Mask Wars

As states begin to reopen and America tries to recreate normalcy, masks have replaced social distancing as the new moral statement. Just as adherence to lockdowns was framed by many as a sign of virtue—with some arguing that those who refused to abide by the lockdown orders should forfeit medical care for Covid-related indications—masks have become a face-borne signal of righteousness. As a virologist, I find this perplexing, considering the limited evidence in favor of masks.

More than anything, the scientific rationale behind masks appears to be that wearing them does little harm. Countervailing benefit need not be particularly significant to justify a public-health intervention. Indeed, a veritable cottage industry of homemade and custom masks has sprung up in the wake of Covid-19, many of questionable quality and efficacy. The viral particles that spread Covid-19 are tiny bundles of proteins and nucleic acids, about 0.1 micron in size—or one hundred-thousandth of a centimeter. The CDC generously describes the evidence in favor of cloth face masks’ efficacy as “emerging,” but by the standards we use to assess clinical interventions, the efficacy of masks, especially nonsurgical masks, is undetermined. Clearly, reducing the speed and pressure of droplets from sneezing or coughing that spread infections, as those of the coronavirus responsible for Covid-19 do, is likely to have some effect, but how much remains to be seen.

Understanding of the mask issue has been considerably clouded by unreliable and badly presented evidence—especially a paper by Renyi Zhang for the Proceedings of the National Academy of Sciences, contributed to PNAS by Mario Molina, who won the Nobel Prize in chemistry for the discovery of the effect of chlorofluorocarbons on the ozone layer. Molina and Zhang are atmospheric scientists with no background in epidemiology, virology, or the propagation of infectious diseases. Within the wider epidemiological community, their paper, which makes wild assertions about the effectiveness of masks while almost completely discounting the effect of other non-pharmacological interventions—and does so based on an unfounded comparison of Wuhan, Italy, and the United States—has drawn largely critical responses, with several noted epidemiologists calling for PNAS to withdraw it.

The paper fails not only in its scientific methodology but also in its fundamental grasp of facts and evidence, alleging, among other claims, that, as of April 17, the only difference between New York City and the rest of the United States was a mask mandate in the former. This is demonstrably false, ignoring the vast diversity of public-health responses around America (many of which were just as strict as New York’s, including mandatory mask use indoors), while assuming that an order to wear masks equates to immediate and broad social compliance and that the absence of such an order equates to people generally not wearing masks. Clearly, this is not the case, as people have many motivations to wear face shields, masks, and other personal protective equipment. By late April, mask usage was nearly universal in public spaces within the hardest-hit states.

Yet the Zhang paper was not only the basis for ordering universal mask use in public; it was also twisted into a strange moral argument. The Washington Post, for instance, editorialized on June 16 that “by discouraging mask wearing, [President] Trump [was] condemning many of his supporters to illness.” Masks likely remain a useful tool in curbing transmission potential where social interactions are unavoidable, and even cloth masks, though much less effective than surgical masks and N95 respirators, may have some benefit. As an epidemiologist, all too aware of the microbial multitudes that we all contain, I’ve been carrying a pair of gloves and an N95 respirator in my backpack for years and agree with the general approach of using whatever preventive measures are appropriate as states open up.

Yet the evidence is hardly strong enough to elevate mask-wearing into the epitome of moral behavior. Doing so reflects a greater preoccupation with the psychological effect of masks—perhaps as a restoration of control in the face of an unseen and often perplexing enemy with no cure and no prophylaxis—than with their scientific reality. Americans should demand evidence-based decision-making and policies driven by soundly attested facts, not assumptions or psychological palliatives.

Chris von Csefalvay is an epidemiologist specializing in bat-borne viruses. He is currently VP of Special Projects at Starschema.

https://www.city-journal.org/reality-of-wearing-masks

The Wrong Cuts

New York City has approved a new, pandemic-squeezed budget that’s making headlines because it includes a $1 billion cut to the NYPD amid calls, in the wake of the George Floyd killing in Minneapolis, to defund police. The reality is less dramatic, with about half of that $1 billion coming from shifting money and workers from the NYPD to other departments.

