Battle over COVID-19 school openings goes to the courts

Battle over COVID-19 school openings goes to the courts

Nearly 800 COVID-19 lawsuits have been filed, according to law firm's  tracker

Teachers unions are waging court fights across the country aimed at unwinding what they say are unsafe and politically motivated timetables for reopening schools that risk exposing personnel to the coronavirus pandemic.

State officials eager to ramp up brick-and-mortar operations are facing lawsuits from Florida to Texas to Iowa over reopening plans as well as access to the COVID-19 infection data needed to monitor the rate of spread within school communities. 

At the same time, lawsuits are flying from the opposition direction: Parents in several states, including New York, Massachusetts and Oregon, dissatisfied with web-based teaching alternatives, are suing to force state officials to reopen physical schools sooner as courts are increasingly called upon to referee the fight over education in the age of coronavirus.

“A legal storm is brewing as safety and social distancing requirements for a physical return to school begin to take shape around the country,” Maria Ferguson, executive director of the Center on Education Policy at George Washington University, wrote on the education website The 74.

As millions of students prepare for the first day of school — whether in-person, remote or a hybrid of the two — the fight over the reopening physical school buildings is likely to intensify.

The debate over in-person K-12 instruction planning is inseparably tied to the issues of child care needs and parents’ ability to return to the workforce to help revive the struggling economy, all of which is playing out against the backdrop of a fast-approaching November election in a country that has seen nearly 6 million cases and more than 181,000 deaths from COVID-19.

Perhaps the highest-profile legal battle is taking place in the courts of Florida, where Republican Gov. Ron DeSantis signed off last month on an emergency order over school reopenings.

Under the order, most Florida school districts would be required to hold in-person classes five days a week by the end of August or risk losing funding. President Trump, who counts DeSantis as a close ally, has also threatened to cut off federal funding for schools if they do not resume in-person learning this fall.

The Florida policy prompted a lawsuit from the Florida Education Association (FEA), a statewide teachers union, and several other plaintiffs in favor of a more cautious return to in-person teaching.

“Public schools are not designed for COVID safety, and indeed, the government has recognized that they are high-contact environments,” said Kendall Coffey, the lead plaintiff’s attorney in the Florida case, who likened prematurely opened schools to “disease factories” and called the Florida policy “financial bullying.”

There are any number of issues, in terms of hallway sizes, the flow of students in and out of classrooms, ventilation, even how many students go into the bathroom,” he told The Hill. “There are many elements that are virtually impossible to guarantee when you’re dealing with children in large amounts.”

On Aug. 24, a Florida judge ruled in favor of the union and temporarily halted the statewide order. In his decision, Judge Charles Dodson struck down the order’s unconstitutional provisions and blasted DeSantis for having “essentially ignored” the state’s constitutional requirement that schools be operated safely.

“The districts have no meaningful alternative,” wrote Dodson, of Leon County. “If an individual school district chooses safety, that is, delaying the start of schools until it individually determines it is safe to do so for its county, it risks losing state funding, even though every student is being taught.”

A Florida appeals court agreed to temporarily halt Judge Dodson’s order from taking effect while DeSantis appeals.

The state contends that the benefit of in-person instruction outweighs the health risks associated with reopening brick-and-mortar schools. Some Florida school officials have also declined to disclose incidents of positive COVID-19 cases to school communities, citing the need for patient privacy. 

Attorneys for Florida have also argued in hearings that courts should not substitute their judgment for that of policymakers who have balanced all the equities and decided a prompt in-person reopening is the best policy.

Randi Weingarten, president of the American Federation of Teachers (AFT), one of the largest teachers unions in the country, said Florida has its priorities backward.

“What their arguments show is that they don’t care about human life,” Weingarten told The Hill.

According to Weingarten, internal AFT polling in June showed that about 3 in 4 teachers said they would be comfortable returning to the classroom if guidelines from the Centers for Disease Control and Prevention (CDC) were implemented in schools.

But she predicts that attitudes among teachers have shifted dramatically in past months as the Trump administration has failed to adequately manage the virus to ensure schools can be reopened safely.

“We’re polling right now,” she said. “And my hunch is that just like the public polls, it’s totally flipped.”

The AFT is backing lawsuits in Florida, New Mexico and Texas. Before schools can reopen safely — for what Weingarten calls “the biggest move indoors that the nation has done since March” — the group says local positivity rates should be below 3 percent and schools should have visibility into daily transmission rates. 

The union is also pushing for protocols that involve testing, contact tracing and isolation and implement best practices from the CDC for things such as ventilation, cleaning, physical distancing, mask-wearing and other safeguards.

