U.S. Healthcare COVID-19 2020 August 1 –

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U.S. Healthcare COVID-19 2020 – July 31

Ad Council’s Challenge: Persuade Skeptics to Believe in Covid Vaccines
The nonprofit marketing group led a polio vaccine campaign in the 1950s. Now it is working on a $50 million ad blitz to counter concerns about coming treatments

22 November
Biden’s Covid-19 Mission
As Donald Trump continues to find new ways to make things worse, Joe Biden is preparing to take immediate action on an escalating crisis.
(New Yorker magazine 30 Nov.) Biden can undertake some immediate actions, like recommitting to the World Health Organization, by executive order. For others, such as putting together a new COVID-relief package that will help individuals, businesses that may be forced to close, and states facing budget shortfalls, he will need Congress’s coöperation. (And control of the Senate won’t be clear until after Georgia’s runoff elections, on January 5th.) Biden has spoken of a nationwide mask mandate; even with limits on federal power, he can use tools like incentives and persuasion to try to organize one. He can also lend his authority to guidelines for targeted shutdowns and reopenings. …

18 November
White House Coronavirus Task Force Warns Pence: Take Action or Risk 2,000 Deaths a Day by Christmas
(The Daily Beast) Doctors on the White House Coronavirus Task Force have reportedly delivered a dire warning to Vice President Mike Pence: If the Trump administration doesn’t change course now, then the United States could be recording 2,000 COVID-19 deaths by Christmas.

9 November
Covid-19 vaccine 90 percent effective in first analysis, Pfizer says
(NBC) Though the findings are preliminary, the Pfizer-led study indicates a far higher success rate than many experts had expected. People who received two doses as part of the trial saw 90 percent fewer symptomatic cases of Covid-19 than participants who were given a placebo.
Pandemic on course to overwhelm U.S. health system before Biden takes office
(Politico) The country’s health care system is already buckling under the load of the resurgent outbreak that’s approaching 10 million cases nationwide.
Rick Bright, Atul Gawande on Biden’s covid task force
(Politico) Previously unreported members of the panel include Rick Bright, who was ousted as chief of the Biomedical Advanced Research and Development Authority earlier this year and became an outspoken critic of the Trump administration before leaving government last month.
The Biden team also will tap high-profile surgeon and New Yorker writer Atul Gawande, who worked at HHS during the Clinton administration and recently led a health care joint venture between Amazon, Berkshire Hathaway and JP Morgan known as Haven.
Other members of the advisory group include Luciana Borio, who served as the FDA’s acting chief scientist and on the National Security Council during the Trump administration, and University of Minnesota infectious disease specialist Michael Osterholm.
The task force also includes UCSF’s Eric Goosby, who helped shape HIV/AIDS policy during the Clinton and Obama administration; UCSF emergency physician Robert Rodriguez; and Loyce Pace of the Global Health Council.
The advisory board’s co-chairs are former Surgeon General Vivek Murthy, former FDA Commissioner David Kessler and Yale’s Marcella Nunez-Smith. The group also includes NYU’s Celine Gounder, Obama White House aide Zeke Emanuel and RWJF’s Julie Morita

8 November
An Explanation for Some Covid-19 Deaths May Not Be Holding Up
Recent studies have created doubts about an agent in cytokine storms, and suggest that treatments for it may not help.
(NYT) Medical researchers are raising significant doubts about whether an agent of the human immune system causes some coronavirus patients to end up in the hospital with injured lungs and other organs, struggling to breathe. What remains is a continuing mystery about what causes certain people to die from Covid-19, and how best to prevent that.

President-Elect Biden’s Victory Speech
Priority one: The pandemic.
Mr. Biden left no doubt that the coronavirus pandemic would be a priority for his administration in a way that it has not been under Mr. Trump.

7 November
U.S. infections are breaking records day after day, and deaths are rising in more than half the country.
(NYT) …the nation recorded more than 100,000 new cases for the third straight day and more than 1,000 deaths for the fourth straight day — places that held the virus at manageable levels for months are now experiencing major outbreaks.
Nebraska, Colorado, Wyoming — states that drew little attention compared with epicenters like New York or Florida — are now repeatedly setting single-day case records. And deaths are rising in more than half the country.

22 October
Covid-19 Live Updates: F.D.A. Approves First Drug for Treating Coronavirus Patients
(NYT) The Food and Drug Administration said Thursday that it had formally approved remdesivir as the first drug to treat Covid-19, a move that indicated the government’s confidence in its safe and effective use for hospitalized patients.
The drug does not prevent deaths in Covid-19 patients.
The formal approval now granted by the F.D.A. indicates that the drug cleared more rigorous regulatory hurdles involving a more thorough review of clinical data and manufacturing quality since it was given emergency authorization in May.
“The FDA is committed to expediting the development and availability of Covid-19 treatments during this unprecedented public health emergency,” Stephen M. Hahn, the F.D.A. commissioner, said in a statement. “Today’s approval is supported by data from multiple clinical trials that the agency has rigorously assessed and represents an important scientific milestone in the Covid-19 pandemic.

