Tag Archives: Pharmacy

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For public health, a momentous collision and missed opportunities

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The COVID-19 pandemic took a new and surprising turn as October began when the President of the United States tested positive for the virus, as did many of his associates and direct contacts. At a volatile time during a highly charged election cycle, more than 1 million dead worldwide, and a mounting number of infections in countries around the world, the collision of this novel coronavirus with the leader of what some dub “the only superpower on earth” is one that cannot be brushed aside.

Can this direct meeting of the virus and such an influential leader deliver an outcome other than more missed opportunities and misinformation?

“Don’t Be Afraid of COVID”

Discharged from Walter Reed Army Medical Center after four hospitalized nights, the President quickly tweeted, “Don’t be afraid of COVID. Don’t let it dominate your life.” One might imagine those 11 words sending chills down the spines of healthcare providers, infectious disease specialists, and public health experts who were likely hoping for a humbler, more unifying message to be delivered to the American public after their highest elected leader’s close brush with this existential enemy.

In the face of a new surge of cases nationwide amidst the oncoming flu season, we are indeed preparing for all eventualities, and this presidential missive was an extremely unfortunate, poorly timed, and potentially highly deleterious miscalculation.

Fear of COVID-19 is, for all intents and purposes, a healthy fear, especially as the numbers of sick and dead continue to expand. A lack of unified messaging has been the United States’ tragic Achilles’ heel since the virus reached our shores, as has the politicization of mask-wearing and the mocking of the practice when citizens truly need to be encouraged to follow clear guidelines backed by irrefutable evidence.

Fear of the coronavirus and the potential for death can galvanize thoughtful citizens to do their due diligence by wearing masks, practicing social distancing, traveling only when essential, limiting close interaction to select family members and/or friends, and otherwise being prudent vis-à-vis avoiding contracting and spreading the virus.

When politicians and other figures of influence sow confusion, stoke mistrust in science, and undermine the efforts of those working tirelessly in the fields of science, medicine, and public health, a different kind of fear sets in: the fear, on the part of those who understand the science, that their work to protect public safety will continue to be hampered, if not crippled.

When Intelligence Trumps Ignorance

The willful encouragement of ignorance leads to misdirected anger, suspicion, and groupthink that directly oppose the judicious employment of intelligence and facts. And when elected leaders choose to fan the flames of ignorance and suspicion in the face of an existential threat such as this virus, this cavalier dismissiveness spreads like necrotic tissue. Something is indeed rotten in Denmark, as Marcellus utters in “Hamlet,” and the peddling of misinformation and dismissive attitudes towards our viral common enemy is endangerment of the highest order.

We all have an enormous responsibility to do our part in this all-out war on the novel coronavirus that has a consistently tenacious and universal hold on humanity. Countless citizens and public servants of all stripes will most certainly fall on the right side of history by using science, facts, and innate intelligence as their guide to making judicious choices, engaging in sensible behavior, and working as part of a united front that will, in the end, overcome the ravages of this pandemic and excise the aforementioned necrosis of ignorance.

Intelligence must trump ignorance in the end, and if a collision with the virus itself cannot change the irresponsible behavior of those in power, then power must be shifted so that reason can once again rule the day.

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The power of curiosity and critical thinking in healthcare

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In healthcare, thinking critically is central to successful outcomes. In research, education, and other avenues of inquiry, it is the ability to examine a situation from as many angles as possible that drives innovation forward.

Simultaneously, curiosity is a key factor in the unlocking of potential solutions. Curiosity is one driver of critical thinking, and the aptitude for thinking critically can lead to a never-ending positive feedback loop of discovery.

Critical Thinking and Curiosity: Essential Skills

A 2014 article published on the website of the National Library of Medicine states that for nursing students to think critically, they must “develop independence of thought, fairness, perspicacity [at the] personal and social level, humility, spiritual courage, integrity, perseverance, self-confidence, interest in research, and curiosity.”

The article continues:

The Socratic Method, where the question and the answer are sought, is a technique in which one can investigate below the surface, recognize and examine the condition, look for the consequences, investigate the multiple data views and distinguish between what one knows and what he simply believes.”

