Trump sidelines public health advisers in growing rift over coronavirus response

https://www.washingtonpost.com/health/trump-sidelines-public-health-advisers-in-growing-rift-over-coronavirus-response/2020/07/09/ad803218-c12a-11ea-9fdd-b7ac6b051dc8_story.html?fbclid=IwAR0MI5VGiJQmUsyEpzYDj09Q0VVxxYMlHwx-UjfHdmMu1PdGD6uIzv8R2fM&utm_campaign=wp_main&utm_medium=social&utm_source=facebook

The Health 202: Health officials promise to ramp up pandemic ...

The June 28 email to the director of the Centers for Disease Control and Prevention was ominous: A senior adviser to a top Health and Human Services Department official accused the CDC of “undermining the President” by putting out a report about the potential risks of the coronavirus to pregnant women.

The adviser, Paul Alexander, criticized the agency’s methods, and said its warning to pregnant women “reads in a way to frighten women . . . as if the President and his administration can’t fix this and it is getting worse.”

As the country enters a frightening phase of the pandemic with new daily cases surpassing 62,000 on Wednesday, the CDC, the nation’s top public health agency, is coming under intense pressure from President Trump and his allies, who are downplaying the dangers in a bid to revive the economy ahead of the Nov. 3 election. In a White House guided by the president’s instincts, rather than by evidence-based policy, the CDC finds itself forced constantly to backtrack or sidelined from pivotal decisions.

The latest clash between the White House and its top public health advisers erupted Wednesday, when the president slammed the agency’s recommendation that schools planning to reopen should keep students’ desks six feet apart, among other steps to reduce infection risks. In a tweet, Trump — who has demanded schools at all levels hold in-person classes this fall — called the advice “very tough & expensive.”

“While they want them open, they are asking schools to do very impractical things. I will be meeting with them!!!” Trump tweeted Wednesday. Within hours, Vice President Pence had asserted the agency would release new guidance next week.

“The president said today we just don’t want the guidance to be too tough,” Pence told reporters. “And that’s the reason next week the CDC is going to be issuing a new set of tools.”

Analysts say the deepening divide is undermining the authority of one of the world’s premier public health agencies, which previously led fights against malaria, smallpox and HIV/AIDS. Amid the worst public health crisis in a century, the CDC has in recent months altered or rescinded recommendations on topics including wearing masks and safely reopening restaurants and houses of worship as a result of conflicts with top administration officials.

“At a time when our country needs an orchestrated, all-hands-on deck response, there is simply no hand on the tiller,” said Beth Cameron, former senior director for global health security and biodefense on the White House National Security Council.

In the absence of strong federal leadership, state and local officials have been left to figure things out for themselves, leading to conflicting messaging and chaotic responses. Trump’s decision to pull the U.S. out of the World Health Organization further undermined efforts to influence global strategies against the coronavirus, including how vaccines will be distributed.

The CDC, meanwhile, is increasingly isolated — a function both of its growing differences with the White House and of its own significant missteps earlier in the outbreak.

Those stumbles include the botched rollout of test kits likely contaminated at a CDC lab in late January, which led to critical delays in states’ ability to know where the virus was circulating. And the CDC’s initial decision to test only a narrow set of people gave the virus a head start spreading undetected across the country.

During a May lunch with Senate Republicans, Trump told the group the CDC “blew it” on the coronavirus test and that he’d installed a team of “geniuses” led by his son-in-law Jared Kushner to handle much of the response,” according to two people familiar with the lunch who spoke on the condition of anonymity.

“There is a view the CDC is staffed with deep state Democrats that are trying to tweak the administration,” said one adviser who also spoke on the condition of anonymity to reveal private conversations.

White House officials, who see the president’s reelection prospects tied to economic recovery, also say they’ve been deeply frustrated by what they view as career staffers at the agency determined “to keep things closed,” according to a senior administration official who spoke on the condition of anonymity to reveal internal deliberations.

Trump believes the CDC is “ineffective” and a “waste of time,” but doesn’t blame CDC Director Robert Redfield and generally likes him, said another official speaking on the condition of anonymity. “He just thinks he is a poor communicator,” the official added.

Joe Grogan, former head of the White House Domestic Policy Council, said Redfield had fans inside the White House who work on “addiction issues, on life issues, on HIV issues,” among other topics.

But he said Redfield has few political appointees to help him run a complex agency. “How do you run a place like that with … [few] appointees?” Grogan asked.

HHS Secretary Alex Azar called the director “a key scientific guide for the President and his administration, a trusted source for the American people, and a closely engaged partner of state and local governments.”

But Redfield is not a voice in coronavirus task force meetings, and “is never really in the Oval [Office] with the president,” said another senior administration official, who also spoke on the condition of anonymity to discuss the internal dynamics.

Even Redfield’s supporters say he has failed to be an effective advocate for the agency.

