NYtimes:https://www.nytimes.com/2020/04/06/us/politics/coronavirus-trump-malaria-drug.html
Trump’s Aggressive Advocacy of Malaria Drug for Treating Coronavirus Divides Medical Community

While Dr. Anthony Fauci has urged caution in using hydroxychloroquine, some doctors are prescribing it to patients who have the virus despite the fact it has never been tested for it.

WASHINGTON — President Trump made a rare appearance in the Situation Room on Sunday as his pandemic task force was meeting, determined to talk about the anti-malaria medicine that he has aggressively promoted lately as a treatment for the coronavirus.

Once again, according to a person briefed on the session, the experts warned against overselling a drug yet to be proved a safe remedy, particularly for heart patients. “Yes, the heart stuff,” Mr. Trump acknowledged. Then he headed out to the cameras to promote it anyway. “So what do I know?” he conceded to reporters at his daily briefing. “I’m not a doctor. But I have common sense.”

Day after day, the salesman turned president has encouraged coronavirus patients to try hydroxychloroquine with all of the enthusiasm of a real estate developer. The passing reference he makes to the possible dangers is usually overwhelmed by the full-throated endorsement. “What do you have to lose?” he asked five times on Sunday.

Bolstered by his trade adviser, a television doctor, Larry Ellison of Oracle and Rudolph W. Giuliani, a former New York mayor, Mr. Trump has seized on the drug as a miracle cure for the virus that has killed thousands and paralyzed American life. Along the way, he has prompted an international debate about a drug that many doctors in New York and elsewhere have been trying in desperation even without conclusive scientific studies.

Mr. Trump may ultimately be right, and physicians report anecdotal evidence that has provided hope. But it remains far from certain, and the president’s assertiveness in pressing the case over the advice of advisers like Dr. Anthony S. Fauci, the government’s top infectious disease specialist, has driven a wedge inside his coronavirus task force and has raised questions about his motives.

If hydroxychloroquine becomes an accepted treatment, several pharmaceutical companies stand to profit, including shareholders and senior executives with connections to the president. Mr. Trump himself has a small personal financial interest in Sanofi, the French drugmaker that makes Plaquenil, the brand-name version of hydroxychloroquine.

“I certainly understand why the president is pushing it,” said Dr. Joshua Rosenberg, a critical care at Brooklyn Hospital Center. “He’s the president of the United States. He has to project hope. And when you are in a situation without hope, things go very badly. So I’m not faulting him for pushing it even if there isn’t a lot of science behind it, because it is, at this point, the best, most available option for use.”

A senior physician at Wyckoff Heights Medical Center in Brooklyn, where doctors are not providing the drug, however, said the current demand was worrisome for patients on it chronically for rheumatic diseases. At St. Barnabas Hospital in the Bronx, another doctor said his staff was giving it to coronavirus patients but criticized the president and Gov. Andrew M. Cuomo for “cheerleading” the drug without proof. “False hope can be bad, too,” he said.

The professional organization that published a positive French study cited by Mr. Trump’s allies changed its mind in recent days. The International Society of Antimicrobial Chemotherapy said, “The article does not meet the society’s expected standard.” Some hospitals in Sweden stopped providing hydroxychloroquine to treat the coronavirus after reports of adverse side effects, according to Swedish news media.

But Mr. Cuomo told reporters on Monday that he would ask Mr. Trump to increase the federal supply of hydroxychloroquine to New York pharmacies, allowing the state to lift a limit on purchases. “There has been anecdotal evidence that it is promising,” Mr. Cuomo said, while noting the lack of a formal study….see link

The U.S. was beset by denial and dysfunction as the coronavirus raged
From the Oval Office to the CDC, political and institutional failures cascaded through the system and opportunities to mitigate the pandemic were lost.

https://www.washingtonpost.com/national-security/2020/04/04/coronavirus-government-dysfunction/?arc404=true

By the time Donald Trump proclaimed himself a wartime president — and the coronavirus the enemy — the United States was already on course to see more of its people die than in the wars of Korea, Vietnam, Afghanistan and Iraq combined.

The country has adopted an array of wartime measures never employed collectively in U.S. history — banning incoming travelers from two continents, bringing commerce to a near-halt, enlisting industry to make emergency medical gear, and confining 230 million Americans to their homes in a desperate bid to survive an attack by an unseen adversary.

Despite these and other extreme steps, the United States will likely go down as the country that was supposedly best prepared to fight a pandemic but ended up catastrophically overmatched by the novel coronavirus, sustaining heavier casualties than any other nation.

It did not have to happen this way. Though not perfectly prepared, the United States had more expertise, resources, plans and epidemiological experience than dozens of countries that ultimately fared far better in fending off the virus.

The failure has echoes of the period leading up to 9/11: Warnings were sounded, including at the highest levels of government, but the president was deaf to them until the enemy had already struck.

The Trump administration received its first formal notification of the outbreak of the coronavirus in China on Jan. 3. Within days, U.S. spy agencies were signaling the seriousness of the threat to Trump by including a warning about the coronavirus — the first of many — in the President’s Daily Brief.

And yet, it took 70 days from that initial notification for Trump to treat the coronavirus not as a distant threat or harmless flu strain well under control, but as a lethal force that had outflanked America’s defenses and was poised to kill tens of thousands of citizens. That more-than-two-month stretch now stands as critical time that was squandered.

33 times Trump downplayed the coronavirus

Trump’s baseless assertions in those weeks, including his claim that it would all just “miraculously” go away, sowed significant public confusion and contradicted the urgent messages of public health experts.

“While the media would rather speculate about outrageous claims of palace intrigue, President Trump and this Administration remain completely focused on the health and safety of the American people with around the clock work to slow the spread of the virus, expand testing, and expedite vaccine development,” said Judd Deere, a spokesman for the president. “Because of the President’s leadership we will emerge from this challenge healthy, stronger, and with a prosperous and growing economy.”

The president’s behavior and combative statements were merely a visible layer on top of deeper levels of dysfunction.

The most consequential failure involved a breakdown in efforts to develop a diagnostic test that could be mass produced and distributed across the United States, enabling agencies to map early outbreaks of the disease, and impose quarantine measures to contain them. At one point, a Food and Drug Administration official tore into lab officials at the Centers for Disease Control and Prevention, telling them their lapses in protocol, including concerns that the lab did not meet the criteria for sterile conditions, were so serious that the FDA would “shut you down” if the CDC were a commercial, rather than government, entity.

Other failures cascaded through the system. The administration often seemed weeks behind the curve in reacting to the viral spread, closing doors that were already contaminated. Protracted arguments between the White House and public health agencies over funding, combined with a meager existing stockpile of emergency supplies, left vast stretches of the country’s health-care system without protective gear until the outbreak had become a pandemic. Infighting, turf wars and abrupt leadership changes hobbled the work of the coronavirus task force.

It may never be known how many thousands of deaths, or millions of infections, might have been prevented with a response that was more coherent, urgent and effective. But even now, there are many indications that the administration’s handling of the crisis had potentially devastating consequences.

Even the president’s base has begun to confront this reality. In mid-March, as Trump was rebranding himself a wartime president and belatedly urging the public to help slow the spread of the virus, Republican leaders were poring over grim polling data that suggested Trump was lulling his followers into a false sense of security in the face of a lethal threat.

The poll showed that far more Republicans than Democrats were being influenced by Trump’s dismissive depictions of the virus and the comparably scornful coverage on Fox News and other conservative networks. As a result, Republicans were in distressingly large numbers refusing to change travel plans, follow “social distancing” guidelines, stock up on supplies or otherwise take the coronavirus threat seriously.

“Denial is not likely to be a successful strategy for survival,” GOP pollster Neil Newhouse concluded in a document that was shared with GOP leaders on Capitol Hill and discussed widely at the White House. Trump’s most ardent supporters, it said, were “putting themselves and their loved ones in danger.”

Trump’s message was changing as the report swept through the GOP’s senior ranks. In recent days, Trump has bristled at reminders that he had once claimed the caseload would soon be “down to zero.”

More than 7,000 people have died of the coronavirus in the United States so far, with about 240,000 cases reported. But Trump has acknowledged that new models suggest that the eventual national death toll could be between 100,000 and 240,000.

Beyond the suffering in store for thousands of victims and their families, the outcome has altered the international standing of the United States, damaging and diminishing its reputation as a global leader in times of extraordinary adversity.

“This has been a real blow to the sense that America was competent,” said Gregory F. Treverton, a former chairman of the National Intelligence Council, the government’s senior-most provider of intelligence analysis. He stepped down from the NIC in January 2017 and now teaches at the University of Southern California. “That was part of our global role. Traditional friends and allies looked to us because they thought we could be competently called upon to work with them in a crisis. This has been the opposite of that.”

This article, which retraces the failures over the first 70 days of the coronavirus crisis, is based on 47 interviews with administration officials, public health experts, intelligence officers and others involved in fighting the pandemic. Many spoke on the condition of anonymity to discuss sensitive information and decisions.

Scanning the horizon

Public health authorities are part of a special breed of public servant — along with counterterrorism officials, military planners, aviation authorities and others — whose careers are consumed with contemplating worst-case scenarios.

The arsenal they wield against viral invaders is powerful, capable of smothering a new pathogen while scrambling for a cure, but easily overwhelmed if not mobilized in time. As a result, officials at the Department of Health and Human Services, the CDC and other agencies spend their days scanning the horizon for emerging dangers.

The CDC learned of a cluster of cases in China on Dec. 31 and began developing reports for HHS on Jan. 1. But the most unambiguous warning that U.S. officials received about the coronavirus came Jan. 3, when Robert Redfield, the CDC director, received a call from a counterpart in China. The official told Redfield that a mysterious respiratory illness was spreading in Wuhan, a congested commercial city of 11 million people in the communist country’s interior.

Redfield quickly relayed the disturbing news to Alex Azar, the secretary of HHS, the agency that oversees the CDC and other public health entities. Azar, in turn, ensured that the White House was notified, instructing his chief of staff to share the Chinese report with the National Security Council.

From that moment, the administration and the virus were locked in a race against a ticking clock, a competition for the upper hand between pathogen and prevention that would dictate the scale of the outbreak when it reached American shores, and determine how many would get sick or die.
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The initial response was promising, but officials also immediately encountered obstacles.

On Jan. 6, Redfield sent a letter to the Chinese offering to send help, including a team of CDC scientists. China rebuffed the offer for weeks, turning away assistance and depriving U.S. authorities of an early chance to get a sample of the virus, critical for developing diagnostic tests and any potential vaccine.

China impeded the U.S. response in other ways, including by withholding accurate information about the outbreak. Beijing had a long track record of downplaying illnesses that emerged within its borders, an impulse that U.S. officials attribute to a desire by the country’s leaders to avoid embarrassment and accountability with China’s 1.3 billion people and other countries that find themselves in the pathogen’s path.

China stuck to this costly script in the case of the coronavirus, reporting Jan. 14 that it had seen “no clear evidence of human-to-human transmission.” U.S. officials treated the claim with skepticism that intensified when the first case surfaced outside China with a reported infection in Thailand.

A week earlier, senior officials at HHS had begun convening an intra-agency task force including Redfield, Azar and Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases. The following week, there were also scattered meetings at the White House with officials from the National Security Council and State Department, focused mainly on when and whether to bring back government employees in China.

