Category Archives: Public Safety

Sturgis Motorcycle Rally Is Now Linked to More Than 250,000 Coronavirus Cases

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Sturgis Motorcycle Rally Is Now Linked to More Than 250,000 Coronavirus Cases

Sturgis Motorcycle Rally Is Now Linked to More Than 250,000 Coronavirus Cases – Mother Jones

One study estimates the public health cost of the super-spreading event is near $12 billion.

The inevitable fallout from last month’s Sturgis Motorcycle Rally, an annual event that packed nearly 500,000 people into a small town in South Dakota, is becoming clear, and the emerging picture is grim.

According to a new study, which tracked anonymized cellphone data from the rally, over 250,000 coronavirus cases have now been tied to the 10-day event, one of the largest to be held since the start of the pandemic. It drew motorcycle enthusiasts from around the country, many of whom were seen without face coverings inside crowded bars, restaurants, and other indoor establishments.

The explosion in cases, the study from the Germany-based IZA Institute of Labor Economics finds, is expected to reach $12 billion in public health costs.

“The Sturgis Motorcycle Rally represents a situation where many of the ‘worst-case scenarios’ for super-spreading occurred simultaneously,” the researchers wrote, “the event was prolonged, included individuals packed closely together, involved a large out-of-town population, and had low compliance with recommended infection countermeasures such as the use of masks.”

The conclusion, while staggering, is unlikely to surprise to public health officials who warned that proceeding with the rally could be disastrous, particularly given the region’s relaxed attitude towards social distancing guidelines and some of the attendees’ mockery of the pandemic. “Screw COVID. I went to Sturgis,” read one t-shirt from the rally, where overwhelming support for President Trump was the norm.

The study comes on the heels of the first reported death from the event, a Minnesota man in his 60’s who attended the rally who died last week. South Dakota now has one of the country’s highest rates of coronavirus cases. 

 

 

 

 

Cartoon – State of the Union: Thank You All for Coming

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Medical Conferences Cartoons and Comics - funny pictures from CartoonStock

Cartoon – Federal Coronavirus Testing Guidelines

Posted on by • Posted in 2020 Election Issues, Cartoon, Centers for Disease Control & Prevention (CDC), Clinical Testing, Coronavirus, Crisis, Crisis Management, Don't Ask Don't Tell, False Hope, False Narrative, 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, Scientists, Silencing, Silencing Speech, Social Distancing • Leave a comment

This company boasted to Trump about its COVID-19 vaccine. Experts are skeptical. - Hartford Courant

Cartoon – Something that would greatly Prevent Covid 19

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U.S. sets record for new coronavirus cases, surpassing 53,000 - The Washington Post

Cartoon – Federal Coronavirus Response

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10 Dilbert Cartoons That Get Project Management Just Right

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

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

Analysis: Trump administration's coronavirus advice is secret, fragmented and contradictory – Center for Public Integrity

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.

 

 

Covid-19 has killed more police officers this year than all other causes combined, data shows

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https://www.washingtonpost.com/business/2020/09/02/coronavirus-deaths-police-officers-2020/?utm_campaign=wp_main&utm_medium=social&utm_source=facebook&fbclid=IwAR3KWZcuMmVXy_R7mDh_m58_BLdQkz6rw5iU9nsii950Bx46lwc0nbfC3p4

By one estimate, coronavirus deaths among law enforcement are likely to surpass those of 9/11.

In a speech this week in Pittsburgh, Joe Biden linked the Trump administration’s mismanagement of the coronavirus to its handling of protests and riots with a surprising statistic: “More cops have died from covid this year than have been killed on patrol,” he said.

The Democratic presidential nominee’s claim is true, according to data compiled by the Officer Down Memorial Page and the National Law Enforcement Officers Memorial Fund, two nonprofits that have tracked law enforcement fatalities for decades.

As of Sept. 2, on-the-job coronavirus infections were responsible for a least 100 officer deaths, more than gun violence, car accidents and all other causes combined, according to the Officer Down group. NLEOMF reported a nearly identical number of covid-related law enforcement deaths.

NLEOMF reported a nearly identical number of covid-related law enforcement deaths. It also noted that fatalities due to non-covid causes are actually down year-over-year, undermining President Trump’s claims that “law enforcement has become the target of a dangerous assault by the radical left.”

Both organizations only count covid deaths “if it is determined that the officer died as a result of exposure to the virus while performing official duties,” as the National Law Enforcement Officers Memorial Fund put it. “Substantive evidence will be required to show the death was more than likely due to the direct and proximate result of a duty-related incident.”

In addition to the 100 confirmed coronavirus fatalities listed on the Officer Down website, the nonprofit said it is in the process of verifying an additional 150 officer deaths due to covid-19 and presumed to have been contracted in the line of duty, said Chris Cosgriff, executive director of ODMP, in an email.

