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This post comingles topics in chronological order to explore the intersection of Coronavirus science and politics.

“The Food and Drug Administration on Sunday gave emergency approval for expanded use of antibody-rich blood plasma to help hospitalized coronavirus patients, allowing President Trump, who has been pressuring the agency to move faster to address the pandemic, to claim progress on the eve of the Republican convention.

Mr. Trump cited the approval, which had been held up by concerns among top government scientists about the data behind it, as welcome news in fighting a disease that has led to 176,000 deaths in the United States and left the nation lagging far behind most others in the effectiveness of its response.

At a news briefing, he described the treatment as “a powerful therapy” made possible “by marshaling the full power of the federal government.”

The decision will broaden use of a treatment that has already been administered to more than 70,000 patients. But the F.D.A. cited benefits for only some patients. And, unlike a new drug, plasma cannot be manufactured in millions of doses; its availability is limited by blood donations. Mr. Trump urged everyone who has recovered from the virus to donate plasma, saying there is a nationwide campaign to collect it.

Mr. Trump has portrayed his demands to cut red tape and speed approval of treatments and vaccines as a necessary response to a public health emergency.” (A)

“Trump administration officials met with congressional leaders last month and told them they would probably give emergency approval to a coronavirus vaccine before the end of Phase 3 clinical trials in the United States, perhaps as early as late September, according to two people briefed on the discussion.

The move would be highly unusual and would most likely prompt concerns about whether the administration is cutting corners on approvals for political purposes.

The two-hour meeting involving Treasury Secretary Steven Mnuchin; the White House chief of staff, Mark Meadows; House Speaker Nancy Pelosi; and Senator Chuck Schumer, the Democratic leader, took place on the evening of July 30 in Ms. Pelosi’s conference room.

During the discussion, the people briefed on it said, Mr. Meadows indicated that a vaccine being developed by AstraZeneca and Oxford University was the most likely candidate.

The projected timeline shows the administration’s hopes for a major victory against the pandemic before the election. It also suggests that officials have high expectations for the results of overseas drug trials, which began ahead of domestic ones.

Senior administration officials disputed the account, saying Mr. Meadows and Mr. Mnuchin were either being misrepresented or had been misunderstood on every major point.” (B)

“As the coronavirus surged across the Sunbelt, President Trump told a crowd gathered at the White House on July 4 that 99 percent of virus cases are “totally harmless.”

The next morning on CNN, the host Dana Bash asked Dr. Stephen Hahn, the commissioner of the Food and Drug Administration and one of the nation’s most powerful health officials: “Is the president wrong?”

Dr. Hahn, an oncologist and former hospital executive, certainly understood the deadly toll of the virus, and the danger posed by the president’s false statements. But he ducked the journalist’s question.

“I’m not going to get into who’s right and who’s wrong,” he said.

The exchange illustrates the predicament that Dr. Hahn and other doctors face working for a president who often disregards scientific evidence. But as head of the agency that will decide what treatments are approved for Covid-19 and whether a new vaccine is safe enough to be given to millions of Americans, Dr. Hahn may be pressured like no one else.

Unlike Dr. Anthony S. Fauci or Dr. Francis S. Collins, leaders at the National Institutes of Health who have decades of experience operating under Republican and Democratic administrations, Dr. Hahn was a Washington outsider…

Many medical experts — including members of his own staff — worry about whether Dr. Hahn, despite his good intentions, has the fortitude and political savvy to protect the scientific integrity of the F.D.A. from the president. Critics point to a series of worrisome responses to the coronavirus epidemic under Dr. Hahn’s leadership, most notably the emergency authorization the agency gave to the president’s favorite drug, hydroxychloroquine, a decision it reversed three months later because the treatment did not work and harmed some people…

In an interview, Dr. Hahn, 60, defended his record as F.D.A. chief. All of his decisions have been guided by the data, he said, and sometimes, rapidly evolving science has led to policy changes.

“I do not feel squeezed,” Dr. Hahn said. “I have been consistent in my message internally about using data and science to make decisions.”

On the line as he spoke was Michael Caputo, a deputy to Dr. Hahn’s boss, Alex M. Azar II, the secretary of the Department of Health and Human Services…

Dr. Hahn is not allowed to speak to the press without Mr. Caputo or another official on the phone — a marked contrast to the practice under the last F.D.A. commissioner, Dr. Scott Gottlieb, a powerful force in Washington who came to the job with years of experience at the F.D.A. and political think tanks. He called reporters whenever he felt like it, which was often.” (C)

“Dr. Anthony Fauci on Monday warned against the notion of early emergency use authorization for a potential coronavirus vaccine, explaining that such a step could damage efforts to develop other vaccines…

Fauci, the nation’s leading infectious disease expert, told Reuters that “the one thing that you would not want to see with a vaccine is getting an EUA before you have a signal of efficacy.”

“One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial,” he said….

President Donald Trump has promised that a vaccine would be available by the end of the year, though vaccinologists told CNN that timeline is unrealistic. And though Trump has commented that a vaccine could be ready “a lot sooner” than the end of the year, a senior administration official close to the coronavirus task force said the timeline for a vaccine remains the same and a vaccine is still expected late this year or early next year.

On Saturday, Trump also accused, without providing any evidence, the US Food and Drug Administration of deliberately delaying coronavirus vaccine trials.

“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump tweeted, continuing to push his unfounded theory that there is a “deep state” embedded within the government bureaucracy working against his reelection.

He accused the agency of delaying a vaccine for the virus until after the fall election, tweeting, “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”… (D)

“White House economic adviser Peter Navarro said on Tuesday that recommendations from health experts that convalescent plasma undergo a randomized trial as a COVID-19 treatment before receiving an emergency authorization are a “crazy talking point.”…

What they’re saying: “On the issue of not being able to do randomized trials, what is the calculus here? Are we going to wait to use something that can save thousands of lives just so we can have a study that tells us what we already know?” Navarro told MSNBC.

“The odds of this being able to hurt you are close to zero, so it’s safe. The odds of it being able to help you are close to 100%,” Navarro claimed.

Reality check: The odds of plasma being able to help COVID-19 patients are not “close to 100%.”

The other side: Speaker Nancy Pelosi told MSNBC after Navarro’s appearance that the Trump administration is “politicizing science.” She warned of the need to watch out for the politicization of the vaccine process because the Trump administration has “already indicated that they will overstate the safety and the efficacy of a drug.”” (E)

“The National Institutes of Health on Tuesday put out a blunt statement on the use of convalescent plasma to treat Covid-19, calling the evidence for its effectiveness “insufficient.”

“There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of Covid-19,” according an NIH treatment guidelines panel that reviewed the evidence. “There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19.”…

The FDA memo outlining the EUA for convalescent plasma cites just two randomized controlled trials, both of which were stopped early — one because it failed to recruit enough participants and the other because they found that the patients that were receiving plasma already had high levels of antibodies. Both found little to no benefit from the treatment, but they remain some of the best-constructed studies…

During the August 23 press conference, Hahn reported that convalescent plasma would yield a 35 percent improvement in the survival rate of Covid-19 patients.

“A 35 percent improvement in survival is a pretty substantial clinical benefit,” said Hahn during a Sunday press conference. “What that means is, if the data continue to pan out, if 100 people are sick with Covid-19, 35 would have been saved with the administration of plasma.”

But other researchers said that Hahn’s 35 percent improvement in survival claim was wildly misleading. It came from a retrospective preprint study that hasn’t undergone peer review, so some of the methods and findings may have flaws that would ordinarily be caught in the review process.”  (F)

“President Donald Trump said Sunday that he believed “political reasons” had slowed down the Food and Drug Administration’s approval of emergency use authorization for convalescent plasma but that he “broke the logjam” over the last week.

His remarks amount to tacit confirmation that he applied pressure on the agency ahead of its announcement Sunday issuing emergency use authorization for Covid-19 patients.

“I think there might have been a hold up, but we broke the logjam over the last week to be honest,” Trump said at a late afternoon news conference announcing the new authorization.

He said he believed there were officials at the FDA and in the Department of Health and Human Services “that can see things being help up and wouldn’t mind so much.”

“It’s my opinion, very strong opinion, and that’s for political reasons,” Trump continued, insisting that his focus on treatments for coronavirus — which has slowed the American economy and caused his poll numbers to sink — was apolitical…

However, like blood, convalescent plasma is in limited supply and must come from donors. And while there are promising signals from some studies, there is not yet randomized clinical trial data on convalescent plasma to treat Covid-19. Some of those trials are underway.

Earlier in the briefing, Trump appeared enthusiastic when asked by a reporter from Fox News whether patients should have access to treatments or vaccines before they reach the end of trials.

“We have all of these great, seemingly great answers that are ready to come out, but because of the process it takes — can we use some of this early under right to try?” he asked, referring to legislation that allows patients access to drugs that are still in the investigation phase.”  (G)

“Much of the controversy centered around how Hahn presented data from the expanded access protocol for convalescent plasma run by the Mayo Clinic and used in part to support the issuance of the EUA.

 “In the optimal patients … treated with convalescent plasma at the highest titers, there was a 35% improvement in survival, which is a significant clinical benefit,” Hahn said during the press conference, noting that, “This clearly meets the criteria that we’ve established for emergency use authorization.”

 Hahn went on to say that, “A 35% improvement in survival is a pretty substantial clinical benefit. What that means is—and if the data continue to pan out—100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma.”

 Experts were quick to point out that the 35% figure Hahn cited referred to the reduction in relative, not absolute, risk between patients who received high- and low-titer units of plasma….

On Monday evening, Hahn took to Twitter himself to address the issue: “I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”

 Hahn also disputed the notion that politics played into the agency’s decision to issue the EUA. “Media coverage of FDA’s decision to issue emergency authorization for convalescent plasma has questioned whether this was a politically motivated decision. The decision was made by FDA career scientists based on data submitted a few weeks ago,” he wrote.” (H)

“Anthony Fauci, the nation’s top infectious disease expert, is warning against prematurely distributing a potential coronavirus vaccine through an emergency use authorization, saying it could negatively harm the testing for other vaccines.

“The one thing that you would not want to see with a vaccine is getting an EUA [emergency use authorization] before you have a signal of efficacy,” Fauci, a key member of the White House coronavirus task force, said in an interview with Reuters.

He added that “one of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial.”…

“To me, it’s absolutely paramount that you definitively show that a vaccine is safe and effective, both,” Fauci told Reuters. “We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective.”

His most recent comments to Reuters came just days after President Trump lashed out at the Food and Drug Administration (FDA), claimed members of the “deep state” inside the FDA were making it difficult for drug companies to test coronavirus vaccines and therapeutics…

Fauci noted FDA guidance calls for a vaccine being proven to be safe and effective before receiving emergency use or final approval. He said emergency use authorization would only be appropriate if a drug had proven to be safe and effective before the FDA completed a review of other matters related to it.” (I)

“The largest study on plasma was conducted by the Mayo Clinic, headquartered in Rochester, and was sponsored by the National Institutes of Health, the US agency for biomedical research. It enrolled 35,322 patients between April and June, and attempted to study the effect of the therapy on mortality among patients with severe Covid-19…

However, promising as the study seemed, it was not randomised or controlled. There were no other patients to compare the effects of plasma transfusion with to ascertain whether the mortality was different among those who didn’t receive plasma. There was no placebo group as well, and everyone enrolled received the treatment. ..

Studying plasma therapy poses challenges of its own, as results seem to rely on antibody concentrations in blood— something which cannot be standardised. Researchers in some places are not able to test whether plasma contains powerful neutralising antibodies due to costs and procedures.

Additionally, since compassionate use is already allowed, doctors and hospitals prescribe the plasma treatment without a proper procedure to log or collect outcomes or data.

There also isn’t enough data on whether plasma could worsen an illness, as seen among some patients during diseases such as Ebola.

Studies like the Mayo Clinic one have their own shortcomings, where it is difficult to judge the cause of the outcome for certainty: for example, to determine if those who received the plasma therapy were also enrolled in medical centres that had better health care infrastructure and thus had a higher chance of survival.

However, there are multiple randomised controlled trials that are ongoing, including the UK’s RECOVERY trial. Results from rigorous trials are expected by the end of the year.” (J)

“The head of the Food and Drug Administration ousted its top spokeswoman from her position on Friday in an urgent bid to restore the tarnished credibility of the agency after he made erroneous claims that overstated the benefits of plasma treatments for Covid-19 at a news conference with President Trump.

The decision came just a day after the F.D.A.’s parent agency, the Department of Health and Human Services, terminated the contract of a public relations consultant who had advised the F.D.A. commissioner, Dr. Stephen M. Hahn, to correct his misleading claims that 35 out of 100 Covid-19 patients “would have been saved because of the administration of plasma.”

The removals come at a moment when the agency, which will be making critical decisions about whether to approve coronavirus vaccines and treatments, is struggling to salvage its reputation as a neutral scientific arbiter.

The ousted spokeswoman, Emily Miller, had little experience in health care. She had spent years working in Washington for Republicans, including the former Texas Congressman Tom DeLay and Senator Ted Cruz of Texas, and as a journalist for One America News, the conservative cable network. She was in her agency post for just 11 days.

“This is a low moment for the F.D.A. in at least a generation,” Daniel Carpenter, a professor at Harvard University who studies the agency, said of Dr. Hahn’s failure to control the public message about the plasma authorization. “This was a major self-inflicted wound.”..

“The agency needs to work very hard to regain the trust of the American people — there have been too many unforced errors,” said Dr. David A. Kessler, who was F.D.A. commissioner under Presidents George Bush and Clinton, and is advising Joseph R. Biden Jr.’s presidential campaign. “It needs to focus on what it does best, which is to put the data in front of the medical and scientific community and the American public, and stick with the data.””  (K)

“Trump, Aug. 23: We’ve provided $48 million to fund the Mayo Clinic study that tested the efficacy of convalescent plasma for patients with the virus. Through this study, over 100,000 Americans have already enrolled to receive this treatment, and it has proven to reduce mortality by 35%. …The FDA, MIT, Harvard and Mount Sinai hospital have also found convalescent plasma to be a very effective method of fighting this horrible disease. Based on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective.

In fact, the FDA did not determine that convalescent plasma is “safe and very effective,” as few randomized controlled trials exist, making its true efficacy unknown. Instead, the agency decided that the totality of the evidence supports the idea that plasma “may be effective in the treatment of hospitalized patients with COVID-19,” and that it is reasonable to think that the potential benefits outweigh the known and potential risks…

While this might seem to be a small error, Dr. David Boulware, an infectious disease specialist at the University of Minnesota, told us that it wasn’t.

“THIS IS A HUGE MISTAKE which is very basic,” he said in an email. “I want to give Dr. Steve Hahn the benefit of the doubt that he was speaking extemporaneously and flubbed something,” he added, but the difference in this case is “huge.”

Indeed, if it is based on the preprint figure, that would mean Hahn exaggerated the effect of convalescent plasma sevenfold.

Boulware said he suspected that compared to no plasma, patients getting convalescent plasma probably are better off — but this remains an unanswered question. So are other critical questions, such as which patients benefit, which is especially important to know in deciding how to allocate a limited supply.

The Expanded Access Program, Boulware said, “was meant to be a short term bridge back in April. Yet tens of thousands of patients later, we don’t know what the benefit of plasma is.”

As for the EUA, Boulware said it “may” be warranted, but the hype beforehand was not — and that Hahn’s portrayal of a 35% absolute reduction in mortality was “deceptively misleading.”

While the administration claims the EUA will expand access of convalescent plasma, Boulware said it changes little other than the paperwork. “Plasma remains a scarce resource,” he said. “We use all the plasma locally that is available.”.. “( L)

“Trump said Monday he’s the reason the FDA authorized a new treatment for COVID-19 and that it wouldn’t have happened under another administration.

“We got the FDA to do it very quickly,” he told a crowd of supporters in Asheville, North Carolina.

In fact, Trump said his arm twisting was so effective, no other administration would have done it.

“The job that the FDA has done and the approval process has gone far faster than it would have ever gone under any other administration,” Trump said.

Earlier on Sunday, Mark Meadows told ABC’s “This Week” that the FDA wasn’t immediately on board and that the politicians in charge had to nudge them along.

“They want to do things the way they’ve always done it,” Meadows said, adding at one point that the FDA “had to make sure that they felt the heat.”

“We have been fighting for weeks now, weeks, to get that decision,” Trump’s top trade adviser, Peter Navarro, told reporters outside the White House Monday morning.

If true, such statements are extremely problematic for the reputation of FDA, a cadre of mostly career scientists who research the safety and efficacy of drugs without political interference. The agency isn’t supposed to speed up or slow authorizations or approvals at the whim of the White House…

That’s the reason the Infectious Diseases Society of America spoke out against the authorization.

“While the data to date show some positive signals that convalescent plasma can be helpful in treating individuals with COVID-19, especially if given early in the trajectory of disease, we lack the randomized controlled trial data we need to better understand its utility in COVID-19 treatment,” said Dr. Thomas File, Jr., president of IDSA.”  (M)

“Dr. Scott Gottlieb told CNBC on Monday that the late-stage coronavirus vaccine trials underway in the U.S. are unlikely to have gathered enough evidence to receive emergency approval ahead of the November presidential election.

“I think it’s very unlikely. I think it’s more likely you’re going to get a top-line result some point in November and maybe be able to make a decision about an emergency use authorization after that,” the former Food and Drug Administration commissioner said on “Squawk Box.”

Gottlieb — who sits on the board of Pfizer, which is developing a vaccine to prevent Covid-19 — said the more effective the vaccine is, the sooner the trial is likely to generate data on effectiveness.

“If the vaccines are very effective at preventing Covid disease, probably 70% to 80% effective based on how the trials are powered, you could get a readout at some point in October, a sort of top-line readout,” he said. “But it’s more likely that you’re going to get a readout from those trials in November.”..

Gottlieb’s comments Monday came after the current FDA chief, Dr. Stephen Hahn, indicated the public health agency could issue emergency authorization for a vaccine before phase three clinical trials are completed if the benefits outweigh the risks.

“It is up to the [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn said in an interview with the Financial Times. “If they do that before the end of phase three, we may find that appropriate. We may find that inappropriate, we will make a determination.”

Gottlieb, who preceded Hahn at the FDA, said he was not exactly sure what Hahn’s comments meant…

“It’s likely to be the case that there’s going to be an emergency use authorization if these vaccines are otherwise safe and effective for some select, high-risk populations like perhaps front-line health-care workers or people who have infirmities, elderly patients in nursing homes who are at higher risk of a bad outcome,” Gottlieb added. “That might be what he meant by saying they might issue an emergency use authorization before the trials are quote-unquote complete.” … 

Gottlieb said the process to approve a vaccine “has a lot of integrity to it,” expressing confidence in the longtime scientists at the FDA. 

“This is process where you have multiple layers of scientific review. You have objective criteria that the agency has issued in the form of guidance documents that lay out what the approvable endpoints are for these clinical trials, and what kind of safety they want to make a preliminary read on whether or not these vaccines are safe,” he said. “The final signoff is a career head of the biologics center at FDA who is exceptional.”

“I think if the commissioner would trust the process and elevate that process, people would have confidence in what’s unfolding inside the agency,” Gottlieb added.” (N)

“A new coronavirus adviser is pushing the White House to adopt a “herd immunity” strategy that would allow the disease to spread through most of the population to build resistance, five sources told The Washington Post on Monday.

Scott Atlas, a healthcare policy fellow at Stanford University’s conservative Hoover Institution think tank, joined the Trump administration earlier this month as a top pandemic adviser. His expertise is in neuroradiology, and he “does not have a background in infectious diseases or epidemiology,” The Post said…

It’s unclear exactly how many people would need to become infected to achieve herd immunity; estimates have ranged from 20% to 70% of the population, according to The Post.

The Post reported that Atlas had also suggested that an increased case count would not lead to more deaths if vulnerable people were protected, a claim that most infectious-disease experts strongly dispute. More than 25,000 people under age 65 have died of the virus in the US so far, the report said.

Before joining the coronavirus task force, Atlas regularly advocated reopening schools and businesses. He frequently appeared on Fox News to share his opinions, many of which aligned with those expressed by President Donald Trump’s. Atlas now meets with Trump more than any other health official, The Post said.