We note that curiosity is mentioned as a key characteristic in the development of critical thinking, and that looking “below the surface” can lead to novel insights.

In a Harvard Business Review article entitled “Why Curiosity Matters,” author Francesca Gino writes, “The impulse to seek new information and experiences and explore novel possibilities is a basic human attribute.” She adds, “When our curiosity is triggered, we think more deeply and rationally about decisions and come up with more-creative solutions.”

No salient argument can be made against critical thinking and curiosity being essential in the minds of those pursuing the advancement of knowledge. What impact do the above-named characteristics have in breeding such abilities?

The Critical Thinking Muscle

Circling back to the 2014 article referenced above, we recognize that independence of thought is central to the development of critical thinking, as are other attributes. Let’s examine each in turn.

Independence of thought: When a clinician has independence of thought, they are not easily swayed by the herd mentality. An independent thinker might notice colleagues saying, “That’s the way we’ve always done it,” but will be curious why no one else has asked, “But why?” Going against groupthink, the independent thinker pursues creative solutions.

Fairness: Using fairness as a barometer, the independent critical thinker gives each possibility equal attention, withholding judgment and seeing possibilities without bias.

Perspicacity at the personal and social level: Perspicacity manifests as discernment and clear-sightedness. The perspicacious critical thinker sees his or her work in the context of their own lives and the greater society. This portends pulling the metaphorical camera back and seeing the bigger picture.

Humility: Hubris can be the death of good clinical practice. Feeling that one cannot possibly be wrong can be the utter downfall of a clinician’s ability to make prudent decisions. Humility is the ability to say, “I don’t know” or “I was mistaken.” Without humility, critical thinking withers on the vine.

Spiritual courage: Spirituality doesn’t necessarily reflect religious belief. Rather, spiritual courage means seeing deeply into the human condition, the larger forces at play, and the aspects of human frailty that make life simultaneously so precious and so tenuous.

Integrity: With integrity, a sense of honor pervades the individual’s practice. Having integrity points to honesty, truthfulness, and decency.

Perseverance: Without perseverance, healthcare providers and patients alike cannot achieve optimal outcomes. A critical thinker perseveres and moves through perceived roadblocks to new realizations.

Self-confidence: Self-confidence is essential for the critical thinker to move into the unknown. Without self-confidence, we lean on what we already know and miss out on manifesting a new vision.

Interest in research: Research is critical thinking in action. Hypotheses are tested, rejected, retooled, and tested again. We must embrace this process in order to curiously explore.

The Winds of Innovation

These essential characteristics make critical thinkers who they are; thus, we must teach them, instill them in others, and nurture their development.

In an uncertain world, those who think critically with the power of the above-named characteristics as their engines can bring about great evolution of thought, and increased hope in a world so desperately in need.

We have the power to stretch, explore, and innovate. When we empower critical thinkers in curiously and fearlessly applying their minds and hearts to the task at hand, the door to potentially life-changing innovation is blown wide open. And when that door is open, the winds of innovation are welcomed into a world ready for novel insights that can improve health, save lives, and encourage even more innovation to take place in the interest of the greater good.

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How the election will affect manufacturing

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Manufacturing is a crucial issue for the 2020 election. According to a Morning Consult column, this was supposed to be the year of the manufacturing election. Both Biden and Trump have revealed plans to revive the economy and the manufacturing sector. The latter is directly proportional to the well-being of the former.

However, when Morning Consult made that prediction, in February, it had a robust and running industry in mind. But then came COVID-19 and lockdowns that brought entire industries to a halt. Yet, manufacturing remains a pivotal factor.

The Morning Consult column referenced a study finding that nine in 10 voters believe manufacturing is critical to economic revival. Months after the disruption wrought by COVID-19, those views are as strong as ever.

Each presidential candidate has proclaimed to bring about political and economic stability. To do so, they will have to overcome an unprecedented pandemic, usher in an era of domestic manufacturing jobs, and establish sound international trade policies.