While the mayor pushes back against the “defund” bandwagon, his sleight of hand misses an opportunity in a time of crisis. The police budget has grown enormously because of lavish benefits that the city has awarded to NYPD employees and because New York State laws make it difficult to slow the increase in those costs once the perks have been awarded. The de Blasio administration is doing little to address those problems. Resisting calls to defund the department shouldn’t mean carrying on with a cost structure growing increasingly unwieldy. Police in New York have a hard job, but the extraordinary increase in the department’s benefit costs makes the budget a target.

In the past ten years, the police budget has increased by $2.8 billion—to $10.9 billion—a compound growth rate of 3 percent annually. That’s slower than the rate of increase of the city’s overall budget, but more than half of the increase in the NYPD’s total budget has been for pensions and fringe benefits, mostly health-care premiums for workers and retirees. When you add in debt service, these costs alone now account for 49 percent of the department’s budget. In other words, for every dollar the department spends on salaries, which constitute the main part of the rest of the NYPD budget, it’s spending another dollar on benefits. This is wildly disproportionate.

The cost of fringe benefits has expanded by 56 percent in the last decade, to $2.3 billion. The city provides nearly full medical coverage to employees and retirees, requiring only small contributions from some beneficiaries. Retirees under age 65—and almost all cops retire after 20 years on the job—don’t qualify for Medicare, a federal program, so the city pays the entire cost of their health benefits. According to a recent study, retiree coverage cost $17,000 annually for families and $7,500 for individuals. The NYPD, with more retirees than current active members of the force, absorbs a big part of the cost. Some 60 percent of the department’s spending on retiree health care is for those no longer working but who have not yet reached 65. The rest of the money is spent paying smaller Medicare premiums for city retirees over 65. The city is carrying full health-care costs for two workforces—the actual employees of the NYPD and its retirees.

While retiree benefits for cops are more expensive anyway, due to their younger age of retirement, New York’s costs are huge even compared with those of other cities. A 2013 study by the Citizens Budget Commission found that cost sharing between retirees and the government was far more common elsewhere, where retirees typically pay about 25 percent of their health-care costs. In the private sector, such cost sharing is even greater—if an employer offers any retiree health-care program.

The other benefits monster is pensions. The annual cost to the department to fund retirements equals $2.7 billion and essentially adds 50 cents to every dollar the department spends on salaries. One of the biggest perks that uniformed personnel enjoy is the ability to count overtime pay toward their pensions—something rare in the private sector and at most government jobs in other jurisdictions. One recent report estimated that this perk alone will add $2.5 billion to the cost of pensions in the department over the next two decades. It’s also a big reason why the average pension for a retired police officer is about $75,000 a year.

In the past, even well-intentioned reformers have had trouble hacking away at these costs because of unusual state constraints. A state constitutional amendment, for instance, limits the ability of municipalities to reform or reduce pension costs once a worker joins the system, even for work that the employee has not yet performed. This means that once a municipality hires a person, the rate at which the employee earns pension benefits cannot be reduced for the rest of his career. By contrast, pension laws in most other states let an employer change the rate of pension benefits for future work. In New York, the only recourse to savings is to change benefit rates for workers not yet hired, though it takes years for those savings to kick in.

Health benefits are not subject to constitutional restrictions and can be reduced. But changes must be bargained for, and the Taylor Law, which retains existing contract provisions in the event of a stalemate, makes that difficult. It provides a disincentive for unions to agree to concessions. The law also gives public-safety unions the right to bring contract impasses to arbitration; over the years, arbitrators have often ruled favorably toward unions.

During his tenure, de Blasio has gained few concessions from unions. In the current circumstances, the only way to cut costs quickly is to reduce the workforce. The new budget cuts some 1,100 workers from the NYPD and saves money through gimmicks like transferring entire functions—such as school safety—to other agencies, which must absorb the benefit costs. But the city has left numerous options typically exercised by other governments off the table—including larger contributions by retirees toward their insurance, especially those under 65, and reductions in coverage for entire families of retirees. The pandemic is the kind of crisis that demands state reforms and better city contracts to save money, not reducing the number of police officers needed to maintain safe streets.

