POST 47. September 24, 2020. CORONAVIRUS. “Perry N. Halkitis, dean of the School of Public Health at Rutgers University…called New York City’s 35 percent rate for eliciting contacts “very bad.” “For each person, you should be in touch with 75 percent of their contacts within a day,” he said”

to read Posts 1-47 in chronological order highlight and click on http://doctordidyouwashyourhands.com/2020/09/coronovirus-tracking-links-to-parts-1-47/

Gov. Phil Murphy, speaking during a Friday news conference, said New Jersey has run into trouble in its efforts to contain the coronavirus because of contact-tracing problems. Murphy made the announcement as he revealed 313 new coronavirus cases and 13 more confirmed deaths were reported (you can watch it here, below).

The update comes as the number of cases rose to 188,817 and 14,112 confirmed deaths have been reported. Read more: NJ Coronavirus, School Reopen Updates: Here’s What You Need To Know

Murphy said more than half of the people contacted through contact tracing have refused to provide information and “this is highly disturbing, to say the least.”

Murphy suggested that the lack of participation in providing information to contact tracers may have slowed efforts to track the virus and ultimately quarantine people to reduce the spread.

The number of people not picking up the call is 19 percent, and the number of people not providing contacts is 52 percent, said Health Commissioner Judith Persichilli.

“It is essential that residents join with the contact tracers in containing this disease,” Persichilli said. “Contact tracers are calling with lifesaving information that will keep you and your loved ones and our communities safe and healthy.”

It also could explain why New Jersey has had a hard time recently in keeping its transmission rate below 1.0, which is considered too high. That means every person with the coronavirus is spreading the disease, on average, to at least one other person.

After weeks of having a rate around 0.82, New Jersey’s rate is currently at 1.04. (A)

“The tracing approach is built on a simple idea: When someone tests positive for the new coronavirus or becomes sick with COVID-19, you find all the people the infected person came into contact with, because they, too, may be infected. Then you help them quarantine for two weeks—almost everyone who becomes sick will show symptoms within 14 days—so they do not accidentally spread the virus any further. The goal is to stop the chain of transmission, says Emily Gurley, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, who has created a free online course to train contact tracers…

Large-scale contact-tracing programs in places such as South Korea and Germany have been instrumental in suppressing the novel coronavirus, SARS-CoV-2. Within days of detecting its first case on January 20, South Korea created an emergency response committee that quickly developed wide-scale virus testing, followed by an extensive scaling up of the nation’s network of contact tracers. Germany similarly committed resources to mobilizing a tracing workforce. In both countries, cases have dropped dramatically.

By contrast, tracing efforts lag in the U.S., where COVID-19 cases hit record highs in mid-July and which leads the world with more than 3.7 million infections and more than 140,000 deaths. The country has no national strategy for contact tracing, says Adriane Casalotti, chief of government and public affairs at the National Association of County and City Health Officials (NACCHO). Instead “the federal government has said to states, ‘do as you wish,’” she adds. According to news reports, this week the White House moved to block $25 billion for tracing and testing in the latest pandemic relief bill being considered by Congress, contending that states already have funding.

Yet many states do not have the money to start large tracing programs. In fact, state public health departments across the U.S. were drastically underfunded even before the pandemic. Since 2008, local health departments have lost close to 25 percent of their employees.

The result is a patchwork of programs with insufficient money and uneven implementation. NACCHO estimates that, given national levels of confirmed cases, the nation needs at least 100,000 contact tracers. And that number would cost local, state, territorial, Native American and federal public health agencies at least $3.7 billion. So far, however, no federal dollars have been specifically allocated to contact tracing “or to any federal contact tracing programs,” Casalotti says…

The next action that comes after a tracer has identified a potential infected person—getting that individual to adhere to quarantine—has proved exceptionally difficult in the U.S. For stopping the spread of a virus, however, isolation is absolutely key. “You can do the contact tracing all you want. But if you’re not also providing these support services people need to isolate, it won’t work,” Madad says. No one is going to quarantine for 14 days if that means losing a job and income or abandoning caregiving.”  (B)

“The countries where contact tracing has worked best set up their tracing systems before cases exploded, and as cases grew, they hired more tracers. The U.S. has not done this. In June, when states were in the throes of reopening, only seven states and Washington, D.C., met the Centers for Disease Control and Prevention’s recommendation of 30 contact tracers per 100,000 residents, according to an NPR analysis. According to the latest data from Test and Trace, an organization that grades states on their testing and tracing capabilities, only seven states are currently considered “fully prepared to test and trace.” States meet this threshold if they have a test-positivity rate of 3 percent or less, provide test results in two days or less, and employ five to 15 contact tracers per positive test….

The logistical testing delays are exacerbated by quirks of the American health-care system that are making it even harder for people to get tested and quickly quarantine. Many people can’t get paid leave from work unless they provide proof of a positive COVID-19 test. So if Aunt Sally is feeling sick but her test results haven’t come back yet, she might be required to report to work or forfeit her paycheck for the day. “If that test isn’t showing up for a week, then they’ve already been exposing people for a week,” said another Texas contact tracer, who asked to remain anonymous, because she’s not authorized to speak with the press.

It’s likely that the first time many Americans heard the term contact tracing was this spring. Before that, some public-health departments were little more than two people and an old computer, having lost a quarter of their workforce through aggressive budget cuts since 2009. Because the U.S. has had such an enfeebled public-health system for so long, the public doesn’t trust public-health workers at a time when it’s crucial that they do so. When called by a department they’ve never heard of and asked for a list of all their friends, Americans could be forgiven for thinking, Who the hell are these people?..

These trust issues have become especially pronounced in the Black and Hispanic communities, two populations that have been disproportionately affected by COVID-19. Black and Hispanic people are more than twice as likely as white people to get COVID-19, and are more than four times as likely to be hospitalized with it. Several experts told me that wariness of the government in these communities has been exacerbated by the Trump administration’s public-charge rule, under which immigrants might jeopardize their green card if they accept public benefits. “If the word gets out in a community, ‘Don’t talk to the government, because we are worried the government will do bad things to us,’ then you don’t have trust,” John Auerbach, the president of Trust for America’s Health, a nonprofit that promotes public health, told me…

People have more trust in public-health workers when local health departments, governors, and the president speak with one voice. But some officials have downplayed the virus, some have taken it seriously, and others have ignored it entirely. Other than claiming that the U.S. has gotten “good at” it, Donald Trump hasn’t said much about contact tracing. But perhaps his actions should speak louder than his words: When someone in the White House gets sick, the executive branch traces all of that person’s contacts.” (C)

“Public health is called public health for a reason, says Emily Gurley, an infectious disease expert at the Johns Hopkins School of Public Health: Strategies like contact tracing can only be effective if the community cooperates.

However, there’s no one metric by which to judge a successful contact tracing effort, says Gurley. “You don’t have to be perfect to have an impact,” she said. “And just because cases are still going up doesn’t mean you’re not having an impact, as well.”

If a community tests only a few people, but reaches 100% of respondents, they may be less effective at stopping transmission than a community that identifies all the local cases through testing but only reaches 40% of them by phone. And response rates don’t reflect the efficacy of each interview. Picking up the phone is one thing; giving out a list of close contacts is another.

But contact tracers do need all the responses they can get, and, crucially, as many honest, comprehensive interviews as possible. To safely lift lockdowns, the COVID-Local guide recommends cities ensure they’re reaching 75% of each positive patient’s close contacts within a day of testing…

Like mask-wearing, which became fiercely politicized despite evidence that it significantly reduces transmission of disease, attitudes towards contact tracing have been muddied by misinformation and mixed messaging. …

This resistance varies by region and by state, Waters says, but it tends to line up with political differences. “A large proportion of the population views not participating in contact tracing as aligned with their political tribe,” he said on a panel at the Disease Prevention and Control Summit last month. 

But contact tracing pushback isn’t just about politics. Even as coronavirus disproportionately impacts communities of color, trust in the federal government is lowest among Black people, and reports show that some Latinx communities are wary of getting tested for the virus and more fearful of seeking medical help because of fears of immigration enforcement….

Already, one promising contact tracing tool in the U.S. has been stymied by privacy fears. In April, Apple and Google introduced a plan to facilitate contact tracing by allowing people who tested positive to send out an anonymous ping via the Bluetooth connection that most smartphones have, to alert anyone who had come into close contact with their device in the previous few days. Despite privacy and anonymity assurances, surveys showed that people were wary of their location being linked to their health information…

In part because health officials understand this reticence — and in part because of coordination and technical issues — the U.S. has yet to roll out widespread app-based testing, as many other nations in Europe and Asia have, and the Apple and Google API has yet to be adopted at scale. Even officials from Singapore and Iceland, where sophisticated contact tracing apps were part of an early coronavirus response, advocate a hybrid approach. Pairing targeted phone alerts with traditional human “disease detectives” who call on the phone can capture the widest swath of the population, they say.

“It’s not too late for public health authorities to communicate better about this tech, what it entails and why it’s important,” said Kreps…” (D)

“Our local public health authorities haven’t skimped on sharing data tied to the novel coronavirus. Visit the dashboards on the Department of Health and Public Health—Seattle and King County websites and you’re liable to get dizzy from all the curves outlining the changes in cases, hospitalizations, and tests since the start of the pandemic.

But until recently, Washington officials had held out on publicly quantifying one area of our response to Covid-19: contact tracing, or the effort to identify and isolate people who have crossed paths with infectious hosts to curb the virus’s spread. Though we knew the state had struggled, both initially and later on, to reach cases and their close contacts, we couldn’t point to any numbers assessing the current state of our disease containment effort.

Now we know why officials weren’t exactly in a rush to divulge the details. On Wednesday, the DOH released a report that showed the department had fallen well short of its case investigation and contact tracing goals despite mobilizing an army of sleuths. The department had sought to reach 90 percent of cases within one day of a positive test result. During the weeks between August 2 and September 5, the state never topped 51 percent in that area. The DOH had also targeted an 80-percent connection rate with contacts 48 hours post-case confirmation. It hasn’t yet met that mark. “While we expect our outcomes to improve over time, this initial data shows we have work to do,” state secretary of health John Wiesman said in a press release.

Are those goals too lofty? Hard to say. Many states still haven’t published their contact tracing stats, and those that have often use slightly different metrics. Public Health—Seattle and King County’s latest dashboard doesn’t lend itself to an apples-to-apples comparison with the broader state data, either, but it does provide some more interesting bits. For example, 60 Covid-19 contact tracers currently work for the authority. In mid-July, when cases were rising again, the number was half that.

Since the local headcount bump, the county’s case interview performance has stabilized. Roughly 60 percent of positive cases get interviewed (not just reached) on the same day they’re assigned to a contact tracer. Still, thanks to the pre-symptomatic period and lags between symptom onset and testing, nearly nine days of viral shedding have typically passed by the time tracers speak with infected individuals. Not ideal.”  (E)

“New York Gov. Andrew Cuomo (D) was joined remotely by former New York City Mayor Michael Bloomberg on Thursday as Cuomo described efforts to develop and implement a comprehensive coronavirus contact tracing program in the Empire State.

Such a program, Cuomo said in his daily briefing, will “require, under any estimate, a tracing army to come up to scale very quickly,” which he said will be a vital part of any state efforts to reopen businesses and institutions.

Bloomberg, joining the briefing through a video link, described a contact tracing system as “one of the most important steps we need to take,” adding “when social distancing is relaxed, contact tracing is our best hope for isolating the virus when it appears and keeping it isolated.”

Bloomberg said his philanthropic foundation will develop the system in partnership with Johns Hopkins University, “the best public health school in the world,” as well as the organizations Vital Strategies and Resolve to Save Lives.

The former mayor said the City University of New York and State University of New York will help identify potential applicants for contact tracing jobs and that Johns Hopkins has developed an online training class that will conclude with a mandatory test.

“We’re not going to put up people there that don’t know what they’re doing,” he added.

Bloomberg also noted that the program will help develop a broader “playbook” for contact tracing through its efforts, saying “we will release that playbook publicly so cities and states around the country can use it and scan nations around the world. That way the work we do here in New York really can help fight the virus globally.”

Cuomo expressed a similar sentiment, saying of the state: “In many cases we’ve dealt with challenges first; we figure it out and then we work with other places to actually learn from what we’ve done.”

“I think this is going to be one of those examples,” he added. “It will also be a laboratory to put together the best system ever put together so we can share that with other governments, and that’s what Mayor Bloomberg does so well.”” (F)

“New York City’s ambitious contact-tracing program, a crucial initiative in the effort to curb the coronavirus, has gotten off to a worrisome start just as the city’s reopening enters a new phase on Monday, with outdoor dining, in-store shopping and office work resuming.

The city has hired 3,000 disease detectives and case monitors, who are supposed to identify anyone who has come into contact with the hundreds of people who are still testing positive for the virus in the city every day. But the first statistics from the program, which began on June 1, indicate that tracers are often unable to locate infected people or gather information from them.

Only 35 percent of the 5,347 city residents who tested positive or were presumed positive for the coronavirus in the program’s first two weeks gave information about close contacts to tracers, the city said in releasing the first statistics. The number ticked up slightly, to 42 percent, during the third week, Avery Cohen, a spokeswoman to Mayor Bill de Blasio, said on Sunday.

Contact tracing is one of the few tools that public health officials have to fight Covid-19 in lieu of a vaccine, along with widespread testing and isolation of those exposed to the coronavirus. The early results of New York’s program raise fresh concerns about the difficulties in preventing a surge of new cases as states across the country reopen.

The city has successfully done contact tracing before, with diseases like tuberculosis and measles. But as with much involving the coronavirus outbreak, officials have never faced the challenge at this scale, with so many cases across the five boroughs.

The city’s program has so far been limited by a low response rate, scant use of technology, privacy concerns and a far less sweeping mandate than that in some other countries, where apartment buildings, stores, restaurants and other private businesses are often required to collect visitors’ personal information, which makes tracking the spread easier…

Perry N. Halkitis, dean of the School of Public Health at Rutgers University…called New York City’s 35 percent rate for eliciting contacts “very bad.”

“For each person, you should be in touch with 75 percent of their contacts within a day,” he said.

He suggested that the poor showing stemmed in part from the inexperience of the contact tracers and insufficient hands-on training.

“This is a skill,” he said. “You need to practice.”…

Dr. Halkitis at Rutgers said he thought the low cooperation rate was likely due to several factors, including the inexperience of the tracers; widespread reluctance among Americans to share personal information with the government; and Mayor de Blasio’s decision to shift the program away from the city’s Department of Health.”  (G)

“HONOLULU (KHON2) — The head of the state’s contact tracing program, who took over just before a Department of Health leadership shakeup, has already made big inroads in overhauling the system. Dr. Emily Roberson spoke for the first time with Always Investigating. Under Roberson’s new system, the health department is now collecting key data that shows what kind of settings and activities are spreading COVID, and where and how it is being safely blocked…

“They are reaching out as soon as people test positive,” Roberson said, “to make sure they have the information they need in terms of education and to make sure we’re able to screen for any specialized follow-ups that may be needed.”

“First contact callers” are dialing up every positive person with 24 hours and screening for whether specialized follow-ups are needed.

“We have about 50% of the people we attempt to reach within 24 hours, either they have a bad number, they have no number or we are just not able to get them on the phone,” she said.

Of those they can reach, the callers sort the cases among eight specialized investigation teams led by a disease investigator and supported by the National Guard and a cadre of contact tracers.

Additional targeted support such as nurses, community workers, monitors and even translators can jump in when needed…

Roberson’s other overhaul efforts include changing the forms, scripts and procedures to rapidly collect more detailed data…

Now, Roberson tells Always Investigating that her team has collected weeks of data that gets down to business.

“It does include questions about gyms, personal care services, congregate settings, schools, correctional facilities and a whole bunch of information about that, restaurants for example, bars,” she explained.

“There are a lot of times where we might have clusters that involve a specific type of employee or a specific workplace, but when we really investigate them further we find out that the transmission is taking place outside of that location,” Roberson said, adding that social after-work parties, lunch-break hangouts, smoke breaks, or roommates who happen to work together becoming infected at home appear to be the actual source of spread.

“It could be there’s transmission happening technically around the work building but it’s not so much associated with the work itself, it’s more when you’re on your break, or you’re hanging out with your friends,” Roberson said. “Even though there were this many cases at this workplace, it seems everyone got it when they went to this party. It’s not a case where they put their customers or, in health-care their patients, at risk as much as people relax when they are with their friends and it’s spreading socially.”

That is consistent with what small businesses and organizations have been saying about their own contact tracing, finding off-work social spread, not on-the-job, in-store or in-restaurant where masks, barriers, distancing and sanitation regimes are followed to the tee.

“As a business, we’re already doing that, so we know it’s not coming from us,” Tina Yamaki, President of the Retail Merchants of Hawaii, said at the House economic hearing. “If a majority of the numbers are coming from funeral homes or private parties or care homes, we need to take that into consideration, too, instead of a full shutdown.””  (H)

“Washington state will join California and Oregon in soon launching a voluntary contact tracing application that Google and Apple jointly developed that alerts users if they have been exposed to the coronvirus.

The app will be voluntary and anonymously notify a user if they have been exposed to someone who tests positive, Gov. Jay Inslee said Thursday.

“You volunteer to share your information, if you desire, with the app, and you’re voluntarily notified should you desire that,” Inslee said. “And all of this is maintained with great privacy protections. We’ve insisted on that.”

Washington Department of Health officials have had mixed results when it comes to their contact tracing efforts, and while they have the adequate staffing to make calls in 16 counties that require their help, State Secretary of Health John Wiesman told reporters Wednesday, that their challenges are not unique.

“Other states have been experiencing the same kinds of issues with folks not returning calls or difficulty getting the phone numbers,” he said.

