Avirmax Issued Patent for Enzyme to Treat Covid Beta Variants

 Avirmax, Inc. (www.avirmax.com), a company focused on delivering protein therapeutics via recombinant adeno-associated viral (rAAV) vectors announced today that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,453,869, which is directed to the composition and methods related to the use and administration of catalysis deactivated angiotensin-converting enzyme 2 (ACE2) for preventing SARS-COV-1 and SARS-COV-2 infection.

Patent Summary

Human ACE2 has been confirmed as a specific receptor for several β group coronaviruses including severe respiratory syndrome (SARS) coronavirus (SARS-CoV-1), a low pathogenic coronavirus of HCoV-NL63, a member in α-coronavirus group and SARS-CoV-2, the causative agent of COVID-19. The patent covers the extracellular domain (ECD) polypeptide of ACE2 with one or more mutations in the enzyme catalytic center that cause the loss of ACE2 catalytic activity (herein referred as ACE2-vECD) and enhance the binding affinity to the SARS-CoV1 and SARS-COV-2 S1 spike proteins. The ACE2-vECD fused to the Fc fragment of human IgG1 (ACE2-vECD-Fc1) can function as a common blocking reagent, similar to neutralization antibodies, preventing COVID-19 variants or SARS-COV1 to enter host cells and the viral replication cycle. The rAAV mediated expression of the catalysis deactivated ACE2 in nasal/olfactory epithelium therefore acts as a decoy receptor for SARS-COV blocking infection of epithelial cells and the following viral replication.

https://www.biospace.com/article/releases/avirmax-inc-announces-issuance-of-u-s-patent-covering-catalysis-deactivated-angiotensin-converting-enzyme-2-ace2-variants-for-treatment-of-beta-group-sars-cov-viral-infection/

Wasteful administrative spending costs U.S. healthcare up to $570B a year

 Administrative spending makes up 15% to 30% of all U.S. medical spending—multiple times as much as other comparable countries—and “at least half” of that spending “does not contribute to health outcomes in any discernable way,” according to estimates cited in a new Health Affairs research brief.

So-called wasteful administrative spending is estimated to comprise 7.5% to 15% of the nation’s total healthcare spending, translating to anywhere from $285 billion to $570 billion in 2019, the journal’s researchers wrote.

Those totals could reach even higher in recent years due pandemic-driven spending increases, as reports from the Centers for Medicare and Medicaid Services showed health spending increased from 17.7% of gross domestic product in 2019 to 19.7% in 2020.

Health Affairs calculated its estimates based on a review of seven published administrative spending analyses. These estimates largely varied due to what their authors defined as administrative costs.

“Some of these estimates encompass only billing- and insurance-related expenses and, as a result, are lower than those that include both billing- and insurance-related and non–billing- and insurance-related costs,” Health Affairs staff wrote in the brief.

“Even at the lower end of estimates, U.S. spending on administrative costs annually accounts for twice the spending on care for cardiovascular disease and three times the spending for cancer care.”

The journal contextualized the country’s spending with a Peterson Foundation analysis of 2021 data that estimated the U.S. spends $1,055 per capita on healthcare administrative costs. The next highest per capita administrative spending among wealthy Organisation for Economic Co-operation and Development members was Germany with $306.

Still, Health Affairs noted that it’s important to distinguish between overall administrative spend and administrative waste when weighing any systemic or targeted interventions.

“Not all administrative spending is wasteful. Much of it is necessary and efficient, facilitating coordination among multiple actors and allowing for a level of choice in insurers, benefits, plans, providers and procedures,” Health Affairs staff wrote in the brief.

The journal’s review highlighted three often-posed systemic reforms—all-payer rate setting, a single-payer system and capitated payments—as having “the potential to not only reduce administrative waste but also offer other benefits to the healthcare system.”