“Bob Redfield’s commitment to public health is completely strong,” said William Schaffner, a veteran infectious-disease specialist at Vanderbilt University. But he said Redfield lacks the standing, deftness, and communication capacity to persuade skeptical audiences, including those in the White House, that protecting public health and fostering economic recovery are not opposing goals.

Redfield, for his part, downplayed Trump’s criticism of the CDC school reopeniing guidelines after a coronavirus task force briefing Wednesday, saying the agency and the president were “totally aligned.”

“We’re both trying to open the schools,” he said.

White House spokesman Judd Deere also disputed big differences, saying in a statement the White House and the CDC “have been working together in partnership since the very beginning of this pandemic to carry out the President’s highest priority: the health and safety of the American public.

“The CDC is the nation’s trusted health protection agency and its infectious disease and public health experts have helped deliver critical solutions to save lives. We encourage all Americans to continue to follow the CDC’s guidelines and use best-practices they have learned, such as social distancing, face coverings, and good hygiene, to maintain public health and continue our Transition to Greatness.”

But some health experts were indignant the agency had been ordered to rewrite guidance to reopen schools to “make it easier and cost less” — a demand that effectively “turns science on its head,” said Tom Inglesby, director of Johns Hopkins University’s Center for Health Security.

“CDC should be giving their best judgments on how to lower risks to make schools safer,” he said. “That’s their job. If they aren’t allowed to do that, the public will lose confidence in the guidance.”

Why are they ‘not shouting “fire”?’

The diminished role of the 74-year-old agency has bewildered infectious-disease experts, as well as members of the public seeking guidance.

After six states set one-day case records on July 3, Carlos del Rio, executive associate dean at Emory University’s School of Medicine, tweeted at Tom Frieden, a former CDC director, “Tom, where is @CDCgov ? Why are they not out there shouting ‘fire’?”

Frieden shot back: “They are still there, still doing great work, just not being allowed to talk about it, not being allowed to guide policy, not being allowed to develop, standardize, and post information that would give, by state and county, the status of the epidemic and of our control measures.”

Jeffrey Duchin, the health officer at Seattle and King County health department, added: “Agree. Muzzled, neutered and exiled.”

The agency has been largely invisible. After more than three months of silence, it resumed briefings for the public last month. There have been two.

By comparison, when the H1N1 swine flu pandemic hit the United States in the spring of 2009, the CDC held briefings almost every day for six consecutive weeks.

During this outbreak, the agency’s regular briefings ended abruptly after White House officials were angered when a top CDC leader warned that Americans could face “significant disruption” to their lives as a result of the virus’s spread to the United States.

CDC officials say they are still getting their message out, pointing to more than 2,000 documents providing pandemic-related information about reopening and staying safe for dozens of groups and venues, including funeral home directors, amusement parks, and pet owners. Each Friday, the CDC also posts CovidView, a weekly report of selected data and trends on testing, hospitalizations, and reported deaths.

But the information is posted without additional explanation or analysis.

“I want to hear a real person give me three minutes based on these findings,” said del Rio, also a global health and infectious-disease professor at Emory. “I want to see them in the news, being interviewed, giving us the data.”

Scientists at the CDC and former colleagues speak of deep frustration and low morale over its inability to fully share and explain scientific and medical information.

Researchers are fearful for their jobs and want to protect the integrity of the data they release. “If you want to say something, you’re thinking, ‘what’s the White House going to say and how are they going to use it,’ ” said one longtime scientist who spoke on the condition of anonymity for fear of retaliation.

The lack of briefings has fostered misunderstandings at times. In early April, for instance, when the agency reversed its position and recommended the use of cloth face coverings, CDC scientists gave no public briefings explaining why they made the change.

“It’s not rocket science,” said Nancy Cox, a virologist and former CDC official who led the influenza program for 22 years and was part of the agency’s response during the 2009 H1N1 swine flu pandemic. “But the reasoning behind those changes should be explained as clearly as possible and then you can get everyone on board.”

In the CDC’s absence, academic medical centers, public health and professional disease groups have filled the void by holding coronavirus briefings and providing analysis of key issues, data and research studies. Frieden, the president of Resolve to Save Lives, a New York nonprofit, has also been posting long Twitter threads analyzing the weekly CDC data released on Fridays.

Speaking ‘with an unfettered voice’

Alarmed at the agency’s diminished role, nearly 350 public health organizations sent a letter Tuesday to Azar urging him to advocate for the CDC. The agency must be allowed to speak based on the best available science “and with an unfettered voice,” said John Auerbach, president and chief executive of Trust for America’s Health, a public health nonprofit that led the effort.

House Democrats echoed those concerns in a separate letter to Azar last month. Reps. Diana DeGette of Colorado and Frank Pallone Jr. of New Jersey, who chairs the House Energy and Commerce Committee, said they were troubled by reports that administration officials are considering narrowing the CDC’s mission and embedding more political appointees at the Atlanta-based agency.