Ideally, contact tracing and case investigations are done at a local level, Wiesman said, and the majority of local health jurisdictions in the state are doing their own case investigations and contact tracing, or bringing on contractors to help. Last week, in Spokane County, 76% of COVID-19 cases were epidemiologically-linked, connected to one another through contact tracing or investigators identifying spread in a similar location.

A report from DOH shows that their case investigators made contact with about 65% of people with confirmed cases of COVID-19 for an interview.

Wiesman said the Apple-Google application product is forthcoming, and the department is working with the companies to identify some “pilot opportunities.””  (I)

“But state leaders remain guarded in their enthusiasm, recognizing some Oregonians may be unlikely to participate over privacy concerns and acknowledging equity challenges over who may access the technology. An unrelated symptom-monitoring project touted as a “game changer” by Gov. Kate Brown got shelved last month for failing to ensure enough participation among people of color.

“Knowledge is power when it comes to stopping the spread of COVID-19, and this pilot project will help people make informed decisions to keep themselves healthy, while still protecting individual privacy,” Brown said in a statement this week announcing the new technology effort.

“Oregon officials would not say where the technology will be available under the pilot, noting details are still being finalized. But the Oregon Health Authority is in talks with a university or universities about promoting the system for students, suggesting it could be available in Eugene at the University of Oregon, Corvallis for Oregon State University or in Portland at Portland State University.

The digital contact tracing system will be voluntary and completely anonymous, said Dr. Timothy Menza, a senior health adviser for the Oregon Health Authority.

It works by using Bluetooth signals from cell phones to record anonymized identifiers for cell phones that are in close proximity. The technology is able to determine roughly how close and how long the phones are near one another, with the federal government considering close contact as within six feet for at least 15 minutes.

That anonymized data would stay on an individual’s phone unless the person later tests positive for COVID-19, Menza said. At that point, the infected person would receive a personal identification number from the state or county health department after the COVID-19 diagnosis had been confirmed.

The person could then voluntarily enter the PIN into their cell phone, which would begin the process of uploading the anonymized Bluetooth data to a national server, Menza said. Other participants’ phones would regularly scan the national database to see if they’ve been in close contact with a confirmed coronavirus case – and if there’s a match the person would receive a notice on the phone about exposure and suggesting testing.

State and local health departments would not receive notice about exposures, Menza said. But people who are infected, or people who seek testing after receiving a notice, could voluntarily disclose that they are using the technology.

So-called proximity tracing applications do not take the place of traditional contact tracing by public health officials that involves detailed case investigations to determine the names of people who might have been exposed to a person with a confirmed infection.

But the technology does allow for more thorough tracing efforts, allowing notification among people whose identities might not be known to an infected person – such as someone who rode the same bus, ate at the same restaurant or attended the same party.

Proximity technology is controversial, particularly among some Americans who are unwilling to share personal data for privacy reasons and skeptical of the big tech companies offering the service. But it’s been embraced in some places, including Scotland, where a new app was reportedly downloaded 600,000 times.

Menza said proximity tracing apps have the potential to make a big difference if widely adopted. He pointed to research by the University of Oxford, which estimates that cases and hospitalizations could decline if just 15 percent of the population uses the technology.

Modeled for the state of Washington, that adoption level suggested a 15 percent decline in infections and 11 percent reduction in deaths.

“In that sense,” Menza said, “it seems pretty powerful.”

But that would require participation of more than 600,000 Oregonians, essentially the entire population of Portland.

“We’ll have to put in the work to make that happen,” Menza said.”  (J)

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CORONOVIRUS TRACKING Links to Parts 1-47

CORONOVIRUS TRACKING

 Links to Parts 1-47

Doctor, Did You Wash Your Hands?®

http://doctordidyouwashyourhands.com/

Curated Contemporaneous Case Study Methodology

Jonathan M. Metsch, Dr.P.H.

https://www.mountsinai.org/profiles/jonathan-m-metsch

PART 1. January 21, 2020. CORONAVIRUS. “The Centers for Disease Control and Prevention on Tuesday confirmed the first U.S. case of a deadly new coronavirus that has killed six people in China.”

PART 2. January 29, 2020. CORONAVIRUS. “If it’s not contained shortly, I think we are looking at a pandemic..”….. “With isolated cases of the dangerous new coronavirus cropping up in a number of states, public health officials say it is only a matter of time before the virus appears in New York City.”

PART3. February 3, 2020. “The Wuhan coronavirus spreading from China is now likely to become a pandemic that circles the globe…”..Trump appeared to downplay concerns about the flu-like virus …We’re gonna see what happens, but we did shut it down..” (D)

PART 4. February 9, 2020. Coronavirus. “A study published Friday in JAMA found that 41% of the first 138 patients diagnosed at one hospital in Wuhan, China, were presumed to be infected in that hospital.….

PART 5. February 12, 2020. CORONAVIRUS. “In short, shoe-leather public health and basic medical care—not miracle drugs—are generally what stop outbreaks of emerging infections..”

POST 6. February 18, 2020.  Coronovirus. “Amid assurances that the (ocean liner) Westerdam was disease free, hundreds of people disembarked in Cambodia…” “ One was later found to be infected”…. “Over 1,000… passengers were in…transit home”…. “This could be a turning point””

PART 7. February 20, 2020. CORONAVIRUS. With SARS preparedness underway in NJ LibertyHealth/ Jersey City Medical Center, where I was President, proposed that our 100 bed community hospital with all single-bedded rooms, be immediately transformed into an EMERGENCY SARS ISOLATION Hospital.

PART 8. February 24, 2020. CORONAVIRUS. “…every country’s top priority should be to protect its health care workers. This is partly to ensure that hospitals themselves do not become sites where the coronavirus is spread more than it is contained.”

PART 9. February 27, 2020. CORONAVIRUS. Responding to a question about the likelihood of a U.S. outbreak, President Trump said, “I don’t think it’s inevitable…”It probably will. It possibly will,” he continued. “It could be at a very small level, or it could be at a larger level.”

Part 10. March 1, 2020. CORONAVIRUS. Stop Surprise Medical Bills for Coronavirus care. (&) Lessons Learned (or not) In California and Washington State from community acquired cases.

PART 11. March 5, 2020.  CORONAVIRUS. “Gov. Andrew Cuomo… would require employers to pay workers and protect their jobs if they are quarantined because of the coronavirus.”

Part 12. March 10, 2020. CORONAVIRUS. “Tom Bossert, Donald Trump’s former homeland security advisor…(said) that due to the coronavirus outbreak, “We are 10 days from the hospitals getting creamed.”

Part 13.. March 14, 2020. CORONAVIRUS. “If I’m buying real estate in New York, I’ll listen to the President….If I’m asking about infectious diseases, I’m going to listen to Tony Fauci,”

PART 14. March 17, 2020. CORONAVIRUS. “ “Most physicians have never seen this level of angst and anxiety in their careers”…. One said “I am sort of a pariah in my family.”

PART 15. March 22, 2020. CORONAVIRUS. “…Crimson Contagion” and imagining an influenza pandemic, was simulated by the Trump administration….in a series of exercises that ran from last January to August.

PART 16. March 27, 2020. CORONAVIRUS. I am not a clinician or a medical ethicist but articles on Coronavirus patient triage started me Googling………to learn about FUTILE TREATMENT

PART 17. April 2, 2020. CORONAVIRUS. Florida allows churches to continue holding services. Gun stores deemed “essential.”  “New York’s private and public hospitals unite to manage patient load and share resources.

PART 18. April 9, 2020. CORONAVIRUS. “The federal government’s emergency stockpile of personal protective equipment (PPE) is depleted, and states will not be receiving any more shipments, administration staff told a House panel.

PART 19. April 13, 2020 CORONOAVIRUS. “…overlooked in the United States’ halting mobilization against the novel coronavirus: the personal aides, hospice attendants, nurses and occupational or physical therapists who deliver medical or support services to patients in their homes.”

PART 20. April 20, 2020. CORONAVIRUS. “…nothing is mentioned in the “Opening Up America Again” plan about how states should handle a resurgence.”

PART 21. April 23, 2020. CORONAVIRUS. “We need to ask, are we using ventilators in a way that makes sense for other diseases but not this one?”

POST 22. April 29, 2020. CORONAVIRUS. ..the “ACS released a list of 10 issues that should be addressed before a healthcare organization resumes elective surgeries[JM1] ….”

POST 23. May 3, 2020. CORONAVIRUS. … what Dr. Fauci really wants,…”is just to go to a baseball game. That will have to wait. The level of testing for the virus is not adequate enough to allow for such mass gatherings.’ (K)

POST 24. May 7, 2020. CORONAVIRUS. Former New Jersey governor Chris Christie said: “there are going to be deaths no matter what”… but that people needed to get back to work.

POST 25. May 10, 2020, CORONAVIRUS. “It is scary to go to work,” said Kevin Hassett, a top economic adviser to the president. “I think that I’d be a lot safer if I was sitting at home than I would be going to the West Wing.”

POST 26. May 14, 2020. CORONAVIRUS, “Deep cleaning is not a scientific concept”….”there is no universal protocol for a “deep clean” to eradicate the coronavirus”

POST 27. May 19, 2020. CORONAVIRUS. “Hospital…executives…are taking pay cuts…to help offset the financial fallout from COVID-19.” As “front line” layoffs and furloughs accelerate…

POST 28. May 23, 2020. CORONAVIRUS. ““You’ve got to be kidding me,”..”How could the CDC make that mistake? This is a mess.” CDC conflates viral and antibody tests numbers.

PART 29. May 22, 2020. CORONAVIRUS. “The economy did not close down. It closed down for people who, frankly, had the luxury of staying home,” (Governor Cuomo). But not so for frontline workers!

POST 30. June 3,202. CORONAVIRUS. “The wave of mass protests across the United States will almost certainly set off new chains of infection for the novel coronavirus, experts say….

POST 31. June 9, 2020. CORONAVIRUS. “I think we had an unintended consequence: I think we made people afraid to come back to the hospital,”

Post 32. June 16, 2020. CORONAVIRUS. Could the Trump administration be pursuing herd immunity by “inaction”?  “ If Fauci didn’t exist, we’d have to invent him.”

POST 33. June 21, 2002. CORONAVIRUS….. Smashing (lowering the daily number of cases) v. flattening the curve (maintaining a plateau)

POST 34. June 26, 2020. CORONAVIRUS. CDC Director Redfield… “the number of coronavirus infections…could be 10 times higher than the confirmed case count — a total of more than 20 million.” As Florida, Texas and Arizona become eipicenters!

POST 35. June 29, 2020. CORONAVIRUS. Pence: “We slowed the spread. We flattened the curve. We saved lives..”  While Dr. Fauci “warned that outbreaks in the South and West could engulf the country…”

POST 36. July 2, 2020. CORONAVIRUS. “There’s just a handful of interventions proven to curb the spread of the coronavirus. One of them is contact tracing, and “it’s not going well,” (Dr. Anthony Fauci)..

POST 37. June 8, 2020. CORONAVIRUS. When “crews arrive at a hospital with a patient suspected of having COVID-19, the hospital may have a physical bed open for them, but not enough nurses or doctors to staff it.”

POST 38. July 15, 2020. CORONAVIRUS. Some Lessons Learned, or not. AdventHealth CEO Terry Shaw: I wouldn’t hesitate to go to Disney as a healthcare CEO — based on the fact that they’re working extremely hard to keep people safe,” (M)

POST 39. July, 23,2020. CORONAVIRUS. A Tale of Two Cities. Seattle becomes New York (rolls back reopening) while New York becomes Seattle (moves to partial phase 4 reopening)

POST 40. July 27, 2020. CORONAVIRUS.” One canon of medical practice is that you order a test only if you can act on the result. And with a turnaround time of a week or two, you cannot. What we have now is often not testing — it’s testing theater.”

POST 41. August 2, 2020. CORONAVIRUS. “Whenever a vaccine for the coronavirus becomes available, one thing is virtually certain: There won’t be enough to go around. That means there will be rationing.”

POST 42. August 11, 2020. CORONAVIRUS. “I think that if future historians look back on this period, what they will see is a tragedy of denial….

POST 43. August 22, 2020. CORONAVIRUS.”  “we’ve achieved something great as a nation. We’ve created an unyielding market for FAUCI BOBBLEHEADS”!! (W)

POST 44.  September 1, 2020. CORONAVIRUS. “The CDC…modified its coronavirus testing guidelines…to exclude people who do not have symptoms of Covid-19.” (While Dr. Fauci was undergoing surgery.) A White House official said: “Everybody is going to catch this thing eventually..”

POST 45. September 9, 2020. CORONAVIRUS.  Trump on Fauci. ‘You inherit a lot of people, and you have some you love, some you don’t. I like him. I don’t agree with him that often but I like him.’

POST 46.  September 17, 2020. CORONAVIRUS. “Bill Gates used to think of the US Food and Drug Administration as the world’s premier public-health authority. Not anymore. And he doesn’t trust the Centers for Disease Control and Protection either….”

POST 47. September 24, 2020. CORONAVIRUS. “Perry N. Halkitis, dean of the School of Public Health at Rutgers University…called New York City’s 35 percent rate for eliciting contacts “very bad.” “For each person, you should be in touch with 75 percent of their contacts within a day,” he said”

September 23, 2020


 [JM1]

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POST 46. September 17, 2020. CORONAVIRUS. “Bill Gates used to think of the US Food and Drug Administration as the world’s premier public-health authority. Not anymore. And he doesn’t trust the Centers for Disease Control and Protection either….”

to read POSTS 1-46 in chronological order, highlight and click on

“President Donald Trump continues to baselessly claim the coronavirus will simply “go away” even as the number of COVID-19 cases in the U.S. skyrocket under an administration fumbling its response to the pandemic.

“This is going to go away,” Trump said of the deadly virus at the White House on Tuesday. “And whether it comes back in a modified form in the fall, we’ll be able to handle it, we’ll be able to put out spurts, and we’re very prepared to handle it.”..

“It’s going to disappear,” he said of the coronavirus at the time as infection numbers began to trickle in. “One day it’s like a miracle, it will disappear.”” (J)

“Bill Gates used to think of the US Food and Drug Administration as the world’s premier public-health authority. Not anymore.

And he doesn’t trust the Centers for Disease Control and Protection either.

Both, in his view, are casualties of a presidency that has downplayed or dismissed science and medicine in the pursuit of political gain. One recent example came when FDA Commissioner Stephen Hahn, speaking at one of President Donald Trump’s news conferences, exaggerated the benefit of blood plasma as a treatment for Covid-19, then backtracked the following day.

“We saw with the completely bungled plasma statements that when you start pressuring people to say optimistic things, they go completely off the rails. The FDA lost a lot of credibility there,” Gates, the billionaire philanthropist, said in an interview on Bloomberg Television.

“Historically, just like the CDC was viewed as the best in the world, the FDA had that same reputation as a top-notch regulator,” Gates said. “But there’s been some cracks with some of the things they’ve said at the commissioner level.”

At stake is nothing less than public confidence in the vaccine that could end the coronavirus pandemic, and which the FDA would have to approve. Polls conducted in the past two months show a majority of Americans worry development of the vaccine is being rushed and a third wouldn’t get inoculated.” (A)

“In an interview with STAT, Gates sounded exasperated at times as he described the badly bungled launch of Covid-19 testing, the enlisting of a neuroradiologist — rather than an epidemiologist or infectious diseases specialist — to help guide the White House’s response decisions, and the recent move to discourage testing of people who have been in contact with a known case but who aren’t yet showing symptoms.

“You know, this has been a mismanaged situation every step of the way,” Gates said in the wide-ranging interview. “It’s shocking. It’s unbelievable — the fact that we would be among the worst in the world.”

He leveled his harshest criticism at Food and Drug Administration Commissioner Stephen Hahn, who mischaracterized findings from a Mayo Clinic study on Covid-19 and said researchers had seen a 35% survival benefit with the use of convalescent plasma. “Many of you know I was a cancer doctor before I became FDA commissioner,” Hahn said at the time. “And a 35% improvement in survival is a pretty substantial clinical benefit.”

“This is third grade math. I mean, are you kidding?” Gates said. “The head of the FDA got up and said it was a 35% death reduction where it’s not even a 3% reduction based on just a tiny little subset that was nonstatistical. This is unheard of.”…

Early in the outbreak, as it was becoming clear the new coronavirus was spreading from China, experts from the Bill and Melinda Gates Foundation were in regular contact with the Trump administration, urging officials to come up with a plan for who to test and how to test them, and to get surveillance data up on the website of the Centers for Disease Control and Prevention.

Gates said from the start the foundation insisted that commercial laboratories should only be paid for their work if they returned test results within 24 hours — a target rarely reached in the U.S. response. Anything longer than that meant the tests were not useful for containing spread of the virus, he said, adding: “You get to write apology notes to the people you infected in the meantime.”

This advice still isn’t being heeded. “I’ve been saying this and I just don’t get why it hasn’t changed,” Gates said.

The CDC’s early missteps on testing — “they created this overly complicated test,” Gates said — was followed by a slow rollout of commercial tests. The commercial tests use polymerase chain reaction, or PCR, to look for small fragments of the genetic material of the virus in mucus swabbed out of the nasal passages of people who are tested.

“We have way more PCR machines than any country in the world. I mean, we are PCR central,” he said with emphasis. “So, the idea that we actually made it harder to get PCR tests approved by the commercial sector, it’s mind-blowing.”..

Likewise, Gates could not believe the administration’s recent move to rewrite CDC testing guidance to state that people who weren’t displaying symptoms didn’t need to be tested. Experts said the revised recommendations will make it harder to find and isolate people who are just becoming infectious — undermining efforts to limit spread of the virus. “It blows the mind,” Gates said.

The new advice reportedly had the support of Scott Atlas, a recent addition to the White House coronavirus task force. Atlas, a neuroradiologist and a public policy fellow at Stanford University’s Hoover Institution, has reportedly been advocating a policy of allowing the virus to spread unchecked so the country can reach herd immunity quicker.