New York City’s police have a hard job, and they do it well. But the combined salary and benefits costs of the average patrolman now reaches about $180,000 annually. It’s much higher for officers. Those costs have helped make the NYPD budget a focus of critics. The city may live to regret that.

Steven Malanga is the senior editor of City Journal, the George M. Yeager Fellow at the Manhattan Institute, and the author of Shakedown: The Continuing Conspiracy Against the American Taxpayer.

https://www.city-journal.org/nypd-budget-problem-is-benefit-costs

The Swamp mucks up America’s coronavirus response

In a pandemic, government efficiency can make the difference between life and death. You would expect our civil “servants” to rise to the occasion. Some are. But the Government Accountability Office, a federal watchdog, is sounding the alarm that for the most part, Washington bureaucrats are dithering while Americans die.

In a report released this week, the GAO details dozens of dangerous failings in one government department after another — failings that needlessly put you and your loved ones at risk.

Start with air travel. After the 2015 Ebola threat, the GAO urged the US Department of Transportation to draft a plan for safe air travel during an infectious-disease outbreak. Five years later, the DOT is still squabbling, insisting the job should be done by the Centers for Disease Control and Prevention instead — travelers be damned.

This week, American Airlines announced it will start running packed flights. Delta, Southwest and JetBlue are promising to keep middle seats open, but only for a few

weeks more. As part of the pandemic rescue bill, the airline industry got a $25 billion grant. The DOT should have recommended requiring airlines keep middle seats open in return for the money. The public got zip. No art of the deal in that arrangement.

One of the GAO’s most serious concerns is the absence of a specific vaccine distribution plan. President Trump launched Operation Warp Speed to develop, manufacture and distribute a vaccine for the novel coronavirus. Development and manufacturing are on a warp-speed timetable — or as close as we can get to it in an otherwise slow and daunting process. But the CDC, which acknowledges responsibility for distribution, is dragging its feet.

The public wants specifics. If and when a vaccine is ready, where should they go — to a doctor’s office, a hospital, a drugstore, a testing site? Who will be at the head of the line — the elderly, health workers, first responders, minority communities? These questions should be discussed publicly now, instead of causing delays once the scientists complete their job.

NIH infectious diseases expert Anthony Fauci has warned that getting enough Americans vaccinated to create herd immunity won’t be easy, because of anti-vax sentiment. An Associated Press poll found that only 49 percent of Americans intend to get vaccinated. “It’s going to be very difficult,” Fauci says, and will require a major educational initiative.

That should be in the works ­today, not tomorrow. Changing public opinion takes time. Advertising before the vaccine is ready may be risky, but the CDC should have ads in the can, with sports figures and media stars advocating vaccines.

No other agency has performed worse than the CDC. It flubbed developing a COVID-19 test, costing weeks at a critical time. It ignored nursing homes until it was too late. And it misled the public about masks. All deadly mistakes.

The GAO reports that even now, four months in, the CDC can’t provide accurate data on who is getting tested. In the private economy, these CDC officials would be fired. It’s disappointing that Trump has put up with this chronic incompetence.

Here’s the icing on the cake. The Internal Revenue Service sent out $1.4 billion in relief checks to people who are dead or in prison. IRS bureaucrats had no intention of trying to recover the funds, until the GAO suggested it. A billion dollars down the rat hole doesn’t seem to matter to bureaucrats on the federal gravy train.

When the pandemic struck and the CDC botched testing, Trump marshaled private firms to rush masks, ventilators, tests and other equipment into production. He had no time to reform anything. He bypassed the bureaucracy, saving lives as a result. Now he is doing it with vaccine development. Those are Trump’s healthy instincts as a businessman.

