Category Archives: Expert Opinion

‘That’s Ridiculous.’ How America’s Coronavirus Response Looks Abroad.

Posted on by • Posted in 2020 Election Issues, Clinical Testing, Contact Tracing, Coronavirus, Credibility, Crisis, Crisis Management, Economic Crisis, Economic Recovery, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Expert, Expert Opinion, False Hope, False Narrative, Infection Control, Infection Control Plan, Infectious Virus, Job, Job Loss, Job Market, Job Search, Job Security, Leadership Decentralized, Misleading, Mistake, Mistrust, Mixed Message, Mortality, National Strategy, Pandemic, Partisanship, Public Health, Public Safety, Quarantine, Scientists, Social Distancing, Underinsured, Undocumented Immigrants, Unemployment, Uninsured • Leave a comment

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Video -'That's Ridiculous.' How America's Coronavirus Response ...

From lockdowns to testing, we showed people around the world the facts and figures on how the U.S. has handled the pandemic.

The United States leads the world in Covid-19 deaths, nearing 150,000 lost lives. The unemployment figures brought on by the pandemic are mind-boggling. The Trump administration’s slow and haphazard response has been widely criticized. But what does it look like to young people around the world, whose governments moved quickly and aggressively to contain the coronavirus?

We wanted to know, so we reached out to quite a few and showed them charts, facts, photos and videos illustrating the U.S. response. Spoiler: They were not impressed.

Many advanced economies, from Germany to Singapore, directly supplemented salaries to save jobs. Other nations with fewer resources started mass testing at the first sign of an outbreak. Many countries mandated universal lockdowns — and successfully flattened the curve. In some parts of Europe, you could be fined for straying too far from your home. And Vietnam, a nation of 95 million people, has not seen a single Covid-19 death.

This Opinion video is a follow-up to a popular video we produced last year, which asked young Europeans to respond to American policies such as health care and parental leave. Many comments suggested we produce a sequel. Well, here it is — the Covid-19 edition.

 

 

 

 

‘The virus doesn’t care about excuses’: US faces terrifying autumn as Covid-19 surges

Posted on by • Posted in 2020 Election Issues, Asymptomatic Transmission, Blame, Centers for Disease Control & Prevention (CDC), Clinical Testing, Contact Tracing, Coronavirus, Credibility, Crisis, Crisis Management, Economic Crisis, Economy Reopening, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Expert Opinion, False Hope, False Narrative, False Reassurance, Health Policy, Health System, Herd Immunity, Hospital, Hospital Industry, Infection Control, Infection Control Plan, Infectious Virus, Job, Job Loss, Job Market, Job Search, Job Security, Leadership Decentralized, Misinformation, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Mortality, National Strategy, Pandemic, Partisanship, Personal Protective Equipment (PPE), Preexisting Conditions, Public Health, Public Safety, Quarantine, School Reopening, Scientists, Social Distancing, Trust, Truth, Uncertainty, Underinsured, Unemployment, Unemployment Insurance, Uninsured, Vulnerable Populations, Wishful Thinking • Leave a comment

https://www.theguardian.com/world/2020/jul/18/us-coronavirus-fall-second-wave-autumn

The breathing space afforded by lockdowns in the spring has been squandered, with new cases running at five times the rate of the whole of Europe. Things will only get worse, experts warn.

In early June, the United States awoke from a months-long nightmare.

Coronavirus had brutalized the north-east, with New York City alone recording more than 20,000 deaths, the bodies piling up in refrigerated trucks. Thousands sheltered at home. Rice, flour and toilet paper ran out. Millions of jobs disappeared.

But then the national curve flattened, governors declared success and patrons returned to restaurants, bars and beaches. “We are winning the fight against the invisible enemy,” vice-president Mike Pence wrote in a 16 June op-ed, titled, “There isn’t a coronavirus ‘second wave’.”

Except, in truth, the nightmare was not over – the country was not awake – and a new wave of cases was gathering with terrifying force.

As Pence was writing, the virus was spreading across the American south and interior, finding thousands of untouched communities and infecting millions of new bodies. Except for the precipitous drop in New York cases, the curve was not flat at all. It was surging, in line with epidemiological predictions.

Now, four months into the pandemic, with test results delayed, contact tracing scarce, protective equipment dwindling and emergency rooms once again filling, the United States finds itself in a fight for its life: swamped by partisanship, mistrustful of science, engulfed in mask wars and led by a president whose incompetence is rivaled only by his indifference to Americans’ suffering.

With flu season on the horizon and Donald Trump demanding that millions of students return to school in the fall – not to mention a presidential election quickly approaching – the country appears at risk of being torn apart.

“I feel like it’s March all over again,” said William Hanage, a professor of epidemiology at the Harvard TH Chan School of Public Health. “There is no way in which a large number of cases of disease, and indeed a large number of deaths, are going to be avoided.”

The problem facing the United States is plain. New cases nationally are up a remarkable 50% over the last two weeks and the daily death toll is up 42% over the same period. Cases are on the rise in 40 out of 50 states, Washington DC and Puerto Rico. Last week America recorded more than 75,000 new cases daily – five times the rate of all Europe.

“We are unfortunately seeing more higher daily case numbers than we’ve ever seen, even exceeding pre-lockdown times,” said Jennifer Nuzzo, an epidemiologist at the Johns Hopkins Center for Health Security. “The number of new cases that occur each day in the US are greater than we’ve yet experienced. So this is obviously a very worrisome direction that we’re headed in.”

The mayor of Houston, Texas, proposed a “two-week shutdown” last week after cases in the state climbed by tens of thousands. The governor of California reclosed restaurants, churches and bars, while the governors of Louisiana, Alabama and Montana made mask-wearing in public compulsory.

