Quality control problems at an Eli Lilly plant discovered last year by FDA investigators could make it even harder for the company to get emergency approval for its coronavirus antibody drug, a Reuters investigation found.
US drug inspectors uncovered serious compliance issues at an Eli Lilly pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs touted by President Trump as ‘a cure’ for the disease, according to government documents and three sources familiar with the matter.
The Lilly antibody therapy, which is experimental and not yet approved by regulators as safe and effective, is similar to a drug from Regeneron Pharmaceuticals that was given to the president during his bout with COVID-19.
Trump, who credits the Regeneron drug with speeding his recovery, has called for both therapies to become available immediately on an emergency basis, for free, while incorrectly referring to them as ‘cures.’
His promotion of the drugs has raised expectations among some scientists and policy experts that the administration will imminently release an Emergency Use Authorization (EUA) for the drug.
The president’s push is key to his efforts to convince voters he has an answer to the pandemic that has killed more than 215,000 Americans.
But compliance issues at the manufacturing facility could undermine those efforts by calling the company’s fitness to safely produce the drug into question, sources within the agency and outside legal experts told Reuters.
Last year, FDA inspectors found compliance issues at an Eli Lilly plant manufacturing the coronavirus antibody drug the firm is seeking approval for. The regulatory red flags could jeopardize its chances of emergency authorization from the FDA (file)
The findings have not been disclosed previously.
That’s because U.S. law generally requires compliance with manufacturing standards for authorization of a drug.
The three sources who spoke to Reuters requested that their names be withheld so they could speak freely without fear of retaliation.
Inspectors who visited the Lilly plant in Branchburg, New Jersey, last November found that data on the plant’s various manufacturing processes had been deleted and not appropriately audited, government inspection documents show.
‘The deleted incidents and related audit trail were not reviewed by the quality unit,’ the FDA inspectors wrote.
Because the government inspection documents reviewed by Reuters were heavily redacted by the FDA it was not possible to see the inspectors’ more specific findings.
Following its November inspection, the FDA classified the problems as the most serious level of violation, resulting in an ‘Official Action Indicated’ (OAI) notice.
That ‘means that the violations are serious enough and have a significant enough impact on the public health that something needs to be fixed,’ said Patricia Zettler, a former associate chief counsel at the FDA who is now a law professor at Ohio State University.
Separately, Lilly said on Tuesday it had paused its clinical trial for the COVID drug in hospitalized patients ‘out of an abundance of caution’ over a potential safety concern.
The company did not release information on what the problem was and declined to say how the news might affect their EUA request.
In response to Reuters’ questions on Monday about the manufacturing issues, Lilly confirmed the OAI notice but declined to provide details on what prompted the FDA action.
The drugmaker said it has launched a ‘comprehensive remediation plan,’ has increased staffing at the site and was working ‘aggressively’ to address all concerns raised during the inspection.
The data deletions cited by the FDA, Lilly said, were not related to production of the drug.
Lilly has developed two antibody treatments for coronavirus and has applied to the FDA for emergency approval of one of them. At least one is being manufactured at the New Jersey plant where FDA inspectors found oversight and drug control issues in November and August
‘These findings do not impact product quality or patient safety, as outlined in a detailed assessment submitted to FDA,’ the company´s statement said. ‘Lilly continues to provide updates to the FDA on progress towards completion of our detailed plan.’
The drugmaker declined to provide a copy of the assessment it gave the FDA.
The FDA did not respond to requests for comment. The White House declined to comment.
One of the sources told Reuters that Lilly employees had complained about problems at the plant, including insufficient staffing and falsified records tracking whether workers had followed FDA manufacturing standards.
Lilly said the FDA has not made any findings of falsification at the site.
Out of 563 total inspections concluded in fiscal year 2019 by the FDA across the country, only a small fraction resulted in the most serious OAI classification, FDA data shows, and no other Lilly facility has received such a notice in at least 10 years.
None of Regeneron’s facilities have received OAIs based on inspections through the end of October 2019, FDA records show. Regeneron said in a statement it was ‘proud’ of the company´s efforts to comply with manufacturing requirements, which ‘is reflected in our FDA inspection record.’
Lilly has not disclosed the FDA inspections in its U.S. Securities and Exchange Commission filings. U.S. courts, in cases involving other companies, have ruled that such information could be material to investors.