Traditionally the CDC has one political appointee, the director. Now it has Redfield and five other political appointees, including two advisers who were added in recent weeks.

“Now more than ever, the American people need a robust and effective CDC that is not repeatedly undermined by others in the administration, including the President and the Vice President,” the letter said.

White House Chief of Staff Mark Meadows views the agency as a problem and has criticized the CDC repeatedly to other administration officials, said a senior administration official.

White House and HHS officials are discussing what the CDC’s “core mission needs to be,” said one adviser familiar with the talks who spoke on the condition of anonymity to comment on policy deliberations. The discussions were first reported by Politico.

Over the years, the agency that was founded to fight malaria now works on virtually every aspect of public health. “It has tried to be everything to everyone,” the adviser said, suggesting the agency might need to refocus more narrowly.

On the global front, administration officials are also weighing a $2.5 billion initiative called the President’s Response to Outbreaks that would move a significant portion of national and international pandemic responses to the State Department, according to a draft obtained by The Post. Details were first reported by Devex.

“There is no clear leadership role for CDC” in this plan, said Jennifer Kates, a senior vice president for global health and HIV policy at the Kaiser Family Foundation. “In global health, you need an engaged CDC.”

Taken together, the administration efforts seem “designed to position CDC to the margins,” said one federal health official who spoke on the condition of anonymity for fear of retaliation.

‘Boogeyman where there aren’t any’

The report that drew the email attack, accusing the agency of undermining the president, had provided detailed but incomplete information about pregnancy risks related to the coronavirus. It found pregnant women with covid-19 were more likely to be hospitalized, admitted to an intensive care unit, and to need ventilator support than infected women who are not pregnant.

The sender, Alexander, a specialist in health research methods, is a senior adviser to Michael Caputo, a longtime Trump ally who was recently appointed assistant HHS secretary for public affairs , which includes the CDC.

The email was directed to Redfield and Caputo.

Even amid the intense criticism of the agency, the email “crosses the line,” said the official, who was aware of the content.

Like all of the CDC’s reports, the analysis itself noted several limitations. One key one that researchers acknowledged was that they did not have data to indicate whether the pregnant women were hospitalized because of labor and delivery, or because they had covid-19.

Administration officials are “seeing political boogeymen where there aren’t any,” the federal health official said, adding that such narratives could further hamper the U.S. response.

“It could feed the fire to limit the flow of scientific data and communication to the general population,” the official said. “People are getting sick and dying. Can we just focus on the science?”

Alexander said in his email that the lack of data about why women were hospitalized was a “key issue.”

“The CDC is undermining the President by what they put out, this is my opinion and sense, and I am reading it and can see the subtle and direct hits,” he wrote.

Alexander, also a part-time assistant professor at McMaster University in Hamilton, Ontario, did not respond to emails and telephone calls seeking comment.

Caputo said in an interview that he agreed with Alexander. The CDC represents itself as the gold standard for public health agencies, he said, “but in the case of pregnancy analysis, it wasn’t even bronze.”

He called CDC’s track record “spotty” and “questionable,” pointing to Zika diagnostic testing errors in 2016.

“In many cases over the years, regardless of administration, the CDC has undermined presidents and themselves,” Caputo said, referring to leaked drafts of CDC guidances. “Who says the CDC is the sole font of wisdom when it comes to detecting and fighting deadly pathogens?”

Experts say that even with some big unanswered questions, the pregnancy findings represent the best available evidence and are important. The lack of data reflects decades of long-neglected national surveillance on pregnancy.

“I don’t think this is frightening women,” said Denise Jamieson, who heads the obstetrics and gynecology department at Emory University and Emory Healthcare. True, the report “suffers from completeness of data,” she said. But now doctors can be more confident that pregnant women are more likely to have severe disease and use “this really important information” to counsel patients, she said.

 

 

Merkel says pandemic reveals limits of ‘fact-denying populism’

Merkel says pandemic reveals limits of ‘fact-denying populism’

Covid-19 has exposed the limits of 'fact-denying populism', Merkel ...

German Chancellor Angela Merkel told European Union (EU) countries Wednesday that the coronavirus pandemic is showing the limits of “fact-denying populism” as she urged the bloc to reach an agreement on an economic recovery package.

Merkel said that the EU “must show that a return to nationalism means not more, but less control,” according to France 24.

Without naming any specific nations, Merkel said: “We are seeing at the moment that the pandemic can’t be fought with lies and disinformation, and neither can it be with hatred and agitation.”

“Fact-denying populism is being shown its limits,” she added. “In a democracy, facts and transparency are needed. That distinguishes Europe, and Germany will stand up for it during its presidency.”

