The Covid administration

Trump administration officials are starting to move towards coronavirus policies that are in line with a “herd immunity” strategy — a controversial approach that involves deliberately allowing the coronavirus to spread to build up population resistance more quickly while protecting the most vulnerable.

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Soumya Swaminathan, WHO’s chief scientist, said focusing on controlling transmission through public health measures while scientists develop vaccines should be the primary strategy. She pointed out that “there really hasn’t been any infectious disease that has been controlled just by allowing natural immunity to happen.”

The United Kingdom pursued such a strategy early on but abandoned it when officials saw the consequences. Sweden, which pursued a similar strategy, has been heavily criticized by public health officials and infectious-disease experts as reckless: The country has among the highest infection and death rates in the world.

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Depending on the virus, there is a certain percentage of population that needs to achieve immunity before herd immunity can be reached — called the “herd immunity threshold.”

For example, measles — an especially contagious disease — slows down only after about 95 percent of people become immune.

It remains unclear how large a portion of the population must become infected with the new coronavirus to reach that threshold.

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Such a strategy is also complicated in the United States by the fact that a larger portion of young and middle-aged people here have higher rates than elsewhere of obesity, heart and lung disease and other health issues that make them more likely to have serious or lethal cases of the disease.

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Conservative television host Laura Ingraham has tweeted that pursuing herd immunity was the “only practical way forward.”

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In theory, as the number of survivors with immunity increases to a certain level, the virus’s spread would slow and eventually stop. The only problem: A whole lot of people would die before that point.

  WaPo

They're counting on the fact that the virus disproportionately fells the poor, mostly people of color. So, they don't care.

With a population of 328 million in the United States, it may require more than 2 million deaths to reach a 65 percent threshold of herd immunity, assuming the virus has a 1 percent fatality rate, according to an analysis by The Washington Post. Even if both the herd immunity threshold and the fatality rate proved to be toward the lower end of current estimates — with 40 percent needing to be infected and a 0.5 percent fatality rate — the country could still expect 656,000 deaths to achieve herd immunity, nearly four times as many as the country has already suffered.

They'll just call it a plan and brag about their accomplishment.

President Trump’s accusatory tweet barreled in at 7:49 a.m. a week ago Saturday: The “deep state” at the Food and Drug Administration was trying to sandbag his election prospects by slowing progress on coronavirus treatments and vaccines until after Nov. 3.

Shocked and upset, FDA Commissioner Stephen Hahn, who was tagged in the tweet, immediately began calling his contacts at the White House to find out why the president was angry. During his conversations, he mentioned the FDA was on the verge of granting emergency authorization to convalescent plasma as a treatment for covid-19. The agency planned to issue a news release.

The White House would upend those plans, turning a preliminary finding of modest efficacy into something much bigger — a presidential announcement of a “major therapeutic breakthrough on the China Virus,” as White House press secretary Kayleigh McEnany previewed in a tweet late that Saturday night.

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For more than a century, doctors have used the plasma from patients who have recovered from infectious diseases to treat sick people; the theory is that antibodies in the plasma bolster the immune system’s war against the infection. The FDA, swamped by individual requests to use the approach on dying patients, shifted gears and approved plans by the Mayo Clinic to set up a nationwide program to give patients access to the therapy.

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The program was initially set up to treat 5,000 patients, but it grew to more than 75,000. Plasma donations can vary widely in the dose of antibodies they contain, so Mayo researchers began testing samples to see if the patients who had received higher doses of antibodies fared better than those who got lower doses. Such a finding wouldn’t prove it worked without a control group for comparison, but it would be suggestive.

By late July, Mayo researchers were finding that patients who received high-dose plasma were less likely to die than those who received low-dose plasma, if they received it early.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, which regulates blood products and was overseeing the authorization process, believed that convalescent plasma met the relatively low bar for an emergency authorization. He thought the evidence — which included several different analyses of the Mayo data, use of the plasma to treat other respiratory illnesses, animal studies and more than a dozen clinical reports — showed it was likely to provide a modest benefit for certain patients.

But the agency’s effort to authorize plasma got bogged down. [...] NIH Director Francis Collins was skeptical and immediately expressed his opposition to the emergency authorization, saying the evidence was too weak, according to two individuals familiar with the situation. Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, also was critical.

Hoping to bring NIH on board, the FDA delayed a decision on the authorization and asked Mayo for more data.

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The White House, meanwhile, was increasingly impatient about getting clearance for what Trump called “the beautiful ingredient.”

Aides including Adam Boehler, the chief executive of the U.S. International Development Finance Corporation and a close associate of Jared Kushner, the president’s son-in-law, repeatedly called the FDA to check its progress. Sometimes, the officials would call several times a day, according to an individual familiar with the situation.

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On Aug. 19, the New York Times reported the emergency authorization was on hold because of objections from top NIH officials. The FDA, furious about NIH’s public airing of concerns, issued a statement saying NIH did not dictate FDA decisions and vowed to press forward.

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As Trump was briefed on the disagreement between the FDA and NIH, he was increasingly annoyed, White House officials said. That helped prompt the Aug. 22 tweet, which turned a debate over clinical data into a politically charged drama.

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Even as the debate swirled, FDA officials made the decision to authorize plasma by Aug. 24. The Mayo program had become far larger than anyone expected and was becoming a burden for the medical center.

But while the FDA plan was to issue a news release, and perhaps brief reporters on a call, HHS and the White House saw a political opportunity.

“HHS is always looking for good news that the president can be involved in,” said an individual familiar with the situation. “By talking about plasma, it got him off the vaccine itch for a couple of minutes. It scratched that itch."