But that depends on several factors, including the severity of the FDA´s findings, as well as whether the company has failed to correct the deficiencies.
In its statement to Reuters, Lilly did not respond to a question about why the inspections were’t disclosed.
PRESSURE TO GET ANTIBODY TREATMENTS APPROVED BEARS DOWN ON DRUGMAKERS AFTER TRUMP SHIFTS ELECTION FOCUS
Trump had previously focused on a promise to deliver a coronavirus vaccine by the November 3 election, but that effort has since lost momentum due to doubts that any drugmaker will have enough proof of safety and efficacy in the coming weeks.
Now under increased pressure to act swiftly against the pandemic, the FDA has discretion to approve Lilly´s COVID-19 therapy for emergency use even if the manufacturing issues have not been fully resolved.
President Trump has been pushing for emergency approval of both Eli Lilly’s coronavirus antibody treatment, and Regeneron’s antibody drug, which he received during his bout with COVID-19 (pictured: Trump upon his return to the White House from treatment at Walter Reed)
The FDA has already been criticized by some scientists and politicians for issuing EUAs for use of anti-malarial drug hydroxychloroquine and convalescent plasma treatment in coronavirus patients, despite little or problematic data. The agency ultimately withdrew its authorization for hydroxychloroquine and the plasma authorization remains in place.
WHAT IS REGENERON’S ANTIBODY COCKTAIL?
Regeneron’s drug ‘cocktail,’ REGN-COV2, contains an antibody made by the company from mice and another isolated from a recovered COVID-19 patient, each of which may help to neutralize coronavirus.
The firm’s latest data from the ongoing trials, show the drug drove down the viral loads of patients who were not hospitalized and cut their recovery times by nearly half.
But it’s very much an experimental treatment, and the data announced earlier this week are the first published from the trial.
Two patients treated with the antibody cocktail had ‘adverse events’ – undesirable side effects. One of those was a ‘serious’ adverse event, but Regeneron did not reveal details of what happened to the patient, who received a low dose of the drug.
REGN-COV2 is comprised of a duo of therapeutics in a class of drugs known as monoclonal antibodies (hence REGN-COV2’s distinction as a ‘polyclonal antibody’), which are clones of antibody that attacks a specific antigen.
The Branchburg plant specializes in a range of drugs that are injected by syringe or infused intravenously. Partly because of the risk of contamination, such treatments are more complex to make than conventional pills and require additional vigilance to ensure quality and safety, pharmaceutical experts say.
Lilly´s drug, known as LY-CoV555, is a manufactured copy of an antibody from a patient who recovered from COVID-19. Known as monoclonal antibodies, such treatments work by recognizing and locking onto foreign invaders to block infection of healthy cells.
Leading scientists have pointed to antibody drugs as a promising way to treat people who are already sick, and also to temporarily prevent infection in people at high risk of COVID-19, until a successful vaccine is identified.
Lilly´s clinical trial data thus far show its therapy may help reduce hospital stays and emergency room visits for COVID-19 patients. The company has asked U.S. regulators to approve emergency use of the drug for higher-risk patients who have been recently diagnosed with mild to moderate coronavirus.
Antibody drugs for the coronavirus are very limited in number, but Lilly says it expects to produce around one million doses of the treatment by the end of this year.
The Trump administration´s program to accelerate development of COVID-19 vaccines and therapies, dubbed Operation Warp Speed, has already reached a $450 million deal with Regeneron for up to 300,000 treatment doses of its antibody treatment, REGN-COV2.
No such agreement has been reached with Lilly, but the government´s interest in its therapy appears keen. Earlier this month, Warp Speed officials traveled to Branchburg to meet with Lilly executives, according to two sources briefed on the visit. Among the attendees were Lilly Chief Executive David Ricks and Chief Science Officer Dan Skovronsky, one source said.
A potential complication is the former relationship between Health and Human Services Secretary Alex Azar and Lilly, where he held a high-level position until 2017.
Generally, he would have to sign off on a waiver for any company seeking an EUA that had been cited by the FDA for manufacturing problems.
HHS secretary Alex Azar is a former Eli Lilly executive, and may have to recuse himself from review of the company’s application for emergency approval of COVID-19 drugs (file)
But because he is a former Lilly executive, Azar’s involvement in the deliberations could pose a potential conflict of interest, legal experts said.