U.S. officials began taking preliminary steps to counter a potential outbreak. By mid-January, Robert Kadlec, an Air Force officer and physician who serves as assistant secretary for preparedness and response at HHS, had instructed subordinates to draw up contingency plans for enforcing the Defense Production Act, a measure that enables the government to compel private companies to produce equipment or devices critical to the country’s security. Aides were bitterly divided over whether to implement the act, and nothing happened for many weeks.

On Jan. 14, Kadlec scribbled a single word in a notebook he carries: “Coronavirus!!!”

Despite the flurry of activity at lower levels of his administration, Trump was not substantially briefed by health officials about the coronavirus until Jan.18, when, while spending the weekend at Mar-a-Lago, he took a call from Azar.

Even before the heath secretary could get a word in about the virus, Trump cut him off and began criticizing Azar for his handling of an aborted federal ban on vaping products, a matter that vexed the president.

At the time, Trump was in the throes of an impeachment battle over his alleged attempt to coerce political favors from the leader of Ukraine. Acquittal seemed certain by the GOP-controlled Senate, but Trump was preoccupied with the trial, calling lawmakers late at night to rant, and making lists of perceived enemies he would seek to punish when the case against him concluded.

In hindsight, officials said, Azar could have been more forceful in urging Trump to turn at least some of his attention to a threat that would soon pose an even graver test to his presidency, a crisis that would cost American lives and consume the final year of Trump’s first term.

But the secretary, who had a strained relationship with Trump and many others in the administration, assured the president that those responsible were working on and monitoring the issue. Azar told several associates that the president believed he was “alarmist” and Azar struggled to get Trump’s attention to focus on the issue, even asking one confidant for advice.

Within days, there were new causes for alarm.

On Jan. 21, a Seattle man who had recently traveled to Wuhan tested positive for the coronavirus, becoming the first known infection on U.S. soil. Then, two days later, Chinese authorities took the drastic step of shutting down Wuhan, turning the teeming metropolis into a ghost city of empty highways and shuttered skyscrapers, with millions of people marooned in their homes.

“That was like, whoa,” said a senior U.S. official involved in White House meetings on the crisis. “That was when the Richter scale hit 8.”

It was also when U.S. officials began to confront the failings of their own efforts to respond.

Azar, who had served in senior positions at HHS through crises including the 9/11 terrorist attacks and the outbreak of bird flu in 2005, was intimately familiar with the playbook for crisis management.

He instructed subordinates to move rapidly to establish a nationwide surveillance system to track the spread of the coronavirus — a stepped-up version of what the CDC does every year to monitor new strains of the ordinary flu.

But doing so would require assets that would elude U.S. officials for months — a diagnostic test that could accurately identify those infected with the new virus and be produced on a mass scale for rapid deployment across the United States, and money to implement the system.

Azar’s team also hit another obstacle. The Chinese were still refusing to share the viral samples they had collected and were using to develop their own tests. In frustration, U.S. officials looked for other possible routes.

A biocontainment lab at the University of Texas medical branch in Galveston had a research partnership with the Wuhan Institute of Virology.

Kadlec, who knew the Galveston lab director, hoped scientists could arrange a transaction on their own without government interference. At first, the lab in Wuhan agreed, but officials in Beijing intervened Jan. 24 and blocked any lab-to-lab transfer.

There is no indication that officials sought to escalate the matter or enlist Trump to intervene. In fact, Trump has consistently praised Chinese President Xi Jinping despite warnings from U.S. intelligence and health officials that Beijing was concealing the true scale of the outbreak and impeding cooperation on key fronts.

The CDC had issued its first public alert about the coronavirus Jan. 8, and by the 17th was monitoring major airports in Los Angeles, San Francisco and New York, where large numbers of passengers arrived each day from China.

In other ways, though, the situation was already spinning out of control, with multiplying cases in Seattle, intransigence by the Chinese, mounting questions from the public, and nothing in place to stop infected travelers from arriving from abroad.

Trump was out of the country for this critical stretch, taking part in the annual global economic forum in Davos, Switzerland. He was accompanied by a contingent of top officials including national security adviser Robert O’Brien, who took a trans-Atlantic call from an anxious Azar.

Azar told O’Brien that it was “mayhem” at the White House, with HHS officials being pressed to provide nearly identical briefings to three audiences on the same day.

Azar urged O’Brien to have the NSC assert control over a matter with potential implications for air travel, immigration authorities, the State Department and the Pentagon. O’Brien seemed to grasp the urgency, and put his deputy, Matthew Pottinger, who had worked in China as a journalist for the Wall Street Journal, in charge of coordinating the still-nascent U.S. response.

But the rising anxiety within the administration appeared not to register with the president. On Jan. 22, Trump received his first question about the coronavirus in an interview on CNBC while in Davos. Asked whether he was worried about a potential pandemic, Trump said, “No. Not at all. And we have it totally under control. It’s one person coming in from China. . . . It’s going to be just fine.”

Spreading uncontrollably

\The move by the NSC to seize control of the response marked an opportunity to reorient U.S. strategy around containing the virus where possible and procuring resources that hospitals would need in any U.S. outbreak, including such basic equipment as protective masks and ventilators.

But instead of mobilizing for what was coming, U.S. officials seemed more preoccupied with logistical problems, including how to evacuate Americans from China.

In Washington, then-acting chief of staff Mick Mulvaney and Pottinger began convening meetings at the White House with senior officials from HHS, the CDC and the State Department.

The group, which included Azar, Pottinger and Fauci, as well as nine others across the administration, formed the core of what would become the administration’s coronavirus task force. But it primarily focused on efforts to keep infected people in China from traveling to the United States even while evacuating thousands of U.S. citizens. The meetings did not seriously focus on testing or supplies, which have since become the administration’s most challenging problems.

The task force was formally announced on Jan. 29.

“The genesis of this group was around border control and repatriation,” said a senior official involved in the meetings. “It wasn’t a comprehensive, whole-of-government group to run everything.”

The State Department agenda dominated those early discussions, according to participants. Officials began making plans to charter aircraft to evacuate 6,000 Americans stranded in Wuhan. They also debated language for travel advisories that State could issue to discourage other travel in and out of China.

On Jan. 29, Mulvaney chaired a meeting in the White House Situation Room in which officials debated moving travel restrictions to “Level 4,” meaning a “do not travel” advisory from the State Department. Then, the next day, China took the draconian step of locking down the entire Hubei province, which encompasses Wuhan.

That move by Beijing finally prompted a commensurate action by the Trump administration. On Jan. 31, Azar announced restrictions barring any non-U.S. citizen who had been in China during the preceding two weeks from entering the United States.

Trump has, with some justification, pointed to the China-related restriction as evidence that he had responded aggressively and early to the outbreak. It was among the few intervention options throughout the crisis that played to the instincts of the president, who often seems fixated on erecting borders and keeping foreigners out of the country.

But by that point, 300,000 people had come into the United States from China over the previous month. There were only 7,818 confirmed cases around the world at the end of January, according to figures released by the World Health Organization — but it is now clear that the virus was spreading uncontrollably.

Pottinger was by then pushing for another travel ban, this time restricting the flow of travelers from Italy and other nations in the European Union that were rapidly emerging as major new nodes of the outbreak. Pottinger’s proposal was endorsed by key health-care officials, including Fauci, who argued that it was critical to close off any path the virus might take into the country.

This time, the plan met with resistance from Treasury Secretary Steven Mnuchin and others who worried about the impact on the U.S. economy. It was an early sign of tension in an area that would split the administration, pitting those who prioritized public health against those determined to avoid any disruption in an election year to the run of expansion and employment growth.

Those backing the economy prevailed with the president. And it was more than a month before the administration issued a belated and confusing ban on flights into the United States from Europe. Hundreds of thousands of people crossed the Atlantic during that interval.

A wall of resistance

While fights over air travel played out in the White House, public health officials began to panic over a startling shortage of critical medical equipment including protective masks for doctors and nurses, as well as a rapidly shrinking pool of money needed to pay for such things.

By early February, the administration was quickly draining a $105 million congressional fund to respond to infectious disease outbreaks. The coronavirus threat to the United States still seemed distant if not entirely hypothetical to much of the public. But to health officials charged with stockpiling supplies for worst-case-scenarios, disaster appeared increasingly inevitable.

A national stockpile of N95 protective masks, gowns, gloves and other supplies was already woefully inadequate after years of underfunding. The prospects for replenishing that store were suddenly threatened by the unfolding crisis in China, which disrupted offshore supply chains.

Much of the manufacturing of such equipment had long since migrated to China, where factories were now shuttered because workers were on order to stay in their households. At the same time, China was buying up masks and other gear to gird for its own coronavirus outbreak, driving up costs and monopolizing supplies.

In late January and early February, leaders at HHS sent two letters to the White House Office of Management and Budget asking to use its transfer authority to shift $136 million of department funds into pools that could be tapped for combating the coronavirus. Azar and his aides also began raising the need for a multibillion-dollar supplemental budget request to send to Congress.

Yet White House budget hawks argued that appropriating too much money at once when there were only a few U.S. cases would be viewed as alarmist.

Joe Grogan, head of the Domestic Policy Council, clashed with health officials over preparedness. He mistrusted how the money would be used and questioned how health officials had used previous preparedness funds.

Azar then spoke to Russell Vought, the acting director of the White House Office of Management and Budget, during Trump’s State of the Union speech on Feb. 4. Vought seemed amenable, and told Azar to submit a proposal.

Azar did so the next day, drafting a supplemental request for more than $4 billion, a sum that OMB officials and others at the White House greeted as an outrage. Azar arrived at the White House that day for a tense meeting in the Situation Room that erupted in a shouting match, according to three people familiar with the incident.

A deputy in the budget office accused Azar of preemptively lobbying Congress for a gigantic sum that White House officials had no interest in granting. Azar bristled at the criticism and defended the need for an emergency infusion. But his standing with White House officials, already shaky before the coronavirus crisis began, was damaged further.

Trump on his ‘natural ability’ for medical science: ‘I really get it’

White House officials relented to a degree weeks later as the feared coronavirus surge in the United States began to materialize. The OMB team whittled Azar’s demands down to $2.5 billion, money that would be available only in the current fiscal year. Congress ignored that figure, approving an $8 billion supplemental bill that Trump signed into law March 6.

But again, delays proved costly. The disputes meant that the United States missed a narrow window to stockpile ventilators, masks and other protective gear before the administration was bidding against many other desperate nations, and state officials fed up with federal failures began scouring for supplies themselves.

In late March, the administration ordered 10,000 ventilators — far short of what public health officials and governors said was needed. And many will not arrive until the summer or fall, when models expect the pandemic to be receding.

“It’s actually kind of a joke,” said one administration official involved in deliberations about the belated purchase.

Inconclusive tests

Although viruses travel unseen, public health officials have developed elaborate ways of mapping and tracking their movements. Stemming an outbreak or slowing a pandemic in many ways comes down to the ability to quickly divide the population into those who are infected and those who are not.

Doing so, however, hinges on having an accurate test to diagnose patients and deploy it rapidly to labs across the country. The time it took to accomplish that in the United States may have been more costly to American efforts than any other failing.

“If you had the testing, you could say, ‘Oh my god, there’s circulating virus in Seattle, let’s jump on it. There’s circulating virus in Chicago, let’s jump on it,’ ” said a senior administration official involved in battling the outbreak. “We didn’t have that visibility.”