“When younger, healthier people get the disease, they don’t have a problem with the disease,” Atlas said in a Fox News interview in July. “I’m not sure why that’s so difficult for everyone to acknowledge.”

Atlas has clashed with other officials, including Dr. Deborah Birx and Dr. Anthony Fauci, the US’s top infectious-disease expert. A senior administration official told The Post that Atlas had positioned himself as an “anti-Dr. Fauci.”

Shortly after The Post published its report on Monday, Atlas released a statement denying any push for a herd-immunity strategy. “There is no policy of the President or this administration of achieving herd immunity,” he said. “There never has been any such policy recommended to the President or to anyone else from me.”

A White House representative also said there was no change to its approach.” (O)

“Dr. Anthony Fauci.. said.. “The way the pace of the enrollment is going on and the level of the infections that are going on in the United States, it is likely that we’ll get an answer by the end of the year.”..

“I would say a safe bet is at least knowing that you have a safe and effective vaccine by November, December,” …“I would not be satisfied until a vaccine was proven to be safe and effective, before it was actually approved for general use.”…

In a separate interview with the “Colors” podcast on Friday, Fauci said it was imperative to enroll a diverse number of people in a vaccine to ensure that it is safe and effective for everyone, and said that coronavirus has shed “very bright light” on the disparities in the U.S. health-care system. Even post-vaccine, he said something needed to be done about those disparities.

‘The likelihood that African Americans will get infected versus whites or others and — when and if they do get infected — the likelihood of their getting a serious outcome more so than whites. The answer is unfortunately, ‘Yes,’ to both.’…

“There are two elements that need to be clarified,”… “One: The likelihood that African Americans will get infected versus whites or others and — when and if they do get infected — the likelihood of their getting a serious outcome more so than whites. The answer is unfortunately, ‘Yes,’ to both.”

He said, “You want to show that it is safe and effective in all elements of society. If we don’t get African Americans and Latinx and Asian Americans and Native Americans, if we don’t get them properly represented in the proportion of those that are in the trial, we will not know for sure — although you can assume it, but you want to prove it — that it is safe and effective in that group.””  (P)

“There is a certain element of antiscience sentiment in the United States and Europe that Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, finds troubling.

Thinking about outbreaks like the measles one from a few years ago, what can health care leaders do to keep emphasizing the importance of public health and restore the public trust in science?..

A lot of it relates to a fundamental antiscience feeling, because of kind of moments of pushback from authority, and science tends to fall into the category of authoritative. People don’t like that. They don’t like people telling them what to do. But sometimes you go to the extreme, and you don’t listen to things that you should be doing, because you think people are telling you, you have to do that. That’s a problem.

But a lot of the vaccine stuff is misinformation, you know, dating back to the now infamous fraudulent reporting of certain negative consequences of measles vaccines with autism and things like that. That really set us back. Because one, something that’s incorrect, particularly in the era of social media and the era of the internet, when something that’s incorrect, gets propagated, it becomes very difficult to erase it. Because it’s out there.

This is not the way it used to be pre-internet, pre-social media, when if something was false, you’ve corrected and that was it. Not so now, even if you correct it, it’s still lingering in there somewhere. That’s one of the problems.” (Q)

“Using its authority to approve treatments for emergency use, the Food and Drug Administration recently allowed convalescent plasma for hospitalized Covid-19 patients. But because the large 35,000-person study on the treatment lacked true randomization and placebos, we don’t really know if antibody-rich plasma actually improves mortality.

In fact, both Dr. Francis Collins, the director of the National Institutes of Health, and Dr. Anthony Fauci, the government’s top infectious disease expert, raised concerns that emerging data on the treatment was not strong enough to merit emergency approval.

Convalescent plasma illustrates more than a problem with the F.D.A.’s approval process. It points to a larger shortcoming in clinical research in the United States.

Americans and American biomedical researchers have often prided themselves on conducting the best clinical research in the world. Yet with over six million coronavirus cases and 183,000 deaths, the United States has produced little pathbreaking clinical research on treatments to reduce cases, hospitalizations and deaths. Even one of the most important U.S. studies to date, which showed that the antiviral drug remdesivir could reduce the time Covid-19 patients spent in the hospital to 11 days from about 15, had too few subjects to demonstrate a statistically significant reduction in mortality.

Progress on therapeutics research has been a very different story in Britain. In mid-March researchers there began a randomized evaluation of Covid-19 therapies, known as Recovery, that involves every hospital in the nation. The goal was to conduct large, rapid and simple randomized trials to define standard treatment. Some 12,000 patients were quickly randomized — that is, assigned by chance to receive different treatments — and within 100 days of the effort’s start, researchers made three major discoveries that transformed Covid-19 care worldwide…

In the United States, by comparison, the government-sponsored Patient-Centered Outcomes Research Institute has spent millions of dollars creating a large clinical research network but has produced no research results on Covid-19 therapeutics…

Maybe the most important factor is an attitudinal difference: British clinical researchers have a longstanding commitment to large, simple and rapid randomized trials. American researchers prefer smaller, selective and complex trials with many restrictions on patients who can enroll…

What Britain has done is not beyond the United States. America has health networks with comprehensive patient data on a meaningfully large scale. Though networks don’t encapsulate the full population, they cover enough patients to provide background data for large clinical trials.

Moreover, the United States has no shortage of researchers, who can be deployed on Covid-19 therapeutic research, especially as many have been freed up with other research having been put on hold.

Unfortunately, unlike Britain, the United States has lacked a clear, unified message from government health care leaders, major insurance companies and hospital systems to put in place large, simple randomized trials that are considered the standard of care for Covid-19 treatment. We need to change that muddled approach now and reassert the nation’s clinical research excellence.” (R)

“Donald Trump said Monday he ‘disagrees with a lot of what Dr. Anthony Fauci has said’ in his coronavirus response.

In an wide ranging interview with Fox News host Laura Ingraham, the president said he ‘inherited’ the nation’s top infectious disease expert…

‘I just, I get along with him, but every once in a while he’ll come up with one that I say, ‘Where did that come from?’ I inherited him. He was here. He was part of this huge piece of [the] machine.

‘You inherit a lot of people, and you have some you love, some you don’t. I like him. I don’t agree with him that often but I like him.’ “  (S)

“Dr. Scott W. Atlas has argued that the science of mask wearing is uncertain, that children cannot pass on the coronavirus and 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…

Ideas like these, both ideologically freighted and scientifically disputed, have propelled the radiologist and senior fellow at Stanford University’s conservative Hoover Institution into President Trump’s White House, where he is pushing to reshape the administration’s response to the pandemic.

Mr. Trump has embraced Dr. Atlas, as has Mark Meadows, the White House chief of staff, even as he upsets the balance of power within the White House coronavirus task force with ideas that top government doctors and scientists like Anthony S. Fauci, Deborah L. Birx and Jerome Adams, the surgeon general, find misguided — even dangerous — according to people familiar with the task force’s deliberations.

That might be the point.

“I think Trump clearly does not like the advice he was receiving from the people who are the experts — Fauci, Birx, etc. — so he has slowly shifted from their advice to somebody who tells him what he wants to hear,” said Dr. Carlos del Rio, an infectious disease expert at Emory University who is close to Dr. Birx, the White House coronavirus response coordinator.

Dr. Atlas is neither an epidemiologist nor an infectious disease expert, the two jobs usually associated with pandemic response. But his frequent appearances on Fox News Channel and his ideological surety caught the president’s eye.

So when Mr. Trump resumed his coronavirus news conferences in July and August, it was Dr. Atlas who helped prepare his briefing materials, according to people familiar with them. And it was his ideas that spilled from the president’s mouth.

“He has many great ideas,” Mr. Trump told reporters at a White House briefing last month with Dr. Atlas seated feet away. “And he thinks what we’ve done is really good, and now we’ll take it to a new level.”…

Mr. Trump is clearly enamored with Dr. Atlas’s arguments, which back up the president’s desire to restart the economy, open schools and move beyond the daily drumbeat of dire virus news.

But fully embracing any version of a policy resembling herd immunity has profound medical and political risks. Simply allowing the virus to travel through most of the population could lead to hundreds of thousands, if not millions, of deaths. And medical officials are still not sure how long that immunity might last, and how long-lasting some effects of the virus could be.

“Trying to get to herd immunity other than with a vaccine isn’t a strategy,” said Dr. Tom Frieden, a former C.D.C. director. “It’s a catastrophe.”…. (T)

“We were startled and dismayed last week to learn that the Centers for Disease Control and Prevention, in a perplexing series of statements, had altered its testing guidelines to reduce the testing of asymptomatic people for the coronavirus.

These changes by the C.D.C. will undermine efforts to end the pandemic, slow the return to normal economic, educational and social activities, and increase the loss of lives…

But under its revised guidelines, the C.D.C. seeks to dissuade people who are asymptomatic from being tested. Yet this group poses both the greatest threat to pandemic control and the greatest opportunity to bring the pandemic to an end. It is with this group that our country has failed most miserably….

These are practical and essential actions that need to be taken now. In the absence of sensible guidance from the C.D.C., what can the country do to control the pandemic? We urge at least three actions.

State and local leaders should be emboldened to act independently of the federal government and do more testing. Some governors and local public health officials, from both parties, are already doing so and are ignoring the C.D.C.’s revisions. This position is legally sound, since the C.D.C. is an advisory agency, not a regulatory one. Still, such discord undermines confidence in public health directives.

Insurance companies, city and state governments, and the Center for Medicare and Medicaid Services should recognize the economic and health benefits of testing prioritized, asymptomatic populations and provide reasonable reimbursement for these tests. A major impediment to more widespread testing has been the lack of coverage in the absence of symptoms or known contacts with infected individuals. The costs of testing are decreasing as new methods, like antigen testing, are introduced, and may be further reduced as the pooling of samples makes testing more efficient.

While more widespread testing for the virus is an essential factor in pandemic control, we need to make it part of a broad program that helps prevent transmission — mask-wearing, hand-washing, quarantining and use of personal protective equipment.

The C.D.C., the federal agency that should be crushing the pandemic, is promoting policies that prolong it. That means that local, state and organizational leaders will have to do what the federal government won’t.” (U)

“A COVID-19 vaccine could be available earlier than expected if ongoing clinical trials produce overwhelmingly positive results, said Dr. Anthony Fauci,…

Although two ongoing clinical trials of 30,000 volunteers are expected to conclude by the end of the year, Fauci said an independent board has the authority to end the trials weeks early if interim results are overwhelmingly positive or negative.

The Data and Safety Monitoring Board could say, “‘The data is so good right now that you can say it’s safe and effective,’” Fauci said. In that case, researchers would have “a moral obligation” to end the trial early and make the active vaccine available to everyone in the study, including those who had been given placebos — and accelerate the process to give the vaccine to millions….

Fauci, …said he trusts the independent members of the DSMB — who are not government employees — to hold vaccines to high standards without being politically influenced. Members of the board are typically experts in vaccine science and biostatistics who teach at major medical schools.

“If you are making a decision about the vaccine, you’d better be sure you have very good evidence that it is both safe and effective,” Fauci said. “I’m not concerned about political pressure.”

The safety board periodically looks at data from a clinical trial to determine if it’s ethical to continue enrolling volunteers, who are randomly assigned to receive either an experimental vaccine or a placebo shot. Neither the volunteers nor the health workers who vaccinate them know which shot they’re receiving…

Safety boards set “stopping rules” at the beginning of a study, making their criteria for ending a trial very clear, said Dr. Eric Topol, executive vice president for research at Scripps Research in San Diego and an expert on the use of data in medical research.

Although the safety board can recommend stopping a trial, the ultimate decision to halt a study is made by the scientists running the trial, Topol said.

A vaccine manufacturer could then apply to the Food and Drug Administration for an emergency use authorization, which can be granted quickly, or continue through the regular drug approval process, which requires more time and evidence.

Safety monitors also can stop a trial because of safety concerns, “if it looks like it’s actually harming people in the vaccine arm, due to a lot of adverse events,” Fauci said…

And Fauci acknowledged that cutting a trial short could undermine public confidence in COVID vaccines. One American in three is unwilling to get a COVID vaccine, according to a recent Gallup Poll.” (V)

“The history of medicine is rife with promising therapies that have later proven to be ineffective or, even worse, harmful. When I was a doctor in training first working in the intensive care unit, I learned to use a drug called activated drotrecogin alfa (sold as Xigris), which was touted as a lifesaver for patients suffering from severe sepsis. I distinctly remember giving it to patients who subsequently improved, seemingly pulled back from the brink.

We are wired to infer cause, and so I congratulated myself for my decision and used this drug whenever I could. But when it was studied in a rigorously designed clinical trial, researchers found that it was no better than a placebo, and it was taken off the market.

That’s why we have to do clinical trials. They are the gold standard to test a treatment’s efficacy but have been scarce in the pandemic. In these trials, investigators randomly assign patients to receive either the drug that’s being studied or — as a control — a placebo or standard care.

This relies on a concept called clinical equipoise, which means that the medical community at large is uncertain about whether a new treatment is actually better or worse than standard care. If we knew beyond doubt that something was lifesaving — like using a parachute when jumping out of an airplane in flight — we couldn’t ethically test it against a placebo on our patients.

Additionally, patients who consent to be part of a randomized trial must be willing to risk a 50 percent chance of receiving the placebo. The process becomes far more challenging, then, when the drug that is being studied is broadly available outside the trial framework.

This is the case with convalescent plasma. The idea behind it is attractively simple: Harvest blood plasma from patients who have recovered from Covid-19, test it to make sure it has antibodies to the virus and then inject it into patients with the virus to help them fight it until their own antibodies kick in…

Since that time, more than 70,000 patients in the country have received convalescent plasma. But we still don’t know if it helps.

The data cited in the news conference announcing the emergency approval come from a large continuing study of more than 35,000 patients, and though the benefit was grossly inflated, the true results do suggest that convalescent plasma might have been associated with fewer deaths in patients who got it early on in their hospital course. But there are major drawbacks to making any conclusions here.

The study, which has not been peer reviewed or published in a medical journal, is part of an “expanded access program.” This is not a randomized trial but instead a way to get a potentially promising treatment to patients while tracking how they do.

As a result, there was no control group for comparison, which makes it impossible to state with certainty that convalescent plasma is really the reason for an observed decrease in mortality. Maybe convalescent plasma has a small or moderate benefit. But it might also be neutral or even harmful. The question remains open.

And now we might never be able to answer it. Because if convalescent plasma is widely available and hailed as a major breakthrough, who is going to sign up for a trial where a roll of the dice might leave the patient with a placebo?

In the haste to do something and the inability to sit with uncertainty, we might have deprived ourselves of the very answers that we need. This will be one of the many sad legacies of our response to this pandemic…

Even now, treatment protocols vary across the country. Well-intentioned clinicians continue off-label use of a panoply of therapies while defending their decisions with an almost religious fervor.

This is not just about the coronavirus. It is about the extent to which we are committed to science and to each other. As we look toward a vaccine, which will rely on the trust of the public and the medical community for widespread dissemination, this would have been the time to get it right.”  (W)

“The director of the Centers for Disease Control and Prevention told governors last week to prepare for the “large-scale” distribution of a coronavirus vaccine by Nov. 1, according to a letter obtained Wednesday by NBC News.

In the Aug. 27 letter, the director, Dr. Robert Redfield, said the CDC had contracted with a pharmaceutical company, McKesson Corp., to potentially distribute hundreds of millions of vaccine doses to health departments and medical facilities across the country in the fall.

Redfield called the effort “massive” and asked governors for their help expediting applications for distribution facilities that will be set up and operated by McKesson.

“If necessary,” Redfield added, the agency “asks you to consider waiving requirements that would prevent these facilities from being fully operational by November 1, 2020.”

It remains highly uncertain, however, whether a vaccine will be ready by then or which manufacturer will make it. The Nov. 1 target date is two days before the presidential election.

A planning document obtained by The New York Times described the “vaccine landscape” as “evolving and uncertain,” but it described different hypothetical supply and operations scenarios for local officials and doctors. One scenario showed 2 million doses distributed by the end of October, and another showed 10 million to 20 million doses by the end of November…

Food and Drug Administration Commissioner Stephen Hahn told The Financial Times that the FDA could fast-track a vaccine, giving a developer federal approval before rigorous Phase 3 clinical trials are completed.

“We may find that appropriate,” he told the newspaper in a story published Sunday. “We may find that inappropriate. We will make a determination.”” (X)

(Y)………………………..

(Z)………………………..

“Is President Trump embracing a “herd immunity” strategy for the COVID-19 pandemic?…

We can see why this idea would appeal to the president. It’s a lot easier than undertaking the widespread testing, tracing and supported isolation recommended by public health experts. It also would allow shuttered schools and businesses to reopen immediately and, theoretically, let the stalled economy roar back to life in time to give him a reelection bounce.

The problem is that the Swedish model didn’t work out well. And following it means accepting deaths far above the more than 184,000 Americans who have already died from COVID-19…

Nevertheless, Atlas, a senior fellow at the conservative Hoover Institution, is still pushing this strategy. He says that resources should be focused on protecting vulnerable people — although the younger and healthy people who’ve died from the coronavirus wouldn’t have been considered “vulnerable” — while the rest of us get back to normal, get infected and then recover. And now he apparently has the ear of a president who is primed to listen.

Trump has lent his support to pandemic deniers, recently tweeting a fringe — and wrong — theory that the real death toll for COVID-19 in the U.S. is almost 20 times lower than has been reported. This faulty argument hinges on data posted on the CDC website that says 6% of the COVID-19 deaths reported to the agency cited no other health conditions. But the extrapolation that the rest didn’t die from the infection is wrong. Most people die with multiple complications, and reporting these factors doesn’t mean that the infection wasn’t ultimately to blame.

Undergirding a herd immunity strategy is the morally reprehensible notion that older people and those with chronic conditions such as diabetes and obesity (conditions that afflict a significant number of Americans) are expendable because they would die soon anyhow. That’s an idea that has no place in a civilized society.” (AA)

The U.S. is seeing roughly 40,000 new cases a day, but it needs to bring daily infections below 10,000, White House coronavirus advisor Dr. Anthony Fauci said.

He said the public’s behavior over the Labor Day holiday weekend will determine how the coronavirus spreads through the colder months….

“We know from prior experience as you get into the holiday weekend, the Fourth of July, Memorial Day, there’s a tendency of people to be careless somewhat with regard to the public health measures,” he said. “I want to use this opportunity to almost have a plea to the people in this country to realize that we really still need to get our arms around this and to suppress these types of surges we’ve seen.”

He added: “We’re around 40,000 cases. That’s an unacceptably high baseline. We’ve got to get it down to, I’d like to see 10,000 or less.”

Earlier in the year, coronavirus cases in the U.S. began to pick up shortly after the Memorial Day holiday.

New cases had hit a peak in April of about 31,000 before steadily falling to about 20,000 cases a day by the end of May. But after the holiday, new cases began to climb again, surging to about 70,000 cases a day in July, according a CNBC analysis of Johns Hopkins University data.

Data is again showing some worrying signs of another surge. The U.S. reported 43,253 new cases of the coronavirus on Tuesday, pushing the seven-day average past 42,300, up 0.6% compared with a week earlier, according to Hopkins data.”  (BB)

“International clinical trials published on Wednesday confirmed hope that cheap, widely available steroid drugs can help seriously ill patients survive Covid-19.

After the release of the new data, the World Health Organization strongly recommended steroids for treatment of patients with severe or critical Covid-19 worldwide. But the agency recommended against giving the drugs to patients with mild disease.

The new studies include an analysis that pooled data from seven randomized clinical trials evaluating three steroids in over 1,700 patients. The study concluded that each of the three drugs reduced the risk of death.

That paper and three related studies were published in the journal JAMA, along with an editorial describing the research as an “important step forward in the treatment of patients with Covid-19.”

Corticosteroids should now be the first-line treatment for critically ill patients, the authors said. The only other drug shown to be effective in seriously ill patients — and only modestly at that — has been remdesivir.

Steroids like dexamethasone, hydrocortisone and methylprednisolone are often used by doctors to tamp down the body’s immune system, alleviating inflammation, swelling and pain. Many Covid-19 patients die not of the virus but of the body’s overreaction to the infection.

