C.D.C. Tells States How to Prepare for Covid-19 Vaccine by Early November

Posted on September 3, 2020 by henrykotula • Posted in 2020 Election Issues, Campaign, Centers for Disease Control & Prevention (CDC), Coronavirus, Credibility, Crisis, Crisis Management, Distribution, Election, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Expert, Expert Opinion, Health Policy, Hype, Mortality, Pandemic, Risk, Risk Assessment, Risk Management, Risk Tolerance, Scientists, Supply Chain, Transparency, Trust, Truth, Vaccine, Vaccine Distribution, Wishful Thinking • Leave a comment

As President Trump pushes the possibility of a vaccine this year, the C.D.C. has outlined technical scenarios to state public health officials for an unidentified Vaccine A and Vaccine B.

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.

The new C.D.C. guidance is the latest sign of an accelerating race for a vaccine to ease a pandemic that has killed more than 184,000 Americans. The documents were sent out on the same day that President Trump told the nation in his speech to the Republican National Convention that a vaccine might arrive before the end of the year.

Over the past week, both Dr. Anthony S. Fauci, the country’s top infectious disease expert, and Dr. Stephen Hahn, who heads the Food and Drug Administration, have said in interviews with news organizations that a vaccine may be available for certain groups before clinical trials have been completed, if the data is overwhelmingly positive.

Public health experts agree that agencies at all levels of government should urgently prepare for what will eventually be a vast, complex effort to vaccinate hundreds of millions of Americans. But the possibility of a rollout in late October or early November has heightened concerns that the Trump administration is seeking to rush the distribution of a vaccine — or simply to hype that one is possible — before Election Day on Nov. 3.

For an administration that has struggled with the logistical challenges of containing the coronavirus, the distribution of millions of vaccines that must be stored in subzero temperatures and provided first to high-risk groups through America’s flawed, fragmented health care system would be a daunting challenge. Even the C.D.C.’s guidance acknowledged that its plan was hypothetical and based on the need to immediately begin organizing the gigantic effort that would be required if the F.D.A. were to allow the use of a vaccine or two this year.

The C.D.C. plans lay out technical specifications for two candidates described as Vaccine A and Vaccine B, including requirements for shipping, mixing, storage and administration. The details seem to match the products developed by Pfizer and Moderna, which are the furthest along in late-stage clinical trials. On Aug. 20, Pfizer said it was “on track” for seeking government review “as early as October 2020.”

Credit…

“This timeline of the initial deployment at the end of October is deeply worrisome for the politicization of public health and the potential safety ramifications,” said Saskia Popescu, an infection prevention epidemiologist based in Arizona. “It’s hard not to see this as a push for a pre-election vaccine.”

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.

That’s a positive development, “so it doesn’t just all wind up in high-income, affluent suburbs,” said Dr. Cedric Dark, an emergency medicine physician at Baylor College of Medicine in Texas.

The C.D.C. noted in its guidance that “limited Covid-19 vaccine doses may be available by early November 2020.” The documents were dispatched the same day that Dr. Robert Redfield, director of the C.D.C., sent a letter to governors asking them to prepare vaccine distribution sites by Nov. 1, as McClatchy reported.

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.

Many of the details listed for the two vaccines — including required storage temperature, the number of days needed between doses, and the type of medical center that can accommodate the product’s storage — match what Pfizer and Moderna have said about their products, which are based on so-called mRNA technology. Neither company responded to requests for comment.

The scenarios, which assume that the two vaccines will demonstrate sufficient safety and effectiveness for an emergency authorization from the F.D.A. by the end of October, noted that Vaccine A, which seems to match Pfizer’s, would have about two million doses ready within this time frame, and that Vaccine B, whose description matches Moderna’s, would have about one million doses ready, with tens of millions of doses of each vaccine ready by the end of the year. Although it’s possible that some promising preliminary data may emerge by the end of October, experts are skeptical.

“The timeline that’s reported seems a bit ambitious to me,” Dr. Dark said. “October’s like 30 days away.”

Trials that test a vaccine’s effectiveness can take years to yield reliable results. It’s possible to draw conclusions sooner “if there is an overwhelming effect” in which vaccinated people appear to be far better protected from disease, said Padmini Pillai, a vaccine researcher and immunologist at M.I.T.

But there can be significant risks in approving a vaccine for broad use in the public before Phase 3 clinical trials involving tens of thousand of participants are completed. Rare but dangerous side effects may only surface over time, after such large numbers of people have received the vaccine.

And data gathered early in a trial might not hold true months down the line. Researchers also need time to test large numbers of people from a variety of backgrounds to determine how well the vaccine works in different populations — including the vulnerable communities identified in the guidelines.

Should any of these snags occur, Dr. Pillai said, “all of this together could diminish public trust in the vaccine.”

James S. Blumenstock, senior vice president of pandemic response and recovery at the Association of State and Territorial Health Officials, confirmed that the three C.D.C. documents were sent to all state and territorial health departments last week. “It is now the time to enhance organizational structure and involve all partners in this planning process going forward,” he said.

Lisa Stromme, a spokeswoman for the Washington State Department of Health, said that her state’s health officials were still at “a very early stage in a planning process,” but were already working toward developing infrastructure that would accommodate the assumptions laid out by the C.D.C.

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.”

The technical comparison of Vaccine A and Vaccine B has some echoes of what was discussed at an Aug. 26 meeting of the Advisory Committee on Immunization Practices of the C.D.C. At the meeting, Dr. Kathleen Dooling, a C.D.C. medical officer, laid out three scenarios: Vaccine A, or the Pfizer vaccine, is approved, Vaccine B, the Moderna vaccine, is approved, or both. The requirement that Pfizer’s vaccine be stored at minus 70 degrees Celsius would mean that it couldn’t be administered at most small sites, she said. The C.D.C. documents noted that orders of Vaccine A would go “to large administration sites only.” The Moderna vaccine requires storage at minus 20 degrees Celsius.

The C.D.C. documents said the vaccine would be free to patients, but that providers might not be reimbursed for administrative costs if the vaccine was given an emergency authorization, rather than a standard approval.

Experts worry that the process is unlikely to go off without a hitch, given the last-minute scramble and the mixed messaging so far. “I think distribution is going to be very tricky for the vaccine, particularly if there is a cold storage requirement,” Dr. Bell said.

There are also likely to be challenges administering both doses of the proposed vaccines, which must be given weeks apart, Dr. Dark said. “How are you going to make sure people get both?”

ANALYSIS: ADMINISTRATION’S CORONAVIRUS ADVICE IS SECRET, FRAGMENTED AND CONTRADICTORY

Posted on September 3, 2020 by henrykotula • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Contradictory, Coronavirus, Crisis, Crisis Management, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Failed, Failed Repeatedly, Failure, False Hope, False Narrative, Fragmentation, Health Policy, Infection Control, Infection Control Plan, Infectious Virus, Leadership Decentralized, Misinformation, Misinterpret, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Mortality, National Strategy, Pandemic, Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Quarantine, School Reopening, Scientists, Secret, Silencing, Silencing Speech, Social Distancing, Transparency, Trust, Truth • Leave a comment

Analysis: Trump administration’s coronavirus advice is secret, fragmented and contradictory

ANALYSIS: TRUMP ADMINISTRATION’S CORONAVIRUS ADVICE IS SECRET, FRAGMENTED AND CONTRADICTORY

Dr. Deborah Birx speaks to reporters in the rotunda of the State Capitol in Lincoln, Neb., Aug. 14, 2020, after meeting with Gov. Pete Ricketts and community and state health officials. (AP Photo/Nati Harnik)

Private calls and unpublished reports leave many Americans and local officials in the dark.

This is a news analysis from the Center for Public Integrity.

From behind a podium and a black mask, Tulsa mayor G.T. Bynum faced the press. It was late July, and one percent of his city had tested positive for COVID-19 since the beginning of the pandemic.