Gates is not a fan. “The administration’s now hired this Stanford guy who has no background at all just because he agrees with their crackpot theories.” “ (B)

“The health department’s politically appointed communications aides have demanded the right to review and seek changes to the Centers for Disease Control and Prevention’s weekly scientific reports charting the progress of the coronavirus pandemic, in what officials characterized as an attempt to intimidate the reports’ authors and water down their communications to health professionals.

In some cases, emails from communications aides to CDC Director Robert Redfield and other senior officials openly complained that the agency’s reports would undermine President Donald Trump’s optimistic messages about the outbreak, according to emails reviewed by POLITICO and three people familiar with the situation.

CDC officials have fought back against the most sweeping changes, but have increasingly agreed to allow the political officials to review the reports and, in a few cases, compromised on the wording, according to three people familiar with the exchanges. The communications aides’ efforts to change the language in the CDC’s reports have been constant across the summer and continued as recently as Friday afternoon.

The CDC’s Morbidity and Mortality Weekly Reports are authored by career scientists and serve as the main vehicle for the agency to inform doctors, researchers and the general public about how Covid-19 is spreading and who is at risk. Such reports have historically been published with little fanfare and no political interference, said several longtime health department officials, and have been viewed as a cornerstone of the nation’s public health work for decades.

But since Michael Caputo, a former Trump campaign official with no medical or scientific background, was installed in April as the Health and Human Services department’s new spokesperson, there have been substantial efforts to align the reports with Trump’s statements, including the president’s claims that fears about the outbreak are overstated, or stop the reports altogether.

Caputo and his team have attempted to add caveats to the CDC’s findings, including an effort to retroactively change agency reports that they said wrongly inflated the risks of Covid-19 and should have made clear that Americans sickened by the virus may have been infected because of their own behavior, according to the individuals familiar with the situation and emails reviewed by POLITICO.

Caputo’s team also has tried to halt the release of some CDC reports, including delaying a report that addressed how doctors were prescribing hydroxychloroquine, the malaria drug favored by Trump as a coronavirus treatment despite scant evidence. The report, which was held for about a month after Caputo’s team raised questions about its authors’ political leanings, was finally published last week. It said that “the potential benefits of these drugs do not outweigh their risks.”

In one clash, an aide to Caputo berated CDC scientists for attempting to use the reports to “hurt the President” in an Aug. 8 email sent to CDC Director Robert Redfield and other officials that was widely circulated inside the department and obtained by POLITICO….

CDC officials have fought the efforts to retroactively change reports but have increasingly allowed Caputo and his team to review them before publication, according to the three individuals with knowledge of the situation. Caputo also helped install CDC’s interim chief of staff last month, two individuals added, ensuring that Caputo himself would have more visibility into an agency that has often been at odds with HHS political officials during the pandemic….

But public health experts told POLITICO that they were particularly alarmed that the CDC’s reports could face political interference, praising the MMWRs as essential to fighting the pandemic.

“It’s the go-to place for the public health community to get information that’s scientifically vetted,” said Jennifer Kates, who leads the Kaiser Family Foundation’s global health work. In an interview with POLITICO, Kates rattled off nearly a dozen examples of MMWR reports that she and other researchers have relied on to determine how Covid-19 has spread and who’s at highest risk, including reports on how the virus has been transmitted in nursing homes, at churches and among children.

“They’re so important, and CDC has done so many,” Kates said…

Caputo defended his team’s interventions as necessary to the coronavirus response. “Buried in this good [CDC] work are sometimes stories which seem to purposefully mislead and undermine the President’s Covid response with what some scientists label as poor scholarship — and others call politics disguised in science,” Caputo told POLITICO.

The battles over delaying or modifying the reports have weighed on CDC officials and been a distraction in the middle of the pandemic response, said three individuals familiar with the situation. “Dr. Redfield has pushed back on this,” said one individual. “These are scientifically driven articles. He’s worked to shake some of them loose.”

Kates, the Kaiser Family Foundation’s global health expert, defended the CDC’s process as rigorous and said that there was no reason for politically appointed officials to review the work of scientists. “MMWRs are famously known for being very clear about their limitations as well as being clear for what they’ve found,” she said.

Kates also said that the CDC reports have played an essential role in combating epidemics for decades, pointing to an MMWR posted in 1981 — the first published report on what became the HIV epidemic.

“Physicians recognized there was some kind of pattern and disseminated it around the country and the world,” Kates said. “We can now see how important it was to have that publication, in that moment.”” (C)

“White House officials are advising Dr. Anthony Fauci, the nation’s top infectious disease expert, to promote messages that prioritize political positions over scientific findings, an attempt to bolster Donald Trump’s misleading claims about the coronavirus. The pressure is apparently coming from Paul Alexander, a Trump appointee at the Department of Health and Human Services who, in emails reported by Politico, has repeatedly tried to edit Fauci’s planned responses to outlets including Bloomberg News, BuzzFeed, HuffPost, and the science journal Cell. Just this week, Alexander reportedly sent a message to Fauci’s press team urging him not to promote mask-wearing by children in an MSNBC interview.

“Can you ensure Dr. Fauci indicates masks are for the teachers in schools. Not for children,” Alexander wrote. “There is no data, none, zero, across the entire world, that shows children especially young children, spread this virus to other children, or to adults or to their teachers. None. And if it did occur, the risk is essentially zero,” he said, adding—without evidence—that children “take influenza home but do not take COVID home.” The advice prompted long email threads between Alexander and some of Fauci’s aides pushing back against the misleading claims. Alexander is a senior adviser to Michael Caputo, an ally of the president who currently oversees HHS’s media strategy and who said in a statement that he “hired Dr. Alexander for his expertise and not to simply resonate others’ opinions.”…

Fauci told Politico he had not seen the emails, nor had his staff advised him to minimize the risk coronavirus poses to kids or the need for mask-wearing. “No one tells me what I can say and cannot say,” Fauci said. “I speak on scientific evidence,” a point he reiterated in a pair of interviews on Friday. Asked by CNN’s Wolf Blitzer whether the public should listen to Fauci or Trump—who on Thursday claimed “we’re rounding the corner” of the pandemic—Fauci remarked, “You don’t have to listen to any individual” if you “look at the data. The data speak for themselves,” he said. “We’re still getting up to 40,000 new infections a day and 1,000 deaths. That is what you look at. Look at the science, the evidence and the data and you can make a pretty easy conclusion.”  (D)

“Current and former senior health officials with direct knowledge of phone calls, emails and other communication between the agencies confirmed on Saturday a report in Politico late Friday that the C.D.C.’s public Morbidity and Mortality Weekly Reports have been targeted by senior officials in the Health and Human Services’ communications office.

The reports, which one former top health official called the “holiest of the holy” in agency literature, are written largely for scientists and public health experts, to update them on trends in infectious diseases, not only the coronavirus but also other outbreaks around the country. They are guarded so closely by agency staff members that political appointees only see them just before they are published.

The reports became the subject of intense scrutiny this summer by Michael Caputo, a Republican political operative and former Trump campaign official the White House installed as the top spokesman at the department in April, despite his having no background in health.

Mr. Caputo himself said on Saturday that Politico’s report was largely accurate, but he denied that there was any overt pressure involved. He said that the primary person involved in critiquing the reports, Paul Alexander, an assistant professor of health research at McMaster University in Canada whom he hired to advise him on the science of the pandemic, simply offered direct reactions to the drafts of the C.D.C.’s Morbidity and Mortality Weekly Reports.

“He digs into these M.M.W.R.s and makes his position known, and his position isn’t popular with the career scientists sometimes,” Mr. Caputo said of Dr. Alexander. “That’s called science. Disagreement is science. Nobody has been ever ordered to do anything. Some changes have been accepted, most have been rejected. It’s my understanding that that’s how science is played.”

In an email obtained by Politico and confirmed to The Times by a health official with direct knowledge of the message, Dr. Alexander accused C.D.C. scientists of trying to “hurt the president,” referring to the weekly reports as “hit pieces on the administration.” Dr. Alexander asked Dr. Robert R. Redfield, the C.D.C. director, to edit reports that had already been published, which he believed overstated the risks of the virus for children and undermined the administration’s efforts to encourage school reopenings.

The meddling from Washington concerned Dr. Redfield, according to one former senior health official, who often pushed back when Mr. Caputo called to pester him about the reports.” (E)

“The MMWR Weekly reports are authored by scientists and published by the CDC. Their purpose is to inform doctors, medical professionals and researchers and offer statistics, data and trends on all aspects of health issues in the United States. The MMWR Weekly report is also in the public domain and can be reprinted without permission – all reports dating back to 1982 are available on the CDC’s online database. Notable MMWR Weekly articles included a report on AIDS in 1981 and an alert on lead-contaminated drinking water in Washington in 2001. The MMWR Weekly reports have always been published without any kind of interference from political parties – until now.

Caputo, a former Republican operative who comes from neither a medical nor a scientific background, has allegedly modified MMWR reports to play down the health risks associated with Covid-19 or sometimes block certain articles from being included at all. In an email sent to CDC Director Robert Redfield which Politico has gained access to, Paul Alexander, a member of Caputo’s team accused CDC scientists of deliberately using the reports “as hit pieces to hurt the President”. In the same email, Alexander asked Redfield to make changes to two reports which had already been published online, claiming that they were “misleading” and wrongly inflated Coronavirus’ risks to children – consequently hindering Trump’s plans to reopen schools.

Alexander also requested that publication of all future MMWR reports should be halted “immediately” adding that the publication process should be completely revamped to enable him to review and edit reports before they were published. “The reports must be read by someone outside of CDC like myself; and we cannot allow the reporting to go on as it has been, for it is outrageous. Its lunacy,” Alexander wrote in one email to Redfield. “Nothing to go out unless I read and agree with the findings how they CDC, wrote it and I tweak it to ensure it is fair and balanced and complete”.

When Politico approached Caputo to ask why he and his team were demanding changes to MMWR reports, Caputo responded with a statement in which he heaped praise on Alexander, who he hailed as “an Oxford-educated epidemiologist who specializes in analysing the work of other scientists”.” (F)

“Scientists and physicians reacted with words such as “aghast,” “despicable” and “outrageous” over the weekend as news spread that White House appointees interfered with a basic national public health report when it conflicted with President Donald Trump’s coronavirus messaging.

Michael Caputo, the Health and Human Services assistant secretary for public affairs, acknowledged Saturday that since June, he and an adviser have scrutinized and at times pushed for changes to a weekly health report distributed by the U.S. Centers for Disease Control and Prevention.

The meddling, first reported by Politico, included efforts to stop the publication of a report last week on the use of hydroxychloroquine, a malaria drug often touted by Trump, delay a 10-state study of COVID-19 infection statistics in June and another on the spread of coronavirus at a Georgia sleep-away camp….

The Morbidity and Mortality Weekly Report is a series of dry and sometimes dense brief updates on public health incidents that come out on Thursdays. They typically describe events or topics and are an important way for doctors and health officials to get the latest data.

Dr. William Schaffner, who is on the publication’s editorial board, said he was “aghast” and “appalled” by the reported attempts to delay, stop or change reports. He described the publication as a vital part of the global conversation among public health officials who track diseases and dangers.

“It has been the voice of the U.S. government’s health system, of integrity and scientific rigor, for years,” said Schaffner, a professor and infectious disease expert at the Vanderbilt University School of Medicine in Nashville, Tennessee. “Indeed, the MMWR has been a model for other countries’ ministries of public health for creating similar newsletters in their countries.”

The interference is not just anti-science but disinformation intended to deceive the American public, said Dr. Eric Topol, a professor of molecular medicine at the Scripps Research Institute in La Jolla, California.

“This is outright egregious. It’s despicable,” Topol said, accusing Redfield and other leaders of allowing the agency to be hijacked by politics.

“What we’re seeing is multiple actors, important people who are just laying down, who are complicit with the anti-science machinations of the Trump administration,” he said….

On Twitter, Dr. Sherri Bucher, a global health researcher, wrote, “There are no words to articulate how horrific this is. Trust & credibility, shattered, overnight. MMWR has been, for a long time, one of the most reliable, steadfast, scientific resources; unquestioned veracity, impeccable reputation for quality of data/analysis. No longer.”” (G)

“On Saturday, members of the public health community aired frustration over the report, which has not been confirmed by CNBC. Dr. Carlos Del Rio, an infectious disease specialist at Emory University, called the reports “incredibly concerning.”

“It’s very upsetting also for those of us in public health and medicine. The MMWR is a landmark CDC publication,” he said in an interview with CNN’s Fredricka Whitfield. “I think that MMWR are still trying to get the information out there, but certainly now, I will start reading with a degree of skepticism.”

Marc Lipsitch, an epidemiologist at Harvard University, said on Twitter that the move is “outrageous and dangerous” to public trust in the CDC. He added that the move is “unsurprising.”..

Dr. Atul Gawande, a professor in the Department of Health Policy and Management at Harvard, said on Twitter that political appointees “should have no role in scientific publications. None.”

Natalie Dean, a biostatistician at the University of Florida, urged the Trump administration to give career professionals at the CDC more freedom so speak.

“It remains unthinkable to me that during a global pandemic that has so severely impacted the United States, we hear so little from the CDC,” she said on Twitter. “The expertise is there. Let the scientists speak.”

Through MMWR, the CDC has continued to regularly publish important studies about Covid-19, including one this week that emphasized the risk of spread associated with dining at a restaurant and another demonstrating kids’ ability to spread the virus despite not becoming severely sick with the disease.

HHS Secretary Alex Azar, in a statement to CNBC, said Trump has always been receptive to “the data and science.” The CDC falls under the responsibility of HHS. 

“As the Secretary of Health and Human Services, I have briefed President Trump alongside the nation’s top doctors and I have insisted that he have direct access to these doctors throughout the COVID-19 pandemic,” Azar said. “He has always been receptive to the data and science presented by me and other members of the task force. President Trump’s science-based decision making has saved lives.”” (H)

“As acting director of the CDC at the dawn of the H1N1 pandemic in 2009, I felt the natural tensions that can occur between political appointees and career public health officials at CDC. During my tenure, the science was always—without exception—the driving force in the review process and in our communications to the public. Indeed, in the many decades I’ve spent in public health, including 13 years at CDC, science has been the arbiter of truth and carried the day no matter the administration or the political party. That must remain the case today.

The MMWR is among the most sober and least political public health communiques one can imagine. The name itself—Mortality and Morbidity Weekly Report—could only have been conceived by scientists rather than professional communicators. I’ve reviewed hundreds and co-authored several of these reports, which are notoriously meticulous, built on foundations of data and notably devoid of adjectives. The just-the-facts approach could be frustrating, in fact, because any public health guidance that carried even a whiff of the subjective would be expunged from the reports by science-driven editors. This is as it should be for public health communications written for the public health community, and it’s why the integrity of these reports has been second to none.

In 2009, the first communications from CDC about H1N1 were included in the MMWR. Two cases in California detailed in an MMWR in April of that year gave us an early indication that the virus first reported in Mexico had crossed into the United States. From that point forward—much as we’re seeing today—the MMWRs would serve as a valuable tool in filling in the gaps in knowledge while informing public health officials in every state in the country, and in real time, what they might be facing. These reports are the keepers of the latest statistics and allow for sharing of information to be used in planning and response during a public health crisis.

Because the voice of the CDC has largely been silenced during the coronavirus pandemic and unable to regularly reach the public, the MMWRs have become an even more critical conduit for the latest information and data. Produced like clockwork and driven by scientific rigor, they have detailed everything from COVID-19 spread at church events to outbreaks among college students to a comprehensive look at who is dying from COVID-19 in the U.S. The latest report, issued the day the Politico story broke, detailed COVID-19 outbreaks at three Utah childcare facilities. Each report is an important puzzle piece in helping on-the-ground public health officials better understand the virus and emerging epidemiological learnings….

The landmark of 200,000 deaths that is fast approaching reflects a scale of tragedy that the United States did not have to bear. CDC science should not be undermined nor the voices of its experts muted, or our nation will suffer a crisis of confidence and trust that will continue to hamper our recovery from this pandemic and open the door for more death and more suffering.

We cannot let this happen.” (I)

“Testifying before Congress on Wednesday, Dr. Robert Redfield, the director of the Centers for Disease Control and Prevention, strongly disputed that his agency’s scientific research has been influenced by political appointees attempting to bring those findings in line with President Trump’s views.

“We’re not going to let political influence try to modulate” the agency’s scientific conclusions, Redfield said. Those conclusions are customarily conveyed in a regular CDC publication called the Morbidity and Mortality Weekly Report, or MMWR…

“The scientific integrity of the MMWR has not been compromised,” Redfield said in his Senate testimony on Wednesday. “It will not be compromised on my watch.” He added that he would “stand by” his agency’s “scientific experts” and ensure that their work is free of political taint.” (K)

“President Trump on Wednesday rejected the professional scientific conclusions of his own government about the prospects for a widely available coronavirus vaccine and the effectiveness of masks in curbing the spread of the virus as the death toll in the United States from the disease neared 200,000.

In a remarkable display even for him, Mr. Trump publicly slapped down Dr. Robert R. Redfield, the director of the Centers for Disease Control and Prevention, as the president promised that a vaccine could be available in weeks and go “immediately” to the general public while diminishing the usefulness of masks despite evidence to the contrary.

The president’s comments put him at odds with the C.D.C., the world’s premier public health agency, over the course of a pandemic that he keeps insisting is “rounding the corner” to an end. Mr. Trump lashed out just hours after Dr. Redfield told a Senate committee that a vaccine would not be widely available until the middle of next year and that masks were so vital in fighting the disease caused by the coronavirus, Covid-19, that they may even more important than a vaccine….