“By the end of this pandemic, it is very likely that COVID will surpass 9/11 as the single largest incident cause of death for law enforcement officers,” he wrote. Seventy-one officers were killed in the attacks on the twin towers, one officer was killed on United Flight 93, and more than 300 have passed away since then as a result of cancer contracted in the wake of the attacks, according to ODMP.

At the state level, Texas stands out for having the highest number of law enforcement covid fatalities with at least 21, according to NLEOMF. At least 16 of those represent officers with the Texas Department of Criminal Justice, which manages the state’s correctional facilities. Louisiana has 12 covid-related officer deaths. Florida, New Jersey and Illinois round out the top five with eight each.

According to both organizations, officers in correctional facilities account for a substantial number of covid-related law enforcement deaths, reflecting the dire epidemiological situation in many of the nation’s prisons and jails.

“Corrections officers and Corrections Departments have been hit harder than regular police agencies,” Cosgriff said. According to the Marshall Project, a nonprofit criminal justice news site, more than 100,000 U.S. prison inmates have tested positive for coronavirus and at least 928 have died. There have been an additional 24,000 cases and 72 deaths among prison staff.

ODMP’s tally includes police officers, sheriff’s deputies, correctional officers, federal law enforcement officers and military police officers killed outside of military conflict. NLEOMF’s inclusion criteria are similar.

This year, Trump signed the Safeguarding America’s First Responders Act of 2020, which guarantees law enforcement officers and their survivors federal benefits if the officer is killed or disabled by covid. For legal purposes, the legislation presumes that covid cases among officers were contracted in the line of duty.

 

 

 

 

Unemployment Claims Are ‘Stubbornly High’ as Layoffs Persist

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Rise in Unemployment Claims Signals an Economic Reversal - The New York Times

Just over one million Americans filed new claims for state jobless benefits last week, the latest sign that the economy is losing momentum just as federal aid to the unemployed has been pulled away.

Weekly claims briefly dipped below the one million mark early this month, offering a glimmer of hope in an otherwise gloomy job market. But filings jumped to 1.1 million the next week, and stayed above one million last week, the Labor Department said Thursday.

“It’s devastating how stubbornly high initial claims are,” said Julia Pollak, a labor economist at the employment site ZipRecruiter. “There are still huge numbers of layoffs taking place.”

Another 608,000 people filed for benefits under the federal Pandemic Unemployment Assistance program, which offers aid to independent contractors, self-employed workers and others not covered by regular state programs. That number, unlike the figures for state claims, is not seasonally adjusted.

Other recent indicators also suggest that the recovery is faltering. Job growth slowed in July, and real-time data from private-sector sources suggests that hiring has slumped further in August. On Tuesday, American Airlines said it will furlough 19,000 workers on Oct. 1, the latest in a string of such announcements from major corporations.

“It is worrying because it does signal that these large companies are pessimistic about the state of the recovery and don’t think that we are going to be returning to normal anytime soon,” said Daniel Zhao, senior economist at the career site Glassdoor.

Unemployment filings have fallen sharply since early April, when 6.6 million applied for benefits in a single week. But even after that decline, weekly filings far exceed any previous period. Close to 30 million Americans are receiving benefits under various state and federal programs.

The rate of job losses remains high as government support for the unemployed is waning. A $600-a-week federal supplement to state unemployment benefits expired at the end of July, and efforts to replace it have stalled in Congress. President Trump announced this month that he was using his executive authority to give jobless workers an additional $300 or $400 a week, but few states have begun paying out the new benefit.

Economists warn that the loss of federal support could act as a brake on the recovery. Nancy Vanden Houten, lead economist for the forecasting firm Oxford Economics, estimated that the lapse in extra unemployment benefits would reduce household income by $45 billion in August. That could lead to a drop in consumer spending and further layoffs, she said.

The benefit initiated by Mr. Trump would use federal emergency funds to provide $300 a week in extra payments to most unemployed workers. (States can choose to chip in an additional $100 a week, but few are doing so.) As of Wednesday, 34 states had been approved for grants under the program, known as Lost Wages Assistance.

Arizona, the first state to turn the grants into payments, sent $252.6 million to about 400,000 recipients last week, a sum that included retroactive payments for the first two weeks of August. Texas this week has paid out $424 million and expects to deliver nearly $1 billion more to cover the first three weeks of benefits. A handful of other states are paying benefits or expect to begin doing so within days.

Most, however, said it could take until mid-September or later.

Once the money starts flowing, it may not last long. Mr. Trump’s order authorized spending up to $44 billion, which federal officials said last week would cover four or five weeks of payments. That means jobless workers in many states may receive a lump sum covering several weeks of retroactive benefits, but nothing more without congressional action.

A crowd thronged a temporary unemployment office in Kentucky in June. Adapting computer systems to new benefits has been a crucial factor in processing claims.