As teachers unions make their case in court, parents in at least five states have filed lawsuits of their own to accelerate school reopenings.

A nonprofit litigation group called the Center for American Liberty, co-founded by lawyer and GOP official Harmeet Dhillon, is backing one such suit in California. Democratic Gov. Gavin Newsom’s restrictions on in-person school openings in the Golden State will affect an estimated 80 percent of K-12 students.

“The effects of this ham-handed policy are as predictable as they are tragic,” the lawsuit filed in a federal court in California states. “Hundreds of thousands of students will essentially drop out of school, whether because they lack the technological resources to engage with ‘online learning’ or because their parents cannot assist them.”

The litigation raises concerns about everything from school closures exacerbating the achievement gap and disproportionately harming special needs students and those without convenient internet access to challenges over the constitutional validity of government health orders.

Weingarten, of AFT, said it’s important to remember that despite seemingly irreconcilable differences over the policy details, all parties want to see schools reopen as soon as it’s safe to do so.

“None of us believes that remote is a substitute,” she said. “It’s a supplement.”

 

 

Children might play a bigger role in COVID transmission than first thought. Schools must prepare

https://theconversation.com/children-might-play-a-bigger-role-in-covid-transmission-than-first-thought-schools-must-prepare-144947?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=Children%20might%20play%20a%20bigger%20role%20in%20COVID%20transmission%20than%20first%20thought%20Schools%20must%20prepare

Children might play a bigger role in COVID transmission than first thought—schools  must prepare

Over the weekend, the World Health Organisation made an announcement you might have missed.

It recommended children aged 12 years and older should wear masks, and that masks should be considered for those aged 6-11 years. The German Society for Virology went further, recommending masks be worn by all children attending school.

This seems at odds with what we assumed about kids and COVID-19 at the start of the pandemic. Indeed, one positive in this pandemic so far has been that children who contract the virus typically experience mild illness. Most children don’t require hospitalisation and very few die from the disease. However, some children can develop a severe inflammatory syndrome similar to Kawasaki disease, although this is thankfully rare.

This generally mild picture has contributed to cases in children being overlooked. But emerging evidence suggests children might play a bigger role in transmission than originally thought. They may be equally as infectious as adults based on the amount of viral genetic material found in swabs, and we have seen large school clusters emerge in Australia and around the world.

How likely are children to be infected?

Working out how susceptible children are has been difficult. Pre-emptive school closures occurred in many countries, removing opportunities for the virus to circulate in younger age groups. Children have also missed out on testing because they typically have mild symptoms. In Australia, testing criteria were initially very restrictive. People had to have a fever or a cough to be tested, which children don’t always have. This hindered our ability to detect cases in children, and created a perception children weren’t commonly infected.

One way to address this issue is through antibody testing, which can detect evidence of past infection. A study of over 60,000 people in Spain found 3.4% of children and teenagers had antibodies to the virus, compared with 4.4% to 6.0% of adults. But Spain’s schools were also closed, which likely reduced children’s exposure.

Another method is to look at what happens to people living in the same household as a known case. The results of these studies are mixed. Some have suggested a lower risk for children, while others have suggested children and adults are at equal risk.

Children might have some protection compared to adults, because they have less of the enzyme which the virus uses to enter the body. So, given the same short exposure, a child might be less likely to be infected than an adult. But prolonged contact probably makes any such advantage moot.

The way in which children and adults interact in the household might explain the differences seen in some studies. This is supported by a new study conducted by the Centers for Disease Control and Prevention. Children and partners of a known case were more likely to be infected than other people living in the same house. This suggests the amount of close, prolonged contact may ultimately be the deciding factor.

How often do children transmit the virus?

Several studies show children and adults have similar amounts of viral RNA in their nose and throat. This suggests children and adults are equally infectious, although it’s possible children transmit the virus slightly less often than adults in practice. Because children are physically smaller and generally have more mild symptoms, they might release less of the virus.

In Italy, researchers looked at what happened to people who’d been in contact with infected children, and found the contacts of children were more likely to be infected than the contacts of adults with the virus.

Teenagers are of course closer to adults, and it’s possible younger children might be less likely to transmit the virus than older children. However, reports of outbreaks in childcare centres and primary schools suggest there’s still some risk.

What have we seen in schools?

Large clusters have been reported in schools around the world, most notably in Israel. There, an outbreak in a high school affected at least 153 students, 25 staff members, and 87 others. Interestingly, that particular outbreak coincided with an extreme heatwave where students were granted an exemption from having to wear face masks, and air conditioning was used continuously.