A reporter had a question: What did Bynum have to say about the newly leaked White House Coronavirus Task Force document that recommended Tulsa close bars and limit gatherings to 10 people?

The “alleged White House document” was “never officially presented to us … by either the federal government or the state government,” the mayor said. But he was familiar with the document’s recommendations, having read them online. “All of that remains very much on the table.”

Fast-forward a month, at a press conference that looked exactly like the last, and Bynum still hadn’t received any of the weekly reports from the White House. “It was news to me that there had been eight different reports. I only knew about the one that was leaked to the media,” he said. “That’s all data that, of course, we would like to know.”

Indeed, the White House reports — chock full of local data and recommendations — would be useful for many city leaders, many of whom still don’t know what percentage of coronavirus tests in their metro areas are positive. But Bynum and others didn’t have that information. The White House was sending each state’s report directly to its governor and a select group of other officials instead of distributing the documents widely or posting them publicly.

The nation’s coronavirus response must be “locally executed, state managed, federally supported,” White House officials have said repeatedly. In fact, much of their public health advice has been secret, segmented and inconsistent. Federal guidance isn’t always reaching the local officials it’s meant to support. And scattershot messages mean that average citizens weighing visits to grandparents or countless other daily risks have limited — and sometimes conflicting — information from the officials they are expected to trust.

THE SUMMER OF SECRET WARNINGS

In late June, the White House Coronavirus Task Force began sending reports to governors showing how their states were faring in the pandemic. Dr. Deborah Birx, a leader of the task force, held the documents aloft at a press conference July 8, but they weren’t distributed to reporters. Birx said several states were in the coronavirus “red zone” — with high numbers of cases — and should take special precautions, but Vice President Mike Pence delivered the primary message of the press conference: Reopen schools.

Later that month, the Center for Public Integrity obtained a copy of the compiled report for all 50 states and published it, revealing that 18 states were in the red zone. The next morning, presidential adviser Kellyanne Conway suggested Public Integrity, a 30-year-old nonprofit, nonpartisan newsroom, had nefarious motives for disclosing public information: “I don’t know about that particular document, and respectfully the Center for Public Integrity is an outside organization that I’m sure doesn’t support the president’s election,” she told reporters.

A spokesman for Pence, Devin O’Malley, later acknowledged the document’s authenticity. But the White House still didn’t release the reports and stayed mum on why it was keeping them secret. Weeks later, White House spokesman Judd Deere sent an email to Public Integrity that didn’t quite answer the question: “The White House Coronavirus Task Force is providing tailored recommendations weekly to every governor and health commissioner for their states and counties,” he wrote. “Local leaders are best positioned to make on-the-ground decisions for their communities … The United States will not be shut down again.”

Meanwhile, Birx hit the road, zigzagging across the country to meet with governors in person and privately urge some of them to ratchet up virus precautions. On closed-to-the-press conference calls with state and local officials, Birx warned individual cities that they should take “aggressive action” to curb the coronavirus, according to recordings obtained by Public Integrity.

But officials from those cities weren’t always on the calls: Baltimore and Cleveland leaders missed a call in which Birx pinpointed them. And some of them weren’t getting the reports she was referencing. In late August, the most recent White House report the Arkansas Department of Health had was three weeks old.

Public health experts say the reports should be public. “This is a pandemic,” Harvard epidemiologist Bill Hanage told Public Integrity in July. “You cannot hide it under the carpet.”

Dr. David Rubin, who has provided epidemiological modeling to the task force as director of PolicyLab at the Children’s Hospital of Philadelphia Research Institute, is also befuddled as to why the reports are secret. “I think we’d be in a lot different place today if we had national standards around certain things,” he said. But he doesn’t blame Birx or other scientists working with the White House. “They’re playing the hand that they were dealt.”

CUSTOM-MADE OR CONFUSING?

In mid-March, a 4×6” blue-and-white postcard appeared in mailboxes across the nation, emblazoned with “President Trump’s Coronavirus Guidelines for America” and both the White House and Centers for Disease Control and Prevention logos. On the back were a dozen lines of advice, including: “Even if you are young, or otherwise healthy, you are at risk and your activities can increase the risk for others.”

The postcard appeared in the days when the president, vice president, Birx and National Institute of Allergy and Infectious Diseases Director Anthony Fauci together updated the nation daily on television about the state of the coronavirus. The administration had already pressed the mute button on the CDC (though the agency posted guidance online, it wasn’t giving the regular briefings it had in past epidemics), but the White House was still attempting to send out a cohesive public health message.

Then, as the economy cratered, Trump shifted gears to reopening and pushed responsibility for the pandemic response to the states. After decades of relying on national entities for public health advice and regulation — the CDC, the Food and Drug Administration, the surgeon general and others — America handed responsibility for infectious-disease containment to the states.

Doing so allows governors to respond to their unique virus conditions, defenders of the administration said. The U.S. needs “a decentralized approach” said Heritage Foundation visiting fellow Doug Badger, because states have police powers to enforce lockdowns and because they are “better suited to responding to this pandemic, where there is great variation between and within states. […] There’s no one-size-fits-all policy.” Indeed, epidemics unfold at different rates in different geographies, and it makes sense to adjust advice based on whether people live close together or far apart, and how widely the virus is spreading in their communities.

But experts say that even though some public health warnings should be specific to local areas, many messages, such as the need to wear masks, should be nationally consistent. Contradictory guidance undermines trust, and the virus exploits the communities with weakest defenses. “Diseases don’t care about national or state borders,” said Jessica Malaty Rivera, Science Communication Lead at the Covid Tracking Project, a volunteer organization collecting pandemic data. “You can’t look at this in a fragmented way otherwise we’re going to continue this fragmented progress.”

“Diseases don’t care about national or state borders.”

JESSICA MALATY RIVERA, SCIENCE COMMUNICATION LEAD AT THE COVID TRACKING PROJECT

And some think the Trump administration’s advice isn’t as tailored or helpful as it should be. “For weeks, the Trump Administration has been issuing these cookie-cutter reports based on little or no review of existing regulations or conditions on the ground, while failing to pull together a national strategy for COVID-19 testing, contact tracing, and response,” Charles Boyle, a spokesman for Oregon Gov. Kate Brown, wrote in an email. “None of the recommendations in these weekly reports have been paired with the resources or the federal support to implement them.”

In addition, Trump’s desire for state leadership has been selective. After weeks of insisting on a governor-led response, in July Trump Tweeted, “SCHOOLS MUST OPEN IN THE FALL!!!” and threatened to withhold federal funding from school districts that did not open their doors.

WHO DO YOU LISTEN TO?

Splitting public health advice into pieces means that some of those fragments don’t line up. On a private call with state and local leaders earlier this month, Birx said colleges should be testing students as they return to campus, and even be prepared to do 5,000 or 10,000 tests in one day. But the CDC hasn’t endorsed such testing because its effectiveness hasn’t been “systematically studied.”

Nowhere has the fractured advice been more evident than on the topic of how to reopen K-12 schools. The CDC in May issued guidelines, but later replaced them with a more lenient version after the president objected. After insisting schools open their doors, Trump acknowledged that some hot spots may need to delay opening. CDC director Robert Redfield said that schools should go virtual if their areas have more than 5 percent test positivity — a threshold that only 17 states and the District of Columbia met as of Aug. 26 according to a New York Times tracker. Birx has stayed noticeably quiet on the topic. The secret reports from her task force recently endorsed West Virginia’s school reopening guidelines, which say schools must switch to virtual learning if daily new cases in a county exceed 25 per 100,000 residents.

All this leaves local officials with a dizzying set of choices and advice, stuck making the decisions others don’t want blame for.

“This really stinks for local health departments,” said Lori Tremmel Freeman, CEO of the National Association of County and City Health Officials. “Everybody wants to relinquish authority to the local health department. The authority ends up coming and going depending on how hard it is to address the issue. And it just is not fair to them.”

