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      Trump officials tried to ‘bully’ FDA over Covid treatments, House panel says

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      Trump officials tried to ‘bully’ FDA over Covid treatments, House panel saysCongressional investigation finds new evidence of efforts to override health decisions early in pandemic Officials in the Trump White House tried to pressure health experts to reauthorize a discredited Covid treatment, according to a congressional investigation.A report published on Wednesday by the Democratic-led House select subcommittee on the coronavirus crisis contained new evidence of efforts to override Food and Drug Administration (FDA) decisions early in the pandemic.Biden unveils plan to cancel $10,000 in student loan debt for millionsRead moreThe report also shed new light on the role TV personalities played in bringing hydroxychloroquine, an anti-malarial drug, to the attention of top White House officials.The FDA authorized the use of hydroxychloroquine in late March 2020, based on small studies suggesting it could have some effectiveness against the coronavirus.At that time, many researchers hoped existing antiviral drugs could be used. But by June 2020 FDA officials had concluded the drug was likely ineffective and could cause potentially dangerous heart complications. Authorization for emergency use was revoked.The report by the House subcommittee focused on pressure on the FDA, which serves as gatekeeper for drugs, vaccines and other counter-measures against Covid.The subcommittee chairman, James Clyburn of South Carolina, said: “As today’s report makes clear, senior Trump administration officials undermined public health experts because they believed doing so would benefit the former president politically.”He also said officials had been “plotting covertly with known conspiracy theorists to dangerously push a disproven coronavirus treatment, bullying FDA to change its vaccine guidance, and advocating for federal investigations into those who stood in their way”.Much of the subcommittee’s information came from an interview with Stephen Hahn, who Trump picked as FDA commissioner in late 2019. Frustrated by the pace of FDA reviews, Trump repeatedly accused Hahn – without evidence – of delaying decisions on Covid drugs and vaccines for political reasons.Although FDA commissioners are politically appointed, agency scientists are expected to conduct reviews free from outside influence. Hahn told investigators he felt pressure due to the “persistence” of the Trump aide Peter Navarro to reauthorize hydroxychloroquine after the decision to pull its emergency use.“We took a different stance at the FDA,” Hahn told investigators. “So that disagreement, which of course ultimately became somewhat public, was a source of pressure.”Much of the report focuses on actions taken by Navarro and Steven Hatfill, a virologist and outside adviser described by the subcommittee as a “full-time volunteer” on Covid for the White House.“Dr Hatfill and Mr Navarro devised multiple pressure schemes targeting FDA and federal officials who they contended were wrongly impeding widespread access to hydroxychloroquine,” the report said.The report found that Hatfill and Navarro attempted to gain outside support for hydroxychloroquine by engaging “known extremists and prolific conspiracists like former White House chief strategist Steve Bannon, Jerome Corsi, and the Association of American Physicians and Surgeons” (AAPS).The report found that Hatfill, under Navarro’s supervision, coordinated with the AAPS executive director, Jane Orient, and Bannon to gather support for a petition to “keep pressure on the FDA and the new emergency use authorization request”.According to the report, Hatfill also “courted researchers to pursue a study to show the purported benefits of hydroxychloroquine by dangling millions of taxpayer dollars in promised funding – doing so after the drug was shown to be ineffective and potentially dangerous for certain patients”.Responding, Hatfill said: “We never wrongly pressured anyone. We simply followed the science and the overwhelming evidence as detailed in several studies available at the time.”Navarro said the subcommittee was “wrongly” claiming hydroxychloroquine to be “somehow dangerous”.There is no evidence White House efforts changed FDA decisions on hydroxychloroquine or any other therapies.In fall 2020, the focus of FDA and White House officials turned to the authorization of the first Covid vaccines, from Pfizer and Moderna.As previously reported, the White House objected to an FDA requirement that vaccine makers gather two months of safety data before filing applications, contending it would delay launch of the shots. Trump repeatedly said shots would be authorized before election day, despite government scientists signaling that was unlikely.The House report suggested that FDA guidance for vaccine manufacturers was delayed more than three weeks from mid-September until early October, due to White House concerns.Hahn told investigators the agency faced “pushback about the issue” from officials including Trump’s chief of staff, Mark Meadows, who told Hahn on 23 September 2020 that the White House would not sign off on the two-month requirement.On 6 October, the FDA published its vaccine guidelines as part of a larger set of documents for drugmakers. After the materials posted online, Hahn said Meadows called him to indicate that the guidelines were approved. The online publication drew fury from Trump on Twitter.“New FDA rules make it more difficult for them to speed up vaccines for approval before election day,” Trump tweeted at Hahn. “Just another political hit job!”TopicsCoronavirusDonald TrumpUS politicsnewsReuse this content More

