NBC Says Trump Will Hold Town Hall Meeting Thursday, Competing Against Biden

President Trump may not be debating Joseph R. Biden Jr. on the same stage on Thursday night as originally planned. But the two candidates will still face off head-to-head.

NBC News confirmed on Wednesday that it would broadcast a prime-time town-hall-style event with Mr. Trump from Miami on Thursday at 8 p.m. Eastern, with the president fielding questions from Florida voters.

The event will directly overlap with an already-scheduled ABC televised town-hall meeting with Mr. Biden in Philadelphia, which will begin at the same time.

Mr. Biden’s town hall has been on the books since last week, after Mr. Trump, who had recently contracted the coronavirus, rejected plans to convert the second formal presidential debate into a virtual matchup; the debate was eventually canceled.

The NBC event, to be moderated by the “Today” show host Savannah Guthrie, had been contingent on the Trump campaign providing independent proof that the president would not pose a safety risk to the other participants — including NBC crew members, voters and Ms. Guthrie herself.

Keep up with Election 2020

As late as Tuesday afternoon, NBC executives were waiting for that proof, but the network determined late Tuesday that it would be comfortable moving forward, according to two people familiar with the planning.

On Wednesday’s “Today” show, the NBC anchor Craig Melvin said the town hall would occur “in accordance with the guidelines set forth by health officials” and proffered a statement from Clifford Lane, a clinical director at the National Institutes of Health.

In the statement, Dr. Lane said he had reviewed medical data about Mr. Trump’s condition, including a so-called P.C.R. test — a widely used diagnostic test for the coronavirus that is considered more reliable than a rapid antigen test — that the N.I.H. “collected and analyzed” on Tuesday. Dr. Lane concluded “with a high degree of confidence” that the president is “not shedding infectious virus,” NBC said.

The network did not explicitly say that Mr. Trump had received a negative result from the P.C.R. test.

Mr. Trump and his aides have not shared extensive details about the president’s medical condition with the public, and over the past few days, NBC executives were no exception. Until late Tuesday, the network had been prepared to cancel the event if the president’s team did not present convincing evidence that Mr. Trump would not potentially infect those around him, one of the people said.

The town hall on Thursday will be held outdoors at the Pérez Art Museum in Miami, and audience members will be required to wear face masks, the network said. Ms. Guthrie and Mr. Trump will be seated at least 12 feet apart.

NBC officials began discussing the possibility of a town hall with the Trump campaign last week, after Mr. Trump pulled out of the second planned presidential debate. The network made clear at the start that it needed outside proof of the president’s medical condition.

NBC officials did not say exactly what testing

Read More →

Eli Lilly pauses trial of antibody drug Trump touted as COVID-19 ‘cure’ over safety concern

By Michael Erman and Carl O’Donnell

(Reuters) – Eli Lilly and Co said on Tuesday that the government-sponsored clinical trial of its COVID-19 antibody treatment similar to one taken by U.S. President Donald Trump has been paused because of a safety concern.

Trump touted the Lilly drug, along with the antibody treatment from Regeneron Pharmaceuticals Inc that he received for his COVID-19, as tantamount to a cure in a video he posted last week.

The announcement comes one day after Johnson & Johnson said it was forced to pause a large high-profile trial of its experimental coronavirus vaccine because a volunteer fell ill. J&J said it does not yet know if that person was given the vaccine or a placebo.

AstraZeneca Plc’s U.S. trial for its experimental COVID-19 vaccine has also been on hold for over a month after a volunteer in its UK study fell ill. Trials of that vaccine resumed in other regions after a brief halt.

Lilly said earlier this month it was applying for emergency use authorization (EUA) for the antibody drug, LY-CoV555, for patients with mild to moderate COVID-19 based on data from another clinical trial.

It is not uncommon to pause drug trials to investigate safety concerns, and such actions do not necessarily indicate a serious problem. Because of the urgent need for drugs and vaccines to tackle a pandemic that has claimed over 1 million lives worldwide – and the speed with which they are being developed – these trials have come under intense scrutiny.

“Out of an abundance of caution, the ACTIV-3 independent data safety monitoring board (DSMB) has recommended a pause in enrollment,” Lilly spokeswoman Molly McCully said in an emailed statement. “Lilly is supportive of the decision by the independent DSMB to cautiously ensure the safety of the patients participating in this study.”

The Indianapolis-based drugmaker did not comment on the implications for the paused trial, called ACTIV-3, which is testing the treatment on COVID-19 patients who require hospitalization, or on its other ongoing trials. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.

The U.S. Food and Drug Administration and the National Institutes of Health did not immediately reply to requests for comment.

Lilly began its ACTIV-3 trial in August and is aiming to recruit 10,000 patients primarily in the United States.