The public scolding of Dr. Redfield was only the latest but perhaps the starkest instance when the president has rejected not just the policy advice of his public health officials but the facts and information that they provided. Public health officials are in strong agreement about the value of masks even as Mr. Trump generally refuses to wear one, mocks his opponent for doing so and twice in the past two days questioned their utility based on the advice of restaurant waiters.” (L)

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CORONOVIRUS CORONAVIRUS TRACKING Links to Parts 1-46

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POST 45. September 9, 2020. CORONAVIRUS. Trump on Fauci. ‘You inherit a lot of people, and you have some you love, some you don’t. I like him. I don’t agree with him that often but I like him.’

to read posts 1-45 in chronological order, highlight and click on

This post comingles topics in chronological order to explore the intersection of Coronavirus science and politics.

“The Food and Drug Administration on Sunday gave emergency approval for expanded use of antibody-rich blood plasma to help hospitalized coronavirus patients, allowing President Trump, who has been pressuring the agency to move faster to address the pandemic, to claim progress on the eve of the Republican convention.

Mr. Trump cited the approval, which had been held up by concerns among top government scientists about the data behind it, as welcome news in fighting a disease that has led to 176,000 deaths in the United States and left the nation lagging far behind most others in the effectiveness of its response.

At a news briefing, he described the treatment as “a powerful therapy” made possible “by marshaling the full power of the federal government.”

The decision will broaden use of a treatment that has already been administered to more than 70,000 patients. But the F.D.A. cited benefits for only some patients. And, unlike a new drug, plasma cannot be manufactured in millions of doses; its availability is limited by blood donations. Mr. Trump urged everyone who has recovered from the virus to donate plasma, saying there is a nationwide campaign to collect it.

Mr. Trump has portrayed his demands to cut red tape and speed approval of treatments and vaccines as a necessary response to a public health emergency.” (A)

“Trump administration officials met with congressional leaders last month and told them they would probably give emergency approval to a coronavirus vaccine before the end of Phase 3 clinical trials in the United States, perhaps as early as late September, according to two people briefed on the discussion.

The move would be highly unusual and would most likely prompt concerns about whether the administration is cutting corners on approvals for political purposes.

The two-hour meeting involving Treasury Secretary Steven Mnuchin; the White House chief of staff, Mark Meadows; House Speaker Nancy Pelosi; and Senator Chuck Schumer, the Democratic leader, took place on the evening of July 30 in Ms. Pelosi’s conference room.

During the discussion, the people briefed on it said, Mr. Meadows indicated that a vaccine being developed by AstraZeneca and Oxford University was the most likely candidate.

The projected timeline shows the administration’s hopes for a major victory against the pandemic before the election. It also suggests that officials have high expectations for the results of overseas drug trials, which began ahead of domestic ones.

Senior administration officials disputed the account, saying Mr. Meadows and Mr. Mnuchin were either being misrepresented or had been misunderstood on every major point.” (B)

“As the coronavirus surged across the Sunbelt, President Trump told a crowd gathered at the White House on July 4 that 99 percent of virus cases are “totally harmless.”

The next morning on CNN, the host Dana Bash asked Dr. Stephen Hahn, the commissioner of the Food and Drug Administration and one of the nation’s most powerful health officials: “Is the president wrong?”

Dr. Hahn, an oncologist and former hospital executive, certainly understood the deadly toll of the virus, and the danger posed by the president’s false statements. But he ducked the journalist’s question.

“I’m not going to get into who’s right and who’s wrong,” he said.

The exchange illustrates the predicament that Dr. Hahn and other doctors face working for a president who often disregards scientific evidence. But as head of the agency that will decide what treatments are approved for Covid-19 and whether a new vaccine is safe enough to be given to millions of Americans, Dr. Hahn may be pressured like no one else.

Unlike Dr. Anthony S. Fauci or Dr. Francis S. Collins, leaders at the National Institutes of Health who have decades of experience operating under Republican and Democratic administrations, Dr. Hahn was a Washington outsider…

Many medical experts — including members of his own staff — worry about whether Dr. Hahn, despite his good intentions, has the fortitude and political savvy to protect the scientific integrity of the F.D.A. from the president. Critics point to a series of worrisome responses to the coronavirus epidemic under Dr. Hahn’s leadership, most notably the emergency authorization the agency gave to the president’s favorite drug, hydroxychloroquine, a decision it reversed three months later because the treatment did not work and harmed some people…

In an interview, Dr. Hahn, 60, defended his record as F.D.A. chief. All of his decisions have been guided by the data, he said, and sometimes, rapidly evolving science has led to policy changes.

“I do not feel squeezed,” Dr. Hahn said. “I have been consistent in my message internally about using data and science to make decisions.”

On the line as he spoke was Michael Caputo, a deputy to Dr. Hahn’s boss, Alex M. Azar II, the secretary of the Department of Health and Human Services…

Dr. Hahn is not allowed to speak to the press without Mr. Caputo or another official on the phone — a marked contrast to the practice under the last F.D.A. commissioner, Dr. Scott Gottlieb, a powerful force in Washington who came to the job with years of experience at the F.D.A. and political think tanks. He called reporters whenever he felt like it, which was often.” (C)

“Dr. Anthony Fauci on Monday warned against the notion of early emergency use authorization for a potential coronavirus vaccine, explaining that such a step could damage efforts to develop other vaccines…

Fauci, the nation’s leading infectious disease expert, told Reuters that “the one thing that you would not want to see with a vaccine is getting an EUA before you have a signal of efficacy.”

“One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial,” he said….

President Donald Trump has promised that a vaccine would be available by the end of the year, though vaccinologists told CNN that timeline is unrealistic. And though Trump has commented that a vaccine could be ready “a lot sooner” than the end of the year, a senior administration official close to the coronavirus task force said the timeline for a vaccine remains the same and a vaccine is still expected late this year or early next year.

On Saturday, Trump also accused, without providing any evidence, the US Food and Drug Administration of deliberately delaying coronavirus vaccine trials.

“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” Trump tweeted, continuing to push his unfounded theory that there is a “deep state” embedded within the government bureaucracy working against his reelection.

He accused the agency of delaying a vaccine for the virus until after the fall election, tweeting, “Obviously, they are hoping to delay the answer until after November 3rd. Must focus on speed, and saving lives!”… (D)

“White House economic adviser Peter Navarro said on Tuesday that recommendations from health experts that convalescent plasma undergo a randomized trial as a COVID-19 treatment before receiving an emergency authorization are a “crazy talking point.”…

What they’re saying: “On the issue of not being able to do randomized trials, what is the calculus here? Are we going to wait to use something that can save thousands of lives just so we can have a study that tells us what we already know?” Navarro told MSNBC.

“The odds of this being able to hurt you are close to zero, so it’s safe. The odds of it being able to help you are close to 100%,” Navarro claimed.

Reality check: The odds of plasma being able to help COVID-19 patients are not “close to 100%.”

The other side: Speaker Nancy Pelosi told MSNBC after Navarro’s appearance that the Trump administration is “politicizing science.” She warned of the need to watch out for the politicization of the vaccine process because the Trump administration has “already indicated that they will overstate the safety and the efficacy of a drug.”” (E)

“The National Institutes of Health on Tuesday put out a blunt statement on the use of convalescent plasma to treat Covid-19, calling the evidence for its effectiveness “insufficient.”

“There are currently no data from well-controlled, adequately powered randomized clinical trials that demonstrate the efficacy and safety of convalescent plasma for the treatment of Covid-19,” according an NIH treatment guidelines panel that reviewed the evidence. “There are insufficient data to recommend either for or against the use of convalescent plasma for the treatment of COVID-19.”…

The FDA memo outlining the EUA for convalescent plasma cites just two randomized controlled trials, both of which were stopped early — one because it failed to recruit enough participants and the other because they found that the patients that were receiving plasma already had high levels of antibodies. Both found little to no benefit from the treatment, but they remain some of the best-constructed studies…

During the August 23 press conference, Hahn reported that convalescent plasma would yield a 35 percent improvement in the survival rate of Covid-19 patients.

“A 35 percent improvement in survival is a pretty substantial clinical benefit,” said Hahn during a Sunday press conference. “What that means is, if the data continue to pan out, if 100 people are sick with Covid-19, 35 would have been saved with the administration of plasma.”

But other researchers said that Hahn’s 35 percent improvement in survival claim was wildly misleading. It came from a retrospective preprint study that hasn’t undergone peer review, so some of the methods and findings may have flaws that would ordinarily be caught in the review process.”  (F)

“President Donald Trump said Sunday that he believed “political reasons” had slowed down the Food and Drug Administration’s approval of emergency use authorization for convalescent plasma but that he “broke the logjam” over the last week.

His remarks amount to tacit confirmation that he applied pressure on the agency ahead of its announcement Sunday issuing emergency use authorization for Covid-19 patients.

“I think there might have been a hold up, but we broke the logjam over the last week to be honest,” Trump said at a late afternoon news conference announcing the new authorization.

He said he believed there were officials at the FDA and in the Department of Health and Human Services “that can see things being help up and wouldn’t mind so much.”

“It’s my opinion, very strong opinion, and that’s for political reasons,” Trump continued, insisting that his focus on treatments for coronavirus — which has slowed the American economy and caused his poll numbers to sink — was apolitical…

However, like blood, convalescent plasma is in limited supply and must come from donors. And while there are promising signals from some studies, there is not yet randomized clinical trial data on convalescent plasma to treat Covid-19. Some of those trials are underway.

Earlier in the briefing, Trump appeared enthusiastic when asked by a reporter from Fox News whether patients should have access to treatments or vaccines before they reach the end of trials.

“We have all of these great, seemingly great answers that are ready to come out, but because of the process it takes — can we use some of this early under right to try?” he asked, referring to legislation that allows patients access to drugs that are still in the investigation phase.”  (G)

“Much of the controversy centered around how Hahn presented data from the expanded access protocol for convalescent plasma run by the Mayo Clinic and used in part to support the issuance of the EUA.

 “In the optimal patients … treated with convalescent plasma at the highest titers, there was a 35% improvement in survival, which is a significant clinical benefit,” Hahn said during the press conference, noting that, “This clearly meets the criteria that we’ve established for emergency use authorization.”

 Hahn went on to say that, “A 35% improvement in survival is a pretty substantial clinical benefit. What that means is—and if the data continue to pan out—100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma.”

 Experts were quick to point out that the 35% figure Hahn cited referred to the reduction in relative, not absolute, risk between patients who received high- and low-titer units of plasma….

On Monday evening, Hahn took to Twitter himself to address the issue: “I have been criticized for remarks I made Sunday night about the benefits of convalescent plasma. The criticism is entirely justified. What I should have said better is that the data show a relative risk reduction not an absolute risk reduction.”

 Hahn also disputed the notion that politics played into the agency’s decision to issue the EUA. “Media coverage of FDA’s decision to issue emergency authorization for convalescent plasma has questioned whether this was a politically motivated decision. The decision was made by FDA career scientists based on data submitted a few weeks ago,” he wrote.” (H)

“Anthony Fauci, the nation’s top infectious disease expert, is warning against prematurely distributing a potential coronavirus vaccine through an emergency use authorization, saying it could negatively harm the testing for other vaccines.

“The one thing that you would not want to see with a vaccine is getting an EUA [emergency use authorization] before you have a signal of efficacy,” Fauci, a key member of the White House coronavirus task force, said in an interview with Reuters.

He added that “one of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial.”…

“To me, it’s absolutely paramount that you definitively show that a vaccine is safe and effective, both,” Fauci told Reuters. “We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective.”

His most recent comments to Reuters came just days after President Trump lashed out at the Food and Drug Administration (FDA), claimed members of the “deep state” inside the FDA were making it difficult for drug companies to test coronavirus vaccines and therapeutics…

Fauci noted FDA guidance calls for a vaccine being proven to be safe and effective before receiving emergency use or final approval. He said emergency use authorization would only be appropriate if a drug had proven to be safe and effective before the FDA completed a review of other matters related to it.” (I)

“The largest study on plasma was conducted by the Mayo Clinic, headquartered in Rochester, and was sponsored by the National Institutes of Health, the US agency for biomedical research. It enrolled 35,322 patients between April and June, and attempted to study the effect of the therapy on mortality among patients with severe Covid-19…

However, promising as the study seemed, it was not randomised or controlled. There were no other patients to compare the effects of plasma transfusion with to ascertain whether the mortality was different among those who didn’t receive plasma. There was no placebo group as well, and everyone enrolled received the treatment. ..

Studying plasma therapy poses challenges of its own, as results seem to rely on antibody concentrations in blood— something which cannot be standardised. Researchers in some places are not able to test whether plasma contains powerful neutralising antibodies due to costs and procedures.

Additionally, since compassionate use is already allowed, doctors and hospitals prescribe the plasma treatment without a proper procedure to log or collect outcomes or data.

There also isn’t enough data on whether plasma could worsen an illness, as seen among some patients during diseases such as Ebola.

Studies like the Mayo Clinic one have their own shortcomings, where it is difficult to judge the cause of the outcome for certainty: for example, to determine if those who received the plasma therapy were also enrolled in medical centres that had better health care infrastructure and thus had a higher chance of survival.

However, there are multiple randomised controlled trials that are ongoing, including the UK’s RECOVERY trial. Results from rigorous trials are expected by the end of the year.” (J)

“The head of the Food and Drug Administration ousted its top spokeswoman from her position on Friday in an urgent bid to restore the tarnished credibility of the agency after he made erroneous claims that overstated the benefits of plasma treatments for Covid-19 at a news conference with President Trump.

The decision came just a day after the F.D.A.’s parent agency, the Department of Health and Human Services, terminated the contract of a public relations consultant who had advised the F.D.A. commissioner, Dr. Stephen M. Hahn, to correct his misleading claims that 35 out of 100 Covid-19 patients “would have been saved because of the administration of plasma.”

The removals come at a moment when the agency, which will be making critical decisions about whether to approve coronavirus vaccines and treatments, is struggling to salvage its reputation as a neutral scientific arbiter.

The ousted spokeswoman, Emily Miller, had little experience in health care. She had spent years working in Washington for Republicans, including the former Texas Congressman Tom DeLay and Senator Ted Cruz of Texas, and as a journalist for One America News, the conservative cable network. She was in her agency post for just 11 days.

“This is a low moment for the F.D.A. in at least a generation,” Daniel Carpenter, a professor at Harvard University who studies the agency, said of Dr. Hahn’s failure to control the public message about the plasma authorization. “This was a major self-inflicted wound.”..

“The agency needs to work very hard to regain the trust of the American people — there have been too many unforced errors,” said Dr. David A. Kessler, who was F.D.A. commissioner under Presidents George Bush and Clinton, and is advising Joseph R. Biden Jr.’s presidential campaign. “It needs to focus on what it does best, which is to put the data in front of the medical and scientific community and the American public, and stick with the data.””  (K)

“Trump, Aug. 23: We’ve provided $48 million to fund the Mayo Clinic study that tested the efficacy of convalescent plasma for patients with the virus. Through this study, over 100,000 Americans have already enrolled to receive this treatment, and it has proven to reduce mortality by 35%. …The FDA, MIT, Harvard and Mount Sinai hospital have also found convalescent plasma to be a very effective method of fighting this horrible disease. Based on the science and the data, the FDA has made the independent determination that the treatment is safe and very effective.

In fact, the FDA did not determine that convalescent plasma is “safe and very effective,” as few randomized controlled trials exist, making its true efficacy unknown. Instead, the agency decided that the totality of the evidence supports the idea that plasma “may be effective in the treatment of hospitalized patients with COVID-19,” and that it is reasonable to think that the potential benefits outweigh the known and potential risks…

While this might seem to be a small error, Dr. David Boulware, an infectious disease specialist at the University of Minnesota, told us that it wasn’t.

“THIS IS A HUGE MISTAKE which is very basic,” he said in an email. “I want to give Dr. Steve Hahn the benefit of the doubt that he was speaking extemporaneously and flubbed something,” he added, but the difference in this case is “huge.”

Indeed, if it is based on the preprint figure, that would mean Hahn exaggerated the effect of convalescent plasma sevenfold.

Boulware said he suspected that compared to no plasma, patients getting convalescent plasma probably are better off — but this remains an unanswered question. So are other critical questions, such as which patients benefit, which is especially important to know in deciding how to allocate a limited supply.

The Expanded Access Program, Boulware said, “was meant to be a short term bridge back in April. Yet tens of thousands of patients later, we don’t know what the benefit of plasma is.”

As for the EUA, Boulware said it “may” be warranted, but the hype beforehand was not — and that Hahn’s portrayal of a 35% absolute reduction in mortality was “deceptively misleading.”

While the administration claims the EUA will expand access of convalescent plasma, Boulware said it changes little other than the paperwork. “Plasma remains a scarce resource,” he said. “We use all the plasma locally that is available.”.. “( L)

“Trump said Monday he’s the reason the FDA authorized a new treatment for COVID-19 and that it wouldn’t have happened under another administration.

“We got the FDA to do it very quickly,” he told a crowd of supporters in Asheville, North Carolina.

In fact, Trump said his arm twisting was so effective, no other administration would have done it.

“The job that the FDA has done and the approval process has gone far faster than it would have ever gone under any other administration,” Trump said.

Earlier on Sunday, Mark Meadows told ABC’s “This Week” that the FDA wasn’t immediately on board and that the politicians in charge had to nudge them along.

“They want to do things the way they’ve always done it,” Meadows said, adding at one point that the FDA “had to make sure that they felt the heat.”

“We have been fighting for weeks now, weeks, to get that decision,” Trump’s top trade adviser, Peter Navarro, told reporters outside the White House Monday morning.

If true, such statements are extremely problematic for the reputation of FDA, a cadre of mostly career scientists who research the safety and efficacy of drugs without political interference. The agency isn’t supposed to speed up or slow authorizations or approvals at the whim of the White House…

That’s the reason the Infectious Diseases Society of America spoke out against the authorization.

