Category Archives: Evidence-Based Plan

Cartoon – Gilligan’s Island

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Editorial cartoon (2): June 6, 2020 | The Daily Courier | Prescott, AZ

Cartoon – Containing Your Hot Spot?

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Editorial cartoons for Sunday, June 21 | HeraldNet.com

High numbers of Los Angeles patients complained about coughs as early as December, study says

Posted on by • Posted in 2020 Election Issues, Asymptomatic Transmission, Clinical Testing, Contact Tracing, Coronavirus, Crisis, Crisis Management, Emergency Preparedness, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Infection Control, Infection Control Plan, Infectious Virus, Leadership Decentralized, Mixed Message, Mortality, National Strategy, Pandemic, Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Quarantine, Scientists, Social Distancing • Leave a comment

https://www.washingtonpost.com/science/2020/09/10/los-angeles-patients-covid-coughing/?utm_campaign=wp_main&utm_medium=social&utm_source=facebook&fbclid=IwAR35fvTDN4Tq476ktGM0O8aIT3cvjVP1wP7I104tEQU3bRRgiLZs_nk6PYE

The number of patients complaining of coughs and respiratory illnesses surged at a sprawling Los Angeles medical system from late December through February, raising questions about whether the novel coronavirus was spreading earlier than thought, according to a study of electronic medical records.

The authors of the report, published Thursday in the Journal of Medical Internet Research, suggested that coronavirus infections may have caused this rise weeks before U.S. officials began warning the public about an outbreak. But the researchers cautioned that the results cannot prove that the pathogen reached California so soon, and other disease trackers expressed skepticism that the findings signaled an early arrival.

The debate about the findings underscores just how much remains to be known about the coronavirus, which has killed at least 187,000 people in the United States, according to a Washington Post analysis.

“This is consistent with the growing body of data that suggests that there’s been community spread much earlier than we had anticipated,” said study author Joann G. Elmore, a doctor and epidemiologist at the David Geffen School of Medicine at the University of California at Los Angeles.

The researchers examined six years of electronic health records, representing nearly 10 million patients, at the UCLA health system from July 2014 through February. That included patient visits to three UCLA hospitals and to nearly 200 associated outpatient clinics.

Health agencies have surveillance systems in place to detect the early signals of disease outbreaks, such as a rise in patients with fever checking into hospitals. But medical records were an under-tapped resource, Elmore said. “People weren’t paying attention to the outpatient setting,” she said.

The study authors searched outpatient and emergency department reports that used the word “cough,” and tallied the number of people hospitalized for acute respiratory failure.

That approach revealed an uptick in patients that began the week of Dec. 22 and remained elevated for 10 weeks. The number of extra people exceeded the researchers’ predictions by 50 percent, totaling about 1,000 more patients compared with the previous five flu seasons.

Influenza cannot be ruled out as a cause of the increase, Elmore said. “And, you know, we did see a bad bout of flu this year,” she said. But what gave her pause was the consistent, weeks-long trend found only in this most recent season and not others.

Some experts said they doubted that coronavirus infections were the likely cause of respiratory problems in California so far back in time. “The data countywide would suggest that it really began to spread in March,” said Brad Spellberg, chief medical officer at the Los Angeles County+USC Medical Center, who was not involved with the new research.

Although the virus may have infected a small number of people sooner than previously reported, Spellberg said he doubted that “meaningful transmission” occurred in December or January.

Using data from emergency departments that reported patients with flu-like illnesses, Spellberg and his colleagues observed two peaks in patients in December and February, as they reported in JAMA this spring.

Those increases were consistent with a severe flu season, Spellberg said. Los Angeles’s third spike in flu-like illnesses, this time caused by the coronavirus, came later.

What’s more, between March 2 and March 18, only 5 percent of 131 patients with flu-like illnesses tested positive for the coronavirus in the JAMA study. Spellberg said that if the virus had an earlier foothold in California, he would have expected that percentage to be higher. “You would have seen an explosion of cases,” he said.

Understanding how long the virus circulated within a population helps refine epidemiological models of transmission. Infectious-disease scientists and doctors in many pockets of the world are eager to uncover when the coronavirus first spread outside of China.

In late December 2019, Chinese health officials identified clusters of viral pneumonia in Wuhan. Researchers sequenced the culprit’s genome, describing the new coronavirus strain, in early January. The first officially reported U.S. case of coronavirus, a man who traveled home from Wuhan, occurred two weeks later.