In addition, perhaps due in part to the mixed messaging, whatever advice the White House does have isn’t always followed. In Arkansas, where the task force has recommended that bars close, they remain open. In Georgia, where the task force recommended a state mask mandate, Gov. Brian Kemp sued to block Atlanta from requiring face coverings, though he later relented. In Tennessee in July, Gov. Bill Lee ignored Birx’s suggestion that he close bars, limit indoor dining and mandate masks.

All this has meant that in the first major pandemic in a century, despite the feeble and disjointed efforts of the White House to corral them, the United States were not united, not even in the messages sent to citizens. That has some experts worried about what’s to come in the fall, when the reluctance of some to be vaccinated could mean the nation fails to reach the threshold for herd immunity that would protect everyone. Rivera, of the Covid Tracking Project, is “absolutely terrified” about that possibility; united messaging is key when trying to help people understand the scientific rigor behind a vaccine, she said. “All it takes is one rumor to completely shift public health behavior.”

HELP FROM THE FOURTH ESTATE

In Tulsa, Bynum can now see all the White House reports. That’s because Public Integrity published a recent Oklahoma report, and local journalists pressed the governor on why he hadn’t handed it out. Last week he agreed to post all of the state’s White House reports.

In other parts of the country, people still don’t know what White House experts are saying about their states or counties. The federal map of red, yellow and green zones — an easy-to-understand stoplight that could help people quickly decide whether to cross state lines, for example — remains off limits to the public. President Trump resumed daily coronavirus briefings this month, but Birx remains relegated to private calls and local press briefings on her treks across states. The CDC continues its silence; Fauci is recovering from a vocal cord surgery and can’t speak.

For more than a century, Congress has given the federal government a prominent role in helping stop the spread of disease from state to state. Americans can debate whether governors or the president should make the big decisions in this particular pandemic. But neither statute nor scientific wisdom puts limits on the federal government’s ability to dole out health advice. And there is no national security reason to make such advice secret.

Coronavirus Metric, The Case Fatality, Is Unreliable

Posted on September 2, 2020 by henrykotula • Posted in 2020 Election Issues, Case Fatality Rate, Coronavirus, Credibility, False Hope, False Narrative, Honesty, Integrity, Key Performance Indicators, Lagging Indicator, Misinformation, Misinterpret, Mislead, Misleading, Misleading Metric, Mistake, Mistrust, Mixed Message, Mortality, National Strategy, Pandemic, Transparency, Trust, Truth, Undermining, Wishful Thinking • Leave a comment

https://www.npr.org/2020/07/24/894818106/trumps-favorite-coronavirus-metric-the-case-fatality-is-unreliable?fbclid=IwAR3Zfo29Yhv49yu7ORp9ytjSc8f6uqlhXP0BEFvBGOBUcvXZH0dYrJha2Sc

blog | Teksten, Wijsheid

As the number of coronavirus cases started spiking again this month, the White House keyed in on a different number — one that paints a more rosy picture of the pandemic: the case fatality rate.

When asked about rising cases at a recent briefing, press secretary Kayleigh McEnany quickly parried. “We’re seeing the fatality rate in this country come down,” said McEnany. “That is a very good thing.”

The case fatality rate is the result of a simple mathematical calculation: the number of deaths divided by the number of diagnosed coronavirus cases. But it’s also a moving target. Case numbers are rising fast; deaths are a lagging indicator, running several weeks behind.

“Measuring … mortality rates on any given day is not a reliable way of communicating about this pandemic,” said Dr. Tom Inglesby, director of the Johns Hopkins Center for Health Security.

It is possible that innovations in treatment methods and therapeutic drugs have helped improve the survivability of COVID-19. It is also possible that with more young people being infected in this latest round, they are less likely to die. But medical experts warn it is also just too soon to be sure. And, they say, it’s an unreliable and misleading metric.

But that hasn’t stopped President Trump from boasting about the figure.

“Our case fatality rate has continued to decline and is lower than the European Union and almost everywhere else in the world,” Trump said Tuesday at his first White House coronavirus briefing in nearly three months.

In his interview on Fox News Sunday with Chris Wallace, Trump asked his staff to bring him the “death chart.” He said “the death chart is much more important” as Wallace ticked through 75,000 daily cases and 1,000 daily deaths.

Trump had that chart displayed behind him during the briefing. But this isn’t a metric public health experts have been using.

Inglesby says that by a more direct measure (the sheer number of deaths), and even adjusted for population size, the U.S. is not doing well compared to other countries around the world.

“What national leaders have the obligation to tell people is just the direct truth,” Inglesby said. “If we give them a false sense that things are getting better when they’re not, then they’re going to make decisions that increase the risk of transmission. And they’re also going to stop having confidence in the information they’re being given.”

Focusing on the fatality rate also glosses over other serious problems with the coronavirus, says Dr. David Relman, who specializes in immunology and infectious diseases at Stanford. He says about 20% of people get really sick with potential long-term health consequences. Plus, he says, the coronavirus is stressing the medical system. And as long as it is uncontained, the virus is holding the economy back. So, as he sees it, talking about the case fatality rate is counterproductive.

“What you do instead when you pull out one little piece and dangle it in front of people is to confuse and distract and undermine the overall message,” said Relman.

He says people need to take this virus seriously and take precautions, and that is a sacrifice that requires leaders to get the public on board. For Trump, accentuating the positive might have short-term political benefits, but there are longer-term risks.

“I think it was a mistake early on to be dismissive of the seriousness of it and that it was just going to go away,” said Mike DuHaime, a Republican strategist.

DuHaime gives Trump credit for coming out this week and treating the coronavirus more seriously than he has in the past, telling people to wear masks and avoid crowds. But he readily acknowledges that Trump has gone through other brief spurts urging the public to sacrifice to slow the spread of the virus, only to reverse himself, downplay the severity and pressure states to reopen.

“In order for him to succeed here politically, his credibility has to be as strong as possible,” said DuHaime, who now works at the firm Mercury.

Trump’s credibility has taken a major hit through this crisis. According to the latest Pew Poll, only 30% of Americans trust Trump to get the facts right on the virus. And Trump’s approval rating has tanked too, something he is attempting to repair with the resumed daily briefings.

“At the end of the day, he just needs to do a good job. I know that sounds simplistic, but when you’re an incumbent running for reelection, doing a good job is really the most important thing,” said DuHaime. “And to this point people haven’t seen him do a good job on what they think is the greatest challenge of his presidency.”

DuHaime points out that people are checking the numbers every day — the number of new cases in their city and state, the number of hospitalizations and deaths. Those numbers are all readily available and easier to find than the case fatality rate.

Decision-making amid COVID-19: 6 takeaways from health system CEOs and CFOs

Posted on September 2, 2020 by henrykotula • Posted in Chief Executive Officer (CEO), Chief Financial Officer (CFO), Communication, Crisis, Crisis Management, Decision Making, Decision Making Authority, Exit Strategy, Information Technology, Innovation, Investing, Investment, Investments, Leadership, Leadership Alignment, Pandemic, Problem Solving, Technology, Telemedicine, Transparency, Trust, Truth • Leave a comment

https://www.beckershospitalreview.com/hospital-management-administration/decision-making-amid-covid-19-6-takeaways-from-health-system-ceos-and-cfos.html?utm_medium=email

Alignment between CEOs and CFOs has become even more essential during the pandemic.

Many health systems halted elective surgeries earlier this year at the height of the pandemic to conserve resources while caring for COVID-19 patients. Now, in many areas, those procedures are returning and hospitals are slowly resuming more normal operations. But damage has been done to the hospital’s bottom line. Moving forward, the relationship between top executives will be crucial to make the right decisions for patients and the overall health of their organizations.

During the Becker’s Healthcare CEO+CFO Virtual Forum on Aug. 11, CEOs and CFOs for top hospitals and health systems gathered virtually to share insights and strategies as well as discuss the biggest challenges ahead for their institutions. Click here to view the panels on-demand.