The pandemic has killed more than 100,000 people in the 27 EU nations and sparked what is expected to be the largest recession the continent has experienced in decades.

On Tuesday the EU released a report predicting the bloc’s economy will contract more than initially expected due to coronavirus-related lockdowns.

Merkel on Wednesday joined EU Economy Commissioner Paolo Gentiloni in urging the commission to quickly reach an agreement on the 750 billion-euro stimulus package proposed earlier this year.

“The depth of the economic decline demands that we hurry,” Merkel told lawmakers, according to The Associated Press. “We must waste no time — only the weakest would suffer from that. I very much hope that we can reach an agreement this summer. That will require a lot of readiness to compromise from all sides — and from you too.

 

 

 

 

U.S. coronavirus cases rise by nearly 50,000 in biggest one-day spike of pandemic

https://www.yahoo.com/news/u-coronavirus-cases-rise-nearly-013221004.html

Dr Fauci warns US could see 100,000 new coronavirus cases PER DAY ...

New U.S. COVID-19 cases rose by nearly 50,000 on Wednesday, according to a Reuters tally, marking the biggest one-day spike since the start of the pandemic.

The record follows a warning by the government’s top infectious diseases expert that the number could soon double to 100,000 cases a day if Americans do not come together to take steps necessary to halt the virus’ resurgent spread, such as wearing masks when unable to practice social distancing.

In the first week of June, the United States added about 22,000 new coronavirus cases each day. But as the month progressed, hotspots began to emerge across the Sun Belt. In the last seven days of June, daily new infections almost doubled to 42,000 nationally.

Brazil is the only other country to report more than 50,000 new cases in one day. The United States reported at least 49,286 cases on Tuesday.

More than half of new U.S. cases each day come from Arizona, California, Florida and Texas, home to 30% of the country’s population. All four states plus 10 others saw new cases more than double in June.

The daily increase in new cases could reach 100,000 unless a nationwide push was made to tamp down the fast-spreading virus, Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, told a U.S. Senate committee on Tuesday.

“We can’t just focus on those areas that are having the surge. It puts the entire country at risk,” Fauci said.

The rise in cases is not just the result of more testing. Hospitalizations are also skyrocketing.

Nationally, 7% of coronavirus diagnostic tests came back positive last week, up from 5% the prior week, according to a Reuters analysis. Arizona’s positivity test rate was 24% last week, Florida’s was 16%. Nevada, South Carolina and Texas were all 15%, according to the analysis.

(Open https://tmsnrt.rs/2WTOZDR in an external browser for a Reuters interactive)

Some of the recent increase traces back to Memorial Day holiday celebrations in late May. Health experts are worried about Independence Day celebrations this weekend, when Americans traditionally flock to beaches and campgrounds to watch fireworks displays.

 

 

Quick Visual Summary of Covid-19 in the United States

No photo description available.

Coronavirus Cases may be 10x higher than official count says CDC

https://www.axios.com/newsletters/axios-vitals-59e9ac1a-ab86-4f8a-917a-8c9d52f5835f.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

NC coronavirus update June 25: North Carolina's mask mandate goes ...

The real number of U.S. coronavirus cases could be as high as 23 million — 10 times the 2.3 million currently confirmed cases — the Centers for Disease Control and Prevention told reporters yesterday, Axios’ Marisa Fernandez reports.

Between the lines: The new estimate is based on antibody testing, which indicates whether someone has previously been infected by the virus regardless of whether they had symptoms.

  • “This virus causes so much asymptomatic infection. The traditional approach of looking for symptomatic illness and diagnosing it obviously underestimates the total amount of infections,” CDC director Robert Redfield said.

The agency also expanded its warnings of which demographic groups are at risk, which now include younger people who are obese and who have underlying health problems.

  • The shift reflects what states and hospitals have been seeing since the pandemic began, which is that young people can get seriously ill from COVID-19.

The new guidance also categorizes medical conditions that can affect the severity of illness:

  • Conditions that increase risk: Chronic kidney disease; chronic obstructive pulmonary disease; obesity; weakened immune system from solid organ transplant; serious heart conditions, such as heart failure, coronary artery disease or cardiomyopathies; sickle cell disease; Type 2 diabetes.
  • Conditions that may increase risk: Chronic lung diseases, including moderate to severe asthma and cystic fibrosis; high blood pressure; a weakened immune system; neurologic conditions, such as dementia or history of stroke; liver disease; pregnancy.

 

 

 

 

The U.S. divide on coronavirus masks

https://www.axios.com/political-divide-coronavirus-masks-1053d5bd-deb3-4cf4-9570-0ba492134f3e.html

Politics, not public health, drive Americans' attitudes toward ...

Mask-wearing has become the latest partisan division in an increasingly politically divided pandemic.