The analysis of pooled data found that steroids were linked with a one-third reduction in deaths among Covid-19 patients. Dexamethasone produced the strongest results: a 36 percent drop in deaths in 1,282 patients treated in three separate trials.”  (CC)

“Moncef Slaoui, the chief adviser for the White House vaccine program, said on Thursday that it was “extremely unlikely but not impossible” that a vaccine could be available by the end of October.

In an interview with National Public Radio, Dr. Slaoui, the chief scientific adviser of the Trump administration’s coronavirus vaccine and treatment initiative, called Operation Warp Speed, explained that the Centers for Disease Control and Prevention’s guidance to states to prepare for a vaccine as early as late October — a notification Dr. Slaoui said he had learned of through the news media — was “the right thing to do” in case a vaccine was ready by that time. “It would be irresponsible not to be ready if that was the case,” he said.

However, he described that as a “very, very low chance.”

That message ran counter to the optimistic assertions in recent days from the White House that a vaccine could be ready for distribution before Election Day in November. President Trump, during the Republican National Convention, said a vaccine could be ready “before the end of the year or maybe even sooner.” And he and others have tried to project confidence in a quick victory.

Dr. Slaoui confirmed that the two main candidates, referred to as Vaccine A and Vaccine B, were being developed by Pfizer and Moderna. He said that there was “no intent” to introduce a vaccine before clinical trials were completed, and that trials would only be completed when an independent safety monitoring board, separate from the government, affirmed the effectiveness of the vaccine.

The interviewer, Mary Louise Kelly, raised the timing of a possible vaccine given in the documents the C.D.C. recently sent to public health officials, and asked directly whether the delivery of the vaccine was being motivated by political concerns.

“For us there is absolutely nothing to do with politics,” Dr. Slaoui responded, saying that those involved were working as hard as they could because so many people were dying every day. “Many of us may or may not be supportive of this administration. It’s irrelevant, frankly.” (DD)

“Talking to ScienceInsider today, Slaoui insisted he won’t be swayed by political pressures to rush an unsafe or ineffective vaccine, and that science will carry the day—or he’ll quit.” (EE)

“White House trade adviser Peter Navarro on Tuesday defended President Trump’s emergency authorization of convalescent plasma therapy as treatment for COVID-19, even after Food and Drug Administration Commissioner Stephen Hahn conceded that he had overhyped its effectiveness.

When pressed during an MSNBC interview on Hahn’s tweet the night before that the criticism he’s faced over his remarks about the benefits of convalescent plasma was “entirely justified,” Navarro hit back at the notion that emergency approval of the unproven treatment for COVID-19 “falsely inflates hopes.”

“I don’t accept that,” Navarro said. “That, to me, is like a crazy talking point.”

After pointing out that both Hahn and the Mayo Clinic have said that the emergency approval of using plasma to treat COVID-19 reduces the possibility of having a proper randomized study on it, MSNBC’s Andrea Mitchell asked Navarro whether Hahn was wrong.

“On the issue of not being able to do randomized trials, what is the calculus here?” Navarro said. “Are we going to wait to use something that can save thousands of lives just so we can have a study that tells us what we already know?”

Mitchell cut in to point out “yes, that is scientific practice, sir” because it’s how vaccines and drugs are approved.

Navarro responded by circling back to asking whether it’s worth waiting for a therapy that “likely works.”

“This is an important debate for the American people and your viewers to have: Do you want to wait for a therapy which likely works to get these scientific studies which are going to take three, six months, whatever?” Navarro said. “Or do you want to have the right to try?”

After Navarro boasted that Trump is “the right to try president” and that the debate over convalescent plasma “puzzles me, frankly” because it’s been used as a therapy for over a century, Mitchell hit back that it’s a treatment for other diseases and that COVID-19 is a new virus.

Navarro went on to claim that the odds of the plasma treatment “being able to hurt you are close to zero, so it’s safe” while “the odds of it being able to help you are close to 100%.” Mitchell called that out for being an incorrect assertion…

“The question for your viewers is simple: People are dying out there. Does convalescent plasma likely help people in terms of saving lives? And I think the answer is yes,” Navarro said. “The question of how much it helps, that’s to be determined. But I think that it’s good that it’s out there.” (FF)

“The Centers for Disease Control and Prevention has notified public health officials in all 50 states and five large cities to prepare to distribute a coronavirus vaccine to health care workers and other high-risk groups as soon as late October or early November…

Three documents were sent to public health officials in all states and territories as well as officials in New York, Chicago, Philadelphia, Houston and San Antonio on Aug. 27. They outlined detailed scenarios for distributing two unidentified vaccine candidates, each requiring two doses a few weeks apart, at hospitals, mobile clinics and other facilities offering easy access to the first targeted recipients.

The guidance noted that health care professionals, including long-term care employees, would be among the first to receive the product, along with other essential workers and national security employees. People 65 or older, as well as Native Americans and those who are from “racial and ethnic minority populations” or incarcerated — all communities known to be at greater risk of contracting the virus and experiencing severe disease — were also prioritized in the documents…

The agency also said its plans were as yet hypothetical, noting, “The Covid-19 vaccine landscape is evolving and uncertain, and these scenarios may evolve as more information is available.” A C.D.C. spokeswoman confirmed that the documents were sent but declined to comment further…

The C.D.C. documents said that public health administrators should review lessons learned from the 2009 H1N1 pandemic vaccination campaign, which did not have enough doses at the beginning to meet demand.

“It’s good to have a plan out for hospitals and health care systems to prepare” for a potential rollout, said Dr. Taison Bell, a pulmonary and critical care physician at the University of Virginia. But Dr. Bell added that he was concerned that the timeline outlined in the documents “is incredibly ambitious and makes me worry that the administration will prioritize this arbitrary deadline rather than maintaining diligence with following the science.””  (GG)

“I think Trump clearly does not like the advice he was receiving from the people who are the experts — Fauci, Birx, etc. — so he has slowly shifted from their advice to somebody who tells him what he wants to hear,” said Dr. Carlos del Rio, an infectious disease expert at Emory University who is close to Dr. Birx, the White House coronavirus response coordinator.

Dr. Atlas is neither an epidemiologist nor an infectious disease expert, the two jobs usually associated with pandemic response. But his frequent appearances on Fox News Channel and his ideological surety caught the president’s eye.

So when Mr. Trump resumed his coronavirus news conferences in July and August, it was Dr. Atlas who helped prepare his briefing materials, according to people familiar with them. And it was his ideas that spilled from the president’s mouth.

“He has many great ideas,” Mr. Trump told reporters at a White House briefing last month with Dr. Atlas seated feet away. “And he thinks what we’ve done is really good, and now we’ll take it to a new level.”

The core of his appeal in the West Wing rests in his libertarian-style approach to disease management in which the government focuses on small populations of at-risk individuals — the elderly, the sick and the immune-compromised — and minimizes restrictions for the rest of the population, akin to an approach used to disastrous effect in Sweden. The argument: Most people infected by the coronavirus will not get seriously ill, and at some point, enough people will have antibodies from Covid-19 to deprive the virus of carriers — “herd immunity.”

“Once you get to a certain number — we use the word herd — once you get to a certain number, it’s going to go away,” Mr. Trump told Laura Ingraham on Fox News on Monday night.

Dr. Atlas’s push has led to repeated private confrontations with Dr. Birx, who in recent weeks has been advocating rigorous rules on wearing masks, limiting bars and restaurants, and minimizing large public gatherings….

Mr. Trump is clearly enamored with Dr. Atlas’s arguments, which back up the president’s desire to restart the economy, open schools and move beyond the daily drumbeat of dire virus news.

But fully embracing any version of a policy resembling herd immunity has profound medical and political risks. Simply allowing the virus to travel through most of the population could lead to hundreds of thousands, if not millions, of deaths. And medical officials are still not sure how long that immunity might last, and how long-lasting some effects of the virus could be.

“Trying to get to herd immunity other than with a vaccine isn’t a strategy,” said Dr. Tom Frieden, a former C.D.C. director. “It’s a catastrophe.”  (HH)

“As many as 45 hospitals from coast to coast have expressed interest in collaborating on a randomized, controlled clinical trial sponsored by Vanderbilt University Medical Center, said principal investigator Dr. Todd Rice.

Officials at some hospitals said they are considering committing only to the clinical trial — and either avoiding or minimizing use of convalescent plasma through an emergency use authorization issued Aug. 23 by the federal Food and Drug Administration.

Plasma should not be considered standard care for coronavirus, NIH panel says

The response comes amid concerns that the Trump administration pressured the FDA into approving broader use of convalescent plasma, which already has been administered to more than 77,000 COVID patients in the U.S. President Donald Trump characterized the treatment as a “powerful therapy,” even as government scientists called for more evidence that COVID plasma is beneficial.

A National Institutes of Health panel this week countered the FDA’s decision, saying that the therapy “should not be considered the standard of care for the treatment of patients with COVID-19” and that well-designed trials are needed to determine whether the therapy is helpful. Data so far suggests the treatment could be beneficial, but it’s not definitive.

“It’s an important scientific question that we don’t have the answer to yet,” said Rice, an associate professor of medicine and director of VUMC’s medical intensive care unit…

Issuing the EUA puts the fate of clinical trials into “extreme jeopardy,” said Arthur Caplan, a professor of bioethics at the New York University School of Medicine. With convalescent plasma in very short supply, it sets the stage for fights over access and makes sick patients less inclined to join a trial, where they might receive a placebo.

“If you have the EUA, it starts to damage the trials,” Caplan said.

Still, given that the FDA has authorized convalescent plasma for patients ill with COVID-19, hospitals that hesitate or refuse to provide it outside a trial are sure to face questions from families.

That creates “a very interesting and delicate ethics problem,” said Cohn.

“If you commit to the randomized controlled trial only, you’re committing to a long-term dedication to science,” she said. “The question is, is it ethically inappropriate not to provide a therapy that has been shown to be possibly beneficial?”  (II)

“The US Centers for Disease Control and Prevention is asking states to get ready to distribute a coronavirus vaccine by as early as next month. The CEO of Pfizer says he thinks it’s possible his company will have enough data to ask the US Food and Drug Administration (FDA) for authorization by October.

And officials inside the FDA have told CNN that US President Donald Trump has consistently pressed agencies to speed up their timeline for developing a vaccine so he can have a vaccine victory by Election Day.

But is it really possible we could have a coronavirus vaccine by November?

The doctors running clinical trials would know best … and they don’t think so.

“Do the simple math,” said Dr. Larry Corey of the Fred Hutchinson Cancer Research Center in Seattle, who is leading the team coordinating clinical trials for federally backed coronavirus vaccines in the US.

“We designed the trial to get to 130, 140 endpoints seven months from starting the trial,” Corey told CNN. “The first one started in mid-July.”

 If you add seven months to July, you get February.

That doesn’t mean it’s impossible to have an answer before then: If one of the vaccines being tested is highly effective, and there is a high rate of infection among trial volunteers, it’s possible many people who got placebo shots would get infected quickly.

“If you had a highly effective vaccine, maybe you’d find that five months from designing the trial,” Corey said.

But if you add five months to July, you get December.” (JJ)

“Many health experts say a safe and effective vaccine might not be publicly available until early 2021. But it’s possible the Food and Drug Administration could give an emergency use authorization for a vaccine to be distributed before its Phase 3 clinical trial is over, if the data is very promising.

Some doctors say they’d rather see a vaccine go through all the rigors to get a full FDA approval.

“How can you justify a substandard or lesser review for something that would be injected in tens of millions, maybe hundreds of millions of Americans?” said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine…

And that’s not likely to happen by late October, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

“If you look at the projection, of the enrollment (of trial participants) and the kinds of things you’ll need to get a decision about whether the vaccine is safe and effective, most of us project that that’s going to be by November, December, by the end of the year,” Fauci told CNN on Thursday.

“Could this be earlier? Sure … that’s unlikely (but) not impossible.”

President Donald Trump has touted the idea that a vaccine could be out to the public by the November 3 election. But vaccine experts have said that’s not realistic.

Any decision about approving or authorizing a coronavirus vaccine will be driven by science and evidence, Health and Human Services Secretary Alex Azar said.

“Thanks to President Trump’s leadership of this Operation Warp Speed, we’re making historic progress towards a vaccine,” Azar said on CBS Thursday.

He said that he doesn’t know when the data will come, as it will depend on the rate of infection in the communities where the vaccine candidate and placebo have been administered.

“President Trump has made it clear, and I’ve made it clear, these decisions will be driven by the standards of science and evidence and FDA’s gold standards,” he said.” (KK)

“Dr. Anthony Fauci said Friday that he’s not sure what President Donald Trump meant when he said earlier that evening that the country is “rounding the corner” on the coronavirus pandemic.

“I’m not sure what he means,” Fauci, the director of the National Institute of Allergy and Infectious Diseases, told CNN’s Jim Acosta on “The Situation Room.”

“There are certain states that are actually doing well in the sense of that the case numbers are coming down.” However, Fauci continued, experts remain concerned by a number of states, including Montana, Michigan, Minnesota and the Dakotas, that are starting to see an uptick in the percentage of coronavirus tests coming back positive — an indication of spread of the virus.

The exchange marked another example of a top scientist and a member of the White House coronavirus task force publicly disputing the President’s claims about the virus, a dynamic that has played out nearly since the start of the pandemic.

“By the way, we are rounding the corner,” Trump said during a news briefing at the White House. “We are rounding the corner on the virus.” (LL)

“The head of the NIH told Congress that U.S. health officials will not skip or abbreviate any safety assessments in the development of a coronavirus vaccine.

NIH Director Dr. Francis Collins said studying the safety and effectiveness of Covid-19 vaccine candidates is now the agency’s “top priority.”…

“The critical final steps in clinical trials will be well coordinated and done in parallel with manufacturing, but with NIH and industry providing the FDA with all of the critical safety and efficacy data necessary for sound scientific decision-making,” he told the Senate Committee on Health, Education, Labor and Pensions in prepared remarks submitted ahead of a hearing on coronavirus vaccines.

An independent data and safety monitoring board is reviewing the integrity of the trials and continues to monitor ongoing results to ensure participants are safe, Collins told the lawmakers. The protocols for the trials are being overseen by the U.S. government, in contrast to traditional trials in which pharmaceutical companies are solely responsible for design and implementation, he added.”  (MM)

“Nine pharmaceutical companies issued a joint pledge on Tuesday that they would “stand with science” and not put forward a vaccine until it had been thoroughly vetted for safety and efficacy.

The companies did not rule out seeking an emergency authorization of their vaccines, but promised that any potential coronavirus vaccine would be decided based on “large, high quality clinical trials” and that the companies would follow guidance from regulatory agencies like the Food and Drug Administration.

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which Covid-19 vaccines are evaluated and may ultimately be approved,” the companies said.” (NN)

“Dr. Anthony Fauci has said that the US needs to get the daily number of new coronavirus cases down below 10,000 before fall arrives.

A number of states, including Iowa and Indiana, are currently experiencing new surges in coronavirus infections.

Over the past few weeks, Dr. Anthony Fauci has made it clear that the US needs to get the daily number of new coronavirus cases down below 10,000 by fall lest we see a massive spike in infections. Unfortunately, the simple reality is that we’re not anywhere close to reaching the 10,000 threshold.

Over the past few weeks, the number of new coronavirus cases in the US has hovered within the range of 35,000 to 45,000 new cases per day. And with fall just about two weeks away, there’s a chance that we’re already past the point of no return with respect to getting the number of coronavirus cases down to an acceptable level as we head into flu season.

Recently, Dr. Fauci appeared on CNN‘s The Situation Room and articulated what aspect of the current pandemic he finds to be the most worrisome. Specifically, Fauci explained that the number of states currently seeing a significant increase in new coronavirus cases is “disturbing.”..

“And the reason we know they’re new cases [is] because, when you have the increase in cases, it’s invariably followed by an increase in hospitalization and ultimately by an increase in deaths. That’s the real bottom line. The critical issue is the percent positives of the tests that you do. And we’re starting to see an uptick in that in certain areas that’s disturbing. And that’s why we call out to the governors and the leaders of those states to please pay attention to that, because that can be a predictor of surges that we really are trying to avoid.” (OO)

“White House coronavirus advisor Dr. Anthony Fauci said Tuesday a coronavirus vaccine probably won’t be ready by the U.S. presidential election even as the Centers for Disease and Prevention asks states to ready distribution facilities by Nov. 1.

At a health conference, Fauci said it’s more likely a vaccine will be ready by “the end of the year” as drug companies Moderna and Pfizer race to complete patient enrollment for their late-stage vaccine trials by the end of September.

 “It’s unlikely we’ll have a definitive answer” by the Nov. 3 election, the director of the National Institute of Allergy and Infectious Diseases said at the Research! America 2020 National Health Research Forum.

The comments are also at odds with President Donald Trump, who suggested at a press conference Monday that a vaccine could be ready for distribution by Election Day.

“We could have a vaccine soon, maybe even before a very special day. You know what day I’m talking about,” Trump told reporters.” (PP)