But ultimately, the president is head of a vast federal bureaucracy. He can’t abolish it. He has to manage it — and demand results.

Candidate Donald Trump vowed to raise standards and clear out slackers clogging the bureaucracy. He has taken some steps to do that. But the poor performance of several agencies during the pandemic is proof more heads need to roll, starting at the CDC.

Betsy McCaughey is the chairwoman of the Committee to Reduce Infection Deaths and author of the forthcoming book “The Next Pandemic.”

https://nypost.com/2020/07/02/how-the-swamp-mucked-up-americas-coronavirus-response/

Kroger gives employees at-home coronavirus testing kits

Kroger is giving employees access to free at-home coronavirus tests, the company announced this week.

The grocery store chain said Wednesday that the Food and Drug Administration (FDA) granted them emergency use authorization for their COVID-19 home kit.

Kroger said the goal is to be processing up to 60,000 tests per week by the end of July and it will make the kits available to other companies and organizations in the coming weeks.

Employers are responsible for the cost of the kits, which will be free to employees “who meet established clinical criteria for likely COVID-19 infection or exposure,” according to the statement.

A health care professional will guide patients through the nasal swab collection process at home through two-way video chats.

In partnership with clinical laboratory Gravity Diagnostics, the Kroger home collection kit will be shipped overnight to be processed within 24-48 hours.

“As our country experiences an increase in COVID-19 cases, physical distancing, wearing protective masks and testing remains paramount to flattening the curve,” Jim Kirby, senior director of Kroger Health, said in a statement. “We know flexible, accessible testing options like home solutions that leverage telehealth technology are critical to accelerating America’s reopening and recovery.”

Kroger Health, the health care division, in April opened up public drive-thru and walk-up COVID-19 testing sites. The company reported that it has administered more than 100,000 tests across 19 states.

https://thehill.com/business-a-lobbying/505770-kroger-gives-employees-at-home-coronavirus-testing-kits

Annexon grabs $100M from a host of top VC firms for complement therapies

Annexon Biosciences has grabbed a healthy $100 million round to take its clinical work closer to the finishing line as it tees up shots on multiple targets.

That $100 million comes from a who’s who of VC firms led by new investor Redmile Group, with other new investors including funds and accounts managed by BlackRock, Deerfield Management Company, Eventide Asset Management, Farallon Capital Management, Janus Henderson Investors and Logos Capital.

That’s not all: These guys were joined by existing investors Adage Capital Partners, Bain Capital Life Sciences, Blackstone Life Sciences, New Enterprise Associates, Satter Medical Technology Partners and Surveyor Capital (a Citadel company).

The cash boost will be put toward pushing a series of the biotech’s candidates forward, including ANX005 and ANX007. The former is an investigational monoclonal antibody designed to block C1q and activation of the classical complement cascade, and is moving into phase 2/3 study in patients with Guillain-Barré syndrome.

There’s also plans to test warm antibody hemolytic anemia, Huntington’s disease and amyotrophic lateral sclerosis.

Then there’s ANX007, a C1q antigen-binding fragment, or Fab, designed for intravitreal administration in patients with complement-mediated neurodegenerative ophthalmic disorders, which is moving into a midstage test clinical trial in geographic atrophy.

“We are very pleased to have such a strong investor group supporting our team, unique platform and deep pipeline of product candidates for patients with autoimmune and neurodegenerative disorders,” commented Douglas Love, president and CEO of Annexon.

“These funds allow us to accelerate both our clinical and preclinical programs with the goal of exploiting the vast potential of our pioneering approach to combating classical complement-mediated diseases.”

https://www.fiercebiotech.com/biotech/annexon-grabs-100m-from-a-host-top-vc-firms-for-complement-therapies

Protective antibodies identified for rare, polio-like disease in children

Researchers at Vanderbilt University Medical Center, Purdue University and the University of Wisconsin-Madison have isolated human monoclonal antibodies that potentially can prevent a rare but devastating polio-like illness in children linked to a respiratory viral infection.