Why it matters: It’s becoming increasingly clear that wearing even a basic cloth mask is one of the most effective ways to prevent the spread of COVID-19. But whether or not people are willing to wear one has less to do with the risk of the pandemic than their political affiliation.

By the numbers: Results from months of the Axios-Ipsos coronavirus polls show a clear and growing political divide between Democrats and Republicans on mask-wearing habits.

  • Nationally, the percentage of Democrats who reported wearing a mask all the time when leaving home rose from 49% between April 10 and May 4 to 65% between May 8 and June 22.
  • During the same time period, the percentage of Republicans who reported constant mask-wearing rose from 29% to just 35%.

Context: The political divide Americans are reporting on mask use echoes one seen within nearly all levels of the government.

  • President Trump has not been seen to wear a mask, and he told Axios last week that attendees at his Tulsa campaign event on June 20 should “do what they want” on masks, which were not required at the rally.
  • Governors in many red states like Nebraska have refused to mandate facial masks in public, even as cases have begun to rise in recent weeks. At the same time, leaders in blue states — especially those that grappled with large outbreaks of COVID-19 — have urged residents to wear masks, with California Gov. Gavin Newsom mandating their use last week as cases in the state passed 4,000 a day.
  • The situation is even more divided at the local level, with leaders of red towns in blue states pushing back against mask mandates, and vice versa.

Flashback: Some of the blame for the divide can be traced back to muddled public health messaging on mask use in the early stages of the pandemic, when Americans were urged not to go out and buy masks in bulk because of concerns that there wasn’t enough personal protective equipment for front-line health care workers.

  • Those fears were real, as government virus expert Anthony Fauci pointed out in congressional testimony on Tuesday. And public health officials worried that pushing masks would inadvertently encourage Americans to continue going out in public at a moment when lockdowns demanded they stay inside.
  • Like the divide among experts on whether mass protests would increase coronavirus cases, just the perception that health advice might be based on politics rather than science gives cover to those who would forego masks, especially since the outbreak itself initially seemed like a blue state problem.

Health experts now know that cloth masks are most effective not so much at protecting individuals from infection as protecting the community from infected individuals. But that makes masks as much about social signaling as they are about public health.

  • Conservatives who prize individual autonomy over social responsibility experience “a massive pushback of psychological resistance” when presented with mask mandates, says Steven Taylor, the author of “The Psychology of Pandemics.”
  • That reaction is reinforced “if leaders like Trump downplay the significance of COVID-19 or if they won’t wear masks,” says Taylor. As a result, wearing a mask in conservative communities means visibly going against public opinion, while the opposite is true in communities where mask use is common.
  • The Axios-Ipsos data reflects this reality, showing that while Republicans in blue states use masks less than Democrats, they wear them at higher rates than Republicans in red states, just as Democrats in red states use masks at lower rates than Democrats in blue states.

What to watch: The one factor that seems capable of breaking the political deadlock is the outbreak itself. As cases have skyrocketed in red states like Arizona recently, there’s been a significant increase in Google searches for masks.

 

 

 

 

Fauci: US seeing ‘disturbing’ new surge of infections

https://thehill.com/policy/healthcare/504087-fauci-country-seeing-disturbing-new-urge-of-infections?userid=12325

Fauci: US seeing 'disturbing' new surge of infections | TheHill

Anthony Fauci, the administration’s top infectious disease doctor, told a House panel on Tuesday that the country’s response to the COVID-19 pandemic has been a “mixed bag,” adding that a new increase in cases is “disturbing.”

“In some respects, we’ve done very well,” Fauci said during an Energy and Commerce Committee hearing, specifically praising the way New York has been containing the worst outbreak in the country to date.

“However, in other areas of the country, we are now seeing a disturbing surge of infections that looks like it’s a combination, but one of the things is an increase in community spread. And that’s something I’m really quite concerned about,” Fauci said.

There are now about 30,000 new cases per day in the United States. The number of new cases had leveled off at about 20,000, and stayed there for weeks before rising this past weekend.

The rise in the U.S. comes as the Trump administration has sought to paint a rosier picture of the U.S. outlook. Both President Trump and Vice President Pence have inaccurately tried to attribute the increase in cases to more tests being performed.

The new spike in the U.S. is being driven in part by worsening outbreaks across the South and Southwest, including in Arizona, Texas, Florida and the Carolinas, even as the situation has greatly improved in once hard-hit states in the Northeast like New York and Massachusetts.

Many of the states now being hit hard were on the more aggressive side in reopening their economies.  

“Right now, the next couple of weeks are going to be critical in our ability to address those surgings in Florida, in Texas, in Arizona, and in other states,” Fauci said on Tuesday.

 

 

 

 

Trump says Covid-19 is ‘dying out.’ Experts fear his dismissiveness could prolong the crisis

Trump says Covid-19 is ‘dying out.’ Experts fear his dismissiveness could prolong the crisis

The Trump Administration Paid Millions for Test Tubes — and Got ...