• A.F.D.A. Allows Expanded Use of Plasma to Treat Coronavirus Patients, By Sharon LaFraniere, Sheri Fink, Katie Thomas and Maggie Haberman, F.D.A. Allows Expanded Use of Plasma to Treat Coronavirus Patients, https://www.nytimes.com/2020/08/23/us/politics/fda-plasma-coronavirus.html?referringSource=articleShare
• B.U.S. Authorizes Plasma Treatment for Virus, but the Big Prize for the White House Is a Vaccine, https://www.nytimes.com/2020/08/23/world/covid-19-coronavirus.html?referringSource=articleShare
• C.Stephen Hahn, F.D.A. Chief, Is Caught Between Scientists and the President, By Sheila Kaplan, https://www.nytimes.com/2020/08/10/health/stephen-hahn-fda.html?referringSource=articleShare
• D.Fauci warns against premature authorization of coronavirus vaccine, By Paul LeBlanc, https://www.cnn.com/2020/08/24/politics/fauci-coronavirus-vaccine-emergency-use-authorization/index.html
• E.Navarro says need for randomized trial on plasma is a “crazy talking point”, by Ursula Perano, https://www.axios.com/plasma-coronavirus-covid-navarro-trump-fda-975137a5-a496-4a91-b3f0-899c952ac752.html
• F.Does convalescent plasma help treat Covid-19? The NIH says we don’t yet know., By Umair Irfan, https://www.vox.com/2020/8/24/21399007/trump-covid-19-convalescent-plasma-coronavirus-fda-nih-stephen-hahn
• G.Coronavirus: Trump claims ‘political reasons’ held up plasma authorization, By Kevin Liptak and Paul LeBlanc, https://www.msn.com/en-us/news/politics/coronavirus-trump-claims-political-reasons-held-up-plasma-authorization/ar-BB18hWDI
• H.Lawmakers, experts raise questions after convalescent plasma EUA, By Michael Mezher, https://www.raps.org/news-and-articles/news-articles/2020/8/lawmakers-experts-raise-questions-after-convalesce
• I.Fauci warns against emergency coronavirus vaccine approval before widespread testing, BY JUSTIN WISE, https://thehill.com/policy/healthcare/513497-fauci-warns-against-emergency-coronavirus-vaccine-approval-before
• J.Convalescent plasma therapy holds promise, but here’s why scientists are still studying it, SANDHYA RAMESH, https://theprint.in/health/convalescent-plasma-therapy-holds-promise-but-heres-why-scientists-are-still-studying-it/488285/
• K.Two P.R. Experts at F.D.A. Have Been Ousted After Blood Plasma Fiasco, By Sheila Kaplan and Katie Thomas, https://www.nytimes.com/2020/08/28/health/blood-plasma-fda.html?referringSource=articleShare
• L.Trump, Hahn Mischaracterize Data on COVID-19 Convalescent Plasma, By Jessica McDonald, https://www.factcheck.org/2020/08/trump-hahn-mischaracterize-data-on-covid-19-convalescent-plasma/
• M.Convalescent plasma went from promising to politically tainted: 3 things to know, By Anne Flaherty, https://abcnews.go.com/Politics/convalescent-plasma-promising-politically-tainted-things/story?id=72599272
• N.Coronavirus vaccine before election unlikely — Dr. Gottlieb on FDA chief’s possible fast track, by Kevin Stankiewicz, https://www.cnbc.com/2020/08/31/dr-scott-gottlieb-says-coronavirus-vaccine-before-election-unlikely.html
• O.A top White House coronavirus adviser is reportedly pushing the Trump administration to adopt a controversial ‘herd immunity’ strategy, by Oma Seddiq, https://www.businessinsider.com/coronavirus-adviser-is-pushing-white-house-to-adopt-herd-immunity-2020-8
• P.Dr. Fauci: It’s ‘conceivable’ we’ll know by November if a safe, effective vaccine is coming, By Quentin Fottrell,  https://www.marketwatch.com/story/as-covid-19-cases-hit-25-million-dr-fauci-says-its-conceivable-well-know-if-theres-a-safe-vaccine-by-november-2020-08-30
• Q.Dr Anthony Fauci Tackles the Issue of Antiscience Sentiments, https://www.ajmc.com/view/dr-fauci-tackles-the-issue-of-antiscience-sentiments
• R.Where Is America’s Groundbreaking Covid-19 Research?, By Ezekiel J. Emanuel, Cathy Zhang and Amaya Diana, https://www.nytimes.com/2020/09/01/opinion/coronavirus-clinical-research.html?referringSource=articleShare
• S.Donald Trump says he ‘inherited’ Dr. Fauci and ‘disagrees with a lot’ of what the nation’s top infectious disease expert has said during the COVID-19 response, By LAUREN FRUEN, https://www.dailymail.co.uk/news/article-8684205/Donald-Trump-says-inherited-Dr-Fauci-disagrees-lot-said.html
• T.A New Coronavirus Adviser Roils the White House With Unorthodox Ideas, by Noah Weiland, Sheryl Gay Stolberg, Michael D. Shear and Jim Tankersley, https://www.msn.com/en-us/news/politics/a-new-coronavirus-adviser-roils-the-white-house-with-unorthodox-ideas/ar-BB18CTyN
• U.It Has Come to This: Ignore the C.D.C., By Harold Varmus and Rajiv Shah, https://www.nytimes.com/2020/08/31/opinion/cdc-testing-coronavirus.html?referringSource=articleShare
• V.Fauci Says COVID Vaccine Trials Could End Early If Results Are Overwhelming, By Liz Szabo, https://khn.org/news/dr-fauci-says-covid-vaccine-trials-could-end-early-if-results-are-overwhelming/?mkt_tok=eyJpIjoiTW1OalkyRTVPR1pqWVRVMCIsInQiOiJQcWl4R3FibnM5N0s1M2wwVmsrOXFqMjZrY2JuXC84Q0RETWRZOTFQMHpEcjRlMk1pMjBWR2V0VGhUOURRcWgreCs4MDZlTXdPQnZ2OVo1b1N3YytcLzRLSnh4THNRQUs3aXdWenZQRW9neFM1U05qY21iSStORmVQNTF4ZjFsd0xqIn0%3D&referringSource=articleShare
• W.More Than 70,000 Covid-19 Patients Have Received Plasma. Does It Help?, By Daniela J. Lamas, https://www.nytimes.com/2020/09/02/opinion/coronavirus-convalescent-plasma.html?referringSource=articleShare
• X.CDC tells states to prepare for distribution of COVID-19 vaccine by Nov. 1, by Tim Stelloh and Meg Tirrell and Ryan Ruggiero, https://news.yahoo.com/cdc-tells-states-prepare-distribution-231945460.html
• Y…
• Z…
• AA.Editorial: Coronavirus ‘herd immunity’ is just another way to say ‘let people die’, https://www.latimes.com/opinion/story/2020-09-02/coronavirus-herd-immunity-trump
• BB.r. Anthony Fauci says U.S. coronavirus cases are ‘unacceptably high’ going into Labor Day, by Berkeley Lovelace Jr., https://www.cnbc.com/2020/09/02/dr-fauci-says-us-coronavirus-cases-are-unacceptably-high-going-into-labor-day.html
• CC.W.H.O. Recommends Steroids for Critically Ill Coronavirus Patients, https://www.nytimes.com/2020/09/02/world/coronavirus-covid-live.html?referringSource=articleShare#link-6adaa75a
• DD.President Trump’s vaccine chief sees a ‘very, very low chance’ of a vaccine by Election Day., https://www.nytimes.com/2020/09/03/world/covid-coronavirus.html?referringSource=articleShare
• EE.Leader of U.S. vaccine push says he‘ll quit if politics trumps science, By Jon Cohen, https://www.sciencemag.org/news/2020/09/leader-us-vaccine-push-says-he-ll-quit-if-politics-trumps-science-approval-process#
• FF.Navarro Dismisses Criticism Of Plasma Treatment For COVID-19 As ‘Crazy Talking Point’, By Summer Concepcion, https://talkingpointsmemo.com/news/peter-navarro-plasma-treatment-covid-19-fda-stephen-hahn
• GGF.C.D.C. Tells States How to Prepare for Covid-19 Vaccine by Early November, By Sheila Kaplan, Katherine J. Wu and Katie Thomas, https://www.nytimes.com/2020/09/02/health/covid-19-vaccine-cdc-plans.html?referringSource=articleShare
• HH.A New Coronavirus Adviser Roils the White House With Unorthodox Ideas, By Noah Weiland, Sheryl Gay Stolberg, Michael D. Shear and Jim Tankersley, https://www.nytimes.com/2020/09/02/us/politics/trump-scott-atlas-coronavirus.html?referringSource=articleShare
• II.Dozens of hospitals poised to defy FDA’s directive on Covid plasma, By JoNel Aleccia, https://www.cnn.com/2020/09/03/health/coronavirus-hospitals-plasma-defiance/index.html
• JJ.Here’s why it’s unlikely the US will have a coronavirus vaccine by Election Day, by Maggie Fox, https://edition.cnn.com/world/live-news/coronavirus-pandemic-09-03-20-intl/index.html
• KK.Doctors warn against rushing a Covid-19 vaccine as Fauci says it’s critical to have a safe Labor Day, By Holly Yan, Madeline Holcombe and Shelby Lin Erdman, https://www.cnn.com/2020/09/03/health/us-coronavirus-thursday/index.html
• LL.Fauci unsure what Trump means by saying the country is ’rounding the corner on the virus’, by Caroline Kelly and Jen Christensen, https://www.cnn.com/2020/09/04/politics/fauci-trump-unsure-rounding-the-corner-covid/index.html
• MM.IH promises Congress the U.S. won’t skip safety steps in coronavirus vaccine approval, by Berkeley Lovelace Jr., https://www.cnbc.com/2020/09/09/coronavirus-vaccine-nih-promises-congress-the-us-wont-skip-safety-steps-in-approval.html
• NN.9 Drug Companies Pledge to ‘Stand With Science’ on Coronavirus Vaccines, By Katie Thomas, https://www.nytimes.com/2020/09/08/health/9-drug-companies-pledge-coronavirus-vaccine.html
• OO.Dr. Fauci explains why the US is headed for another coronavirus catastrophe, By Yoni Heisler, https://bgr.com/2020/09/08/coronavirus-update-fauci-cases-usa-rising-what-states-disturbing/
• PP.Fauci says a coronavirus vaccine is ‘unlikely’ by U.S. election, by Berkeley Lovelace Jr., https://www.cnbc.com/2020/09/08/coronavirus-vaccine-dr-fauci-says-its-unlikely-it-will-be-ready-by-us-election.html

CORONOVIRUS TRACKING Links to Parts 1-45

Doctor, Did You Wash Your Hands?®

Curated Contemporaneous Case Study Methodology

Jonathan M. Metsch, Dr.P.H.

PART 1. January 21, 2020. CORONAVIRUS. “The Centers for Disease Control and Prevention on Tuesday confirmed the first U.S. case of a deadly new coronavirus that has killed six people in China.”

PART 2. January 29, 2020. CORONAVIRUS. “If it’s not contained shortly, I think we are looking at a pandemic..”….. “With isolated cases of the dangerous new coronavirus cropping up in a number of states, public health officials say it is only a matter of time before the virus appears in New York City.”

PART3. February 3, 2020. “The Wuhan coronavirus spreading from China is now likely to become a pandemic that circles the globe…”..Trump appeared to downplay concerns about the flu-like virus …We’re gonna see what happens, but we did shut it down..” (D)

PART 4. February 9, 2020. Coronavirus. “A study published Friday in JAMA found that 41% of the first 138 patients diagnosed at one hospital in Wuhan, China, were presumed to be infected in that hospital.….

PART 5. February 12, 2020. CORONAVIRUS. “In short, shoe-leather public health and basic medical care—not miracle drugs—are generally what stop outbreaks of emerging infections..”

POST 6. February 18, 2020.  Coronovirus. “Amid assurances that the (ocean liner) Westerdam was disease free, hundreds of people disembarked in Cambodia…” “ One was later found to be infected”…. “Over 1,000… passengers were in…transit home”…. “This could be a turning point””

PART 7. February 20, 2020. CORONAVIRUS. With SARS preparedness underway in NJ LibertyHealth/ Jersey City Medical Center, where I was President, proposed that our 100 bed community hospital with all single-bedded rooms, be immediately transformed into an EMERGENCY SARS ISOLATION Hospital.

PART 8. February 24, 2020. CORONAVIRUS. “…every country’s top priority should be to protect its health care workers. This is partly to ensure that hospitals themselves do not become sites where the coronavirus is spread more than it is contained.”

PART 9. February 27, 2020. CORONAVIRUS. Responding to a question about the likelihood of a U.S. outbreak, President Trump said, “I don’t think it’s inevitable…”It probably will. It possibly will,” he continued. “It could be at a very small level, or it could be at a larger level.”

Part 10. March 1, 2020. CORONAVIRUS. Stop Surprise Medical Bills for Coronavirus care. (&) Lessons Learned (or not) In California and Washington State from community acquired cases.

PART 11. March 5, 2020.  CORONAVIRUS. “Gov. Andrew Cuomo… would require employers to pay workers and protect their jobs if they are quarantined because of the coronavirus.”

Part 12. March 10, 2020. CORONAVIRUS. “Tom Bossert, Donald Trump’s former homeland security advisor…(said) that due to the coronavirus outbreak, “We are 10 days from the hospitals getting creamed.”

Part 13.. March 14, 2020. CORONAVIRUS. “If I’m buying real estate in New York, I’ll listen to the President….If I’m asking about infectious diseases, I’m going to listen to Tony Fauci,”

PART 14. March 17, 2020. CORONAVIRUS. “ “Most physicians have never seen this level of angst and anxiety in their careers”…. One said “I am sort of a pariah in my family.”

PART 15. March 22, 2020. CORONAVIRUS. “…Crimson Contagion” and imagining an influenza pandemic, was simulated by the Trump administration….in a series of exercises that ran from last January to August.

PART 16. March 27, 2020. CORONAVIRUS. I am not a clinician or a medical ethicist but articles on Coronavirus patient triage started me Googling………to learn about FUTILE TREATMENT

PART 17. April 2, 2020. CORONAVIRUS. Florida allows churches to continue holding services. Gun stores deemed “essential.”  “New York’s private and public hospitals unite to manage patient load and share resources.

PART 18. April 9, 2020. CORONAVIRUS. “The federal government’s emergency stockpile of personal protective equipment (PPE) is depleted, and states will not be receiving any more shipments, administration staff told a House panel.

PART 19. April 13, 2020 CORONOAVIRUS. “…overlooked in the United States’ halting mobilization against the novel coronavirus: the personal aides, hospice attendants, nurses and occupational or physical therapists who deliver medical or support services to patients in their homes.”

PART 20. April 20, 2020. CORONAVIRUS. “…nothing is mentioned in the “Opening Up America Again” plan about how states should handle a resurgence.”

PART 21. April 23, 2020. CORONAVIRUS. “We need to ask, are we using ventilators in a way that makes sense for other diseases but not this one?”

POST 22. April 29, 2020. CORONAVIRUS. ..the “ACS released a list of 10 issues that should be addressed before a healthcare organization resumes elective surgeries[JM1] ….”

POST 23. May 3, 2020. CORONAVIRUS. … what Dr. Fauci really wants,…”is just to go to a baseball game. That will have to wait. The level of testing for the virus is not adequate enough to allow for such mass gatherings.’ (K)

POST 24. May 7, 2020. CORONAVIRUS. Former New Jersey governor Chris Christie said: “there are going to be deaths no matter what”… but that people needed to get back to work.

POST 25. May 10, 2020, CORONAVIRUS. “It is scary to go to work,” said Kevin Hassett, a top economic adviser to the president. “I think that I’d be a lot safer if I was sitting at home than I would be going to the West Wing.”

POST 26. May 14, 2020. CORONAVIRUS, “Deep cleaning is not a scientific concept”….”there is no universal protocol for a “deep clean” to eradicate the coronavirus”

POST 27. May 19, 2020. CORONAVIRUS. “Hospital…executives…are taking pay cuts…to help offset the financial fallout from COVID-19.” As “front line” layoffs and furloughs accelerate…

POST 28. May 23, 2020. CORONAVIRUS. ““You’ve got to be kidding me,”..”How could the CDC make that mistake? This is a mess.” CDC conflates viral and antibody tests numbers.

PART 29. May 22, 2020. CORONAVIRUS. “The economy did not close down. It closed down for people who, frankly, had the luxury of staying home,” (Governor Cuomo). But not so for frontline workers!

POST 30. June 3,202. CORONAVIRUS. “The wave of mass protests across the United States will almost certainly set off new chains of infection for the novel coronavirus, experts say….

POST 31. June 9, 2020. CORONAVIRUS. “I think we had an unintended consequence: I think we made people afraid to come back to the hospital,”

Post 32. June 16, 2020. CORONAVIRUS. Could the Trump administration be pursuing herd immunity by “inaction”?  “ If Fauci didn’t exist, we’d have to invent him.”

POST 33. June 21, 2002. CORONAVIRUS….. Smashing (lowering the daily number of cases) v. flattening the curve (maintaining a plateau)

POST 34. June 26, 2020. CORONAVIRUS. CDC Director Redfield… “the number of coronavirus infections…could be 10 times higher than the confirmed case count — a total of more than 20 million.” As Florida, Texas and Arizona become eipicenters!

POST 35. June 29, 2020. CORONAVIRUS. Pence: “We slowed the spread. We flattened the curve. We saved lives..”  While Dr. Fauci “warned that outbreaks in the South and West could engulf the country…”

POST 36. July 2, 2020. CORONAVIRUS. “There’s just a handful of interventions proven to curb the spread of the coronavirus. One of them is contact tracing, and “it’s not going well,” (Dr. Anthony Fauci)..

POST 37. June 8, 2020. CORONAVIRUS. When “crews arrive at a hospital with a patient suspected of having COVID-19, the hospital may have a physical bed open for them, but not enough nurses or doctors to staff it.”

POST 38. July 15, 2020. CORONAVIRUS. Some Lessons Learned, or not. AdventHealth CEO Terry Shaw: I wouldn’t hesitate to go to Disney as a healthcare CEO — based on the fact that they’re working extremely hard to keep people safe,” (M)

POST 39. July, 23,2020. CORONAVIRUS. A Tale of Two Cities. Seattle becomes New York (rolls back reopening) while New York becomes Seattle (moves to partial phase 4 reopening)

POST 40. July 27, 2020. CORONAVIRUS.” One canon of medical practice is that you order a test only if you can act on the result. And with a turnaround time of a week or two, you cannot. What we have now is often not testing — it’s testing theater.”

POST 41. August 2, 2020. CORONAVIRUS. “Whenever a vaccine for the coronavirus becomes available, one thing is virtually certain: There won’t be enough to go around. That means there will be rationing.”

POST 42. August 11, 2020. CORONAVIRUS. “I think that if future historians look back on this period, what they will see is a tragedy of denial….

POST 43. August 22, 2020. CORONAVIRUS.”  “we’ve achieved something great as a nation. We’ve created an unyielding market for FAUCI BOBBLEHEADS”!! (W)

POST 44.  September 1, 2020. CORONAVIRUS. “The CDC…modified its coronavirus testing guidelines…to exclude people who do not have symptoms of Covid-19.” (While Dr. Fauci was undergoing surgery.) A White House official said: “Everybody is going to catch this thing eventually..”

POST 45. September 9, 2020. CORONAVIRUS.  Trump on Fauci. ‘You inherit a lot of people, and you have some you love, some you don’t. I like him. I don’t agree with him that often but I like him.’

September 9, 2020

 [JM1]

to read POSTS 1-44 in chronological order, highlight and click on

“This is a story about four people named Everybody, Somebody, Anybody and Nobody. There was an important job to be done and Everybody was sure that Somebody would do it. Anybody could have done it, but Nobody did it. Somebody got angry about that, because it was Everybody’s job. Everybody thought Anybody could do it, but Nobody realized that Everybody wouldn’t do it. It ended up that Everybody blamed Somebody when Nobody did what Anybody could have.” (A)

“Speakers during Tuesday’s portion of the RNC repeatedly referred to the coronavirus pandemic in the past tense, as though it’s something the US has already overcome thanks to President Donald Trump’s leadership. In reality, the virus continues to ravage the country, and Trump hasn’t developed a plan to get things under control beyond blustering and buck-passing.

The worst offender was White House economics adviser Larry Kudlow, whose speech on Tuesday made it sound like the coronavirus was over.

“It was awful,” Kudlow said. “Health and economic impacts were tragic. Hardship and heartbreak were everywhere. But presidential leadership came swiftly and effectively with an extraordinary rescue for health and safety to successfully fight the Covid virus.” “(B)

“A White House official’s flippant response to concerns about the maskless crowds of attendees at the Republican National Convention—and the GOP’s ignoring of the coronavirus’s horrific toll—have sparked widespred outrage this week.

“Everybody is going to catch this thing eventually,” a senior White House official told CNN’s Jim Acosta Thursday.” (C)

“The Centers for Disease Control and Prevention quietly modified its coronavirus testing guidelines this week to exclude people who do not have symptoms of Covid-19 — even if they have been recently exposed to the virus.

Experts questioned the revision, pointing to the importance of identifying infections in the small window immediately before the onset of symptoms, when many individuals appear to be most contagious.

Models suggest that about half of transmission events can be traced back to individuals still in this so-called pre-symptomatic stage, before they start to feel ill — if they ever feel sick at all…

Prior iterations of the C.D.C.’s testing guidelines struck a markedly different tone, explicitly stating that “testing is recommended for all close contacts” of people infected with the coronavirus, regardless of symptoms. The agency also specifically emphasized “the potential for asymptomatic and pre-symptomatic transmission” as an important factor in the spread of the virus.

The newest version, which was posted on Monday, amended the agency’s guidance to say that people who have been in close contact with an infected individual — typically defined as being within six feet of a person with the coronavirus and for at least 15 minutes — “do not necessarily need a test” if they do not have symptoms. Exceptions, the agency noted, might be made for “vulnerable” individuals, or if health care providers or state or local public health officials recommend testing.” (D)

“CDC referred questions to HHS. In a statement provided Wednesday to CNN, HHS Assistant Secretary Dr. Brett Giroir said: “This Guidance has been updated to reflect current evidence and best public health practices, and to further emphasize using CDC-approved prevention strategies to protect yourself, your family, and the most vulnerable of all ages.”

HHS has not specified what change in “current evidence” may have driven the change.” (E)

“White House Coronavirus Task Force member Dr. Anthony Fauci said he was undergoing surgery and not in the August 20 task force meeting for the discussion on updated US Centers for Disease Control and Prevention guidelines that suggest asymptomatic people may not need to be tested for Covid-19, even if they’ve been in close contact with an infected person.

“I was under general anesthesia in the operating room and was not part of any discussion or deliberation regarding the new testing recommendations” at that meeting, Fauci told CNN Chief Medical Correspondent Dr. Sanjay Gupta.

“I am concerned about the interpretation of these recommendations and worried it will give people the incorrect assumption that asymptomatic spread is not of great concern. In fact it is,” said Fauci, director of the National Institute of Allergy and Infectious Diseases.

CDC was pressured ‘from the top down’ to change coronavirus testing guidance, official says

Fauci’s comments undercut claims by Adm. Brett Giroir, the administration’s coronavirus testing point person, who told reporters on Wednesday that the new guidelines had the White House coronavirus task force’s stamp of approval. Asked whether Fauci signed off on the guidelines, Giroir said, “Yes, all the docs signed off on this before it even got to the task force level.”

