “avoidable harm” were children born with malformations after their mothers used the drug Primodos.
These hormone-packed pills were prescribed as a pregnancy test to thousands of women in the 1960s and 70s and are alleged to have caused a range of malformations to babies, from shortened limbs to heart defects, which the manufacturer denies.
Marie Lyon, lead campaigner for the Association for Children Damaged by Hormone Pregnancy Tests
Lead campaigner for the Association for Children Damaged by Hormone Pregnancy Tests (ACDHPT), Marie Lyon, told Sky News: “Our families were utterly overjoyed that somebody at last had listened, and Julia Cumberlege did a thorough review. Our expectations were wow! This is it now. An apology from the health secretary, all these years and we’ve finally got there, and then nothing.
“Five years and may I say, five years and 31 deaths. That’s how many of our members have died since that report was published in 2020 and we’ve still not received justice. It’s a disgrace.”
Baroness Cumberlege also recommended the government create a redress scheme for women left debilitated by pelvic mesh implants.
Kath Sansom, founder of the Sling The Mesh campaign group
‘The government are dragging their feet’
Kath Sansom, founder of the Sling The Mesh campaign group, told Sky News: “There are women in there who can’t walk any more, who need a stick or a mobility scooter – they’ve lost jobs, marriages, pensions. Some have had to sell their homes, and it feels really unfair that we are still waiting for a reply on redress.
“The government are dragging their feet. We keep being told that they are working on it at pace – but the phrase within the group is – a snail’s pace.”
The Department of Health and Social Care said: “The harm caused by pelvic mesh continues to be felt today” and “we are fully focused on how best to support patients and prevent future harm.”
“Health Minister Baroness Gillian Merron met patients affected and has committed to providing a further update.”
Government considering recommendations
The government says it is considering the recommendations by the patient safety commissioner last year for a redress scheme, but it’s notable there is no timescale and no reference to the harm caused by valproate or Primodos in their statement.
Dr Alison Cave, chief safety officer at the Medicines and Healthcare products Regulatory Agency (MHRA), said: “Patient safety is our highest priority and no one should stop taking valproate without seeking advice from their healthcare professional.
“Valproate is a highly teratogenic medicine and there is evolving evidence for harms in males, which is why the Commission on Human Medicines (CHM) recommended new regulatory measures to reduce the known harms from valproate, including the significant risk of serious harm to the baby if taken during pregnancy and the risk of impaired fertility in male.”
Sanofi, manufacturers of sodium valproate, told us: “We have always worked closely with the MHRA and fully met all our legal and regulatory obligations in relation to valproate which is an essential medicine used to treat a serious and potentially life-threatening condition.
“Sanofi has at all times provided information regarding valproate that reflects current knowledge as approved by MHRA.
“We are committed to working with all concerned stakeholders to continue educating about the risks and precautions for the appropriate use of valproate.”
The dates for Donald Trump’s state visit to the UK have been announced, with the US president due to be welcomed by the King from 17 to 19 September.
Buckingham Palace also confirmed that President Trump and first lady Melania will be hosted by the King and Queen at Windsor Castle.
It was expected that the three-day state visit would take place in September after Mr Trump let slip earlier in April that he believed that was when his second “fest” was being planned for.
Windsor was also anticipated to be the location after the US president told reporters in the Oval Office that the letter from the King said Windsor would be the setting. Refurbishment works at Buckingham Palace also meant that Windsor was used last week for French President Emmanuel Macron’s visit.
This will be Mr Trump’s second state visit to the UK, an unprecedented gesture towards an American leader, having previously been invited to Buckingham Palace in 2019.
Donald Trump and Melania Trump posing with Charles and Camilla in 2019. Pic: Reuters
He has also been to Windsor Castle before, in 2018, but despite the considerable military pageantry of the day, and some confusion around inspecting the guard, it was simply for tea with Queen Elizabeth II.
Further details of what will happen during the three-day visit in September will be announced in due course.
On Friday, Sky News revealed it is now unlikely that the US president will address parliament, usually an honour given to visiting heads of state as part of their visit. Some MPs had raised significant concerns about him being given the privilege.
But the House of Commons will not be sitting at the time of Mr Trump’s visit as it will rise for party conference season on the 16 September, meaning the president will not be able to speak in parliament as President Macron did during his state visit this week. However, the House of Lords will be sitting.
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In February this year, Prime Minister Sir Keir Starmer presented the US president with the letter from the King inviting him to visit during a meeting at the White House.
After reading it, Mr Trump said it was a “great, great honour”, adding “and that says at Windsor – that’s really something”.
In February, Sir Keir Starmer revealed a letter from the King inviting Donald Trump to the UK. Pic: Reuters
In the letter, the King suggested they might meet at Balmoral or Dumfries House in Scotland first before the much grander state visit. However, it is understood that, although all options were explored, complexities in both the King and Mr Trump’s diaries meant it wasn’t possible.