A few observations indicate that the virus may have traveled farther, earlier, before it flared into a global pandemic. A study of Italian sewage revealed traces of the virus in December. When researchers retested a nasal swab from a man hospitalized near Paris dating to Dec. 27, they detected the coronavirus.

Genetic sequencing of coronavirus samples in New York suggests that the virus was spreading there by the end of January. In April, two autopsies in Santa Clara County, Calif., pushed back the first U.S. covid-19 deaths from late to early February.

Study author Judith Currier, a UCLA infectious-disease physician, said that when it comes to people who wonder whether they were exposed to the virus many months ago, she does not recommend “antibody testing for people who never had a symptomatic illness,” citing guidelines from the Centers for Disease Control and Prevention.

“If someone had a compatible clinical illness but never had testing for covid during that time, antibody testing could help to confirm,” she said. “Although we don’t know how long the antibodies last, so it would not be definitive.”

 

 

 

 

Major coronavirus vaccine trial is paused to investigate unexplained illness

Posted on by • Posted in 2020 Election Issues, Clinical Research, Coronavirus, Election, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Food and Drug Administration (FDA), National Institute of Health (NIH), Pharmaceutical Industry, Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Scientists, Vaccine • Leave a comment

https://www.washingtonpost.com/health/2020/09/09/astrazeneca-covid-vaccine-safety-trial/?utm_campaign=wp_main&utm_medium=social&utm_source=facebook&fbclid=IwAR2gomNZclHdUubRHKRqa3u5a6b06VEM2-wwNYFHitq9pK8_5ya8XflTFI0

The halt shows that safety protections are working, experts say

A major coronavirus vaccine trial is on hold as an independent committee investigates whether a case of spinal inflammation in a single British participant is linked to the vaccine — a step that several experts said is a sign of the protections in place to ensure the safety of products ultimately used in millions of healthy people.

The hold on human testing of the vaccine candidate being developed by the pharmaceutical company AstraZeneca and the University of Oxford was confirmed by the company in a statement Tuesday evening, calling it a “routine action.”

“The announcement yesterday about the AstraZeneca vaccine is a concrete example of how even a single case of an unexpected illness is sufficient to require a clinical hold for the trial in multiple counties,” said Francis Collins, director of the National Institutes of Health, at a Senate hearing.

The announcement comes as scientists and a growing numbers of Americans express concern about the politicization of the vaccine approval process during a presidential election campaign. President Trump has made approval of a coronavirus vaccine a cornerstone of his campaign and repeatedly said it could be greenlighted before the Nov. 3 election.

But Collins and other scientists pointed to AstraZeneca’s decision as evidence that scientists, rather than politicians, are running the process. The experts said that it was hard to estimate how long the investigation would take, but that the pause was a good sign and not unexpected in trials of this size and scale, where many thousands of people are closely followed.

Collins testified that while minimal information is available about the adverse event, he has heard it described as transverse myelitis, rare inflammation of the spinal cord that has been associated with vaccinations, but has also been documented in a few cases of covid-19 and can occur in immune system disorders such as multiple sclerosis.

A study in the journal Lupus reported that between 1970 and 2009, there were 37 cases of transverse myelitis associated with various vaccines.

“The event is being investigated by an independent committee, and it is too early to conclude the specific diagnosis,” said AstraZeneca spokesman Brendan McEvoy.

Serious adverse events are closely monitored in clinical trials to determine whether they are likely to be linked to the drug or vaccine being administered. In trials with many thousands of people, sicknesses are likely to occur, and they may have no connection to the drug or vaccine being tested.

Collins also said he was not worried that the delay or even possible elimination of the AstraZeneca vaccine candidate would limit the eventual availability of vaccines to Americans.

“The reason we’re investing not in one, but in six different vaccines is because of the expectation that they won’t all work,” he told members of the Senate Health, Education, Labor and Pensions Committee.

“To have a clinical hold as has been placed on AstraZeneca as of yesterday because of a single serious adverse effect is not at all unprecedented,” Collins said.

He said that if after a thorough investigation, the adverse reaction is traced back to the vaccine candidate, then all the doses of that vaccine being manufactured would be thrown away. The United States has committed up to $1.2 billion to AstraZeneca to support development of the vaccine and to purchase 300 million doses.