“Today I am sounding the alarm,” Governor Kate Brown said. “We are at risk of Covid-19 getting out of control in Oregon.”

As dire as the current position seems, the months ahead look even worse. The country anticipates hundred of thousands of hospitalizations, if the annual averages hold, during the upcoming flu season. Those hospitalizations will further strain the capacity of overstretched clinics.

But a flu outbreak could also hamper the country’s ability to fight coronavirus in other ways. Because the two viruses have similar symptoms – fever, chills, diarrhea, fatigue – mistaken diagnoses could delay care for some patients until it’s too late, and make outbreaks harder to catch, one of the country’s top health officials has warned.

“I am worried,” Dr Robert Redfield, the director of the Centers for Disease Control (CDC), said last week. “I do think the fall and the winter of 2020 and 2021 are probably going to be one of the most difficult times that we have experienced in American public health because of … the co-occurrence of Covid and influenza.”

Other factors will be in play. A precipitous reopening of schools in the fall, as demanded by Trump and the education secretary, Betsy DeVos, without safety measures recommended by the CDC, could create new superspreader events, with unknown consequences for children.

“We would expect that to be throwing fuel on the fire,” said Hanage of blanket school reopenings. “So it’s going to be bad over the next month or so. You can pretty much expect it to be getting worse in the fall.”

The list of aggravating circumstances goes on and on. A federal unemployment assistance program that gave each claimant an extra $600 a week is set to expire at the end of July. A new coronavirus relief package is being held up in Congress by Republicans’ accusations that states are wasting money, and their insistence that any new legislation include liability protections for businesses that reopen during the pandemic.

Cable broadcasts and social media have been filled, meanwhile, with video clips of furious confrontations on sidewalks, in stores and streets over wearing facial masks. In Michigan, a sheriff’s deputy shot dead a man who had stabbed another man for challenging him about not wearing a mask at a convenience store. In Georgia, the Republican governor sued the Democratic mayor of Atlanta for issuing a city-wide mask mandate.

The partisan divide on masks is slowly closing as the outbreaks intensify. The share of Republicans saying they wear masks whenever they leave home rose 10 points to 45% in the first two weeks of July, while 78% of Democrats reported doing so, according to an Axios-Ipsos poll.

Another divide has proven tragically resilient. As hotspots have shifted south, the virus continues to affect Black and Latinx communities disproportionately. Members of those communities are three times as likely to become infected and twice as likely to die from the virus as white people, according to data from early July.

The raging virus has prompted speculation in some corners that the only way out for the United States is through some kind of “herd immunity” achieved by simply giving up. But that grossly underestimates the human tragedy such a scenario would involve, epidemiologists say, in the form of tens of millions of new cases and unknown thousands of deaths.

“I think that every single serology study that’s been done to date suggests that the vast majority of Americans have not yet been exposed to this virus,” Nuzzo said. “So we’re still very much in the early stages.

“Which is good, that’s actually really good news. I don’t want to strive for herd immunity, because that means the vast majority of us will get sick and that will mean many, many more deaths. The point is to slow the spread as much as possible, protect ourselves as much as possible, until we have other tools.”

But the ability of the US to take that basic step – to slow the spread, as dozens of other countries have done – is in perilous doubt. After half a year, the Trump administration has made no effort to establish a national protocol for testing, contact tracing and supported isolation – the same proven three-pronged strategy by which other countries control their outbreaks.

Critics say that instead, Trump has dithered and denied as the national death toll climbed to almost 140,000. The Democratic presidential candidate, Joe Biden, who is hoping to unseat Trump in November, blasted the president for refusing until recently to wear a mask in public.

“He wasted four months that Americans have been making sacrifices by stoking divisions and actively discouraging people from taking a very basic step to protect each other,” Biden said in a statement last weekend.

Meanwhile the White House has attacked Dr Anthony Fauci, the country’s foremost expert on infectious diseases whose refusal to lie to the public has enraged Trump, by publishing an op-ed signed by one of the president’s top aides titled “Anthony Fauci has been wrong about everything I have interacted with him on” and by releasing a file of opposition research to the Washington Post.

Trump claimed the number of cases was a function of unusually robust testing, though experts said that positivity rates of 20% in multiple states suggested that the United States is testing too little – and that in any case closing one’s eyes to the problem by testing less would not make it go away.

“We’ve done 45 million tests,” Trump said this week, padding the figure only slightly. “If we did half that number, you’d have half the cases, probably around that number. If we did another half of that, you’d have half the numbers. Everyone would be saying we’re doing well on cases.”

Such statements by Trump have encouraged unfavorable comparisons of the US pandemic response with those in countries such as Italy, which recorded just 169 new cases on Monday after a horrific spring, and South Korea, which has kept cases in the low double-digits since April.

But the United States could also look to many African countries for lessons in pandemic response, said Amanda McClelland, who runs a global epidemic prevention program at Resolve to Save Lives.

“We’ve seen some good success in countries like Ghana, who have really focused on contact tracing, and being able to follow up superspreading events,” said McClelland. “We see Ethiopia: they kept their borders open for a lot longer than other countries, but they have really aggressive testing and active case-finding to make sure that they’re not missing cases.

“I think what we’ve seen is that you need not just a strong health system but strong leadership and governance to be able to manage the outbreak, and we’ve seen countries that have all three do well.”

But in America, the large laboratories that process Covid-19 tests are unable to keep up with demand. Quest Diagnostics announced on Tuesday that the turnaround time for most non-emergency test results was at least seven days.

“We want patients and healthcare providers to know that we will not be in a position to reduce our turnaround times as long as cases of Covid-19 continue to increase dramatically,” the lab said.

“You can’t have unlimited lab capacity, and what we’ve done is allow, to some extent, cases to go beyond our capacity,” said McClelland. “We’re never going to be able to treat and track and trace uncontrolled transmission. This outbreak is just too infectious.”