“We worked on this all together to make sure that there was absolute consensus that reflected the best possible evidence, and the best public health for the American people,” Giroir also said earlier in the call, pushing back on the notion that the new guidelines were the result of political pressure. “I worked on them, Dr. Fauci worked on them, Dr. (Deborah) Birx worked on them. Dr. (Stephen) Hahn worked on them.”

The new CDC guidelines appeared to be the result of an idea raised to the task force by CDC Director Robert Redfield a month earlier, when a surge of coronavirus cases strained US testing resources and some members were looking for new messaging on how to stem excess testing.

Rather than continue to encourage anyone in close contact with a coronavirus-positive individual to get tested, Redfield suggested the CDC could relax the guidance, deeming a test unnecessary for otherwise healthy individuals not experiencing any symptoms, two sources familiar with the matter said. Experts worry that this will discourage the widespread testing of asymptomatic individuals that could help bring the pandemic under control.

The idea was met with immediate resistance from several task force members. In a coronavirus task force meeting Thursday, members debated the guidelines in-depth and in person, when Fauci was absent…” (F)

“In a brief interview, Dr. Fauci said he had seen an early iteration of the guidelines and did not object. But the final debate over the revisions took place at a task force meeting on Thursday, when Dr. Fauci was having surgery under general anesthesia to remove a polyp on his vocal cord. In retrospect, he said, he now had “some concerns” about advising people against getting tested, because the virus could be spread through asymptomatic contact.

“My concern is that it will be misinterpreted,” Dr. Fauci said.

The newest version of the C.D.C. guidelines, posted on Monday, amended the agency’s guidance to say that people who had been in close contact with an infected individual — typically defined as being within six feet of a person with the coronavirus and for at least 15 minutes — “do not necessarily need a test” if they do not have symptoms.

Exceptions might be made for “vulnerable” individuals, the agency noted, or if health care providers or state or local public health officials recommended testing.

Dr. Giroir said the new recommendation matched existing guidance for hospital workers and others in frontline jobs who have “close exposures” to people infected with the coronavirus. Such workers are advised to take proper precautions, like wearing masks, socially distancing, washing their hands frequently and monitoring themselves for symptoms.

He argued that testing those exposed to the virus was of little utility, because tests capture only a single point in time, and that the results could give people a false sense of security.

“A negative test on Day 2 doesn’t mean you’re negative. So what is the value of that?” Dr. Giroir asked, adding, “It doesn’t mean on Day 4 you can go out and visit Grandma or on Day 6 go out without a mask on in school.”

The guidelines come amid growing concern that the C.D.C., the agency charged with tracking and fighting outbreaks of infectious disease, is being sidelined by its parent agency, the Department of Health and Human Services, and the White House. Under ordinary circumstances, administering public health advice to the nation would fall squarely within the C.D.C.’s portfolio…

Mr. Trump has suggested that the nation should do less testing, arguing that administering more tests was driving up case numbers and making the United States look bad. But experts say the true measure of the pandemic is not case numbers but test positivity rates — the percentage of tests coming back positive.

As Dr. Giroir denied that politics was involved, he encouraged the continued testing of asymptomatic people for surveillance purposes — to determine the prevalence of the virus in a given community — and said such “baseline surveillance testing” would still be appropriate in schools and on college campuses.

“We’re trying to do appropriate testing, not less testing,” he said.”  (G)

“Susan R. Bailey, MD, president of the American Medical Association:

“Months into this pandemic, we know COVID-19 is spread by asymptomatic people. Suggesting that people without symptoms, who have known exposure to COVID-positive individuals, do not need testing is a recipe for community spread and more spikes in coronavirus. When the Centers for Disease Control and Prevention updates a guidance, the agency should provide a rationale for the change. We urge CDC and the Department of Health and Human Services to release the scientific justification for this change in testing guidelines.”

Association of American Medical Colleges President and CEO David J. Skorton, MD, and Chief Scientific Officer Ross McKinney Jr., MD:

“The AAMC is alarmed at the changes to the CDC’s guidelines for SARS-CoV-2 (COVID-19) testing, which recommends that individuals who have been exposed to someone with COVID-19 do not need to be tested unless they show symptoms of the disease. This recommendation is irresponsible when we know that roughly 40 percent of SARS-CoV-2 transmissions come from an asymptomatic person. The revised guidance will result in less testing at exactly the time when we need more testing in order to control the pandemic.

“These CDC guidelines go against the best interests of the American people and are a step backward in fighting the pandemic. The AAMC urges the CDC to return to its earlier testing recommendations, and we stand ready to discuss and work with our colleagues at the CDC to optimize future recommendations.”

California Gov. Gavin Newsom:

“I don’t agree with the new CDC guidance, period, full stop. It’s not the policy in the state of California. We will not be influenced by that change. We’re influenced by those who are experts in the field who feel very differently,” the governor stated during an Aug. 26 news briefing, as reported by KABC-TV.

New York Gov. Andrew Cuomo said his state won’t be following the new guideline, according to an Aug. 26 interview with MSNBC. Mr. Cuomo said CDC officials suggested to New York Health Commissioner Howard Zucker, MD, that the change in guidelines was more of a “political position” and not a scientific one…

Heather E. Gantzer, MD, Chair of the Board of Regents of the American College of Physicians

“The American College of Physicians, representing 163,000 internal medicine physicians (internists), related subspecialists and medical students, strongly supports the use of science, based on the best available evidence, in the fight against COVID-19. Public health agencies should not be subjected to pressure or be influenced to issue policies that are not based on evidence and expert recommendations of their own scientists. This can have a detrimental effect on the public’s trust and adherence to evidence-based guidelines.”

“The recent revision of the CDC’s COVID-19 testing guidelines of asymptomatic individuals lacks transparency and clarity, sending a confusing message to both physicians and the public on appropriate and necessary testing that will ultimately help to mitigate the spread of COVID-19. Asymptomatic patients contribute to the spread of COVID-19. The ability to conduct widespread testing using a rapid and accurate test is critical to appropriately manage the spread of SARS-CoV2. ACP recommends that in the absence of currently effective vaccine or treatment options available for COVID-19, state and local authorities should prioritize a strategy of case finding, screening and surveillance to track and reduce further spread. ACP believes that the United States should urgently expand health system capacity to diagnose, test, and conduct contact tracing (with privacy protections).”” (H)

“Two organizations that represent thousands of local public health departments in the United States sent a letter to senior Trump administration officials on Friday asking that they “pull the revised guidance” on virus testing and restore recommendations that individuals who have been exposed to the virus be tested whether or not they have symptoms.

The letter — addressed to Dr. Robert R. Redfield, director of the Centers for Disease Control and Prevention, and Adm. Brett P. Giroir, an assistant secretary of health at the Department of Health and Human Services — was sent by the leaders of the National Association of County and City Health Officials, and the Big Cities Health Coalition. The organizations’ leaders wrote that their members were “incredibly concerned” about the changes…

The letter sent on Friday said, “As public health professionals, we are troubled about the lack of evidence cited to inform this change. CDC’s own data suggest that perhaps as many as 40 percent of Covid-19 cases are attributable to asymptomatic transmission. Changing testing guidelines to suggest that close contacts to confirmed positives without symptoms do not need to be tested is inconsistent with the science and the data.”

The letter went on to say that while the new guidance allows local or state health officials to make exceptions, it “will make their ability to respond to the pandemic even harder,” allowing skeptical officials or members of the public to blame and question them. “This revision and its resulting impact is adding yet another obstacle for public health practitioners to effectively address the pandemic.””  (I)

“The director of the Centers for Disease Control and Prevention, seeking to clarify recommendations on coronavirus testing that incited an uproar, said that “testing may be considered for all close contacts of confirmed or probable Covid-19 patients.”

But his clarification may have further confused the issue.

The statement by the director, Dr. Robert R. Redfield, was issued to some news outlets late Wednesday, and more broadly Thursday morning, after a storm of criticism over new C.D.C. guidelines. Those guidelines asserted that people who had been in close contact with an infected individual — typically defined as being within six feet of a person with the coronavirus for at least 15 minutes — “do not necessarily need a test” if they do not have symptoms.

Administration officials said that “not necessarily” needing a test was consistent with “may be considered” for one. But experts said the shift in language was leaving patients, doctors and state and local public health officials — who rely on the C.D.C. for guidance — perplexed.

“‘May be’?” asked Dr. Carlos del Rio, an infectious disease expert at Emory University. “I want a little more than that in a recommendation. ‘May be’ doesn’t help.”…

In his statement, Dr. Redfield sought to explain: “Testing is meant to drive actions and achieve specific public health objectives. Everyone who needs a Covid-19 test can get a test. Everyone who wants a test does not necessarily need a test; the key is to engage the needed public health community in the decision with the appropriate follow-up action.”

The clarification does not change the new guidelines, which remain on the C.D.C.’s website. But it is unusual. Public health experts say clear, consistent communications are essential to fighting an infectious disease outbreak, and in interviews several said that statements from the C.D.C. and Dr. Redfield had fallen far short of that goal.

“What we need from the C.D.C. is clear, specific, directive guidance,” said Dr. Leana Wen, a former health commissioner of Baltimore. “It shouldn’t be a Rorschach blot that we’re looking at, and everybody’s getting a different response by looking at the same guidance.”

Dr. Wen said she was concerned about the effect of the rule on insurance coverage for testing. Insurers have been chafing against the mandate to pay for all tests without requiring a co-payment from patients. Gregg Gonsalves, an assistant professor of epidemiology at the Yale School of Medicine, said the new guidance suggested the administration was “not going to support asymptomatic testing with new money or allow Medicaid to pay for it.”

“I don’t think the C.D.C.’s decision forbids states from covering tests beyond the C.D.C.’s authorization, but it might give states cover to save money by making cutbacks,” said Stan Dorn, a senior fellow at Families USA, a nonpartisan health consumer advocacy group.

One person close to the C.D.C. and the White House said the new guidelines were put in place in part to make them comport with testing for other infectious diseases, like Zika, and in part because of a sense among administration scientists — as well as doctors and insurers — that “too many people were getting tested out of fear and emotion.”

The flap came as the Trump administration announced the purchase and production of 150 million rapid tests to be distributed across the country. White House officials said the administration had teamed with Abbott Laboratories to produce inexpensive and easy-to-use BinaxNOW tests.

In the new testing guidelines, posted on Monday, the C.D.C. said close contacts of Covid-19 patients “do not necessarily need a test” unless they are vulnerable or their doctor or a state or local public heath official recommended it.

In an interview on Wednesday, Dr. Anthony S. Fauci, a member of the task force and the government’s top infectious disease expert, said he was concerned that the guidelines could be misinterpreted. Dr. Fauci had signed off on an early version of the rule but was undergoing surgery for removal of a polyp on his vocal cord when it was completed last Thursday…

In the statement, Dr. Redfield said the agency was “placing an emphasis on testing individuals with symptomatic illness, individuals with a significant exposure, vulnerable populations including nursing homes or long-term care facilities, critical infrastructure workers, health care workers and first responders, or those individuals who may be asymptomatic when prioritized by medical and public health officials.”

Dr. Redfield also said that anyone — even people who tested negative — exposed to someone who is or may be infected should “strictly adhere” to public health guidelines, like social distancing, wearing a mask, avoiding crowded indoor spaces and frequently washing their hands.” (J)

“Six months into the pandemic, testing remains a major obstacle in America’s efforts to stop the coronavirus. Some of the supply shortages that caused problems earlier have eased, but even after improvements, test results in some cases are still not being returned within a day or two, hindering efforts to quickly isolate patients and trace their contacts. Now, the number of tests being given has slowed just as the nation braces for the possibility of another surge as schools reopen and cooler weather drives people indoors.

“We’re clearly not doing enough,” said Dr. Mark McClellan, the director of the Duke-Margolis Center for Health Policy and the commissioner of the Food and Drug Administration under former President George W. Bush.

The downward trend may turn out to be only a short-term setback: The nation reported more than 800,000 tests on Thursday and Friday. There are also limitations to the data, which is largely drawn from state health departments, some of which have recently struggled with backlogs and other issues. It may not include tests done in labs not certified by the federal government.

But according to the figures available, tests were declining in 20 states this week, and data collected by the Department of Health and Human Services showed a similar overall trend nationally.

Without a vaccine or a highly successful treatment, widespread testing is seen as a cornerstone for fighting a pandemic in which as many as 40 percent of infected people do not show symptoms and may unknowingly spread the virus. Testing a lot of people is crucial to seeing where the virus is going and identifying hot spots before they get out of hand. Experts see extensive testing as a key part of safely reopening schools, businesses and sports.

The nation’s testing capacity has expanded from where it was only a few months ago, but public health experts believe it must grow far more to bring the virus under control.

The Harvard Global Health Institute has suggested the country needs at least 1 million tests per day to slow the spread of the virus, and as many as 4 million per day to get ahead of the virus and stop new cases. Some experts view that goal as too ambitious, and others say the benchmark should focus not on a particular number of tests but on the percent of people testing positive.

Yet there is broad consensus that the current level of testing is inadequate and that any decrease in testing is a worrisome move in the wrong direction.

“There is a reasonable disagreement about what that number ought to be, but all of them are way ahead of where we are right now,” said Dr. Ashish Jha, director of the Harvard Global Health Institute. “There is no expert that I know of that thinks that our testing infrastructure right now meets the needs of the American people.”

Adm. Brett P. Giroir, the assistant secretary for health and the Trump administration’s virus testing czar, said that conducting millions of tests per day was not realistic. The administration has asked states to test at least 2 percent of their populations each month, or the equivalent of about 220,000 people per day nationally, which Admiral Giroir said would be enough to identify rising hot spots.

“We are doing the appropriate amount of testing now to reduce the spread, flatten the curve, save lives,” he told reporters on Thursday…”  (K)

“On March 15, as the novel coronavirus was beginning to surge in the United States, Dr. Anthony S. Fauci accomplished a rare Washington feat: He appeared on all five major Sunday talk shows.

But the White House worried that Dr. Fauci might upstage (and sometimes contradict) President Trump, and soon his media handlers were no longer approving his high-profile interview requests.

So Dr. Fauci found another way to get his message out: He said yes to pretty much every small offer that came his way: academic webinars, Instagram feeds and niche science podcasts, as well as a few celebrity interviews…

Whether by design or not, Dr. Fauci has effectively circumvented efforts by the White House to mute him. Since Mark Meadows took over as chief of staff on March 31, White House communications officials have approved very few requests from major outlets. But there is no such review process for smaller ones, like the weekly podcast of the Journal of the American Medical Association, or the KC O’Dea radio show.

In recent weeks, Dr. Fauci has been joining as many as five such shows a day. On Aug. 13, he appeared on Mr. O’Dea’s show, which serves the Raleigh-Durham, N.C., market; a podcast affiliated with the Walter Reed National Military Medical Center; “The Pat McCrory Show with Bo Thompson”; a National Geographic special on pandemics; and a local Fox affiliate in High Point, N.C. He also appeared on “NewsHour,” the PBS evening news show.

His appearances are widely watched by reporters from larger outlets, who then quote him in their news reports….

Journalists with major news broadcasts are frustrated they can’t book Dr. Fauci during a public health emergency. Margaret Brennan, the host of CBS’s “Face the Nation,” told her audience in July that the White House had not approved any interviews with Dr. Fauci since March, inhibiting public understanding of the pandemic. “We will continue our efforts,” she said. Mary Hager, the executive producer of the show, said they asked for Dr. Fauci and other government scientists every week.

“We have this genius and this gold mine of a guest,” she said. “And we can’t use him to his absolute maximum capacity at a time when people are dying.””  (L)

“If you were world-renowned in your field, contributed decades to improving public health, were given commendations by multiple presidents and medical organizations for your work, led the country through major pandemics, would you want to stay in a role where you were suddenly constantly criticized and undermined by your current administrator and were receiving death threats?

Anthony Fauci MD, Director of the National Institute of Allergy and Infectious Diseases is in that position. The Trump administration has continually tried to silence or discredit Fauci…

Fauci has a stellar reputation both academically and in the federal government. As per Trump’s administration, if you have scientific evidence that disagrees with the administration’s stance, you are punished. Trump’s administration had talking points for reporters that refuted Fauci’s statements and his credibility. An op-ed was written by a high-ranking Trump administration official with the purpose of making the public question Fauci. Fauci has been omitted from Trump’s Covid-19 briefings…

If more government officials don’t speak out in support of Fauci and condemns the Trump administration’s undermining of his work and silence about threats made against Fauci, the US is at risk of losing one of the country’s foremost experts on pandemics. This means that the public is losing a well-regarded voice of reason and factual, science-based information.

While Fauci has not directly stated that he is considering leaving his position, it would be understandable that the stress from threats, constant undermining and disrespect would make anyone reconsider staying at their position.” (M)

“The United States signed a $750 million deal with Abbott Laboratories for 150 million rapid coronavirus tests, the White House announced Thursday.

“By strategically distributing 150 million of these tests to where they’re needed most, we can track the virus like never before and protect millions of Americans at risk in especially vulnerable situations,” Department of Health and Human Services Secretary Alex Azar said in a statement.

On Wednesday, the Federal Drug Administration granted the company emergency authorization for its new COVID-19 test.

The test called BinaxNow can deliver results in 15 minutes without using lab equipment and would cost $5.” (N)

• A.The Story of Everybody, Somebody, Anybody, Nobody, by Adal Bisharat, https://www.linkedin.com/pulse/20140929051422-22397928-the-story-of-everybody-somebody-anybody-nobody/
• B.The RNC keeps referring to Covid-19 in the past tense. 1,147 American deaths were reported Tuesday., By Aaron Rupar, https://www.vox.com/2020/8/26/21402124/rnc-coronavirus-past-tense-larry-kudlow
• C.’Everybody Is Going to Catch This Thing Eventually’: Senior Trump Official Brushes Off Criticism of Maskless Crowd at RNC, b yLisa Newcomb, https://www.commondreams.org/news/2020/08/28/everybody-going-catch-thing-eventually-senior-trump-official-brushes-criticism
• D.C.D.C. Now Says People Without Covid-19 Symptoms Do Not Need Testing, By Katherine J. Wu, https://www.nytimes.com/2020/08/25/health/covid-19-testing-cdc.html?referringSource=articleShare
• E.Updated CDC guidelines now say people exposed to coronavirus may not need to be tested, By Jamie Gumbrecht, Maggie Fox and Michael Nedelman, https://www.cnn.com/2020/08/26/health/cdc-guidelines-coronavirus-testing/index.html
• F.Fauci says he was in surgery when task force discussed CDC testing guidelines, By Jeremy Diamond, Kristen Holmes and Dr. Sanjay Gupta, https://www.cnn.com/2020/08/26/politics/fauci-coronavirus-cdc-testing/index.html
• G.Top U.S. Officials Told C.D.C. to Soften Coronavirus Testing Guidelines, By Sheryl Gay Stolberg, https://www.nytimes.com/2020/08/26/us/politics/coronavirus-testing-trump-cdc.html?referringSource=articleShare
• H.9 leaders, medical associations react to CDC’s new testing guidelines, Mackenzie Bean and Gabrielle Masson, https://www.beckershospitalreview.com/public-health/7-leaders-react-to-cdc-s-new-testing-guidelines.html
• I.‘We are incredibly concerned’: Local health departments urge the C.D.C. to pull its new guidance on testing., https://www.nytimes.com/2020/08/28/world/covid-19-coronavirus.html?action=click&module=Top%20Stories&pgtype=Homepage
• J.C.D.C.’s ‘Clarification’ on Coronavirus Testing Offers More Confusion, By Sheryl Gay Stolberg, https://www.nytimes.com/2020/08/27/us/politics/trump-coronavirus-testing.html?referringSource=articleShare
• K.‘We’re Clearly Not Doing Enough’: Drop in Testing Hampers Coronavirus Response, By Sarah Mervosh, Nicholas Bogel-Burroughs and Sheryl Gay Stolberg, https://www.nytimes.com/2020/08/15/us/coronavirus-testing-decrease.html?referringSource=articleShare
• L.How Dr. Fauci Found Himself Talking to Julia Roberts, Lil Wayne and Just About Any Podcaster Who Asked, By Quoctrung Bui, Margot Sanger-Katz, Sheryl Gay Stolberg, Noah Weiland and Kitty Bennett, https://www.nytimes.com/interactive/2020/08/27/upshot/fauci-media-appearances.html
• M.The US Is At Risk Of Losing Dr. Fauci’s Guidance, by Stephanie Sarkis, https://www.forbes.com/sites/stephaniesarkis/2020/08/27/the-us-is-at-risk-of-losing-dr-faucis-guidance/#34be4c0926e5
• N.White House signs $750 million deal with Abbott Labs to buy 150 million rapid coronavirus tests, by Sarah Al-Arshani, https://www.msn.com/en-us/health/medical/white-house-signs-dollar750-million-deal-with-abbott-labs-to-buy-150-million-rapid-coronavirus-tests/ar-BB18rHFK?ocid=uxbndlbing

CORONOVIRUS TRACKING

Links to Parts 1-44

Doctor, Did You Wash Your Hands?®

Curated Contemporaneous Case Study Methodology

Jonathan M. Metsch, Dr.P.H.