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      Fauci to step down in December to ‘pursue next chapter’ of career

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      Fauci to step down in December to ‘pursue next chapter’ of careerExpert, 81, who has led National Institute of Allergy and Infectious Diseases since 1984, clashed with Trump over Covid response Top US infectious disease expert Anthony Fauci plans to step down from his post in December to “pursue the next chapter” of his career, he announced in a statement on Monday.Fauci, 81, has led the National Institute of Allergy and Infectious Diseases (Niaid) since 1984. He has advised seven presidents, as far back as Ronald Reagan, on emerging infectious disease outbreaks that have plagued the nation, testifying before Congress and the World Health Organization on the HIV/Aids epidemic to Ebola to, most recently, the coronavirus pandemic.In his statement, Fauci stopped short of saying precisely what his plans are. He pledged to pursue a new professional phase while he still had “energy and passion” for his field.“I want to use what I have learned as Niaid director to continue to advance science and public health and to inspire and mentor the next generation of scientific leaders as they help prepare the world to face future infectious disease threats,” he said.In a White House statement, Joe Biden thanked for Fauci for his decades of service. The president also praised Fauci as a “dedicated public servant, and a steady hand with wisdom and insight honed over decades at the forefront of some of our most dangerous and challenging public health crises”.“Because of Dr Fauci’s many contributions to public health, lives here in the United States and around the world have been saved,” Biden said.Under George W Bush, Fauci worked as one of the principal architects of the President’s Emergency Plan for Aids Relief, a global public health initiative launched in 2003 aimed at expanding access to therapies to curtail the HIV/Aids epidemic, long credited as a historic effort that saved millions of lives.He won the Presidential Medal of Freedom in 2008 for his “determined and aggressive efforts to help others live longer and healthier lives” in the fight against the HIV/Aids epidemic, even as he clashed with activists early on.As the deadly coronavirus spread throughout the world in March 2020, Fauci – whose calm, measured presence drew admiration – emerged as the face of the US’s response to the pandemic. He notably clashed with former president Donald Trump at the start of the crisis, along with congressional Republicans, over what the US response should be. Fauci advocated for more restrictions to suppress the virus, a stark contrast from the Trump administration’s approach to publicly downplay it in hopes of shielding economic markets from being affected.Memorably, earlier this year, Fauci bluntly said he would quit if Trump managed to take the Oval Office back from Biden in the 2024 election. He previously indicated he would stay through Biden’s first term and leave by January 2025.TopicsAnthony FauciUS politicsCoronavirusnewsReuse this content More

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      Jill Biden tests negative for Covid and will end isolation in South Carolina

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      Jill Biden tests negative for Covid and will end isolation in South CarolinaFirst lady will travel to Delaware to rejoin the president after getting negative results from two consecutive tests First lady Jill Biden has tested negative for Covid-19 and will leave South Carolina – where she had isolated since vacationing with Joe Biden – and rejoin the president at their Delaware beach home, her office said Sunday.The White House announced on Tuesday that the first lady, 71, who like her husband has been twice-vaccinated and twice-boosted with the Pfizer Covid-19 vaccine, had tested positive for the coronavirus. She first had symptoms on Monday.The president, 79, recovered from a rebound case of the virus on 7 August.Jill Biden was prescribed the antiviral drug Paxlovid and isolated at the Kiawah Island vacation home for five days before receiving negative results from two consecutive Covid-19 tests, spokesperson Elizabeth Alexander said. Jill Biden planned to travel to Delaware later Sunday.TopicsJill BidenJoe BidenUS politicsCoronavirusInfectious diseasesnewsReuse this content More