The White House is taking a new position on the coronavirus pandemic: a daily count of 750 deaths is a testament to the federal government’s successful pandemic response.

On Wednesday, when U.S. health officials reported nearly 27,000 new Covid-19 cases, President Trump said in a television interview that the virus was “dying out.” He brushed off concerns about an upcoming rally in Tulsa, Okla., because the number of cases there is “very miniscule,” despite the state’s surging infection rate. In a Wall Street Journal interview Wednesday, Trump argued coronavirus testing was “overrated” because it reveals large numbers of new Covid-19 cases, which in turn “makes us look bad,” and suggested that some Americans who wear masks do so not only to guard against the virus, but perhaps to display their anti-Trump animus.

But a range of public health experts told STAT that this messaging not only diverts attention from a pandemic that has already caused 120,000 U.S. deaths, but has more practical implications: It could make it difficult for local governments to enlist the public in the mitigation measures necessary to reduce the continued spread of the virus.

“The science behind how people process public warnings in a crisis supports this: You have to have people speaking with one voice,” said Monica Schoch-Spana, a medical anthropologist at the Johns Hopkins Center for Health Security. “You need a chorus.”

Conflicting directives can make it more difficult for recommendations coming from state and local leaders to have an impact, said Sara Bleich, a professor of public health policy at Harvard’s T.H. Chan School of Public Health.

“It sends a mixed message, which is confusing, particularly because while many people will get infected, most will not get severely sick, so it’s easy to say this won’t happen to me,” she said. “And it’s that sort of attitude that will keep us in this situation for a very long time.”

While the president has for weeks, if not months, underplayed the pandemic, his sharp and repeated remarks this week represent a remarkable attempt from the leader of American government to effectively declare the U.S. Covid-19 epidemic over.

The president’s rhetoric comes at a time that his coronavirus task force, which once conducted daily briefings, has not addressed the public since May. The president’s resumption of campaign rallies flouts federal guidance that encourages mask use (Trump’s campaign will hand out masks and hand sanitizer at the rally, but has not said it will require attendees to use them) and discourages large indoor gatherings. And the president has repeatedly claimed, misleadingly, that persistently high U.S. case totals are simply the result of increased testing.

Health experts say that political leaders preaching caution and modeling proper behavior — such as wearing a mask and demonstrating proper hand hygiene — can send a powerful signal to people that these steps can not only protect them, but their communities. They say that, essentially, national and state leaders need to walk the walk in a situation when individual behavior, like staying home when sick and cooperating with contact tracing, can make a large impact in curbing contagion.

Trump’s counterproductive behavior, Schoch-Spana said, extends far beyond the consistently dismissive tone he has taken toward the health risks of Covid-19. With few exceptions, the president has refused to wear a mask in public, and has insisted on continuing in-person briefings and White House events that effectively defy federal health guidance about gathering indoors in large groups.

“It’s not just words, it’s actions,” she said. “So when you have the nation’s top executive refusing to wear a mask, holding meetings where people are shoulder to shoulder, where he’s signing executive orders — that is also a form of communication.”

Experts also say continued federal commitments to combating the virus are crucial as the public grows tired of abatement measures. Instead, Trump has only elevated his monthslong campaign of downplaying the virus.

And Vice President Mike Pence, in a Wall Street Journal op-ed, framed the declines in cases and deaths since April as “testament to the leadership of President Trump” — even as hundreds of Americans are still dying every day and cases are not dropping further.

Rep. Donna Shalala (D-Fla.), who served as health secretary during the Clinton administration, said she hoped Americans would listen to public health guidance from local officials, not Trump and Pence.

“The president of the United States is dangerous to the health of the people of my district, because he’s giving out misinformation and false hope,” she said. “For those that believe him, they’re putting themselves and their families at risk.”

Public health experts have raised a number of issues with the administration’s messaging.

For one, a plateau of cases and deaths should not be celebrated, they say. While some countries in Europe and Asia have not only flattened their curve but driven them down, that hasn’t happened in the United States. Daily cases and deaths dipped from the peak in April, but have averaged about 20,000 and 800, respectively, for weeks.

Beyond those numbers representing real people getting sick and dying, there are other problems with sustained high levels of spread. The more cases there are, the more difficult it is for the surveillance system, including contact tracing, to keep up. It’s also more likely that some of the cases will spiral into explosive spread; 20,000 cases can turn into 40,000 a lot faster than one case can turn into 20,000.

Plus, a failure to suppress spread now could lead to more prolonged disruptions to daily life. If transmission rates come fall are still what they are now in certain communities, that makes it harder to reopen schools, for example.