However, the review acknowledged that more targeted proposals are “more realistic and actionable in the U.S. in the near future” and could still bring hundreds of millions to billions in potential annual administrative waste savings. These proposed policies could include a centralized claims clearinghouse ($300 million estimated annual waste savings), a fully electronic prior authorization system ($417 million savings), harmonized quality reporting ($7 billion savings) and standardization of provider directories ($1.1 billion savings).

Regardless of the specific intervention, direction from the federal government will likely be most effective in corralling the industry’s diverse actors toward change, analyses cited by the journal agreed.

“It is notable that much of the literature on solutions to administrative waste proposes action by either the federal government or an agency created by the same, perhaps because of a glaring market failure inherent to administrative costs: they are not generally borne by those imposing them,” Health Affairs staff wrote.

https://www.fiercehealthcare.com/finance/administrative-waste-makes-75-15-total-us-healthcare-spending-review-estimates

September jobs gain brings healthcare back to pre-pandemic employment

 Healthcare employment saw major gains in September and jobs numbers not seen since February 2020, according to the U.S. Bureau of Labor Statistics’ monthly report released Friday morning.

The preliminary data show hospitals, ambulatory healthcare services and nursing and residential care facilities added roughly 60,100 jobs last month, accounting for more than a fifth of all jobs gained across the U.S. economy. 

Employment in the sector had picked up over the summer with 56,700 jobs added in June, 69,600 in July and 48,200 in August, according to BLS. The healthcare industry is up by about 489,800 jobs since September of last year.

The month's growth was largely split between hospitals and ambulatory care, with the former picking up 27,500 jobs and the latter adding 28,100.

“It’s a pleasant surprise, but I would caution against operators reading too much into it,” Matt Wolf, director and healthcare senior analyst at consulting firm RSM US, told Fierce Healthcare. “We've also seen unemployment decline, labor force participation rates decline as well, which further supports the narrative that we've seen that the hospital operators just simply aren't going to be able to hire their way out of this situation.”

Economy-wide unemployment dipped from 3.7% in September to 3.5%, according to BLS, while labor force participation inched down a tenth of a percent to 62.3%.

While healthcare has returned to its pre-pandemic employment numbers, Wolf noted that demand hasn't spent the past two and a half years waiting around.

Total national health expenditure as measured by the Centers for Medicare and Medicaid Services was $4.1 trillion in 2020 and is estimated to hit $4.5 trillion in 2022, he said.

“That's a 10% increase in health expenditures in two years,” Wolf said. “We still have a much higher demand, still have about 10,000 Americans becoming eligible for Medicare every day, and we're just now back to the pre-pandemic level of employment.”

“We’re going to have to find new ways to leverage technology, automation, analytics, different clinical workflows, different ways of approaching healthcare in general in order to meet the demand,” he continued. “We just won’t be able to hire enough doctors and enough nurses and enough administrators to solve healthcare problems in the way that we did prior to the pandemic. Demand is increasing much faster than the supply of labor.”

September’s strong jobs showing among hospitals and ambulatory care was not shared by nursing and residential care facilities, which according to BLS added just 4,500 positions since August.

The subsector had seen gains of roughly 11,000 jobs per month since April. Industry groups have warned throughout the pandemic of hundreds of thousands of job vacancies across these settings that limit hospital discharges and jeopardize other downstream care.

Much of the challenge for nursing and residential care facilities has been competition from other industries that have increased their wages over the past few years, Wolf said.

“We have a lot of other employers outside of healthcare—retailers, food service—that are paying $19 an hour and offering additional benefits,” he said. “A lot of the caregivers in senior care said ‘Well, I can go and make similar money working outside of this industry,’ and for many of them the work is much better—they’re restocking shelves, not changing colostomy bags.”

Healthcare facilities are often slower to increase wages than other industries because they are largely unable to raise prices and pass along the costs to consumers, he noted.

Hospitals and ambulatory settings’ clinical workforce have been less affected by the rising wage floor as these positions already demanded higher rates, Wolf said. Their administrative workers, however, are still ripe for the picking.