Here are six takeaways from the event:

1. The three keys to a strong CEO and CFO partnership are trust, transparency and communication.

2. It’s common for a health system CEO and CFO to have different priorities and different opinions about where investments should be made. To help come to an agreement, they should look at every decision as if it’s a decision being made by the organization as a whole and not an individual executive. For example, there are no decisions by the CFO. There are only decisions by the health system. The CFOs said it’s important to remember that the patient comes first and that health systems don’t exist to make money.

3. Technology has of course been paramount during the pandemic in terms of telehealth. But so are nontraditional partnerships with other health systems that have allowed providers to share research and education.

4. When it comes to evaluating technology, there’s a difference between being on the cutting edge versus the bleeding edge. Investing in new technology requires firm exit strategies. If warning signs show an investment is not going to give the return a health system hoped for, they need to let go of ideals and stick to the exit strategy.

5. Communication and transparency with staff and the public is key while making challenging decisions. Many hard decisions, including furloughs or personnel reductions, were made this spring to protect the financial viability of healthcare organizations. These decisions, which were not made lightly, were critiqued highly by the public. One of the best ways to ensure the message was not getting lost in translation and to help navigate the criticism included creating a communication plan and sharing that with employees, physicians and the public.

6. The pandemic required hospitals to think on their feet and innovate quickly. Many of the usual ways to solve a problem could not be used during that time. For example, large systems had to rethink how to acquire personal protective gear. Typically, in a large health system amid a disaster, when a supply item is running low, organizations can call up another hospital in the network and ask them to send some supplies. However, everyone in the pandemic was running low on the same items, which required innovation and problem-solving that is outside of the norm.

Administration’s new pandemic adviser pushes controversial ‘herd immunity’ strategy, worrying public health officials

Posted on August 31, 2020 by henrykotula • Posted in 2020 Election Issues, Asymptomatic Transmission, Centers for Disease Control & Prevention (CDC), Clinical Testing, Contact Tracing, Coronavirus, Credibility, Crisis, Crisis Management, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Expert, Expert Opinion, False Hope, False Narrative, Herd Immunity, Immunity, Infection Control, Infection Control Plan, Infectious Virus, Judgement, Leadership Cares, Leadership Culture, Leadership Decentralized, Leadership Integrity, Leadership Intent, Leadership Messaging, Leadership Political, Leadership Trust, Long COVID, Misinformation, Misinterpret, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Mortality, National Strategy, Pandemic, Partisanship, Personal Protective Equipment (PPE), Public Health, Public Opinion, Public Perception, Public Safety, Public Schools, Public Trust, Quarantine, School Reopening, Scientists, Silencing, Silencing Speech, Social Distancing, Transparency, Trust, Truth, Wishful Thinking, World Health Organization (WHO) • Leave a comment

https://www.washingtonpost.com/politics/trump-coronavirus-scott-atlas-herd-immunity/2020/08/30/925e68fe-e93b-11ea-970a-64c73a1c2392_story.html?utm_campaign=wp_post_most&utm_medium=email&utm_source=newsletter&wpisrc=nl_most

One of President Trump’s top medical advisers is urging the White House to embrace a controversial “herd immunity” strategy to combat the pandemic, which would entail allowing the coronavirus to spread through most of the population to quickly build resistance to the virus, while taking steps to protect those in nursing homes and other vulnerable populations, according to five people familiar with the discussions.

The administration has already begun to implement some policies along these lines, according to current and former officials as well as experts, particularly with regard to testing.

The approach’s chief proponent is Scott Atlas, a neuroradiologist from Stanford’s conservative Hoover Institution, who joined the White House earlier this month as a pandemic adviser. He has advocated that the United States adopt the model Sweden has used to respond to the virus outbreak, according to these officials, which relies on lifting restrictions so the healthy can build up immunity to the disease rather than limiting social and business interactions to prevent the virus from spreading.

Sweden’s handling of the pandemic has been heavily criticized by public health officials and infectious-disease experts as reckless — the country has among the highest infection and death rates in the world. It also hasn’t escaped the deep economic problems resulting from the pandemic.

But Sweden’s approach has gained support among some conservatives who argue that social distancing restrictions are crushing the economy and infringing on people’s liberties.

That this approach is even being discussed inside the White House is drawing concern from experts inside and outside the government who note that a herd immunity strategy could lead to the country suffering hundreds of thousands, if not millions, of lost lives.

“The administration faces some pretty serious hurdles in making this argument. One is a lot of people will die, even if you can protect people in nursing homes,” said Paul Romer, a professor at New York University who won the Nobel Prize in economics in 2018. “Once it’s out in the community, we’ve seen over and over again, it ends up spreading everywhere.”

Atlas, who does not have a background in infectious diseases or epidemiology, has expanded his influence inside the White House by advocating policies that appeal to Trump’s desire to move past the pandemic and get the economy going, distressing health officials on the White House coronavirus task force and throughout the administration who worry that their advice is being followed less and less.

Atlas declined several interview requests in recent days. After the publication of this story, he released a statement through the White House: “There is no policy of the President or this administration of achieving herd immunity. There never has been any such policy recommended to the President or to anyone else from me.”

White House communications director Alyssa Farah said there is no change in the White House’s approach toward combatting the pandemic.

“President Trump is fully focused on defeating the virus through therapeutics and ultimately a vaccine. There is no discussion about changing our strategy,” she said in a statement. “We have initiated an unprecedented effort under Operation Warp Speed to safely bring a vaccine to market in record time — ending this virus through medicine is our top focus.”

White House officials said Trump has asked questions about herd immunity but has not formally embraced the strategy. The president, however, has made public comments that advocate a similar approach.

“We are aggressively sheltering those at highest risk, especially the elderly, while allowing lower-risk Americans to safely return to work and to school, and we want to see so many of those great states be open,” he said during his address to the Republican National Convention Thursday night. “We want them to be open. They have to be open. They have to get back to work.”

Atlas has fashioned himself as the “anti-Dr. Fauci,” one senior administration official said, referring to Anthony S. Fauci, the nation’s top infectious-disease official, who has repeatedly been at odds with the president over his public comments about the threat posed by the virus. He has clashed with Fauci as well as Deborah Birx, the White House coronavirus response coordinator, over the administration’s pandemic response.

Atlas has argued both internally and in public that an increased case count will move the nation more quickly to herd immunity and won’t lead to more deaths if the vulnerable are protected. But infectious-disease experts strongly dispute that, noting that more than 25,000 people younger than 65 have died of the virus in the United States. In addition, the United States has a higher number of vulnerable people of all ages because of high rates of heart and lung disease and obesity, and millions of vulnerable people live outside nursing homes — many in the same households with children, whom Atlas believes should return to school.

“When younger, healthier people get the disease, they don’t have a problem with the disease. I’m not sure why that’s so difficult for everyone to acknowledge,” Atlas said in an interview with Fox News’s Brian Kilmeade in July. “These people getting the infection is not really a problem and in fact, as we said months ago, when you isolate everyone, including all the healthy people, you’re prolonging the problem because you’re preventing population immunity. Low-risk groups getting the infection is not a problem.”

Atlas has said that lockdowns and social distancing restrictions during the pandemic have had a health cost as well, noting the problems associated with unemployment and people forgoing health care because they are afraid to visit a doctor.

“From personal communications with neurosurgery colleagues, about half of their patients have not appeared for treatment of disease which, left untreated, risks brain hemorrhage, paralysis or death,” he wrote in The Hill newspaper in May

The White House has left many of the day-to-day decisions regarding the pandemic to governors and local officials, many of whom have disregarded Trump’s advice, making it unclear how many states would embrace the Swedish model, or elements of it, if Trump begins to aggressively push for it to be adopted.

But two senior administration officials and one former official, as well as medical experts, noted that the administration is already taking steps to move the country in this direction.