  WaPo

Ladies and gentlemen, this is your president.

At 9 p.m. on Aug. 22, the additional data that had been requested weeks before by NIH and FDA landed in the inboxes of FDA officials. In a mad dash, government statisticians tried to determine what it showed. But they found the data hard to interpret and full of errors.

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FDA officials had already decided they would not stop the authorization based on new information unless it showed a safety problem, which this did not. They are continuing to review it, confident it will confirm their view of a modest benefit. Hahn has publicly said the agency would reconsider its decision if new data shows the treatment is ineffective.

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At a news conference on the eve of the Republican National Convention, Trump lauded an emergency authorization for convalescent plasma as a “very historic breakthrough.” Hahn, who had rushed back to Washington from a family home in Colorado, was initially restrained but then doubled down on Trump’s talking points. He said that 35 of 100 people with covid-19 “would have been saved because of the administration of plasma”— a gross overstatement denounced by scientists and public health experts.

The misrepresentations became a stunning debacle for the FDA, shaking its professional staff to the core and undermining its credibility as it approaches one of the most important and fraught decisions in its history amid a divisive presidential election — deciding when a coronavirus vaccine is safe and effective.

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Hahn apologized the following day for misspeaking, saying on Twitter, “The criticism is entirely justified.” But demoralized employees felt he had allowed the agency to become a prop in the president’s reelection campaign.

They felt that way because that's what he did.

How, they wondered, would the FDA have any credibility on a vaccine decision if it bungled something much simpler?

“There is this weird Stockholm syndrome where FDA higher-ups are starting to identify with their captors,” said Gregg Gonsalves, an assistant professor at the Yale School of Public Health. “. . . It’s not clear they’re going to do the right thing.”

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Leading up to the event were infighting among some of the nation’s top scientists, frustrating delays and the last-minute arrival, just hours before the news conference, of a trove of new data, previously undisclosed, that was rough and difficult to interpret but that some thought raised questions about convalescent plasma’s benefit.

Weeks before the briefing, FDA scientists had concluded that plasma, an old therapy in which the yellowish liquid portion of blood is taken from recovered patients and transfused into ill people, was safe and might offer benefit to some hospitalized covid-19 patients. They reviewed published data, as well as a national, early-access plasma program being overseen by the Mayo Clinic, and were confident the treatment met the relatively low standard for an emergency use authorization. Such clearance, a temporary approval used during public health emergencies, requires only that a treatment “may be effective” and its “known and potential benefits” outweighed its risks.

But the FDA would soon learn scientists at the National Institutes of Health disagreed with that assessment. Officials’ willingness to hear NIH’s objections slowed the process and frustrated several White House officials.

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HHS Secretary Alex Azar and [FDA chief Stephen] Hahn disagree on policy matters. Over Hahn’s vociferous objections, HHS recently blocked FDA from regulating laboratory-developed tests, including some coronavirus tests, a move that raised concerns about an influx of faulty tests.

Early last week, HHS’s political leadership was angry that Hahn had publicly apologized for misstating plasma’s potential benefits without clearing that with HHS communications staff.

HHS officials are “making clear what their expectations are in a way that is not traditional,” said another individual familiar with the situation. “It doesn’t mean it’s illegal or wrong. . . . Generally speaking, you don’t have HHS leadership weigh in on specific drug approvals, an [emergency use authorization], or those sorts of things.” The FDA does have “less and less autonomy.”

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The growing political pressure on the FDA comes as some administration officials say they are trying to design a PR campaign to convince the public that scientists are in charge of developing vaccines and treatments and that anything the government approves will be safe and effective — an effort repeatedly upended by Trump. The growing political pressure on the FDA comes as some administration officials say they are trying to design a PR campaign to convince the public that scientists are in charge of developing vaccines and treatments and that anything the government approves will be safe and effective — an effort repeatedly upended by Trump.

Fire up the gaslights.  "A PR campaign" when your health - and your life - are at stake.

Some FDA staffers acknowledge concerns. “For the first time,” said one official, “the agency is involved in something that is existential to the president. It’s our turn in the barrel.”

Everybody in Trumpworld gets a turn.

“CDC is not a public health agency anymore,” [one] official said. “And I would like to try to make sure that the FDA doesn’t end up being a disaster area also.”

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[There is] a long-running narrative of a White House repeatedly undermining its health and science experts, not just at the FDA but also at the Centers for Disease Control and Prevention. Last week, the CDC came under fire from a host of medical and public health groups and infectious-disease experts for an abrupt change to its guidelines, which no longer recommend testing for asymptomatic people even if they had contact with an infected individual — a shift that coincides with the president’s stated desire to reduce testing.

“I’ve been following health regulatory decisions for decades and have never seen this amount of White House arm-twisting to force agencies like FDA and CDC to make decisions based on political pressure, rather than the best science,” said Jerome Avorn, a professor of medicine at Harvard Medical School, who decried the “routine policy distortions we now see nearly every week.”

The lack of integrity in Trumpworld is astonishing.

Another sign the White House was exerting more political control was its installation about two weeks ago of a new chief FDA spokesperson — Emily Miller, a staunch gun rights advocate with no health or science expertise. She previously worked as a reporter for One America News, a conservative cable channel that frequently espouses conspiracy theories and is allied with Trump.

JFC.

On Friday, Miller, the agency’s newly arrived spokeswoman, was removed in what many agency watchers saw as an effort to restore credibility. In addition, a longtime communications consultant who had advised Hahn to correct his misstatements about convalescent plasma[, Wayne Pines,] had his FDA contract terminated.

What a fucking shitshow.

"The beautiful ingredient."

...but hey, do what you want...you will anyway.

UPDATE: