Category Archives: False Hope

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

Posted on by • 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.”

 

 

 

 

History tells us trying to stop diseases like COVID-19 at the border is a failed strategy

Posted on by • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Clinical Testing, Contact Tracing, Coronavirus, Culture, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Failed, Failed Repeatedly, Failure, False Hope, False Narrative, Germ Theory, Health Policy, Individualism, Infection Control, Infection Control Plan, Infectious Virus, Leadership Decentralized, Misinformation, Misinterpret, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Mortality, National Strategy, Pandemic, Partisanship, Public Health, Public Opinion, Public Perception, Public Safety, Public Schools, Public Trust, Quarantine, School Reopening, Scientists, Social Distancing • Leave a comment

https://theconversation.com/history-tells-us-trying-to-stop-diseases-like-covid-19-at-the-border-is-a-failed-strategy-145016?utm_medium=email&utm_campaign=Latest%20from%20The%20Conversation%20for%20August%2028%202020%20-%201715916573&utm_content=Latest%20from%20The%20Conversation%20for%20August%2028%202020%20-%201715916573+Version+A+CID_8719e3ecf842bc9762e48ce42f2ba6ad&utm_source=campaign_monitor_us&utm_term=History%20tells%20us%20trying%20to%20stop%20diseases%20like%20COVID-19%20at%20the%20border%20is%20a%20failed%20strategy

History tells us trying to stop diseases like COVID-19 at the border is a failed strategy

To explain why the coronavirus pandemic is much worse in the U.S. than anywhere else in the world, commentators have blamed the federal government’s mismanaged response and the lack of leadership from the Trump White House.

Others have pointed to our culture of individualism, the decentralized nature of our public health, and our polarized politics.

All valid explanations, but there’s another reason, much older, for the failed response: our approach to fighting infectious disease, inherited from the 19th century, has become overly focused on keeping disease out of the country through border controls.

As a professor of medical sociology, I’ve studied the response to infectious disease and public health policy. In my new book, “Diseased States,” I examine how the early experience of outbreaks in Britain and the United States shaped their current disease control systems. I believe that America’s preoccupation with border controls has hurt our nation’s ability to manage the devastation produced by a domestically occurring outbreak of disease.

Germ theory and the military

Though outbreaks of yellow fever, smallpox, and cholera occurred throughout the 19th century, the federal government didn’t take the fight against infectious disease seriously until the yellow fever outbreak of 1878. During that same year, President Rutherford B. Hayes signed the National Quarantine Act, the first federal disease control legislation.

By the early 20th century, a distinctly American approach to disease control had evolved: “New Public Health.” It was markedly different from the older European concept of public health, which emphasized sanitation and social conditions. Instead, U.S. health officials were fascinated by the newly popular “germ theory,” which theorized that microorganisms, too small to be seen by the naked eye, caused disease. The U.S. became focused on isolating the infectious. The typhoid carrier Mary Mallon, known as “Typhoid Mary,” was isolated on New York’s Brother Island for 23 years of her life.

Originally, the military managed disease control. After the yellow fever outbreak, the U.S. Marine Hospital Service (MHS) was charged with operating maritime quarantine stations countrywide. In 1912, the MHS became the U.S. Public Health Service; to this day, that includes the Public Health Service Commissioned Corps led by the surgeon general. Even the Centers for Disease Control and Prevention started as a military organization during World War II, as the Malaria Control in War Areas program. Connecting the military to disease control promoted the notion that an attack of infectious disease was like an invasion of a foreign enemy.

Germ theory and military management put the U.S. system of disease control down a path in which it prioritized border controls and quarantine throughout the 20th century. During the 1918 influenza pandemic, New York City held all incoming ships at quarantine stations and forcibly removed sick passengers into isolation to a local hospital. Other states followed suit. In Minnesota, the city of Minneapolis isolated all flu patients in a special ward of the city hospital and then denied them visitors. During the 1980s, the Immigration and Naturalization Service denied HIV-positive persons from entering the country and tested over three million potential immigrants for HIV.

Defending the nation from the external threat of disease generally meant stopping the potentially infectious from ever entering the country and isolating those who were able to gain entry.

Our mistakes

This continues to be our predominant strategy in the 21st century. One of President Trump’s first coronavirus actions was to enforce a travel ban on China and then to limit travel from Europe.