13 October
FDA faults quality control at Lilly plant making Trump-touted COVID drug
(Reuters) – U.S. drug inspectors uncovered serious quality control problems at an Eli Lilly and Co LLY.N pharmaceutical plant that is ramping up to manufacture one of two promising COVID-19 drugs touted by President Trump as “a cure” for the disease, according to government documents and three sources familiar with the matter.
The Lilly antibody therapy, which is experimental and not yet approved by regulators as safe and effective, is similar to a drug from Regeneron Pharmaceuticals REGN.O that was given to the president during his bout with COVID-19.

11 October
Another casualty of the coronavirus pandemic: Trust in science
Polls show trust in a potential vaccine has plunged. A Pew Research poll in September found that only 21 percent of respondents said they would definitely get a coronavirus vaccine if it were available immediately, down from 42 percent in May.
(WaPo) This has been the 2020 pattern: Politics has thoroughly contaminated the scientific process. The result has been an epidemic of distrust, which further undermines the nation’s already chaotic and ineffective response to the coronavirus.
The White House has repeatedly meddled with decisions by career professionals at the FDA, Centers for Disease Control and Prevention and other science-based agencies. Many of the nation’s leading scientists, including some of the top doctors in the administration, are deeply disturbed by the collision of politics and science and bemoan its effects on public health.
Trust has been damaged by White House intrusions and the FDA’s own mistakes. Earlier this year, the agency granted emergency authorization to hydroxychloroquine, the malaria drug wrongly touted by Trump as a treatment for covid-19, then reversed course when it became clear the medication could cause dangerous complications. In August, FDA Commissioner Stephen Hahn drew sharp criticism for inaccurately describing the benefits of convalescent plasma, statements for which he later apologized.

Regeneron Asks F.D.A. for Emergency Approval for Drug That Trump Claimed Cured Him
By Katie Thomas
(NYT) The drug maker Regeneron said on Wednesday evening that it had submitted an application to the Food and Drug Administration for emergency approval of the experimental antibody cocktail that President Trump had praised just hours earlier without evidence as a ‘cure’ for the coronavirus.
“The company said that at first, access to the treatment would be extremely limited, with only enough doses for 50,000 patients, a far cry from the ‘hundreds of thousands’ of doses that Mr. Trump said in a video released Wednesday he would soon be making available to Americans free of charge.
In the five-minute video, Mr. Trump said that it was a “blessing from God” that he had been infected with the coronavirus and that the Regeneron cocktail had suddenly made him feel better. “I felt unbelievable,” he said. “I felt good immediately.”

Robin Wright: The Coronavirus Pandemic Is Now a Threat to National Security
After a possible coronavirus exposure, the entire Joint Chiefs of Staff, including General Mark Milley, the principal military adviser to the President, has gone into isolation.
From multiple angles, including the fact that President Trump is also the Commander-in-Chief, the coronavirus is now a genuine national-security threat for the United States. And the rest of the world knows it. The potential dangers abound.
These are not only commanders who control the world’s mightiest military, run wars, order bombings, and authorize special-operations raids; they are part of the most consistent and sane wing of the American government right now.

CDC revises guidance
U.S. Centers for Disease Control and Prevention (CDC) said COVID-19 can spread through virus lingering in the air, sometimes for hours, acknowledging concerns widely voiced by public health experts about airborne transmission.
The CDC guidance comes weeks after the agency published – and then took down – a similar warning, sparking debate over how the virus spreads.

23 September
Fauci spars with Rand Paul over Covid-19 response
Fauci rejected Paul’s assertion that the United States’ mitigation and lockdown efforts were misguided.
The government’s top infectious disease doctor on Wednesday accused Sen. Rand Paul of repeatedly misconstruing information about the U.S. response to the coronavirus pandemic, including making misleading claims about herd immunity and the effects of mitigation measures.
Testifying before the Senate Health, Education, Labor and Pensions Committee, Anthony Fauci rejected Paul’s assertion that the United States’ mitigation and lockdown efforts were misguided.