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      Biden under ‘strict isolation measures’ as he continues to test positive for Covid

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      Biden under ‘strict isolation measures’ as he continues to test positive for CovidPresident feels well, White House says, after he tests positive only days after he tested negative Joe Biden continued to test positive for coronavirus on Sunday and will “continue his strict isolation measures” his physician said.The US president feels well, the White House said. Biden tweeted about the economy and about regretting being unable to meet in person to commiserate with military veterans and their families visiting Capitol Hill in support of a long-awaited bipartisan bill that would expand healthcare access for those exposed to toxic burn pits.Some Republican senators had reversed their support for the legislation at the last minute.Biden tweeted a video of himself sitting outside at the White House on a green sofa, wearing an open-necked blue shirt and a baseball cap with the presidential seal as he video-chatted with the families gathered on the steps leading up to the US Congress and had pizza sent to them.I’d planned to stop by the Capitol and visit families fighting to pass burn pits legislation. COVID got in the way, so I FaceTimed them and sent some pizza. It’s our sacred obligation to care for our veterans. I won’t stop fighting alongside them to get this bill passed. pic.twitter.com/6vURnVSuC9— President Biden (@POTUS) July 31, 2022
      The president on Saturday tested positive for Covid-19 only days after testing negative and having apparently largely shrugged off an infection with the virus.His physician, Kevin O’Connor, said on Sunday that Biden is being monitored daily and his positive test that morning was unsurprising.The president had originally contracted Covid and tested positive on July 21, then apparently recovered.But Biden had been taking the anti-viral medication Paxlovid, which has reported numerous cases of effectively reducing the viral load of Covid only for it to return once the medication is stopped.In accordance with Centers for Disease Control and Prevention guidelines, on Saturday Biden, 79, had re-entered isolation for at least five days. The agency says most “rebound” cases remain mild and that severe disease during that period has not been reported.Paxlovid has been proven to significantly reduce severe disease and death among those most vulnerable to severe Covid.Biden is fully vaccinated, after getting two doses of the Pfizer coronavirus vaccine shortly before taking office, a first booster shot in September and an additional dose 30 March.The weekend positive tests jeopardize a Tuesday trip Biden had planned to Michigan, which is holding its fiercely-contested primary elections that day.TopicsJoe BidenOmicron variantCoronavirusUS politicsnewsReuse this content More

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      Democratic senator Joe Manchin tests positive for Covid

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      Democratic senator Joe Manchin tests positive for CovidWest Virginia senator, 74, who has thwarted Joe Biden on key policy goals, is fully vaccinated and has only mild symptoms Senator Joe Manchin, the West Virginia Democrat who has thwarted many of Joe Biden’s most ambitious policy goals, has tested positive for Covid.The 74-year-old senator is fully vaccinated and said on Twitter on Monday he was experiencing mild symptoms.This morning I tested positive for COVID-19. I am fully vaccinated and boosted and am experiencing mild symptoms. I will isolate and follow CDC guidelines as I continue to work remotely to serve West Virginians.— Senator Joe Manchin (@Sen_JoeManchin) July 25, 2022
      Manchin’s positive diagnosis comes as Biden himself is recovering from Covid-19. After four days of taking the antiviral Paxlovid medication, the president’s symptoms from the virus “have now almost completely resolved”, his physician, Kevin O’Connor, said in a statement on Monday. “When questioned, at this point he only notes some residual nasal congestion and minimal hoarseness.”Both men tested positive amid a surge in Covid cases across the US in recent weeks. The highly contagious BA.5 subvariant, which can avoid immunity from vaccines better than its predecessors, is now the dominant strain of the virus in the US.Manchin’s diagnosis could affect an expected vote this week on increasing semiconductor chip production in the US, the Associated Press reported. While members of the US House of Representatives can vote remotely by proxy, members of the Senate cannot.Manchin dealt a significant blow to Democrats earlier this month when he said he would not support climate change and tax provisions in a bill Biden hoped would be a signature part of his domestic agenda.TopicsJoe ManchinUS politicsJoe BidenCoronavirusnewsReuse this content More