At first glance, the Australian experience seems to suggest a small role for children in transmission. A study of COVID-19 in educational settings in New South Wales in the first half of the year found limited evidence of transmission, although a large outbreak was noted to have occurred in a childcare centre.

This might seem reassuring, but it’s important to remember the majority of cases in Australia were acquired overseas at the time of the study, and there was limited community transmission. Also, schools switched to distance learning during the study, after which school attendance dropped to 5%. This suggests school safety is dependent on the level of community transmission.

Additionally, we shouldn’t be reassured by examples where children have not transmitted the virus to others. Approximately 80% of secondary COVID-19 cases are generated by only 10% of people. There are also many examples where adults haven’t transmitted the virus.

As community transmission has grown in Victoria, so has the significance of school clusters. The Al-Taqwa College outbreak remains one of Australia’s largest clusters. Importantly, the outbreak there has been linked to other clusters in Melbourne, including a major outbreak in the city’s public housing towers.

Close schools when community transmission is high

This evidence means we need to take a precautionary approach. When community transmission is low, face-to-face teaching is probably low-risk. But schools should switch to distance learning during periods of sustained community transmission. If we fail to address the risk of school outbreaks, they can spread into the wider community.

While most children won’t become severely ill if they contract the virus, the same cannot be said for their adult family members or their teachers. In the US, 40% of teachers have risk factors for severe COVID-19, as do 28.6 million adults living with school-aged children.

Recent recommendations on mask-wearing by older and younger children mirror risk-reduction guidelines for schools developed by the Harvard T. H. Chan School of Public Health. These guidelines stress the importance of face masks, improving ventilation, and the regular disinfection of shared surfaces.

The changing landscape

As the virus has spread more widely, the demographic profile of cases has changed. The virus is no longer confined to adult travellers and their contacts, and children are now commonly infected. In Germany, the proportion of children in the number of new infections is now consistent with their share of the total population.

While children are thankfully much less likely to experience severe illness than adults, we must consider who children have contact with and how they can contribute to community transmission. Unless we do, we won’t succeed in controlling the pandemic.

 

 

 

 

Hospitals face closure as $100B in Medicare loans come due

https://www.beckershospitalreview.com/finance/hospitals-face-closure-as-100b-in-medicare-loans-come-due.html?utm_medium=email

HCA posts a billion-dollar profit, bolstered by CARES Act funds - MedCity  News

CMS accelerated payments to hospitals and other healthcare providers at the beginning of the COVID-19 pandemic to help temporarily relieve financial strain. It’s time to begin repaying the Medicare loans but that isn’t possible for some rural hospitals, according to NPR

CMS expanded the Accelerated and Advance Payment Program in late March to help offset financial damage caused by the COVID-19 pandemic. CMS announced April 26 that it was reevaluating pending and new applications for advance payments due to the availability of funds under the Coronavirus Aid, Relief and Economic Security Act. As of May, CMS had paid out $100 billion in advance payments, the bulk of which went to hospitals. 

Hospitals and other healthcare providers are required to start repaying the Medicare loans this month. Most hospitals will have one year from the date the first loan payment was made to repay the loans, according to Kaiser Family Foundation.

Ozarks Community Hospital, 25-bed critical access hospital in Gravette, Ark., is one of the hospitals that applied for and accepted the Medicare loans. The hospital also received grants made available under the CARES Act, which do not have to be repaid.

CEO Paul Taylor said Ozarks Community Hospital’s revenue is still constrained, and he doesn’t know how it will pay back its $8 million Medicare loan. Payments for new Medicare claims will be offset to repay the loans, but losing those payments could force the hospital to close, Mr. Taylor told NPR.

“If I get no relief and they take the money … we won’t still be open,” he said.

Ozarks Community Hospital is one of more than 850 critical access hospitals in rural areas that received Medicare loans, according to NPR. Given the shaky financial footing of many rural hospitals before the pandemic, the strain of having Medicare payments withheld could be enough to force others to shut down. 

Before the pandemic, more than 600 rural hospitals across the U.S. were vulnerable to closure, according to an estimate from iVantage Health Analytics, a firm that compiles a hospital strength index based on data about financial stability, patients and quality indicators.

If the financial pressures tied to the pandemic force any of those hospitals to shut down, they’ll join the list of 131 rural hospitals that have closed over the past decade, according to the Cecil G. Sheps Center for Health Services Research.

 

 

 

 

Billions in Hospital Virus Aid Rested on Compliance With Private Vendor

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

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

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

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

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

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

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

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

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

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

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

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

But critics remain alarmed.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Some hospital officials also objected to the change.