“While the data to date show some positive signals that convalescent plasma can be helpful in treating individuals with COVID-19, especially if given early in the trajectory of disease, we lack the randomized controlled trial data we need to better understand its utility in COVID-19 treatment,” said Dr. Thomas File, Jr., president of IDSA.”  (M)

“Dr. Scott Gottlieb told CNBC on Monday that the late-stage coronavirus vaccine trials underway in the U.S. are unlikely to have gathered enough evidence to receive emergency approval ahead of the November presidential election.

“I think it’s very unlikely. I think it’s more likely you’re going to get a top-line result some point in November and maybe be able to make a decision about an emergency use authorization after that,” the former Food and Drug Administration commissioner said on “Squawk Box.”

Gottlieb — who sits on the board of Pfizer, which is developing a vaccine to prevent Covid-19 — said the more effective the vaccine is, the sooner the trial is likely to generate data on effectiveness.

“If the vaccines are very effective at preventing Covid disease, probably 70% to 80% effective based on how the trials are powered, you could get a readout at some point in October, a sort of top-line readout,” he said. “But it’s more likely that you’re going to get a readout from those trials in November.”..

Gottlieb’s comments Monday came after the current FDA chief, Dr. Stephen Hahn, indicated the public health agency could issue emergency authorization for a vaccine before phase three clinical trials are completed if the benefits outweigh the risks.

“It is up to the [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn said in an interview with the Financial Times. “If they do that before the end of phase three, we may find that appropriate. We may find that inappropriate, we will make a determination.”

Gottlieb, who preceded Hahn at the FDA, said he was not exactly sure what Hahn’s comments meant…

“It’s likely to be the case that there’s going to be an emergency use authorization if these vaccines are otherwise safe and effective for some select, high-risk populations like perhaps front-line health-care workers or people who have infirmities, elderly patients in nursing homes who are at higher risk of a bad outcome,” Gottlieb added. “That might be what he meant by saying they might issue an emergency use authorization before the trials are quote-unquote complete.” … 

Gottlieb said the process to approve a vaccine “has a lot of integrity to it,” expressing confidence in the longtime scientists at the FDA. 

“This is process where you have multiple layers of scientific review. You have objective criteria that the agency has issued in the form of guidance documents that lay out what the approvable endpoints are for these clinical trials, and what kind of safety they want to make a preliminary read on whether or not these vaccines are safe,” he said. “The final signoff is a career head of the biologics center at FDA who is exceptional.”

“I think if the commissioner would trust the process and elevate that process, people would have confidence in what’s unfolding inside the agency,” Gottlieb added.” (N)

“A new coronavirus adviser is pushing the White House to adopt a “herd immunity” strategy that would allow the disease to spread through most of the population to build resistance, five sources told The Washington Post on Monday.

Scott Atlas, a healthcare policy fellow at Stanford University’s conservative Hoover Institution think tank, joined the Trump administration earlier this month as a top pandemic adviser. His expertise is in neuroradiology, and he “does not have a background in infectious diseases or epidemiology,” The Post said…

It’s unclear exactly how many people would need to become infected to achieve herd immunity; estimates have ranged from 20% to 70% of the population, according to The Post.

The Post reported that Atlas had also suggested that an increased case count would not lead to more deaths if vulnerable people were protected, a claim that most infectious-disease experts strongly dispute. More than 25,000 people under age 65 have died of the virus in the US so far, the report said.

Before joining the coronavirus task force, Atlas regularly advocated reopening schools and businesses. He frequently appeared on Fox News to share his opinions, many of which aligned with those expressed by President Donald Trump’s. Atlas now meets with Trump more than any other health official, The Post said.

“When younger, healthier people get the disease, they don’t have a problem with the disease,” Atlas said in a Fox News interview in July. “I’m not sure why that’s so difficult for everyone to acknowledge.”

Atlas has clashed with other officials, including Dr. Deborah Birx and Dr. Anthony Fauci, the US’s top infectious-disease expert. A senior administration official told The Post that Atlas had positioned himself as an “anti-Dr. Fauci.”

Shortly after The Post published its report on Monday, Atlas released a statement denying any push for a herd-immunity strategy. “There is no policy of the President or this administration of achieving herd immunity,” he said. “There never has been any such policy recommended to the President or to anyone else from me.”

A White House representative also said there was no change to its approach.” (O)

“Dr. Anthony Fauci.. said.. “The way the pace of the enrollment is going on and the level of the infections that are going on in the United States, it is likely that we’ll get an answer by the end of the year.”..

“I would say a safe bet is at least knowing that you have a safe and effective vaccine by November, December,” …“I would not be satisfied until a vaccine was proven to be safe and effective, before it was actually approved for general use.”…

In a separate interview with the “Colors” podcast on Friday, Fauci said it was imperative to enroll a diverse number of people in a vaccine to ensure that it is safe and effective for everyone, and said that coronavirus has shed “very bright light” on the disparities in the U.S. health-care system. Even post-vaccine, he said something needed to be done about those disparities.

‘The likelihood that African Americans will get infected versus whites or others and — when and if they do get infected — the likelihood of their getting a serious outcome more so than whites. The answer is unfortunately, ‘Yes,’ to both.’…

“There are two elements that need to be clarified,”… “One: The likelihood that African Americans will get infected versus whites or others and — when and if they do get infected — the likelihood of their getting a serious outcome more so than whites. The answer is unfortunately, ‘Yes,’ to both.”

He said, “You want to show that it is safe and effective in all elements of society. If we don’t get African Americans and Latinx and Asian Americans and Native Americans, if we don’t get them properly represented in the proportion of those that are in the trial, we will not know for sure — although you can assume it, but you want to prove it — that it is safe and effective in that group.””  (P)

“There is a certain element of antiscience sentiment in the United States and Europe that Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, finds troubling.

Thinking about outbreaks like the measles one from a few years ago, what can health care leaders do to keep emphasizing the importance of public health and restore the public trust in science?..

A lot of it relates to a fundamental antiscience feeling, because of kind of moments of pushback from authority, and science tends to fall into the category of authoritative. People don’t like that. They don’t like people telling them what to do. But sometimes you go to the extreme, and you don’t listen to things that you should be doing, because you think people are telling you, you have to do that. That’s a problem.

But a lot of the vaccine stuff is misinformation, you know, dating back to the now infamous fraudulent reporting of certain negative consequences of measles vaccines with autism and things like that. That really set us back. Because one, something that’s incorrect, particularly in the era of social media and the era of the internet, when something that’s incorrect, gets propagated, it becomes very difficult to erase it. Because it’s out there.

This is not the way it used to be pre-internet, pre-social media, when if something was false, you’ve corrected and that was it. Not so now, even if you correct it, it’s still lingering in there somewhere. That’s one of the problems.” (Q)

“Using its authority to approve treatments for emergency use, the Food and Drug Administration recently allowed convalescent plasma for hospitalized Covid-19 patients. But because the large 35,000-person study on the treatment lacked true randomization and placebos, we don’t really know if antibody-rich plasma actually improves mortality.

In fact, both Dr. Francis Collins, the director of the National Institutes of Health, and Dr. Anthony Fauci, the government’s top infectious disease expert, raised concerns that emerging data on the treatment was not strong enough to merit emergency approval.

Convalescent plasma illustrates more than a problem with the F.D.A.’s approval process. It points to a larger shortcoming in clinical research in the United States.

Americans and American biomedical researchers have often prided themselves on conducting the best clinical research in the world. Yet with over six million coronavirus cases and 183,000 deaths, the United States has produced little pathbreaking clinical research on treatments to reduce cases, hospitalizations and deaths. Even one of the most important U.S. studies to date, which showed that the antiviral drug remdesivir could reduce the time Covid-19 patients spent in the hospital to 11 days from about 15, had too few subjects to demonstrate a statistically significant reduction in mortality.

Progress on therapeutics research has been a very different story in Britain. In mid-March researchers there began a randomized evaluation of Covid-19 therapies, known as Recovery, that involves every hospital in the nation. The goal was to conduct large, rapid and simple randomized trials to define standard treatment. Some 12,000 patients were quickly randomized — that is, assigned by chance to receive different treatments — and within 100 days of the effort’s start, researchers made three major discoveries that transformed Covid-19 care worldwide…

In the United States, by comparison, the government-sponsored Patient-Centered Outcomes Research Institute has spent millions of dollars creating a large clinical research network but has produced no research results on Covid-19 therapeutics…

Maybe the most important factor is an attitudinal difference: British clinical researchers have a longstanding commitment to large, simple and rapid randomized trials. American researchers prefer smaller, selective and complex trials with many restrictions on patients who can enroll…

What Britain has done is not beyond the United States. America has health networks with comprehensive patient data on a meaningfully large scale. Though networks don’t encapsulate the full population, they cover enough patients to provide background data for large clinical trials.

Moreover, the United States has no shortage of researchers, who can be deployed on Covid-19 therapeutic research, especially as many have been freed up with other research having been put on hold.

Unfortunately, unlike Britain, the United States has lacked a clear, unified message from government health care leaders, major insurance companies and hospital systems to put in place large, simple randomized trials that are considered the standard of care for Covid-19 treatment. We need to change that muddled approach now and reassert the nation’s clinical research excellence.” (R)

“Donald Trump said Monday he ‘disagrees with a lot of what Dr. Anthony Fauci has said’ in his coronavirus response.

In an wide ranging interview with Fox News host Laura Ingraham, the president said he ‘inherited’ the nation’s top infectious disease expert…

‘I just, I get along with him, but every once in a while he’ll come up with one that I say, ‘Where did that come from?’ I inherited him. He was here. He was part of this huge piece of [the] machine.

‘You inherit a lot of people, and you have some you love, some you don’t. I like him. I don’t agree with him that often but I like him.’ “  (S)

“Dr. Scott W. Atlas has argued that the science of mask wearing is uncertain, that children cannot pass on the coronavirus and that the role of the government is not to stamp out the virus but to protect its most vulnerable citizens as Covid-19 takes its course…

Ideas like these, both ideologically freighted and scientifically disputed, have propelled the radiologist and senior fellow at Stanford University’s conservative Hoover Institution into President Trump’s White House, where he is pushing to reshape the administration’s response to the pandemic.

Mr. Trump has embraced Dr. Atlas, as has Mark Meadows, the White House chief of staff, even as he upsets the balance of power within the White House coronavirus task force with ideas that top government doctors and scientists like Anthony S. Fauci, Deborah L. Birx and Jerome Adams, the surgeon general, find misguided — even dangerous — according to people familiar with the task force’s deliberations.

That might be the point.

“I think Trump clearly does not like the advice he was receiving from the people who are the experts — Fauci, Birx, etc. — so he has slowly shifted from their advice to somebody who tells him what he wants to hear,” said Dr. Carlos del Rio, an infectious disease expert at Emory University who is close to Dr. Birx, the White House coronavirus response coordinator.

Dr. Atlas is neither an epidemiologist nor an infectious disease expert, the two jobs usually associated with pandemic response. But his frequent appearances on Fox News Channel and his ideological surety caught the president’s eye.

So when Mr. Trump resumed his coronavirus news conferences in July and August, it was Dr. Atlas who helped prepare his briefing materials, according to people familiar with them. And it was his ideas that spilled from the president’s mouth.

“He has many great ideas,” Mr. Trump told reporters at a White House briefing last month with Dr. Atlas seated feet away. “And he thinks what we’ve done is really good, and now we’ll take it to a new level.”…

Mr. Trump is clearly enamored with Dr. Atlas’s arguments, which back up the president’s desire to restart the economy, open schools and move beyond the daily drumbeat of dire virus news.

But fully embracing any version of a policy resembling herd immunity has profound medical and political risks. Simply allowing the virus to travel through most of the population could lead to hundreds of thousands, if not millions, of deaths. And medical officials are still not sure how long that immunity might last, and how long-lasting some effects of the virus could be.

“Trying to get to herd immunity other than with a vaccine isn’t a strategy,” said Dr. Tom Frieden, a former C.D.C. director. “It’s a catastrophe.”…. (T)

“We were startled and dismayed last week to learn that the Centers for Disease Control and Prevention, in a perplexing series of statements, had altered its testing guidelines to reduce the testing of asymptomatic people for the coronavirus.

These changes by the C.D.C. will undermine efforts to end the pandemic, slow the return to normal economic, educational and social activities, and increase the loss of lives…

But under its revised guidelines, the C.D.C. seeks to dissuade people who are asymptomatic from being tested. Yet this group poses both the greatest threat to pandemic control and the greatest opportunity to bring the pandemic to an end. It is with this group that our country has failed most miserably….

These are practical and essential actions that need to be taken now. In the absence of sensible guidance from the C.D.C., what can the country do to control the pandemic? We urge at least three actions.

State and local leaders should be emboldened to act independently of the federal government and do more testing. Some governors and local public health officials, from both parties, are already doing so and are ignoring the C.D.C.’s revisions. This position is legally sound, since the C.D.C. is an advisory agency, not a regulatory one. Still, such discord undermines confidence in public health directives.

Insurance companies, city and state governments, and the Center for Medicare and Medicaid Services should recognize the economic and health benefits of testing prioritized, asymptomatic populations and provide reasonable reimbursement for these tests. A major impediment to more widespread testing has been the lack of coverage in the absence of symptoms or known contacts with infected individuals. The costs of testing are decreasing as new methods, like antigen testing, are introduced, and may be further reduced as the pooling of samples makes testing more efficient.

While more widespread testing for the virus is an essential factor in pandemic control, we need to make it part of a broad program that helps prevent transmission — mask-wearing, hand-washing, quarantining and use of personal protective equipment.

The C.D.C., the federal agency that should be crushing the pandemic, is promoting policies that prolong it. That means that local, state and organizational leaders will have to do what the federal government won’t.” (U)

“A COVID-19 vaccine could be available earlier than expected if ongoing clinical trials produce overwhelmingly positive results, said Dr. Anthony Fauci,…

Although two ongoing clinical trials of 30,000 volunteers are expected to conclude by the end of the year, Fauci said an independent board has the authority to end the trials weeks early if interim results are overwhelmingly positive or negative.

The Data and Safety Monitoring Board could say, “‘The data is so good right now that you can say it’s safe and effective,’” Fauci said. In that case, researchers would have “a moral obligation” to end the trial early and make the active vaccine available to everyone in the study, including those who had been given placebos — and accelerate the process to give the vaccine to millions….

Fauci, …said he trusts the independent members of the DSMB — who are not government employees — to hold vaccines to high standards without being politically influenced. Members of the board are typically experts in vaccine science and biostatistics who teach at major medical schools.

“If you are making a decision about the vaccine, you’d better be sure you have very good evidence that it is both safe and effective,” Fauci said. “I’m not concerned about political pressure.”

The safety board periodically looks at data from a clinical trial to determine if it’s ethical to continue enrolling volunteers, who are randomly assigned to receive either an experimental vaccine or a placebo shot. Neither the volunteers nor the health workers who vaccinate them know which shot they’re receiving…

Safety boards set “stopping rules” at the beginning of a study, making their criteria for ending a trial very clear, said Dr. Eric Topol, executive vice president for research at Scripps Research in San Diego and an expert on the use of data in medical research.

Although the safety board can recommend stopping a trial, the ultimate decision to halt a study is made by the scientists running the trial, Topol said.

A vaccine manufacturer could then apply to the Food and Drug Administration for an emergency use authorization, which can be granted quickly, or continue through the regular drug approval process, which requires more time and evidence.

Safety monitors also can stop a trial because of safety concerns, “if it looks like it’s actually harming people in the vaccine arm, due to a lot of adverse events,” Fauci said…

And Fauci acknowledged that cutting a trial short could undermine public confidence in COVID vaccines. One American in three is unwilling to get a COVID vaccine, according to a recent Gallup Poll.” (V)

“The history of medicine is rife with promising therapies that have later proven to be ineffective or, even worse, harmful. When I was a doctor in training first working in the intensive care unit, I learned to use a drug called activated drotrecogin alfa (sold as Xigris), which was touted as a lifesaver for patients suffering from severe sepsis. I distinctly remember giving it to patients who subsequently improved, seemingly pulled back from the brink.

We are wired to infer cause, and so I congratulated myself for my decision and used this drug whenever I could. But when it was studied in a rigorously designed clinical trial, researchers found that it was no better than a placebo, and it was taken off the market.

That’s why we have to do clinical trials. They are the gold standard to test a treatment’s efficacy but have been scarce in the pandemic. In these trials, investigators randomly assign patients to receive either the drug that’s being studied or — as a control — a placebo or standard care.

This relies on a concept called clinical equipoise, which means that the medical community at large is uncertain about whether a new treatment is actually better or worse than standard care. If we knew beyond doubt that something was lifesaving — like using a parachute when jumping out of an airplane in flight — we couldn’t ethically test it against a placebo on our patients.

Additionally, patients who consent to be part of a randomized trial must be willing to risk a 50 percent chance of receiving the placebo. The process becomes far more challenging, then, when the drug that is being studied is broadly available outside the trial framework.

This is the case with convalescent plasma. The idea behind it is attractively simple: Harvest blood plasma from patients who have recovered from Covid-19, test it to make sure it has antibodies to the virus and then inject it into patients with the virus to help them fight it until their own antibodies kick in…

Since that time, more than 70,000 patients in the country have received convalescent plasma. But we still don’t know if it helps.

The data cited in the news conference announcing the emergency approval come from a large continuing study of more than 35,000 patients, and though the benefit was grossly inflated, the true results do suggest that convalescent plasma might have been associated with fewer deaths in patients who got it early on in their hospital course. But there are major drawbacks to making any conclusions here.

The study, which has not been peer reviewed or published in a medical journal, is part of an “expanded access program.” This is not a randomized trial but instead a way to get a potentially promising treatment to patients while tracking how they do.

As a result, there was no control group for comparison, which makes it impossible to state with certainty that convalescent plasma is really the reason for an observed decrease in mortality. Maybe convalescent plasma has a small or moderate benefit. But it might also be neutral or even harmful. The question remains open.

And now we might never be able to answer it. Because if convalescent plasma is widely available and hailed as a major breakthrough, who is going to sign up for a trial where a roll of the dice might leave the patient with a placebo?