Experts also point to evidence suggesting that the daily case and death numbers won’t stay flat for long. While new cases in the Northeast and Midwest are declining, a number of states in the West and South — Arizona, Texas, Florida, California, and Oregon among them — have reported record number of new cases this week. What worries public health officials is that, without measures to stem those increases, those outbreaks could keep growing. Those thousands of new cases also signal that, in a week or two, some portion of those people will show up in the hospital, and, about a week after that, a number of them will be dead, even as clinicians have learned more about treating severe Covid-19.

Some states in the South and West are already reporting record hospitalizations from Covid-19.

The White House’s shrug has been echoed by some governors, who insist, like Pence and Trump, that increased testing explains away the rise in cases. That is certainly one reason; testing has become more widespread, so states are capturing a more accurate reading of their true case burden.

But experts say increased testing can only account for some of the data states are reporting. Other metrics — including rising hospitalizations, filling ICUs, and the increasing rate of tests that are positive for the virus — signal broader spread.

Until Wednesday, leaders of Texas and Arizona also bristled at efforts from city and county officials to institute mask requirements, but acceded to growing pressure even as they have not ordered statewide mandates.

Cameron Wolfe, an infectious disease expert at Duke University, said he was seeing a growing “fatigue” among the public to keep up with precautionary steps like physical distancing and mask wearing. People letting down their guard was coinciding with an increase of cases in states, including North Carolina.

He said medical experts and health workers needed to model proper behavior to show others that the coronavirus epidemic was still something that required action. But, he added, “that also comes from political leaders buying into this.”

Federal and state authorities, he said, need to be “taking this to heart. That has not yet happened. That needs to change if we’re going to get people to buy into this.”

 

 

 

 

Cartoon – Coronavirus Leadership

Hake's - JACK DAVIS ARTWORK ON NETWORK PROMO BUTTON FOR "CHICO AND ...

Coronavirus drugmakers’ latest tactics: Science by press release

https://www.politico.com/news/2020/06/05/drugmakers-media-coronavirus-303895

Coronavirus drugmakers' latest tactics: Science by press release ...

Pharmaceutical companies are using the media to tout treatments that are still under review.

Vaccine maker Moderna attracted glowing headlines and bullish investors when it revealed that eight participants in a preliminary clinical trial of its coronavirus vaccine had developed antibodies to the virus. The company’s share price jumped nearly 20 percent that day as it released a massive stock offering.

But the full results of the 45-person safety study haven’t been published, even though Moderna began a second, larger trial in late May aimed at determining whether the vaccine works. Several vaccine researchers say the scant public information on the earlier safety study is hard to evaluate because it addresses less than 20 percent of participants.

Call it science by press release — a tactic that pharmaceutical companies are increasingly relying upon to set their experimental coronavirus drugs and vaccines apart in a crowded field, shape public opinion and court regulators. Public health experts say the approach could increase political pressure on federal health officials to green-light drugs and vaccines before it is clear they are safe or effective, with potentially dangerous consequences.

“There’s a long history of pharmaceutical manufacturers putting out self-serving press releases related to clinical trial data that they’re developing that present an overly rosy picture of the data, usually with a boilerplate disclaimer at the end, which is fairly useless,” said Aaron Kesselheim, a professor of medicine at Harvard Medical School who studies drug regulation and pricing.

There are already signs of hype and political pressure influencing the U.S.’ coronavirus response. The Food and Drug Administration authorized emergency use of the malaria drug hydroxychloroquine in March without any proof that it was safe or effective for coronavirus patients — but with the backing of President Donald Trump, who had begun touting the treatment during daily White House briefings.

Subsequent studies have found that hydroxychloroquine doesn’t help those with Covid-19 and can cause potentially fatal side effects. And a top government scientist, Rick Bright, filed a whistleblower complaint in May alleging that he was ousted from his job leading the Biomedical Advanced Research Authority after he resisted political pressure to greenlight widespread use of the drug.

“The FDA has remained an unwavering, science-based voice helping to guide the all-of-government response,” agency Commissioner Stephen Hahn said in a statement. “I have never felt any pressure to make decisions, other than the urgency of the situation around COVID-19.”

But observers aren’t so sure. “From the outside looking in, there seems to be more political pressure than ever,” said Marc Scheineson, a former associate commissioner at the FDA and head of the FDA group at Alston & Bird. “The example in the White House is trickling down and there is a lot of pressure on the FDA … to color information on the optimistic side for political purposes and that is a hugely disturbing trend.”

A spokesperson for Moderna, which has received nearly a half billion dollars from the U.S. government and praise from Trump, said the company previewed its vaccine trial results by press release because it was concerned that the data might leak. The National Institutes of Health’s top infectious disease expert, Anthony Fauci, had hinted at the results in an interview with National Geographic, and data from a trial of the experimental drug remdesivir had leaked in April.

“You had this data moving widely around NIH and the remdesivir leak was also in our minds,” the Moderna spokesperson said.

