White House chief of staff Mark Meadows said Sunday that the US is “not going to control” the coronavirus pandemic, as cases surge across the country and nearly 225,000 Americans have died from the virus.“We are not going to control the pandemic. We are going to control the fact that we get vaccines, therapeutics and other mitigation areas,” Meadows told CNN’s Jake Tapper on “State of the Union.”The comments from President Donald Trump’s chief of staff come as coronavirus cases surge across the US and the administration continues to consistently disregard advice from government health experts to wear masks, social distance and avoid large gatherings as a way to curb the spread of the virus. The White House is also facing a potential second outbreak of the virus after at least five people in Pence’s inner circle have tested positive in recent days, according to a source familiar with the situation.Pressed by Tapper on why the US isn’t going to get the pandemic under control, Meadows said: “Because it is a contagious virus just like the flu.” He added that the Trump administration is “making efforts to contain it.”“What we need to do is make sure that we have the proper mitigation factors, whether it’s therapies or vaccines or treatments to make sure that people don’t die from this,” Meadows said.The US reported its second-highest day of new cases on Saturday, with nearly 84,000 Americans contracting the deadly virus. As of Sunday, there were at least 8,575,000 total cases of coronavirus in the US, and at least 224,800 Americans have died from the virus, according to Johns Hopkins University.
Pence to continue campaigningBut as concerns grow that more people surrounding the vice president could test positive in the coming days, Pence, who is the head of the White House’s coronavirus task force, does not currently plan to self-quarantine, in defiance of US Centers for Disease Control and Prevention guidelines, and will continue campaigning as the election nears.Pence and second lady Karen Pence each tested negative for coronavirus on Sunday, a White House official said.“I spoke to the vice president last night at midnight and I can tell you that what he is doing is wearing a mask, socially distancing and when he goes up to speak he will take the mask off and put it back on,” Meadows said. “He is wearing a mask as it relates to this particular thing because the doctors have advised him to do that.”Meadows also refused to disclose the extent of the Covid-19 outbreak in Pence’s orbit, saying the administration doesn’t share personal information and that such disclosures are only appropriate in the case of the President, vice president or those in their inner circle.“Anytime there’s someone in harm’s way, we have an obligation to let people know for contract-tracing,” he said.Meadows argued that Pence would continue with travel plans because he is “essential personnel.”“I’m not saying he is not campaigning, I’m saying that is only part of what he is doing and as we look at that, ‘essential personnel,’ whether it’s the vice president of the United States or anyone else, has to continue on,” he said.Pence, who is known to rarely wear a mask while flying on Air Force Two, traveled on Saturday to Florida for campaign rallies in Lakeland and Tallahassee. The vice president walked across the tarmac from Marine Two in a mask and boarded Air Force Two about an hour behind schedule.Pence emerged maskless from Air Force Two in Florida, running down the steps and jogging across the tarmac, fist pumping as he approached the podium.An official told CNN’s Kevin Liptak on Sunday that Pence is expected to campaign every day until Election Day and those plans remain in place for now.After visiting North Carolina later Sunday, the vice president is traveling to Minnesota on Monday and back to North and South Carolina on Tuesday. He’s also expected to return to the upper Midwest this week. The official said Pence would continue to be tested but, like Trump, still plans to be on the road every day for the next week.
‘They are admitting defeat’California Sen. Kamala Harris, the Democratic nominee for vice president, said Sunday that Pence “should be following the guidelines,” when asked about his decision to continue campaigning despite news of the positive tests. “We’re doing it. I think what we have modeled (is) the right and good behavior, and they just take our lead.”Harris canceled travel a week ago “out of an abundance of caution” after two people in her orbit tested positive for the virus.Harris, speaking shortly after arriving in Detroit, said that Meadows’ comments to Tapper on Sunday show the Trump administration is “admitting defeat.”“We are breaking records of the number of people that are contracting, a deadly virus, and this administration fails to take personal responsibility or responsibility in terms of leading the nation through this dangerous, dangerous and deadly mass casualty event,” she said. “And that’s why they have forfeited their right to a second term in office.”
A boss who threatened to lay off his employees if Democrats take the White House in a recent letter has now apparently fired one worker for speaking up about it. Stan Smith, an employee at the military and aerospace contractor Daniels Manufacturing Corporation, told local news he thought the letter was “unfair” because employees should make their own political decisions. Smith was fired this week. Company president George Daniels, who reportedly donated $614,000 to President Donald Trump’s re-election campaign, had said he might lay off all his employees should Joe Biden win the November election. Earlier this month, he had included a note with employees’ pay stubs that read, “If Trump and the Republicans win the election, DMC will hopefully be able to continue operating, more or less as it has been operating lately. However, if Biden and the Democrats win, DMC could be forced to begin permanent layoffs beginning in late 2020 and/or early 2021.” Smith has retained an attorney and told local station WESH that he is preparing a lawsuit against his former employer.