The first setback came when China refused to share samples of the virus, depriving U.S. researchers of supplies to bombard with drugs and therapies in a search for ways to defeat it. But even when samples had been procured, the U.S. effort was hampered by systemic problems and institutional hubris.

Among the costliest errors was a misplaced assessment by top health officials that the outbreak would probably be limited in scale inside the United States — as had been the case with every other infection for decades — and that the CDC could be trusted on its own to develop a coronavirus diagnostic test.

The CDC, launched in the 1940s to contain an outbreak of malaria in the southern United States, had taken the lead on the development of diagnostic tests in major outbreaks including Ebola, zika and H1N1. But the CDC was not built to mass-produce tests.

The CDC’s success had fostered an institutional arrogance, a sense that even in the face of a potential crisis there was no pressing need to involve private labs, academic institutions, hospitals and global health organizations also capable of developing tests.

Yet some were concerned that the CDC test would not be enough. Stephen Hahn, the FDA commissioner, sought authority in early February to begin calling private diagnostic and pharmaceutical companies to enlist their help.

FDA leaders were split on whether it would be bad optics for Hahn to be personally calling companies he regulated. When FDA officials consulted leaders at HHS, they understood it as a direction to stand down.

At that point, Azar, the HHS secretary, seemed committed to a plan he was pursuing that would keep his agency at the center of the response effort: securing a test from the CDC and then building a national coronavirus surveillance system by relying on an existing network of labs used to track the ordinary flu.

In task force meetings, Azar and Redfield pushed for $100 million to fund the plan, but were shot down because of the cost, according to a document outlining the testing strategy obtained by The Washington Post.

Relying so heavily on the CDC would have been problematic even if it had succeeded in quickly developing an effective test that could be distributed across the country. The scale of the epidemic, and the need for mass testing far beyond the capabilities of the flu network, would have overwhelmed the plan, which didn’t envision engaging commercial lab companies for up to six months.

The effort collapsed when the CDC failed its basic assignment to create a working test and the task force rejected Azar’s plan.

On Feb. 6, when the World Health Organization reported that it was shipping 250,000 test kits to labs around the world, the CDC began distributing 90 kits to a smattering of state-run health labs.

Almost immediately, the state facilities encountered problems. The results were inconclusive in trial runs at more than half the labs, meaning they couldn’t be relied upon to diagnose actual patients. The CDC issued a stopgap measure, instructing labs to send tests to its headquarters in Atlanta, a practice that would delay results for days.

The scarcity of effective tests led officials to impose constraints on when and how to use them, and delayed surveillance testing. Initial guidelines were so restrictive that states were discouraged from testing patients exhibiting symptoms unless they had traveled to China and come into contact with a confirmed case, when the pathogen had by that point almost certainly spread more broadly into the general population.

The limits left top officials largely blind to the true dimensions of the outbreak.

In a meeting in the Situation Room in mid-February, Fauci and Redfield told White House officials that there was no evidence yet of worrisome person-to-person transmission in the United States. In hindsight, it appears almost certain that the virus was taking hold in communities at that point. But even the country’s top experts had little meaningful data about the domestic dimensions of the threat. Fauci later conceded that as they learned more their views changed.

At the same time, as the president’s subordinates were growing increasingly alarmed, Trump continued to exhibit little concern. On Feb. 10, he held a political rally in New Hampshire attended by thousands where he declared that “by April, you know, in theory, when it gets a little warmer, it miraculously goes away.”

The New Hampshire rally was one of eight that Trump held after he had been told by Azar about the coronavirus, a period when he also went to his golf courses six times.

A day earlier, on Feb. 9, a group of governors in town for a black-tie gala at the White House secured a private meeting with Fauci and Redfield. The briefing rattled many of the governors, bearing little resemblance to the words of the president. “The doctors and the scientists, they were telling us then exactly what they are saying now,” Maryland Gov. Larry Hogan (R) said.

That month, federal medical and public health officials were emailing increasingly dire forecasts among themselves, with one Veterans Affairs medical adviser warning, ‘We are flying blind,’” according to emails obtained by the watchdog group American Oversight.

Later in February, U.S. officials discovered indications that the CDC laboratory was failing to meet basic quality-control standards. On a Feb. 27 conference call with a range of health officials, a senior FDA official lashed out at the CDC for its repeated lapses.

Jeffrey Shuren, the FDA’s director for devices and radiological health, told the CDC that if it were subjected to the same scrutiny as a privately run lab, “I would shut you down.”

On Feb. 29, a Washington state man became the first American to die of a coronavirus infection. That same day, the FDA released guidance, signaling that private labs were free to proceed in developing their own diagnostics.

Another four-week stretch had been squandered.

Life and death

One week later, on March 6, Trump toured the facilities at the CDC wearing a red “Keep America Great” hat. He boasted that the CDC tests were nearly perfect and that “anybody who wants a test will get a test,” a promise that nearly a month later remains unmet.

He also professed to have a keen medical mind. “I like this stuff. I really get it,” he said. “People here are surprised that I understand it. Every one of these doctors said, ‘How do you know so much about this?’ ”

In reality, many of the failures to stem the coronavirus outbreak in the United States were either a result of, or exacerbated by, his leadership.

For weeks, he had barely uttered a word about the crisis that didn’t downplay its severity or propagate demonstrably false information. He dismissed the warnings of intelligence officials and top public health officials in his administration.

At times, he voiced far more authentic concern about the trajectory of the stock market than the spread of the virus in the United States, railing at the chairman of the Federal Reserve and others with an intensity that he never seemed to exhibit about the possible human toll of the outbreak.

In March, as state after state imposed sweeping new restrictions on their citizens’ daily lives to protect them — triggering severe shudders in the economy — Trump second-guessed the lockdowns.

The common flu kills tens of thousands each year and “nothing is shut down, life & the economy go on,” he tweeted March 9. A day later, he pledged that the virus would “go away. Just stay calm.”

Two days later, Trump finally ordered the halt to incoming travel from Europe that his deputy national security adviser had been advocating for weeks. But Trump botched the Oval Office announcement so badly that White House officials spent days trying to correct erroneous statements that triggered a stampede by U.S. citizens overseas to get home.

“There was some coming to grips with the problem and the true nature of it — the 13th of March is when I saw him really turn the corner. It took a while to realize you’re at war,” Sen. Lindsey O. Graham (R-S.C.) said. “That’s when he took decisive action that set in motion some real payoffs.”

Trump spent many weeks shuffling responsibility for leading his administration’s response to the crisis, putting Azar in charge of the task force at first, relying on Pottinger, the deputy national security adviser, for brief periods, before finally putting Vice President Pence in the role toward the end of February.

Other officials have emerged during the crisis to help right the United States’ course, and at times, the statements of the president. But even as Fauci, Azar and others sought to assert themselves, Trump was behind the scenes turning to others with no credentials, experience or discernible insight in navigating a pandemic.

Foremost among them was his adviser and son-in-law, Jared Kushner. A team reporting to Kushner commandeered space on the seventh floor of the HHS building to pursue a series of inchoate initiatives.

One plan involved having Google create a website to direct those with symptoms to testing facilities that were supposed to spring up in Walmart parking lots across the country, but which never materialized. Another centered on an idea advanced by Oracle chairman Larry Ellison to use software to monitor the unproven use of anti-malaria drugs against the coronavirus pathogen.

So far, the plans have failed to come close to delivering on the promises made when they were touted in White House news conferences. The Kushner initiatives have, however, often interrupted the work of those under immense pressure to manage the U.S. response.

Current and former officials said that Kadlec, Fauci, Redfield and others have repeatedly had to divert their attentions from core operations to contend with ill-conceived requests from the White House they don’t believe they can ignore. And Azar, who once ran the response, has since been sidelined, with his agency disempowered in decision-making and his performance pilloried by a range of White House officials, including Kushner.

“Right now Fauci is trying to roll out the most ambitious clinical trial ever implemented” to hasten the development of a vaccine, said a former senior administration official in frequent touch with former colleagues. And yet, the nation’s top health officials “are getting calls from the White House or Jared’s team asking, ‘Wouldn’t it be nice to do this with Oracle?’ ”

If the coronavirus has exposed the country’s misplaced confidence in its ability to handle a crisis, it also has cast harsh light on the limits of Trump’s approach to the presidency — his disdain for facts, science and experience.

He has survived other challenges to his presidency — including the Russia investigation and impeachment — by fiercely contesting the facts arrayed against him and trying to control the public’s understanding of events with streams of falsehoods.

The coronavirus may be the first crisis Trump has faced in office where the facts — the thousands of mounting deaths and infections — are so devastatingly evident that they defy these tactics.

After months of dismissing the severity of the coronavirus, resisting calls for austere measures to contain it, and recasting himself as a wartime president, Trump seemed finally to succumb to the coronavirus reality. In a meeting with a Republican ally in the Oval Office last month, the president said his campaign no longer mattered because his reelection would hinge on his coronavirus response.

“It’s absolutely critical for the American people to follow the guidelines for the next 30 days,” he said at his March 31 news conference. “It’s a matter of life and death.”

The Lost Month: How a Failure to Test Blinded the U.S. to Covid-19
Aggressive screening might have helped contain the coronavirus in the United States. But technical flaws, regulatory hurdles and lapses in leadership let it spread undetected for weeks.

link https://www.nytimes.com/2020/03/28/us/testing-coronavirus-pandemic.html

WASHINGTON — Early on, the dozen federal officials charged with defending America against the coronavirus gathered day after day in the White House Situation Room, consumed by crises. They grappled with how to evacuate the United States consulate in Wuhan, China, ban Chinese travelers and extract Americans from the Diamond Princess and other cruise ships.

The members of the coronavirus task force typically devoted only five or 10 minutes, often at the end of contentious meetings, to talk about testing, several participants recalled. The Centers for Disease Control and Prevention, its leaders assured the others, had developed a diagnostic model that would be rolled out quickly as a first step.

But as the deadly virus from China spread with ferocity across the United States between late January and early March, large-scale testing of people who might have been infected did not happen — because of technical flaws, regulatory hurdles, business-as-usual bureaucracies and lack of leadership at multiple levels, according to interviews with more than 50 current and former public health officials, administration officials, senior scientists and company executives.

The result was a lost month, when the world’s richest country — armed with some of the most highly trained scientists and infectious disease specialists — squandered its best chance of containing the virus’s spread. Instead, Americans were left largely blind to the scale of a looming public health catastrophe.

The absence of robust screening until it was “far too late” revealed failures across the government, said Dr. Thomas Frieden, the former C.D.C. director. Jennifer Nuzzo, an epidemiologist at Johns Hopkins, said the Trump administration had “incredibly limited” views of the pathogen’s potential impact. Dr. Margaret Hamburg, the former commissioner of the Food and Drug Administration, said the lapse enabled “exponential growth of cases.”

And Dr. Anthony S. Fauci, a top government scientist involved in the fight against the virus, told members of Congress that the early inability to test was “a failing” of the administration’s response to a deadly, global pandemic. “Why,” he asked later in a magazine interview, “were we not able to mobilize on a broader scale?”

Across the government, they said, three agencies responsible for detecting and combating threats like the coronavirus failed to prepare quickly enough. Even as scientists looked at China and sounded alarms, none of the agencies’ directors conveyed the urgency required to spur a no-holds-barred defense.