An HHS spokeswoman said Azar is not prohibited from participating in the deliberations about Lilly’s manufacturing issues or its EUA. But she said that in general, Azar has delegated his emergency authorization powers to the FDA. HHS did not make Azar available for comment.
FDA INVESTIGATORS FOUND DELETED DATA ON PRODUCTION SYSTEMS AND GAPS IN DRUG STRENGTH AND TESTING PRACTICES
Lilly acquired the New Jersey site in question when it bought ImClone Systems in 2008, and over the next ten years the FDA inspected the facility several times and found no serious problems.
That changed last November.
Two inspectors spent ten days at the facility, according to the redacted copy of their report, known as a ‘483 letter’, which was reviewed by Reuters.
The FDA inspectors described problems with ‘appropriate controls over computers and production systems,’ and noted that data had been ‘deleted’ and went unreviewed by company auditors.
After the November 2019 inspection, the FDA returned to the Lilly site for a follow up audit and found additional problems in August, issuing a second 483 letter, according to an FDA inspection log.
Among the problems: Lilly did not always have proper laboratory controls for drugs manufactured at the plant, the November inspection report said.
One source said, for instance, that the plant failed to maintain systems meant to ensure that a popular anti-migraine drug, Emgality, met strength and purity standards.
If the issues aren’t fixed, then the FDA could escalate the matter by issuing a warning letter, which sets out a deadline for correcting the problems. Ultimately, the FDA could order a company to cease producing certain drugs at a facility.
Lilly said it had not received a warning letter.
Meanwhile, Trump is leaning on the FDA for a quick approval of the antibody drugs. He does not have the authority to issue an EUA under the law.
However, he said in a video last week ‘I have emergency use authorization all set. And we’ve got to get it signed now.’
This post first appeared on dailymail.co.uk
BLM protests: Mother of black man who died in chase MACED by police
A second night of looting broke out in Philadelphia Tuesday amid protests there, in Washington DC and in New York City over the deaths of two black men.
Walter Wallace, 27, was killed Monday when Philadelphia police officers fired at him. His family had called for an ambulance to get him help with a mental health crisis, not for police intervention, their lawyer said Tuesday. Karon Hylton, 20, died Monday after crashing into a car while being chased on a Revel scooter by police in DC.
Pictures from both cities Tuesday showed continued unrest over the deaths. Trouble also flared in New York City, where a car was filmed driving into a line of cops. The deaths are just the latest in a string of police killings of black men and women across America in recent months.
Images from Philadelphia shows stores in the city being looted. Philadelphia Police tweeted: ‘*Alert* A large crowd of appx 1000 is looting businesses in the area of Castor and Aramingo. Avoid the area.’ Police later urged residents to stay inside their homes.
The Philadelphia Office of Emergency Management tweeted: ‘The Philadelphia Police Department is requesting that all residents in the 12, 16, 18, 19, 24, 25, and 26th Districts remain indoors except when necessary. These areas are experiencing widespread demonstrations that have turned violent with looting.’
Philadelphia officials had anticipated a second night of unrest Tuesday, and a Pennsylvania National Guard spokesperson told The Inquirer that several hundred guardsmen were expected to arrive in the city within 24 to 48 hours.
Wallace was shot before 4 p.m. Monday in an episode filmed by a bystander and posted on social media. Witnesses complained that police fired excessive shots.
Chief Police Inspector Frank Vanore said that police had received a call about a man screaming and that he was armed with a knife. The Herald Mail Media reports police had been called to the home two times before fatal shots were fired Monday.
Officers said they found Wallace holding a knife and ordered him to drop the weapon several times. Wallace advanced toward the officers, who fired several times, said Officer Tanya Little, a police spokesperson.
Throughout the day Tuesday, state and local officials called for transparency and a thorough investigation, including the release of body camera footage from the two officers who fired their weapons.
Philadelphia: A protestor confronts police during a march Tuesday in Philadelphia. Hundreds of demonstrators marched over the death of Walter Wallace, a black man who was killed by police in Philadelphia on Monday.