PART 1. January 21, 2020. CORONAVIRUS. “The Centers for Disease Control and Prevention on Tuesday confirmed the first U.S. case of a deadly new coronavirus that has killed six people in China.”

PART 2. January 29, 2020. CORONAVIRUS. “If it’s not contained shortly, I think we are looking at a pandemic..”….. “With isolated cases of the dangerous new coronavirus cropping up in a number of states, public health officials say it is only a matter of time before the virus appears in New York City.”

PART3. February 3, 2020. “The Wuhan coronavirus spreading from China is now likely to become a pandemic that circles the globe…”..Trump appeared to downplay concerns about the flu-like virus …We’re gonna see what happens, but we did shut it down..” (D)

PART 4. February 9, 2020. Coronavirus. “A study published Friday in JAMA found that 41% of the first 138 patients diagnosed at one hospital in Wuhan, China, were presumed to be infected in that hospital.….

PART 5. February 12, 2020. CORONAVIRUS. “In short, shoe-leather public health and basic medical care—not miracle drugs—are generally what stop outbreaks of emerging infections..”

POST 6. February 18, 2020.  Coronovirus. “Amid assurances that the (ocean liner) Westerdam was disease free, hundreds of people disembarked in Cambodia…” “ One was later found to be infected”…. “Over 1,000… passengers were in…transit home”…. “This could be a turning point””

PART 7. February 20, 2020. CORONAVIRUS. With SARS preparedness underway in NJ LibertyHealth/ Jersey City Medical Center, where I was President, proposed that our 100 bed community hospital with all single-bedded rooms, be immediately transformed into an EMERGENCY SARS ISOLATION Hospital.

PART 8. February 24, 2020. CORONAVIRUS. “…every country’s top priority should be to protect its health care workers. This is partly to ensure that hospitals themselves do not become sites where the coronavirus is spread more than it is contained.”

PART 9. February 27, 2020. CORONAVIRUS. Responding to a question about the likelihood of a U.S. outbreak, President Trump said, “I don’t think it’s inevitable…”It probably will. It possibly will,” he continued. “It could be at a very small level, or it could be at a larger level.”

Part 10. March 1, 2020. CORONAVIRUS. Stop Surprise Medical Bills for Coronavirus care. (&) Lessons Learned (or not) In California and Washington State from community acquired cases.

PART 11. March 5, 2020.  CORONAVIRUS. “Gov. Andrew Cuomo… would require employers to pay workers and protect their jobs if they are quarantined because of the coronavirus.”

Part 12. March 10, 2020. CORONAVIRUS. “Tom Bossert, Donald Trump’s former homeland security advisor…(said) that due to the coronavirus outbreak, “We are 10 days from the hospitals getting creamed.”

Part 13.. March 14, 2020. CORONAVIRUS. “If I’m buying real estate in New York, I’ll listen to the President….If I’m asking about infectious diseases, I’m going to listen to Tony Fauci,”

PART 14. March 17, 2020. CORONAVIRUS. “ “Most physicians have never seen this level of angst and anxiety in their careers”…. One said “I am sort of a pariah in my family.”

PART 15. March 22, 2020. CORONAVIRUS. “…Crimson Contagion” and imagining an influenza pandemic, was simulated by the Trump administration….in a series of exercises that ran from last January to August.

PART 16. March 27, 2020. CORONAVIRUS. I am not a clinician or a medical ethicist but articles on Coronavirus patient triage started me Googling………to learn about FUTILE TREATMENT

PART 17. April 2, 2020. CORONAVIRUS. Florida allows churches to continue holding services. Gun stores deemed “essential.”  “New York’s private and public hospitals unite to manage patient load and share resources.

PART 18. April 9, 2020. CORONAVIRUS. “The federal government’s emergency stockpile of personal protective equipment (PPE) is depleted, and states will not be receiving any more shipments, administration staff told a House panel.

PART 19. April 13, 2020 CORONOAVIRUS. “…overlooked in the United States’ halting mobilization against the novel coronavirus: the personal aides, hospice attendants, nurses and occupational or physical therapists who deliver medical or support services to patients in their homes.”

PART 20. April 20, 2020. CORONAVIRUS. “…nothing is mentioned in the “Opening Up America Again” plan about how states should handle a resurgence.”

PART 21. April 23, 2020. CORONAVIRUS. “We need to ask, are we using ventilators in a way that makes sense for other diseases but not this one?”

POST 22. April 29, 2020. CORONAVIRUS. ..the “ACS released a list of 10 issues that should be addressed before a healthcare organization resumes elective surgeries[JM1] ….”

POST 23. May 3, 2020. CORONAVIRUS. … what Dr. Fauci really wants,…”is just to go to a baseball game. That will have to wait. The level of testing for the virus is not adequate enough to allow for such mass gatherings.’ (K)

POST 24. May 7, 2020. CORONAVIRUS. Former New Jersey governor Chris Christie said: “there are going to be deaths no matter what”… but that people needed to get back to work.

POST 25. May 10, 2020, CORONAVIRUS. “It is scary to go to work,” said Kevin Hassett, a top economic adviser to the president. “I think that I’d be a lot safer if I was sitting at home than I would be going to the West Wing.”

POST 26. May 14, 2020. CORONAVIRUS, “Deep cleaning is not a scientific concept”….”there is no universal protocol for a “deep clean” to eradicate the coronavirus”

POST 27. May 19, 2020. CORONAVIRUS. “Hospital…executives…are taking pay cuts…to help offset the financial fallout from COVID-19.” As “front line” layoffs and furloughs accelerate…

POST 28. May 23, 2020. CORONAVIRUS. ““You’ve got to be kidding me,”..”How could the CDC make that mistake? This is a mess.” CDC conflates viral and antibody tests numbers.

PART 29. May 22, 2020. CORONAVIRUS. “The economy did not close down. It closed down for people who, frankly, had the luxury of staying home,” (Governor Cuomo). But not so for frontline workers!

POST 30. June 3,202. CORONAVIRUS. “The wave of mass protests across the United States will almost certainly set off new chains of infection for the novel coronavirus, experts say….

POST 31. June 9, 2020. CORONAVIRUS. “I think we had an unintended consequence: I think we made people afraid to come back to the hospital,”

Post 32. June 16, 2020. CORONAVIRUS. Could the Trump administration be pursuing herd immunity by “inaction”?  “ If Fauci didn’t exist, we’d have to invent him.”

POST 33. June 21, 2002. CORONAVIRUS….. Smashing (lowering the daily number of cases) v. flattening the curve (maintaining a plateau)

POST 34. June 26, 2020. CORONAVIRUS. CDC Director Redfield… “the number of coronavirus infections…could be 10 times higher than the confirmed case count — a total of more than 20 million.” As Florida, Texas and Arizona become eipicenters!

POST 35. June 29, 2020. CORONAVIRUS. Pence: “We slowed the spread. We flattened the curve. We saved lives..”  While Dr. Fauci “warned that outbreaks in the South and West could engulf the country…”

POST 36. July 2, 2020. CORONAVIRUS. “There’s just a handful of interventions proven to curb the spread of the coronavirus. One of them is contact tracing, and “it’s not going well,” (Dr. Anthony Fauci)..

POST 37. June 8, 2020. CORONAVIRUS. When “crews arrive at a hospital with a patient suspected of having COVID-19, the hospital may have a physical bed open for them, but not enough nurses or doctors to staff it.”

POST 38. July 15, 2020. CORONAVIRUS. Some Lessons Learned, or not. AdventHealth CEO Terry Shaw: I wouldn’t hesitate to go to Disney as a healthcare CEO — based on the fact that they’re working extremely hard to keep people safe,” (M)

POST 39. July, 23,2020. CORONAVIRUS. A Tale of Two Cities. Seattle becomes New York (rolls back reopening) while New York becomes Seattle (moves to partial phase 4 reopening)

POST 40. July 27, 2020. CORONAVIRUS.” One canon of medical practice is that you order a test only if you can act on the result. And with a turnaround time of a week or two, you cannot. What we have now is often not testing — it’s testing theater.”

POST 41. August 2, 2020. CORONAVIRUS. “Whenever a vaccine for the coronavirus becomes available, one thing is virtually certain: There won’t be enough to go around. That means there will be rationing.”

POST 42. August 11, 2020. CORONAVIRUS. “I think that if future historians look back on this period, what they will see is a tragedy of denial….

POST 43. August 22, 2020. CORONAVIRUS.”  “we’ve achieved something great as a nation. We’ve created an unyielding market for FAUCI BOBBLEHEADS”!! (W)

POST 44.  September 1, 2020. CORONAVIRUS. “The CDC…modified its coronavirus testing guidelines…to exclude people who do not have symptoms of Covid-19.” (While Dr. Fauci was undergoing surgery.) A White House official said: “Everybody is going to catch this thing eventually..”

August 31, 2020

 [JM1]

to read all POSTS in chronological order, highlight and click on

I used to teach a case study course on COMPLEX PROBLEMS: situations where the decision-maker must integrate or reconcile at least two competing priorities that may not be linear or complementary; having to reach agreement on goals while simultaneously evaluating options; where goals are clear but political support is not; where the definition of the problem keeps changing and consensus has to constantly be reestablished; where there are so many variables it is difficult to determine the actual possible outcomes; and, various combinations/ permutations of the above.

So here is a late-summer discombobulated collage of the COMPLEX PROBLEM OF CORONAVIRUS: successes; failures; conundrums; oxymorons; contradictions; unknown unknowns; and kerfuffles.

______________

“Looking back to the early days of the coronavirus pandemic, the White House coronavirus task force coordinator said Monday she wished the United States had gone into a stricter lockdown.

“I wish that when we went into lockdown (in March), we looked like Italy,” Dr. Deborah Birx said Monday. “When Italy locked down, I mean, people weren’t allowed out of their houses (without a pass). Americans don’t react well to that kind of prohibition.”…

Gov. Asa Hutchinson, Birx said she has learned what Americans are willing to do to combat the virus, and that officials must meet people where they are.

Birx cited the strategy Arizona has used to reduce the rising number of cases. People were still able to go to malls and restaurants at reduced capacity, but gyms and bars were closed, mask mandates were implemented, and gatherings of more than 10 people were prohibited…

“Tens of thousands of lives can be saved if we wear masks, and we don’t have parties in our backyards … taking those masks off,” Birx said.

Jared Kushner, a White House senior adviser, disagreed, saying President Donald Trump was “very forward-leaning” when he and the task force issued 15-day guidelines in mid-March.

“This was done at the time to make sure that we had enough hospital capacity and supplies, so that we didn’t end up like Italy, where there were people dying on gurneys in waiting rooms,” Kushner told CNN’s Wolf Blitzer.

He complimented the President on the administration’s response to a ventilator shortage, repeating the White House line that no American who needed a ventilator didn’t get one.

“So, I think we have done much better than Italy with regards to how we handled this initially,” he said.” (A)

“White House coronavirus advisor Dr. Anthony Fauci said the U.S. is currently “in the middle of a very serious historic pandemic,” adding that he has concerns about some regions seeing upticks of coronavirus….

Fauci said he is “not pleased with how things are going.” “We certainly are not where I hope we would be, we are in the middle of very serious historic pandemic,” he added. “When you look at other parts of the country – this is the thing that’s disturbing to me – is that we’re starting to see the inkling of the upticks in the percent of the tests that are positive. We know now, from sad past experience, that that’s a predictor that you’re going to have more surges.” (B)

“Even as reality continues to intrude, President Trump has either largely dismissed or ignored his science and medical advisers. And the result is that the economy, the one thing he seems to care most about, and which he hoped would escort him to a second term, has been devastated.

As both history and data from today demonstrate, health and the economy are not antagonistic; they are dance partners, with public health taking the lead. The safer people feel, the more they will engage in economic activity…

Indeed, a Morgan Stanley model predicts that under current policies the U.S. is currently on track to have 150,000 new cases a day later this year. And that number is not even a worst case. If we do suffer case counts anything like those, dramatic growth in the economy simply won’t happen.

Bad as the virus has been this summer, it actually spreads better in low temperatures, and when temperatures fall, more people will be inside in poorly ventilated areas where transmission is also more likely. If the U.S. goes into the fall with new daily cases in the tens of thousands, as they are now, then the numbers could explode and the Morgan Stanley prediction could come true. Considering our containment efforts to date, there is little reason for optimism.

If that occurs, the economy will not come back. Jerome Powell, the chairman of the Federal Reserve, said as much recently. “The path forward for the economy is extraordinarily uncertain and will depend in large part on our success in keeping the virus in check,” he said at a July 29 news conference. He added: “A full recovery is unlikely until people are confident that it is safe to re-engage in a broad range of activities.”..

Bringing the economy back requires precisely the same three measures that controlling the virus does: First, better compliance with social distancing, wearing masks, personal hygiene and avoiding crowds; second, finally — finally — getting the supply chain and personnel infrastructure in place to support the necessary testing and contact tracing; and, third, the bitter medicine of regional shutdowns…

Without active, aggressive White House leadership we cannot achieve that and — reality again — there isn’t the slightest hint that will happen. But in 1918 leadership came from cities and states. If governors and mayors act aggressively, especially if they act jointly, we can still make significant progress.” (C)

__________________

“If you’re heading to a gym lately, you might be asked to wash your hands, have an infrared gun pointed at your head and wait for an army of workers to sanitize every surface before you touch a machine — all in the name of safety.

But how much of a difference do these kinds of measures make when it comes to coronavirus transmission?

The evidence is mixed, some experts say. And measures might not always be there for the reasons you think.

Take temperature checks, which are currently being performed at several Canadian airports. Some businesses, like the Apple Store, have also been checking customers before they enter.

“We know that this is not effective,” said Colin Furness, an infectious disease epidemiologist with the University of Toronto.

“I mean, really, just as a screening tool it’s not effective at all.”

Given that people can spread the virus before ever showing symptoms, he said, checking someone’s temperature is definitely not a guarantee that they’re healthy. Illnesses other than COVID-19 can raise a person’s temperature, too.

“And if you really want to get on that plane, you take a Tylenol and you’ll glide right past that temperature check,” Furness said.

Even the U.S. Food and Drug Administration notes that non-contact thermometers aren’t a very good screening tool.

“Even when the devices are used properly, temperature assessment may have limited impact on reducing the spread of COVID-19 infections,” the agency wrote on their website.

“Some studies suggest that temperature measurements alone may miss more than half of infected people.”…(D)

“Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said Thursday that temperature checks are unreliable for detecting coronavirus symptoms in people entering businesses and other establishments as infrared thermometers have been embraced as part of safety protocol for reopenings.

Fauci made the comments during a Facebook Live broadcast with Walter Reed Medical Center, and was referencing the popular infrared thermometers that take a person’s body temperature by aiming the device at their forehead.

“We have found at the [National Institutes of Health] that it is much, much better to just question people when they come in and save the time, because the temperatures are notoriously inaccurate many times,” Fauci said.

Hot summer weather also causes inaccurate readings, Fauci said, adding that his own readings have gone as high as 103 before entering a building’s air-conditioning.

Prior to Fauci’s comments, measures like temperature screenings—along with spraying disinfectant in public transportation, or walking through hand sanitizer showers—had been criticized as “safety theater,” meaning they are not proven to stem the spread of the virus…

“All in all, temperature screening may catch some cases of the Covid-19 coronavirus. But it could miss many others,” wrote public health expert Bruce Y. Lee for Forbes in July. “Thus, be skeptical whenever anyone tries to assure you that things are safe just because they are doing temperature and symptom screening.”” (L)

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“Health experts in New York City thought that coronavirus cases would be rising again by now. Their models predicted it. They were wrong.

New York State has managed not only to control its outbreak since the devastation of the early spring, but also to contain it for far longer than even top officials expected.

Now, as other places struggle to beat back a resurgence and cases climb in former success-story states like California and Rhode Island, New York’s leaders are consumed by the likelihood that, any day now, their numbers will begin rising.

The current levels of infection are so remarkable that they have surprised state and city officials: Around 1 percent of the roughly 30,000 tests each day in the city are positive for the virus. In Los Angeles, it’s 7 percent, while it’s 13 percent in Miami-Dade County and around 15 percent in Houston.

The virus is simply no longer as present in New York as it once was, epidemiologists and public health officials said.

“New York is like our South Korea now,” said Dr. Thomas Tsai of the Harvard Global Health Institute.

But nothing is static about the viral outbreak, experts cautioned. The question now is whether the state, where 32,000 people have died of the virus, can keep from being overwhelmed by another wave, as threats loom from arriving travelers, struggles with contact tracing and rising cases just over the Hudson River in New Jersey…

In more than a dozen interviews, epidemiologists, public health officials and infectious disease specialists said New York owed its current success in large part to how New Yorkers reacted to the viciousness with which the virus attacked the state in April.

State officials shut down schools and businesses, sacrificing jobs and weakening the economy to save lives. Adherence to mask wearing has been strong. Many vulnerable New Yorkers are still sheltering in their apartments. Others decamped to second homes.

And, critically, Gov. Andrew M. Cuomo and Mayor Bill de Blasio reopened cautiously, deciding in late June against allowing indoor dining and bars after seeing those activities connected to outbreaks in other states.

“People in New York have taken matters much more seriously than in other places,” said Dr. Howard Markel, a historian of epidemics at the University of Michigan. “And all they’re doing is reducing the risk. They’re not extinguishing the virus.”

Still a resurgence is all but inevitable, public health experts said…

And even at the currently low levels, the number of new virus cases in New York City — 386 reported positive on Tuesday out of 46,185 tested, according to state data — is still too great for its contact tracers to effectively determine where people are becoming infected, said Dr. Barbot. The new norms of behavior have to continue for the foreseeable future, she said.” (E)

“We’ve known from the beginning how the end will arrive. Eventually, the coronavirus will be unable to find enough susceptible hosts to survive, fading out wherever it briefly emerges.

To achieve so-called herd immunity — the point at which the virus can no longer spread widely because there are not enough vulnerable humans — scientists have suggested that perhaps 70 percent of a given population must be immune, through vaccination or because they survived the infection.

Now some researchers are wrestling with a hopeful possibility. In interviews with The New York Times, more than a dozen scientists said that the threshold is likely to be much lower: just 50 percent, perhaps even less. If that’s true, then it may be possible to turn back the coronavirus more quickly than once thought.

The new estimates result from complicated statistical modeling of the pandemic, and the models have all taken divergent approaches, yielding inconsistent estimates. It is not certain that any community in the world has enough residents now immune to the virus to resist a second wave.

But in parts of New York, London and Mumbai, for example, it is not inconceivable that there is already substantial immunity to the coronavirus, scientists said.

“I’m quite prepared to believe that there are pockets in New York City and London which have substantial immunity,” said Bill Hanage, an epidemiologist at the Harvard T.H. Chan School of Public Health. “What happens this winter will reflect that.”

“The question of what it means for the population as a whole, however, is much more fraught,” he added.

Herd immunity is calculated from the epidemic’s so-called reproductive number, R0, an indicator of how many people each infected person spreads the virus to.

The initial calculations for the herd immunity threshold assumed that each community member had the same susceptibility to the virus and mixed randomly with everyone else in the community.

“That doesn’t happen in real life,” said Dr. Saad Omer, director of the Yale Institute for Global Health. “Herd immunity could vary from group to group, and subpopulation to subpopulation,” and even by postal codes, he said.