Dr. Robert R. Redfield, 68, a former military doctor and prominent AIDS researcher who directs the C.D.C., trusted his veteran scientists to create the world’s most precise test for the coronavirus and share it with state laboratories. When flaws in the test became apparent in February, he promised a quick fix, though it took weeks to settle on a solution.

The C.D.C. also tightly restricted who could get tested and was slow to conduct “community-based surveillance,” a standard screening practice to detect the virus’s reach. Had the United States been able to track its earliest movements and identify hidden hot spots, local quarantines might have confined the disease.

Dr. Stephen Hahn, 60, the commissioner of the Food and Drug Administration, enforced regulations that paradoxically made it tougher for hospitals, private clinics and companies to deploy diagnostic tests in an emergency. Other countries that had mobilized businesses were performing tens of thousands of tests daily, compared with fewer than 100 on average in the United States, frustrating local health officials, lawmakers and desperate Americans.

Alex M. Azar II, who led the Department of Health and Human Services, oversaw the two other agencies and coordinated the government’s public health response to the pandemic. While he grew frustrated as public criticism over the testing issues intensified, he was unable to push either agency to speed up or change course.

Mr. Azar, 52, who chaired the coronavirus task force until late February, when Vice President Mike Pence took charge, had been at odds for months with the White House over other issues. The task force’s chief liaison to the president was Mick Mulvaney, the acting White House chief of staff, who was being forced out by Mr. Trump. Without high-level interest — or demands for action — the testing issue festered.

At the start of that crucial lost month, when his government could have rallied, the president was distracted by impeachment and dismissive of the threat to the public’s health or the nation’s economy. By the end of the month, Mr. Trump claimed the virus was about to dissipate in the United States, saying: “It’s going to disappear. One day — it’s like a miracle — it will disappear.”

By early March, after federal officials finally announced changes to expand testing, it was too late. With the early lapses, containment was no longer an option. The tool kit of epidemiology would shift — lockdowns, social disruption, intensive medical treatment — in hopes of mitigating the harm.

Now, the United States has more than 100,000 coronavirus cases, the most of any country in the world. Deaths are rising, cities are shuttered, the economy is sputtering and everyday life is upended. And still, many Americans sickened by the virus cannot get tested.

In a statement, Judd Deere, a White House spokesman, said that “any suggestion that President Trump did not take the threat of Covid-19 seriously or that the United States was not prepared is false.” He added that at Mr. Trump’s direction, the administration had “expanded testing capacities.”

Dr. Bruce Aylward, a senior adviser at the World Health Organization, led an expert team to China last month to research the mysterious new virus. Testing, he said, was “absolutely vital” for understanding how to defeat a disease — what distinguishes it from others, the spectrum of illness and, most important, its path through populations.

“You want to know whether or not you have it,” Dr. Aylward said. “You want to know whether the people around you have it. Because you know what? Then you could stop it.”

“You can’t stop it,” he warned, “if you can’t see it.”

A Startling Setback

The first time Dr. Robert Redfield heard about the severity of the virus from his Chinese counterparts was around New Year’s Day, when he was on vacation with his family. He spent so much time on the phone that they barely saw him. And what he heard rattled him; in one grim conversation about the virus days later, George F. Gao, the director of the Chinese Center for Disease Control and Prevention, burst into tears.

Dr. Redfield, a longtime AIDS researcher, had never run a government agency before his appointment to lead the C.D.C. in 2018. Until then, his biggest priorities had been fighting the opioid epidemic and the spread of H.I.V. Suddenly, a man who preferred treating patients in Haiti or Africa to being in the public glare was facing a new pandemic threat.

At first, Dr. Redfield’s agency moved quickly.

On Jan. 7, the C.D.C. created an “incident management system” for the coronavirus and advised travelers to Wuhan to take precautions. By Jan. 20, just two weeks after Chinese scientists shared the genetic sequence of the virus, the C.D.C. had developed its own test, as usual, and deployed it to detect the country’s first coronavirus case.

“That’s our prime mission,” Dr. Redfield said later in an interview, “to get eyes on this thing.”

Assessing the virus would prove challenging. It was so new that scientists had little information to work with. China provided limited data, and rebuffed an early attempt by Mr. Azar and Dr. Redfield to send C.D.C. experts there to learn more. That the virus could cause no symptoms and still spread — something not initially known — made it all the more difficult to understand.

To identify the virus, the C.D.C. test used three small genetic sequences to match up with portions of a virus’s genome extracted from a swab. A German-developed test that the W.H.O. was distributing to other countries used just two, potentially making it less precise.

But soon after the F.D.A. cleared the C.D.C. to share its test kits with state health department labs, some discovered a problem. The third sequence, or “probe,” gave inconclusive results. While the C.D.C. explored the cause — contamination or a design issue — it told those state labs to stop testing.

The startling setback stalled the C.D.C.’s efforts to track the virus when it mattered most. By mid-February, the nation was testing only about 100 samples per day, according to the C.D.C.’s website.

Dr. Redfield played down the problem in task force meetings and conversations with Mr. Azar, assuring him it would be fixed quickly, several administration officials said.

With capacity so limited, the C.D.C.’s criteria for who was tested remained extremely narrow for weeks to come: only people who had recently traveled to China or had been in contact with someone who had the virus.

A string of critical errors.

The lack of tests in the states also meant local public health officials could not use another essential epidemiological tool: surveillance testing. To see where the virus might be hiding, nasal swab samples from people screened for the common flu would also be checked for the coronavirus.

The C.D.C. announced a plan on Feb. 14 to perform the screening in five high-risk cities: New York, Chicago, Los Angeles, San Francisco and Seattle. An agency official said it could provide “an early warning signal to trigger a change in our response strategy.” But most of the cities could not carry it out.

“Had we had done more testing from the very beginning and caught cases earlier,” said Dr. Nuzzo, of Johns Hopkins, “we would be in a far different place.”

The consequences became clear by the end of February. For the first time, someone with no known exposure to the virus or history of travel tested positive, in the Seattle area, where the U.S.’s first case had been detected more than a month earlier. The virus had probably been spreading there and elsewhere for weeks, researchers later concluded. Without a more complete picture of who had been infected, public health workers could not do “contact tracing” — finding all those with whom any contagious people had interacted and then quarantining them to stop further transmission.

The C.D.C. gave little thought to adopting the test being used by the W.H.O. The C.D.C.’s test was working in its own lab — still processing samples from states — which gave agency officials confidence. Dr. Anne Schuchat, the agency’s principal deputy director, would later say that the C.D.C. did not think “we needed somebody else’s test.”

And the German-designed W.H.O. test had not been through the American regulatory approval process, which would take time.

Throughout February, Dr. Redfield shuttled between Atlanta, where the C.D.C. is based, and Washington, holding multiple calls every day with Mr. Azar and participating in the coronavirus task force.

Mr. Azar’s take-charge style contrasted with the more deliberative manner of Dr. Redfield, who lacked the kind of commanding television presence that impressed Mr. Trump. He was “a consensus person,” as one colleague described him, who sought to avoid conflict. He relied heavily on some of the C.D.C.’s career scientists, like Dr. Schuchat and Dr. Nancy Messonnier, the director of the agency’s National Center for Immunization and Respiratory Diseases.

Under scrutiny from Congress, Dr. Redfield offered reassurances. Responding on Feb. 24 to a letter from 49 members of Congress about the need for testing in the states, he wrote, “CDC’s aggressive response enables us to identify potential cases early and make sure that they are properly handled.”

Days later, his agency provided a workaround, telling state and local health department labs that they could finally begin testing. Rather than awaiting replacements, they should use their C.D.C. test kits and leave out the problematic third probe.

Meanwhile, the agency’s epidemiologists were growing more concerned as the virus spread in South Korea and Italy. On Feb. 25, Dr. Messonnier gave a briefing with a much blunter warning than usual. “Disruption to everyday life might be severe,” she said.

Mr. Trump, returning from a trip to India, was furious, according to senior administration officials. Later that day, Mr. Azar seemed to be tamping down the level of concern. All Dr. Messonnier had meant, he said at a news conference, was that people should “start thinking about, in their own lives, what that might involve.”

“Might,” Mr. Azar repeated emphatically. “Might involve.”

Barriers to Testing

Dr. Stephen Hahn’s first day as F.D.A. commissioner came just six weeks before Mr. Azar declared a public health emergency on Jan. 31. A radiation oncologist and researcher who helped turn around MD Anderson in Houston, one of the nation’s leading cancer centers, Dr. Hahn had come to Washington to oversee a sprawling federal agency that regulates everything from lifesaving therapies to dog food.

But overnight, his mission — to manage 15,000 employees in a culture defined by precision and caution — was upended. A pathogen that Mr. Trump would later call the “invisible enemy” was hurtling toward the United States. It would fall to the newly arrived Dr. Hahn to help build a huge national capacity for testing by academic and private labs.

Instead, under his leadership, the F.D.A. became a significant roadblock, according to current and former officials as well as researchers and doctors at laboratories around the country.

Private-sector tests were supposed to be the next tier after the C.D.C. fulfilled its obligation to jump-start screening at public labs. In other countries hit hard by the coronavirus, governments acted quickly to speed tests to their populations. In South Korea, for example, regulators in early February summoned executives from 20 medical manufacturers, easing rules as they demanded tests.

But Dr. Hahn took a cautious approach. He was not proactive in reaching out to manufacturers, and instead deferred to his scientists, following the F.D.A.’s often cumbersome methods for approving medical screening.

Even the nation’s public health labs were looking for the F.D.A.’s help. “We are now many weeks into the response with still no diagnostic or surveillance test available outside of C.D.C. for the vast majority of our member laboratories,” Scott Becker, chief executive of the Association of Public Health Laboratories, wrote to Mr. Hahn in late February. “We believe a more expeditious route is needed at this time.”

Ironically, it was Mr. Azar’s emergency declaration that established the rules Dr. Hahn insisted on following. Designed to make it easier for drugmakers to pursue vaccines and other therapies during a crisis, such a declaration lets the F.D.A. speed approvals that could otherwise take a year or more.

But the emergency announcement created a new barrier for hospitals and laboratories that wanted to create their own tests to diagnose the coronavirus. Usually, they faced minimal federal regulation. But once Mr. Azar took action, they were subject to an F.D.A. process called an “emergency use authorization.”

Even though researchers around the country quickly began creating tests that could diagnose Covid-19, many said they were hindered by the F.D.A.’s approval process. The new tests sat unused at labs around the country.

Stanford was one of them. Researchers at the world-renowned university had a working test by February, based on protocols published by the W.H.O. The organization had already delivered more than 250,000 of the German-designed tests to 70 laboratories around the world, and doctors at the Stanford lab wanted to be prepared for a pandemic.

“Even if it didn’t come, it would be better to be ready than not to be ready,” said Dr. Benjamin Pinsky, the lab’s medical director.

But in the face of what he called “relatively tight” rules at the F.D.A., Dr. Pinsky and his colleagues decided against even trying to win permission. The Stanford clinical lab would not begin testing coronavirus samples until early March, when Dr. Hahn finally relaxed the rules.