On the surface, the new lost wages program looks like the earlier $600-a-week federal supplement, just cut in half. But there are subtle differences: The program has a different funding source (the Federal Emergency Management Agency instead of the Labor Department) and new restrictions (people receiving less than $100 a week in regular benefits don’t qualify).

Those kinds of adjustments would be trivial on a modern computer system. But many state unemployment systems are running on computers that are anything but modern.

In Oklahoma, for example, the unemployment system uses a 40-year-old mainframe computer that turns even minor adjustments into a major programming task. As a result, even though the state was among the first to apply for the $300 benefit this month, it doesn’t expect to begin paying the new benefit until late September.

“The fact that I’m working with a mainframe from 1978 to process claims is just crippling to the agency,” said Shelley Zumwalt, interim executive director of the agency that oversees Oklahoma’s unemployment system. “We are just holding that system together with masking tape and chewing gum.”

When the pandemic hit, Arizona, too, was stuck with archaic computer systems. It built a new system virtually from scratch to begin paying out federally funded emergency benefits, and it was among the last states to do so.

But the approach left Arizona better able to handle curveballs like the new $300 benefit.

“Through that chaos, we created a pandemic unemployment system,” said Michael Wisehart, director of the Arizona Department of Economic Security.

Christy Miller says there are three things that shape her identity: making people laugh, making people strong and lifting heavy objects. She can’t do any of those right now, and she isn’t sure when she will be able to again.

Ms. Miller, 49, is a standup comedian in New York, where comedy clubs have been closed since March. She is also a personal trainer and an amateur power lifter — activities she has had to give up because gyms, too, remain closed in the city.

The $600-a-week supplement to her unemployment pay didn’t just allow her to pay rent and buy food. It also freed up the time and mental energy for her to learn video production, podcasting and other skills to help her survive the pandemic-driven shutdown of her industry.

“I would give up the $600 a week any day for this coronavirus to go away and get back to work,” she said. “But the $600 has allowed me not to be homeless, to learn more computer stuff that I never would have learned or had the time to learn.”

None of those ventures are producing much income yet, though. She saved as much of her unemployment benefits as she could, and has enough to cover rent through the end of the year. But other bills are another matter. And there is little guarantee that her business will bounce back before her savings run out.

“If they don’t fix this pandemic thing, I may have to leave New York because I can’t afford to stay here,” she said.

Kris Fusco is finally back at work. That doesn’t mean her coronavirus worries are behind her.

When Ms. Fusco’s employer — a small, family-owned business in Massachusetts that rents musical instruments to students — laid her off in March, she expected to be out of work for a couple of weeks. That got extended to April, then to June. Eventually one of the owners called her to tell her they didn’t know when they could reopen.

“I said, ‘You do what you need to do to keep your business afloat, and I’m just going to hold on as long as I can,’” she said. Fortunately, her employer called her back shortly after the $600 supplement expired. She returned to work last week, and, despite some nervousness about going into the office with the virus still spreading, she said she was grateful for the paycheck.

But Ms. Fusco, 50, doesn’t know how long her good fortune will last. With many schools still teaching remotely or canceling activities like band, she worries that her company’s business will suffer. Already, she has noticed a large number of instruments being returned.

“It’s very worrisome for me because I can see the snowball effect from Covid-19 all around me,” she said. “It’s always lurking right behind my eyeballs that in six months I might be out of a job again.”

 

 

 

Unemployed struggle to cover basic expenses following CARES expiration: poll

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Unemployed struggle to cover basic expenses following CARES expiration: poll

The number of jobless people saying that unemployment insurance does not cover basic expenses including food, clothing, housing and transportation nearly doubled after key benefits expired in July.

A new survey from Morning Consult found that 50 percent of unemployed people said their benefits fell short of covering basic expenses, up from 27 percent in July.

The $600 in extra weekly benefits that Congress passed in March expired at the end of July, leaving many with significantly lower payments.

Republicans argued the $600 increase was too high and discouraged people from returning to work. Democrats countered that at a time of record high unemployment and limited job openings, the extra pay was unlikely to prevent jobs from getting filled.

A month later, negotiations between the White House and congressional Democrats remain stalled. Senate Republicans are setting a goal of voting on a more limited package of COVID-19 relief measures next week, though Speaker Nancy Pelosi (D-Calif.) has dismissed the idea of approving a limited bill.

An executive order by President Trump to provide $300 in additional benefits to a more limited pool of recipients has lagged in implementation, with only a handful of states able to start making new payments.

In the meantime, the pandemic continues to stifle the economy.

A CNBC poll found that 14 percent of those surveyed had completely wiped out their emergency savings during the pandemic, and 39 percent were forced to take some sort of emergency measures to shore up their finances.