Washington DC: Washington Metropolitan Police Department officers stand near the fourth district police station in Washington, Tuesday after the death of Karon Hylton on a Revel scooter by police in the nation’s capital
Washington DC: Demonstrators broke windows at the police station in protest over a fatal a crash involving a moped driver who died when he police were attempting to pull him over. The crash happened last Friday
Washington DC: A woman identified as Hylton’s mom was filmed outside the police station in the city Tuesday telling officers: ‘You know it was wrong.’ She later appears to have been maced by officers during protests, pictured
Philadelphia officials had anticipated a second night of unrest Tuesday, and a Pennsylvania National Guard spokesperson told The Inquirer that several hundred guardsmen were expected to arrive in the city within 24 to 48 hours
Protesters confront police during a march, Tuesday. Police shot and killed the 27-year-old Wallace on a Philadelphia street after yelling at him to drop his knife.
New York City: Footage appeared to show a car driving through a line of cops in Brooklyn; it is not known if any officers were injured. Around 200 protesters came out in response to Wallace’s death
As violence spilled over into other US cities windows were smashed by protesters at a police station in Washington DC, NBC reports over the death of revel scooter driver Hylton; one person was arrested and four officers are said to have suffered non life threatening injuries.
DC police say Hylton died after they saw him riding without a helmet. But the dad-of-one’s friend said: ‘They hit him in the back of his scooter and pushed him into the oncoming car.’
A woman identified as Hylton’s mom was filmed outside the police station in the city Tuesday telling officers: ‘You know it was wrong.’ She later appears to have been maced by officers during protests.
Other footage from the city shows tear gas has been deployed.
Black Lives Matter DC tweeted: ‘We need all hands on deck @MayorBowser and @ChiefNewsham terror gang is literally at war with the community at 4D police station. They shooting teargas and rubber bullets.’
Wallace was shot multiple times and killed around 4 p.m. Monday when officers were called out to reports of a domestic incident at Locust and South 61st streets in Cobbs Creek, West Philadelphia. The footage shot on a witness’s smartphone begins with Wallace walking between parked cars outside the front of some homes in the residential neighborhood. A woman, later identified as his mother, is following him trying to get hold of him as shouts ring the air
Karon Hylton, 20, died Monday while being chased on his scooter by police in the nation’s capital
Police Commissioner Danielle Outlaw said at a news conference Tuesday that she was still reviewing when and what information would be released to the public with regards to Wallace’s death.
The officers had not been interviewed as of Tuesday afternoon, she said. Neither had a Taser or similar device at the time of the shooting, Outlaw said, noting the department had previously asked for funding to equip more officers with those devices.
Outlaw said the officers’ names and other identifying information, including their race, would be withheld until the department could be sure releasing the information would not pose a threat to their safety. The officers were taken off street duty during the investigation.
Police officials said they could not confirm what information had been given to the responding officers, whether they were told about a possible mental illness or how many calls they had received for help at Wallace’s address Monday.
Wallace’s father, Walter Wallace Sr. said Tuesday night that he is haunted by the way his son was ‘butchered.”It’s in my mind. I can’t even sleep at night. I can’t even close my eyes,’ he said.
Wallace Sr. condemned the violence Tuesday night, adding: ‘They’re not helping my family, they’re showing disrespect. Stop this violence and chaos. People have businesses. We all got to eat.’
Philadelphia: Protesters confront police during a march Tuesday; Wallace’s family had called for an ambulance to get him help with a mental health crisis, not for police intervention, their lawyer said Tuesday
Images from Philadelphia shows stores in the city being looted. Philadelphia Police tweeted: ‘*Alert* A large crowd of appx 1000 is looting businesses in the area of Castor and Aramingo. Avoid the area;
Protestors hold a banner reading ‘enough is enough’ during a rally after the death of Wallace
Washington DC: Demonstrators gather outside the 4th District Police Station during a protest against Karon Hylton’s death
Washington DC: Police officers stand guard outside the 4th District Police Station; Hylton, 20, succumbed to his injuries on Monday after he was hit by a car while riding an electric scooter. Family members accused the police of causing the crash
Washington DC: Windows were smashed by protesters at a police station in DC, NBC reports; one person was arrested and four officers are said to have suffered non life threatening injuries
About 500 people had gathered at a West Philadelphia park Tuesday night and began marching through the neighborhood, chanting and demanding the names of the officers who opened fire.
There were sporadic reports of arrests in other areas of the city Tuesday night around 9 p.m., as well as the video of people streaming into stores and stealing goods as they left.