“On the administrative side we’ve seen that the competition isn’t so much in what they’re paying, but [if] there’s flexibility,” he said. “By and large, other industries are more flexible with their administrative functions, allowing them to work from home. We’ve, anecdotally, worked with a lot of clients and systems where, as they emerged from the pandemic, they told their IT people or their rev cycle people or whomever ‘Okay, we’re now going back into the office five days a week.’

“Those functions just said no and went and worked in other industries. That’s challenging for healthcare systems to navigate well. Many providers are doing it well, and many have things to learn yet about managing a hybrid workforce.”

https://www.fiercehealthcare.com/providers/septembers-strong-jobs-gain-brings-healthcare-back-pre-pandemic-employment-bls-reports

Desert Oasis Healthcare signs on to pilot Google Health's Care Studio for outpatient care

 Medical group Desert Oasis Healthcare has jumped on board to pilot Google Health's clinical software Care Studio.

It marks Google Health's third provider partnership, and its first outpatient collaboration, for its clinician-facing search tool that harmonizes healthcare data from different sources.

Starting next year, a small number of Desert Oasis Healthcare clinicians will test out Care Studio’s search and summarization capabilities that leverage artificial intelligence to bring context to physicians' clinical notes. The plan is to gradually expand the technology to more users over time, the organizations told Fierce Healthcare in an exclusive interview this week.

"This is really impressive technology. We are kind of geeked to work with Google on this shared mission," Brian Hodgkins, Pharm.D., executive vice president of clinical operations and ACO at Desert Oasis Healthcare said in an interview. "We honestly expect this to be a game changer for healthcare."

Care Studio was born out of Google's partnership with Ascension to pilot an electronic health record search tool that pulls patient electronic health records into an interface to help clinicians more easily find useful information. In February 2021, Beth Israel Deaconess Medical Center also signed on to pilot the clinical search tool, since named Care Studio.

At the ViVE 2022 conference in March, Google Health unveiled a new feature, called Conditions, that uses natural language processing (NLP) to provide physicians with a dynamic list of conditions pulled from the patient record plus related information including medications, labs, vitals and notes.

Also last spring Google Health announced a partnership with Meditech, marking Care Studio's first integration with an electronic health record vendor.

Desert Oasis Healthcare, part of the Heritage Provider Network, is a network of primary and specialty care providers that provide primary care, immediate care, home health, palliative care, clinical research studies and other services to more than 60,000 members and patients living in the greater Coachella Valley and the Morongo Basin of Riverside and San Bernardino counties in Southern California.

The organization is comprised of about 110 primary care providers and 350 specialists.

DOHC serves a population with complex medical histories, often managing chronic conditions. The medical group takes a preventive approach to care, but data fragmentation and information silos make this challenging, according to Hodgkins. Oftentimes, clinicians have to comb through different systems to understand a patient’s medical history to prepare for their visits.

Google Health's Care Studio technology will give DOHC clinicians a more complete picture of a patient’s history all in one place, according to Paul Muret, vice president and general manager of Care Studio at Google Health.

For Google, the partnership provides the tech giant's healthcare division an opportunity to explore the use of its technology in a value-based care setting, Muret said.

"Desert Oasis Healthcare is a value-based primary care organization focused on annual wellness and care coordination and they have a large Medicare Advantage program. What's exciting about that is they are looking to take care of patients in a much more holistic way to really help keep them healthy. To do that, they really need comprehensive and deep information about each patient so they can really see the conditions and issues and things that are going on with each patient," he said.

Muret added, "It really lines up nicely with our ability to organize information that's both structured and unstructured and look across different systems and summarize that in ways that is really effective for clinicians. We're very excited to work with them and we think it's a great match."

Muret stressed that the patient information shared with Google Health by DOHC and its providers is protected by HIPAA (The Health Insurance Portability and Accountability Act) and covered under a business associate agreement between the parties. The data shared with Google Health to provide Care Studio will be used solely to provide Care Studio services to DOHC. 

Google will not use patient data for advertising, nor will we sell patient data, he said.