The Department of Health and Human Services, for instance, invoked the Defense Production Act earlier this month to expedite the shipment of tests to nursing homes — but the administration has not significantly ramped up spending on testing elsewhere, despite persistent shortages. Trump and top White House aides, including Atlas, have also repeatedly pushed to reopen schools and lift lockdown orders, despite outbreaks in several schools that attempted to resume in-person classes.

The Centers for Disease Control and Prevention also updated its testing guidance last week to say that those who are asymptomatic do not necessarily have to be tested. That prompted an outcry from medical groups, infectious-disease experts and local health officials, who said the change meant that asymptomatic people who had contact with an infected person would not be tested. The CDC estimates that about 40 percent of people infected with covid-19, the disease caused by the coronavirus, are asymptomatic, and experts said much of the summer surge in infections was due to asymptomatic spread among young, healthy people.

Trump has previously floated “going herd” before being convinced by Fauci and others that it was not a good idea, according to one official.

The discussions come as at least 5.9 million infections have been reported and at least 179,000 have died from the virus this year and as public opinion polls show that Trump’s biggest liability with voters in his contest against Democratic nominee Joe Biden is his handling of the pandemic. The United States leads the world in coronavirus cases and deaths, with far more casualties and infections than any other developed nation.

The nations that have most successfully managed the coronavirus outbreak imposed stringent lockdown measures that a vast majority of the country abided by, quickly ramped up testing and contact tracing, and imposed mask mandates.

Atlas meets with Trump almost every day, far more than any other health official, and inside the White House is viewed as aligned with the president and White House Chief of Staff Mark Meadows on how to handle the outbreak, according to three senior administration officials.

In meetings, Atlas has argued that metropolitan areas such as New York, Chicago and New Orleans have already reached herd immunity, according to two senior administration officials. But Birx and Fauci have disputed that, arguing that even cities that peaked to potential herd immunity levels experience similar levels of infection if they reopen too quickly, the officials said.

Trump asked Birx in a meeting last month whether New York and New Jersey had reached herd immunity, according to a senior administration official. Birx told the president there was not enough data to support that conclusion.

Atlas has supporters who argue that his presence in the White House is a good thing and that he brings a new perspective.

“Epidemiology is not the only discipline that matters for public policy here. That is a fundamentally wrong way to think about this whole situation,” said Avik Roy, president of the Foundation for Research on Equal Opportunity, a think tank that researches market-based solutions to help low-income Americans. “You have to think about what are the costs of lockdowns, what are the trade-offs, and those are fundamentally subjective judgments policymakers have to make.”

It remains unclear how large a percentage of the population must become infected to achieve “herd immunity,” which is when enough people become immune to a disease that it slows its spread, even among those who have not been infected. That can occur either through mass vaccination efforts, or when enough people in the population become infected with coronavirus and develop antibodies that protect them against future infection.

Estimates have ranged from 20 percent to 70 percent for how much of a population would need to be infected. Soumya Swaminathan, the World Health Organization’s chief scientist, said given the transmissibility of the novel coronavirus, it is likely that about 65 to 70 percent of the population would need to become infected for there to be herd immunity.

With a population of 328 million in the United States, it may require 2.13 million deaths to reach a 65 percent threshold of herd immunity, assuming the virus has a 1 percent fatality rate, according to an analysis by The Washington Post.

It also remains unclear whether people who recover from covid-19 have long-term immunity to the virus or can become reinfected, and scientists are still learning who is vulnerable to the disease. From a practical standpoint, it is also nearly impossible to sufficiently isolate people at most risk of dying due to the virus from the younger, healthier population, according to public health experts.

Atlas has argued that the country should only be testing people with symptoms, despite the fact that asymptomatic carriers spread the virus. He has also repeatedly pushed to reopen schools and advocated for college sports to resume. Atlas has said, without evidence, that children do not spread the virus and do not have any real risk from covid-19, arguing that more children die of influenza — an argument he has made in television and radio interviews.

Atlas’s appointment comes after Trump earlier this summer encouraged his White House advisers to find a new doctor who would argue an alternative point of view from Birx and Fauci, whom the president has grown increasingly annoyed with for public comments that he believes contradict his own assertions that the threat of the virus is receding. Advisers sought a doctor with Ivy League or top university credentials who could make the case on television that the virus is a receding threat.

Atlas caught Trump’s attention with a spate of Fox News appearances in recent months, and the president has found a more simpatico figure in the Stanford doctor for his push to reopen the country so he can focus on his reelection. Atlas now often sits in the briefing room with Trump during his coronavirus news conferences, even as other doctors do not. He has given the president somewhat of a medical imprimatur for his statements and regularly helps draft the administration’s coronavirus talking points from his West Wing office as well as the slides that Trump often relies on for his argument of a diminishing threat.

Atlas has also said he is unsure “scientifically” whether masks make sense, despite broad consensus among scientists that they are effective. He has selectively presented research and findings that support his argument for herd immunity and his other ideas, two senior administration officials said.

Fauci and Birx have both said the virus is a threat in every part of the country. They have also put forward policy recommendations that the president views as too draconian, including mask mandates and partial lockdowns in areas experiencing surges of the virus.

Birx has been at odds with Atlas on several occasions, with one disagreement growing so heated at a coronavirus meeting earlier this month that other administration officials grew uncomfortable, according to a senior administration official.

One of the main points of tension between the two is over school reopenings. Atlas has pushed to reopen schools and Birx is more cautious.

“This is really unfortunate to have this fellow Scott Atlas, who was basically recruited to crowd out Tony Fauci and the voice of reason,” said Eric Topol, a cardiologist and head of the Scripps Research Translational Institute in San Diego. “Not only do we not embrace the science, but we repudiate the science by our president, and that has extended by bringing in another unreliable misinformation vector.”

Convalescent Plasma: The Unanswered Questions

Posted on August 29, 2020 by henrykotula • Posted in 2020 Election Issues, Clinical Research, Coronavirus, Coronavirus Treatment, Credibility, Data Analytics, Data Consistency, Data Governance, Data Integrity, Data Interpretation, Data Quality, Data Transparency, Decision Making, False Hope, False Narrative, Food and Drug Administration (FDA), Hydroxychloroquine, Hypothesis, Transparency, Trust, Truth, Undermining • Leave a comment

https://www.medpagetoday.com/infectiousdisease/covid19/88264?xid=fb_o&trw=no&fbclid=IwAR0F6xiRAQ7ngBz4pNozJ2VqWm0-UJqGdlQojfOeyXbPJjbAeYtGL8jbAiw

“The data don’t show anything useful”

Problems with the government’s rationale for authorizing use of convalescent plasma in COVID-19 patients go far beyond the dustup over the purported 35% survival benefit cited by top officials on Sunday, numerous researchers say.

That figure quickly came under fire, leading to an apology from Commissioner Stephen Hahn, MD — but that’s not the only criticism leveled at the FDA’s analysis of the available data.

Much of it came from the Mayo Clinic and FDA expanded access program (EAP), at this point published only as a preprint manuscript. Although a large number of patients were included, the study was observational only, with no untreated control group. That makes the findings merely hypothesis-generating, and can’t offer any firm conclusions.

That’s fine for issuing an emergency use authorization (EUA), but not so much for making claims about survival benefit, independent researchers said.

“It’s not even a question of overstating,” Adam Gaffney, MD, MPH, a critical care doctor and health policy researcher at Harvard Medical School, told MedPage Today. “You can’t state much at all when you don’t have a randomized controlled trial.”

“People have made a big deal of Hahn referring to relative versus absolute risk reduction, but I think that’s less of a big deal,” Gaffney said. “The biggest problem is that the data they are citing … is not randomized. That’s the source of all the problems.”

Hahn took heat for saying that a “35% improvement in survival is a pretty substantial clinical benefit” further explaining that of “100 people who are sick with COVID-19, 35 would have been saved because of the administration of plasma.”