Hundreds of people had already taken to the streets in west Philadelphia Monday night and into the early hours of Tuesday, with interactions between protesters and police turning violent at times, the Inquirer reported.
Video showed many yelling at officers and crying.
Dozens of protesters gathered at a nearby park, chanting ‘Black lives matter.’
Police cars and dumpsters were set on fire as officers struggled to contain the crowds. More than a dozen officers, many with batons in hand, formed a line as they ran down 52nd Street, dispersing most of the crowd.
The 52nd Street corridor was also the site of protests against police brutality at the end of May, after George Floyd was killed by Minneapolis police. Those protests have been the subject of City Council hearings, with protesters describing harsh and unnecessary tactics, including tear gas and projectiles fired by police.
Wallace was shot before 4 p.m. Monday in an episode filmed by a bystander and posted on social media. Witnesses complained that police fired excessive shots. Officers said they found Wallace holding a knife and ordered him to drop the weapon several times. Wallace advanced toward the officers, who fired several times, said a police spokesperson
Washington DC: Police officers speak to a man outside the 4th District Police Station on Tuesday evening
Washington DC: DC police say Hylton died after they saw him riding without a helmet. But the dad-of-one’s friend said: ‘They hit him in the back of his scooter and pushed him into the oncoming car’
Police arrested at least 91 people during unrest Monday night and Tuesday morning in Philadelphia, with three people cited for failing to disperse and about a dozen charged with assault of an officer.
Authorities had previously said 30 officers were injured in the unrest, most of them hit with thrown objects like bricks.
One officer was still hospitalized Tuesday with a broken leg after being purposely run over by a pickup truck, police said.
In video filmed by a bystander and posted on social media, officers yell for Wallace to drop a knife. In the video, Wallace’s mother and at least one man follow Wallace, trying to get him to listen to officers, as he briskly walks across the street and between cars.
Wallace advanced toward the officers, who then fired several times, said police spokesperson Officer Tanya Little. Wallace’s mother screams and throws something at an officer after her son is shot and falls to the ground.
The video does not make it clear whether he was in fact holding a knife, but witnesses said he was. Police would not confirm any details about the weapon Wallace was alleged to be holding Tuesday, saying it is still part of the open investigation.
Wallace was hit in the shoulder and chest, Little said. One officer drove him to a hospital, where he was pronounced dead a short time later, she said.
Philadelphia: Walter Wallace, Sr. speaks to the press about the police killing of his son, Walter Wallace, Jr
Demonstrators have been taking to the streets nationwide for months demanding an end to police brutality and systemic racism following the Memorial Day death of George Floyd.
Floyd died back in May after white cop Derek Chauvin knelt on his neck for almost nine minutes as he begged for air and said ‘I can’t breathe’.
EMT Breonna Taylor, 26, was shot six times in March when three plainclothes officers performed a botched raid at her Louisville apartment.
In June, unarmed father Rayshard Brooks was shot dead while he ran from cops in the drive-thru of a Wendy’s restaurant in Atlanta.
Then, in August, Jacob Blake was shot seven times in the back by a white cop in front of his three young children, leaving the father-of-six paralyzed from the waist down.
In early September, footage was released by the family of Daniel Prude, 41, showing cops in Rochester, New York, putting a spit hood over his face and pushing his face into the ground for two minutes until he passed out and died on March 23.
This post first appeared on dailymail.co.uk
Australian Special forces soldiers ‘fuelled by bloodlust’ gloated about killing Afghan teenagers
Australian special forces soldiers gloated about torturing and killing teenagers when they were serving in Afghanistan, a new report has claimed.
The alleged conduct, which was reportedly covered up, has been compared to the widely condemned behaviour of American soldiers serving in Iraq’s Abu Ghraib prison from 2003 onwards.
The confidential report was commissioned in 2016 by then chief of army Angus Campbell. It is said to reveal unarmed civilians and prisoners in Afghanistan were shot dead or had their throats slit by Australian soldiers.
The report claims a few servicemen were said to have ‘gloated’ about illegal killings.
Defence consultant Samantha Crompvoets (pictured above) produced the report after interviewing a number of special forces soldiers
Defence consultant Samantha Crompvoets produced the report which contains a number of candid interviews with special forces soldiers.
The allegations include claims that war crimes being normalised by some soldiers, that there was ‘competition killing and blood lust’ and that prisoners were treated ‘inhumanely’.