The trial compares patients who receive its antibody drug plus Gilead Sciences Inc’s antiviral drug remdesivir with those who receive remdesivir alone.

Lilly sought the EUA from U.S. regulators after publishing data in September showing LY-CoV555 helped cut hospitalization and emergency room visits for COVID-19 patients. The treatment is being developed with Canadian biotech AbCellera.

Lilly shares closed nearly 3%.

(Reporting by Michael Erman and Carl O’Donnell in New York; Additional reporting by Deena Beasley in Los Angeles; Editing by Bill Berkrot)

Source Article

Read More →

FDA pushes back on Trump administration attempt to rebrand ‘emergency authorization’

While Congress mandated earlier this year that Medicare cover the cost of administering a licensed vaccine, the requirement did not include drugs authorized under emergency-use designations. That’s raised the prospect that millions of people could be forced to pay out of pocket unless Congress were to adopt a quick fix.

HHS officials over the past month thought they found a solution, with Charrow arguing that the FDA should make clear that emergency authorization of a Covid-19 vaccine is equal to a “pre-licensure,” and should be covered by Medicare as a result, the officials said.

But Hahn firmly opposed the idea, amid concerns that failing to stick to the FDA’s technical language would erode the agency’s credibility and open it up to accusations that it’s allowing politics to influence its role in the Trump administration’s vaccine hunt.

“Hahn is hell bent against any modification of definitions, because it would be viewed as a politicization of science,” one senior administration official said, adding that while Hahn has so far rebuffed the proposal, some believe the White House could still get involved and demand changes.

Of particular concern, the official said, is that referring to a Covid-19 vaccine as having won a “pre-licensure” would be conflated with the shot being fully licensed by the FDA – a level of regulatory approval that signals the vaccine has met significantly higher standards for safety and effectiveness, and one the agency does not expect to grant to any vaccine candidates any time soon.

President Donald Trump has already spent months contradicting his own health officials involved in the complicated vaccine development process, claiming repeatedly that a viable vaccine is just around the corner and could be delivered faster than the end-of-year target agreed upon by the officials.

Suddenly changing how the FDA labels an eventual coronavirus vaccine could further muddle the situation, FDA officials worried, sparking confusion and deepening distrust of its work toward authorizing a vaccine.

In a statement, an FDA spokesperson pointed to “important substantive differences” between an emergency use authorization and the more stringent process required to seek full licensure of a vaccine.

“There is no such thing as ‘pre-licensure’ or ‘pre-approval’ under the laws FDA administers,” the spokesperson said.

An HHS spokesperson said that its Centers for Medicare and Medicaid Services is still exploring coverage options for vaccines authorized under an emergency use designation. And two administration officials downplayed the “pre-licensure” concept as an “academic discussion” about safety and effectiveness that never rose to the level of HHS Secretary Alex Azar.

But in talks with Hahn over the past several weeks, HHS officials presented the “pre-licensure” relabeling as the simplest and quickest way to close the Medicare coverage loophole, officials familiar with the conversations said.

The move would also prevent the Trump administration from having to rely on Congress to pass a legislative fix – a path that could get bogged down in gridlock on Capitol Hill.

“They’re trying to get creative – Congress is in disarray and they want a solution

Read More →

Fauci Says Trump Campaign Ad Uses His Words ‘Completely Out of Context’

WASHINGTON — Dr. Anthony S. Fauci, whose blunt public health advice has frequently been at odds with President Trump, said on Tuesday that a Trump campaign ad quoted him “completely out of context” by incorrectly implying that he was praising the administration’s coronavirus response.

But in an interview, he said he saw no “rift” between him and the president.

The comments by Dr. Fauci, a career government scientist who has advised six presidents and has run the National Institute of Allergy and Infectious Diseases since 1984, were his sharpest criticism yet of the president, though he carefully framed them as an attack on the campaign, not Mr. Trump.

“That ad clearly implies strongly that I’m endorsing a political candidate, and I have not given them my permission to do that,” Dr. Fauci said, adding that in his five decades of public life, he had never been involved in partisan politics. “And in addition to that, the quote that they took is completely out of context.”

He also warned that the campaign “may turn off a lot of people” by airing an ad to which he is so vocally opposed.

The Trump campaign released the new ad last week, after the president was discharged from Walter Reed National Military Medical Center following treatment for Covid-19. The ad uses an interview clip to make it seem as though Dr. Fauci is praising the administration’s pandemic response.

Keep up with Election 2020

“President Trump tackled the virus head on, as leaders should,” the ad declares, before switching to a shot of Dr. Fauci saying, “I can’t imagine that anybody could be doing more.”