Among those who took emergency measures, 17 percent tapped into savings, 11 percent borrowed money, 6 percent stopped retirement contributions and 4 percent moved in with a family member.

 

 

 

 

 

What makes a Bad Vaccine?

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A Covid-19 vaccine, amazingly, is close. Why am I so worried?

A mere six months after identifying the SARS-CoV-2 virus as the cause of Covid-19, scientists are on the precipice of a having a vaccine to fight it. Moderna and the National Institutes of Health recently announced the start of a Phase 3 clinical trial, joining several others in a constructive rivalry that could save millions of lives.

It’s a truly impressive a feat and a testament to the power of basic and applied medical sciences. Under normal circumstances, vaccine approvals are measured in decades. Milestones that once took months or years have been achieved in days or weeks. If these efforts are successful, the Covid-19 vaccine could take a place alongside the Apollo missions as one of history’s greatest scientific achievements.

I’m optimistic. And yet, as someone who studies drug development, I want to temper expectations with a dose of realism and perhaps a bit of angst. Behind the proud declarations, many science and medical professionals have been whispering concerns. These whispers have escalated into a murmur. It’s time to cry them loudly:

Hey, Food and Drug Administration: Don’t be rash! Premature approval of a sub-standard Covid-19 vaccine could have dire implications, and not just for this pandemic. It could harm public health for years, if not generations, to come.

Unfortunately, elements now in place make such a disastrous outcome not only possible but in fact quite likely. Specifically, the FDA and its staff of chronically overworked and underappreciated regulators will face enormous public and political pressure to approve a vaccine. Whether or not one worries about an “October surprise” aimed at the upcoming election, regulators will be pressed hard. Some will stand firm. Some may resign in protest. But others could break and allow a bad vaccine to be released.

What makes a “bad vaccine”? Insufficient protection against the disease it is designed for, unwanted side effects, or some combination of the two. If an approved Covid-19 vaccine turns out to be ineffective, this could unintentionally promote wider spread of the disease by individuals who presume they were protected from it. Likewise, a negative experience with one vaccine might discourage the use of other vaccines that are far more safe and effective, whether they are for Covid-19 or other vaccine-preventable diseases.

Some things take time. Under normal circumstances, ensuring that a vaccine’s effects are safe and durable requires years of study and monitoring. And there is some evidence that natural immune responses to SARS-CoV-2 infection could be transient, making sustained investigation all the more necessary. A merely short-term effect could encourage vaccinated individuals to resume risky behaviors, which would all but guarantee that the epidemic endures. And if unintended side effects turn out to include, for instance, chronic inflammatory or autoimmune disease, a bad vaccine could impart lifelong damage.

But wait, there’s worse! A bad Covid-19 vaccine could further undermine confidence in the many safe, reliable vaccines already in our public health arsenal. Vaccine skepticism and anti-science bias, propagated by B-list celebrities and Russian troll farms, have been gaining strength all year. Combined with disappointing Covid-19 outcomes, such malign forces could facilitate the reemergence of once-vanquished foes — polio, measles, mumps, rubella, diphtheria, whooping cough, and tetanus — that once killed multitudes of children each year.

These are enormous risks. Placing all of our bets on a small set of untried vaccine technologies would be gobsmackingly foolish. Yet this is exactly what we are now doing. Most of the high-profile names capturing headlines are pursuing comparatively minor variations on a theme of genetic vaccines (those delivered via DNA or RNA). If one approach happens to work, the odds are higher the others will work as well. Disappointing results from one candidate, though, might presage failure across the board.

Rather than investing in a balanced portfolio of vaccines with different approaches — not to mention different therapies, devices, and diagnostics for treating Covid-19 — too many observers, too many companies, and too many governmental officials seem to be narrowly focused on hopes for a “savior” vaccine. Were that savior to fail, our national morale, already low, could plummet even further.

Don’t get me wrong. I, along with millions of Americans, want a Covid-19 vaccine. But we deserve one that’s been proven to be safe and effective.

It’s not too late to take a deep breath and devise a strategy to balance short- and long-term goals, including vaccination, improved diagnostics, and existing and novel treatments. We must support the FDA and hope that its scientists and physicians retain the strength and conviction to resist approving a substandard vaccine.

For encouragement, we should look to Frances Oldham Kelsey, a veritable patron saint of the FDA. In 1960, during her first month working for the agency, Kelsey was asked to approve a sedative called Kevadon, which had the potential to generate billions in revenue. Despite enormous pressure, Kelsey spotted a risk for toxicity and dug in her heels. She refused to rubber stamp the approval. Her actions saved the lives of countless babies. Kevadon, better known as thalidomide, proved to be one of the most dangerous and disfiguring drugs in history.

Kelsey passed away in 2015 at the age of 101. We must pray that her spirit inspires a new generation of FDA leaders with the courage to say, “No.”