The illness, called acute flaccid myelitis (AFM), causes sudden weakness in the arms and legs following a fever or respiratory illness. More than 600 cases have been identified since the U.S. Centers for Disease Control and Prevention began tracking the disease in 2014.

There is no specific treatment for AFM, which tends to strike in the late summer or early fall and which has been associated with some deaths. However, the disease has recently been linked to a group of respiratory viruses called enterovirus D68 (EV-D68).

Researchers at the Vanderbilt Vaccine Center isolated antibody-producing blood cells from the blood of children who had previously been infected by EV-D68. By fusing the blood cells to fast-growing myeloma cells, the researchers were able to generate a panel of monoclonal antibodies that potently neutralized the virus in laboratory studies.

Colleagues at Purdue determined the structure of the antibodies, which shed light on how they specifically recognize and bind to EV-D68. One of the antibodies protected mice from respiratory and neurologic disease when given either before or after infection by the enterovirus.

Comments from researchers

“We were excited to isolate potent human antibodies that inhibit this devastating polio-like virus, and these studies will form the basis for taking them forward to clinical trials,” Dr. James Crowe, director, Vanderbilt Vaccine Center; Ann Scott Carell Chair and professor of Pediatrics and Pathology, Microbiology and Immunology in the Vanderbilt University School of Medicine.

“Studying infectious disease from a very basic level and applying the results in an animal model of disease is very powerful; hopefully, our studies will translate to a future therapeutic for this disease in children,” Richard Kuhn, Purdue’s Trent and Judith Anderson Distinguished Professor in Science; Krenicki Family Director, Purdue Institute of Inflammation, Immunology and Infectious Disease

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The study was supported by National Institutes of Health grants HL069765, AI117905, HL070831, AI104317 and AI011219, and the Center for Structural Genomics of Infectious Diseases.

ABSTRACT

Human antibodies neutralize enterovirus D68 and protect against infection and paralytic disease

Matthew R. Vogt1, Jianing Fu2, Nurgun Kose3, Lauren E. Williamson4, Robin Bombardi3,

Ian Setliff5, Ivelin S. Georgiev3,4,5, Thomas Klose2, Michael G. Rossmann2 (deceased), Yury A. Bochkov6, James E. Gern6,7, Richard J. Kuhn2, James E. Crowe Jr.1,3,4,5

1Department of Pediatrics (Infectious Diseases), Vanderbilt University Medical Center, Nashville, Tenn.

2Department of Biological Sciences and Purdue Institute of Inflammation, Immunology, and Infectious Disease, Purdue University, West Lafayette, Ind.

3Vanderbilt Vaccine Center, Vanderbilt University Medical Center, Nashville, Tenn.

4Department of Pathology, Microbiology, and Immunology, Vanderbilt University Medical Center, Nashville, Tenn.

5Program in Chemical and Physical Biology, Vanderbilt University, Nashville, Tenn.

6Department of Pediatrics, University of Wisconsin-Madison, Madison, Wisc.

7Department of Medicine, University of Wisconsin-Madison, Madison, Wisc.

Enterovirus D68 (EV-D68) causes outbreaks of respiratory illness, and there is increasing evidence that it causes outbreaks of acute flaccid myelitis (AFM). There are no licensed therapies to prevent or treat EV-D68 infection or AFM disease. We isolated a panel of EV-D68-reactive human monoclonal antibodies that recognize diverse antigenic variants from participants with prior infection. One potently neutralizing cross-reactive antibody, EV68-228, protected mice from respiratory and neurologic disease when given either before or after infection. Cryo-electron microscopy studies revealed that EV68-228 and another potently neutralizing antibody (EV68-159) bound around the fivefold or threefold axes of symmetry on virion particles, respectively. The structures suggest diverse mechanisms of action by these antibodies. The high potency and effectiveness observed in vivo suggest that antibodies are a mechanistic correlate of protection against AFM disease and are candidates for clinical use in humans with EV-D68 infection.

https://www.eurekalert.org/pub_releases/2020-07/pu-pai070220.php