Public health experts emphasize that the United States does not have to accept as its fate a cascade of tens of millions of new cases, and tens of thousands of deaths, in the months ahead. Focused leadership and individual resolve could yet help the country follow in the footsteps of other nations that have successfully faced serious outbreaks – and brought them under control.

But it is clear that the most vulnerable Americans, including the elderly and those with pre-existing conditions, face grave danger. Republicans have argued in recent weeks that while cases in the US have soared, death rates are not climbing so quickly, because the new cases are disproportionately affecting younger adults.

That is a false reassurance, health experts say, because deaths are a lagging indicator – cases necessarily rise before deaths do – and because large outbreaks among any demographic group speeds the virus’s ability to get inside nursing homes, care facilities and other places where residents are most vulnerable.

“If we don’t do anything to stop the virus, it’s going to be very difficult to prevent it from getting to people who will die,” said Nuzzo.

There is a question of whether the United States, for all its wealth and expertise – and its self-regard as an exceptional actor on the world stage – can summon the will to keep up the fight. People are tired of fighting the virus, and of fighting each other.

“I think unfortunately people are emotionally exhausted from having to think about and worry about this virus,” said Nuzzo. “They feel like they’ve already sacrificed a lot. So the worry that I have is, what willingness is there left, to do what it takes?”

It is as if the country is “treading water in the middle of the ocean”, Hanage said.

“People tend to be shuffling very quickly between denial and fatalism,” he said. “That’s really not helpful. There are a number of things that can be done.

“What I would hope is that this marks a point when the United States finally wakes up and realizes that this is a pandemic and starts taking it seriously.

“Folks tend to look at what has happened elsewhere and then they make up some kind of magical reason why it’s not going to happen to them.

“People keep making these excuses, and the virus doesn’t care about the excuses. The virus just keeps going. If you give it the opportunity, it will take it.”

 

 

 

 

Administration’s war on the public health experts

Posted on by • Posted in 2020 Election Issues, Blame, Centers for Disease Control & Prevention (CDC), Clinical Testing, Contact Tracing, Coronavirus, Credibility, Crisis, Crisis Management, Data Control, Data Integrity, Data Interpretation, Data Management, Expert, Expert Opinion, False Hope, False Narrative, Health Policy, Honesty, Integrity, Misinformation, Misinterpret, Mislead, Misleading, Mistrust, Mixed Message, Mortality, National Strategy, Pandemic, Public Health, Public Safety, Public Trust, Responsibility, Scientists, Transparency, Trust, Truth, Wishful Thinking • Leave a comment

https://www.axios.com/trump-public-health-experts-cdc-fauci-e1509d14-0cf1-4b1c-b107-7753bf95395d.html

Trump's war on the public health experts - Axios

A pandemic would normally be a time when public health expertise and data are in urgent demand — yet President Trump and his administration have been going all out to undermine them.

Why it matters: There’s a new example almost every day of this administration trying to marginalize the experts and data that most administrations lean on and defer to in the middle of a global crisis.

Here’s how it has been happening just in the past few weeks:

  • The administration has repeatedly undermined the Centers for Disease Control and Prevention. Most recently, Trump has criticized the CDC’s school reopening guidelines, Education Secretary Betsy DeVos declared that “kids need to be in school,” and the administration has reportedly ordered hospitals to bypass the CDC in reporting coronavirus patient information.
  • It has repeatedly undermined Anthony Fauci. Trump distanced himself on Wednesday from an op-ed attack by White House trade adviser Peter Navarro, but longtime Trump aide Dan Scavino also called the infectious diseases specialist “Dr. Faucet” in a Facebook post accusing him of leaking his disagreements. And the White House gave a opposition research-style list of the times Fauci “has been wrong” to the Washington Post and other media outlets.
  • Trump himself undermined public health experts generally with his retweet of former game show host Chuck Woolery’s “everyone is lying” tweet — which blamed “The CDC, Media, Democrats, our Doctors, not all but most, that we are told to trust.”
  • Trump has made numerous statements suggesting, over and over again, that we wouldn’t have as many COVID cases if we just tested less. (From his Tuesday press conference at the White House: “If we did half the testing we would have half the cases.”)

The impact: The result is that the CDC — which is supposed to be the go-to agency in a public health crisis — is distracted by constant public critiques from the highest levels. And Fauci, “America’s Doctor,” is the subject of yet another round of stories about whether Trump is freezing him out.

  • “The way to make Americans safer is to build on, not bypass, our public health system,” Tom Frieden, a former CDC director under Barack Obama, said in a statement to Axios about the efforts to sideline the agency.
  • “Unfortunately, as with mask-up recommendations and schools reopening guidance, the administration has chosen to sideline and undermine our nation’s premier disease fighting agency in the middle of the worst pandemic in 100 years,” Frieden said.
  • And Fauci, in an interview with The Atlantic, said of the efforts to discredit him: “Ultimately, it hurts the president to do that … It doesn’t do anything but reflect poorly on them.”

The other side: The White House insists there’s no problem. “President Trump has always acted on the science and valued the input of public health experts throughout this crisis,” said White House deputy press secretary Sarah Matthews.

  • Trump campaign communications director Tim Murtaugh closed ranks with the experts as well. “President Trump has said repeatedly that he has a strong relationship with Dr. Fauci, and Dr. Fauci has always said that the President listens to his advice,” he said.
  • And Department of Health and Human Services spokesman Michael Caputo declared that “the scientists and doctors speak openly, they are listened to closely, and their advice and counsel helps guide the response.”
  • “Frankly, when it comes to this tempest in a teapot over Dr. Fauci, I blame the media and their unending search for a ‘Resistance’ hero, for turning half a century of a brilliant scientist’s hard work into a clickbait headline that helps reporters undermine the president’s coronavirus response,” Caputo said.