Dr. Fauci said that comment was made “months and months ago,” in reference to the hard work of the White House coronavirus task force. He declined to say what he actually thought about the Trump administration’s coronavirus response, saying, “I’m not going to go there right now.”

He has said he wanted the ad taken down. The campaign said it would not oblige.

“These are Dr. Fauci’s own words,” Tim Murtaugh, a campaign spokesman, said in an emailed statement. “The video is from a nationally broadcast television interview in which Dr. Fauci was praising the work of the Trump administration. The words spoken are accurate and directly from Dr. Fauci’s mouth.”

At the outset of the pandemic, Dr. Fauci was often by the president’s side at news conferences, joined by Dr. Deborah L. Birx, the White House coronavirus task force coordinator. But the two appear to have been sidelined by Dr. Scott W. Atlas, the president’s new science adviser, a radiologist who has argued that the role of the government is not to stamp out the virus but to protect its most vulnerable citizens as Covid-19 takes its course.

That last idea appears to have taken hold in the White House, where two senior administration officials on Monday embraced a declaration arguing that the authorities should allow the coronavirus to spread naturally among young, healthy people while protecting the vulnerable

Read More →

Trump praises Barrett’s performance on day one of questioning

President TrumpDonald John TrumpTwo ethics groups call on House to begin impeachment inquiry against Barr Trump relishes return to large rallies following COVID-19 diagnosis McGrath: McConnell ‘can’t get it done’ on COVID-19 relief MORE on Tuesday praised Supreme Court nominee Amy Coney Barrett for her performance before the Senate Judiciary Committee and lashed out at Sen. Cory BookerCory Anthony BookerSenate kicks off fight over Trump’s Supreme Court pick Trump pick noncommittal on recusing from election-related cases Debate is Harris’s turn at bat, but will she score? MORE (D-N.J.) in particular for pressing the judge on the fate of the Affordable Care Act (ACA).

“I think Amy is doing incredibly well. It’s been a great day,” Trump told reporters as he left the White House for a campaign rally in Pennsylvania.

The president did not take questions as he departed, but it was apparent he spent a portion of his day watching Barrett’s confirmation hearing. Tuesday marked the second day of the hearing but the first time Barrett took questions from senators.

Trump tweeted shortly before he left about Booker’s line of questioning, which focused on the fate of the ACA.

“How dare failed Presidential Candidate (1% and falling!) @CoryBooker make false charges and statements about me in addressing Judge Barrett,” Trump tweeted of Booker, who dropped out of the Democratic presidential primary months ago.

“Guy is a total loser! I want better Healthcare for far less money, always protecting people with Pre-existing conditions. He has done nothing on Healthcare, cost or otherwise, or virtually anything else. An empty suit!!!” the president added. 

Trump has not presented any health care plan to replace ObamaCare, but his administration is suing to dismantle it. The Supreme Court is slated to hear a case on the health care law next month, something that has been a clear focus for Democrats as they question Barrett.

During his time questioning the judge, Booker pointed to Trump’s tweet while he was campaigning for president that he would appoint only judges who would overturn the Affordable Care Act.

“Is it unreasonable for people to fear… that the ACA would be overturned if you were confirmed to the court?” Booker asked.

“I want to stress to you, Sen. Booker, as I’ve stressed to some of your colleagues today, that I am my own person. I’m independent under Article III, and I don’t take orders from the executive branch or the legislative branch,” Barrett responded.

Booker also asked Barrett whether presidents should commit to a peaceful transfer of power, a clear nod to Trump’s refusal to do so in recent weeks should he lose the election next month. Barrett sought to avoid the question, noting that she felt she may be stepping into a political matter, but said a peaceful transfer of power has been a hallmark of the

Read More →

Former Trump doctor Ronny Jackson questions Biden’s mental fitness for office

Ronny Jackson, the former White House physician-turned-GOP congressional candidate, suggested on Tuesday that Democratic nominee Joe BidenJoe BidenMcConnell challenger dodges court packing question ‘Hamilton’ cast to reunite for Biden fundraiser Trump relishes return to large rallies following COVID-19 diagnosis MORE is mentally unfit for office, citing what he called cognitive decline.

The remarks from Jackson, who has not evaluated Biden, came during a phone call organized by President TrumpDonald John TrumpTwo ethics groups call on House to begin impeachment inquiry against Barr Trump relishes return to large rallies following COVID-19 diagnosis McGrath: McConnell ‘can’t get it done’ on COVID-19 relief MORE’s campaign and are part of a sustained effort by Trump’s allies to highlight Biden’s gaffes on the campaign trail, arguing they make him mentally incapable of serving as commander in chief.

Jackson said Tuesday that he was speaking as a “concerned citizen” and not as a Republican congressional candidate.