His actions were nothing new. In 2014, during the Ebola outbreak, California, New York and New Jersey created laws to forcibly quarantine health care workers returning from west Africa. New Jersey put this into practice when it isolated U.S. nurse Kaci Hickox after she returned from Sierra Leone, where she was treating Ebola patients.

In 2007, responding to pandemic influenza, the Department of Homeland Security and the CDC developed a “do not board” list to stop potentially infected people from traveling to the U.S.

When such actions stop outbreaks from occurring, they are obviously sound public policy. But when a global outbreak is so large that it’s impossible to keep out, then border controls and quarantine are no longer useful.

This is what has happened with the coronavirus. With today’s globalization, international travel, and an increasing number of pandemics, attempting to keep infectious disease from ever entering the country looks more and more like a futile effort.

Moreover, the U.S. preoccupation with border controls means we did not invest as much as we should have in limiting the internal spread of COVID-19. Unlike countries that mounted an effective response, the U.S. has lagged behind in testing, contact tracing, and the development of a robust health care system able to handle a surge of infected patients. The longstanding focus on stopping an outbreak from ever occurring left us more vulnerable when it inevitably did.

For decades, the U.S. has been underfunding public health. When “swine flu” struck the country in 2009, the CDC said 159 million doses of flu shots were needed to cover “high risk” groups, particularly health care workers and pregnant women. We only produced 32 million doses. And in a pronouncement that now looks prescient, a Robert Wood Johnson Foundation report said if the swine flu outbreak had been any worse, U.S. health departments would have been overwhelmed. By the time Ebola appeared in 2014, the situation was no better. Once again, multiple government reports slammed our response to the outbreak.

Many causes exist for the U.S.‘s failed response to this crisis. But part of the problem lies with our past battles with disease. By emphasizing border controls and quarantine, the U.S. has disregarded more practical strategies of disease control. We can’t change the past, but by learning from it, we can develop more effective ways of dealing with future outbreaks.

 

 

 

 

Six months ago, Trump said that coronavirus cases would soon go to zero. They … didn’t.

Posted on by • Posted in 2020 Election Issues, Asymptomatic Transmission, Blame, Centers for Disease Control & Prevention (CDC), Clinical Testing, Coronavirus, Credibility, Crisis, Crisis Management, Emergency Preparedness, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Expert, Expert Opinion, Failed, Failed Repeatedly, Failure, False Hope, False Narrative, Honesty, Integrity, Misinformation, Misinterpret, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Mortality, National Strategy, Pandemic, Public Health, Public Opinion, Public Perception, Public Safety, Public Schools, Public Trust, Quarantine, School Reopening, Scientists, Social Distancing, Wishful Thinking • Leave a comment

https://www.washingtonpost.com/politics/2020/08/26/six-months-ago-trump-said-that-coronavirus-cases-would-soon-go-zero-they-didnt/?utm_campaign=wp_main&utm_medium=social&utm_source=facebook&fbclid=IwAR2-yqYYel73YR3zJXfqtn25DXNEA8Yi1qc0L0RQ3PNP-NqUJ299PFNdeWc

 

But with new constraints on testing, Trump may get his wish eventually.

It was exactly six months ago Wednesday when the spread of the coronavirus in the United States had become too significant for President Trump to wave away. He and several members of the team planning the administration’s response held a news briefing designed to inform the public about the virus and, more important, to allay concerns.

This was the briefing in which Trump made one of his most wildly incorrect assertions about what the country could expect.

“The level that we’ve had in our country is very low,” Trump said, referring to new confirmed infections, “and those people are getting better, or we think that in almost all cases they’re better, or getting. We have a total of 15. We took in some from Japan — you heard about that — because they’re American citizens, and they’re in quarantine.”

That part was generally true. At the time, there had been only a smattering of confirmed cases, with the addition of passengers from the cruise ship Diamond Princess pushing the confirmed total to more than 50.

“So, again,” he added later, “when you have 15 people, and the 15 within a couple of days is going to be down to close to zero, that’s a pretty good job we’ve done.”

It was a brash prediction and seemingly an off-the-cuff one. Trump’s point was less about what was going to happen than arguing that his administration had done a good job. But by linking those two things, he made it simple for observers to use his assertion that the number of cases would fade as a baseline for measuring everything that followed.