Executives at bioMérieux, a French diagnostics company, had a similar experience. The company makes a countertop testing system, BioFire, that is routinely used to check for the flu and other respiratory illnesses in 1,700 hospitals around the country. It can provide results in about 45 minutes.

“A lot of us said, you know, your typical E.U.A. is just much too demanding,” said Dr. Mark Miller, the company’s chief medical officer, referring to the emergency approval. “It’s going to take much too much time. And can’t you do something to shorten that?”

Officials at the F.D.A. tried to be responsive, Dr. Miller said. But rather than throw out the rules, the agency only modified the regulatory requirements, still requiring weeks of discussions and negotiations.

After conversations with the F.D.A. in mid-February, the company received emergency approval for its BioFire test on March 24. (The company also began talking to the F.D.A. in January about another type of test, but decided not to pursue it in the United States for now.) Dr. Miller said that while he was ultimately satisfied with the F.D.A.’s actions, the overall response by the government was too slow, especially when it came to logistical questions like getting enough testing supplies to those who needed them.

“You’ve got other countries — and I’m sorry, unfortunately, the U.S. is one of those — where they’ve been slow, disorganized,” he said. “There are still not enough tests available there to test everybody who needs it.”

In an emailed statement, Dr. Hahn maintained that his agency had moved as quickly as it safely could to ensure that tests would be accurate. “Since the early days of this pandemic,” he said, “the F.D.A.’s doors have always been and still remain open to test developers.”

A Lack of Trust

Alex Azar had sounded confident at the end of January. At a news conference in the hulking H.H.S. headquarters in Washington, he said he had the government’s response to the new coronavirus under control, pointing out high-ranking jobs he had held in the department during the 2003 SARS outbreak and other infectious threats.

“I know this playbook well,” he told reporters.

A Yale-trained lawyer who once served as the top attorney at the health department, Mr. Azar had spent a decade as a top executive at Eli Lilly, one of the world’s largest drug companies. But he caught Mr. Trump’s attention in part because of other credentials: After law school, Mr. Azar was a clerk for some of the nation’s most conservative judges, including Justice Antonin Scalia of the Supreme Court. And for two years, he worked as Ken Starr’s deputy on the Clinton Whitewater investigation.

As Mr. Trump’s second health secretary, confirmed at the beginning of 2018, Mr. Azar has been quick to compliment the president and focus on the issues he cares about: lowering drug prices and fighting opioid addiction. On Feb. 6 — even as the W.H.O. announced that there were more than 28,000 coronavirus cases around the globe — Mr. Azar was in the second row in the White House’s East Room, demonstrating his loyalty to the president as Mr. Trump claimed vindication from his impeachment acquittal the day before and lashed out at “evil” lawmakers and the F.B.I.’s “top scum.”

As public attention on the virus threat intensified in January and February, Mr. Azar grew increasingly frustrated about the harsh spotlight on his department and the leaders of agencies who reported to him, according to people familiar with the response to the virus inside the agencies.

Described as a prickly boss by some administration officials, Mr. Azar has had a longstanding feud with Seema Verma, the Medicare and Medicaid chief, who recently became a regular presence at Mr. Trump’s televised briefings on the pandemic. Mr. Azar did not include Dr. Hahn on the virus task force he led, though some of the F.D.A. commissioner’s aides participated in H.H.S. meetings on the subject.

And tensions grew between the secretary and Dr. Redfield as the testing issue persisted. Mr. Azar and Dr. Redfield have been on the phone as often as a half-dozen times a day. But throughout February, as the C.D.C. test faltered, Mr. Azar became convinced that Dr. Redfield’s agency was providing him with inaccurate information about testing that the secretary repeated publicly, according to several administration officials.

In one instance, Mr. Azar appeared on Sunday morning news programs and said that more than 3,600 people had been tested for the virus. In fact, the real number was much smaller because many patients were tested multiple times, an error the C.D.C. had to correct in congressional testimony that week. One health department official said Mr. Azar was repeatedly assured that the C.D.C.’s test would be widely available within a week or 10 days, only to be given the same promise a week later.

Asked about criticism of his agency’s response to the pandemic, Dr. Redfield said: “I’m personally not focused on whether they’re pointing fingers here or there. We’re focused on doing all we can to get through this outbreak as quickly as possible and keep America safe.”

For all Mr. Azar’s complaints, however, he continued to defer to the scientists at the two agencies, according to several administration officials. Mr. Azar’s allies said he was told by Dr. Redfield and Dr. Fauci that the C.D.C. had the resources it needed, that there was no reason to believe the virus was spreading through the country from person to person and that it was important to test only people who met certain criteria.

But even in the face of a crescendo of complaints from doctors and health care researchers around the country, Mr. Azar failed to push those under him to do the one thing that could have helped: broader testing.

In a statement, Caitlin Oakley, Mr. Azar’s spokeswoman, said that the secretary had “empowered and followed the guidance of world-renowned U.S. scientists” on the testing issue. “Any insinuation that Secretary Azar did not respond with needed urgency to the response or testing efforts,” she said, “are just plain wrong and disproven by the facts.”

By Feb. 26, Dr. Fauci was concerned that the stalled testing had become an urgent issue that needed to be addressed. He called Brian Harrison, Mr. Azar’s chief of staff, and asked him to gather the group of officials overseeing screening efforts.

Around noon on Feb. 27, Dr. Hahn, Dr. Redfield and top aides from the F.D.A. and H.H.S. dialed in to a conference call. Mr. Harrison began with an ultimatum: No one leaves until we resolve the lag in testing. We don’t have answers and we need them, one senior administration official recalled him saying. Get it done.

By the end of the day, the group agreed that the F.D.A. should loosen regulations so that hospitals and independent labs could move forward quickly with their own tests.

But the evening before, Mr. Azar had been effectively removed as the leader of the task force when Mr. Trump abruptly put Mr. Pence in charge, a decision so last-minute that even the top health officials in the White House learned of it while watching the announcement.

Previous presidents have moved quickly to confront disease threats from inside the White House by installing a “czar” to manage the effort.

During an outbreak of the Ebola virus in 2014, President Barack Obama tapped Ron Klain, his vice president’s former chief of staff, to direct the response from the West Wing. Mr. Obama later created an office of global health security inside the National Security Council to coordinate future crises.

“If you look historically in the United States when it is challenged with something like this — whether it’s H.I.V. crises, whether it’s pandemic, whether it’s whatever — man, they pull out all the stops across the system and they make it work,” said Dr. Aylward, the W.H.O. epidemiologist.

But faced with the coronavirus, Mr. Trump chose not to have the White House lead the planning until nearly two months after it began. Mr. Obama’s global health office had been disbanded a year earlier. And until Mr. Pence took charge, the task force lacked a single White House official with the power to compel action.

Since then, testing has ramped up quickly, with nearly 100 labs at hospitals and elsewhere performing it. On Friday, the health care giant Abbott said it had received emergency approval for a portable test that could detect the virus in five minutes.

The president boasted on Tuesday that the United States had “created a new system that now we are doing unbelievably big numbers” of tests for the virus. The U.S., he said, had done more testing for the coronavirus in the last eight days than South Korea had done in eight weeks.

Yet hospitals and clinics across the country still must deny tests to those with milder symptoms, trying to save them for the most serious cases, and they often wait a week for results. In tacit acknowledgment of the shortage, Mr. Trump asked South Korea’s president on Monday to send as many test kits as possible from the 100,000 produced there daily, more than the country needs.

Public health experts reacted positively to the increased capacity. But having the ability to diagnose the disease three months after it was first disclosed by China does little to address why the United States was unable to do so sooner, when it might have helped reduce the toll of the pandemic.

“Testing is the crack that split apart the rest of the response, when it should have tied everything together,” said Dr. Nahid Bhadelia, ​the medical director of the Special Pathogens Unit at Boston University School of Medicine.

“It seeps into every other aspect of our response, touches all of us,” she said. “The delay of the testing has impacted the response across the board.”

=======================
Analysis of outcomes in 50k chinese people with covid-19

Posted by dan on March 20, 2020, 9:03 pm

Tweet from @Menon_Cambridge: Rigorous analysis of~50k Wuhan cases. Case fatality for COVID-19 =1.4% in symptomatic patients (below past estimates). OR for death 0.6 in those <30; and 5.1 in those >59 y. Risk of symptomatic infection increased ~4% per year between 30 & 60 years.

link:https://www.nature.com/articles/s41591-020-0822-7.epdf

How the Coronavirus Became an American Catastrophe
The death and economic damage sweeping the United States could have been avoided—if only we had started testing for the virus sooner.

MARCH 21, 2020

https://www.theatlantic.com/health/archive/2020/03/how-many-americans-are-sick-lost-february/608521/

How many people are sick with the coronavirus in the United States, and when did they get sick?
These are crucial questions to answer, but they have never been answered well. Archived data from the Centers for Disease Control and Prevention—illustrated in the chart below—reveal that the government dramatically misunderstood what was happening in America as the outbreak began.
On the last day of February, the CDC reported that 15 Americans had tested positive for COVID-19, the disease caused by the coronavirus.

In the past week, as the country’s testing capacity has increased, officials have discovered more cases. Today, more than 17,000 people have tested positive.

That may sound like a lot. But experts believe that the United States still isn’t testing enough people to detect the outbreak’s true spread. The virologist Trevor Bedford has found evidence that the coronavirus began spreading in the United States in January. It has already infected approximately 87,000 Americans, he says.

The truth is: We don’t know how many Americans are infected with the coronavirus.
The United States is a country soon to be overrun with sick people. As the positive tests for the new coronavirus have ticked upward, so, inevitably, will the deaths.

When Wuhan began burning with infections in December, the U.S. government took only illogical, inadequate actions to stop the virus’s spread: It banned foreigners from entering from China, but inconsistently monitored Americans returning from the country. The president laughed off the virus and the Democrats’ response to it, calling it their “new hoax,” which immediately polarized the citizenry’s response to precautionary public-health information. When the sparks of this conflagration hit, Seattle was aflame before anyone at the CDC had started to reach for water.

What’s happening here, in this country, was avoidable. Nearly every flaw in America’s response to the virus has one source: America did not test enough people for COVID-19.

Testing should have told doctors how to triage patients and hospitals when to prepare their wards. It should have allowed governors to gauge the severity of a local outbreak and informed federal officials as they allocated scarce masks and ventilators. Testing should have answered the all-important question in any pandemic: How many people are sick right now? Had the nation known that, the systems that were put into place over years of pandemic planning could have powered on, protecting millions of Americans and containing the illness.

Instead, the CDC botched its own test development. It sent testing kits to state public-health labs with a nonfunctioning ingredient. And by then, the virus was already spreading. It was already spreading as the Food and Drug Administration held up independent labs that had made their own tests. It was spreading as samples piled up, as the world’s top virology researchers pleaded to be permitted to test them and as the FDA denied their requests.

The virus was spreading as a delay in test kits became a national shortage. When community transmission in the United States was discovered, and states and hospitals lacked the supplies to diagnose even a dangerously ill patient, it was spreading. When a week passed, and the market began to collapse, and the country had barely tested 1,000 people, it was still spreading. Even as kits started to trickle out, the CDC and many state officials clung to restrictive rules that allowed only patients who had traveled internationally or been exposed to a known case to be tested, even though the coronavirus was already clearly spreading in American offices, day cares, and movie theaters. Doctors and nurses with all the symptoms of COVID-19 were denied tests because they could not prove exposure. The virus was still spreading.