General Campbell was also told of testimony from special forces that some soldiers were ‘glorifying crimes’ and were involved in the ‘cover-ups of unlawful killing and other atrocities’ in Afghanistan between 2001 and 2015.
‘If they didn’t do it, they saw it (killings). And if they didn’t see it, they knew about it,’ an insider reportedly stated.
The briefing goes onto point out major failures in Defence leadership that contributed to the scandal. Focus was also placed on inadequate whistle-blowing avenues, which would have assisted soldiers in reporting war crimes without fear of retribution.
The behaviour of British and US soldiers in Afghanistan was ‘far worse’, according to a special forces informant, the Sydney Morning Herald reports.
‘I’ve watched our young guys stand by and hero worship what they were doing, salivating at how the US were torturing people. You just stand there and roll your eyes and wait for it to end,’ he said in a recording.
Australian soldiers were also said to have killed two boys suspected of being Taliban sympathisers. The pair allegedly had their throats slit, with the bodies later thrown into a nearby river.
Dr Crompvoets’ briefing to General Campbell in early 2016 was the catalyst for soon to be completed four year inquiry into war crimes by senior judge Paul Brereton.
Defence Force General Angus Campbell (pictured above) commissioned a report in 2016 which revealed alleged misconduct of Australian soldiers in Afghanistan between 2001-2015
This post first appeared on dailymail.co.uk
School meals: Government has ‘moral obligation’ says food tsar
Henry Dimbleby, the Government’s food tsar, said ministers need to do more to tackle food poverty
Boris Johnson’s own food tsar yesterday accused him of ‘not doing enough’ to prevent children going hungry – as he urged Downing Street to spend £1.2 billion tackling the problem.
Henry Dimbleby, the co-founder of the Leon restaurant, demanded urgent action including the nationwide rollout of holiday clubs during school breaks.
The Government is facing mounting public anger at its refusal to extend free school meals into half-term and beyond following a campaign spearheaded by Marcus Rashford.
Stars including Coldplay and One Direction’s Louis Tomlinson yesterday urged fans to sign a petition organised by the Manchester United and England footballer, which has reached almost one million signatures.
Mr Dimbleby, who leads the National Food Strategy, last night told The Times the Government had ‘walked into a massive bear trap’ over whether to provide free school meals during holidays.
He said: ‘There is a genuine problem with food poverty that has been massively exacerbated by this [coronavirus] crisis. We have a moral obligation to set aside questions of ideology.
‘I don’t understand why they [the government] haven’t owned this. Their mission is to level up. Clearly there was a massive bear trap that they walked straight into.
‘It has cut through to a wide proportion of the population who ask why when you’re spending all this money are you letting children go hungry.’
Mr Dimbleby has sent Downing Street a four-point programme to tackle child hunger which would cost £1.2 billion a year.
It includes £670 million to extend free school meals, £500 million towards an activity and food programme, and £100 million for vouchers to encourage healthy eating.
Earlier yesterday, he told BBC Radio 4’s Today programme: ‘This problem is real. It should go without saying it’s serious.. It’s immediate and it’s going to get worse as employment gets worse and the Government isn’t doing enough.
‘One in seven families already are reporting not being able to afford enough food.’
The Government is facing mounting public anger at its refusal to extend free school meals into half-term and beyond following a campaign spearheaded by Marcus Rashford
He said that ‘in-kind support’ through holiday clubs, providing food and education, had been shown to have a better impact than putting the same ‘small amount of money’ into Universal Credit.
‘I haven’t been backward in coming forward with ideas that I have been feeding in to Treasury, to (the Department for) Education and to Number 10, ideas of how they could rapidly implement this by Christmas,’ he said.
‘But… the dark centre of government is invisible to me and I have no idea exactly what they’re working on as we speak.’
Chancellor Rishi Sunak insisted yesterday the Government is ‘absolutely committed’ to ensuring vulnerable children do not go hungry.
But he told BBC Radio 1’s Newsbeat: ‘We’ve taken the view that we have provided resources for local authorities to help in a targeted way the most vulnerable children that they need to look after.’
Mr Sunak said ‘we should be able to trust local councils in different areas to make decisions for their people’.