Between the lines: Murtaugh deflected several times when asked whether there was a deliberate strategy to marginalize the CDC and the experts: “The President and the White House have consistently advised Americans to follow CDC guidelines. The President also believes we can open schools safely on time and that we must do so.”

  • However, one administration official said there were parts of the CDC school reopening guidelines that were impractical, and noted that kids can also suffer long-term harm by staying out of school too long.

Our thought bubble, by Axios White House reporter Alayna Treene: The responses make it clear that the White House and the Trump campaign don’t want to advance the narrative that they’re deliberately battling with America’s health experts, or that there’s any kind of strategy behind it.

The bottom line: When the history of this pandemic is written, it will show that the public health experts who were trying to fight it also had to deal with political fights that made their jobs harder.

 

 

 

 

 

White House goes public with attacks on Fauci

Posted on by • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Coronavirus, Crisis, Crisis Management, Economic Crisis, Economy Reopening, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Expert, Expert Opinion, False Hope, False Narrative, Health Policy, Honesty, Infection Control, Infection Control Plan, Infectious Virus, Integrity, Mislead, Misleading, Mortality, National Strategy, Pandemic, Partisanship, Personal Protective Equipment (PPE), Public Health, Public Safety, Quarantine, Scientists, Social Distancing, Transparency, Trust, Truth • Leave a comment

White House goes public with attacks on Fauci

Dr. Anthony Fauci describes his 'very different' relationships ...

Tensions between the White House and Anthony Fauci, the government’s top infectious diseases expert, are spilling into the open as officials openly attack the doctor for his public health advice during the coronavirus pandemic. 

Fauci’s advice has often run contrary to President Trump’s views, and the attacks on Fauci have begun to look like a traditional negative political campaign against an opponent. Yet this time, the opponent is a public health expert and career civil servant working within the administration. 

Dan Scavino, deputy chief of staff for communications, shared a cartoon on his Facebook page late Sunday that depicted Fauci as a faucet flushing the U.S. economy down the drain with overzealous health guidance to slow the spread of the pandemic.

The cartoon, which shows Fauci declaring schools should remain closed and calling for “indefinite lockdowns,” did not accurately portray what Fauci has advised in public.

Adm. Brett Giroir, the administration’s testing czar, downplayed any riff within the White House coronavirus task force before offering some criticism of Fauci.

“I respect Dr. Fauci a lot, but Dr. Fauci is not 100 percent right and he also doesn’t necessarily, and he admits that, have the whole national interest in mind,” Giroir told “Meet the Press” on Sunday. “He looks at it from a very narrow public health point of view.”

There have been tensions between Trump and Fauci throughout the pandemic. The president has repeatedly downplayed the severity of the virus, broken with the advice of his own public health experts and painted rosy but at times misleading pictures of the U.S. response. Fauci, who has served four decades in his current post, has offered blunt talk on the dangers of the pandemic that has directly contradicted the president from time to time.

But the latest criticisms mark a shift as the White House has begun publicly undermining one of the leading public health voices in the administration at a time when multiple states are struggling to get new outbreaks under control.

White House trade adviser Peter Navarro, whom the president tapped to manage the use of the Defense Production Act, said he personally proceeds with caution before heeding Fauci’s advice.

Trump said last week that Fauci is a nice man but that he’s “made a lot of mistakes.”

A White House official this weekend sent media outlets a lengthy list of “mistakes” Fauci has made since the pandemic began, like his comment in March that there is no need for people to wear masks.

That comment came before scientists knew people could spread the virus without showing symptoms, and Fauci, the Centers for Disease Control and Prevention (CDC) and other experts now urge people to use face coverings in public.

Public health experts have leaped to Fauci’s defense on Twitter, noting that Fauci is one of the most respected health experts in the world, having worked for six presidents and researched HIV/AIDS, Ebola, Zika and a variety of other infectious diseases.

“When studies show that, opposite from SARS & MERS, COVID19 is most infectious soon after infection & less infectious later, we recognize asymptomatic transmission and importance of masks,” tweeted Tom Frieden, the former director of the CDC.

“That’s called science, not a mistake. The real, deadly mistake is not listening to science.” 

Ashish Jha, director of the Harvard Global Health Institute, tweeted, “His track record isn’t perfect. It’s just better than anyone else I know. Sidelining Dr. Fauci makes the federal response worse. And it’s the American people who suffer.”

Polls still show the public trusts Fauci more than Trump for accurate information on the virus, with Democrats more likely than Republicans to believe the infectious diseases expert.

White House press secretary Kayleigh McEnany during a “Fox & Friends” interview Monday insisted Fauci’s recommendations were reaching Trump, while saying he represented only “one viewpoint” among many considered by the president.

“The point of the task force is to be a whole of government look at what is best for this country,” McEnany said when asked about the status of the relationship between Trump and Fauci. “Dr. Fauci is one member of a team, but rest assured, his viewpoint is represented and the information gets to the president through the task force.”

Still, Fauci’s public appearances became few and far between as his dire warnings about the state of the pandemic in the U.S. increasingly clashed from more hopeful messages coming from the White House. 

Fauci also told the Financial Times last week that he hadn’t briefed Trump in two months, in which time a growing number of states have experienced significant surges in cases.

Fauci was not present at the White House coronavirus task force media briefing last week, events that have become rarer even as the COVID crisis grows worse.

And while he was a regular on cable news in the early days of the pandemic, his appearances have dwindled, a fact he said last week could be because of his “honesty.” 

While Fauci has warned that the U.S. could hit 100,000 new COVID-19 cases per day if steps aren’t taken to alter the trajectory of the outbreaks, Trump has tied the rise in cases to increased testing. 