For example, a neighborhood of older people may have little contact with others but succumb to the virus quickly when they encounter it, whereas teenagers may bequeath the virus to dozens of contacts and yet stay healthy themselves. The virus moves slowly in suburban and rural areas, where people live far apart, but zips through cities and households thick with people.

Once such real-world variations in density and demographics are accounted for, the estimates for herd immunity fall. Some researchers even suggested the figure may be in the range of 10 to 20 percent, but they were in the minority…

“We are still nowhere near back to normal in our daily behavior,” said Virginia Pitzer, a mathematical epidemiologist at the Yale School of Public Health. “To think that we can just stop doing all that and go back to normal and not see a rise in cases I think is wrong, is incorrect.” “ (F)

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“Of all the ways to describe the fraught decision to reopen schools during a pandemic, Gov. Ron DeSantis of Florida, a former Navy prosecutor, chose an especially dramatic example when he compared the commitment of teachers and administrators to the resolve of Navy SEALs given the mission to go after Osama bin Laden.

“Just as the SEALs surmounted obstacles to bring Osama bin Laden to justice, so, too, would the Martin County school system find a way to provide parents with a meaningful choice of in-person instruction or continued distance learning — all in, all the time,” he said, citing the leader of a local school district.

He meant for the line to be inspirational. But perhaps unintentionally, Mr. DeSantis also highlighted an undeniable truth in Florida since students began returning to classrooms last week: There will be virus casualties.

In one of the states hardest hit by the coronavirus pandemic, 13 counties reopened their schools last week in accordance with a statewide order for all schools to offer in-person instruction by the end of the month. At least three districts soon reported positive coronavirus tests among students or teachers, and with the state expected to hit the 10,000-death mark this week, there is a move among some local school officials to try to delay reopenings — a pushback that has been met with threats of a loss in state funding and a reminder that the road back will not be an easy one.

“If you have a Covid case or you have symptoms, don’t panic,” the state education commissioner, Richard Corcoran, told Florida school superintendents last week. “We are going to have cases, and that’s OK.”..

Mr. DeSantis has spent weeks promoting school openings, holding events with administrators, teachers and parents who say they are eager to go back to the classroom. The benefits of opening outweigh the health risks in most of the state, Mr. DeSantis says, and it is up to each district to decide how its reopening will work in practice…

Gov. Ron DeSantis of Florida has likened reopening schools to a military operation, highlighting an undeniable truth: There will be virus casualties.” (G)

“The Los Angeles Unified School District on Sunday unveiled a plan to provide regular COVID-19 testing and contact tracing to school staff, students and their families.

The plan will begin Monday in a measured fashion, with the first test provided to staff already working at schools and their children. The program will then be expanded to provide testing to all staff and students over time, with a goal in the early phase to establish a baseline, the district said in a release.

The goal is to implement the program to help get students back into school for in-person instruction as the district is set to begin the school year with virtual learning.

“Extraordinary circumstances call for extraordinary actions, and while this testing and contact tracing effort is unprecedented, it is necessary and appropriate,” Superintendent Austin Beutner said in a statement. “This will provide a public health benefit to the school community, as well as the greater Los Angeles area.”

“This program will also provide significant education benefits for students by getting them back to school sooner and safer and keeping them there. We hope this effort also will provide learnings which can benefit other school systems and communities across the nation as we all combat this pandemic,” Beutner added.

The program is in collaboration with scientists from the University of California Los Angeles (UCLA), Stanford University, Johns Hopkins University, Microsoft and healthcare companies Anthem Blue Cross and Health Net.

Stanford, UCLA and Johns Hopkins will provide a strategic interpretation of the evidence on testing and epidemiological modeling services pro bono. Microsoft will provide an app that will allow school administrators and health officials to track insights into trends and potential risks to help manage COVID-19 exposures and cases.

Beutner did not identify the source of funding for the program. The plan to test all students and staff will cost roughly $300 per student over a year, close to $150 million, according to the Los Angeles Times. The district has received hundreds of millions of state and federal dollars for its coronavirus response efforts, the newspaper noted.

Last month the Los Angeles school district, along with San Diego, said they will start instruction in August virtually amid an outbreak of the virus across California.” (H)

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“HENDERSONVILLE, N.C. — The coronavirus entered Cherry Springs Village quietly, then struck with force. Nearly every staff member and resident of the long-term care facility would become infected.

They needed help — fast — and the county responded: It sent in a “strike team” of medical workers, emergency responders, clergy and others, in what is becoming a new model for combating Covid-19 in residential care centers.

Nurses and doctors from hours away came to aid sick residents and replace staff who had contracted the virus. They set up oxygen and IV drips, to avoid sending residents with milder illness to overburdened hospitals.

Members of the county’s emergency management department conducted rapid testing of all staff and residents. The Henderson County Rescue Squad, a volunteer paramedic group, erected decontamination tents outside for staff to safely remove protective gowns, masks and other equipment after shifts, and educated them on proper use and removal of the garments.

Chaplains and therapists came from a nearby hospice to provide emotional support to families and staff, who sometimes witnessed several residents die in one day. A public relations employee was dispatched to communicate with family members about ill loved ones and the situation inside.

Covid strike teams apply an emergency response model traditionally used in natural disasters like hurricanes and wildfires to combating outbreaks in long-term care facilities. Composed of about eight to 10 members from local emergency management departments, health departments, nonprofit organizations, private businesses — and at times, the National Guard — the teams are designed to bring more resources and personnel to a disaster scene.”  (I)

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“Without a vaccine or a highly successful treatment, widespread testing is seen as a cornerstone for fighting a pandemic in which as many as 40 percent of infected people do not show symptoms and may unknowingly spread the virus. Testing a lot of people is crucial to seeing where the virus is going and identifying hot spots before they get out of hand. Experts see extensive testing as a key part of safely reopening schools, businesses and sports.

The nation’s testing capacity has expanded from where it was only a few months ago, but public health experts believe it must grow far more to bring the virus under control.

The Harvard Global Health Institute has suggested the country needs at least 1 million tests per day to slow the spread of the virus, and as many as 4 million per day to get ahead of the virus and stop new cases. Some experts view that goal as too ambitious, and others say the benchmark should focus not on a particular number of tests but on the percent of people testing positive.

Yet there is broad consensus that the current level of testing is inadequate and that any decrease in testing is a worrisome move in the wrong direction.

“There is a reasonable disagreement about what that number ought to be, but all of them are way ahead of where we are right now,” said Dr. Ashish Jha, director of the Harvard Global Health Institute. “There is no expert that I know of that thinks that our testing infrastructure right now meets the needs of the American people.”

Adm. Brett P. Giroir, the assistant secretary for health and the Trump administration’s virus testing czar, said that conducting millions of tests per day was not realistic. The administration has asked states to test at least 2 percent of their populations each month, or the equivalent of about 220,000 people per day nationally, which Admiral Giroir said would be enough to identify rising hot spots.

“We are doing the appropriate amount of testing now to reduce the spread, flatten the curve, save lives,” he told reporters on Thursday.

He said the government was already testing large numbers of asymptomatic people, and he described an effort to strategically deploy tests, including to those who are hospitalized and in nursing homes. “You do not beat the virus by shotgun testing everyone all the time,” Admiral Giroir said, adding: “Don’t get hung up on a number.”

Admiral Giroir also cited a decline in known cases in states like Florida as an indication that testing is sufficient. But experts say the rate of people testing positive in places like Florida remains high, suggesting too little testing.” (J)

“Earlier this summer, Trump administration officials hailed a new strategy for catching coronavirus infections: pooled testing.

The decades-old approach combines samples from multiple people to save time and precious testing supplies. Federal health officials like Dr. Anthony S. Fauci and Adm. Brett Giroir said pooling would allow for constant surveillance of large sectors of the community, and said they hoped it would be up and running nationwide by the time students returned to school.

But now, when the nation desperately needs more tests to get a handle on the virus’s spread, this efficient approach has become worthless in many places, in part because there are simply too many cases to catch.

Pooled testing only works when the vast majority of batches test negative, among other drawbacks with the procedure. If the proportion of positives is too high, more pools come up positive — requiring each individual sample to then be retested, wasting precious chemicals.

Nebraska’s state public health laboratory, for example, was a pooling trailblazer when it began combining five samples a test in mid-March, cutting the number of necessary tests by about half.

But the lab was forced to halt its streak on April 27, when local positivity rates — the proportion of tests that turn up positive — surged past 10 percent. With that many positives, there was little benefit in pooling.

“It’s definitely frustrating,” said Dr. Baha Abdalhamid, the assistant director of the laboratory. In combination with physical distancing and mask wearing, pooling could have helped keep the virus in check, he added. But the pooling window, for now, has slammed shut.

Still, the strategy has made significant headway in some parts of the country. In New York, where test positivity rates have held at or below 1 percent since June, universities, hospitals, private companies and public health labs are using the technique in a variety of settings, often to catch people who aren’t feeling sick, said Gareth Rhodes, an aide to the governor and a member of his virus response team. Last week, the State University of New York was cleared to start combining up to 25 samples at once.” (K)

“Gov. Phil Murphy has vetoed a coronavirus bill that would have expanded testing in New Jersey, while also signing five into law. One new law gives student-athletes more leeway with physical testing amid the crisis.

Murphy vetoed a bill that would have allowed licensed pharmacists to order and administer COVID-19 tests authorized and approved by the federal Food and Drug Administration.

Under the bill (S2436), in order to administer the test, the pharmacy must ensure that personal protection equipment is distributed to all pharmacy staff and that proper social distancing protocols are observed…

Murphy also wants to make sure that administering a test includes “collecting or overseeing the collection of a specimen and causing the specimen to be sent to a laboratory with the capacity to perform the test.”  (M)

“Today, the U.S. Food and Drug Administration posted a new template for commercial developers to help them develop and submit emergency use authorization (EUA) requests for COVID-19 diagnostic tests that can be performed entirely at home or in other settings besides a lab, such as offices or schools, and that could be available without a prescription.

“The FDA continues to help facilitate innovation in test development, thereby enhancing Americans’ access to COVID-19 tests,” said FDA Commissioner Stephen M. Hahn, M.D. “The recommendations provided today are intended to help get tests to market that are simple enough to use at home, similar to a pregnancy test. We hope that with the innovation we’ve seen in test development, we could see tests that you could buy at a drug store, swab your nose or collect saliva, run the test, and receive results within minutes at home, once these tests become available. These types of tests will be a game changer in our fight against COVID-19 and will be crucial as the nation looks toward reopening.”” (N)

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Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and expert on infectious diseases for four decades, delivered some blunt messages to the American public during an online video interview with actor Matthew McConaughey. In an election year, the doctor asked the American people NOT to politicize the coroanvirus pandemic.

In response to a question about the politicization of the virus, he compared the pandemic to other challenging times in U.S. history. “Our country has been through very, very difficult situations. We’ve been through a Depression, we’ve been through a World War. We pulled together through 9/11.” But, he added, if you are not taking precautions, “You are part of the problem rather than the solution.”…

In the absence of a vaccine, Fauci told McConaughey that social distancing, regular hand washing and face masks are the only alternatives as “herd immunity” — where those who are immune protect the most vulnerable in the population — is not feasible for coronavirus. That requires a very high level of population immunity for COVID-19, and for the virus to not mutate.

Island nations and Asian countries, such as New Zealand, Singapore and South Korea, managed to control coronavirus. These countries shut down decisively, avoiding the worst of the pandemic, and carried out more effective contact tracing to prevent community spread. Warmer island nations, he said, may have better weathered COVID-19 as people spend more time outside.

Fauci also said that aiming for 100% herd immunity, which Sweden attempted before reversing their policy, instead of maintaining safety procedures and waiting for a vaccine in early 2021, would have dire consequences. “If everyone contracted it, a lot of people are going to die,” he said. “You’re talking about a substantial portion of the population.”” (O)

“The director of the Centers for Disease Control and Prevention (CDC) is “hopeful” that the COVID-19 pandemic will be over by spring next year, as reports emerged that a top Food and Drug Administration (FDA) official threatened to resign if approval for a coronavirus vaccine was rushed…

“I’m hopeful that the steps we take to prevent COVID are going to prevent flu and other respiratory viruses, Redfield said. “People are going to realize this is the year to get flu vaccine and we’ll begin to see our nation get through this pandemic.”

“As we then—and I do anticipate it will happen—begin to deploy an efficacious and safe COVID vaccine, then hopefully when you and I talk next spring we’ll have this pandemic behind us.”

Redfield’s comments came as Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told Reuters he would resign if the Trump administration pressured the agency to approve a COVID vaccine before it has been proven to be safe and effective.” “(Y)

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“Joe Biden, the presumptive Democratic nominee for president, called for a nationwide mask mandate on Thursday, drawing a sharp contrast with President Donald Trump, who rarely wears a mask himself and opposes such mandates.

“Every single American should be wearing a mask when they’re outside for the next three months at a minimum,” Biden said at a press appearance in Wilmington, Delaware. “Every governor should mandate mandatory mask wearing. The estimates by the experts are that it will save over 40,000 lives in the next three months. Forty thousand lives, if people act responsibly.”

“It’s not about your rights. It’s about your responsibilities as an American,” said Biden, flipping the script on Republicans who argue that mandates infringe on an individual’s right not to wear one.” (R)

“President Donald Trump on Thursday rejected former Vice President Joe Biden’s call for a national mask mandate to combat the coronavirus, accusing the Democratic candidate for president of politicizing the outbreak and of shunning science in combating the pandemic.

“It’s a shameful situation for anybody to try and score political points while we’re working to save lives and defeat the pandemic,” Trump said during a White House press briefing…

However, Trump claimed that Biden “wants to shut down our economy and close our schools and grind society to a halt.” Trump, who has repeatedly said lockdowns intended to prevent the further spread of the virus would inflict more harm than good, told reporters that Biden is “in favor of locking all Americans in their basements for months on end.”  (S)

“President Donald Trump has found a new doctor for his coronavirus task force — and this time there’s no daylight between them.

Trump last week announced that Dr. Scott Atlas, a frequent guest on Fox News Channel, has joined the White House as a pandemic adviser. Atlas, the former chief of neuroradiology at Stanford University Medical Center and a fellow at Stanford’s conservative Hoover Institution, has no expertise in public health or infectious diseases.

But he has long been a critic of coronavirus lockdowns and has campaigned for kids to return to the classroom and for the return of college sports, just like Trump.

“Scott is a very famous man who’s also very highly respected,” Trump told reporters as he introduced the addition. “He has many great ideas and he thinks what we’ve done is really good.”

Atlas’ hiring comes amid ongoing tensions between the president and Drs. Anthony Fauci, the nation’s top infectious diseases expert, and Deborah Birx, the task force’s coordinator. While Birx remains closely involved in the administration’s pandemic response, both she and Fauci have publicly contradicted the rosy picture the president has painted of a virus that has now killed more than 167,000 people in the United States and infected millions nationwide.

Atlas, the sole doctor to share the stage at Trump’s pandemic briefings this past week, has long questioned polices that have been embraced by public health experts both in the U.S. and abroad. He has called it a “good thing” for younger, healthy people to be exposed to the virus, while falsely claiming children are at near “zero risk.”

In an April op-ed in The Hill newspaper, Atlas bemoaned that lockdowns may have prevented the development of “natural herd immunity.”

“In the absence of immunization, society needs circulation of the virus, assuming high-risk people can be isolated,” he wrote.

In television appearances, Atlas has called on the nation to “get a grip” and argued that “there’s nothing wrong” with having low-risk people get infected, as long as the vulnerable are protected.

“It doesn’t matter if younger, healthier people get infected. I don’t know how often that has to be said. They have nearly zero risk of a problem from this,” he said in one appearance. “When younger, healthier people get infected, that’s a good thing,” he went on to say, “because that’s exactly the way that population immunity develops.”

While younger people are certainly at far lower risk of developing serious complications from the virus, they can still spread it to others who may be more vulnerable, even when they have no symptoms. And while their chances of dying are slim, some do face severe complications, with one study finding that 35% of young adults had not returned to normal health two weeks to three weeks after testing positive.

But Atlas’ thinking closely aligns with Trump’s perspective on the virus, which he has played down since its earliest days. While Trump eventually supported the lockdowns that once helped slow the disease’s spread, he has since pressured states to reopen schools and businesses as he tries to revive a battered economy before the November election.” (T)

“Last week, just as the Food and Drug Administration was preparing to issue an emergency authorization for blood plasma as a Covid-19 treatment, a group of top federal health officials including Dr. Francis S. Collins and Dr. Anthony S. Fauci intervened, arguing that emerging data on the treatment was too weak, according to two senior administration officials.

The authorization is on hold for now as more data is reviewed, according to H. Clifford Lane, the clinical director at the National Institute of Allergy and Infectious Diseases. An emergency approval could still be issued in the near future, he said.

Donated by people who have survived the disease, antibody-rich plasma is considered safe. President Trump has hailed it as a “beautiful ingredient” in the veins of people who have survived Covid-19.

But clinical trials have not proved whether plasma can help people fighting the coronavirus.

Several top health officials — led by Dr. Collins, the director of the National Institutes of Health; Dr. Fauci, the government’s top infectious disease expert; and Dr. Lane — urged their colleagues last week to hold off, citing recent data from the country’s largest plasma study, run by the Mayo Clinic. They thought the study’s data to date was not strong enough to warrant an emergency approval.

“The three of us are pretty aligned on the importance of robust data through randomized control trials, and that a pandemic does not change that,” Dr. Lane said in an interview on Tuesday.

The drafted emergency authorization leaned on the history of plasma’s use in other disease outbreaks and on animal research and a spate of plasma studies, including the Mayo Clinic’s program, which has given infusions to more than 66,000 Covid-19 patients thanks to financing from the federal government…”  (U)

“Anthony Fauci, the top U.S. infectious disease specialist, said he’s preparing for extended talks with Scott Atlas, President Donald Trump’s newest pandemic adviser who’s been pushing for schools to reopen…

Fauci, a public health expert who has led the U.S. National Institute of Allergy and Infectious Diseases since 1984, said he’s already had brief discussions with Atlas. He hopes to “get a feel of where we are with regard to these issues, and do we differ and if so, how much,” he said Tuesday in a Twitter interview with Bloomberg QuickTake.

Meeting with Atlas will provide an opportunity for the two to exchange views directly, said Fauci, who said he would keep an open mind on the issues.

“I’ve always been of the bent to go right to the source and have an open, honest conversation,” he said. “Hopefully we can come to some sort of agreement, if you want to call it that.”” (V)

“Dr. Scott Atlas, President Trump’s newest coronavirus adviser, is pressing the case for ensuring that schools are open.

“There’s nothing more important than educating our children. In fact, we are the only nation of the Western European and our peer nations … that are somehow sacrificing our children out of our own fear,” Atlas told the Washington Examiner.” (Z)

“Michael Caputo, HHS assistant secretary, told Texas-based News West 9 that the hospital COVID-19 data reporting system will not be transitioning back to the CDC, despite statements made by White House coronavirus official Deborah Birx, MD, earlier this week….

However, Mr. Caputo refuted the change and said the data collection process will stay with HHS after all. An HHS spokesperson clarified that the “interim system” Dr. Birx referred to in her statement was the manual data collection process and that the CDC is working on an automated process that will send the data to the HHS data platform, HHS Protect.” (X)

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“We asked six experts — including scholars from Vanderbilt, Harvard, and Johns Hopkins University — to set an agenda for Biden and Harris’ first day in office, should they win. Here’s what they came up with.

1. Give the CDC its authority back

Almost every expert mentioned the same priority: restoring the authority of the Centers for Disease Control and Prevention, which is headquartered in Atlanta.

2. Institute daily press briefings

If elected, Biden has said, he intends to place one of his first calls to Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases. Multiple experts said a Biden-Harris administration should put Fauci in front of the public on day one.

3. Mandate universal mask-wearing

During their first public address under a Biden-Harris administration, Fauci and his fellow experts should issue a universal mask mandate, Schaffner said. Research clearly shows that face masks can prevent coronavirus transmission and save lives.