Every six days that the country did not test, every six days that it did not act, the number of infected Americans doubled.

“The way no one expected how this response would fail in the U.S. is the testing,” Nahid Bhadelia, the medical director of the Special Pathogen Unit at Boston University School of Medicine, told us. She is an expert in infectious diseases and pandemics, and oversees the medical-response program at one of the few labs in the country permitted to handle the pathogens that cause Ebola, anthrax, and the bubonic plague.

“If you don’t know where the disease is early in the epidemic, you have no hope of containing it,” Bhadelia said. “Even now, [testing is] that Achilles’ heel; it’s the crack that is making its way throughout our entire response.”

Without testing, there was only one way to know the severity of the outbreak: counting the dead. On February 29, Washington State confirmed that a man who had been at the Life Care Center outside Seattle had died, the first American death officially attributed to the virus. According to a now-archived version of the CDC’s website, the United States had, by then, tested 472 total people.

The death came at the end of a month that was America’s last chance at containing COVID-19. But it was too late. February had been lost.

On the last day of January, Trevor Bedford, a scientist at the Fred Hutchinson Cancer Research Center, in Seattle, hit Publish on a 484-word blog post that should have shaken the nation.

Bedford is one of the country’s experts on the evolution and infectiousness of viruses. Virus genomes are like tree rings: They provide clues to where a virus came from and how many times it’s been passed from person to person. With the outbreak raging in Wuhan, Bedford had been studying the genetic sequences of the new coronavirus that Chinese researchers had posted. By January 11, six were in the record, which allowed him to reconstruct the relationships between the individual strains. Though the World Health Organization insisted that this new coronavirus had “limited human-to-human transmission,” the genomes told Bedford otherwise. Whatever this virus was, he suspected it could spread easily among strangers, like the common cold or the flu.

Six days later, when a pair of travelers in Thailand came down with a similar illness, and researchers published the genome of the virus that had infected them, Bedford’s worst fears were confirmed. An epidemic had already begun. The new coronavirus had slipped the cordon in Wuhan, and was out in the world.

“As this became clear to me, I spent the week of Jan 20 alerting every public health official I know,” Bedford wrote that month. On January 23, the Chinese government, which had spent weeks trying to cover up the virus, swung into action. It locked down the city of Wuhan and by mid-February had restricted the movement of 700 million people. On January 24, the CDC announced it had developed a test for the disease. The FDA wouldn’t approve it for another week and a half.

This was the moment that epidemiologists had spent years dreading and anticipating. Almost every city and state in America had a pandemic-preparedness plan, reams of paper ready to put into action.

King County, in which Seattle and Kirkland sit, had a plan, of course. The last revision, dated October 2013, forecast the consequences of a pandemic flu in now-eerie detail. The country, they predicted, would be faced with deaths that could range into the millions. The pandemic “has the potential to suddenly cause illness in a very large number of people, who could easily overwhelm the healthcare system throughout the nation.” No vaccines would be available at first. Community services could break down. Everything could become disrupted “for several weeks, if not months.” So many of the steps that then seemed unthinkable to regular people—closing schools for months, social distancing, curfews, and more—were not only contemplated but gamed out.

Except for one thing. The plan took as a given that a functional testing apparatus would catch diseases on the way in, or at least before the fire started raging. Under its “Planning Assumptions” section, the second bullet point read, “There will be a need for heightened global, national and local surveillance.” Surveillance is public-health jargon for testing and the system that surrounds it. The planners knew there would be a need; they barely considered that it would not be met.

“A heightened local surveillance system … serves as an early warning system for potential pandemics and a critical component of pandemic response plans,” they wrote in another section of the report. “Local surveillance during a pandemic outbreak provides important information regarding the severity of disease, characteristics of the affected population, and impacts on the healthcare system.”

For every contingency that was considered, every difficulty and problem was assumed to be downstream of the high-quality information that would flow from the testing system. Without data about American cases in hand, how to handle the virus would become a matter of guesswork, not judgment.

In late January, as Bedford began to warn public-health officials, there remained, according to the president, nothing to worry about. “We have it totally under control,” President Donald Trump said at Davos. “It’s one person coming in from China, and we have it under control. It’s going to be just fine.”

On or about January 15, someone infected by the coronavirus arrived in the Seattle area, Bedford’s research would later show. The virus began to silently spread in the region. It would not be detected for another six weeks.

If there is one thing about the novel coronavirus that you must understand, it’s that it is a firecracker with a long fuse. Here is what the explosion looks like: Every six days, the number of people infected by the disease doubles, according to estimates from Bedford and other epidemiologists. At the start of February, Bedford now believes, the United States had something like 430 infections; if American interventions have done nothing to slow the disease’s spread, then his simple calculations show that more than 120,000 people could be infected by this weekend. Because of the great uncertainty, it’s probably most appropriate to give Bedford’s range: About 60,000 to 245,000 people are now infected with COVID-19 in the United States.

An invisible fuse sets off this burst of disease. If someone is infected with the coronavirus on Monday, she may start being contagious and infecting other people by Wednesday. But she may not start showing symptoms until Friday—meaning that she was spreading the virus before she even knew she had it. And in some cases, infected people take 14 days to start showing symptoms.

The onset of symptoms starts another awful clock. Many people will recover in a few weeks. But if someone’s case is severe, he may not recover for a month. And even if someone’s case is fatal, she may still survive for three weeks. This means that, first, cases discovered now may not become deaths for weeks; second, some people who will die in early April may only start showing symptoms today.

Mitigation efforts must burn through the same fuse. Even the decision to lock down the Bay Area, the country’s richest region, will not relieve pressure on the medical system for weeks.

Both of these factors mean that time is of the essence. This virus hides effectively and doubles quickly, but it kills slowly and painfully, and it kills most effectively when medical care isn’t available. This makes the coronavirus a particular disaster for the American hospital system, which after decades of streamlining has little spare capacity.

If the coronavirus was in the United States, it had to be found early, before too many explosions could go off.

Helen Y. Chu, an infectious-disease specialist at the University of Washington, thought she had a way to detect COVID-19’s arrival. She directed a monitoring program called the Seattle Flu Study, which studied the spread of the seasonal flu and collected samples from sick people on an ongoing basis. What if some of those patients didn’t have the flu at all, but COVID-19? In January, she and her colleagues began asking federal and state officials for permission to repurpose specimens to test for this other, similar respiratory disease, according to The New York Times. They turned her down then—and they kept rejecting her requests as the weeks wore on. There were legitimate privacy concerns, and government officials were not ready to authorize Chu to look.

On the last day of January, roughly 380 people were already infected with the coronavirus, most of them in the Seattle area, according to Bedford’s estimate. (Bedford is also part of the Seattle Flu Study.)

But then the CDC hit a disastrous roadblock, as it began to send test kits to public-health labs across the country. Two of the test’s reagents were fine, in most cases, but a third chemical initially deemed necessary for the test simply did not work. For the time being, every test for COVID-19 would have to be conducted by the CDC.

As the CDC struggled to find a solution, other laboratories tried to bring their own tests online. They found themselves hamstrung by the FDA, which, though it repeatedly loosened the rules, could not move as fast as the coronavirus.

Alex Greninger, the assistant director of the clinical virology laboratory at the University of Washington, wanted to run a test of the lab’s own design. His lab would end up being one of the fastest to set up testing, and become the most important early source of information about the growth of the outbreak. But initially he, too, found himself caught up in the bureaucratic gears. On February 14, he sent a frustrated email to other clinical laboratories. The obstacles to setting up a test were unbelievable, he wrote: The FDA was asking him to show test results for more specimens than there were confirmed coronavirus cases in the United States—and the FDA wasn’t even making samples from those cases available to him. (The FDA did not immediately respond to The Atlantic’s request for comment.)

No one at the federal level was moving fast enough to actually deal with the looming disaster. “The most pernicious effect of the current regulatory environment is that it kneecaps our ability for preparedness should a true emergency emerge,” Greninger wrote to other laboratory directors. “Why bother getting ready as a clinical lab if you think that you won’t ever be allowed to do anything until May or June?” Even after his lab got FDA approval, another two to three weeks would pass before it could actually test a large number of samples. In coronavirus time, three weeks is about how long it takes for 100 cases to become more than 1,000. “We’ve been exceptionally fortunate to have so few positive cases,” he wrote. “Should that change in the coming weeks, this month will have been the time when we could have expanded our capacity for testing by including clinical labs.”

But the entire American testing effort, which would provide the crucial surveillance capability to understand any incipient outbreak, had stalled. The days ticked by; the virus spread. American public-health labs—which generally have far more capacity than the CDC—had completed only 16 tests, maybe a handful of people, by mid-February. All the way to February 26, only 102 specimens, or perhaps 50 people, had been tested by those labs. Overall, the CDC had tested fewer than 500 people. If the U.S. had a small number of cases, it was only because no one was looking for them. “We just twiddled our thumbs as the coronavirus waltzed in,” William Hanage, a Harvard epidemiologist, wrote in The Washington Post.

Perhaps because of the wildly constrained supply of tests, the criteria to get one were strict. You basically had to go to Wuhan, lick someone, and then develop pneumonia. No one from the federal government even tried to look for community transmission in the United States. In late February, the president voiced his hopes that “the numbers are going to get progressively better as we go along.”

They would not. In fact, as Trump spoke, the virus had reached a nursing home in the Seattle suburb of Kirkland, where it has so far killed 35 residents. The staff knew a mysterious virus was circulating, but life went on as normal. A concerned visitor who had gone to a Mardi Gras party at the center reached out to King County Public Health, the Los Angeles Times reported, and got the runaround.

On February 26, the CDC confirmed what should have been clear much earlier: Community transmission in the United States had begun. The coronavirus was now spreading among Americans who had not traveled abroad or known a confirmed case. At least 60 people in the country now had the virus, according to the CDC’s totals at the time—and, as researchers and analysts soon realized, the true number was almost certainly much higher.

The CDC’s website now says that there were already 268 cases in the United States by that date. When Japan had nearly as many confirmed cases, it closed every school in the country. But because of the testing backlog, the United States remained unaware of its infection rate. And the president encouraged happy thinking. As CDC officials warned that the number of cases could soon quickly rise, Trump disagreed. “Within a couple of days,” he said, the number of cases “is going to be down to close to zero. That’s a pretty good job we’ve done.”

Bedford now estimates that roughly 7,640 people in the United States were already infected.

Chu, the Seattle infectious-disease specialist, decided not to wait for government officials any longer. As the United States declared the first cases of community transmission, she tested through Greninger’s lab without official approval and got a positive. The meaning was obvious to her. “It’s just everywhere already,” she later told The New York Times.

Under pressure to get tests out, the most important fix that our national agencies could make was to simply allow labs to start testing people. In a description that has now been removed from the CDC’s website, the agency gave labs simple instructions: They should use the two working reagents in the old kits. These instructions could have gone out weeks before they actually did, Greninger says, because they relied on the supplies that the CDC had already sent.

Meanwhile, Bedford began examining the new coronavirus strains from patients in Washington State, just as he had, six weeks earlier, analyzed the Asian samples. The Seattle-area specimens led him to a devastating conclusion: The viral genomes were too similar to have arrived in the United States at different times, from different people, but they were also too varied to have arrived recently. By the end of February, the disease had not only established itself in the United States. It had been circulating for close to six weeks. Seattle, on March 1, found itself in the same position as Wuhan did on January 1, with a growing coronavirus outbreak that was on the verge of exploding.