Over time, more cases from the period before Feb. 26 would be discovered, including two early deaths in California from covid-19, the disease caused by the virus. There were actually almost 200 cases that would eventually be confirmed by the time Trump was saying the country would go from 15 to zero.

The experts standing behind Trump would have known that Trump’s claims were inaccurate. As the briefing was underway, The Washington Post reported a confirmed case of “community spread” — a documented infection that couldn’t be traced to international travel. In other words, it was uncontained: The virus was moving from person to person without impediment or detection.

Although about 200 cases in that period eventually would be confirmed, even that number was far lower than the reality. Researchers can use documented cases to estimate the number of cases that weren’t being detected and that also weren’t later confirmed through testing. For example, an estimate produced by data scientist Youyang Gu puts the likely number of new infections on Feb. 26 somewhere in the range of 13,000 to 25,000.

On that day alone.

Within a month, the country would go from Trump’s 15 cases to nearly 88,000 cases. By April 26, the total was nearly a million. By May 26, 1.7 million. The most recent total is north of 5.7 million.

That steady increase is in part a function of Trump repeating the same mistake over and over, portraying the pandemic as ending or functionally ended. As cases faded a bit in May and June, he pushed for a return to normal economic activity, triggering a new surge in confirmed cases. That second increase has been fading for about a month, happily, but the country is still adding 33 percent more confirmed new cases each day than it did at the peak in April.

That’s confirmed cases, a metric that relies on testing. Gu’s estimates of the actual spread of the virus put the country about 40 percent below the peak in daily new cases, which was reached in early July.

Trump, of course, blames testing for revealing the scale of the pandemic in the first place. He has a point, in a way: Had the United States never managed to solve its problems with testing, something that took weeks, there wouldn’t have been millions of confirmed cases. There would still have been millions of cases or, perhaps, tens of millions of cases. We just wouldn’t have known how many there were.

It has been about two months since Trump held a political rally in Tulsa, contributing to a new surge of cases in the city. There, he made a tongue-in-cheek reference to asking his team to slow down on testing, because it was pushing the number of confirmed cases higher. As they say, though, each joke contains a grain of truth, and it was clear that Trump, in fact, would be happy to see the number of tests drop so that the number of confirmed cases did as well.

Data compiled by the COVID Tracking Project show that he has gotten his wish, to a degree. Over the past month, the number of tests being completed each day in the United States has dropped by nearly one-fifth.

Part of this is a function of interference from natural disasters, with storms in Florida and fires in California limiting testing capacity. Part of it, too, is probably a function of the drop in the number of cases coming back positive. Fewer new cases means fewer people feeling sick and seeking tests to confirm an infection. The drop in the percent of tests coming back positive reinforces that trend.

But, increasingly, part of it will stem from the administration de-emphasizing testing. New guidance published by the Centers for Disease Control and Prevention suggested that those who had been in contact with an infected person no longer needed to be tested, particularly when asymptomatic.

This, too, has been something Trump has talked about a lot, complaining that people without symptoms were being tested and confirmed as positive — and added to the total number of infections.

“Many of those cases are young people that would heal in a day,” Trump said in an interview on July 19. “They have the sniffles and we put it down as a test.”

The reason it’s important to track asymptomatic cases, of course, is that those people can still infect others. To defeat the pandemic, we need to contain it, and the new CDC approach runs the significant risk of leaving large holes in that containment effort. But, with the presidential election only about 70 days away, it will mean fewer confirmed cases.

The irony of Trump’s complaints about the virus from the outset is that the United States’ confirmed infection totals already have been minimized because of limited testing. The reason Trump was able to claim that there were only 15 cases six months ago was that the administration had spent the month since the first confirmed case in the country unable to put together a robust testing regimen that would allow the virus to be constrained. South Korea, where such a regimen was quickly implemented, actually did see its virus numbers drop to near zero.

In other words, Trump’s prediction was not only wrong, it was wrong in large part because Trump’s team hadn’t done what would have been needed to make it come true. Trump portrays himself as an unwitting victim of the pandemic, but his comment six months ago Wednesday is a good reminder that he can put a lot of the blame for his position on himself.

 

 

 

Cartoon – The Vagueness Campaign

Posted on by • 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

The Dilbert Strip for September 27, 2012: Social Media Expert This ...