A hold on a trial is not common, but is also not cause for alarm — it is a sign the system in place to protect participants is working, said Susan Ellenberg, a biostatistician at the University of Pennsylvania who has served on the independent data safety monitoring boards that investigate such incidents.

“The process is when something unusual develops, they might want to put a hold on things — and given the incredible attention that’s being given to these vaccines, and the recognition of how fast we’re trying to go, I think people are bending over backwards to show safety is really the top priority,” Ellenberg said.

This is the second pause for the trial. An information sheet for study participants from July noted that the trial had been put on hold after a participant developed neurological symptoms, but those were determined to be caused by an “unrelated neurological illness.”

“I think the company is being prudent to stop and look and to determine whether this severe adverse event, whatever it is, was a coincidence that followed vaccination, or was caused by the vaccine,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “The vaccine is designed to prevent covid-19, not everything else” that adults might develop.

The pause came a day after the leaders of nine drug companies signed a highly unusual pledge that they would be guided by science and prioritize safety in their effort to develop a coronavirus vaccine, amid worries that political pressure could lead to an unsafe or ineffective vaccine to be used in millions of healthy people.

“This temporary pause is living proof that we follow those principles while a single event at one of our trial sites is assessed by a committee of independent experts,” Pascal Soriot, the AstraZeneca chief executive, said in a statement. “We will be guided by this committee as to when the trials could restart, so that we can continue our work at the earliest opportunity to provide this vaccine broadly, equitably and at no profit during this pandemic.”

“Even if it turns out this is causally related to the vaccine, that doesn’t automatically mean this is something you might not carry on,” said Naor Bar-Zeev, deputy director of the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health. “The benefit versus risk needs to be evaluated with the likelihood of each of these things and is clearly context dependent. If there was no covid in the world, you’d not want to take a vaccine.”

But Collins underscored at the hearing that the safety review and pause was just another reason that the United States was spreading its bets so widely, investing in six different vaccines. The United Kingdom has also made purchasing agreements for six vaccines in the final stages of human testing.

At a news conference at 10 Downing Street on Wednesday, United Kingdom chief scientific adviser Patrick Vallance said it was not unusual for a large Phase 3 trial test of effectiveness and safety of vaccines to be paused.

This is precisely why a Phase 3 trial is undertaken, he said.

“A pause is obviously not good,” Vallance said. “But it is sensible to look closely to see what is going on.”

 

 

 

 

A New Front in America’s Pandemic: College Towns

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The coronavirus is spiking around campuses from Texas to Iowa to North Carolina as students return.

Last month, facing a budget shortfall of at least $75 million because of the pandemic, the University of Iowa welcomed thousands of students back to its campus — and into the surrounding community.

Iowa City braced, cautious optimism mixing with rising panic. The university had taken precautions, and only about a quarter of classes would be delivered in person. But each fresh face in town could also carry the virus, and more than 26,000 area residents were university employees.

“Covid has a way of coming in,” said Bruce Teague, the city’s mayor, “even when you’re doing all the right things.”

Within days, students were complaining that they couldn’t get coronavirus tests or were bumping into people who were supposed to be in isolation. Undergraduates were jamming sidewalks and downtown bars, masks hanging below their chins, never mind the city’s mask mandate.

Now, Iowa City is a full-blown pandemic hot spot — one of about 100 college communities around the country where infections have spiked in recent weeks as students have returned for the fall semester. Though the rate of infection has bent downward in the Northeast, where the virus first peaked in the U.S., it continues to remain high across many states in the Midwest and South — and evidence suggests that students returning to big campuses are a major factor.

In a New York Times review of 203 counties in the country where students comprise at least 10 percent of the population, about half experienced their worst weeks of the pandemic since Aug. 1. In about half of those, figures showed the number of new infections is peaking right now.

Despite the surge in cases, there has been no uptick in deaths in college communities, data shows. This suggests that most of the infections are stemming from campuses, since young people who contract the virus are far less likely to die than older people. However, leaders fear that young people who are infected will contribute to a spread of the virus throughout the community.

The surge in infections reported by county health departments comes as many college administrations are also disclosing clusters on their campuses.

*Brazos County, Tex., home to Texas A&M University, added 742 new coronavirus cases during the last week of August, the county’s worst week so far, as the university reported hundreds of new cases.