If Seattle went the route of Wuhan, the nation had three weeks before being set on a track in which hundreds or even thousands of people might die in Washington State alone. If a fire was raging in Seattle, it would throw off sparks across the country, hitting many more.

The clock required urgent action. On March 2, Bedford pressed Seattle officials to implement social-distancing policies immediately. If the epidemic grew any further … well, the CDC knew what might happen.

“Widespread transmission of COVID-19 in the United States would translate into large numbers of people needing medical care at the same time,” the agency warned in a passage titled “What May Happen” on the coronavirus page of its website. “Public health and healthcare systems may become overloaded, with elevated rates of hospitalizations and deaths.”

One day after Bedford published his warning, the CDC announced that it would stop reporting how many people in the United States had been tested for the coronavirus. Donald Trump shared his views on Fox News the following night. “A lot of people will have this, and it’s very mild,” he said. “They’ll get better very rapidly. They don’t even see a doctor. They don’t even call a doctor.”

The virus was now clearly spreading, but the CDC still seemed stuck in neutral. On March 10, CDC Director Robert Redfield described his agency’s strategy to The New York Times. “It’s going to take rigorous, aggressive public health—what I like to say, block and tackle, block and tackle, block and tackle, block and tackle,” he said. “That means if you find a new case, you isolate it.”

Redfield’s advice would have sounded reasonable back on Planet A, where the U.S. surveillance apparatus had not failed so spectacularly, but it was almost nonsensical on Planet B, where we all now live. Almost no one was getting tested, so how could anyone find a new case? A few days earlier, a state-by-state investigation by The Atlantic found little evidence that more than 2,000 people had been tested nationwide. We also found that many states had effectively no ability to test for COVID-19, and the few that did—Washington and California—were already deep into their local outbreaks. After we published the story, reports flooded in from across the country from people who had been denied tests, or doctors who couldn’t get one for patients who they believed needed them. In some cases, even doctors who had treated COVID-19 patients were not able to get tested.

As we heard from dozens of frightened and frustrated people across the country, President Trump told reporters, “Anyone who wants a test can get a test.” This was and is still not true.

The scarcity of tests forced officials to ration them. States, counties, and hospitals implemented strict rules about who could qualify for a test. The rules, while based on CDC guidance, were often too limited, given how widely the virus had already spread: They asked about foreign travel and confirmed exposure to a COVID-19–positive patient, weeks after it was clear that the virus was in the United States and that many cases were going undetected. At least 19 states have used a version of the rules that made it effectively impossible to detect the first signs of community spread in a state or city.

In the few places where officials have tested people without known exposure to COVID-19, they have found the virus. In Sonoma County, California, the public-health department asked four hospitals to test the first 20 patients who walked in the door each day with any coronavirus symptoms—even if the patient had not traveled abroad or been exposed to another known case. They started the project on a Friday. They had found a positive by Saturday. “All we needed was one case to say: Yes, we have community transmission,” Jennifer Larocque, a spokesperson for the county, told us.

In other places, the criteria have prevented residents from understanding the true extent of community spread. Nebraska, which hewed closely to the rules, insisted it had only one case of community spread, even as suspicious cases filled ICUs, according to a 35-year-old doctor who asked not to be named, because she was not authorized to speak with the press. Nebraska announced its second case of community spread on Wednesday. The state has tested 800 people, total, for the coronavirus, the chief medical officer said.

The federal government’s reliance on CDC data about the severity of the outbreak froze efforts to stop it. Even after Bedford’s warning, the government published no studies of viral mutation. The void forced leaders to act on the basis of risk, not solid information. How could a mayor shut down her city if it had only 10 for-sure cases? How could a CEO tell employees to call off their trips—and not to Western Europe or central China, but to Seattle?

American cities, blinded by the lack of testing data, did little as crucial days went by. On March 7, as the severity of the local outbreak was becoming known, huge events were allowed to go on. More than 30,000 people attended a Seattle Sounders game that night. No one wanted to say what has now become clear: February was our chance to get this right. We lost that entire month. And we now live in a new era of work stoppages, overwhelmed hospitals, dead elders, and a wrecked economy.

No one had the guts to say what needed to be said over the past month: To save our people, we will have to keep our cities in a chokehold and decimate our economy. It would have taken guts and the full-throated backing of every level of government and agency, as well as irrefutable data, for local officials to do something like that. No one told them to, and the data did not exist for them to come to that conclusion on their own.

Without strong federal leadership, each state has been going after its own solutions and running its own show, as if its residents would stay neatly within their own state lines. Despite the rising number of cases and hospitalizations, President Trump tried to use partisan rhetorical tactics to fight the virus, and in so doing, encouraged Americans to ignore legitimate, dire warnings. Now, though Trump has begun to mobilize a response to the pandemic, his base has been slow to acknowledge that precautions are necessary. This dangerous remove from reality was possible for too long because of the absence of data showing how bad things already were.

Ironically, given that the debacle started with testing, it may end there as well. South Korea, which on March 1 was the site of the largest confirmed coronavirus outbreak outside of China, has aggressively tested a huge percentage of its population, and continues to screen massive numbers of people. Now, just three weeks later, new COVID-19 cases are declining, and only 102 people have died as of Friday. Washington State, with one-seventh the population of South Korea, already has 83 fatalities. The U.S. caseload has ballooned to almost 20,000, more than twice South Korea’s total. Bedford and other experts believe that Korean-style massive-scale testing will be essential to restoring normal economic conditions. “This is the Apollo program of our times,” he said this week. “Let’s get to it.”

InvaderRam wrote:

wv wrote:

Well, let me know if you meet any centrists or Rightwingers who change their views.

voters or policy makers?

==================

Voters.

People dont change their minds for the most part. Leftist Friend of mine sent me this about her Rightwing Mom:
“My mom posted a meme on facebook. It said something to the effect of ‘Italy is refusing to treat its elderly Coronavirus patients. That’s what happens with socialized healthcare!’
After slamming my head into the keyboard several times, I had things to say.”

I’ve seen that kind of thing over and over and over in my life.

Granted some people change, and change does happen, etc.
But by and large people dont change and change does not happen 🙂

The Dem-Centrist-SuBSystem and the Rep-Rightwing-SubSystem are very effective at selling their stories.

There has never been a corporate-propaganda system like this before, in the history of the world. This is something modern, something new.

w
v

The 4 Key Reasons the U.S. Is So Behind on Coronavirus Testing
Bureaucracy, equipment shortages, an unwillingness to share, and failed leadership doomed the American response to COVID-19.

https://www.theatlantic.com/health/archive/2020/03/why-coronavirus-testing-us-so-delayed/607954/

The COVID-19 outbreak has been a confusing time for Americans, but one thing has been glaringly clear: The U.S. is way behind when it comes to testing people for the coronavirus.

Despite the fact that last week, Vice President Mike Pence promised that “roughly 1.5 million tests” would soon be available, an ongoing Atlantic investigation can confirm only that 13,953 tests have been conducted nationally. New York, which has shut down Broadway and has at least 328 coronavirus cases, is still failing to test patients who have worrying symptoms. As late as March 6, a busy clinic in Brownsville, Texas, a border city of nearly 200,000 whose population crosses back and forth from Mexico frequently, told me they could test only three people. By comparison, South Korea, which has one of the largest outbreaks outside China, is testing nearly 20,000 people a day.

Testing is essential for identifying people who have been infected and for understanding the true scope of the outbreak. But when the initial test from the Centers for Disease Control and Prevention was rolled out to state public-health laboratories in early February, one of its components was discovered to be faulty. Since then, academic, clinical, and other laboratories have struggled to get or make new tests and diagnose patients.

Though some elements of the breakdown are by now understood, the full extent of the difficulties laboratory directors have faced has remained largely opaque. Interviews with laboratory directors and public-health experts reveal a Fyre Festival–like cascade of problems that have led to a dearth of tests at a time when America desperately needs them. The issues began with onerous requirements for the labs that make the tests, continued because of arcane hurdles that prevented researchers from getting the right supplies, and extended to a White House that seemed to lack cohesion in the pandemic’s early days. Getting out lots of tests for a new disease is a major logistical and scientific challenge, but it can be pulled off with the help of highly efficient, effective government leadership. In this case, such leadership didn’t appear to exist.

Here are the four main reasons the testing issues have been so bad:

RED TAPE

The Food and Drug Administration has a protocol called emergency use authorization, or EUA, through which it clears tests from labs around the country for use in an outbreak. Getting more of these tests up and running would greatly increase the capacity of doctors and public-health officials to screen patients for the coronavirus.

Former FDA officials I spoke with said that during past outbreaks, EUAs could be granted in just a couple of days. But this time, the requirements for getting an EUA were so complicated that it would have taken weeks to receive one, says Alex Greninger, the assistant director of the virology division at the University of Washington Medical Center, which is located right near the heart of the American outbreak. Greninger told me clinical labs were not allowed to begin testing at all before they had received the EUA, even if they had already internally made sure their tests worked. Though these regulations are in place to ensure that faulty lab tests don’t get used on patients, several microbiologists told me they felt the precautions were excessive for a fast-moving outbreak of this scale. “The speed of this virus versus the speed of the FDA and the EUA process is mismatched,” he said.

On February 28, Greninger and dozens of other clinical microbiologists wrote a letter to Congress complaining that the EUA process was slowing down the ability of their labs to deploy coronavirus tests. “Many of our clinical laboratories have already validated [tests] that we could begin testing with tomorrow, but cannot due [to] the FDA EUA process,” they wrote. The following day, the FDA changed the EUA process so that labs like Greninger’s could begin testing—they would just have to submit data for the FDA’s authorization two weeks later. But weeks had already passed during which many labs and hospitals were unable to use their tests.

“The EUA pathway … has served for Ebola and Zika, etc.,” says Mark Miller, the chief medical officer at bioMérieux, an infectious-disease diagnostic company based in France. “And then you have a situation like now with coronavirus, which I don’t think any of us have ever lived through.”

Margaret Hamburg, who served as the FDA commissioner from 2009 to 2015, told me that while she doesn’t have knowledge of what went on inside the FDA over the past few months, the agency could have proactively reached out to different national and international labs to see whether their tests could be approved for use in the U.S. For example, the FDA might ask a lab, “Would you be interested to try to redirect what you were doing for a MERS diagnostic to a novel-coronavirus diagnostic?” she says. Instead, as The New York Times reported, federal officials told one Seattle infectious-disease expert, Helen Chu, to stop testing for the coronavirus entirely. (In an email, an FDA spokesperson denied that the agency acted slowly. Ensuring the validity of tests is important, she noted, to prevent false results.)

It looks like Chu was not alone. Dozens of labs in the U.S. were eager to make tests and willing to test patients, but they were hamstrung by regulations for most of February, even as the virus crept silently across the nation.

HARD-TO-GET VIRUS SAMPLES

Labs and companies need samples of the virus itself in order to make their tests, but delays in getting access to samples further slowed down the test-development process. The coronavirus originated in China, and as several microbiologists told me, the Chinese government does not allow specimens to be shipped outside its borders.