FDA chief apologizes for overstating plasma effect on virus

Posted on by • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Coronavirus, Coronavirus Treatment, Credibility, Economic Crisis, False Hope, False Narrative, Food and Drug Administration (FDA), Honesty, Integrity, Misinformation, Misinterpret, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Scientists, Trust, Truth, Unproven, Vaccine, Wishful Thinking • Leave a comment

https://abcnews.go.com/Health/wireStory/fda-commissioner-overstated-effects-virus-therapy-72595122?fbclid=IwAR3Um3rVuom9rJNCOvccmmTBDOrrRePEu1BX1VgRvAzYbpL2NATGjY2-1IY

FDA chief apologizes for overstating plasma effect on virus

Food and Drug Administration Commissioner Stephen Hahn is apologizing for overstating the life-saving benefits of using convalescent plasma to treat COVID-19 patients.

Responding to an outcry from medical experts, Food and Drug Administration Commissioner Stephen Hahn on Tuesday apologized for overstating the life-saving benefits of treating COVID-19 patients with convalescent plasma.

Scientists and medical experts have been pushing back against the claims about the treatment since President Donald Trump’s announcement on Sunday that the FDA had decided to issue emergency authorization for convalescent plasma, taken from patients who have recovered from the coronavirus and rich in disease-fighting antibodies.

Trump hailed the decision as a historic breakthrough even though the treatment’s value has not been established. The announcement on the eve of Trump’s Republican National Convention raised suspicions that it was politically motivated to offset critics of the president’s handling of the pandemic.

Hahn had echoed Trump in saying that 35 more people out of 100 would survive the coronavirus if they were treated with the plasma. That claim vastly overstated preliminary findings of Mayo Clinic observations.

Hahn’s mea culpa comes at a critical moment for the FDA which, under intense pressure from the White House, is responsible for deciding whether upcoming vaccines are safe and effective in preventing COVID-19.

The 35% figure drew condemnation from other scientists and some former FDA officials, who called on Hahn to correct the record.

“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 tweeted.

The FDA made the decision based on data the Mayo Clinic collected from hospitals around the country that were using plasma on patients in wildly varying ways — and there was no comparison group of untreated patients, meaning no conclusions can be drawn about overall survival. People who received plasma with the highest levels of antibodies fared better than those given plasma with fewer antibodies, and those treated sooner after diagnosis fared better than those treated later.

Hahn and other Trump administration officials presented the difference as an absolute survival benefit, rather than a relative difference between two treatment groups. Former FDA officials said the misstatement was inexcusable, particularly for a cancer specialist like Hahn.

“It’s extraordinary to me that a person involved in clinical trials could make that mistake,” said Dr. Peter Lurie, a former FDA official under the Obama administration who now leads the nonprofit Center for Science in the Public Interest. “It’s mind-boggling.”

The 35% benefit was repeated by Health and Human Services Secretary Alex Azar at Sunday’s briefing and promoted on Twitter by the FDA’s communication staff. The number did not appear in FDA’s official letter justifying the emergency authorization.

Hahn has been working to bolster confidence in the agency’s scientific process, stating in interviews and articles that the FDA will only approve a vaccine that meets preset standards for safety and efficacy.

Lawrence Gostin of Georgetown University said Hahn’s performance Sunday undermined those efforts.

“I think the integrity of the FDA took a hit, if I were Stephen Hahn I would not have appeared at such a political show,” said Gostin, a public health attorney.

Hahn pushed back Tuesday morning against suggestions that the plasma announcement was timed to boost Trump ahead of the Republican convention.

“The professionals and the scientists at FDA independently made this decision, and I completely support them,” Hahn said, appearing on “CBS This Morning.”

Trump has recently accused some FDA staff, without evidence, of deliberately holding up new treatments “for political reasons.” And Trump’s chief of staff, Mark Meadows, said over the weekend that FDA scientists “need to feel the heat.”

The administration has sunk vast resources into the race for a vaccine, and Trump aides have been hoping that swift progress could help the president ahead of November’s election.

At Sunday’s briefing Hahn did not correct Trump’s description of the regulatory move as a “breakthrough.” He also did not contradict Trump’s unsupported claim of a “deep state” effort at the agency working to slow down approvals.

Former FDA officials said the political pressure and attacks against the FDA carry enormous risk of undermining trust in the agency just when it’s needed most. A vaccine will only be effective against the virus if it is widely taken by the U.S. population.