While Fauci attributed outbreaks in some states to reopening too quickly after the spring lockdowns, Trump and his top allies have mostly stood by their decision to push governors to jump over checkpoints set by the White House.

Fauci has refuted the president’s claims that the rise in cases is solely tied to increased testing and that 99 percent of cases are “totally harmless.” 

And as Trump touted a falling COVID-19 death rate, which is actually now increasing, Fauci has said the U.S. shouldn’t take comfort in the “false narrative,” noting the disease can cause other severe health outcomes. 

Fauci’s warnings grew more urgent last week when he warned that the U.S. is “facing a serious problem” and the pandemic has become politicized. 

“And you know from experience historically that when you don’t have unanimity in an approach to something, you’re not as effective in how you handle it,” Fauci said in an interview with FiveThirtyEight. “So I think you’d have to make the assumption that if there wasn’t such divisiveness, that we would have a more coordinated approach.”

 

 

 

 

White House goes quiet on coronavirus as outbreak spikes again across the U.S.

Posted on by • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Clinical Testing, Contact Tracing, Coronavirus, Credibility, Crisis, Crisis Management, Dept of Health and Human Services (HHS), Economic Crisis, Economic Stimulus, Economy Reopening, Employee Benefits, Employee Furlough, Employee Hiring Freeze, Employee Layoffs, Employee Pay Cuts, Employee Protections, Expert, Expert Opinion, Health Policy, Infection Control, Infection Control Plan, Infectious Virus, Leadership Decentralized, Mortality, National Strategy, Pandemic, Public Health, Public Safety, Quarantine, Scientists, Social Distancing, Transparency, Trust, Truth • Leave a comment

https://www.politico.com/news/2020/06/10/white-house-stops-talking-about-coronavirus-309993?utm_source=ActiveCampaign&utm_medium=email&utm_content=Mnuchin%3A+More+Stimulus++Definitely++Needed&utm_campaign=TFT+Newsletter+06102020

White House goes quiet on coronavirus as outbreak spikes again ...

The coronavirus is still killing as many as 1,000 Americans per day — but the Trump administration isn’t saying much about it.

It’s been more than a month since the White House halted its daily coronavirus task force briefings. Top officials like infectious disease expert Anthony Fauci have largely disappeared from national television — with Fauci making just four cable TV appearances in May after being a near fixture on Sunday shows across March and April — and are frequently restricted from testifying before Congress. Meanwhile, President Donald Trump is preparing to resume his campaign rallies after a three-month hiatus, an attempted signal to voters that normalcy is returning ahead of November’s election, and that he’s all but put the pandemic behind him.

“We’ve made every decision correctly,” Trump claimed in remarks in the Rose Garden Friday morning. “We may have some embers or some ashes or we may have some flames coming, but we’ll put them out. We’ll stomp them out.”

Inside the White House, top advisers like Jared Kushner privately assured colleagues last month that the outbreak was well in hand — citing data on declines in community spread — and that the long-feared “second wave” may have even been averted, according to three current and former officials.

However, new data from states like Florida and mass protests across the country are renewing concerns about the virus’s spread. Texas, for instance, has reported two straight days of record-breaking coronavirus hospitalizations — highs that come shortly after the state kicked off the third stage of its reopening plan.

Those officials also acknowledge that the Covid-19 task force has scaled back its once-daily internal meetings — the task force now meets twice per week — but insist that the pandemic response remains a priority. One official with direct knowledge of the administration’s strategy cited efforts to scale up testing, accelerate the development of treatments and vaccines and perform other behind-the-scenes work to get ready for a potential fall surge.

“We’re delivering the supplies and resources that states asked for,” said the official. “This doesn’t need to be the public ‘coronavirus show’ every day anymore.”

“You can’t win,” said a senior administration official. “Some people complained for weeks that ‘we don’t want so much White House involvement,’ and that ‘the President should stop doing daily briefings,’ and then they turn around and complain that there aren’t enough or as many briefings.”

But the White House’s apparent eagerness to change the subject comes as new coronavirus clusters — centered around meatpacking plants, prisons and other facilities — drive spikes in disparate states like Utah and Arkansas. Meanwhile, states and major cities are lifting lockdowns and reopening their economies, prompting public health experts to fret that additional outbreaks are imminent. And several Democratic governors also have defied their own states’ social distancing restrictions to join mass protests over police brutality, where hundreds of thousands of Americans have spilled into the streets, further raising public health risks.

The fear is that all the mixed signals will only confuse people, stoke public skepticism over the health threat and promote the belief the worst is over just as the outbreak enters a dangerous new phase.

“Cases are rising, including from cases in congregate settings,” said Luciana Borio, who led pandemic preparedness for the National Security Council between 2017 and 2019. “We still have a pandemic.”

Nine current and former administration officials, as well as outside experts, further detailed how the White House is steadily ramping down the urgency to fight a threat that continues to sicken more than 100,000 Americans per week and is spiking in more than 20 states.

For instance, the administration in recent days told state health officials that it planned to reorganize its pandemic response, with HHS and its agencies taking over the bulk of the day-to-day responsibilities from the Federal Emergency Management Agency.

“The acuity of the response is not what it was, so they’re trying to go back to a little more of a normal ongoing presence,” said Marcus Plescia, the chief medical officer of the Association of State and Territorial Health Officials.

The coronavirus task force, which used to send daily updates to state officials, has done so with less regularity over the last several weeks, Plescia said. And the CDC has restructured its daily conference calls with states, moving away from the practice of giving top-down briefings to encouraging state officials to offer updates on what they’re seeing in their parts of the country.