But Peter Bach, director of Memorial Sloan-Kettering’s Center for Health Policy and Outcomes, said Moderna’s effort to preview its findings in the press “could be construed as an effort to make sure they are part of the conversation — and it worked on that front.”

Other groups have also previewed their hotly anticipated vaccine studies in the press. In late April, The New York Times revealed that six monkeys given a vaccine developed by researchers at the U.K.’s University of Oxford had stayed healthy for 28 days despite sustained exposure to the coronavirus. The article quoted Vincent Munster, a researcher at the NIH’s Rocky Mountain Laboratory, which conducted the monkey study at the British scientists’ behest.

The Oxford researchers, who signed a deal with AstraZeneca two days later to develop the experimental vaccine, did not publish a formal scientific analysis of the monkey data until mid-May. The study revealed that the noses of vaccinated monkeys and unvaccinated monkeys contained similar levels of coronavirus particles, suggesting that the vaccinated animals could still spread the disease — and the vaccine might not be as effective as the earlier data had hinted.

AstraZeneca has since inked a $1.2 billion deal with the U.S. government to provide 300 million vaccine doses, and a £65.5 million ($80 million) agreement with the U.K. government to supply 30 million doses.

Liz Derow, a spokesperson for Oxford’s Jenner Institute, where the vaccine researchers are based, said they did not give the monkey data to The New York Times. The NIH’s National Institute of Allergy and Infectious Disease, which operates the Rocky Mountain Laboratory, said it did not provide the data to the newspaper — but one of its researchers, Vincent Munster, spoke to a Times reporter about the monkey findings at the request of the Jenner Institute.

“I was really disturbed by not just Moderna, but the Oxford group as well, presenting a press release without data, without a scientific review, without knowing what the press release was based on,” said Barry Bloom, an immunologist at the Harvard School of Public Health. “And very positively enough to raise the stock price so two days later officials within the company sold their stock and made a whole lot of money, whether or not the vaccine works.”

Four of the pharmaceutical firm’s top executives together saw gains of $29 million from prescheduled sales of shares in the company in the two days following the vaccine announcement. The company has not yet responded to a request for comment on the stock sales.

Neither the Oxford nor Moderna vaccines are available to the public. But some drugs whose safety and efficacy are now being studied have already been repurposed or authorized for emergency use during the pandemic. The rush to release snippets of information on drug trials to the press ahead of full results has left some doctors wondering how to best treat their patients.

After leaked data from a trial of Gilead’s experimental antiviral remdesivir suggested the drug might be the first shown to help coronavirus patients, the company put out a press release in late April teasing results from a larger, government-run study. Hours later, Fauci revealed some findings of the study during an Oval Office press spray.

But the full analysis of the NIAID trial results was not published until three weeks later. Until that point, frontline physicians had no way to know that patients on ventilators did not benefit from remdesivir treatment — meaning that doctors may have inadvertently wasted some of the United States’ limited stock of the drug.

This lack of understanding on how to use remdesivir was evident in a recent survey more than 250 hospitals by the American Society of Health-System Pharmacists, which found that just 15 percent planned to use their remdesivir doses as described in the FDA’s emergency authorization for the drug.

Andre Kalil, an infectious disease doctor at the University of Nebraska Medical Center who led the NIAID trial, told POLITICO that physicians could have patterned their use of remdesivir on the dosages given during the trial.

Others say doctors using experimental treatments should have as much information as possible.

“If we want doctors to make rational medical decisions based on data, then before an authorized product reaches patients, the data should be available to review in some way, not just a press release,” said Walid Gellad, director of the University of Pittsburgh’s Center for Pharmaceutical Policy and Prescribing.

Kesselheim, too, said that clinical trial data should be made public alongside any emergency authorizations to give physicians “the maximum amount of help they need in figuring out how to prescribe the drug.”

Gilead did not respond to a request for comment. But NIAID said that the urgency of the coronavirus prompted Fauci to share initial results before a full analysis was ready for publication.

Ivan Oransky, a professor of medical journalism at New York University and co-founder of the blog Retraction Watch, which monitors errors and misconduct in scientific research, told POLITICO he fears that the temptation to conduct science by press release will get “worse before it gets better.”

The world is growing more desperate for drugs and vaccines that could bring the coronavirus to heel. And many members of the public and politicians are treating every scrap of scientific information about the pandemic equally, he said — whether data comes from a peer-reviewed study or a company press release.

“There have been mechanisms to review science critically that, given the speed of Covid, have gone out the window,” said Bloom.

And interpreting results of clinical trial data can be difficult under the best of circumstances — especially when that data concerns a virus that was unknown to science until December of last year. When to end a trial and which conclusions to highlight are in many cases a matter of discretion, said Scheineson.

“It’s an art, not a science, in that respect,” he said. “I, for one, will not be the first in line to the new Moderna vaccine.”