In the haste to do something and the inability to sit with uncertainty, we might have deprived ourselves of the very answers that we need. This will be one of the many sad legacies of our response to this pandemic…

Even now, treatment protocols vary across the country. Well-intentioned clinicians continue off-label use of a panoply of therapies while defending their decisions with an almost religious fervor.

This is not just about the coronavirus. It is about the extent to which we are committed to science and to each other. As we look toward a vaccine, which will rely on the trust of the public and the medical community for widespread dissemination, this would have been the time to get it right.”  (W)

“The director of the Centers for Disease Control and Prevention told governors last week to prepare for the “large-scale” distribution of a coronavirus vaccine by Nov. 1, according to a letter obtained Wednesday by NBC News.

In the Aug. 27 letter, the director, Dr. Robert Redfield, said the CDC had contracted with a pharmaceutical company, McKesson Corp., to potentially distribute hundreds of millions of vaccine doses to health departments and medical facilities across the country in the fall.

Redfield called the effort “massive” and asked governors for their help expediting applications for distribution facilities that will be set up and operated by McKesson.

“If necessary,” Redfield added, the agency “asks you to consider waiving requirements that would prevent these facilities from being fully operational by November 1, 2020.”

It remains highly uncertain, however, whether a vaccine will be ready by then or which manufacturer will make it. The Nov. 1 target date is two days before the presidential election.

A planning document obtained by The New York Times described the “vaccine landscape” as “evolving and uncertain,” but it described different hypothetical supply and operations scenarios for local officials and doctors. One scenario showed 2 million doses distributed by the end of October, and another showed 10 million to 20 million doses by the end of November…

Food and Drug Administration Commissioner Stephen Hahn told The Financial Times that the FDA could fast-track a vaccine, giving a developer federal approval before rigorous Phase 3 clinical trials are completed.

“We may find that appropriate,” he told the newspaper in a story published Sunday. “We may find that inappropriate. We will make a determination.”” (X)

(Y)………………………..

(Z)………………………..

“Is President Trump embracing a “herd immunity” strategy for the COVID-19 pandemic?…

We can see why this idea would appeal to the president. It’s a lot easier than undertaking the widespread testing, tracing and supported isolation recommended by public health experts. It also would allow shuttered schools and businesses to reopen immediately and, theoretically, let the stalled economy roar back to life in time to give him a reelection bounce.

The problem is that the Swedish model didn’t work out well. And following it means accepting deaths far above the more than 184,000 Americans who have already died from COVID-19…

Nevertheless, Atlas, a senior fellow at the conservative Hoover Institution, is still pushing this strategy. He says that resources should be focused on protecting vulnerable people — although the younger and healthy people who’ve died from the coronavirus wouldn’t have been considered “vulnerable” — while the rest of us get back to normal, get infected and then recover. And now he apparently has the ear of a president who is primed to listen.

Trump has lent his support to pandemic deniers, recently tweeting a fringe — and wrong — theory that the real death toll for COVID-19 in the U.S. is almost 20 times lower than has been reported. This faulty argument hinges on data posted on the CDC website that says 6% of the COVID-19 deaths reported to the agency cited no other health conditions. But the extrapolation that the rest didn’t die from the infection is wrong. Most people die with multiple complications, and reporting these factors doesn’t mean that the infection wasn’t ultimately to blame.

Undergirding a herd immunity strategy is the morally reprehensible notion that older people and those with chronic conditions such as diabetes and obesity (conditions that afflict a significant number of Americans) are expendable because they would die soon anyhow. That’s an idea that has no place in a civilized society.” (AA)

The U.S. is seeing roughly 40,000 new cases a day, but it needs to bring daily infections below 10,000, White House coronavirus advisor Dr. Anthony Fauci said.

He said the public’s behavior over the Labor Day holiday weekend will determine how the coronavirus spreads through the colder months….

“We know from prior experience as you get into the holiday weekend, the Fourth of July, Memorial Day, there’s a tendency of people to be careless somewhat with regard to the public health measures,” he said. “I want to use this opportunity to almost have a plea to the people in this country to realize that we really still need to get our arms around this and to suppress these types of surges we’ve seen.”

He added: “We’re around 40,000 cases. That’s an unacceptably high baseline. We’ve got to get it down to, I’d like to see 10,000 or less.”

Earlier in the year, coronavirus cases in the U.S. began to pick up shortly after the Memorial Day holiday.

New cases had hit a peak in April of about 31,000 before steadily falling to about 20,000 cases a day by the end of May. But after the holiday, new cases began to climb again, surging to about 70,000 cases a day in July, according a CNBC analysis of Johns Hopkins University data.

Data is again showing some worrying signs of another surge. The U.S. reported 43,253 new cases of the coronavirus on Tuesday, pushing the seven-day average past 42,300, up 0.6% compared with a week earlier, according to Hopkins data.”  (BB)

“International clinical trials published on Wednesday confirmed hope that cheap, widely available steroid drugs can help seriously ill patients survive Covid-19.

After the release of the new data, the World Health Organization strongly recommended steroids for treatment of patients with severe or critical Covid-19 worldwide. But the agency recommended against giving the drugs to patients with mild disease.

The new studies include an analysis that pooled data from seven randomized clinical trials evaluating three steroids in over 1,700 patients. The study concluded that each of the three drugs reduced the risk of death.

That paper and three related studies were published in the journal JAMA, along with an editorial describing the research as an “important step forward in the treatment of patients with Covid-19.”

Corticosteroids should now be the first-line treatment for critically ill patients, the authors said. The only other drug shown to be effective in seriously ill patients — and only modestly at that — has been remdesivir.

Steroids like dexamethasone, hydrocortisone and methylprednisolone are often used by doctors to tamp down the body’s immune system, alleviating inflammation, swelling and pain. Many Covid-19 patients die not of the virus but of the body’s overreaction to the infection.

The analysis of pooled data found that steroids were linked with a one-third reduction in deaths among Covid-19 patients. Dexamethasone produced the strongest results: a 36 percent drop in deaths in 1,282 patients treated in three separate trials.”  (CC)

“Moncef Slaoui, the chief adviser for the White House vaccine program, said on Thursday that it was “extremely unlikely but not impossible” that a vaccine could be available by the end of October.

In an interview with National Public Radio, Dr. Slaoui, the chief scientific adviser of the Trump administration’s coronavirus vaccine and treatment initiative, called Operation Warp Speed, explained that the Centers for Disease Control and Prevention’s guidance to states to prepare for a vaccine as early as late October — a notification Dr. Slaoui said he had learned of through the news media — was “the right thing to do” in case a vaccine was ready by that time. “It would be irresponsible not to be ready if that was the case,” he said.

However, he described that as a “very, very low chance.”

That message ran counter to the optimistic assertions in recent days from the White House that a vaccine could be ready for distribution before Election Day in November. President Trump, during the Republican National Convention, said a vaccine could be ready “before the end of the year or maybe even sooner.” And he and others have tried to project confidence in a quick victory.

Dr. Slaoui confirmed that the two main candidates, referred to as Vaccine A and Vaccine B, were being developed by Pfizer and Moderna. He said that there was “no intent” to introduce a vaccine before clinical trials were completed, and that trials would only be completed when an independent safety monitoring board, separate from the government, affirmed the effectiveness of the vaccine.

The interviewer, Mary Louise Kelly, raised the timing of a possible vaccine given in the documents the C.D.C. recently sent to public health officials, and asked directly whether the delivery of the vaccine was being motivated by political concerns.

“For us there is absolutely nothing to do with politics,” Dr. Slaoui responded, saying that those involved were working as hard as they could because so many people were dying every day. “Many of us may or may not be supportive of this administration. It’s irrelevant, frankly.” (DD)

“Talking to ScienceInsider today, Slaoui insisted he won’t be swayed by political pressures to rush an unsafe or ineffective vaccine, and that science will carry the day—or he’ll quit.” (EE)

“White House trade adviser Peter Navarro on Tuesday defended President Trump’s emergency authorization of convalescent plasma therapy as treatment for COVID-19, even after Food and Drug Administration Commissioner Stephen Hahn conceded that he had overhyped its effectiveness.

When pressed during an MSNBC interview on Hahn’s tweet the night before that the criticism he’s faced over his remarks about the benefits of convalescent plasma was “entirely justified,” Navarro hit back at the notion that emergency approval of the unproven treatment for COVID-19 “falsely inflates hopes.”

“I don’t accept that,” Navarro said. “That, to me, is like a crazy talking point.”

After pointing out that both Hahn and the Mayo Clinic have said that the emergency approval of using plasma to treat COVID-19 reduces the possibility of having a proper randomized study on it, MSNBC’s Andrea Mitchell asked Navarro whether Hahn was wrong.

“On the issue of not being able to do randomized trials, what is the calculus here?” Navarro said. “Are we going to wait to use something that can save thousands of lives just so we can have a study that tells us what we already know?”

Mitchell cut in to point out “yes, that is scientific practice, sir” because it’s how vaccines and drugs are approved.

Navarro responded by circling back to asking whether it’s worth waiting for a therapy that “likely works.”

“This is an important debate for the American people and your viewers to have: Do you want to wait for a therapy which likely works to get these scientific studies which are going to take three, six months, whatever?” Navarro said. “Or do you want to have the right to try?”

After Navarro boasted that Trump is “the right to try president” and that the debate over convalescent plasma “puzzles me, frankly” because it’s been used as a therapy for over a century, Mitchell hit back that it’s a treatment for other diseases and that COVID-19 is a new virus.

Navarro went on to claim that the odds of the plasma treatment “being able to hurt you are close to zero, so it’s safe” while “the odds of it being able to help you are close to 100%.” Mitchell called that out for being an incorrect assertion…

“The question for your viewers is simple: People are dying out there. Does convalescent plasma likely help people in terms of saving lives? And I think the answer is yes,” Navarro said. “The question of how much it helps, that’s to be determined. But I think that it’s good that it’s out there.” (FF)

“The Centers for Disease Control and Prevention has notified public health officials in all 50 states and five large cities to prepare to distribute a coronavirus vaccine to health care workers and other high-risk groups as soon as late October or early November…

Three documents were sent to public health officials in all states and territories as well as officials in New York, Chicago, Philadelphia, Houston and San Antonio on Aug. 27. They outlined detailed scenarios for distributing two unidentified vaccine candidates, each requiring two doses a few weeks apart, at hospitals, mobile clinics and other facilities offering easy access to the first targeted recipients.

The guidance noted that health care professionals, including long-term care employees, would be among the first to receive the product, along with other essential workers and national security employees. People 65 or older, as well as Native Americans and those who are from “racial and ethnic minority populations” or incarcerated — all communities known to be at greater risk of contracting the virus and experiencing severe disease — were also prioritized in the documents…

The agency also said its plans were as yet hypothetical, noting, “The Covid-19 vaccine landscape is evolving and uncertain, and these scenarios may evolve as more information is available.” A C.D.C. spokeswoman confirmed that the documents were sent but declined to comment further…

The C.D.C. documents said that public health administrators should review lessons learned from the 2009 H1N1 pandemic vaccination campaign, which did not have enough doses at the beginning to meet demand.

“It’s good to have a plan out for hospitals and health care systems to prepare” for a potential rollout, said Dr. Taison Bell, a pulmonary and critical care physician at the University of Virginia. But Dr. Bell added that he was concerned that the timeline outlined in the documents “is incredibly ambitious and makes me worry that the administration will prioritize this arbitrary deadline rather than maintaining diligence with following the science.””  (GG)

“I think Trump clearly does not like the advice he was receiving from the people who are the experts — Fauci, Birx, etc. — so he has slowly shifted from their advice to somebody who tells him what he wants to hear,” said Dr. Carlos del Rio, an infectious disease expert at Emory University who is close to Dr. Birx, the White House coronavirus response coordinator.

Dr. Atlas is neither an epidemiologist nor an infectious disease expert, the two jobs usually associated with pandemic response. But his frequent appearances on Fox News Channel and his ideological surety caught the president’s eye.

So when Mr. Trump resumed his coronavirus news conferences in July and August, it was Dr. Atlas who helped prepare his briefing materials, according to people familiar with them. And it was his ideas that spilled from the president’s mouth.

“He has many great ideas,” Mr. Trump told reporters at a White House briefing last month with Dr. Atlas seated feet away. “And he thinks what we’ve done is really good, and now we’ll take it to a new level.”

The core of his appeal in the West Wing rests in his libertarian-style approach to disease management in which the government focuses on small populations of at-risk individuals — the elderly, the sick and the immune-compromised — and minimizes restrictions for the rest of the population, akin to an approach used to disastrous effect in Sweden. The argument: Most people infected by the coronavirus will not get seriously ill, and at some point, enough people will have antibodies from Covid-19 to deprive the virus of carriers — “herd immunity.”

“Once you get to a certain number — we use the word herd — once you get to a certain number, it’s going to go away,” Mr. Trump told Laura Ingraham on Fox News on Monday night.

Dr. Atlas’s push has led to repeated private confrontations with Dr. Birx, who in recent weeks has been advocating rigorous rules on wearing masks, limiting bars and restaurants, and minimizing large public gatherings….

Mr. Trump is clearly enamored with Dr. Atlas’s arguments, which back up the president’s desire to restart the economy, open schools and move beyond the daily drumbeat of dire virus news.

But fully embracing any version of a policy resembling herd immunity has profound medical and political risks. Simply allowing the virus to travel through most of the population could lead to hundreds of thousands, if not millions, of deaths. And medical officials are still not sure how long that immunity might last, and how long-lasting some effects of the virus could be.

“Trying to get to herd immunity other than with a vaccine isn’t a strategy,” said Dr. Tom Frieden, a former C.D.C. director. “It’s a catastrophe.”  (HH)

“As many as 45 hospitals from coast to coast have expressed interest in collaborating on a randomized, controlled clinical trial sponsored by Vanderbilt University Medical Center, said principal investigator Dr. Todd Rice.

Officials at some hospitals said they are considering committing only to the clinical trial — and either avoiding or minimizing use of convalescent plasma through an emergency use authorization issued Aug. 23 by the federal Food and Drug Administration.

Plasma should not be considered standard care for coronavirus, NIH panel says

The response comes amid concerns that the Trump administration pressured the FDA into approving broader use of convalescent plasma, which already has been administered to more than 77,000 COVID patients in the U.S. President Donald Trump characterized the treatment as a “powerful therapy,” even as government scientists called for more evidence that COVID plasma is beneficial.

A National Institutes of Health panel this week countered the FDA’s decision, saying that the therapy “should not be considered the standard of care for the treatment of patients with COVID-19” and that well-designed trials are needed to determine whether the therapy is helpful. Data so far suggests the treatment could be beneficial, but it’s not definitive.

“It’s an important scientific question that we don’t have the answer to yet,” said Rice, an associate professor of medicine and director of VUMC’s medical intensive care unit…

Issuing the EUA puts the fate of clinical trials into “extreme jeopardy,” said Arthur Caplan, a professor of bioethics at the New York University School of Medicine. With convalescent plasma in very short supply, it sets the stage for fights over access and makes sick patients less inclined to join a trial, where they might receive a placebo.

“If you have the EUA, it starts to damage the trials,” Caplan said.

Still, given that the FDA has authorized convalescent plasma for patients ill with COVID-19, hospitals that hesitate or refuse to provide it outside a trial are sure to face questions from families.

That creates “a very interesting and delicate ethics problem,” said Cohn.

“If you commit to the randomized controlled trial only, you’re committing to a long-term dedication to science,” she said. “The question is, is it ethically inappropriate not to provide a therapy that has been shown to be possibly beneficial?”  (II)

“The US Centers for Disease Control and Prevention is asking states to get ready to distribute a coronavirus vaccine by as early as next month. The CEO of Pfizer says he thinks it’s possible his company will have enough data to ask the US Food and Drug Administration (FDA) for authorization by October.

And officials inside the FDA have told CNN that US President Donald Trump has consistently pressed agencies to speed up their timeline for developing a vaccine so he can have a vaccine victory by Election Day.

But is it really possible we could have a coronavirus vaccine by November?

The doctors running clinical trials would know best … and they don’t think so.

“Do the simple math,” said Dr. Larry Corey of the Fred Hutchinson Cancer Research Center in Seattle, who is leading the team coordinating clinical trials for federally backed coronavirus vaccines in the US.

“We designed the trial to get to 130, 140 endpoints seven months from starting the trial,” Corey told CNN. “The first one started in mid-July.”

 If you add seven months to July, you get February.

That doesn’t mean it’s impossible to have an answer before then: If one of the vaccines being tested is highly effective, and there is a high rate of infection among trial volunteers, it’s possible many people who got placebo shots would get infected quickly.

“If you had a highly effective vaccine, maybe you’d find that five months from designing the trial,” Corey said.

But if you add five months to July, you get December.” (JJ)

“Many health experts say a safe and effective vaccine might not be publicly available until early 2021. But it’s possible the Food and Drug Administration could give an emergency use authorization for a vaccine to be distributed before its Phase 3 clinical trial is over, if the data is very promising.

Some doctors say they’d rather see a vaccine go through all the rigors to get a full FDA approval.

“How can you justify a substandard or lesser review for something that would be injected in tens of millions, maybe hundreds of millions of Americans?” said Dr. Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine…

And that’s not likely to happen by late October, said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.

“If you look at the projection, of the enrollment (of trial participants) and the kinds of things you’ll need to get a decision about whether the vaccine is safe and effective, most of us project that that’s going to be by November, December, by the end of the year,” Fauci told CNN on Thursday.

“Could this be earlier? Sure … that’s unlikely (but) not impossible.”

President Donald Trump has touted the idea that a vaccine could be out to the public by the November 3 election. But vaccine experts have said that’s not realistic.

Any decision about approving or authorizing a coronavirus vaccine will be driven by science and evidence, Health and Human Services Secretary Alex Azar said.