Many researchers have had difficulty getting their hands on samples even as the virus has spread. “I was working the phones to try to get access to the virus,” Greninger said.

BioMérieux just released three versions of its coronavirus test this week, after beginning work on it on January 23. Miller says that with every viral outbreak, the company’s biggest problem by far is getting access to virus and patient specimens so that it can validate its tests. Even when working with nonauthoritarian countries, a combination of government processes, researcher reticence, complex shipping regulations, and patient-privacy concerns makes getting samples difficult for diagnostic companies like his.

Miller said it would help if researchers, governments, and companies firmed up pathogen-sharing contracts in advance of an outbreak, but so far that hasn’t happened. “The problem is that in the past, industry has been viewed as this dirty participant in all of this, and we can’t be trusted, and why would I have contracts with you?” Miller says. “But that’s ignoring the plain fact that we’re the ones that create the product in the end.”

LACKING EQUIPMENT

The type of test Greninger is making is called a lab-developed test. To be used in other labs, his test requires special instruments that extract and then amplify the RNA that makes up the virus. However, labs across the country—like those at many county hospitals—don’t have the tools to do this. They can only run a simple type of test called a sample-to-answer test. As late as this week, several lab directors told me that no sample-to-answer versions of the coronavirus test had been approved in the U.S. “That means that the vast majority of clinical labs in this country will not be able to do in-house testing at this time,” says Susan Butler Wu, an associate professor of clinical pathology at the University of Southern California.

The U.S. health-care system is broken up into state and county public-health laboratories, which have different equipment than academic research institutions, which have different equipment than hospitals that diagnose patients. So the same test won’t necessarily work in different places. “We don’t have a nationalized health-care system where you put the same equipment in all the hospitals,” Wu says. “We have all these independent hospital systems with their own equipment in their own labs.”

Even though some hospitals actually have the new, functional CDC tests, the extraction machines and reagents that are used to perform them are in short supply. “We’ve been pleading to the research laboratories to please, if they have RNA-extraction machines, to give them to the hospital,” says Michael Mina, an associate medical director in the department of pathology at Brigham and Women’s Hospital in Boston.

LEADERSHIP AND COORDINATION PROBLEMS

For months, President Trump has made light of the coronavirus, telling attendees at a Black History Month reception, for instance, that perhaps the virus could miraculously disappear. He claimed on Twitter that the U.S. has done a “great job” handling the outbreak. Such a cavalier attitude seems unlikely to have motivated health officials to take things seriously. It also contradicted advice from most public-health experts. Even Scott Gottlieb, who recently resigned as Trump’s FDA commissioner, wrote in The Wall Street Journal on February 4 that “it’s time to start testing more people.”

Containing a new infectious disease requires a lot of close collaboration between the president, the CDC, the FDA, and other parts of the Department of Health and Human Services, several Obama-era health officials told me. “One reason we were able to move quickly [during the Ebola outbreak] was that there was a great deal of coordination and issue spotting and troubleshooting that went on,” Hamburg, the former FDA commissioner, told me.

The different arms of the sprawling health department have to feel like they’re all pulling toward the same goal. “I think you have fabulous people at CDC and FDA all doing the best they can, but we always found it was incredibly important to have all the agencies together in the same room,” says Jesse Goodman, a former FDA chief scientist who helped manage the country’s response to the 2009 H1N1 outbreak. When issues came up that merited the attention of the White House, he says, they got it.

Though Trump has proposed a payroll-tax break, as my colleague Peter Nicholas has pointed out, “Much of what he’s said publicly about the virus has been wrong, a consequence of downplaying any troubles on his watch.”

On top of that, there’s reportedly been tension and infighting between the president and his HHS secretary, Alex Azar, as well as between the FDA and the CDC. Politico reported that Vice President Mike Pence, who has no background in public health, repeatedly sidelined Azar from the coronavirus-response task force, and the White House appears to be blaming Azar for any failures in its coronavirus response. Politico also reported that an FDA scientist was “initially rebuffed”—made to wait overnight—when he attempted to visit the CDC in order to help coordinate testing. (In an email, a CDC spokesperson said this was “in full compliance with standard security processes required for all individuals whether they are federal employees or other visitors.”)

“I gather that there was a huge amount of infighting about who could or who should lead this, and there was a sense that a lot of people [inside HHS] weren’t considering it a major threat,” said a former Obama-administration official who has been in contact with current staffers and who related these private discussions under the condition of anonymity. “And why that was, I don’t know.”

It’s possible that all of these other hurdles could have been cleared if officials at the highest levels of government had been working together smoothly. Instead, we’ve seen confusion, doubt, and even more delays.

Dr. Rob Davidson@DrRobDavidson
As an ER doc trying to treat patients who may have COVID-19, I can’t underscore enough how much harder the lack of testing is making our job. Yes we’re used to making life-or-death decisions with limited information, daily. But this scenario is very different. Here’s why: (1/12)

For us data is everything. Board Certified Emergency Physicians (ER docs) are trained in pattern recognition & rely on research to know when the preponderance of evidence directs us toward one or another path of treatment that could significantly help or harm our patients. (2/12)

With COVID-19, we doctors have very little evidence-based data on the basic science of transmissibility, incubation period or even what measures would be taken to protect patients (& providers). Our best evidence? What has occurred in China, South Korea & Italy thus far… (3/12)

But the difference with these other countries with COVID-19 is that at the earliest point possible, a huge testing regime was used to determine the extent of the virus in the hospitalized “very sick” population & the “walking well” less-sick population. We don’t have that. (4/12)

Because this novel #coronavirus causes such minimal symptoms in so many young people (including children) — as well as in older people at the onset of disease — we’re not able to determine cases based on symptoms. This is how we managed the SARS outbreak of 2002-2003. (5/12)

SARS had a case-fatality rate of 10%, but the ability to ID cases early & isolate them significantly, limited its spread and kept fatalities relatively low. By contrast, COVID-19 cases are difficult to ID early above the background level of other respiratory viruses. (6/12)

During the H1N1 influenza pandemic of 2009, the case-fatality rate was 0.1%, slightly higher than seasonal flu. That’s also ~50% less contagious than COVID-19. The point? With a highly contagious virus that’s difficult to diagnose clinically, early testing is critical. (7/12)

Here’s the kicker: WHO had a test that worked, but it was rejected by the U.S. in January. Then, initial attempts to make our own test failed. As a result, as an ER doc I can’t get most patients tested. And it’s now known that the virus has been here for several weeks. (8/12)

To get a patient tested, they have to have traveled to certain countries, had direct contact with a COVID19+ patient, or be ill enough to be hospitalized & have no other diagnosis. There’s no way around it: Tests are being rationed due to the Administration’s mismanagement.(9/12)

Right now we’re not truly defining the extent of the virus in communities. Short of a complete lockdown,we’re dependent on everyone exercising caution when they have even minor symptoms, to avoid infecting those most at risk of dying (elderly & those with chronic disease).(10/12)

The only path forward is a massive testing regime ID’ing relatively healthy individuals who are infected.Only then can containment stop the spread in communities. And perhaps the more “walking well” positives we get, the more we can convince people that the threat is real.(11/12)

To be blunt: Our ability to fight this virus has been seriously hurt by right-wing pundits & the President, who convinced people it’s “just a cold” and will go away “like that.” For us ER docs to do our job, those comments need to stop. And massive testing needs to start. /END.

from This coronavirus is unlike anything in our lifetime, and we have to stop comparing it to the flu

Business Insider

https://www.yahoo.com/news/coronavirus-unlike-anything-lifetime-stop-201955346.html

…

Our health care system doesn’t have the capacity to deal with this.

Epidemiological experts keep talking about the need to “flatten the curve.” What they mean by that is that we need to slow the speed at which new cases are reported. We may not be able to stop the spread of the coronavirus, but we have to try to manage it. If 1,000 new cases happen over a month instead of a week, the health care system is more able to handle them.

Here’s why this is a worry: Overall, our hospitals have fewer beds than other developed countries, according to recent data from the Organization for Economic Cooperation and Development. The United States had 2.8 beds per 1,000 residents. By comparison, Germany had 8 beds and China 4.3 per 1,000.

The United States looks better when it comes to intensive care beds, but there’s tremendous variation between regions and states. If we experience what parts of China and Italy saw, we won’t have anywhere for sick patients to go. We will quickly run out of capacity.

Even if we have the capacity, we may not have enough supplies.

In a crisis moment, supplies like ventilators and N95 face masks will be key. But as National Geographic and other media have reported, the United States has only a fraction of the medical supplies it needs.

“Three hundred million respirators and face masks. That’s what the United States needs as soon as possible to protect health workers against the coronavirus threat. But the nation’s emergency stockpile has less than 15 percent of these supplies,” the magazine reported.

Others have reported shortfalls as well, and ProPublica has been hearing from health care professionals across the country who say their own institutions are running short of supplies. (Share your story here.)

U.S. Surgeon General Jerome Adams tweeted at the end of February, “Seriously people- STOP BUYING MASKS! They are NOT effective in preventing general public from catching #Coronavirus, but if healthcare providers can’t get them to care for sick patients, it puts them and our communities at risk!”

Another challenge: Hospital staff have been exposed too.

And if that weren’t enough, there’s another problem. Health care workers who have been exposed to the virus are now quarantining themselves, further reducing available staff at hospitals. Kaiser Health News reported on the effects of this:

“In Vacaville, California, alone, one case — the first documented instance of community transmission in the U.S. — left more than 200 hospital workers under quarantine and unable to work for weeks.

“Across California, dozens more health care workers have been ordered home because of possible contagion in response to more than 80 confirmed cases as of Sunday afternoon. In Kirkland, Washington, more than a quarter of the city’s fire department was quarantined after exposure to a handful of infected patients at the Life Care Center nursing home.”

This week, Banner Health in Colorado informed employees that a co-worker is among those with the coronavirus, The Colorado Sun reported. “People who came into prolonged, close contact with the woman in a Banner Health emergency room are being notified and asked to home-quarantine for 14 days, according to a source close to the investigation who spoke to The Sun on the condition of anonymity.”

And my ProPublica colleagues reported Friday how some EMS workers are also being quarantined because of exposure. (It didn’t help, of course, that the EMS system was slow to get up to speed on the threat.)

More than that, many health care workers have children and as schools begin to close, they have to figure out how to care for their own families.

People in rural areas will have little care nearby should they be affected by COVID-19.
Rural areas in the U.S. are losing their hospitals entirely, and residents are having to travel hours for care. According to the Cecil G. Sheps Center for Health Services Research at the University of North Carolina at Chapel Hill, 126 rural hospitals have closed since 2010, including six so far this year. That’s about 6%.

An analysis by the Chartis Center for Rural Health and iVantage Health Analytics this year found that about a quarter of the nation’s 1,844 open rural hospitalsare vulnerable.

As The Washington Post described it last year, “Hospitals like Fairfax Community [in Oklahoma] treat patients that are on average six years older and 40 percent poorer than those in urban hospitals, which means rural hospitals have suffered disproportionately from government cuts to Medicaid and Medicare reimbursement rates. They also treat a higher percentage of uninsured patients, resulting in unpaid bills and rising debts.

“A record 46 percent of rural hospitals lost money last year. More than 400 are classified by health officials as being at ‘high risk of imminent failure.’ Hundreds more have cut services or turned over control to outside ownership groups in an attempt to stave off closure.”

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