“I think the constant pressure, the name-calling, the perception that decisions are made under pressure is damaging,” said Dr. Jesse Goodman of Georgetown University, who previously served as FDA’s chief scientist. “We need the American people to have full confidence that medicines and vaccines are safe.”

Convalescent plasma is a century-old approach to treating the flu, measles and other viruses. But the evidence so far has not been conclusive about whether it works, when to administer it and what dose is needed.

The FDA emergency authorization is expected to increase its availability to additional hospitals. But more than 70,000 Americans have already received the therapy under FDA’s “expanded access” program. That program tracks patients’ response, but cannot prove whether the plasma played a role in their recovery.

Some scientists worry the broadened FDA access to the treatment will make it harder to complete studies of whether the treatment actually works. Those studies require randomizing patients to either receive plasma or a dummy infusion.

 

 

 

Cartoon – Pandemic Stages of Grief

Posted on by • Posted in 2020 Election Issues, Angry, Cartoon, Clinical Testing, Contact Tracing, Coronavirus, Denial, Depression, Economic Crisis, Economic Recovery, False Hope, False Narrative, Infection Control, Infection Control Plan, Infectious Virus, Misinformation, Misinterpret, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Mortality, National Strategy, Pandemic, Personal Protective Equipment (PPE), Public Health, Public Opinion, Public Perception, Public Safety, Public Schools, Quarantine, School Reopening, Scientists, Social Distancing • Leave a comment

Cartoon by Sally-Covid 19 Pandemic Stages of Grief |

Cartoon – Covid Facts Don’t Matter

Posted on by • Posted in 2020 Election Issues, Cartoon, Coronavirus, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Expert, Expert Opinion, Fact-Denying Populism, Facts, False Hope, False Narrative, Infection Control, Infection Control Plan, Infectious Virus, Misinformation, Misinterpret, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Mortality, National Strategy, Pandemic, Partisanship, Public Health, Public Opinion, Public Perception, Public Safety, Public Schools, Public Trust, Quarantine, School Reopening, Scientists, Social Distancing, Wishful Thinking • Leave a comment

Facts Don't Matter (cncartoons033663-514) | Speak Up For Success

South Korea Warns Covid-19 Back In ‘Full Swing’ After Week-Long Case Spike

Posted on by • Posted in 2020 Election Issues, Clinical Testing, Contact Tracing, Coronavirus, Crisis, Crisis Management, Economic Crisis, Economic Recovery, Economy Reopening, False Hope, False Narrative, Infection Control, Infection Control Plan, Infectious Virus, Leadership Decentralized, Mortality, National Strategy, Pandemic, Public Health, Public Opinion, Public Perception, Public Schools, Public Trust, Quarantine, School Reopening, Scientists, Social Distancing • Leave a comment

https://www.forbes.com/sites/alisondurkee/2020/08/20/south-korea-warns-covid-19-back-in-full-swing-after-week-long-case-spike

South Korea Warns Covid-19 Back In 'Full Swing' After Week-Long ...

TOPLINE

South Korea officials warned Thursday that the country is in a “grave situation” after Covid-19 cases rose by triple digits for a week straight, as one of the countries most hailed for its success in containing the coronavirus sees a new resurgence of the virus linked to a far-right church and anti-government protest.

 

KEY FACTS

South Korea added 288 Covid-19 cases Thursday—slightly down from 297 cases Wednesday, the highest number observed in the country since March 8.

“Consider the COVID-19 pandemic now to be in full-swing,” Korea Centers for Disease Control and Prevention deputy director Kwon Jun-wook said, warning that the country could experience similar sustained outbreaks to the U.S. and Europe without aggressive contact tracing.

The new case spikes are largely tied to Sarang Jeil Church, which has been linked to 676 recent cases, and a large anti-government rally held in Seoul Saturday in which many church members participated.

The outbreak is the second time a church has been linked to a large outbreak in the country—5,200 cases in February and March were linked to the Shincheonji Church of Jesus—but officials warn this one has the potential to be worse, and the New York Times notes anti-government sentiment among the church’s members may make efforts to contain the virus more difficult.

South Korean President Moon Jae-in has shut down churches in the country in response to the new outbreak, sparking a broader controversy as conservatives accuse the government of infringing on religious freedoms.