*Pitt County, N.C., site of East Carolina University, saw its coronavirus cases rise above 800 in a single week at the end of August. The Times has identified at least 846 infections involving students, faculty and staff since mid-August.

*In South Dakota’s Clay and Brookings counties, ballooning infections in the past two weeks have reflected outbreaks at the state’s major universities. In McLean County, Ill., the virus has been spreading as more than 1,200 people have contracted the virus at Illinois State University.

*At Washington State University and the University of Idaho, about eight miles apart, combined coronavirus cases have risen since early July to more than 300 infections. In the surrounding communities — rural Whitman County, Wash., and Latah County, Idaho — cases per week have climbed from low single-digits in the first three months of the pandemic, to double-digits in July, to more than 300 cases in the last week of August.

The Times has collected infection data from both state and local health departments and individual colleges. Academic institutions generally report cases involving students, faculty and staff, while the countywide data includes infections for all residents of the county.

It’s unclear precisely how the figures overlap and how many infections in a community outside of campus are definitively tied to campus outbreaks. But epidemiologists have warned that, even with exceptional contact tracing, it would be difficult to completely contain the virus on a campus when students shop, eat and drink in town, and local residents work at the college.

The potential spread of the virus beyond campus greens has deeply affected the workplaces, schools, governments and other institutions of local communities. The result often is an exacerbation of traditional town-and-gown tensions as college towns have tried to balance economic dependence on universities with visceral public health fears.

In Story County, Iowa, a local outcry following a burst of new Iowa State University cases pressured the university on Wednesday to reverse plans to welcome 25,000 football fans for its Sept. 12 opener against the University of Louisiana at Lafayette. In Monroe County, Indiana, the health department quarantined 30 Indiana University fraternity and sorority houses, prompting the university to publicly recommend that members shut them down and move elsewhere.

In Johnson County, where the University of Iowa is located, cases have more than doubled since the start of August, to more than 4,000. Over the past two weeks, Iowa City’s metro area added the fourth-most cases per capita in the country. The university has recorded more than 1,400 cases for the semester.

With a population of roughly 75,000, Iowa City relies on the university as an economic engine. The University of Iowa is by far the community’s largest employer, and its approximately 30,000 students are a critical market. Hawkeye football alone brings $120 million a year into the community, said Nancy Bird, executive director of the Iowa City Downtown District.

When the pandemic first hit in March, the university sent students home and pivoted to remote instruction, like most of the country’s approximately 5,000 colleges and universities. That exodus, heightened by health restrictions, has been an existential challenge for many downtown businesses, Ms. Bird said.

Jim Rinella, who owns The Airliner bar and restaurant, said the 76-year-old landmark across the street from campus “had zero revenue the whole month of April.” May was almost as scant, he said, and in June, he shut down after a couple of employees became infected.

By the time he reopened after July 4, too few students were in town to come close to making up the losses. He and his wife, Sherry, had hoped the campus reopening in August might be a lifeline.

The Rinellas live in Detroit, where they have other businesses, and Mr. Rinella said he was out of town when crowds jammed downtown on the weekend before the Aug. 24 start of classes. He said he immediately called his manager to make sure they were following state and local health rules.

But the photos taken by the local press from outside his establishment and others were damning. In an open letter, the university president lashed out, saying he was “exceedingly disappointed” in the failure of local businesses to keep students masked and socially distanced. Days later, the governor cited high infection rates among young people as she closed bars and restricted restaurants in Johnson County and five other counties with high concentrations of students.

Now The Airliner — where a booth is named for the University of Iowa’s most famous dropout, Tom Brokaw, and a modeling scout is said to have discovered Ashton Kutcher — has to close at 10 p.m. as well as require customers to buy a meal and sit far apart if they want to drink there.

“I’m at a pain point,” Mr. Rinella said. “If my grandfather hadn’t started the place, I’d question whether I want to be in the restaurant business.” A recent lunch hour visit found one customer at the bar drinking a beer.

The rise in local case counts reverberated at the county’s community college, which decided to start its fall semester with continued online instruction. Iowa City’s K-12 schools followed suit, which also meant canceling extracurricular activities, including sports, until students come back to the classroom in person.

“This is one of our last chances for college coaches to see us play or to get recent films sent out to college coaches. For some of us, playing in college is a goal we have been working toward since we were 11 or 12,” Lauren Roman, a 17-year-old high school volleyball player, told the school board last month. She burst into tears as she explained that she has waited since March for college recruiters to see her play. “Some of us really do need that scholarship money.”