4. Ramp up testing

The US is already testing more people per capita than almost any other nation: around 204 daily tests for every 100,000 people. But it also represents a quarter of the world’s coronavirus cases — meaning its testing capacity is still relatively limited. The weekly average of daily tests is now 13% lower than it was at the end of July, according to data from The COVID Tracking Project.

5. Use the Defense Production Act

Experts also hope Biden will more fully utilize the Defense Production Act, which allows the president to require businesses to prioritize the federal government’s supply-chain needs. The law also restricts companies from hoarding or price gouging critical supplies.

6. Appoint Ron Klain as testing czar

One of Biden’s first priorities should be to appoint strong leaders, Gates said.

“There are lots of people who are involved in the global response to Ebola and smallpox and polio, who would love to help out the US bring this thing to a close,” he said.

7. Develop a federal dashboard with live data

In January, researchers at Johns Hopkins University developed a live dashboard to track coronavirus cases. For a while, the tool was one of the sole resources for measuring the scope of the US outbreak. It’s still one of the most prominent and widely used.

8. Convene scientific experts to come up with a new response plan

Finally, experts called for a new national strategy led by a panel of scientific experts.

“The key will be to rely on scientific understanding, not wishful thinking,” Dr. Joshua Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health, said…

“Our big challenge has been that we’ve pitted the economy against health,” Levine added. “That administration, if it were to be elected, needs to bring those two together.” (Q)

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“As some parts of America gingerly begin to open up after months of near total lockdown, people have questions. Will it be safe to take a train? A plane? Visit the hair salon? An indoor restaurant?

There are many knowable parameters in the equation: your health; the prevalence of cases where you live; the safety precautions being taken any place you want to visit. But the final answer may depend on your individual risk tolerance for exposure to infectious disease.

Most Americans alive today have never before had to make that self-assessment.

In the past, deadly outbreaks of plague, flu and polio were regular occurrences. Up until the mid to late 20th century there were mumps, measles and chickenpox to contend with.

In a world of effective antibiotics and antivirals and other treatments, deaths or even serious illnesses from infectious disease seem nearly incomprehensible. So our fear is enormous, and our risk tolerance for exposure is just about zero…

Covid-19 is a very serious disease. But it is not the Black Death, which killed up to half of Europe in the 14th century. A vaccine, when and if it arrives, will be a big help. But in the meantime, we have science. We know what causes Covid-19. We are learning more about how to detect, prevent and treat it every day.

So instead of taking your temperature and checking your pulse oximeter reading twice a day, it may be time to take stock of your risk tolerance. In those places where governments, businesses and administrators have set the stage properly, we can — with sensible precautions — begin to live again.” (P)

“Critics accuse Fauci of “mistakes.” They take one Fauci statement, often out of context, and then blast him when something happens to disprove that statement. The most repeated example of this is when Fauci, and others, advised the public against wearing masks in early 2020. There was a shortage of masks at that time, and healthcare workers might not have been able to get them. Statements made early on during a crisis need to be revised as we learn more, and this pandemic is unlike anything we have seen in our lifetimes.

But critics use such statements to undermine valued experts like Fauci. This makes it impossible for us to solve problems. If we don’t listen to the people who have the most education, training and knowledge, and if we place trust in people who are ignorant and refuse to learn, we ensure that our response to the crisis will continue to fail, as it has for this country.” (AA)

____________

“Former Vice President Joe Biden said in an exclusive interview with ABC “World News Tonight” Anchor David Muir on Friday that as president, he would shut the country down to stop the spread of COVID-19 if the move was recommended to him by scientists.

“I would shut it down; I would listen to the scientists,” Biden told Muir Friday, alongside his running mate, Sen. Kamala Harris, D-Calif., during their first joint interview since officially becoming the Democratic Party’s presidential and vice presidential nominees.

Biden also criticized what he argued is the “fundamental flaw” of the Trump administration’s response to the coronavirus pandemic, that the nation cannot begin to recover economically until the virus and public health emergency is under control.

“I will be prepared to do whatever it takes to save lives because we cannot get the country moving, until we control the virus,” Biden said. “That is the fundamental flaw of this administration’s thinking to begin with. In order to keep the country running and moving and the economy growing, and people employed, you have to fix the virus, you have to deal with the virus.” (BB)

__________

“Well folks, we’ve done it. It took a lot of grit, activism, and cooperation, but we’ve achieved something great as a nation. We’ve created an unyielding market for Bobblehead Faucis.

We’re now almost half a year into the coronavirus pandemic and every other developed country in the world has been able to flatten the curve, some to the point where life looks almost like the Before Times. Idiots. The first rule of Bobblehead Fauci economics is to create an environment so politically and biologically toxic that the only solace people can find is in a $25 hunk of wobbling plastic molded after the septuagenarian tasked with leading a divided nation through a pandemic that disproportionately kills members of his own age group.

The market is so strong right now that the original Bobblehead Fauci is completely sold out, and the proceeds helped raise over $200,000 for frontline healthcare workers.”  (W)

• A.Birx says she wishes US started with lockdown like Italy, https://www.cnn.com/2020/08/17/health/us-coronavirus-monday/index.html
• B.Coronavirus update: Fauci ‘not pleased’; Chicken wings test positive for coronavirus, by Leada Gore, https://www.al.com/news/2020/08/coronavirus-update-fauci-not-pleased-chicken-wings-tests-positive-for-coronavirus.html
• C.A Warning for the United States From the Author of ‘The Great Influenza’, By John M. Barry, https://www.nytimes.com/2020/08/18/opinion/coronavirus-economy.html?referringSource=articleShare
• D.Temperature checks and ‘deep cleaning’ aren’t good at stopping coronavirus. So why do we bother?, By Leslie Young, https://globalnews.ca/news/7257464/coronavirus-prevention-ineffective/
• E.New York Has Tamed the Virus. Can It Hold Off a Second Wave?, By J. David Goodman, https://www.nytimes.com/2020/08/17/nyregion/coronavirus-second-wave-nyc.html?referringSource=articleShare
• F.What if ‘Herd Immunity’ Is Closer Than Scientists Thought?, By Apoorva Mandavilli, https://www.nytimes.com/2020/08/17/health/coronavirus-herd-immunity.html?referringSource=articleShare
• G.‘All In, All the Time’: Reopening Florida Schools Is Likened to Military Operation, By Patricia Mazzei and Manny Fernandez, https://www.nytimes.com/2020/08/19/us/coronavirus-schools-florida-local-control.html?referringSource=articleShare
• H.LA school district unveils coronavirus testing, contact tracing program for students, staff, BY REBECCA KLAR, https://thehill.com/homenews/state-watch/512296-la-school-district-unveils-coronavirus-testing-contact-tracing-program
• I.A Novel Way to Combat Covid-19 in Nursing Homes: Strike Teams, By Hannah Critchfield, https://www.nytimes.com/2020/08/18/health/Covid-nursing-homes.html?referringSource=articleShare
• J.‘We’re Clearly Not Doing Enough’: Drop in Testing Hampers Coronavirus Response, By Sarah Mervosh, Nicholas Bogel-Burroughs and Sheryl Gay Stolberg, https://www.nytimes.com/2020/08/15/us/coronavirus-testing-decrease.html?referringSource=articleShare
• K.Pooled testing has become worthless in areas of the U.S., in part because there are simply too many cases., https://www.nytimes.com/2020/08/18/world/coronavirus-covid.html?referringSource=articleShare
• L.Fauci Says Coronavirus Temperature Checks ‘Notoriously Inaccurate’, by Lisette Voytko, https://www.forbes.com/sites/lisettevoytko/2020/08/13/fauci-says-coronavirus-temperature-checks-notoriously-inaccurate/#1e8aaf1733f0
• M.Gov. Murphy Vetoes NJ Coronavirus Testing Bill, Signs 5 Into Law, By Tom Davis, https://patch.com/new-jersey/hoboken/s/h7l1t/gov-murphy-vetoes-nj-coronavirus-testing-bill-signs-5-into-law?utm_source=nearby-news&utm_medium=email&utm_campaign=alert
• N.Coronavirus (COVID-19) Update: FDA Posts New Template for At-Home and Over-the-Counter Diagnostic Tests for Use in Non-Lab Settings, Such as Homes, Offices or Schools, https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-posts-new-template-home-and-over-counter-diagnostic-tests-use-non
• O.Dr. Fauci: ‘We’ve been through a Depression, we’ve been through a World War. We pulled together through 9/11’, By Quentin Fottrell, https://www.marketwatch.com/story/dr-fauci-on-why-asian-countries-and-island-nations-are-better-controlling-covid-19-and-how-the-us-can-learn-from-them-2020-08-13
• P.You’ve Checked Your Temperature. Now, What’s Your Risk Tolerance?, By Elisabeth Rosenthal, https://www.nytimes.com/2020/08/19/opinion/coronavirus-risk-prevention.html?referringSource=articleShare
• Q.6 public-health experts offer a coronavirus agenda for Biden and Harris’ first day in office, should they win, by Aria Bendix, https://www.businessinsider.com/us-coronavirus-strategy-under-joe-biden-kamala-harris-2020-8
• R.Joe Biden calls for a nationwide mask mandate as he pushes his plan to combat coronavirus, by Christina Wilkie, https://www.cnbc.com/2020/08/13/joe-biden-calls-for-a-nationwide-mask-mandate-to-combat-coronavirus.html
• S.Trump calls Biden’s coronavirus plan unscientific, rejects call for national mask mandate, by Noah Higgins-Dunn, https://www.cnbc.com/2020/08/13/trump-calls-bidens-coronavirus-plan-unscientific-rejects-call-for-national-mask-mandate.html
• T.President Trump makes call for new White House doctor’s coronavirus advice, by Jill Colvin, https://www.clickorlando.com/news/politics/2020/08/16/trump-makes-call-for-new-white-house-doctors-virus-advice/
• U.F.D.A.’s Emergency Approval of Blood Plasma Is Now on Hold, By Noah Weiland, Sharon LaFraniere and Sheri Fink, https://www.nytimes.com/2020/08/19/us/politics/blood-plasma-covid-19.html?referringSource=articleShare
• V.Fauci Prepping to Talk Covid Strategy With Newest Trump Adviser, By John Lauerman and Madison Mills, https://www.bloomberg.com/news/articles/2020-08-18/fauci-prepping-to-talk-covid-strategy-with-newest-trump-adviser
• W.You Can Now Buy a Facepalming Dr. Fauci Bobblehead Because We’re Still F***ing It Up, BY JANE RECKER, https://www.washingtonian.com/2020/08/14/you-can-now-buy-a-facepalming-dr-fauci-bobblehead-because-were-still-fing-it-up/
• X.HHS says COVID-19 data reporting system won’t go back to CDC, Laura Dyrda, https://www.beckershospitalreview.com/data-analytics/hhs-says-covid-19-data-reporting-system-won-t-go-back-to-cdc.html
• Y.CDC Director ‘Hopeful’ Pandemic Will End by Spring, As FDA Official Says He’ll Quit if Vaccine Rushed, BY ARISTOS GEORGIOU, https://www.newsweek.com/cdc-director-hopeful-pandemic-will-end-spring-1526710
• Z.New Trump coronavirus adviser makes case for opening all schools, by Cassidy Morrison, https://www.washingtonexaminer.com/news/new-trump-coronavirus-adviser-makes-case-for-opening-all-schools
• AA.Marcia Meoli: Listen to Fauci and stop with the nonsense, By Marcia Meoli, https://www.hollandsentinel.com/opinion/20200821/marcia-meoli-listen-to-fauci-and-stop-with-nonsense
• BB.Biden to ABC’s David Muir: ‘I would shut [country] down’ to prevent spread of COVID-19 if scientists recommended, by John Verhovek, https://abcnews.go.com/Politics/biden-abcs-david-muir-shut-country-prevent-spread/story?id=72519690

CORONOVIRUS TRACKING

Links to Parts 1-43

Doctor, Did You Wash Your Hands?®

Curated Contemporaneous Case Study Methodology

Jonathan M. Metsch, Dr.P.H.

PART 1. January 21, 2020. CORONAVIRUS. “The Centers for Disease Control and Prevention on Tuesday confirmed the first U.S. case of a deadly new coronavirus that has killed six people in China.”

PART 2. January 29, 2020. CORONAVIRUS. “If it’s not contained shortly, I think we are looking at a pandemic..”….. “With isolated cases of the dangerous new coronavirus cropping up in a number of states, public health officials say it is only a matter of time before the virus appears in New York City.”

PART3. February 3, 2020. “The Wuhan coronavirus spreading from China is now likely to become a pandemic that circles the globe…”..Trump appeared to downplay concerns about the flu-like virus …We’re gonna see what happens, but we did shut it down..” (D)

PART 4. February 9, 2020. Coronavirus. “A study published Friday in JAMA found that 41% of the first 138 patients diagnosed at one hospital in Wuhan, China, were presumed to be infected in that hospital.….

PART 5. February 12, 2020. CORONAVIRUS. “In short, shoe-leather public health and basic medical care—not miracle drugs—are generally what stop outbreaks of emerging infections..”

POST 6. February 18, 2020.  Coronovirus. “Amid assurances that the (ocean liner) Westerdam was disease free, hundreds of people disembarked in Cambodia…” “ One was later found to be infected”…. “Over 1,000… passengers were in…transit home”…. “This could be a turning point””

PART 7. February 20, 2020. CORONAVIRUS. With SARS preparedness underway in NJ LibertyHealth/ Jersey City Medical Center, where I was President, proposed that our 100 bed community hospital with all single-bedded rooms, be immediately transformed into an EMERGENCY SARS ISOLATION Hospital.

PART 8. February 24, 2020. CORONAVIRUS. “…every country’s top priority should be to protect its health care workers. This is partly to ensure that hospitals themselves do not become sites where the coronavirus is spread more than it is contained.”

PART 9. February 27, 2020. CORONAVIRUS. Responding to a question about the likelihood of a U.S. outbreak, President Trump said, “I don’t think it’s inevitable…”It probably will. It possibly will,” he continued. “It could be at a very small level, or it could be at a larger level.”

Part 10. March 1, 2020. CORONAVIRUS. Stop Surprise Medical Bills for Coronavirus care. (&) Lessons Learned (or not) In California and Washington State from community acquired cases.

PART 11. March 5, 2020.  CORONAVIRUS. “Gov. Andrew Cuomo… would require employers to pay workers and protect their jobs if they are quarantined because of the coronavirus.”

Part 12. March 10, 2020. CORONAVIRUS. “Tom Bossert, Donald Trump’s former homeland security advisor…(said) that due to the coronavirus outbreak, “We are 10 days from the hospitals getting creamed.”

Part 13.. March 14, 2020. CORONAVIRUS. “If I’m buying real estate in New York, I’ll listen to the President….If I’m asking about infectious diseases, I’m going to listen to Tony Fauci,”

PART 14. March 17, 2020. CORONAVIRUS. “ “Most physicians have never seen this level of angst and anxiety in their careers”…. One said “I am sort of a pariah in my family.”

PART 15. March 22, 2020. CORONAVIRUS. “…Crimson Contagion” and imagining an influenza pandemic, was simulated by the Trump administration….in a series of exercises that ran from last January to August.

PART 16. March 27, 2020. CORONAVIRUS. I am not a clinician or a medical ethicist but articles on Coronavirus patient triage started me Googling………to learn about FUTILE TREATMENT

PART 17. April 2, 2020. CORONAVIRUS. Florida allows churches to continue holding services. Gun stores deemed “essential.”  “New York’s private and public hospitals unite to manage patient load and share resources.

PART 18. April 9, 2020. CORONAVIRUS. “The federal government’s emergency stockpile of personal protective equipment (PPE) is depleted, and states will not be receiving any more shipments, administration staff told a House panel.

PART 19. April 13, 2020 CORONOAVIRUS. “…overlooked in the United States’ halting mobilization against the novel coronavirus: the personal aides, hospice attendants, nurses and occupational or physical therapists who deliver medical or support services to patients in their homes.”

PART 20. April 20, 2020. CORONAVIRUS. “…nothing is mentioned in the “Opening Up America Again” plan about how states should handle a resurgence.”

PART 21. April 23, 2020. CORONAVIRUS. “We need to ask, are we using ventilators in a way that makes sense for other diseases but not this one?”

POST 22. April 29, 2020. CORONAVIRUS. ..the “ACS released a list of 10 issues that should be addressed before a healthcare organization resumes elective surgeries[JM1] ….”

POST 23. May 3, 2020. CORONAVIRUS. … what Dr. Fauci really wants,…”is just to go to a baseball game. That will have to wait. The level of testing for the virus is not adequate enough to allow for such mass gatherings.’ (K)

POST 24. May 7, 2020. CORONAVIRUS. Former New Jersey governor Chris Christie said: “there are going to be deaths no matter what”… but that people needed to get back to work.

POST 25. May 10, 2020, CORONAVIRUS. “It is scary to go to work,” said Kevin Hassett, a top economic adviser to the president. “I think that I’d be a lot safer if I was sitting at home than I would be going to the West Wing.”

POST 26. May 14, 2020. CORONAVIRUS, “Deep cleaning is not a scientific concept”….”there is no universal protocol for a “deep clean” to eradicate the coronavirus”

POST 27. May 19, 2020. CORONAVIRUS. “Hospital…executives…are taking pay cuts…to help offset the financial fallout from COVID-19.” As “front line” layoffs and furloughs accelerate…

POST 28. May 23, 2020. CORONAVIRUS. ““You’ve got to be kidding me,”..”How could the CDC make that mistake? This is a mess.” CDC conflates viral and antibody tests numbers.

PART 29. May 22, 2020. CORONAVIRUS. “The economy did not close down. It closed down for people who, frankly, had the luxury of staying home,” (Governor Cuomo). But not so for frontline workers!

POST 30. June 3,202. CORONAVIRUS. “The wave of mass protests across the United States will almost certainly set off new chains of infection for the novel coronavirus, experts say….

POST 31. June 9, 2020. CORONAVIRUS. “I think we had an unintended consequence: I think we made people afraid to come back to the hospital,”

Post 32. June 16, 2020. CORONAVIRUS. Could the Trump administration be pursuing herd immunity by “inaction”?  “ If Fauci didn’t exist, we’d have to invent him.”

POST 33. June 21, 2002. CORONAVIRUS….. Smashing (lowering the daily number of cases) v. flattening the curve (maintaining a plateau)

POST 34. June 26, 2020. CORONAVIRUS. CDC Director Redfield… “the number of coronavirus infections…could be 10 times higher than the confirmed case count — a total of more than 20 million.” As Florida, Texas and Arizona become eipicenters!

POST 35. June 29, 2020. CORONAVIRUS. Pence: “We slowed the spread. We flattened the curve. We saved lives..”  While Dr. Fauci “warned that outbreaks in the South and West could engulf the country…”

POST 36. July 2, 2020. CORONAVIRUS. “There’s just a handful of interventions proven to curb the spread of the coronavirus. One of them is contact tracing, and “it’s not going well,” (Dr. Anthony Fauci)..

POST 37. June 8, 2020. CORONAVIRUS. When “crews arrive at a hospital with a patient suspected of having COVID-19, the hospital may have a physical bed open for them, but not enough nurses or doctors to staff it.”

POST 38. July 15, 2020. CORONAVIRUS. Some Lessons Learned, or not. AdventHealth CEO Terry Shaw: I wouldn’t hesitate to go to Disney as a healthcare CEO — based on the fact that they’re working extremely hard to keep people safe,” (M)

POST 39. July, 23,2020. CORONAVIRUS. A Tale of Two Cities. Seattle becomes New York (rolls back reopening) while New York becomes Seattle (moves to partial phase 4 reopening)

POST 40. July 27, 2020. CORONAVIRUS.” One canon of medical practice is that you order a test only if you can act on the result. And with a turnaround time of a week or two, you cannot. What we have now is often not testing — it’s testing theater.”

POST 41. August 2, 2020. CORONAVIRUS. “Whenever a vaccine for the coronavirus becomes available, one thing is virtually certain: There won’t be enough to go around. That means there will be rationing.”

POST 42. August 11, 2020. CORONAVIRUS. “I think that if future historians look back on this period, what they will see is a tragedy of denial….

POST 43. August 22, 2020. CORONAVIRUS.”  “we’ve achieved something great as a nation. We’ve created an unyielding market for FAUCI BOBBLEHEADS”!! (W)

August 22, 2020

 [JM1]