The medical group plans to pilot Care Studio in its Wellness Clinic, which provides a yearly comprehensive clinical assessment for senior patients including lab work and evaluation of chronic conditions to develop a preventive care plan. About 15,000 of DOHC's 30,000 senior patients utilize these services.

During these wellness visits, care teams need to quickly get up to speed on a patient's history and easily see what’s happened with a patient since their last visit. And even with the right data, it can be difficult for care providers to make sense of the most relevant information, Hodgkins said.

"I have 12 providers doing this service. They see 15,000 people and they do a great job, but I have 30,000 seniors and I would like to put them all through this process. In order to do that we have to find some efficiencies in the way that we work. We believe that Care Studio represents the smart solution for our smart clinicians. Google Health's technology can find the proverbial needle in the haystack of medical information," he said.

With Care Studio, Google Health is bringing to bear its medically-tuned search capabilities including the ability to search through scanned documents, faxes and PDFs. The software's Conditions feature provides a concise summary of a patient’s medical conditions, along with context and related information, including labs, medications and reports to help clinicians manage and treat conditions, according to Google Health.

Care Studio's ability to harmonize data quickly and extract meaning out of clinical data can help primary care clinicians provide care more efficiently, Hodgkins said.

"It's about providing good care. In primary care, it's time-consuming. Our population is aged. We have vast differences in socioeconomic status. They have a high burden of disease," he said. "We have to be able to manage this complex population in the midst of a PCP (primary care provider) shortage. Physicians spend time researching patients trying to find information that's really hidden from them in this huge data warehouse known as PHI (protected health information). If  we can put that information in front of the physician, make it more accessible, it makes them work smarter, makes the patient feel more comfortable and the outcomes necessarily are going to be better."

Hodgkins is bullish on the potential of Google's tech expertise to improve healthcare in partnership with providers. "We can do things Google cannot do. And Google can do things we can't do. But together we expect to do great things," he said. " This collaborative relationship is one between our pioneering compassionate healthcare organization and this iconic, innovative technology company that literally has changed the way we interpret the world."

The long-term plan, according to Hodgkins, is to roll out Care Studio across the entire Heritage Provider Network of primary care doctors serving nearly 700,000 patients in California.

Google and its first health system partner, Ascension, faced widespread criticism back in 2019 after news broke about a patient data-sharing arrangement between the two organizations. Google and Ascension both faced significant blowback, including scrutiny from regulators and lawmakers, following news that Google was collecting personal health information on millions of Americans as part of a partnership with the health system.

Controversy swirled around one key aspect of the partnership to pilot an EHR search tool that pulls patient electronic health records into an interface to help clinicians more easily find useful information.

But Google Health has since signed on BIDMC as another major pilot partner and an integration with EHR vendor Meditech.

Desert Oasis Healthcare has a history of working with innovative technology partners, Hodgkins said, and the organization feels confident about Google's approach to data privacy and security.

"Protected health information, in our eyes, is sacred. Everything that we do is predicated on making sure we're protecting patients' health information. We've never worked with a company that's been so dedicated to the same mission. We feel very comfortable that the PHI that we're sharing through our business associate agreement and in the cloud-based algorithms that we'll be using that our patients' PHI is safe and protected," he said.

https://www.fiercehealthcare.com/health-tech/google-health-notches-another-provider-partner-care-studio

Teen drivers often unsafe on the road with speeding and handheld cellphone

 Motor vehicle crashes are a leading cause of death in adolescents, and risky driving behaviors like speeding, rapid accelerations, and cellphone use can contribute to crashes. New research presented during the 2022 American Academy of Pediatrics National Conference & Exhibition finds many teens struggle to abide the rules of the road.

Authors of the abstract, "Using a Novel cellphone Telematic App to Measure Adolescent Driving Behaviors," found that all teens, no matter their sex, behind the wheel of a car were prone to risky behaviors, particularly handheld cellphone use and speeding. Among teen drivers studied, speeding occurred in approximately 40% of trips, and handheld phone use was detected in just over 30% of trips. In 5% of trips tracked by the study, teenagers were using a cellphone while speeding.