One current and one former FEMA official also said they’re keen to have HHS resume its leadership role in containing the coronavirus so FEMA can make contingencies for a summer of hurricanes, floods and other natural disasters.

“Given the likelihood that we will soon see both hurricanes and coronavirus, HHS should manage the ongoing pandemic response so FEMA can prepare for coming ‘coronacanes,’” Daniel Kaniewski, who served as the top deputy at FEMA through January, wrote last week. “But they need to act soon. Coronacanes are in the forecast.”

Meanwhile, officials in at least 19 states have recorded two-week trends of increasing coronavirus cases, including spikes of more than 200 percent in Arizona and more than 180 percent in Kentucky. Two months after the White House issued so-called gating criteria that it recommended states hit before resuming business and social activities, only a handful of states — like Connecticut, New Jersey, New York and South Dakota — currently meet all of those benchmarks, according to CovidExitStrategy.org.

Officials within Trump’s health department are strategizing over how to convey the current level of risk, given data that Americans have put off emergency care and other potential medical needs, fearful of contracting Covid-19. “Our message now is that people should start returning to their health care providers to get the screenings, vaccines, care, or emergency services that they need,” Laura Trueman, the HHS official in charge of external affairs, wrote in an office-wide email to colleagues and shared with external groups on June 3, which was obtained by POLITICO.

Dan Abel, a longtime Coast Guard vice admiral, also has been installed at HHS with a small team, where he’s coordinating daily Covid-19 calls with HHS Secretary Alex Azar and the department’s division leaders, according to four officials with knowledge of the calls — an arrangement that’s raised some questions.

“Why is a Coast Guard admiral leading meetings between the HHS secretary and his senior staff?” asked one senior official, suggesting it created an unnecessary layer of management.

Meanwhile, the department is steadily turning back to its many pre-Covid-19 priorities. At the Food and Drug Administration, officials are returning to hot-button issues like tobacco and CBD regulations. Some staff in the health department’s emergency response arm are pivoting away from Covid-19 and back toward natural disasters as hurricane season begins.

At the same time, the Centers for Disease Control — traditionally the beating heart of the nation’s infectious disease response — remains largely demoralized and often sidelined in fighting what CDC director Robert Redfield last week acknowledged as the nation’s biggest health challenge in more than a century, and one he said is “moving through our social consciousness, our outward expression, and our grief.” That grim message has conflicted with Trump’s frequent vows of victory over the coronavirus.

“We were able to close our country, save millions of lives, open,” Trump said in Friday’s Rose Garden remarks. “And now the trajectory is great.”

“I fully recognize the anguish our Nation is experiencing & am deeply saddened by the many lives lost to COVID19,” Redfield tweeted just minutes later. “I call upon the American people to remain vigilant in protecting the vulnerable – protect your community, grandparents and loved ones from COVID-19.”

Redfield and other top officials also have spent the past week reckoning with the implications of widespread protests over police brutality, from meeting with staff to discuss longstanding concerns about systemic racism in health care to acknowledging the probability that those protests will spark new outbreaks.

HHS also on Monday sent members of Congress a fact sheet on its response to racial disparities in Covid-19 care — a much scrutinized issue in public health, with African Americans contracting and dying from the virus at much higher rates.

But on Capitol Hill, watchdogs say that fact sheets don’t cut it, and they’re frustrated by the lack of access to experts and insight into how the administration is handling a historic pandemic.

“Some are acting like the battle has been won when in reality it’s just beginning,” said a senior Democratic staffer. “The White House still won’t let task force members testify at hearings in June even though they have disappeared from TV and it’s not clear how often they are meeting.”

Fauci, meanwhile, has continued to issue a string of dire warnings in his lower-profile media appearances and at an industry conference on Tuesday.

“We have something that turned out to be my worst nightmare,” Fauci said in virtual remarks aired at a conference of the biotech industry’s Washington trade group, recounting how quickly the virus spread around the globe, outpacing Ebola and HIV. “And it isn’t over yet.”

The White House has maintained that chief of staff Mark Meadows has needed to clear officials like Fauci to testify, so they can stay focused on other priorities, and a spokesperson insisted that Trump has still prioritized the coronavirus fight even as the White House shifts toward focusing on revitalizing the economy.

Several officials have suggested that the task force’s lower profile has been helpful for the response, especially because the daily Covid-19 press briefings were often hijacked by Trump’s meandering remarks or the day’s other political news.

“In some ways, it actually has been easier to get Covid-related work done,” said one HHS staffer who’s helped support the Covid-19 response. “The task force briefings and the prep sessions for them took up a lot of principals’ time, and staff would sometimes have to crash on putting together materials for them.”

But the white-hot spotlight on the coronavirus also brought urgency and intensity, and the increasingly scattered nature of the current response could present new challenges if there’s an uptick in cases.

“This is when a one-government approach is needed more now than ever,” said Howard Koh, who served as President Barack Obama’s HHS assistant secretary for health. “Get all those people together in one room every day at the highest level and track outcomes and address all the questions and try to maximize coordination as much as possible.”

 

 

 

 

How Long Will a Vaccine Really Take?

Posted on by • Posted in 2020 Election Issues, Clinical Research, Clinical Research Funding, Clinical Testing, Clinical Trials, Contact Tracing, Coronavirus, Expectations, Expert Opinion, Food and Drug Administration (FDA), Health Policy, Infection Control, Infectious Virus, Pandemic, Public Health, Public Safety, Quarantine, Social Distancing, Vaccine RNA • Leave a comment

Health - Digg

A vaccine would be the ultimate weapon against the coronavirus and the best route back to normal life. Officials like Dr. Anthony S. Fauci, the top infectious disease expert on the Trump administration’s coronavirus task force, estimate a vaccine could arrive in at least 12 to 18 months.