Some of the key election issues for manufacturers are:

  • Creating and training a skilled workforce to match the digitization of the industry
  • Encouraging companies to invest in R&D with less red tape and tax credits
  • Help manufacturers navigate the complex international trading environment
  • Incentivize companies to digitize on their own like their international counterparts
  • Bring about digital transformation and agile supply chain resiliency
  • Immigration reform and employment-based visa categories to develop a diverse and talented workforce
  • Permanent pro-growth provisions in the tax code and continual assessment of the competitiveness of the U.S. tax system

Most local manufacturers want the next president to focus on coronavirus recovery. Next, they want to bridge the skills gap, workforce development, provide better healthcare, and fix aging infrastructure.

Diversifying the talent pipeline is essential to sustain the evolving manufacturing landscape. A study by Deloitte and The Manufacturing Institute stated that the sector would need 4.6 million workers by 2028.

Both candidates plan to spend on infrastructure during the next four years. Improving aging infrastructure would benefit manufacturing to a certain extent.

Biden’s manufacturing plan involves tax credit for businesses that bring back manufacturing jobs by revitalizing a closed or existing factory. He also mentioned a penalty tax on foreign earnings. Trump announced a tax credit for companies that bring back jobs from China. He pledged no federal contracts for companies that outsource to China.

Economists agree the next administration has a crucial role to play in the future of U.S. manufacturing. Biden’s plans also include investing in vocational training. He is encouraging partnerships between employers and community colleges. The Trump administration is creating incentives for private-level apprenticeships.

One thing both candidates agree upon is the difficulty of maintaining a trade relationship with China. They are equally concerned about the rise of China as a formidable rival in trade. However, their approach to international trade is vastly different.

Trump likes to make discrete trade deals between smaller parties. Biden favors trade agreements where a coalition between the U.S. and a larger group of countries can be built. This would lead to more comprehensive trade rules. Economists feel that the coalition-based trade philosophy improves access for small manufacturers. They can bypass the complex web of trade relationships with each country this way.

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Study: Back-to-school strategies during the COVID-19 pandemic

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One of the most debated and important issues concerning coronavirus disease 2019 (COVID-19) is the reopening of schools. The health, safety, and well-being of students, teachers, staff, and their families are critical considerations in determining whether schools should reopen for in-person learning.

Until recently, it has been thought that children were spared by severe illness, and in the majority of cases, children infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) only develop a mild illness; some are asymptomatic. One study looked at nearly 200 children who visited urgent care clinics or hospitals associated with Massachusetts General with suspected COVID-19, almost 50 of whom tested positive. Most of the children were not particularly ill, and only about half who tested positive had a fever.

While children represent only 9.1% of all cases in states reporting cases by age, over 406,000 children have tested positive for COVID-19 since the onset of the pandemic.However, 75,755 new child cases were reported from July 30 to August 7, 2020 (320,954 to 396,709), a 24% increase in child cases over two weeks.

A recent study shows that children carry high levels of the SARS-CoV-2 even without falling ill, which may impact the spread of the virus to others, especially those at high risk. The researchers also found that infected children younger than five years of age may carry up to 100 times as much of SARS-CoV-2 in their noses and throats as adults do, suggesting the possibility that the youngest children transmit the virus as much as other groups, even if they only develop mild to moderate illness.

One important strategy that school administrators can consider about opening schools is cohorting or forming pods, in which groups of students and sometimes teachers or staff stay together throughout the school day to minimize exposure. Ideally, students and staff within a cohort would only have physical proximity with others in the same cohort, which may help prevent the spread of the virus by limiting crossover of students, teachers, and staff. Since the virus is known to spread via respiratory droplets, it is important to address those features of schools that foster transmission, mainly, crowding.

Some schools that already reopened had to close within a week due to exposure to confirmed COVID-19 cases, indicating that detailed guidelines on both when to reopen and how to reopen are necessary.

A new study described a simple model that will help explore and understand variations in infection rates in both adults and children with different reopening approaches and criteria. The researchers based their analysis on an age-stratified assignment of all those in each school scenario into either 1, 2 or 3 groups. The age-based classification creates a cohort of adults and another of children. Each cohort is ascribed to homogeneous disease attributes.