"Our data gives us another insight into teen driving behaviors. Teens were speeding and using their cellphone while driving, but it did not occur in every trip. We want to encourage safe driving and find ways to help prevent those risky driving behaviors that can lead to a crash," said lead author Catherine McDonald, PhD, RN, FAAN, Associate Professor at the University of Pennsylvania School of Nursing and Co-Director of the PENN Injury Science Center.

The researchers used a cellphone application to track the driving skills of 165 adolescents in Pennsylvania. The average age of teens in the study was 17.3 years, and the average length of licensure was 8 months. The study found that most adolescents drove short trips, an average of under 6 miles per trip, and less than 2% of trips were at night.

There were a couple differences between the driving habits of males and females. Hard braking and rapid accelerations occurred in only about 10% of trips, but males in the sample engaged in this risky driving behavior more often than females. However, there were no significant differences between the males and females in speeding, cellphone use, or nighttime driving.

"Given the rapidly changing technology in the daily life of adolescents, this study also builds on previous research and helps to identify patterns related to cellphone use while driving among adolescents," Dr. McDonald said. "Behavioral variations in this sample highlight opportunities for targeted interventions on risky driving."

This research was supported by the Centers for Disease Control and Prevention and by the National Institute of Nursing Research of the National Institutes of Health.

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Materials provided by American Academy of Pediatrics. Note: Content may be edited for style and length.

https://www.sciencedaily.com/releases/2022/10/221007085737.htm

Kids hospitalized for E-scooter injuries surge from 2011-2020

 Standing electric scooters, commonly referred to as e-scooters, have been increasing in popularity across the country over the past decade. According to a new research abstract presented during the 2022 American Academy of Pediatrics National Conference & Exhibition, e-scooter injuries are becoming much more common and increasingly severe.

Authors of the abstract, "National Trends in Pediatric e-Scooter Injury," found hundreds of e-scooter injuries between 2011-2020. The rate of hospital admittance for patients increased from fewer than 1 out of every 20 e-scooter injuries in 2011 to 1 out of every 8 requiring admittance into a hospital for care in 2020.

"The number of annual e-scooter injuries has increased from 2011 to 2020, likely due in some part to the rise in popularity of rideshare e-scooter apps," said lead author Harrison Hayward, MD, Emergency Medicine fellow at Children's National Hospital. "Our study has characterized the spectrum of injuries that occur in children, which helps emergency room doctors prepare for taking care of them and helps parents and families to practice better safety."

Researchers examined a national database of pediatric e-scooter injuries that were seen in emergency departments at over 100 US hospitals from 2011-2020 to find out what kinds of injuries children were sustaining and if any trends existed. Over 10% of all patients had a head injury, including a concussion, skull fractures, and internal bleeding. The most common injuries were arm fractures (27%), followed by minor abrasions (22%) and lacerations needing stitches (17%). The average age was 11.1 years and 59% of patients were male. Admittance to a hospital rose from 4.2% in 2011 to 12.9% in 2020.

"Parents whose children are riding e-scooters need to know how best to be safe. To that end, helmets are a must, since over 10% of the reported cases were head injuries," said Dr. Hayward. "Children should absolutely be wearing helmets while riding an e-scooter. Research has broadly demonstrated that helmets save lives for bicycle riders, and we should think similarly about e-scooters."

The authors did not receive financial support for this research.

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Materials provided by American Academy of Pediatrics. Note: Content may be edited for style and length.

https://www.sciencedaily.com/releases/2022/10/221007085739.htm

Florida Surgeon General Recommends Against mRNA COVID-19 Vaccines For Males Aged 18–39

 by Mimi Nguyen Ly via The Epoch Times,

Florida’s Surgeon General, Dr. Joseph A. Ladapo, announced new guidance on messenger RNA (mRNA) vaccines on Friday, specifically recommending against mRNA COVID-19 vaccines for males aged 18 to 39.