Mr Dimbleby’s comments came as George Osborne, the ex-chancellor, also stuck the boot into Mr Johnson as he said Marcus Rashford had ‘nutmegged’ the PM and a U-turn on free school meals is now ‘inevitable’.
Mr Dimbleby, who leads the National Food Strategy, last night told The Times the government had ‘walked into a massive bear trap’ over whether to provide free school meals during holidays
The ex-chancellor said the Manchester United and England footballer had made the Cabinet ‘look like a school yard football team’ and with Tory MPs now ‘getting nervy’ the PM will have no choice but to back down.
Earlier today a millionaire minister had claimed holiday activities are ‘more important’ to disadvantaged children than free meals.
Nadhim Zahawi, the business minister, said the ‘best way’ to deal with poverty was through local government schemes and the welfare system as he pointed to a pilot programme which provided food and activities to poor children during the summer holidays.
But the married father-of-three who made his money in oil and gas exploration risked outcry as he claimed parents ‘appreciate the food but more important than the food to them was the activities’.
The Government remains under intense pressure to change tack on free school meals as a campaign led by Mr Rashford continues to gather pace and a Tory revolt grows.
Campaigners want the scheme, which costs about £20million per week, to be extended to cover future school holidays. If it applied to all 13 weeks of school holidays it could therefore cost an estimated £260million extra a year.
Mr Johnson dug in on the issue yesterday as he refused to budge and Rishi Sunak did the same today as he said ‘I don’t think it’s always the right answer that central government comes in and dictates things’.
But the approach taken by Number 10 has sparked widespread Tory anger, with MPs adamant the Government should U-turn.
Conservative backbenchers also signalled on Tuesday they could rebel over ‘unconscionable’ plans to remove a temporary coronavirus-related increase to Universal Credit payments.
Meanwhile, the Government is under fire from council bosses as they accused ministers of short changing them on funding to tackle child poverty.
Councillor David Mellen, the leader of Nottingham City Council, claimed the Government was guilty of ‘double-counting’ funding provided to local authorities.
Mr Dimbleby’s comments came as George Osborne, the ex-chancellor, also stuck the boot into Mr Johnson as he said Marcus Rashford had ‘nutmegged’ the PM and a U-turn on free school meals is now ‘inevitable’
Mr Osborne said Marcus Rashford, a leading campaigner on the issue, had ‘nutmegged’ Boris Johnson who now needed to admit it was ‘game over’
Who is Nadhim Zahawi, the millionaire Tory minister who is often sent out to bat for the Government?
Nadhim Zahawi is a junior minister at the Department for Business, Energy and Industrial Strategy (BEIS) but he has become one of Downing Street’s most trusted communicators during the coronavirus crisis.
Mr Zahawi, a millionaire who made his money in oil and gas exploration and also co-founded polling firm YouGov, is often chosen by Number 10 to represent the Government on particularly difficult morning media rounds.
He is viewed by the Government as a safe pair of hands and is frequently sent out to face the broadcasters on days when ministers are under fire.
However, he has suffered a number of missteps in recent months, particularly after he claimed that struggling parents would rather pay for meals for their children than accept the ‘label’ attached to handouts.
The 53-year-old married father-of-three has been in Parliament as the MP for Stratford on Avon since 2010 but he had a long wait to begin his ministerial career.
He was first elevated to the Tory frontbench in 2018 under Theresa May as a junior minister at the Department for Education.
He was then moved to BEIS when Boris Johnson became PM back in July last year and he has been widely tipped for a much bigger ministerial role in the near future.
Mr Zahawi was born in Baghdad, Iraq, and moved to the UK at the age of nine.
The Government is facing growing calls to retreat over its refusal to extend the free school meals programme to future holidays.
Campaigners, led by Mr Rashford, argue the extension is needed because many families have been left struggling financially because of the coronavirus crisis.
But the Government is so far refusing to give any ground and has instead opted to point to help and funding that is already in place.
Mr Osborne said on Tuesday that Mr Rashford had already ‘nutmegged the British state once’ by forcing ministers to extend the meals to school holidays earlier this year.
The former Tory MP said the Government had therefore ‘set the precedent’ which it will not be able to get away from.
Mr Osborne argued if the food vouchers were ‘justified at Easter, and then again in the summer (thanks to Rashford), how can they not be justified at Christmas?’.
Writing in the Evening Standard, he said: ‘With Tory MPs getting nervy, another Government U-turn is inevitable.