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

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

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

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

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

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

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

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

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

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

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

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

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

 

 

 

FDA chief apologizes for overstating plasma effect on virus

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

Cartoon by Sally-Covid 19 Pandemic Stages of Grief |

When COVID infection becomes a chronic disease

https://mailchi.mp/0e13b5a09ec5/the-weekly-gist-august-21-2020?e=d1e747d2d8

Long COVID-19' a reality; 75 per cent patients suffer from ...

The minimal evidence of serious impact of COVID infection on young healthy individuals has been one of the bright spots of this pandemic. Overall, only a small percentage of those infected, mostly the elderly or those with pre-existing conditions, get very sick, and an even smaller number die.

But a new piece in The Atlantic lays out mounting evidence that many younger patients don’t spring back to good health after a few weeks, as common wisdom suggests; instead, they experience debilitating long-term effects, months after infection. The profile of the average patient with “Long-COVID” is just 44 years old, and previously fit and healthy.

She (the condition is much more common in women) likely suffered a mild initial infection. But now, months later, she still faces a wide range of symptoms. Some patients have significant chronic pulmonary or cardiac function abnormalities (like Georgia State’s star freshman quarterback recruit, sidelined for the year with post-COVID myocarditis).

But others are dealing with a different, but just as debilitating, set of symptoms resembling chronic fatigue syndrome (CFS).

And like CFS patients, many COVID “long-haulers” find their symptoms minimized by their doctors. Early studies show that large numbers of patients may be affected: in a series of 270 non-hospitalized patients, the CDC found a full third hadn’t returned to their usual health after two weeks (as compared to just 10 percent of influenza patients).

A handful of centers have taken the first step toward better understanding “Long-COVID”, establishing dedicated clinics to study and treat the growing number of patients for whom COVID-19 is turning out to be a chronic disease, leaving a wave of people with long-term disabilities in its wake.

 

 

 

2020 Hospital Operating Margins Down 96% Through July

https://www.prnewswire.com/news-releases/2020-hospital-operating-margins-down-96-through-july-301116888.html

Ship in a Storm | ICOExaminer

Hospital Operating Margins have plunged 96% since the start of 2020 in comparison with the first seven months of 2019, according to a new Kaufman Hall report, as uncertainty and volatility continue in the wake of the COVID-19 pandemic.

Those results do not include federal funding from the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Even with that aid, however, Operating Margins are down 28% year-to-date compared to January-July 2019.

Operating Margins fell 2% year-over-year in July without the CARES Act relief, according to the latest edition of Kaufman Hall’s National Hospital Flash Report. Hospitals also saw flat year-over-year gross revenue performance in July, continued high per-patient expenses, and a fifth consecutive month of volumes falling below 2019 performance and below budget.

From June to July, however, hospital Operating Margins were up 24%, likely due to a backlog in demand resulting from the shutdown of many non-urgent services in the early months of the pandemic.

“COVID-19 has created a highly volatile operating environment for our nation’s hospitals and health systems,” said Jim Blake, managing director, Kaufman Hall. “Hospitals have shown some incremental signs of potential financial recovery in recent months. Unfortunately, there is no guarantee these trends will continue, and hospitals still have a long way to go to recover from devastating losses in the early months of the pandemic.”

July volumes continued to fall year-over-year, but showed some signs of potential recovery month-over-month. Adjusted Discharges were down 7% compared to July 2019, but up 6% compared to June 2020. Adjusted Patient Days were down 4% year-over-year, but up 7% month-over-month. Adjusted Discharges are down 13% and Adjusted Patient Days are down 11% since the start of 2020, compared to the first seven months of 2019.

Hospital Emergency Department (ED) volumes have been hardest hit, falling 17% year-to-date compared to the same period in 2019, down 17% year-over-year, and 13% below budget in July. Surgery volumes saw some gains with the continued resumption of non-urgent procedures pushing Operating Room Minutes up 3% month-over-month and 4% above budget in July, but they remain down 15% year-to-date.

Not including CARES Act relief, Gross Operating Revenues were essentially flat year-over-year and 2% below budget for the month, but have fallen 8% year-to-date compared to the same period in 2019. Inpatient Revenue is down 5% year-to-date and fell 3% below budget in July, but increased 1% year-over-year. Outpatient Revenue is down 11% year-to-date, 1% year-over-year, and 2% below budget.