Using a stratified Susceptible-Exposed-Infected-Removed model, they explored the influences of reduced class density, transmission mitigation (such as the use of masks, desk shields, frequent surface cleaning, or outdoor instruction), and viral detection on cumulative prevalence.

The aim of creating more than one cohort is to reduce student density in the classroom, thereby helping to analyze how re-opening at full capacity compares with re-opening at half-capacity with the remaining students continuing remote learning (parallel cohort strategy), or rotating cohorts between alternate weeks or three weeks. These are rotating cohorts.

The simulations in this study suggest that measures that reduce class density by rotating cohorts between in-person and online schooling are likely to have the greatest impact in reducing the spread of SARS-CoV-2 brought on by resuming in-person classroom instruction. The study model predicted that a combination of all three approaches will substantially reduce SARS-CoV-2 prevalence. The model also shows that reduction of class density and the implementation of rapid viral testing, even with imperfect detection, have greater impact than moderate measures for transmission mitigation.

According to the researchers, reducing the number or density of contacts produces a larger effect than diminishing the transmission rate per contact, findings that may help guide the public health policies regarding school reopenings.

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The 5 best practices COVID-19 has created for the spa industry

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It’s important to see how adapting to the challenges of a pandemic has actually strengthened our industry in many ways. Pat yourself on the back if you have had to make serious changes to your business; it hasn’t been easy, I know.

However, though it was hard at first, as time goes on, we become accustomed to these new and improved measures to keep our customers and staff safe during these novel and demanding times. And as a result, we should note the best practices that have evolved from this time and continue to practice them going forward.

1. Efficient flow of service.

One of the biggest benefits of limiting the number of people in your spa is that you have to be really efficient with your staff, scheduling and utilization of your physical space. Online and text message booking has freed up the phone lines in many cases.

Appointment times are set more generously to allow time for proper sanitation between clients. As a result, we are not overbooking clients and causing undesirable wait times and delays. In return, clients are honoring their appointment times more readily and realizing they cannot and shouldn’t be late for them.

We have new systems in place for physical distancing and we are communicating novel strategies for clients to adhere to, so they know they are safe. These are certainly excellent aspects to pursue going forward.

2. In-spa sanitation is the new norm.

Hand sanitizer stations at the entrances of your spa or salon is a fantastic best practice that has come out of this pandemic. Clients are enjoying the touchless soap dispensers and paper towel machines. Air purification equipment is a great add-on as well.

Requiring face coverings to protect the vulnerable population in your spa is also a huge plus. Encouraging hand washing and allowing clients to reschedule when they are ill is advantageous for the health and well-being of your facility. Estheticians and spa owners are becoming accustomed to using equipment like the face shields and disinfecting common areas throughout the day; it’s a great way to maintain a safe environment and keep germs at bay, pandemic or not.

3. Technicians are more protected.

By now, your skin care providers and estheticians are used to using the PPE required for their jobs. In fact, your staff may even feel more safe and secure using their face coverings, shields and gloves. Moreover, even if state and local health regulations do not require these measures in the future, it may not stop staff members from using them. Heightened sanitation procedures and PPE help staff feel confident about performing their duties; they know they are protecting themselves and the people around them. In a country where sanitation measures vary so much, state by state, this pandemic has raised the bar and allowed everyone to work on their A-game.

4. Quality of service improved.

Many spas have streamlined their spa menus; trimmed the fat, so to speak. Because time and space are of the essence, we now focus on offering our most popular and effective services. We are listening to what our clients actually need from us and we are delivering.

We are getting used to booking virtual appointments, whenever possible, to keep everyone safe. We are offering curbside pickup and online ordering, when possible, for retail products. We are working with vendors to offer great promotions and monthly specials. If anything, these unprecedented times have forced us to present our best selves and services to our community and clients.

5. More relaxing guest experience.

Have you noticed that your spa or medspa has become a more relaxed and tranquil place? Your clients are receiving more one-on-one attention and individual service. Many business owners are commenting that now that guests of clients are not permitted in the spa that their lobbies and waiting rooms are much more appealing.