‘We’ll see if it comes in the form of food vouchers, new school holiday clubs or as a large bung to councils.
‘This Downing Street team came into office saying they were much smarter than their predecessors, and wouldn’t make the mistake of chasing headlines. That’s a bold claim.
‘But their ministers have been made to look like a school yard football team, all running in a panic after the ball — until a professional came onto the pitch and put it into the back of their net.’
Mr Osborne said the Government needed to ‘realise that it’s game over’.
Earlier Mr Zahawi had risked a backlash as he told Sky News this morning: ‘The best way to deal with this is through both local government and through the welfare system and that is the right thing to do.
‘We have run a pilot costing £9million this summer, feeding 50,000 children, we will take the learning from that.
‘It is not just about the food. As I said, I spoke to Carol Shanahan in Stoke on Trent [the chairman of Port Vale Football Club], she tells me that in wards where families want to keep their children safe during those activities they also appreciate the food but more important than the food to them was the activities for their children.’
Mr Zahawi’s comments come after he last week insisted struggling parents would rather pay for meals for their children than accept the ‘label’ attached to handouts.
The minister, who co-founded the YouGov polling firm, said Universal Credit benefits were available to support hard-pressed families and suggested research from holiday clubs showed parents prefer to pay a small sum for food.
Rishi Sunak and Gavin Williamson locked in blame game over free school meals
Rishi Sunak and Gavin Williamson are locked in a bitter blame game over the Government’s refusal to extend the free school meals programme as Treasury sources claimed the Education Secretary had not asked for extra funding.
It was reported over the weekend that the Treasury had blocked the £20 million per week needed to roll out the scheme to cover future school holidays.
But the suggestion that Mr Sunak was guilty of ‘parking the Treasury bus’ has prompted a furious response from the Chancellor’s allies who suspect Mr Williamson’s supporters may have briefed the story.
Allies of Mr Sunak said it was impossible for the Treasury to have blocked the funding as they claimed Mr Williamson had not put in a bid for the cash to be made available.
He told BBC Radio 4’s Today programme: ‘The research when we did the pilot demonstrates that families didn’t just want the meals.
‘Although they valued the meals, they didn’t like the labelling of them being free. They actually prefer to pay a modest amount, £1 or £2.’
It came as Mr Mellen accused the Government of failing to live up to its promises on funding to tackle child poverty.
He told Sky News: ‘The Government has given a shortfall in council funding over many years, 10 years of reductions.
‘They promised at the beginning of this year that they would stand shoulder to shoulder with us and meet the needs of our Covid costs and our lost income.
‘We are still several tens of millions short on that promise.
‘I am not convinced that the Government are not double-counting here on the money that they are saying that we already have to meet this need.’
He added: ‘They do that quite often.’
The Prime Minister insisted yesterday the Government would not allow children to go hungry but he refused to bow to demands to extend the free school meals programme.
Mr Johnson highlighted the money already given to councils and said Universal Credit was ‘one of the best ways you can help families in this tough time’.
Mr Sunak echoed a similar sentiment today as he told BBC Radio 1’s Newsbeat programme that ‘we should be able to trust local councils in different areas to make decisions for their people’.
He added: ‘So I don’t think it’s always the right answer that central government comes in and dictates things.’
The Government has increased Universal Credit payments by £20 per week during the pandemic but that increase is due to be scrapped in April next year.
Tory MPs are now calling on ministers to keep the increase in place for longer as they also said the Government should simply U-turn now on free school meals.
Former Cabinet minister Stephen Crabb said the Government should have conceded on the issue last week.
‘I think the Government should just deal with this head on, concede on the issue of vouchers but say very clearly and firmly that vouchers at best are not a long-term solution,’ he said.
Mr Crabb said the Government has created a political problem with ministers talking up the role of Universal Credit.
He said the fact it is a temporary increase is in ‘the small print’, adding: ‘We are on course to cut that money back in just a few months time and for me that’s just unconscionable.
‘You can’t give money to some of the poorest people in the country and then go out publicly and celebrate that fact and then say ‘oh by the way, even though we may still be living with the consequences of the pandemic next April we are going to cut that money back by around £20 per week, £100 per month’.
‘And that’s going to be a much bigger headache for the Government than school meals.’
This post first appeared on dailymail.co.uk
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