Hospitals nationwide also continued to see higher per-patient expenses despite having fewer patients. Total Expense per Adjusted Discharge has jumped 16% year-to-date compared to the same seven-month period in 2019, and rose 9% year-over-year and 5% above budget in July. Labor Expense per Adjusted Discharge is up 18% year-to-date and rose 9% year-over-year and 5% above budget in July. Non-Labor Expense per Adjusted Discharge has increased 15% during the first seven months of 2020 and jumped 11% year-over-year and was 5% above budget for the month.

The National Hospital Flash Report draws on data from more than 800 hospitals.

 

 

 

 

The kids are not all right

https://mailchi.mp/0e13b5a09ec5/the-weekly-gist-august-21-2020?e=d1e747d2d8

Many children heading back to school—in whichever form that that may take this fall—have skipped their annual visit to the pediatrician. The graphic above highlights the sluggish rebound in pediatric ambulatory volume. While adult primary care visits have mostly bounced back, pediatric visits are still 26 percent below pre-COVID levels.

The drop in visits early in the pandemic also impacted immunizations, with 2.5M regular childhood vaccinations missed in the US during the first quarter of 2020—and early data suggests those seem to be rebounding at a similarly anemic rate.

This lack of pediatric routine care is particularly worrisome as COVID-19 cases in children are climbing, with a 90 percent increase from July to August. Though most of the nation’s largest public school districts have opted to begin the school year with online learning, some districts have already returned to in-person classes, and, unsurprisingly, new cases are already being reported.

While COVID-19 is normally neither severe nor fatal in children, infections among school-age kids put others at risk. According to the Kaiser Family Foundation, nearly a quarter of teachers (1.5M) are considered high-risk and almost six percent of seniors (3.3M) live with school-aged children.

Without the traditional back-to-school push for well-child visits, sports physicals, and immunization updates, healthcare providers must think creatively about how to give children with the care they need, whether through personalized communication from pediatricians that assuages parental concerns about office safety, or through more innovative means such as drive-thru vaccination services.

 

 

 

It looks like what happens in Vegas isn’t staying in Vegas.

https://www.forbes.com/sites/suzannerowankelleher/2020/08/21/las-vegas-may-be-a-superspreader-hot-spot-new-study-suggests/?utm_source=newsletter&utm_medium=email&utm_campaign=coronavirus&cdlcid=5d2c97df953109375e4d8b68#506ae817484d

Travelers returning from the Covid-19 hot spot are potentially spreading the virus to virtually every state in the nation, according to a new mobility data study conducted on behalf of the non-profit investigative news organization ProPublica.

The findings highlight the connection between travelers and the spread of the virus during the pandemic.

The ProPublica study looked at a total of 12 days of cellphone data in three batches: four days in May, when Nevada was still shut down; four days in June, just after Las Vegas reopened to tourism; and four days in mid-July. In May, travel from Las Vegas was mainly regional. But since Las Vegas reopened in early June, the mobility of smartphones leaving Las Vegas has become progressively more widespread and nationalized.

Over the final four-day period, in July, the study identified 26,000 smartphones on the Las Vegas Strip, many of which later appeared in 47 states within the same four-day period — every state in the continental United States except Maine.

“About 3,700 of the devices were spotted in Southern California in the same four days; about 2,700 in Arizona, with 740 in Phoenix; around 1,000 in Texas; more than 800 in Milwaukee, Detroit, Chicago and Cleveland; and more than 100 in the New York area,” reported ProPublica.

While the study did not determine how many of these travelers were infected with Covid-19 when they returned to their home states, it is reasonable to assume that many were. For the past several months, Las Vegas has been a hot spot for the disease.

Las Vegas is located in Clark County, Nevada, which is currently struggling with one of the highest rates of new COVID-19 infections in the country, with 26.9 new daily cases per 100,000 people tested over a rolling seven-day average, according to the Harvard Global Health Institute’s Covid-19 tracker. Any community with over 25 new daily cases is deemed to be at a tipping point where stay-at-home orders are necessary, according to Harvard researchers.

This isn’t the first data-driven study to show how travelers are spreading Covid-19 across the United States. In early July, the PolicyLab at Children’s Hospital of Philadelphia (CHOP) released research indicating that the novel coronavirus was spreading along the nation’s interstate highways.

“Travel is certainly a huge driving factor,” the researchers wrote at the time. “We see spread along I-80 between central Illinois and Iowa, as well as along the I-90 corridor across upstate New York.” They pointed to a rise in cases along the I-95 corridor and concluded that interstate travel was creating renewed risk to regions like the Northeast that had successfully flattened the curve of the novel coronavirus.

Yesterday, Clark County’s Twitter account announced a grim milestone: The number of deaths attributed to Covid-19 in the community has now topped 1,000.