Gone are the days of tagalongs and children filling your lobby or waiting room creating unneeded commotion and noise. While it may pose a slight inconvenience for your clients, we can see the many benefits of keeping visitors to a minimum at your spa.

Follow my expert advice and see that there are some brilliant best practices that have come from this challenging time. Increased efficiency in flow of service, better sanitation, safer working conditions, improved services and more relaxing guest experiences are benefits that will last. What benefits have you observed from this challenging time?

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How far can employers go with COVID-19 testing?

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The Equal Employment Opportunity Commission (EEOC) has issued guidelines on COVID-19 testing in the workplace. While the guidelines say that employers can screen employees for COVID-19, they also contain parameters.

Per the EEOC, employers can conduct viral tests if specific conditions are met.

Generally speaking, the Americans with Disabilities Act (ADA) prohibits mandatory medical tests of employees except for when the testing is “job related and consistent with business necessity.”

Regarding the COVID-19 pandemic, the EEOC says that employers can administer viral tests to employees before they enter the workplace, so as to determine whether they have COVID-19 — as an employee with the virus “will pose a direct threat to the health of others.” (Note that a viral test shows whether the individual currently has COVID-19.)

The ability to conduct viral testing for COVID-19 isn’t limited to employers covered by the ADA. “For all employers, regardless of size, viral testing for COVID-19 is permissible, provided it is job related,” said Molly DiBianca, employment attorney at Clark Hill PLC.

She added, “It would not be job related to require viral testing for employees who are working remotely and who have no in-person contact with coworkers, clients, or customers. However, if an employee will or may have in-person contact, viral testing is permissible provided it is done correctly.”

As stated by the EEOC, employers must make sure the tests are “accurate and reliable.” When deciphering what may or may not be safe and accurate testing, employers can refer to guidance from the U.S. Food & Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC), and other public health authorities.

Employers should also consider false-positives or false-negatives tied to a particular test, and that a negative test does not mean the employee won’t catch the virus later.

Temperature checks are permitted.

Pursuant to EEOC guidance, employers can require all employees to undergo daily temperature checks before entering the worksite. However, employers should remember that not everyone with a fever has COVID-19, and not everyone with COVID-19 has a fever.

When considering whether to implement temperature screenings for employees, employers should consider the logistics of managing the screening process,” said DiBianca. “The person designated to perform the temperature screening should be properly trained and must be provided with all necessary personal protective equipment, such as gloves and mask. Ideally, employers should conduct temperature checks in a private area, out of sight of other employees, and should keep the results confidential.”

DiBianca asserted that taking an employee’s temperature is considered a medical exam; so, the employer may not share the results of the test with persons who do not have a legitimate reason to know. Further, the results constitute private medical information and therefore may not be recorded in the employee’s personnel file.

Mandatory antibody testing is not permitted.

Whereas viral testing shows whether the individual currently has COVID-19, antibody testing might reveal whether they previously had the virus.

Under EEOC guidelines, antibody testing for COVID-19 is a medical exam that is not “job related and consistent with business necessity.” Therefore, ADA-covered employers should not require COVID-19 antibody testing.

As for employers not covered by the ADA — meaning, those with fewer than 15 employees — they, too, should proceed with caution.

“Employers with fewer than 15 employees still may be subject to a state anti-discrimination statute, which, like the ADA, limits the use of mandatory medical inquiries and exams,” said DiBianca.

She suggested that very small employers who are not subject to the ADA or a state-law equivalent could have more flexibility when considering whether to implement antibody testing.

However, for most employers, antibody testing is off limits. Per DiBianca, “The EEOC has made clear that antibody testing is not a job-related medical exam and is therefore prohibited under federal law.”

There’s also the tricky matter of employers being subject to federal and state or local COVID-19 testing rules.

DiBianca explained that most employers will be subject to federal and/or state anti-disability discrimination laws, which impose restrictions on when and how COVID-19 testing may be performed. Adding to the potential confusion are state and local laws and executive orders.

As a general rule, federal, state, and/or local laws that do not conflict with one another must all be followed,” said DiBianca. “Where a federal and state or local law do conflict, generally the federal law will prevail. Thus, if a county ordinance requires that all employees over 65 be tested for COVID-19 prior to returning to the physical workplace, federal law, which prohibits discrimination based solely on age, would take precedence.”