18 September
Emails Detail Effort to Silence C.D.C. and Question Its Science
Emails from a former top Trump health official and his science adviser show how the two refused to accept Centers for Disease Control and Prevention science and sought to silence the agency.
(NYT) On June 30, as the coronavirus was cresting toward its summer peak, Dr. Paul Alexander, a new science adviser at the Department of Health and Human Services, composed a scathing two-page critique of an interview given by an experienced scientist at the Centers for Disease Control and Prevention.
Dr. Alexander’s point-by-point assessment, broken into seven parts and forwarded by Mr. Caputo to Dr. Robert R. Redfield, the C.D.C. director, was one of several emails obtained by The New York Times that illustrate how Mr. Caputo and Dr. Alexander tried to browbeat career officials at the C.D.C. at the height of the pandemic, challenging the science behind their public statements and trying to silence agency staff.
On Friday, two days after Mr. Caputo went on medical leave and Dr. Alexander was dismissed from the Department of Health and Human Services, the C.D.C. reversed a heavily criticized recommendation suggesting that people who have had close contact with a person infected with the coronavirus do not need to get tested if they have no symptoms. The emails shed light on the monthslong fight that led to their departures.
Far from hiding what they knew about the virus’s danger, as Bob Woodward’s new book contends President Trump was doing, the emails seem to indicate that aides in Washington were convinced of their own rosy prognostications, even as coronavirus infections were shooting skyward.

2 September
We Can Solve the Coronavirus-Test Mess Now—If We Want To
The key to taming the pandemic will be both a new commitment to “assurance testing” and a new vision of what public health really means.
By (The New Yorker) Many developed countries have met their testing needs, and ready access to speedy tests has been key to containing outbreaks and resuming social and economic activity. Whether you live in England or South Korea, scheduling is straightforward. No doctor’s order is required. Tests, where indicated, are free. And you typically get results within forty-eight hours.
Tactics of fiery White House trade adviser draw new scrutiny as some of his pandemic moves unravel
(WaPo) Amid the Trump administration’s troubled response to the coronavirus pandemic, senior White House aide Peter Navarro has refashioned himself as a powerful government purchasing chief, operating far beyond his original role as an adviser on trade policy. But U.S. officials say the abrasive figure’s shortcomings as a manager could influence how well prepared the United States is for a second wave of coronavirus infections expected this fall.

1 September
U.S. says it won’t join WHO-linked effort to develop, distribute coronavirus vaccine
The Trump administration said it will not join a global effort to develop, manufacture and equitably distribute a coronavirus vaccine, in part because the World Health Organization is involved, a decision that could shape the course of the pandemic and the country’s role in health diplomacy.
More than 170 countries are in talks to participate in the Covid-19 Vaccines Global Access (Covax) Facility, which aims to speed vaccine development, secure doses for all countries and distribute them to the most high-risk segment of each population.

26 August
How Mike Pence slowed down the coronavirus response
Taking the reins in late February, the vice president sought to bring order to a chaotic response. He also slowed things down.
(Politico) How Pence approached the challenges of his first weeks on the job foreshadowed how he would pursue the next six months of the coronavirus crisis — the most important and hands-on role of his tenure. …interviews with 21 people involved with Pence’s coronavirus task force painted a detailed picture of the vice president…as he steered the administration’s evolving response to the pandemic.
Many gave Pence high marks as a listener, and state and local officials praised him for being more responsive to their concerns than the president or his inner circle. All acknowledged that Pence was dealing with a complicated dynamic — trying to please Trump while wrestling with a demoralized health bureaucracy.
But Trump’s mercurial behavior was not solely responsible for what amounted to a slow response to the deadliest pandemic in a century, they said, pointing to Pence’s own leadership style as a force for delay. Many said Pence’s consensus-building approach drained urgency from the mission, pitted interests against each other and gave inappropriate weight to opinions outside the public health realm.
… he’s continued to be seen as a force for moderation and fact-based decision-making within a White House that’s often been plagued by infighting while struggling to develop a comprehensive strategy. He’s provided an open door to industry leaders, state governors and top officials, a welcome contrast for those who view the president as unreliable.
But in the face of a historic pandemic, Pence’s leadership style has often resulted in decisions that health experts view as too slow, too consensus-oriented and too focused on public perception. The task force he’s led has been unwieldy — and over time has evolved into more of a communications forum than a decision-making body.