“As a citizen of this country, I watch Joe Biden on the campaign trail and I am concerned that he does not — am convinced that he does not have the mental capacity, the cognitive ability to serve as our commander in chief and head of state,” Jackson told reporters on the call.

“I really think that he needs some type of cognitive testing before he takes over the reigns as our commander in chief, if that is in the cards,” Jackson added.

Jackson later acknowledged, in response to a question from a reporter, that he has never treated or evaluated Biden and said he was not making a medical assessment of Biden’s mental health.

“I am not making a medical assessment. I actually don’t even practice medicine at this point. I am not doing that,” Jackson said. “I am not trying to remotely diagnose him with anything. I have not accused him of having Alzheimer’s or anything of that nature. I have not made that statement.”

Jackson mentioned a handful of instances from Monday when Biden, who was campaigning in Ohio, could not remember the name of Sen. Mitt RomneyWillard (Mitt) Mitt RomneyThe Hill’s Campaign Report: Barrett hearings take center stage | Trump returns to campaign trail Biden: Faith shouldn’t be a subject in Barrett confirmation fight Nebraska district could prove pivotal for Biden in November MORE (R-Utah) and mistakenly said he was running for the Senate, not the White House.

In a response to Jackson’s comment, Biden spokesman Andrew Bates said in a statement, “I refer you to the first debate.”

Trump and his campaign have been targeting Biden’s mental fitness for months, during which time Biden has built a sizable lead in national polling and an advantage in key battleground states. Trump, meanwhile, has little time to turn his campaign around as Republicans grow concerned about potentially losing the White House and Senate.

Trump’s performance in the first debate against Biden was widely panned by Republicans as a missed opportunity that put scrutiny back on the president instead of Biden. Doug Heye, a

Read More →

Scranton dentist accused of namedropping Trump in deal with feds involving coronavirus test kits – News

Article Tools


Photo: N/A, License: N/A, Created: 2018:05:26 19:36:52

Hazzouri


Scranton dentist Dr. Albert Hazzouri loves dropping the name of his friend, President Donald Trump, in the course of doing business.


The New York Times reported Wednesday that Hazzouri tried to get the federal government to buy coronavirus test kits from his associates. Hazzouri mentioned his Trump connection when he encountered resistance, the newspaper reported.


Two years ago, Hazzouri alluded to his Trump friendship as he sought a Florida dental license before state regulators.


Repeated efforts to reach Hazzouri on Wednesday were unsuccessful.


Citing unnamed sources involved with the Federal Emergency Management Agency’s operations, The New York Times reported Hazzouri repeatedly called FEMA officials and a separate team of Trump administration volunteers working on procurement. He wanted to help facilitate the purchase of about 100,000 kits from Mexico.


Hazzouri, 64, also mentioned his friendship with Trump while trying to obtain a license to practice in Florida.


During a May 2018 dental board meeting, Hazzouri said he frequently visits Florida and Trump wanted him to be able to treat the president, his family and guests.


“I’m personal friends, we talk often, I’ll be seeing him next week. He knows I’m here today,” Hazzouri told the dental board, according to a meeting recording available online.


Hazzouri, who specializes in cosmetic dentistry, also told the dental board he wanted to open a practice that also served veterans, Native Americans, pregnant women, children and the less fortunate.


“I didn’t go down there and say ‘change the rules for me,’ ” Hazzouri told a Times-Tribune reporter in May 2018.


A letter to the Florida dental board identified Hazzouri as Trump’s dentist. In an interview with The Times-Tribune, Hazzouri acknowledged he wasn’t the president’s dentist and faulted his staff for mistakenly sending the letter identifying him that way.


The dental board told him he had not taken a required state dental board exam and never provided proof of his dental education and knowledge of CPR.


Hazzouri withdrew his application for the Florida license, and does not have one, online state records show.


Trump and Hazzouri’s friendship pre-dates Trump’s election.


The dentist, his wife, Lauren, and their daughter attended a New Year’s Eve 2015 gala at Trump’s Mar-A-Lago Club in Palm Beach, Florida. On her Facebook page, Ivanka Trump, the president’s daughter, has highlighted the work of Lauren Hazzouri, a licensed psychologist.


As he ran for president, Trump mentioned his relationship with Hazzouri during a July 27, 2016, rally at Lackawanna College. He noted he knew some of the people present and called out for his friend.


“Stand up, Albert; where the hell are you, Albert? Stand up, Albert,” Mr. Trump shouted.


Hazzouri stood up and waved.


“He’s a good golfer, but I’m actually a better golfer than him, right?” Mr. Trump said.


Contact the writer:


bkrawczeniuk


@timesshamrock.com;


570-348-9147;


@BorysBlogTT on Twitter

Source Article

Read More →