The grim truth behind this rosy forecast is that a vaccine probably won’t arrive any time soon. Clinical trials almost never succeed. We’ve never released a coronavirus vaccine for humans before. Our record for developing an entirely new vaccine is at least four years — more time than the public or the economy can tolerate social-distancing orders.

But if there was any time to fast-track a vaccine, it is now. So Times Opinion asked vaccine experts how we could condense the timeline and get a vaccine in the next few months instead of years.

Here’s how we might achieve the impossible.

Normally, researchers need years to secure funding, get approvals and study results piece by piece. But these are not normal times.

There are already at least 254 therapies and 95 vaccines related to Covid-19 being explored.

“If you want to make that 18-month timeframe, one way to do that is put as many horses in the race as you can,” said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine.

Despite the unprecedented push for a vaccine, researchers caution that less than 10 percent of drugs that enter clinical trials are ever approved by the Food and Drug Administration.

The rest fail in one way or another: They are not effective, don’t perform better than existing drugs or have too many side effects.

Fortunately, we already have a head start on the first phase of vaccine development: research. The outbreaks of SARS and MERS, which are also caused by coronaviruses, spurred lots of research. SARS and SARS-CoV-2, the virus that causes Covid-19, are roughly 80 percent identical, and both use so-called spike proteins to grab onto a specific receptor found on cells in human lungs. This helps explain how scientists developed a test for Covid-19 so quickly.

There’s a cost to moving so quickly, however. The potential Covid-19 vaccines now in the pipeline might be more likely to fail because of the swift march through the research phase, said Robert van Exan, a cell biologist who has worked in the vaccine industry for decades. He predicts we won’t see a vaccine approved until at least 2021 or 2022, and even then, “this is very optimistic and of relatively low probability.”

And yet, he said, this kind of fast-tracking is “worth the try — maybe we will get lucky.”

The next step in the process is pre-clinical and preparation work, where a pilot factory is readied to produce enough vaccine for trials. Researchers relying on groundwork from the SARS and MERS outbreaks could theoretically move through planning steps swiftly.

Sanofi, a French biopharmaceutical company, expects to begin clinical trials late this year for a Covid-19 vaccine that it repurposed from work on a SARS vaccine. If successful, the vaccine could be ready by late 2021.

As a rule, researchers don’t begin jabbing people with experimental vaccines until after rigorous safety checks.

They test the vaccine first on small batches of people — a few dozen during Phase 1, then a few hundred in Phase 2, then thousands in Phase 3. Months normally pass between phases so that researchers can review the findings and get approvals for subsequent phases.

But “if we do it the conventional way, there’s no way we’re going to be reaching that timeline of 18 months,” said Akiko Iwasaki, a professor of immunobiology at Yale University School of Medicine and an investigator at the Howard Hughes Medical Institute.

There are ways to slash time off this process by combining several phases and testing vaccines on more people without as much waiting.

Last week the National Academy of Sciences showed an overlapping timeline, describing it as moving at “pandemic speed.”

It’s here that talk of fast-tracking the timeline meets the messiness of real life: What if a promising vaccine actually makes it easier to catch the virus, or makes the disease worse after someone’s infected?

That’s been the case for a few H.I.V. drugs and vaccines for dengue fever, because of a process called vaccine-induced enhancement, in which the body reacts unexpectedly and makes the disease more dangerous.

Researchers can’t easily infect vaccinated participants with the coronavirus to see how the body behaves. They normally wait until some volunteers contract the virus naturally. That means dosing people in regions hit hardest by the virus, like New York, or vaccinating family members of an infected person to see if they get the virus next. If the pandemic subsides, this step could be slowed.

“That’s why vaccines take such a long time,” said Dr. Iwasaki. “But we’re making everything very short. Hopefully we can evaluate these risks as they occur, as soon as possible.”

This is where the vaccine timelines start to diverge depending on who you are, and where some people might get left behind.

If a vaccine proves successful in early trials, regulators could issue an emergency-use provision so that doctors, nurses and other essential workers could get vaccinated right away — even before the end of the year. Researchers at Oxford announced this week that their coronavirus vaccine could be ready for emergency use by September if trials prove successful.

So researchers might produce a viable vaccine in just 12 to 18 months, but that doesn’t mean you’re going to get it. Millions of people could be in line before you. And that’s only if the United States finds a vaccine first. If another country, like China, beats us to it, we could wait even longer while it doses its citizens first.

You might be glad of that, though, if it turned out that the fast-tracked vaccine caused unexpected problems. Only after hundreds or thousands are vaccinated would researchers be able to see if a fast-tracked vaccine led to problems like vaccine-induced enhancement.

“It’s true that any new technology comes with a learning curve,” said Dr. Paul Offit, the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia. “And sometimes that learning curve has a human price.”

Once we have a working vaccine in hand, companies will need to start producing millions — perhaps billions — of doses, in addition to the millions of vaccine doses that are already made each year for mumps, measles and other illnesses. It’s an undertaking almost unimaginable in scope.

Companies normally build new facilities perfectly tailored to any given vaccine because each vaccine requires different equipment. Some flu vaccines are produced using chicken eggs, using large facilities where a version of the virus is incubated and harvested. Other vaccines require vats in which a virus is cultured in a broth of animal cells and later inactivated and purified.

Those factories follow strict guidelines governing biological facilities and usually take around five years to build, costing at least three times more than conventional pharmaceutical factories. Manufacturers may be able to speed this up by creating or repurposing existing facilities in the middle of clinical trials, long before the vaccine in question receives F.D.A. approval.

“They just can’t wait,” said Dr. Iwasaki. “If it turns out to be a terrible vaccine, they won’t distribute it. But at least they’ll have the capability” to do so if the vaccine is successful.

