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.’

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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