Messenger RNA is the technology utilized by both the Pfizer and Moderna COVID-19 vaccines, the most administered vaccines in the United States and a number of other countries.

The new guidance came after the Florida Department of Health carried out an analysis to evaluate vaccine safety, the department said in a bulletin on Friday.

The statewide analysis of vaccinated Florida residents aged 18 years or older (pdf) found an 84 percent increase in the relative incidence of cardiac-related deaths among males aged 18–39, within 28 days of mRNA vaccination.

“Non-mRNA vaccines were not found to have these increased risks,” the Florida Department of Health noted.

Given the high level of global immunity to COVID-19, the benefit of vaccination with mRNA vaccines “is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group,” the department said.

“As such, the State Surgeon General recommends against males aged 18 to 39 from receiving mRNA COVID-19 vaccines,” it said. “Those with preexisting cardiac conditions, such as myocarditis and pericarditis, should take particular caution when making this decision.”

“Far less attention has been paid to safety and the concerns of many individuals have been dismissed—these are important findings that should be communicated to Floridians,” Ladapo said in a statement, referring to the analysis.

In the new guidance (pdf), Florida’s health department said it also “continues to stand by” its guidance for pediatric COVID-19 vaccines it issued in March. That guidance (pdf) recommends against COVID-19 vaccination for healthy children and adolescents aged 5–17. It now also recommends against COVID-19 vaccination among infants and children under five years old.

Statewide Analysis

The analysis from the Florida Health Department that informed Ladapo’s latest recommendation had sought to “evaluate the risks of all-cause and cardiac-related mortality following COVID-19 vaccination.”

Residents in Florida aged 18 years or older who died within 25 weeks of having received a COVID-19 vaccine, since the start of the vaccination roll-out in the state—Dec. 15, 2020—were included. The study end date was June 1, 2022.

People were excluded from the study if they had a documented COVID-19 infection, had a COVID-19 associated death, had received a COVID-19 vaccine booster, or had received their last COVID-19 vaccine after Dec. 8 2021. The last criterion was put in place to make sure that each person was followed up after 25 weeks.

The study found that COVID-19 vaccination “was not associated with an elevated risk for all-cause mortality,” but “was associated with a modestly increased risk for cardiac-related mortality 28 days following vaccination.”

“Results from the stratified analysis for cardiac-related death following vaccination suggests mRNA vaccination may be driving the increased risk in males, especially among males aged 18–39,” according to the analysis.

It also noted that the risk for both all-cause and cardiac-related deaths was “substantially higher 28 days following COVID-19 infection.”

As such, the study concluded that people should weigh the risk associated with mRNA vaccination with the risk associated with COVID-19 infection.

The analysis was a self-controlled case series (SCCS), which is a study design originally developed to evaluate vaccine safety, the department stated. The SCCS method uses individuals as their own control, such that comparisons are made within individuals.

The U.S. Food and Drug Administration’s authorization of the Pfizer-BioNTech and Moderna COVID-19 vaccines for emergency use in 2020 marked the first time it did so for vaccines that use mRNA technology.

According to the FDA, the mRNA vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the distinctive spike protein of the virus. When a person receives the vaccine, their body produces copies of the spike protein which “does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response” against the virus, according to the agency.

The mRNA-based COVID-19 vaccines from Pfizer-BioNTech and from Moderna have both been linked with heart inflammation, including myocarditis and pericarditis, data from around the world have suggested. Younger populations, especially young men, have been observed to experience these conditions at much higher than expected rates, data from the Centers for Disease Control and Prevention (CDC) previously suggested. A small number of deaths from heart inflammation after COVID-19 vaccine have also been reported.

The primary regimens of the vaccines, which are two doses administrated several weeks apart, were insufficient to protect against infection and showed waning efficacy in protecting against hospitalization amid newly-emerging variants. This prompted the governments of many countries to recommend boosters and subsequent boosters throughout the COVID-19 pandemic.

https://www.zerohedge.com/covid-19/florida-surgeon-general-recommends-against-mrna-covid-19-vaccines-males-aged-18-39