Critics rapidly took to Twitter, stating that the interpretation was incorrect. Hahn was referring to relative risk reduction, not absolute risk reduction. Thus, calculating the number of lives saved — which isn’t something experts recommend doing based on observational data in the first place — would have translated to somewhere more in the ballpark of 5 out of 100.

Moreover, the “risk reduction” came from a comparison of patients treated with high-titer plasma versus those receiving lower-titer preparations. The study offered no basis for concluding how many patients may have been “saved” relative to standard care.

And the 35% reduction in that analysis was for 7-day mortality; the relative reduction at 30 days was only 23%.

Hahn’s recital of the 35% figure “was just PART of the error,” tweeted Vinay Prasad, MD, MPH, of the University of California San Francisco. “The entire comparison is flawed. It is not a suitable control. The data don’t show anything useful.”

“The much broader problem here is the lack of commitment to performing large, national randomized controlled trials,” Gaffney said. “We could have done it for convalescent plasma. Instead, we did the EAP. I understand why people wanted it, but now we don’t know [if convalescent plasma works]. We have a question mark instead of a period.”

Undermining Trust in FDA?

Critics have charged that serious mistakes like Hahn’s misstatement could undermine FDA’s credibility, especially as it faces challenging decisions about potentially approving a vaccine this fall.

“This is playing out in the context of a hyper-politicized moment,” Gaffney said. “It behooves everyone to be extremely cautious in speaking about these things to avoid the appearance of politicization.”

On CBS This Morning on Tuesday, Hahn addressed concerns about politicization by offering reassurance to the “American people that this decision was made based upon sound science and data.”

In response to questions about the timing of the EUA announcement — it came just a day after President Donald Trump tweeted allegations that the “deep state” was holding back access to COVID-19 treatments with Hahn’s Twitter handle cited, and a day before the Republican National Convention got underway — Hahn said the agency had been working on the application for 3 or 4 weeks and was waiting on additional validation data, which were received at the end of last week and over the weekend.

“We’re going to continue to get data and as we’ve done with any other authorization, we will update that decision as new data come,” Hahn said on the news program. His agency initially issued an EUA for hydroxychloroquine, for instance, but later revoked it when the negative randomized trial data became available.

Lack of Access to FDA’s Data Review

Whether the public will ever see the full convalescent plasma data underlying the EUA is another matter. The “Clinical Memorandum” issued as the evidence behind the FDA’s decision glossed over the statistical analysis conducted by the agency; in particular, it made no mention of the 35% relative reduction in deaths.

Another problem with that is the 35% figure’s source isn’t fully clear. Although the EAP preprint manuscript is the most obvious source, Gaffney noted that HHS Secretary Alex Azar said it referred to a subgroup of patients under age 80 who were not on a ventilator. That is not found in the publicly available data. He also pointed to a tweet by FDA spokesperson Emily Miller that contains an agency slide showing a 37% reduction in mortality for non-intubated patients age 80 or under treated within 72 hours who got high-titer convalescent plasma, compared with low-titer product. Neither of those figures is reflected in the EAP manuscript.

The FDA did not return a request by MedPage Today for the full summary of data reviewed by FDA and any independent statistical analysis done by the agency.

Shmuel Shoham, MD, of Johns Hopkins University in Baltimore, said during a press briefing organized by the Infectious Diseases Society of America that “enormous amounts of data have been generated” from the EAP, in which more than 70,000 patients have been treated.

“Some data have been reported in articles and at meetings, but that’s only part of what the FDA — this is their program — has access to,” he said. “The stuff in the public domain is only a fraction of the data they have collected.”

Shoham is on the scientific advisory board of the EAP and is involved in two convalescent plasma clinical trials at Johns Hopkins.

Gaffney said Mayo researchers and FDA reviewers have noted that physicians were blinded to the dose of antibody given in plasma infusions, which he described as a “pseudo-randomization effect. We could use that to make more causal inferences about the effectiveness of antibody titers.”

However, he said there were some significant differences between those who received high-titer versus low-titer antibody, including differences in P-to-F ratio (a measure of inhaled oxygen to blood oxygen) and in those with five or more severe risk factors, suggesting the low-titer group was sicker to begin with than the high-titer group.

Also, patients in the EAP received a variety of other treatments: about half got steroids and 40% were given remdesivir.

“This is why we do randomized controlled trials,” Gaffney said. “Without them it’s very difficult to ensure that the effect you see is the result of the drug, and not the result of patient characteristics.”

Is an Answer Forthcoming?

Several randomized controlled trials of convalescent plasma are underway in the U.S., but the big concern is that wider access to convalescent plasma will limit enrollment. Will clinicians recommend that their patients enroll in a trial in which they might receive placebo? Will patients agree?

For the Hopkins studies, the prevention trial has enrolled 25 people out of a goal of 500, and its outpatient trial has enrolled 50 people of its 600-patient goal.

Liise-anne Pirofski, MD, of Montefiore Medical Center in New York, started a study at the end of April, looking to enroll 300 people. She said the team enrolled the first 150 people quickly, but “then the pandemic began to wane in New York.” With subsequent funding from the NIH, the trial has managed to enroll 190 patients, and has now expanded to four additional sites: New York University, Yale, the University of Miami, and the University of Texas Houston.

Clifton Callaway, MD, PhD, of the University of Pittsburgh Medical Center and lead investigator on the C3PO trial looking at outpatient convalescent plasma, said he hopes the EUA doesn’t discourage participation.

“To the contrary, I believe it should reassure persons considering participation that the FDA feels that convalescent plasma is safe and potentially useful and that the FDA specifically comments: ‘Current data suggest the largest clinical benefit is associated with high-titer units of CCP administered early in the course of disease.’ Giving high-titer convalescent plasma earlier (before you are sick enough to be in the hospital) is exactly what C3PO is testing.”

In addition to determining whether earlier or prophylactic treatment works, Shoham said other unanswered questions include identifying whether other components in plasma are useful therapies and whether low-titer plasma can work at all.

“What everyone agrees on is that the gaps in knowledge that exist can best be addressed by high-quality randomized controlled trials,” he said.

Pirofski said the science and data should be the focus, “rather than the decision and what drove the decision…. I don’t think anyone knows what drove that decision other than the people in that room. Hopefully they know.”

Top U.S. Officials Told C.D.C. to Soften Coronavirus Testing Guidelines

Posted on August 29, 2020 by henrykotula • Posted in 2020 Election Issues, Asymptomatic Transmission, Centers for Disease Control & Prevention (CDC), Clinical Testing, Contact Tracing, Coronavirus, Coronavirus Treatment, Crisis, Crisis Management, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Expert, Expert Opinion, False Hope, False Narrative, Food and Drug Administration (FDA), Honesty, Hydroxychloroquine, Infection Control, Infection Control Plan, Infectious Virus, Integrity, Leadership Culture, Leadership Integrity, Leadership Intent, Leadership Political, Leadership Trust, Misinformation, Misinterpret, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Mortality, National Strategy, Pandemic, Partisanship, Positivity Rate, Public Health, Public Opinion, Public Perception, Public Safety, Public Schools, Public Trust, School Reopening, Scientists, Social Distancing, Transparency, Trust, Truth • Leave a comment

The Centers for Disease Control and Prevention abruptly changed its recommendations, saying people without Covid-19 symptoms should not get tested.

Trump administration officials on Wednesday defended a new recommendation that people without Covid-19 symptoms abstain from testing, even as scientists warned that the policy could hobble an already weak federal response as schools reopen and a potential autumn wave looms.

The day after the Centers for Disease Control and Prevention issued the revised guidance, there were conflicting reports on who was responsible. Two federal health officials said the shift came as a directive to the Atlanta-based C.D.C. from higher-ups in Washington at the White House and the Department of Health and Human Services.

Adm. Brett P. Giroir, the administration’s coronavirus testing czar, called it a “C.D.C. action,” written with input from the agency’s director, Dr. Robert R. Redfield. But he acknowledged that the revision came after a vigorous debate among members of the White House coronavirus task force — including its newest member, Dr. Scott W. Atlas, a frequent Fox News guest and a special adviser to President Trump.