WHO says its massive study was clearly not included in FDA review.
The US Food and Drug Administration on Thursday issued a full approval of the antiviral drug remdesivir for treating COVID-19—just days after a massive global study concluded that the drug provides no benefit.
The FDA made its decision based on three clinical trials on remdesivir, a repurposed experimental antiviral drug brand-named Veklury. One was a randomized, double-blind, placebo-controlled trial run by the National Institute of Allergy and Infectious Diseases. It included 1,062 hospitalized COVID-19 patients, 541 of which received remdesivir. The trial concluded that remdesivir shortened the median recovery time from the infection from 15 days to 10 days. The researchers running the trial defined “recovery” of a patient as either a patient being discharged from the hospital—regardless if the patient still had lingering symptoms that limited activities or required supplemental oxygen to be taken at home—or a patient remaining in the hospital but no longer requiring medical care, such as if they were kept in the hospital for infection-control reasons.
The other two trials the FDA considered were conducted by Gilead, the company that makes remdesivir. One trial looked at about 600 people with moderate cases COVID-19. Patients were split into three groups, each about 200 people—a group that got a 10-day course of remdesivir, a group that got a 5-day course, and a control group that got standard treatments. At day 11 of treatments, the group that had the 5-day course of remdesivir showed a statistically significant improvement in symptom scores compared with the control group. The group that got a 10-day course of remdesivir did not have a statistically significant improvement over the control group, though.
The other Gilead trial looked at 400 patients with severe COVID-19. They were split about evenly into just two groups—a group that got a 5-day course of remdesivir and a group that got a 10-day course. There were no statistically significant differences in recovery or deaths between the two groups.
“The [FDA] approval of Veklury marks an important milestone in efforts to help address the pandemic by offering an effective treatment that helps patients recover faster and, in turn, helps preserve scarce healthcare resources,” Barry Zingman said in a press statement released by Gilead. Zingman is a professor at Albert Einstein College of Medicine and one of the researchers who conducted the NIAID trial of remdesivir.
But the FDA’s approval of remdesivir falls on the heels of data from the fourth and largest trial of the drug, and that trial showed no benefit. The data comes from the World Health Organization’s massive Solidarity trial, which set up an international network of trials enrolling nearly 12,000 patients at 500 sites in over 30 countries, testing multiple repurposed therapeutics. Remdesivir was initially developed over a decade ago as a potential treatment for hepatitis C and RSV (respiratory syncytial virus). It has also been tested against Ebola but was beat out by other treatments.
According to preliminary results from the Solidarity trial—reported online last week ahead of its planned publication in the New England Journal of Medicine—remdesivir was given to 2,743 patients, and their outcomes were compared with those of 2,708 patients given standard treatments. Between the two groups, WHO found that remdesivir did not reduce mortality. It also did not change how many patients progressed to needing mechanical ventilation, nor did it change the proportion of patients discharged after seven days of hospitalization.
When the Solidarity trial data was first released, Gilead blasted the results, saying, “The emerging data appear inconsistent with more robust evidence from multiple randomized, controlled studies validating the clinical benefit of [remdesivir].”
Can’t fudge this
But in a press conference Friday, the WHO hit back, arguing that the data was, in fact, more robust that the smaller trials that came before it and should certainly be included in any regulatory or clinical decision.
“It is the largest trial in the world,” WHO’s chief scientist, Soumya Swaminathan noted. And unlike the NIAID study, which used a somewhat subjective clinical scoring system to compare disease progression and a range of definitions for “recovery,” the Solidarity trial compared only clear, indisputable outcomes: mechanical ventilation, discharge from the hospital, and death.
“[Death is] not a soft end point,” Swaminathan said. “You cannot fudge that endpoint.”
Swaminathan also noted that it was clear that the FDA did not have the Solidarity trial data when it made its decision to approve remdesivir. But she emphasized that the WHO had provided that data to Gilead in advance. “They first saw the results on the 23rd of September,” she said, well before it was made public. But “it appears the results were not considered—not provided to the FDA,” she said.
Though the comments suggest the WHO doesn’t support the FDA’s decision to approve remdesivir for treating COVID-19, WHO experts also suggested that the FDA approval may be irrelevant. Instead, expert clinical guidelines for treating patients are what matter most.
“Regulatory authorities may place items on an approved list,” WHO Executive Director Michael Ryan said in the press conference. “That doesn’t necessarily mean that they will be used in any particular practice unless they pass into clinical guidance that’s given to doctors and nurses.”
The WHO noted that it is working on such clinical guidance and treatment recommendations and expects to release them in three to four weeks.
It is clear that this drug was approved under political pressure from tRump. Hugs
Socialism pays every politician, yet Republicans claim they are against it. The argument against socialism is incredibly dumb, yet insurmountable for the truly low IQ comprising the bulk of the GOP base.
Conservative Christians disrespect Jimmy Carter every chance they get.