“Thanks to President Trump’s leadership of this Operation Warp Speed, we’re making historic progress towards a vaccine,” Azar said on CBS Thursday.

He said that he doesn’t know when the data will come, as it will depend on the rate of infection in the communities where the vaccine candidate and placebo have been administered.

“President Trump has made it clear, and I’ve made it clear, these decisions will be driven by the standards of science and evidence and FDA’s gold standards,” he said.” (KK)

“Dr. Anthony Fauci said Friday that he’s not sure what President Donald Trump meant when he said earlier that evening that the country is “rounding the corner” on the coronavirus pandemic.

“I’m not sure what he means,” Fauci, the director of the National Institute of Allergy and Infectious Diseases, told CNN’s Jim Acosta on “The Situation Room.”

“There are certain states that are actually doing well in the sense of that the case numbers are coming down.” However, Fauci continued, experts remain concerned by a number of states, including Montana, Michigan, Minnesota and the Dakotas, that are starting to see an uptick in the percentage of coronavirus tests coming back positive — an indication of spread of the virus.

The exchange marked another example of a top scientist and a member of the White House coronavirus task force publicly disputing the President’s claims about the virus, a dynamic that has played out nearly since the start of the pandemic.

“By the way, we are rounding the corner,” Trump said during a news briefing at the White House. “We are rounding the corner on the virus.” (LL)

“The head of the NIH told Congress that U.S. health officials will not skip or abbreviate any safety assessments in the development of a coronavirus vaccine.

NIH Director Dr. Francis Collins said studying the safety and effectiveness of Covid-19 vaccine candidates is now the agency’s “top priority.”…

“The critical final steps in clinical trials will be well coordinated and done in parallel with manufacturing, but with NIH and industry providing the FDA with all of the critical safety and efficacy data necessary for sound scientific decision-making,” he told the Senate Committee on Health, Education, Labor and Pensions in prepared remarks submitted ahead of a hearing on coronavirus vaccines.

An independent data and safety monitoring board is reviewing the integrity of the trials and continues to monitor ongoing results to ensure participants are safe, Collins told the lawmakers. The protocols for the trials are being overseen by the U.S. government, in contrast to traditional trials in which pharmaceutical companies are solely responsible for design and implementation, he added.”  (MM)

“Nine pharmaceutical companies issued a joint pledge on Tuesday that they would “stand with science” and not put forward a vaccine until it had been thoroughly vetted for safety and efficacy.

The companies did not rule out seeking an emergency authorization of their vaccines, but promised that any potential coronavirus vaccine would be decided based on “large, high quality clinical trials” and that the companies would follow guidance from regulatory agencies like the Food and Drug Administration.

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which Covid-19 vaccines are evaluated and may ultimately be approved,” the companies said.” (NN)

“Dr. Anthony Fauci has said that the US needs to get the daily number of new coronavirus cases down below 10,000 before fall arrives.

A number of states, including Iowa and Indiana, are currently experiencing new surges in coronavirus infections.

Over the past few weeks, Dr. Anthony Fauci has made it clear that the US needs to get the daily number of new coronavirus cases down below 10,000 by fall lest we see a massive spike in infections. Unfortunately, the simple reality is that we’re not anywhere close to reaching the 10,000 threshold.

Over the past few weeks, the number of new coronavirus cases in the US has hovered within the range of 35,000 to 45,000 new cases per day. And with fall just about two weeks away, there’s a chance that we’re already past the point of no return with respect to getting the number of coronavirus cases down to an acceptable level as we head into flu season.

Recently, Dr. Fauci appeared on CNN‘s The Situation Room and articulated what aspect of the current pandemic he finds to be the most worrisome. Specifically, Fauci explained that the number of states currently seeing a significant increase in new coronavirus cases is “disturbing.”..

“And the reason we know they’re new cases [is] because, when you have the increase in cases, it’s invariably followed by an increase in hospitalization and ultimately by an increase in deaths. That’s the real bottom line. The critical issue is the percent positives of the tests that you do. And we’re starting to see an uptick in that in certain areas that’s disturbing. And that’s why we call out to the governors and the leaders of those states to please pay attention to that, because that can be a predictor of surges that we really are trying to avoid.” (OO)

“White House coronavirus advisor Dr. Anthony Fauci said Tuesday a coronavirus vaccine probably won’t be ready by the U.S. presidential election even as the Centers for Disease and Prevention asks states to ready distribution facilities by Nov. 1.

At a health conference, Fauci said it’s more likely a vaccine will be ready by “the end of the year” as drug companies Moderna and Pfizer race to complete patient enrollment for their late-stage vaccine trials by the end of September.

 “It’s unlikely we’ll have a definitive answer” by the Nov. 3 election, the director of the National Institute of Allergy and Infectious Diseases said at the Research! America 2020 National Health Research Forum.

The comments are also at odds with President Donald Trump, who suggested at a press conference Monday that a vaccine could be ready for distribution by Election Day.

“We could have a vaccine soon, maybe even before a very special day. You know what day I’m talking about,” Trump told reporters.” (PP)

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CORONOVIRUS TRACKING Links to Parts 1-45

CORONOVIRUS TRACKING Links to Parts 1-45

Doctor, Did You Wash Your Hands?®

http://doctordidyouwashyourhands.com/

Curated Contemporaneous Case Study Methodology

Jonathan M. Metsch, Dr.P.H.

https://www.mountsinai.org/profiles/jonathan-m-metsch

PART 1. January 21, 2020. CORONAVIRUS. “The Centers for Disease Control and Prevention on Tuesday confirmed the first U.S. case of a deadly new coronavirus that has killed six people in China.”

PART 2. January 29, 2020. CORONAVIRUS. “If it’s not contained shortly, I think we are looking at a pandemic..”….. “With isolated cases of the dangerous new coronavirus cropping up in a number of states, public health officials say it is only a matter of time before the virus appears in New York City.”

PART3. February 3, 2020. “The Wuhan coronavirus spreading from China is now likely to become a pandemic that circles the globe…”..Trump appeared to downplay concerns about the flu-like virus …We’re gonna see what happens, but we did shut it down..” (D)

PART 4. February 9, 2020. Coronavirus. “A study published Friday in JAMA found that 41% of the first 138 patients diagnosed at one hospital in Wuhan, China, were presumed to be infected in that hospital.….

PART 5. February 12, 2020. CORONAVIRUS. “In short, shoe-leather public health and basic medical care—not miracle drugs—are generally what stop outbreaks of emerging infections..”

POST 6. February 18, 2020.  Coronovirus. “Amid assurances that the (ocean liner) Westerdam was disease free, hundreds of people disembarked in Cambodia…” “ One was later found to be infected”…. “Over 1,000… passengers were in…transit home”…. “This could be a turning point””

PART 7. February 20, 2020. CORONAVIRUS. With SARS preparedness underway in NJ LibertyHealth/ Jersey City Medical Center, where I was President, proposed that our 100 bed community hospital with all single-bedded rooms, be immediately transformed into an EMERGENCY SARS ISOLATION Hospital.

PART 8. February 24, 2020. CORONAVIRUS. “…every country’s top priority should be to protect its health care workers. This is partly to ensure that hospitals themselves do not become sites where the coronavirus is spread more than it is contained.”

PART 9. February 27, 2020. CORONAVIRUS. Responding to a question about the likelihood of a U.S. outbreak, President Trump said, “I don’t think it’s inevitable…”It probably will. It possibly will,” he continued. “It could be at a very small level, or it could be at a larger level.”

Part 10. March 1, 2020. CORONAVIRUS. Stop Surprise Medical Bills for Coronavirus care. (&) Lessons Learned (or not) In California and Washington State from community acquired cases.

PART 11. March 5, 2020.  CORONAVIRUS. “Gov. Andrew Cuomo… would require employers to pay workers and protect their jobs if they are quarantined because of the coronavirus.”

Part 12. March 10, 2020. CORONAVIRUS. “Tom Bossert, Donald Trump’s former homeland security advisor…(said) that due to the coronavirus outbreak, “We are 10 days from the hospitals getting creamed.”

Part 13.. March 14, 2020. CORONAVIRUS. “If I’m buying real estate in New York, I’ll listen to the President….If I’m asking about infectious diseases, I’m going to listen to Tony Fauci,”

PART 14. March 17, 2020. CORONAVIRUS. “ “Most physicians have never seen this level of angst and anxiety in their careers”…. One said “I am sort of a pariah in my family.”

PART 15. March 22, 2020. CORONAVIRUS. “…Crimson Contagion” and imagining an influenza pandemic, was simulated by the Trump administration….in a series of exercises that ran from last January to August.

PART 16. March 27, 2020. CORONAVIRUS. I am not a clinician or a medical ethicist but articles on Coronavirus patient triage started me Googling………to learn about FUTILE TREATMENT

PART 17. April 2, 2020. CORONAVIRUS. Florida allows churches to continue holding services. Gun stores deemed “essential.”  “New York’s private and public hospitals unite to manage patient load and share resources.

PART 18. April 9, 2020. CORONAVIRUS. “The federal government’s emergency stockpile of personal protective equipment (PPE) is depleted, and states will not be receiving any more shipments, administration staff told a House panel.

PART 19. April 13, 2020 CORONOAVIRUS. “…overlooked in the United States’ halting mobilization against the novel coronavirus: the personal aides, hospice attendants, nurses and occupational or physical therapists who deliver medical or support services to patients in their homes.”

PART 20. April 20, 2020. CORONAVIRUS. “…nothing is mentioned in the “Opening Up America Again” plan about how states should handle a resurgence.”

PART 21. April 23, 2020. CORONAVIRUS. “We need to ask, are we using ventilators in a way that makes sense for other diseases but not this one?”

POST 22. April 29, 2020. CORONAVIRUS. ..the “ACS released a list of 10 issues that should be addressed before a healthcare organization resumes elective surgeries[JM1] ….”

POST 23. May 3, 2020. CORONAVIRUS. … what Dr. Fauci really wants,…”is just to go to a baseball game. That will have to wait. The level of testing for the virus is not adequate enough to allow for such mass gatherings.’ (K)

POST 24. May 7, 2020. CORONAVIRUS. Former New Jersey governor Chris Christie said: “there are going to be deaths no matter what”… but that people needed to get back to work.

POST 25. May 10, 2020, CORONAVIRUS. “It is scary to go to work,” said Kevin Hassett, a top economic adviser to the president. “I think that I’d be a lot safer if I was sitting at home than I would be going to the West Wing.”

POST 26. May 14, 2020. CORONAVIRUS, “Deep cleaning is not a scientific concept”….”there is no universal protocol for a “deep clean” to eradicate the coronavirus”

POST 27. May 19, 2020. CORONAVIRUS. “Hospital…executives…are taking pay cuts…to help offset the financial fallout from COVID-19.” As “front line” layoffs and furloughs accelerate…

POST 28. May 23, 2020. CORONAVIRUS. ““You’ve got to be kidding me,”..”How could the CDC make that mistake? This is a mess.” CDC conflates viral and antibody tests numbers.

PART 29. May 22, 2020. CORONAVIRUS. “The economy did not close down. It closed down for people who, frankly, had the luxury of staying home,” (Governor Cuomo). But not so for frontline workers!

POST 30. June 3,202. CORONAVIRUS. “The wave of mass protests across the United States will almost certainly set off new chains of infection for the novel coronavirus, experts say….

POST 31. June 9, 2020. CORONAVIRUS. “I think we had an unintended consequence: I think we made people afraid to come back to the hospital,”

Post 32. June 16, 2020. CORONAVIRUS. Could the Trump administration be pursuing herd immunity by “inaction”?  “ If Fauci didn’t exist, we’d have to invent him.”

POST 33. June 21, 2002. CORONAVIRUS….. Smashing (lowering the daily number of cases) v. flattening the curve (maintaining a plateau)

POST 34. June 26, 2020. CORONAVIRUS. CDC Director Redfield… “the number of coronavirus infections…could be 10 times higher than the confirmed case count — a total of more than 20 million.” As Florida, Texas and Arizona become eipicenters!

POST 35. June 29, 2020. CORONAVIRUS. Pence: “We slowed the spread. We flattened the curve. We saved lives..”  While Dr. Fauci “warned that outbreaks in the South and West could engulf the country…”

POST 36. July 2, 2020. CORONAVIRUS. “There’s just a handful of interventions proven to curb the spread of the coronavirus. One of them is contact tracing, and “it’s not going well,” (Dr. Anthony Fauci)..

POST 37. June 8, 2020. CORONAVIRUS. When “crews arrive at a hospital with a patient suspected of having COVID-19, the hospital may have a physical bed open for them, but not enough nurses or doctors to staff it.”

POST 38. July 15, 2020. CORONAVIRUS. Some Lessons Learned, or not. AdventHealth CEO Terry Shaw: I wouldn’t hesitate to go to Disney as a healthcare CEO — based on the fact that they’re working extremely hard to keep people safe,” (M)

POST 39. July, 23,2020. CORONAVIRUS. A Tale of Two Cities. Seattle becomes New York (rolls back reopening) while New York becomes Seattle (moves to partial phase 4 reopening)

POST 40. July 27, 2020. CORONAVIRUS.” One canon of medical practice is that you order a test only if you can act on the result. And with a turnaround time of a week or two, you cannot. What we have now is often not testing — it’s testing theater.”

POST 41. August 2, 2020. CORONAVIRUS. “Whenever a vaccine for the coronavirus becomes available, one thing is virtually certain: There won’t be enough to go around. That means there will be rationing.”

POST 42. August 11, 2020. CORONAVIRUS. “I think that if future historians look back on this period, what they will see is a tragedy of denial….

POST 43. August 22, 2020. CORONAVIRUS.”  “we’ve achieved something great as a nation. We’ve created an unyielding market for FAUCI BOBBLEHEADS”!! (W)

POST 44.  September 1, 2020. CORONAVIRUS. “The CDC…modified its coronavirus testing guidelines…to exclude people who do not have symptoms of Covid-19.” (While Dr. Fauci was undergoing surgery.) A White House official said: “Everybody is going to catch this thing eventually..”

POST 45. September 9, 2020. CORONAVIRUS.  Trump on Fauci. ‘You inherit a lot of people, and you have some you love, some you don’t. I like him. I don’t agree with him that often but I like him.’

September 9, 2020


 [JM1]

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POST 44. September 1, 2020. CORONAVIRUS. “The CDC…modified its coronavirus testing guidelines…to exclude people who do not have symptoms of Covid-19.” (While Dr. Fauci was undergoing surgery.) A White House official said: “Everybody is going to catch this thing eventually..”

to read POSTS 1-44 in chronological order, highlight and click on

“This is a story about four people named Everybody, Somebody, Anybody and Nobody. There was an important job to be done and Everybody was sure that Somebody would do it. Anybody could have done it, but Nobody did it. Somebody got angry about that, because it was Everybody’s job. Everybody thought Anybody could do it, but Nobody realized that Everybody wouldn’t do it. It ended up that Everybody blamed Somebody when Nobody did what Anybody could have.” (A)

“Speakers during Tuesday’s portion of the RNC repeatedly referred to the coronavirus pandemic in the past tense, as though it’s something the US has already overcome thanks to President Donald Trump’s leadership. In reality, the virus continues to ravage the country, and Trump hasn’t developed a plan to get things under control beyond blustering and buck-passing.

The worst offender was White House economics adviser Larry Kudlow, whose speech on Tuesday made it sound like the coronavirus was over.

“It was awful,” Kudlow said. “Health and economic impacts were tragic. Hardship and heartbreak were everywhere. But presidential leadership came swiftly and effectively with an extraordinary rescue for health and safety to successfully fight the Covid virus.” “(B)

“A White House official’s flippant response to concerns about the maskless crowds of attendees at the Republican National Convention—and the GOP’s ignoring of the coronavirus’s horrific toll—have sparked widespred outrage this week.

“Everybody is going to catch this thing eventually,” a senior White House official told CNN’s Jim Acosta Thursday.” (C)

“The Centers for Disease Control and Prevention quietly modified its coronavirus testing guidelines this week to exclude people who do not have symptoms of Covid-19 — even if they have been recently exposed to the virus.

Experts questioned the revision, pointing to the importance of identifying infections in the small window immediately before the onset of symptoms, when many individuals appear to be most contagious.

Models suggest that about half of transmission events can be traced back to individuals still in this so-called pre-symptomatic stage, before they start to feel ill — if they ever feel sick at all…

Prior iterations of the C.D.C.’s testing guidelines struck a markedly different tone, explicitly stating that “testing is recommended for all close contacts” of people infected with the coronavirus, regardless of symptoms. The agency also specifically emphasized “the potential for asymptomatic and pre-symptomatic transmission” as an important factor in the spread of the virus.

The newest version, which was posted on Monday, amended the agency’s guidance to say that people who have been in close contact with an infected individual — typically defined as being within six feet of a person with the coronavirus and for at least 15 minutes — “do not necessarily need a test” if they do not have symptoms. Exceptions, the agency noted, might be made for “vulnerable” individuals, or if health care providers or state or local public health officials recommend testing.” (D)

“CDC referred questions to HHS. In a statement provided Wednesday to CNN, HHS Assistant Secretary Dr. Brett Giroir said: “This Guidance has been updated to reflect current evidence and best public health practices, and to further emphasize using CDC-approved prevention strategies to protect yourself, your family, and the most vulnerable of all ages.”

HHS has not specified what change in “current evidence” may have driven the change.” (E)

“White House Coronavirus Task Force member Dr. Anthony Fauci said he was undergoing surgery and not in the August 20 task force meeting for the discussion on updated US Centers for Disease Control and Prevention guidelines that suggest asymptomatic people may not need to be tested for Covid-19, even if they’ve been in close contact with an infected person.

“I was under general anesthesia in the operating room and was not part of any discussion or deliberation regarding the new testing recommendations” at that meeting, Fauci told CNN Chief Medical Correspondent Dr. Sanjay Gupta.