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      Biden ‘doing just fine’ after testing positive for Covid, White House says

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      Biden ‘doing just fine’ after testing positive for Covid, White House saysAshish Jha, coronavirus response coordinator, and physician Kevin O’Connor say president contracted BA.5 variant Joe Biden is “feeling well” and “doing just fine” after testing positive for Covid, the White House coronavirus response coordinator said.Joe Biden’s mild Covid symptoms are improving, doctor saysRead moreAppearing on CBS’s Face the Nation, Ashish Jha said: “So it is the BA.5 variant, which is about 80% of infections. But thank goodness, our vaccines and therapeutics work well against it, which is why I think the president’s doing well.“I checked in with his team late last night. He was feeling well. He had a good day yesterday. He’s got a viral syndrome, an upper respiratory infection … and he’s doing just fine.”The White House later released a letter in which Biden’s physician, Kevin O’Connor, said the president’s “predominant symptom now is a sore throat”.O’Connor also said Biden had completed a third full day of treatment with Paxlovid, which would continue and was “experiencing no shortness of breath at all”.Biden’s positive test was announced on Thursday. At 79, the president is the oldest ever inaugurated. He is also, as he said, double-vaccinated and double-boosted and has access to the best possible care.On Sunday the transportation secretary, Pete Buttigieg, told CNN’s State of the Union he knew Biden was still working “because on Thursday I got a call from the White House about something on transportation that he had asked me to follow up on”.Buttigieg also wished Biden “a speedy path back to 100%”.Jha was asked if the White House “will continue to make disclosures if [Biden] has long-term symptoms from this infection”.“Absolutely,” he said. “You know, we think it’s really important for the American people to know how well the president’s doing, which is why we have been so transparent, giving updates several times a day, having people hear from me directly, hear directly from his physician.“And obviously if he has persistent symptoms, if any of them interfere with his ability to carry out his duties, we will disclose that early and often.“But I suspect this is going to be a course of Covid that we’ve seen in many Americans who have been fully vaccinated, double-boosted, getting treated with those tools in hand. You know, the president has been doing well, and we’re gonna expect that he’s going to continue to do so.”Jha also suggested cities seeing high case rates, including New York, Phoenix and Miami, might consider re-instituting indoor mask mandates.“Masks work, right? They clearly slow down transmission. So in areas of high transmission, I think it’s very prudent for people to be wearing masks indoors, especially if they’re in crowded, poorly ventilated spaces. That’s what the [Centers for Disease Control and Prevention] recommends. And I think that’s a very important and effective way of reducing transmission, protecting yourself as well.“You know, in terms of mandates, that’s something that we’ve always felt strongly should be done by local officials, mayors, governors, local health officials, and we’re seeing different officials take different tactics. And I think that’s actually appropriate given that we have a very diverse country with different transmission patterns and and willingness to kind of engage in-in wearing masks.”Jha was also asked about monkeypox, which on Saturday the World Health Organization declared a “public health emergency of international concern”. Would the Biden administration declare a pandemic?“Pandemics are declared by the World Health Organization,” Jha said, “and I actually applaud the World Health Organization for declaring that public health emergency of international concern. We are seeing outbreaks that are out of control in many, many parts of the world. It’s very important that we get our arms around this thing.“In the US right now, we’re looking at public health emergency as something that [the health department] might … invoke but it really depends on what does that allow us to do. Right now we have over 2,000 cases, but we have ramped up vaccinations, ramped up treatments, ramped up testing, and we’re going to continue to look at all sort of policy options. Right now, we think we can get our arms around this thing but obviously if we need further tools we will invoke them as we need them.”Jha said he thought monkeypox could be contained.Monkeypox declared global health emergency by WHO as cases surgeRead more“The way we contain monkeypox is we have a very simple, straightforward strategy on this, which is: make testing widely available. We have done that. And now testing is far more frequent and common.Answering the charge that the US was caught flat-footed by monkeypox, Jha said: “What I would acknowledge is that when we started two months ago, we had a limited supply of vaccines. We have obtained more than any other country, probably more than every other country combined. We have acted swiftly.”Asked if people should be concerned about another infectious disease, polio, which has been detected in New York, Jha said: “There is a lot of surveillance that we do for polio, there’s wastewater surveillance that goes on, we are not seeing outbreaks of polio elsewhere.“This one case has heightened everybody’s surveillance. But … CDC and the Department of Health of New York are doing an investigation to try to understand more, but I do not expect polio to become more widespread in the country, again, because so many Americans are vaccinated against this.”TopicsJoe BidenUS politicsOmicron variantCoronavirusBiden administrationDemocratsnewsReuse this content More