23-25 August
The FDA offers a big correction after helping hype Trump’s coronavirus announcement
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. – Dr. Stephen Hahn 9:36pm, August 24.
Some Trump administration claims on effectiveness of convalescent plasma are wrong or dubious, scientists say
Rigorous trials are still needed to establish efficacy, they say.
Two months ago, the Food and Drug Administration reversed course on President Trump’s much-hyped drug hydroxychloroquine, revoking its authorization for emergency use to treat the novel coronavirus. Given that Trump had pushed for the drug and then bragged about speeding the initial authorization process along, it raised very valid concerns about whether the FDA had made a hasty decision under political pressure.
Those concerns have to resurface after the spectacle we saw Sunday.
At a news conference, Trump announced a new emergency-use authorization, this time for convalescent plasma, which he characterized as a breakthrough. Some scientists are dubious about its usefulness. Others backed the decision, believing that the treatment at least shows promise.
F.D.A. Allows Expanded Use of Plasma to Treat Coronavirus Patients
The move came on the eve of the Republican convention and after President Trump pressed the agency to move faster to address the pandemic.
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.

12 August
Brown University: Stay-at-home orders significantly associated with reduced spread of COVID-19, study finds
(Eureka!Alert) Across the globe, COVID-19 has infected more than 18 million people to date and has killed hundreds of thousands — and the United States has been hit especially hard. Although the U.S. comprises just 4.2% of the global population, it accounted for approximately 33% of all reported infections by the end of April.
However, the majority of U.S. states eventually imposed stay-at-home orders, and those orders appear to have significantly slowed the spread of the disease for the nation as a whole.

11 August
Trump’s Unprecedented Attacks on Our Public-Health System
The most important public-health institutions in America have essentially been hijacked by Donald Trump, who seems to detest science and expertise equally.
(The New Yorker) How worried should we be that the President of the United States recently described as “very impressive” a woman who claims that doctors make medicine using DNA from aliens? Or that he shows no sign of recognizing the magnitude of the COVID-19 pandemic? It’s simply not possible to worry too much.
No single national leader would have been able to prevent the coronavirus pandemic. But Trump’s denialism and hostility toward public-health officials has greatly increased America’s share of suffering and death. On “Fox & Friends,” on Wednesday, he said that the virus is spreading in a “relatively small portion” of the country, and that children are virtually immune; both statements are false. And, as he has done many times before, he declared at a briefing that the pandemic would just “go away.”
Trump has had one consistent response to the pandemic: he attacks leading experts when they attempt to tell the truth.
Meet the most important federal official you probably don’t know — the man who holds the fate of the coronavirus vaccine in his hands
(WaPo) A top Food and Drug Administration career official, Peter Marks is likely to decide in the next several months whether a coronavirus vaccine is safe and effective enough to be given to tens of millions of Americans.
It’s a ruling of intense interest to President Trump, who has not hesitated to attack government health officials he deems politically unhelpful, and who has boasted about pushing officials to speed up vaccine development. Just last week, Trump said in a radio interview that a vaccine might be available “right around” the Nov. 3 election — months earlier than Anthony S. Fauci, the nation’s leading infectious-disease expert, has predicted.
Such statements have scientists, health experts and lawmakers watching anxiously for political pressure on the FDA, in addition to possible technical foul-ups and mistakes in scientific judgment. The way the vaccine decision is handled could have an impact on the presidential election and whether enough people are willing to get vaccinated to curb the pandemic and revive the economy. If safety problems are missed, it could be disastrous for this crisis and undermine public confidence in all vaccines.

3 August
After months of favor, Birx raises Trump’s ire with grim coronavirus assessment
(WaPo) President Trump further disparaged his senior health advisers on Monday even as the pandemic deepened its hold on the nation, as the White House’s top coronavirus coordinator, Deborah Birx, joined Anthony S. Fauci and other scientists on the receiving end of the president’s ire.
…Birx’s grim assessment Sunday on CNN’s “State of the Union,” in which she described the coronavirus as “extraordinary widespread” across the nation and warned that the deadly contagion has infiltrated “both rural and urban” areas. In the interview, she also did not rule out the possibility that the nation’s coronavirus death toll could double by the end of the year to 300,000 and seemed to suggest that, contrary to the president’s stated desires, some schools should offer only distance learning this fall.

2 August
Scientists Worry About Political Influence Over Coronavirus Vaccine Project
Operation Warp Speed has moved along at a rapid clip. But some people involved in the process fear pressure to deliver an October surprise for President Trump.
(NYT) “DEADLINE: Enable broad access to the public by October 2020,”
Given that it typically takes years to develop a vaccine, the timetable for the initiative, called Operation Warp Speed, was incredibly ambitious. With tens of thousands dying and tens of millions out of work, the crisis demanded an all-out public-private response, with the government supplying billions of dollars to pharmaceutical and biotechnology companies, providing logistical support and cutting through red tape. The ensuing race for a vaccine — in the middle of a campaign in which the president’s handling of the pandemic is the key issue after he has spent his time in office undermining science and the expertise of the federal bureaucracy — is now testing the system set up to ensure safe and effective drugs to a degree never before seen.

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