“I am concerned about the interpretation of these recommendations and worried it will give people the incorrect assumption that asymptomatic spread is not of great concern. In fact it is,” said Fauci, director of the National Institute of Allergy and Infectious Diseases.

CDC was pressured ‘from the top down’ to change coronavirus testing guidance, official says

Fauci’s comments undercut claims by Adm. Brett Giroir, the administration’s coronavirus testing point person, who told reporters on Wednesday that the new guidelines had the White House coronavirus task force’s stamp of approval. Asked whether Fauci signed off on the guidelines, Giroir said, “Yes, all the docs signed off on this before it even got to the task force level.”

“We worked on this all together to make sure that there was absolute consensus that reflected the best possible evidence, and the best public health for the American people,” Giroir also said earlier in the call, pushing back on the notion that the new guidelines were the result of political pressure. “I worked on them, Dr. Fauci worked on them, Dr. (Deborah) Birx worked on them. Dr. (Stephen) Hahn worked on them.”

The new CDC guidelines appeared to be the result of an idea raised to the task force by CDC Director Robert Redfield a month earlier, when a surge of coronavirus cases strained US testing resources and some members were looking for new messaging on how to stem excess testing.

Rather than continue to encourage anyone in close contact with a coronavirus-positive individual to get tested, Redfield suggested the CDC could relax the guidance, deeming a test unnecessary for otherwise healthy individuals not experiencing any symptoms, two sources familiar with the matter said. Experts worry that this will discourage the widespread testing of asymptomatic individuals that could help bring the pandemic under control.

The idea was met with immediate resistance from several task force members. In a coronavirus task force meeting Thursday, members debated the guidelines in-depth and in person, when Fauci was absent…” (F)

“In a brief interview, Dr. Fauci said he had seen an early iteration of the guidelines and did not object. But the final debate over the revisions took place at a task force meeting on Thursday, when Dr. Fauci was having surgery under general anesthesia to remove a polyp on his vocal cord. In retrospect, he said, he now had “some concerns” about advising people against getting tested, because the virus could be spread through asymptomatic contact.

“My concern is that it will be misinterpreted,” Dr. Fauci said.

The newest version of the C.D.C. guidelines, posted on Monday, amended the agency’s guidance to say that people who had been in close contact with an infected individual — typically defined as being within six feet of a person with the coronavirus and for at least 15 minutes — “do not necessarily need a test” if they do not have symptoms.

Exceptions might be made for “vulnerable” individuals, the agency noted, or if health care providers or state or local public health officials recommended testing.

Dr. Giroir said the new recommendation matched existing guidance for hospital workers and others in frontline jobs who have “close exposures” to people infected with the coronavirus. Such workers are advised to take proper precautions, like wearing masks, socially distancing, washing their hands frequently and monitoring themselves for symptoms.

He argued that testing those exposed to the virus was of little utility, because tests capture only a single point in time, and that the results could give people a false sense of security.

“A negative test on Day 2 doesn’t mean you’re negative. So what is the value of that?” Dr. Giroir asked, adding, “It doesn’t mean on Day 4 you can go out and visit Grandma or on Day 6 go out without a mask on in school.”

The guidelines come amid growing concern that the C.D.C., the agency charged with tracking and fighting outbreaks of infectious disease, is being sidelined by its parent agency, the Department of Health and Human Services, and the White House. Under ordinary circumstances, administering public health advice to the nation would fall squarely within the C.D.C.’s portfolio…

Mr. Trump has suggested that the nation should do less testing, arguing that administering more tests was driving up case numbers and making the United States look bad. But experts say the true measure of the pandemic is not case numbers but test positivity rates — the percentage of tests coming back positive.

As Dr. Giroir denied that politics was involved, he encouraged the continued testing of asymptomatic people for surveillance purposes — to determine the prevalence of the virus in a given community — and said such “baseline surveillance testing” would still be appropriate in schools and on college campuses.

“We’re trying to do appropriate testing, not less testing,” he said.”  (G)

“Susan R. Bailey, MD, president of the American Medical Association:

“Months into this pandemic, we know COVID-19 is spread by asymptomatic people. Suggesting that people without symptoms, who have known exposure to COVID-positive individuals, do not need testing is a recipe for community spread and more spikes in coronavirus. When the Centers for Disease Control and Prevention updates a guidance, the agency should provide a rationale for the change. We urge CDC and the Department of Health and Human Services to release the scientific justification for this change in testing guidelines.”

Association of American Medical Colleges President and CEO David J. Skorton, MD, and Chief Scientific Officer Ross McKinney Jr., MD:

“The AAMC is alarmed at the changes to the CDC’s guidelines for SARS-CoV-2 (COVID-19) testing, which recommends that individuals who have been exposed to someone with COVID-19 do not need to be tested unless they show symptoms of the disease. This recommendation is irresponsible when we know that roughly 40 percent of SARS-CoV-2 transmissions come from an asymptomatic person. The revised guidance will result in less testing at exactly the time when we need more testing in order to control the pandemic.

“These CDC guidelines go against the best interests of the American people and are a step backward in fighting the pandemic. The AAMC urges the CDC to return to its earlier testing recommendations, and we stand ready to discuss and work with our colleagues at the CDC to optimize future recommendations.”

California Gov. Gavin Newsom:

“I don’t agree with the new CDC guidance, period, full stop. It’s not the policy in the state of California. We will not be influenced by that change. We’re influenced by those who are experts in the field who feel very differently,” the governor stated during an Aug. 26 news briefing, as reported by KABC-TV.

New York Gov. Andrew Cuomo said his state won’t be following the new guideline, according to an Aug. 26 interview with MSNBC. Mr. Cuomo said CDC officials suggested to New York Health Commissioner Howard Zucker, MD, that the change in guidelines was more of a “political position” and not a scientific one…

Heather E. Gantzer, MD, Chair of the Board of Regents of the American College of Physicians

“The American College of Physicians, representing 163,000 internal medicine physicians (internists), related subspecialists and medical students, strongly supports the use of science, based on the best available evidence, in the fight against COVID-19. Public health agencies should not be subjected to pressure or be influenced to issue policies that are not based on evidence and expert recommendations of their own scientists. This can have a detrimental effect on the public’s trust and adherence to evidence-based guidelines.”

“The recent revision of the CDC’s COVID-19 testing guidelines of asymptomatic individuals lacks transparency and clarity, sending a confusing message to both physicians and the public on appropriate and necessary testing that will ultimately help to mitigate the spread of COVID-19. Asymptomatic patients contribute to the spread of COVID-19. The ability to conduct widespread testing using a rapid and accurate test is critical to appropriately manage the spread of SARS-CoV2. ACP recommends that in the absence of currently effective vaccine or treatment options available for COVID-19, state and local authorities should prioritize a strategy of case finding, screening and surveillance to track and reduce further spread. ACP believes that the United States should urgently expand health system capacity to diagnose, test, and conduct contact tracing (with privacy protections).”” (H)

“Two organizations that represent thousands of local public health departments in the United States sent a letter to senior Trump administration officials on Friday asking that they “pull the revised guidance” on virus testing and restore recommendations that individuals who have been exposed to the virus be tested whether or not they have symptoms.

The letter — addressed to Dr. Robert R. Redfield, director of the Centers for Disease Control and Prevention, and Adm. Brett P. Giroir, an assistant secretary of health at the Department of Health and Human Services — was sent by the leaders of the National Association of County and City Health Officials, and the Big Cities Health Coalition. The organizations’ leaders wrote that their members were “incredibly concerned” about the changes…

The letter sent on Friday said, “As public health professionals, we are troubled about the lack of evidence cited to inform this change. CDC’s own data suggest that perhaps as many as 40 percent of Covid-19 cases are attributable to asymptomatic transmission. Changing testing guidelines to suggest that close contacts to confirmed positives without symptoms do not need to be tested is inconsistent with the science and the data.”

The letter went on to say that while the new guidance allows local or state health officials to make exceptions, it “will make their ability to respond to the pandemic even harder,” allowing skeptical officials or members of the public to blame and question them. “This revision and its resulting impact is adding yet another obstacle for public health practitioners to effectively address the pandemic.””  (I)

“The director of the Centers for Disease Control and Prevention, seeking to clarify recommendations on coronavirus testing that incited an uproar, said that “testing may be considered for all close contacts of confirmed or probable Covid-19 patients.”

But his clarification may have further confused the issue.

The statement by the director, Dr. Robert R. Redfield, was issued to some news outlets late Wednesday, and more broadly Thursday morning, after a storm of criticism over new C.D.C. guidelines. Those guidelines asserted that people who had been in close contact with an infected individual — typically defined as being within six feet of a person with the coronavirus for at least 15 minutes — “do not necessarily need a test” if they do not have symptoms.

Administration officials said that “not necessarily” needing a test was consistent with “may be considered” for one. But experts said the shift in language was leaving patients, doctors and state and local public health officials — who rely on the C.D.C. for guidance — perplexed.

“‘May be’?” asked Dr. Carlos del Rio, an infectious disease expert at Emory University. “I want a little more than that in a recommendation. ‘May be’ doesn’t help.”…

In his statement, Dr. Redfield sought to explain: “Testing is meant to drive actions and achieve specific public health objectives. Everyone who needs a Covid-19 test can get a test. Everyone who wants a test does not necessarily need a test; the key is to engage the needed public health community in the decision with the appropriate follow-up action.”

The clarification does not change the new guidelines, which remain on the C.D.C.’s website. But it is unusual. Public health experts say clear, consistent communications are essential to fighting an infectious disease outbreak, and in interviews several said that statements from the C.D.C. and Dr. Redfield had fallen far short of that goal.

“What we need from the C.D.C. is clear, specific, directive guidance,” said Dr. Leana Wen, a former health commissioner of Baltimore. “It shouldn’t be a Rorschach blot that we’re looking at, and everybody’s getting a different response by looking at the same guidance.”

Dr. Wen said she was concerned about the effect of the rule on insurance coverage for testing. Insurers have been chafing against the mandate to pay for all tests without requiring a co-payment from patients. Gregg Gonsalves, an assistant professor of epidemiology at the Yale School of Medicine, said the new guidance suggested the administration was “not going to support asymptomatic testing with new money or allow Medicaid to pay for it.”

“I don’t think the C.D.C.’s decision forbids states from covering tests beyond the C.D.C.’s authorization, but it might give states cover to save money by making cutbacks,” said Stan Dorn, a senior fellow at Families USA, a nonpartisan health consumer advocacy group.

One person close to the C.D.C. and the White House said the new guidelines were put in place in part to make them comport with testing for other infectious diseases, like Zika, and in part because of a sense among administration scientists — as well as doctors and insurers — that “too many people were getting tested out of fear and emotion.”

The flap came as the Trump administration announced the purchase and production of 150 million rapid tests to be distributed across the country. White House officials said the administration had teamed with Abbott Laboratories to produce inexpensive and easy-to-use BinaxNOW tests.

In the new testing guidelines, posted on Monday, the C.D.C. said close contacts of Covid-19 patients “do not necessarily need a test” unless they are vulnerable or their doctor or a state or local public heath official recommended it.

In an interview on Wednesday, Dr. Anthony S. Fauci, a member of the task force and the government’s top infectious disease expert, said he was concerned that the guidelines could be misinterpreted. Dr. Fauci had signed off on an early version of the rule but was undergoing surgery for removal of a polyp on his vocal cord when it was completed last Thursday…

In the statement, Dr. Redfield said the agency was “placing an emphasis on testing individuals with symptomatic illness, individuals with a significant exposure, vulnerable populations including nursing homes or long-term care facilities, critical infrastructure workers, health care workers and first responders, or those individuals who may be asymptomatic when prioritized by medical and public health officials.”

Dr. Redfield also said that anyone — even people who tested negative — exposed to someone who is or may be infected should “strictly adhere” to public health guidelines, like social distancing, wearing a mask, avoiding crowded indoor spaces and frequently washing their hands.” (J)

“Six months into the pandemic, testing remains a major obstacle in America’s efforts to stop the coronavirus. Some of the supply shortages that caused problems earlier have eased, but even after improvements, test results in some cases are still not being returned within a day or two, hindering efforts to quickly isolate patients and trace their contacts. Now, the number of tests being given has slowed just as the nation braces for the possibility of another surge as schools reopen and cooler weather drives people indoors.

“We’re clearly not doing enough,” said Dr. Mark McClellan, the director of the Duke-Margolis Center for Health Policy and the commissioner of the Food and Drug Administration under former President George W. Bush.

The downward trend may turn out to be only a short-term setback: The nation reported more than 800,000 tests on Thursday and Friday. There are also limitations to the data, which is largely drawn from state health departments, some of which have recently struggled with backlogs and other issues. It may not include tests done in labs not certified by the federal government.

But according to the figures available, tests were declining in 20 states this week, and data collected by the Department of Health and Human Services showed a similar overall trend nationally.

Without a vaccine or a highly successful treatment, widespread testing is seen as a cornerstone for fighting a pandemic in which as many as 40 percent of infected people do not show symptoms and may unknowingly spread the virus. Testing a lot of people is crucial to seeing where the virus is going and identifying hot spots before they get out of hand. Experts see extensive testing as a key part of safely reopening schools, businesses and sports.

The nation’s testing capacity has expanded from where it was only a few months ago, but public health experts believe it must grow far more to bring the virus under control.

The Harvard Global Health Institute has suggested the country needs at least 1 million tests per day to slow the spread of the virus, and as many as 4 million per day to get ahead of the virus and stop new cases. Some experts view that goal as too ambitious, and others say the benchmark should focus not on a particular number of tests but on the percent of people testing positive.

Yet there is broad consensus that the current level of testing is inadequate and that any decrease in testing is a worrisome move in the wrong direction.

“There is a reasonable disagreement about what that number ought to be, but all of them are way ahead of where we are right now,” said Dr. Ashish Jha, director of the Harvard Global Health Institute. “There is no expert that I know of that thinks that our testing infrastructure right now meets the needs of the American people.”

Adm. Brett P. Giroir, the assistant secretary for health and the Trump administration’s virus testing czar, said that conducting millions of tests per day was not realistic. The administration has asked states to test at least 2 percent of their populations each month, or the equivalent of about 220,000 people per day nationally, which Admiral Giroir said would be enough to identify rising hot spots.

“We are doing the appropriate amount of testing now to reduce the spread, flatten the curve, save lives,” he told reporters on Thursday…”  (K)

“On March 15, as the novel coronavirus was beginning to surge in the United States, Dr. Anthony S. Fauci accomplished a rare Washington feat: He appeared on all five major Sunday talk shows.

But the White House worried that Dr. Fauci might upstage (and sometimes contradict) President Trump, and soon his media handlers were no longer approving his high-profile interview requests.

So Dr. Fauci found another way to get his message out: He said yes to pretty much every small offer that came his way: academic webinars, Instagram feeds and niche science podcasts, as well as a few celebrity interviews…

Whether by design or not, Dr. Fauci has effectively circumvented efforts by the White House to mute him. Since Mark Meadows took over as chief of staff on March 31, White House communications officials have approved very few requests from major outlets. But there is no such review process for smaller ones, like the weekly podcast of the Journal of the American Medical Association, or the KC O’Dea radio show.

In recent weeks, Dr. Fauci has been joining as many as five such shows a day. On Aug. 13, he appeared on Mr. O’Dea’s show, which serves the Raleigh-Durham, N.C., market; a podcast affiliated with the Walter Reed National Military Medical Center; “The Pat McCrory Show with Bo Thompson”; a National Geographic special on pandemics; and a local Fox affiliate in High Point, N.C. He also appeared on “NewsHour,” the PBS evening news show.

His appearances are widely watched by reporters from larger outlets, who then quote him in their news reports….

Journalists with major news broadcasts are frustrated they can’t book Dr. Fauci during a public health emergency. Margaret Brennan, the host of CBS’s “Face the Nation,” told her audience in July that the White House had not approved any interviews with Dr. Fauci since March, inhibiting public understanding of the pandemic. “We will continue our efforts,” she said. Mary Hager, the executive producer of the show, said they asked for Dr. Fauci and other government scientists every week.

“We have this genius and this gold mine of a guest,” she said. “And we can’t use him to his absolute maximum capacity at a time when people are dying.””  (L)

“If you were world-renowned in your field, contributed decades to improving public health, were given commendations by multiple presidents and medical organizations for your work, led the country through major pandemics, would you want to stay in a role where you were suddenly constantly criticized and undermined by your current administrator and were receiving death threats?

Anthony Fauci MD, Director of the National Institute of Allergy and Infectious Diseases is in that position. The Trump administration has continually tried to silence or discredit Fauci…

Fauci has a stellar reputation both academically and in the federal government. As per Trump’s administration, if you have scientific evidence that disagrees with the administration’s stance, you are punished. Trump’s administration had talking points for reporters that refuted Fauci’s statements and his credibility. An op-ed was written by a high-ranking Trump administration official with the purpose of making the public question Fauci. Fauci has been omitted from Trump’s Covid-19 briefings…

If more government officials don’t speak out in support of Fauci and condemns the Trump administration’s undermining of his work and silence about threats made against Fauci, the US is at risk of losing one of the country’s foremost experts on pandemics. This means that the public is losing a well-regarded voice of reason and factual, science-based information.

While Fauci has not directly stated that he is considering leaving his position, it would be understandable that the stress from threats, constant undermining and disrespect would make anyone reconsider staying at their position.” (M)

“The United States signed a $750 million deal with Abbott Laboratories for 150 million rapid coronavirus tests, the White House announced Thursday.

“By strategically distributing 150 million of these tests to where they’re needed most, we can track the virus like never before and protect millions of Americans at risk in especially vulnerable situations,” Department of Health and Human Services Secretary Alex Azar said in a statement.

On Wednesday, the Federal Drug Administration granted the company emergency authorization for its new COVID-19 test.

The test called BinaxNow can deliver results in 15 minutes without using lab equipment and would cost $5.” (N)

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