“We all signed off on it, the docs, before it ever got to a place where the political leadership would have, you know, even seen it, and this document was approved by the task force by consensus,” Dr. Giroir said. “There was no weight on the scales by the president or the vice president or Secretary Azar,” he added, referring to Alex M. Azar II, the secretary of health and human services.

Regardless of who is responsible, the shift is highly significant, running counter to scientific evidence that people without symptoms could be the most prolific spreaders of the coronavirus. And it comes at a very precarious moment. Hundreds of thousands of college and K-12 students are heading back to campus, and broad testing regimens are central to many of their schools’ plans. Businesses are reopening, and scientists inside and outside the administration are growing concerned about political interference in scientific decisions.

Democratic governors who were weighing how to keep the virus contained as their economies and schools come to life said limiting testing for asymptomatic citizens would make the task impossible.

“The only plausible rationale,” Gov. Andrew M. Cuomo of New York told reporters in a conference call from Albany, N.Y., “is that they want fewer people taking tests, because as the president has said, if we don’t take tests, you won’t know the number of people who are Covid-positive.”

Over the weekend, the Food and Drug Administration, under pressure from Mr. Trump, gave emergency approval to expand the use of antibody-rich blood plasma to treat Covid-19 patients. The move came just days after scientists, including Dr. Anthony S. Fauci, the nation’s top infectious disease expert, and Dr. Francis S. Collins, the director of the National Institutes of Health, intervened to stop the practice because of lack of evidence that it worked.

The move echoed a decision by the Food and Drug Administration to grant an emergency use waiver for hydroxychloroquine, a malaria drug repeatedly sold by Mr. Trump as a treatment for Covid-19. The agency revoked the waiver in June, when clinical trials suggested the drug’s risks outweighed any possible benefits.

The testing shift, experts say, was a far more puzzling reversal. Dr. Giroir said the move was “discussed extensively by” members of the White House coronavirus task force, and he named Dr. Redfield, Dr. Atlas, Dr. Fauci and Dr. Stephen M. Hahn, the commissioner of food and drugs. Notably, he did not name Dr. Deborah L. Birx, the White House coronavirus response coordinator. But he said Dr. Fauci was among those who had “signed off.”

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.

Experts have called the revisions alarming and dangerous, noting that the United States needs more testing, not less. And they have expressed deep concern that the C.D.C. is posting guidelines that its own officials did not author. A former C.D.C. director, Dr. Thomas R. Frieden, railed against the move on Twitter on Wednesday:

Dr. Tom Frieden

@DrTomFrieden

Two unexplained, inexplicable, probably indefensible changes, likely imposed on CDC’s website. * Dammit, if you come from a place with lots of Covid, quarantine for 14 days * If you’re a contact, get tested. If +, we can trace your contacts and stop chains of spread. A sad day.

Later, in an interview, Dr. Frieden elaborated. He noted that the C.D.C. had recently dropped its recommendation that people quarantine for 14 days after traveling from an area with a high number of cases to one where the virus was less prevalent. And he reiterated that testing the contacts of those infected was an important means of curbing the spread of the virus.

“We don’t know the best protocol for testing of contacts: Should you test all contacts? That’s the kind of study that frankly needs to get done,” Dr. Frieden said. But absent the answer to that question, he added, “I certainly wouldn’t say, ‘Don’t test contacts.’”

Democrats, including Speaker Nancy Pelosi and two governors — Mr. Cuomo and Gavin Newsom of California — were outraged by the changes. Mr. Newsom said California would not follow the new guidelines, and Mr. Cuomo blamed Mr. Trump.

Representative Frank Pallone Jr. of New Jersey, a Democrat and the chairman of the House Energy and Commerce Committee, also chimed in on Twitter: “The Trump Admin has a lot of explaining to do. #COVID19 testing is essential to stopping the spread of the pandemic. I’m concerned that CDC is once again caving to political pressure. This simply cannot stand.”

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.

Still, the revisions left many public health officials scratching their heads. They might have made sense when the United States was experiencing a shortage of tests, some experts said, but that no longer appears to be the case. Dr. Frieden, however, said it was possible the administration was trying to conserve testing in case of another surge.

“The problem is we have too many cases, so there is basically no way to keep up the testing if you have a huge outbreak,” he said.

Jennifer Nuzzo, an epidemiologist at Johns Hopkins Bloomberg School of Public Health, said she was “not as up in arms about the content of the guidelines” as she was about the idea that the C.D.C.’s own experts did not write them — and that C.D.C. officials were referring all questions about them to the health department in Washington.

“These guidelines are clearly controversial, and many are calling on C.D.C. to explain its rationale for them, but C.D.C. is unable to comment,” she said in an email. “This is really dangerous precedent, and I fear it will erode public trust in C.D.C.”

Cartoon – The Vagueness Campaign

Posted on August 26, 2020 by henrykotula • Posted in 2020 Election Issues, Ad Campaign, Cartoon, Communication, Election, False Hope, False Narrative, False Reassurance, Honesty, Integrity, Leadership, Leadership Culture, Leadership Integrity, Leadership Messaging, Leadership Trust, Marketing, Mislead, Misleading, Mistrust, Mixed Message, Social Media, Transparency, Trust, Truth, Vague • Leave a comment

Cartoon – Flashy Ad Campaigns

Posted on August 26, 2020 by henrykotula • Posted in 2020 Election Issues, Ad Campaign, Authentic, Communication, Consumer Confidence, Consumer Engagement, Consumer Focus, Consumer Preferences, Election, False Narrative, False Reassurance, Marketing, Mislead, Misleading, Transparency • Leave a comment

Being Yourself: The Importance Of Authenticity In Online Marketing ...

Billions in Hospital Virus Aid Rested on Compliance With Private Vendor

Posted on August 26, 2020 by henrykotula • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Coronavirus, Crisis, Crisis Management, Data, Data Consistency, Data Control, Data Gathering, Data Governance, Data Integrity, Data Management, Data Transparency, Dept of Health and Human Services (HHS), Economic Crisis, Economic Stimulus, Ethics, Health Policy, Health System, Hospital, Hospital Industry, Pandemic, The CARES Act, Transparency, Trust, Truth • Leave a comment

Billions in Hospital Virus Aid Rested on Compliance With Private ...

The Department of Health and Human Services told hospitals in April that reporting to the vendor, TeleTracking Technologies, was a “prerequisite to payment.”

The Trump administration tied billions of dollars in badly needed coronavirus medical funding this spring to hospitals’ cooperation with a private vendor collecting data for a new Covid-19 database that bypassed the Centers for Disease Control and Prevention.

The highly unusual demand, aimed at hospitals in coronavirus hot spots using funds passed by Congress with no preconditions, alarmed some hospital administrators and even some federal health officials.

The office of the health secretary, Alex M. Azar II, laid out the requirement in an April 21 email obtained by The New York Times that instructed hospitals to make a one-time report of their Covid-19 admissions and intensive care unit beds to TeleTracking Technologies, a company in Pittsburgh whose $10.2 million, five-month government contract has drawn scrutiny on Capitol Hill.

“Please be aware that submitting this data will inform the decision-making on targeted Relief Fund payments and is a prerequisite to payment,” the message read.

The financial condition, which has not been previously reported, applied to money from a $100 billion “coronavirus provider relief fund” established by Congress as part of the $2.2 trillion Coronavirus Aid, Relief and Economic Security Act, or CARES Act, signed by President Trump on March 27. Two days later, the administration instructed hospitals to make daily reports to the C.D.C., only to change course.

“Another data reporting ask,” a regional official in the health department informed colleagues in an email exchange obtained by The Times, adding: “It comes with $$ incentive. We really need a consolidated message on the reporting/data requests, this is past ridiculous.”

A colleague replied, “Another wrinkle. What a mess.”