South Korea has been hailed for its effective response to the coronavirus, and was previously able to curb the Shincheonji church outbreak through widespread testing, self-isolation orders and contact tracing.

 

CRUCIAL QUOTE

“We are standing on the cusp of the nationwide outbreak,” Kwon said at a briefing Thursday. “The wider capital region should brace for a massive wave of the outbreak.”

 

BIG NUMBER

16,346: The total number of Covid-19 cases in South Korea since the start of the pandemic, as reported by Johns Hopkins University.

 

KEY BACKGROUND

South Korea is one of many countries to see a worrying resurgence of Covid-19 in recent weeks, as Europe and countries that had successfully contained the virus see new spikes.

Spain and Italy posted new Covid-19 case number highs Wednesday, while France reported Wednesday that it had recorded new Covid-19 cases at the highest rate since May.

Germany reported its highest case count since April on Thursday, with 1,707 new cases.

Outside of Europe, India experienced its highest daily total yet of new Covid-19 cases Thursday—69,672 cases, also the fourth highest daily total reported globally—while Japan reported that more than a third of its 59,213 cases have been recorded since the start of August alone.

New Zealand, one of the countries that had most successfully contained the virus, went back into lockdown last week after seeing Covid-19 spread through community transmission for the first time in 102 days; the outbreak has so far resulted in 80 new cases.

 

 

 

 

Op-Ed: American Exceptionalism or American Insanity?

Posted on by • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Coronavirus, Coronavirus Treatment, False Hope, False Narrative, Hydroxychloroquine, Judgement, Misinformation, Misinterpret, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Pandemic, Panic, Panic Mindset, Physician, Public Health, Public Opinion, Public Perception, Public Safety, Scientists, Unnecessary Care, Wishful Thinking • Leave a comment

https://www.medpagetoday.com/infectiousdisease/covid19/88163?xid=nl_popmed_2020-08-20&eun=g885344d0r&utm_source=Sailthru&utm_medium=email&utm_campaign=PopMedicine_082020&utm_content=Final&utm_term=NL_Gen_Int_PopMedicine_Active

We don’t have all of the answers, but that’s not our biggest problem.

Thirty years ago, in preparation for hunting season, I went to a shooting range to practice with my bow. I felt fine. When I finished, I got in my truck and began to back out. When I pressed on the brake, I felt a sharp pain in my foot. My first instinct was to go over what I did walking back and forth to pull arrows from the target. Had I twisted my foot, did I trip on something? No, I had not injured my foot in any way.

When I got home, I took off my shoe and looked. My big toe was slightly swollen and slightly red. It looked like gout. I took ibuprofen. I was better by the next day. I never had another attack until this week.

I was at a friend’s house drinking wine. My knee suddenly began to hurt. I walk or jog 6-8 miles per day, so my first thought was that all the exercise was catching up to me. I took ibuprofen. It got better. But the next day my ankle suddenly became very painful; then my wrist hurt a bit. I remembered my experience with gout. I treated myself for gout, and got better.

I feel very fortunate to live in a time when gout can be easily treated. One hundred years ago, I would have been in big trouble. Which is not to say that I would not have taken medicine in an attempt to get relief. I would have tried a variety of products that claimed to help but did no good.

Today, we can treat so many illnesses that were brutal and deadly in the past. A long time ago, all children with type 1 diabetes died. Today, we have effective therapy — insulin. When I was a resident in the early 1980s, we had no specific way of treating a heart attack. Today, we can place a stent and reverse the pathological process.

In the past, something as simple as poison ivy could make a person’s life miserable. Today, we can knock it out in a short time. Modern medicine can do amazing things. To a large extent, it can do these amazing things because of effective biomedical science.

However, it can’t cure everything. Nor can it beat death. The amazing accomplishments of the medical profession in the last 100 years seem to have led some to believe, or want to believe, that doctors can solve all medical problems. This belief system came to bear with the COVID-19 pandemic.

Many expected the medical profession to step up and solve the problem. When it didn’t, disappointment arose. Then accusations began to fly. Some claimed that there were conspiracies involving Big Pharma and doctors. Others claimed there were cures that were being suppressed by the government.

Some doctors and scientists responded to this by trying to appease. They turned to in vitro data — such as the zinc/hydroxychloroquine (HCQ) interaction — to claim that zinc and HCQ would work wonders. When other doctors and scientists pointed out flaws in that data, they were attacked. It was another conspiracy. I even heard accusations that this was a plot by Bill Gates for population control.