Precise application of conflicting employment laws is essential to compliance, but it can be difficult to achieve without proper guidance. The same goes for adopting workplace COVID-19 testing policies and procedures. In both scenarios, employers should consider consulting with an experienced employment attorney.

Also important is staying on top of developments (on COVID-19 testing) from the EEOC, FDA, CDC, and other public health authorities.

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Manufacturers poised to scale up production when COVID-19 vaccine arrives

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Drug manufacturers are under immense pressure to develop the COVID-19 vaccine. Now, they think that they can master a process that typically takes years by producing a vaccine in months.

These companies have already received millions of dollars in funding to scale up manufacturing capacity. But many in the medical community are worried about this type of guarantee.

Challenges ahead

While the news of early successes in vaccine trials has given us hope, COVID-19 vaccine developers face the biggest challenge of their lives. Developing the vaccine in record time and distributing it to the masses amidst quarantines and global travel restrictions will be tough.

Parameters like inventing new kinds of vials and syringes to administer billions of doses, avoiding hurdles in an untested supply chain, and managing extreme storage conditions have to be considered. But if companies can overcome these challenges, pharma manufacturers will be successful in pulling off the most significant medical manufacturing feat in history.

Some experts say that the first phase of production may vaccinate 60% of the world’s population.

Inherent risks

Since vaccines have never been developed at this scale before, filling capacity could be the main limiting factor. Companies and governments are scaling up their machinery to address these critical shortages. This unprecedented scale of manufacturing also means that scientists need to find out whether a vaccine works fast so that production in bulk can begin immediately.

There is also a risk that most coronavirus vaccines under development may fail. While stopping the spread of the COVID-19 virus is imperative, manufacturers are risking millions for a yet-untested vaccine. They are scrambling to get their hands on any available capacity and signing up with multiple manufacturing partners across the globe.

Efforts by the key players

  • Emergent is working on four vaccines in parallel. It is experimenting by making it easier to switch from one vaccine to another with single-use disposable bioreactor equipment that features plastic bags rather than stainless steel fermentation equipment.
  • Moderna is experimenting on new ways to mitigate the extreme cold storage demands of its vaccines.
  • SiO2 Materials Science is working on producing shatterproof vials that can resist super-cold temperatures.
  • Johnson & Johnson is dealing with travel restrictions to send its vaccine experts to oversee the launch of production sites.
  • Catalent is focusing on high-speed production of vial-filling and packaging services to handle millions of doses.
  • Pfizer and BioNTech plan to start Phase 3 testing so that they can produce up to 100 million doses by the end of 2020 and 1.2 billion doses by 2021 for global distribution.
  • Novavax‘s vaccine combines its proprietary Matrix-M adjuvant with an antigen generated from the virus’ spike protein. The early data results will help scientists determine the safety, immunity, and disease reduction to move on to the next phase.
  • AstraZeneca announced that it could produce up to 2 billion doses of AZD1222, the University of Oxford’s adenovirus-based COVID-19 shot. It also plans to provide 1 billion doses of the vaccine to low- and middle-income countries.

The U.S. government has invested billions into the Warp Speed initiative to kickstart active COVID-19 vaccine production. Multiple vaccine makers are working at getting legal and administrative approval and begin production with federal backing. The government hopes to make a selection and helps start the production within the next six weeks.

Cautiously optimistic

Vaccine manufacturing is an inherently risky venture. A manufacturing facility is set up only when the clinical data is proven to be safe and effective.

Despite the enormous financial risks stated by experts, finding a vaccine provides hope for the world.

If any of these efforts are successful, it will halt the spread of the deadly virus, which has killed over 650,000 people worldwide and sickened more than 16 million. Economies can reopen, and work and school can resume. Individuals concerned that this race to produce vaccines will upend the traditional drug development process have only to look at the rushing numbers again to see why we need this speedy process.

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New bill in the House aims to protect access to telehealth

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The changes to telehealth utilization and payment reform brought on as a response to the COVID-19 pandemic appear set for permanency as House Telehealth Caucus leaders introduced legislation on July 16 that would allow access to such services for Medicare patients.