The disclosure of the demand in April is the most striking example to surface of the department’s efforts to expand the role of private companies in health data collection, a practice that critics say infringes on what has long been a central mission of the C.D.C. Last month, the federal health department moved beyond financial incentives and abruptly ordered hospitals to send daily coronavirus reports to TeleTracking, not the C.D.C., raising concerns about transparency and reliability of the data.

Officials at the Department of Health and Human Services say that the moves were necessary to improve and streamline data collection in a crisis, and that the one-time reports collected in April by TeleTracking were not available from any other source.

“The national health system has not been challenged in this way in any time in recent history,” Caitlin Oakley, a department spokeswoman, said in a statement, adding that TeleTracking offered a “standardized national hospital capacity tracking system which provided more real-time, better informed data to make decisions from.”

But critics remain alarmed.

“In the middle of a pandemic, the Trump administration is using funds meant to support hospitals as a tool to coerce them to use an unproven, untrusted and deeply flawed system that sidelines public health experts,” Senator Patty Murray of Washington, the ranking Democrat on the Senate Health Committee, said in a statement.

In a statement, TeleTracking said it has three decades of experience providing health care systems “with actionable data and unprecedented visibility to make better, faster decisions.”

Still, public health experts and hospital executives are puzzled as to why the health agency chose such a difficult time to employ an untested private vendor rather than improve the C.D.C.’s National Healthcare Safety Network, a decades-old disease tracking system that was deeply familiar to hospitals and state health departments.

The N.H.S.N., as it is known, had built up trust over decades of working with hospitals and state health departments. Administrators were reluctant to make the switch.

“People — especially in public health and clinical health — are very protective of their data, so that trust factor is certainly an issue,” said Patina Zarcone, the director of informatics for the Association of Public Health Laboratories. “The fear of having their data leaked or misused or used for a purpose that they weren’t aware of or agreed to — I think that’s the biggest rub.”

Ms. Oakley said the C.D.C.’s system was “not designed for use in a disaster response” and could not adapt quickly in a crisis. Allies of the C.D.C. say withholding taxpayer dollars from the CARES Act in lieu of cooperation was an inappropriate effort to push hospitals into a system they were reluctant to use.

“It’s an absolutely enormous lever,” said William Schaffner, an infectious disease expert at Vanderbilt University. “It’s a compulsion to oblige institutions to report to this TeleTracking system because they knew if it weren’t tied to money, it wouldn’t happen.”

The Pittsburgh company has no obvious ties to the Trump administration. Rather, the push appears to be part of a broader privatization. The Health and Human Services Department has also asked the Minnesota-based manufacturer 3M “to create, and continuously update, a nationwide clinical data set on Covid-19 treatment,” according to documents obtained by The Times.

The effort is separate from the TeleTracking data collection. Tim Post, a company spokesman, said that because 3M already operates hospital information systems, it is “uniquely positioned,” with the permission of its clients, to submit information to the health department to help officials study disease patterns and recommend treatment options.

Some experts say this kind of cooperation with the private sector is long overdue. But the push also appears to be driven at least in part by an intensifying rift between the C.D.C., based in Atlanta, and officials at the White House and Department of Health and Human Services, the parent agency of the disease control centers.

Dr. Deborah L. Birx, the White House coronavirus response coordinator, and Mark Meadows, the president’s chief of staff, have taken a dim view of the C.D.C. and believe its reporting systems were inadequate. In a recent interview, Michael Caputo, the spokesman for Mr. Azar, accused the C.D.C. of having “a tantrum.”

Accurate hospital data — including information about coronavirus caseloads, deaths, bed capacity and personal protective equipment — is essential to tracking the pandemic and guiding government decisions about how to distribute scarce resources, like ventilators and the drug remdesivir, the only approved treatment for hospitalized Covid-19 patients.

The health agency has set up a new database, H.H.S. Protect, to collect and analyze Covid-19 data from a range of sources. TeleTracking feeds hospital data to that system.

But the public rollout of H.H.S. Protect has been rocky. The nonpartisan Covid Tracking Project identified big disparities between hospital data reported by states and the federal government and deemed the federal data “unreliable.”

The tension dates to March, when the novel coronavirus was making its first surge in the United States

On March 29, Vice President Mike Pence, charged by Mr. Trump with overseeing the federal response, informed hospital administrators that the C.D.C. was setting up a “Covid-19 Module,” and asked them to file daily reports which, he said, were “necessary in monitoring the spread of severe Covid-19 illness and death as well as the impact to hospitals.”

But around that time, TeleTracking submitted a proposal for data collection to the Trump administration, through an initiative, ASPR Next, created to promote innovation. On April 10, TeleTracking was awarded its contract.

The health department’s spokeswoman said the intent was to complement the C.D.C., not compete with it. Like the C.D.C.’s network, TeleTracking’s system requires manual reporting on a daily basis. But in June, Ms. Murray demanded the administration provide more information about what she called a “multimillion-dollar contract” for a “duplicative health data system.”

Some hospital officials also objected to the change.

“We have been directing our hospitals to N.H.S.N.,” Jackie Gatz, a vice president of the Missouri Hospital Association, wrote to a regional health and human services official in an email obtained by The Times, “and now this email with a much greater carrot — CARES Act distributions — is routing them to TeleTracking.”

When the order was delivered, flaws had already emerged in the new system.

“H.H.S. has acknowledged long wait times for those calling for technical support, and indicated that TeleTracking recently added 100 staff to respond to call center requests,” the American Hospital Association wrote to its members in a “special bulletin” on April 23. “They also are directing hospitals to leave a message if they are unable to reach someone live.”

At the time, hospitals had the option of making their daily coronavirus reports to TeleTracking or the C.D.C. Few were using the new database.

In June, the administration again used a stick to demand that hospitals report to TeleTracking, this time in order to obtain remdesivir. By July, with Dr. Birx pushing to bolster hospital compliance, the administration instructed hospitals to stop filing daily reports to the C.D.C. and to send them to TeleTracking instead.

One official at a major academic hospital, who spoke on the condition of anonymity for fear of angering officials in Washington, said the switch left her “unable to sleep at night.”

“Ethically, it felt like they had taken a very trusted institution in the C.D.C. and all of that trust built up with many public health people,” she said, then “moved it onto a politically and financially motivated portion of this response.”

Health and human services officials say the government now has a much more complete picture of hospital bed capacity, with more than 90 percent of hospitals reporting. But Dr. Janis M. Orlowski, the chief health officer for the Association of American Medical Colleges, who worked with Dr. Birx and the administration to bolster hospital reporting, said that she was “stunned” by the switch and that the increase in reporting came because of efforts by her group and others, not the TeleTracking system.

Dr. Orlowski said the data and maps now published on the administration’s H.H.S. Protect data hub are “just not as sophisticated as the C.D.C.”

The switch also generated pushback inside the C.D.C., where officials have refused to analyze and publish TeleTracking data, saying they could not be assured of its quality and had continuing questions about its accuracy, according to a senior federal health official.

Administration officials say the C.D.C. is working with a little-known office in the executive branch — the United States Digital Service — to build a “modernized automation process” in which data will continue to flow directly to the Department of Health and Human Services. But the project is in its infancy, one senior federal health official said.

Critics say that if the department believed the C.D.C.’s health network had problems, those should have been fixed.

“We have a public health system that depends upon communication from hospitals to state health departments to the C.D.C.,” said Dr. Schaffner, the Vanderbilt University infectious disease expert. “It’s very well established. Can it be improved? Of course. But to cut out the public health infrastructure and report to a private firm essential public health data is misguided in the extreme.”

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HENRY KOTULA

A Healthcare Leadership Blog

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INTRODUCTION

THE SUMMER OF SECRET WARNINGS

CUSTOM-MADE OR CONFUSING?

WHO DO YOU LISTEN TO?

HELP FROM THE FOURTH ESTATE

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“The data don’t show anything useful”

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