Some doctors also turned to poor, anecdotal trials with HCQ that supposedly showed benefit in a few patients. This led quite a few to believe that HCQ was a wonder drug. Once the exaggerations about HCQ came out, it could no longer be found in pharmacies. The panic was just that strong.

Everyone seemed to get caught up in the panic mindset, and then work under the notion that a lack of clear medical success just can’t be possible in the 21st century. Many patients in intensive care units across the country were being put on HCQ, steroids, remdesivir, anti-IL-6 medication, vitamin C, and whatever else seemed like it might do something.

Many patients who were put on that medication cocktail died, because there was no legitimate science behind this approach — whether it helped was unclear.

However, over time, it became more clear that steroids helped. It became more clear that HCQ did not help. Such revelations led to more reasonable, though not entirely proven, therapeutic approaches. But because the less scientific approaches had so much hype in the beginning, and because the panic was so strong, getting away from them has been fraught with problems and accusations, and even physical threats.

Sadly, some of these accusations and threats were fueled by irresponsible doctors in academic medical centers. Misinformation was fed to the public, and the public, being not well-versed in biomedical research, latched onto the credentials of these doctors rather than seeing through their hysterical and misguided arguments about HCQ and such.

The internet and the free flow of information allows many who don’t really understand the ins and outs of biomedical research and clinical medicine to read something that sounds good and believe it because it satisfies psychological needs. This is a clear pattern of behavior when it comes to HCQ.

But it is not just irresponsible people in academic medical centers who contribute to this process. Doctors, many of whom post on medical blogs, accuse anyone who says we should slow down and evaluate our therapy of “wanting to do nothing” or “not caring about the thousands who are dying.” Even well-intentioned doctors get caught up in this need to seem like something is being done, and so they order all sorts of useless tests.

One such useless test being ordered more commonly in COVID patients is an MRI of the heart. One study in a few patients comes out that shows that COVID can affect the heart, and the next thing you know everybody with COVID needs a heart MRI. Whether the MRI is a reliable test for this is unclear. What we do with the information from the MRI is unclear. It just makes some doctors and some patients feel good to engage in such useless practices.

This pattern of behavior, the pattern of engaging in useless practices to give the appearance of care, is quite common in the profession of medicine. I find it interesting that it has not been challenged by progressives, like those so interested in the Green New Deal. The environmental harm done along these lines by misguided doctors might do as much or more environmental harm than fracking — but at least with fracking you get something to show for your efforts.

With out-of-control doctors, ordering useless tests, running MRI machines and CT scans, etc., day in and day out, without valid justifications, produces nothing useful — unless one believes that feeding hypochondriasis and feeding poor medical judgment is useful.

The profession of medicine accomplished great things in the 21st century. These great things came through American exceptionalism. They came through valid biomedical science. These amazing accomplishments led many to believe that the profession of medicine has all the answers.

But it doesn’t. The COVID pandemic has shown us that. I’m sorry that we can’t save everyone. It is tragic. But it will be more tragic if we let our limitations along these lines lead us into a dark place of anger, lack of reason, lack of valid science, and then on to invalid conspiracy theories.

American exceptionalism does not need to die because of COVID. Instead, what needs to die is a type of insanity that makes us think we have all the answers. What needs to die is a type of insanity that makes us think that if we don’t have all the answers, we have to turn to useless testing, unproven therapies, and futile care.

What needs to die is the turning to false prophets and conspiracy theories. The profession of medicine has proven that it can do a very good job combating illness.

Good doctors are trying hard to deal with and solve this pandemic. When a type of insanity gets in the way, it is a problem.

W. Robert Graham, MD, completed medical school and residency at UTHSC-Dallas (Parkland Hospital) and served as chief resident. Graham received a National Institutes of Health fellowship at the Salk Institute for oncogene research in 1985. He was a professor of medicine at Baylor College of Medicine from 1998 through 2016. In retirement, he enjoys writing and ranching.

 

 

 

 

New unemployment claims top 1 million. Again.