The Bill and Melinda Gates Foundation says it will build factories for seven different vaccines. “Even though we’ll end up picking at most two of them, we’re going to fund factories for all seven, just so that we don’t waste time,” Bill Gates said during an appearance on “The Daily Show.”

In the end, the United States will have the capacity to mass-produce only two or three vaccines, said Vijay Samant, the former head of vaccine manufacturing at Merck.

“The manufacturing task is insurmountable,” Mr. Samant said. “I get sleepless nights thinking about it.”

Consider just one seemingly simple step: putting the vaccine into vials. Manufacturers need to procure billions of vials, and billions of stoppers to seal them. Sophisticated machines are needed to fill them precisely, and each vial is inspected on a high-speed line. Then vials are stored, shipped and released to the public using a chain of temperature-controlled facilities and trucks. At each of these stages, producers are already stretched to meet existing demands, Mr. Samant said.

It’s a bottleneck similar to the one that caused a dearth of ventilators, masks and other personal protective equipment just as Covid-19 surged across America.

If you talk about vaccines long enough, a new type of vaccine, called Messenger RNA (or mRNA for short), inevitably comes up. There are hopes it could be manufactured at a record clip. Mr. Gates even included it on his Time magazine list of six innovations that could change the world. Is it the miracle we’re waiting for?

Rather than injecting subjects with disease-specific antigens to stimulate antibody production, mRNA vaccines give the body instructions to create those antigens itself. Because mRNA vaccines don’t need to be cultured in large quantities and then purified, they are much faster to produce. They could change the course of the fight against Covid-19.

“On the other hand,” said Dr. van Exan, “no one has ever made an RNA vaccine for humans.”

Researchers conducting dozens of trials hope to change that, including one by the pharmaceutical company Moderna. Backed by investor capital and spurred by federal funding of up to $483 million to tackle Covid-19, Moderna has already fast-tracked an mRNA vaccine. It’s entering Phase 1 trials this year and the company says it could have a vaccine ready for front-line workers later this year.

“Could it work? Yeah, it could work,” said Dr. Fred Ledley, a professor of natural biology and applied sciences at Bentley University. “But in terms of the probability of success, what our data says is that there’s a lower chance of approval and the trials take longer.”

The technology is decades old, yet mRNA is not very stable and can break down inside the body.

“At this point, I’m hoping for anything to work,” said Dr. Iwasaki. “If it does work, wonderful, that’s great. We just don’t know.”

The fixation on mRNA shows the allure of new and untested treatments during a medical crisis. Faced with the unsatisfying reality that our standard arsenal takes years to progress, the mRNA vaccine offers an enticing story mixed with hope and a hint of mystery. But it’s riskier than other established approaches.

Imagine that the fateful day arrives. Scientists have created a successful vaccine. They’ve manufactured huge quantities of it. People are dying. The economy is crumbling. It’s time to start injecting people.

But first, the federal government wants to take a peek.

That might seem like a bureaucratic nightmare, a rubber stamp that could cost lives. There’s even a common gripe among researchers: For every scientist employed by the F.D.A., there are three lawyers. And all they care about is liability.

Yet F.D.A. approvals are no mere formality. Approvals typically take a full year, during which time scientists and advisory committees review the studies to make sure that the vaccine is as safe and effective as drug makers say it is.

While some steps in the vaccine timeline can be fast-tracked or skipped entirely, approvals aren’t one of them. There are horror stories from the past where vaccines were not properly tested. In the 1950s, for example, a poorly produced batch of a polio vaccine was approved in a few hours. It contained a version of the virus that wasn’t quite dead, so patients who got it actually contracted polio. Several children died.

The same scenario playing out today could be devastating for Covid-19, with the anti-vaccination movement and online conspiracy theorists eager to disrupt the public health response. So while the F.D.A. might do this as fast as possible, expect months to pass before any vaccine gets a green light for mass public use.

At this point you might be asking: Why are all these research teams announcing such optimistic forecasts when so many experts are skeptical about even an 18-month timeline? Perhaps because it’s not just the public listening — it’s investors, too.

“These biotechs are putting out all these press announcements,” said Dr. Hotez. “You just need to recognize they’re writing this for their shareholders, not for the purposes of public health.”

What if It Takes Even Longer Than the Pessimists Predict?

Covid-19 lives in the shadow of the most vexing virus we’ve ever faced: H.I.V. After nearly 40 years of work, here is what we have to show for our vaccine efforts: a few Phase 3 clinical trials, one of which actually made the disease worse, and another with a success rate of just 30 percent.

Researchers say they don’t expect a successful H.I.V. vaccine until 2030 or later, putting the timeline at around 50 years.

That’s unlikely to be the case for Covid-19, because, as opposed to H.I.V., it doesn’t appear to mutate significantly and exists within a family of familiar respiratory viruses. Even still, any delay will be difficult to bear.

But the history of H.I.V. offers a glimmer of hope for how life could continue even without a vaccine. Researchers developed a litany of antiviral drugs that lowered the death rate and improved health outcomes for people living with AIDS. Today’s drugs can lower the viral load in an H.I.V.-positive person so the virus can’t be transmitted through sex.

Therapeutic drugs, rather than vaccines, might likewise change the fight against Covid-19. The World Health Organization began a global search for drugs to treat Covid-19 patients in March. If successful, those drugs could lower the number of hospital admissions and help people recover faster from home while narrowing the infection window so fewer people catch the virus.

Combine that with rigorous testing and contact tracing — where infected patients are identified and their recent contacts notified and quarantined — and the future starts looking a little brighter. So far, the United States is conducting fewer than half the number of tests required and we need to recruit more than 300,000 contact-tracers. But other countries have started reopening following exactly these steps.

If all those things come together, life might return to normal long before a vaccine is ready to shoot into your arm.