The bipartisan bill, the Protecting Access to Post-COVID-19 Telehealth Act, would expand telehealth use by eliminating restrictions on its use in Medicare, which have been a thorn in the side of the technology’s advancement for decades.

Those patients enrolled in certain Medicare plans could benefit immediately because of the change in federal payment for services provided through the service, which likely would lead to private payers for individuals covered under private and employer-sponsored plans.

The passage of such a bill would be monumental for the telehealth movement. Bill co-sponsor Rep. Mike Thompson, D-Calif., said in a statement that it would provide a bridge for patients currently using the practices because of the coronavirus crisis and require a study on the use of telehealth during COVID-19.

Thompson, who is the founder and co-chair of the Congressional Telehealth Caucus, said the legislation would expand the use of telehealth for seniors and those on Medicare. “We know telehealth can be an essential bridge in delivering care, particularly during a crisis and today we are working to ensure telehealth continues in a post-Coronavirus world,” he said.

The bill also was introduced by caucus co-chairs Reps. Peter Welch, D-Vt.; Bill Johnson, R-Ohio; and David Schweikert, R-Ariz., and caucus member Rep. Doris Matsui, D-Calif.

The bill essentially authorizes the Secretary of Health and Human Services to waive or modify application of Medicare requirements with respect to telehealth services during any emergency period, and for other purposes. It also provides regulatory flexibilities that provider groups have long sought, including removing geographic restrictions on where a patient must be located to utilize telehealth services and enabling telehealth services provided to patients in their homes.

Additionally, the bill allows for federally qualified health centers and rural health centers to provide telehealth services and makes permanent the temporary waiver authority for the HHS secretary for future emergency periods and the 90 days after the rescinding of a public health emergency period.

Healthcare groups overwhelmingly cheered the legislative efforts to make telehealth a routine part of healthcare delivery.“HIMSS and PCHAlliance applaud the introduction of the telehealth bill sponsored by Representative Thompson and members of the House Telehealth Caucus, and call upon Congress to take swift action and make permanent the flexibilities that have supported the use of evidence-based connected care technologies to improve healthcare quality, access and value for all Americans during the COVID-19 pandemic,” said Hal Wolf, president and CEO of HIMSS, in a statement.

This legislation addresses many of the priorities HIMSS and more than 300 leading healthcare organizations identified for congressional leaders to make telehealth flexibilities created during the COVID-19 pandemic permanent.

“This unprecedented pandemic has proven that telehealth not only works, but that it’s essential,” said Welch in a statement. “These practical telehealth provisions have been successfully implemented and should be continued to ensure that everyone has access to quality healthcare no matter where they live or how mobile they are. This is a commonsense step to make sure our policies keep pace with our technology.”

“Prior to the coronavirus pandemic, there was still some question as to whether telehealth could be an effective alternative to going to the doctor’s office. The answer is now clear: unequivocally, yes,” said Johnson. “This bipartisan legislation will enable Medicare beneficiaries to continue using telehealth services when the current emergency declaration ends, and ensures that the enormous resources invested in making this technology work are not wasted. It’s time to expand high-quality telehealth services to all Americans, not roll back the progress we’ve made.”

“During the COVID-19 pandemic, telehealth has allowed our nation’s healthcare system to continue to effectively deliver needed care virtually, ensuring patients can safely access care when and where they need it. As the only organization exclusively dedicated to advancing telehealth, the ATA commends the House Telehealth Caucus for introducing this essential but commonsense legislation to ensure Medicare patients continue to have the choice to access telehealth after the current public health emergency,” said Ann Mond Johnson, CEO, of the American Telemedicine Association.

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How llama antibodies could help fight COVID-19

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Scientists around the globe are exploring ways to fight COVID-19 as we self-quarantine and wait. Though a potential treatment for COVID-19 may not be the first thought that comes to mind when you hear your kids watching episodes of “Llama Llama” on Netflix during your Monday morning conference call, llamas may be part of our ticket back to normalcy.