Posted on by • Posted in 2020 Election Issues, Coronavirus, Crisis, Crisis Management, Economic Crisis, Economic Stimulus, Employee Furlough, Employee Hiring Freeze, Employee Layoffs, Employee Pay Cuts, Employer-Based Health Insurance, Essential Health Benefits, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, False Hope, False Narrative, Infection Control, Infection Control Plan, Infectious Virus, Job, Job Loss, Job Market, Job Search, Job Security, Leadership Decentralized, Mixed Message, Mortality, National Strategy, Pandemic, Public Health, Public Opinion, Public Perception, Public Safety, Public Schools, Quarantine, School Reopening, Scientists, Social Distancing, Underinsured, Unemployment, Unemployment Insurance, Uninsured, Wishful Thinking • Leave a comment

https://www.washingtonpost.com/business/2020/08/20/august-unemployment-claims/?wpmk=1&wpisrc=al_business__alert-economy&utm_source=alert&utm_medium=email&utm_campaign=wp_news_alert_revere&location=alert&pwapi_token=eyJ0eXAiOiJKV1QiLCJhbGciOiJIUzI1NiJ9.eyJjb29raWVuYW1lIjoid3BfY3J0aWQiLCJpc3MiOiJDYXJ0YSIsImNvb2tpZXZhbHVlIjoiNWI2M2EzNDJhZGU0ZTI3Nzk1NTBjYTFiIiwidGFnIjoid3BfbmV3c19hbGVydF9yZXZlcmUiLCJ1cmwiOiJodHRwczovL3d3dy53YXNoaW5ndG9ucG9zdC5jb20vYnVzaW5lc3MvMjAyMC8wOC8yMC9hdWd1c3QtdW5lbXBsb3ltZW50LWNsYWltcy8_d3Btaz0xJndwaXNyYz1hbF9idXNpbmVzc19fYWxlcnQtZWNvbm9teSZ1dG1fc291cmNlPWFsZXJ0JnV0bV9tZWRpdW09ZW1haWwmdXRtX2NhbXBhaWduPXdwX25ld3NfYWxlcnRfcmV2ZXJlJmxvY2F0aW9uPWFsZXJ0In0.ns8VggWJk95qb-c_2926acWIaHxyFIBXSRn76O7Lrf0

The number of people applying for the first time for unemployment insurance ticked up last week to 1.1 million, from 970,000 the week before, a sign that job losses continue to plague the labor market five months into the coronavirus pandemic.

The weekly jobless claims had sunk slowly in recent months but have remained well above historical highs, averaging about 1.18 million a week for the last four weeks. Economists had predicted last week’s figure to approach the numbers from the previous week, which had fallen below 1 million for the first time in about five months.

Instead, the initial claims and new claims for Pandemic Unemployment Assistance, the program available to gig and self-employed workers, both went up. About 543,000 new claims were filed for PUA for the week that ended on Aug. 15, up from 488,000 the week before.

“The fact that the claims are so high this far into the crisis is concerning,” said AnnElizabeth Konkel, an economist at the job site Indeed. “Yet the depths of the damage remain to be seen. I would definitely call it a canary raising alarms in the economic coal mine.”

Data shows the number of job postings slowly recovering in recent weeks, compared with postings from the year prior. However, last week, postings took a turn for the worse. They had been running about 18 percent below normal and fell to 20.3 percent below normal last week.

“The longer we go into this crisis, the longer people that have been temporarily laid off may not get called back,” Konkel said. “Businesses can only ride out this crisis for so long.”

More than 28 million people were receiving some form of unemployment benefits as of Aug. 1, the most recent week for that statistic, about equal to the previous week.

Job loss from the pandemic remains a singular crisis, without comparison in modern times. The country’s unemployment rate, last calculated in July, was 10.2 percent, and economists have warned that it could go up in August as the virus continues to alter life around the country.

The extra $600 in unemployment benefits that many workers credit with keeping them afloat expired at the end of July. And funds from the $660 billion PPP program, which gave grants and loans to companies to keep workers on payroll, have been running out for many recipients.

Companies announcing layoffs in recent days include Wieland Copper Products, in North Carolina, a Mohegan Sun casino in Wilkes-Barre, Pa., Amsterdam Printing & Litho, a printing company in Upstate, N.Y., and Ohio sales and marketing company Maritz. School districts and local governments are also beginning to experience deep cuts: New York Mayor Bill de Blasio (D) warned last week that as many as 22,000 city workers faced possible layoffs in the fall.