“This sucks,” the board vice-president Ruthina Malone, agreed at the same meeting, choking up as she described emails she had received from families of children whose education relies on in-person instruction. But, she told the board, “we do not operate in isolation.” Her husband, she said, is an art teacher who would like nothing more than to teach again in person, and she works at the university.

The pandemic has hurt colleges’ finances in multiple ways, adding pressure on many schools to bring students back to campus. It has caused enrollment declines as students have opted for gap years or chosen to stay closer to home, added substantial costs for safety measures, reduced revenue from student room and board and canceled money-generating athletic events.

Governments have not always stepped into the breach: In Iowa, the state cut $8 million from its higher education appropriation even after the Board of Regents, which oversees the state’s universities, requested an $18 million increase. Over the summer, the University of Iowa announced a salary freeze and other significant cuts. This was before the Big Ten Conference postponed fall competition, erasing more than $60 million from the university’s athletics program.

When the university announced its plans for reopening with a combination of in-person and virtual instruction, it did not mention its finances as a factor, though it froze tuition rather than reduce it, as some universities have done. It also mandated mask wearing inside buildings and said it would test students with symptoms or who had been exposed to the virus.

Still, its decision to hold in-person classes drew criticism from some faculty. “We’re scared for our health and yours,” one group of instructors wrote in an open letter to students in July.

And its decision not to test asymptomatic students unless they had been exposed unnerved some city officials. Dr. Dan Fick, the campus health officer, said the university wanted to avoid a false sense of security.

But Janice Weiner, who represented the City Council in meetings with the business community and campus, questioned the approach. “We have a robust and capable medical community, we have good public health officials, we have everything we need,” she said. “But then the university didn’t require everyone coming back to campus to be tested.”

Iowa City is a blue town in a state with a pro-Trump Republican governor, Kim Reynolds, who has clashed with the state’s cities over masks and Covid policies.

Though the governor in March restricted large gatherings, closed Iowa schools and banned indoor operations of many businesses, she began relaxing those orders in May and has argued that face-mask mandates couldn’t be legally enforced.

Several municipalities have nonetheless passed ordinances requiring face masks, including Johnson County and Iowa City — largely in preparation for the return of students. But because state health rules have become a patchwork, not all returning students come from places where mask wearing is required, said Ms. Weiner. And, she said, the inconsistency offers an excuse to those who don’t want to wear them.

Interviews with students suggested that concern had at least some justification.

“If people get sick, they get sick — it happens,” Mady Hanson, a 21-year-old exercise science major, said last week on campus. She added that she and her family had survived Covid-19 and that she resented the city’s “ridiculous” restrictions.

“We’re all farmers and don’t really care about germs, so if we get it, we get it and we have the immunity to it.”

Both university and city officials said they believe the spike in cases has been a wake-up. “When we look back,” said Dr. Fick, “I think we’ll be proud that when students got the message, a majority stepped up.”

On the City Council, Ms. Weiner was less upbeat.

“There’s not a whole use in placing blame — we have to figure out a way forward,” she said. “But it’s going to take a herculean effort here for our numbers to start to go down.”

 

 

 

The coronavirus and a $12 billion motorcycle rally

Posted on by • Posted in 2020 Election Issues, Clinical Testing, Contact Tracing, Coronavirus, Crisis, Crisis Management, Economic Crisis, Economic Recovery, Economic Stimulus, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based 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, Scientists, Social Distancing, Superspreader, Superspreader Event, Superspreader Facilities, Superspreading Events • Leave a comment

https://www.axios.com/newsletters/axios-vitals-9f3757d6-dde4-4b75-a994-9572837e9d3f.html?utm_source=newsletter&utm_medium=email&utm_campaign=newsletter_axiosvitals&stream=top

The coronavirus outbreak tied to the annual motorcycle rally in Sturgis, South Dakota, ended up generating more than $12 billion in public health costs, according to a new discussion paper.

Why it matters: The analysis puts a point on just how bad these superspreader events can be — and the difficulty of preventing them solely with voluntary policies.

Background: The annual rally was held this year over 10 days in August, and included a Smash Mouth concert. The nearly 500,000 attendees came from all over the country, and social distancing and mask-wearing were mostly optional.