A New Study Finds Possible Therapeutic Uses for Llama Antibodies in Treatment of COVID-19

Perhaps it was serendipity?

Researchers from the University of Texas, in collaboration with Ghent University in Belgium, had been exploring how proteins from the viruses that caused MERS and SARS functioned using a llama named Winter when COVID-19 struck.

When COVID-19 hit, they decided to see if any of the nanobodies they harvested from Winter could stop SARS-CoV-2 from infecting cells. SARS-CoV-2 is the strain of coronavirus responsible for the current pandemic.

The team published their results in Cell last month.

Llama Nanobodies to the Rescue

The researchers injected a llama with prefusion-stabilized MERS-CoV and SARS-CoV-1 spikes. Spike proteins are the proteins on the surface of coronaviruses. They undergo a structural change after attaching to cells that allow the virus to fuse with the host cell, enter it, and copy itself to produce more viruses. Nanobodies harvested from llamas are a possible way to prevent the virus from entering cells because they bind to spike proteins.

The SARS VVH-72 nanobody was one of a handful of nanobodies harvested to target SARS and MERS, that also bound spike proteins on SARS-CoV-2, albeit not long enough to be effective.

The researchers fused two copies of SARS VVH-72 to improve its binding capacity. This engineered version prevented SARS-CoV-2 from entering cells.

SARS VVH-72 is among the first antibodies known to neutralize the strain of the virus responsible for COVID-19.

According to the authors of the study, its biophysical properties and robust neutralization capacity render it ideal for further testing in the development of COVID-19 treatments.

Implications for Humans

While a vaccine will likely come along in the next one to two years, there will still be a need for nonvaccine treatments, and that is where the results of this study come into play.

For example, vaccines will not help an infected person, but antibody injections could bolster the infected person’s immune response. Likewise, vaccines are not always enough. People who struggle to develop a sufficient immune response to vaccines would probably benefit from antibody therapy.

Llama antibodies may be a possible treatment for COVID-19, but not as a vaccine. Instead of injecting patients with something that produces an antibody response as is the case with vaccines, doctors and nurses would administer the actual antibodies directly to patients, possibly using an inhaler.

Either way, an antibody treatment is still at least a year off if all the research trials involved in developing this treatment are successful.

Why Llamas?

Llama antibodies are approximately one-quarter of the size of a typical human antibody and can be cloned with relative ease to form smaller antibodies known as nanobodies. Nanobodies are attractive because they are easy to mass-produce, and their properties make them effective weapons for boosting immune responses to specific pathogens.

Alpacas, camels, and sharks are also appealing to researchers for similar reasons.

No Harm to Llama

No harm came to Winter the Llama. Winter was injected with a noninfectious segment of the virus to generate an antibody response.

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New swine flu, unrelated to COVID-19, may be on its way from China

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As we continue to be overwhelmed by COVID-19, which originated in Wuhan, China, near the close of 2019, Chinese researchers have announced that they have identified a new strain of the swine flu that has the potential to become a pandemic.

The flu is carried by pigs and can infect humans. A study of the new virus was published in the Proceedings of the National Academy of Sciences.

So, while the world’s leaders in government and healthcare continue to battle the current pandemic, another may be simmering on the verge of an outbreak, again in China.

Researchers monitoring the virus say it may be possible to spread from person to person and trigger a global outbreak.

Like the COVID-19 outbreak, this new swine flu could be devastating to people across the globe as people likely have little to no immunity to it.

The new strain is being called G4 EA H1N1.

According to reports, the new strain has been found among people who work in Chinese slaughterhouses, and it can grow and multiply in the cells lining human airways.

Professor Kin-Chow Chang and his colleagues at Nottingham University say they are closely monitoring this new strain.

Kin-Chow told the BBC: “Right we are distracted with coronavirus, and rightly so. But we must not lose sight of potentially dangerous new viruses.”

Researchers think it may mutate further so that it can spread quickly from person to person and trigger a global outbreak.

The last pandemic flu the world encountered was in 2009. This new strain is similar to that virus, but with additional evolution.

Current flu vaccines do not appear to protect against it. The 2009 strain is now covered in flu vaccines.

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