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This week, it emerged that Police Scotland are planning for a summer visit from the US president, which is likely to see him visit one or both of his golf clubs in Aberdeenshire and Ayrshire, and require substantial policing resources and probably units to be called in from elsewhere in the UK.
Precedent for second-term US presidents, who have already made a state visit, is usually tea or lunch with the monarch at Windsor Castle, as was the case for George W Bush and Barack Obama.
A small plane has crashed at Southend Airport in Essex.
Essex Police said it was at the scene of a “serious incident”.
Images posted online showed huge flames and a large cloud of black smoke, with one witness saying they saw a “fireball”.
A police statement said: “We were alerted shortly before 4pm to reports of a collision involving one 12-metre plane.
“We are working with all emergency services at the scene now and that work will be ongoing for several hours.
“We would please ask the public to avoid this area where possible while this work continues.”
A huge fireball near the airport. Pic: Ben G
It has been reported that the plane involved in the incident is a Beech B200 Super King Air.
According to flight-tracking service Flightradar, it took off at 3.48pm and was bound for Lelystad, a city in the Netherlands.
One man, who was at Southend Airport with his family around the time of the incident, said the aircraft “crashed headfirst into the ground”.
John Johnson said: “About three or four seconds after taking off, it started to bank heavily to its left, and then within a few seconds of that happening, it more or less inverted and crashed.
“There was a big fireball. Obviously, everybody was in shock in terms of witnessing it. All the kids saw it and the families saw it.”
Mr Johnson added that he phoned 999 to report the crash.
Southend Airport said the incident involved “a general aviation aircraft”.
Four flights scheduled to take off from Southend this afternoon were cancelled, according to its website.
Flightradar data shows two planes that had been due to land at Southend were diverted to nearby airports London Gatwick and London Stansted.
Plumes of black smoke. Pic: UKNIP
Essex County Fire and Rescue Service said four crews, along with off-road vehicles, have attended the scene.
Four ambulances and four hazardous area response team vehicles are also at the airport, as well as an air ambulance, the East of England Ambulance Service said.
Its statement described the incident as “still developing”.
Fire engines at the airport
David Burton-Sampson, the MP for Southend West and Leigh, posted on social media: “I am aware of an incident at Southend Airport. Please keep away and allow the emergency services to do their work.
“My thoughts are with everyone involved.”
Local councillor Matt Dent said on X: “At present all I know is that a small plane has crashed at the airport. My thoughts are with all those involved, and with the emergency services currently responding to the incident.”
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UK
Heidi Alexander says ‘fairness’ will be government’s ‘guiding principle’ when it comes to taxes at next budget
Another hint that tax rises are coming in this autumn’s budget has been given by a senior minister.
Speaking to Sunday Morning with Trevor Phillips, Transport Secretary Heidi Alexander was asked if Sir Keir Starmer and the rest of the cabinet had discussed hiking taxes in the wake of the government’s failed welfare reforms, which were shot down by their own MPs.
Trevor Phillips asked specifically if tax rises were discussed among the cabinet last week – including on an away day on Friday.
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Tax increases were not discussed “directly”, Ms Alexander said, but ministers were “cognisant” of the challenges facing them.
Asked what this means, Ms Alexander added: “I think your viewers would be surprised if we didn’t recognise that at the budget, the chancellor will need to look at the OBR forecast that is given to her and will make decisions in line with the fiscal rules that she has set out.
“We made a commitment in our manifesto not to be putting up taxes on people on modest incomes, working people. We have stuck to that.”
Ms Alexander said she wouldn’t comment directly on taxes and the budget at this point, adding: “So, the chancellor will set her budget. I’m not going to sit in a TV studio today and speculate on what the contents of that budget might be.
“When it comes to taxation, fairness is going to be our guiding principle.”
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Afterwards, shadow home secretary Chris Philp told Phillips: “That sounds to me like a barely disguised reference to tax rises coming in the autumn.”
He then went on to repeat the Conservative attack lines that Labour are “crashing the economy”.
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Chris Philp also criticsed the government’s migration deal with France
Mr Philp then attacked the prime minister as “weak” for being unable to get his welfare reforms through the Commons.
Discussions about potential tax rises have come to the fore after the government had to gut its welfare reforms.
Sir Keir had wanted to change Personal Independence Payments (PIP), but a large Labour rebellion forced him to axe the changes.
With the savings from these proposed changes – around £5bn – already worked into the government’s sums, they will now need to find the money somewhere else.
The general belief is that this will take the form of tax rises, rather than spending cuts, with more money needed for military spending commitments, as well as other areas of priority for the government, such as the NHS.
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