By the numbers: The rally led to 266,796 additional cases, or 19% of the new cases in the U.S. between Aug. 2 and Sept. 2., the paper found.

  • The event led to a 35% increase in cases in South Dakota. In counties that are home to the highest number of rally attendees, cases rose by 10.7% compared to counties without any attendees.
  • If each coronavirus case costs $46,000, that’s an additional $12.2 billion added on to the pandemic’s price tag.

The other side: “Overall, I think the ‘Sturgis Effect’ that the authors document is in large part just a Midwest surge that took place during this time period. There is likely still a small Sturgis Effect … but the results are likely biased upward,” tweeted Devin Pope, a professor at the University of Chicago.

The big picture: Given the state of contact tracing in the U.S. (bad), we’ll never know how many coronavirus cases were actually tied to the Sturgis rally.

  • But it’s a reminder that it takes collective action to contain the virus: As Sturgis revelers head back home, this South Dakota-centered outbreak has the potential to infect people who never went anywhere near Sturgis and thought they were doing everything right.

 

 

 

 

How important is the ACA for people who lose their jobs?

Posted on by • Posted in 2020 Election Issues, ACA, Chronic Care Management, Chronic Conditions, Chronic Diseases, Deferred Healthcare, Employee Furlough, Employee Hiring Freeze, Employee Layoffs, Employer-Based Health Insurance, Essential Health Benefits, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Health Insurance Coverage Adequacy, Health Policy, High Deductible Health Plans, High Drug Prices, High Premiums, High Prices, Medicaid, Medicaid Expansion, Out of Pocket Expenses, Pandemic, Preexisting Conditions, Underinsured, Unemployment, Unemployment Insurance, Uninsured • Leave a comment

https://us3.campaign-archive.com/?u=6ab1fc39a0b1b15521551487c&id=6f9ac3fd86&e=ad91541e82

https://www.nejm.org/doi/full/10.1056/NEJMp2023312

This week’s contributor is Larry Levitt, the Executive Vice President for Health Policy at the Kaiser Family Foundation.

For the first time in an economic downturn, the Affordable Care Act (ACA) exists as a health care safety net for people losing their jobs and employer-provided health insurance. A new study provides some clues as to how well the health care law works for people who lose their jobs and insurance.

The study – by Sumit Agarwal and Benjamin Sommers, published in the New England Journal of Medicine – compares people who lost their jobs before and after the ACA went into effect in 2014 to see if there is a difference in how many people retained health insurance. During the pre-ACA period (2011-2013), there was about a 5% increase in the uninsured rate for people following a job loss. After the ACA went into effect (2014-2016), no such increase occurred. Instead, Medicaid and the marketplaces saw large increases in utilization.

With millions of Americans losing their jobs during the pandemic, the number of people without health coverage has undoubtedly risen. However, by how much is unknown, since we don’t track insurance coverage in real-time like we do employment. Many who have lost jobs may not have had employer-sponsored insurance in the first place, if they worked an industry like food service or retail. And the vast majority of people who are unemployed are classified as on temporary layoff, with employers who may be continuing health benefits for their furloughed workers, at least for now. However, the share of unemployed workers who have permanently lost their jobs is growing.

If the economic crisis persists, the number of people losing job-based health insurance will climb, making the ACA’s role as a safety net more relevant than ever.

 

 

Cartoon – Something that would greatly Prevent Covid 19

Posted on by • Posted in 2020 Election Issues, Cartoon, Coronavirus, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, 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, Personal Protective Equipment (PPE), Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Quarantine, Scientists, Social Distancing • Leave a comment

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

Cartoon – Federal Coronavirus Response

Posted on by • Posted in 2020 Election Issues, Cartoon, Centers for Disease Control & Prevention (CDC), Coronavirus, Crisis, Crisis Management, Evidence-based Leadership, Evidence-Based Plan, Evidence-Based Policy, Expert, Expert Opinion, False Hope, False Narrative, Honesty, Integrity, Misinformation, Misinterpret, Mislead, Misleading, Mistake, Mistrust, Mixed Message, Pandemic, Public Health, Public Opinion, Public Perception, Public Safety, Public Trust, Scientists, Silencing, Silencing Speech, Transparency, Trust, Truth • Leave a comment

10 Dilbert Cartoons That Get Project Management Just Right

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

Posted on by • 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.”

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“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?”