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      Joe Biden tests positive for Covid and has ‘mild symptoms’, White House says

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      Joe Biden tests positive for Covid and has ‘mild symptoms’, White House saysPress chief says Biden, 79, who has had two boosters, is taking antiviral Paxlovid, while first lady Jill Biden has tested negative Joe Biden tested positive for Covid on Thursday, underscoring the persistence of the highly contagious virus as new variants challenge the nation’s efforts to resume normalcy after two and a half years of pandemic disruptions.White House press secretary Karine Jean-Pierre said that Biden was experiencing “mild symptoms” and has begun taking Paxlovid, an antiviral drug designed to reduce the severity of the disease.Biden to unveil $37bn proposal to tackle crime, including 100,000 more policeRead moreShe said Biden “will isolate at the White House and will continue to carry out all of his duties fully during that time.“He has been in contact with members of the White House staff by phone this morning, and will participate in his planned meetings at the White House this morning via phone and Zoom from the residence.”Biden, 79, is fully vaccinated, after getting two doses of the Pfizer coronavirus vaccine shortly before taking office, a first booster shot in September and an additional dose March 30.In a letter released by the White House, Kevin O’Connor, the president’s physician, described Biden’s symptoms as mild.“Mostly rhinorrhea (or runny nose) and fatigue, with an occasional dry cough, which started yesterday evening,” O’Connor wrote. He noted that he anticipates that “he will respond favorably” to Paxlovid, as “most maximally protected patients do”.First lady Jill Biden has tested negative, according to her office. The first lady is in Detroit for an event at a local school. Before the event started, Biden briefly addressed news of her husband testing positive for Covid.“My husband tested positive for Covid. I talked to him just a few minutes ago. He’s doing fine, he’s feeling good,” she said. “I tested negative this morning. I am going to keep my schedule.”The president was scheduled to deliver a speech on gun violence in Pennsylvania on Thursday. That trip has been cancelled, and he is expected to stay at his home in Wilmington, Delaware, for the weekend.While this is Biden’s first bout of coronavirus, multiple members of his administration have contracted the virus. Vice-president Kamala Harris had Covid in April, and Xavier Becerra, the secretary of health and human services, and Antony Blinken, the secretary of state, both tested positive in May.Coronavirus cases in the United States have been on the rise once again as the contagious BA.5 variant has become the dominant strain. The US has been recording as many as 150,000 new Covid cases a day, according to Johns Hopkins University.In her statement, Jean-Pierre said that the White House will provide a daily update on Biden’s status “as he continues to [work] in isolation”.TopicsJoe BidenUS politicsCoronavirusnewsReuse this content More