American Cancels 1,500 Flights Over Weekend, Denies Any Relation To Vaccine Mandate

 By Zachary Stieber of Epoch Times

American Airlines canceled over 1,500 flights between Oct. 29 and Oct. 31, blaming staff shortages and inclement weather. In addition to 340 flights being canceled on Friday, 540 were canceled on Saturday, and 650 were canceled on Sunday, a spokeswoman for the Texas-based airline told The Epoch Times in an email.

In a letter to employees obtained by The Epoch Times, American’s Chief Operating Officer David Seymour blamed “severe winds” in the Dallas-Fort Worth area with creating the situation.

“With additional weather throughout the system, our staffing begins to run tight as crew members end up out of their regular flight sequences,” he said. “To make sure we are taking care of our customers and providing scheduling certainty for our crews, we have adjusted our operation for the last few days this month by proactively canceling some flights.”

American projects having the issues resolved soon.

The spokeswoman said that the problems aren’t related to the company’s COVID-19 vaccine mandate. Capt. Dennis Tajer, a spokesman for the Allied Pilots Association, which represents American pilots, also said the cancellations are not linked to the vaccination requirements. Weather was the catalyst, but management failure also contributed, Tajer told The Epoch Times in an email.

“Management is failing at the most fundamental part of running an airline. Connecting crews to the airplane. Our employees are suffering this failure as much as passengers as crews are stuck out into their days off while scrambling to find hotels,” he said.

“Mother nature generates a storm and management’s failure to properly schedule creates storms days after,” he added.

Of the flights canceled on Saturday, all but around a dozen were due to the inability to connect workers to airplanes, Tajer said.

American announced the COVID-19 vaccine mandate on Oct. 1.

“While we are still working through the details of the federal requirements, it is clear that team members who choose to remain unvaccinated will not be able to work at American Airlines,” Doug Parker, American Airlines chief executive, said in a memorandum that day.

Executives at the company later said employees must be fully vaccinated by Nov. 24 or be fired.

Most U.S.-based airlines have imposed mandates, some in response to President Joe Biden’s plans to force private businesses to either get proof of vaccination from employees or require them to undergo weekly COVID-19 testing.

The head of the pilots association warned the White House and Congress last month that mandates could trigger chaos in the near future.

Southwest Airlines canceled thousands of flights earlier this month, leaving many travelers stranded for days. The airline claimed the problems were mostly due to unfavorable weather and not related to the mandate it imposed, though other airlines didn’t suffer problems at the same time and it later delayed a plan to put workers who don’t comply with the vaccination requirements on unpaid leave.

In addition to the weekend cancellations from American, the airline delayed hundreds of flights between Friday and Sunday, according to the tracking site FlightAware. That included 73 delays early Oct. 31.

American said nearly 1,800 flight attendants who were on leave would be returning to work soon and that it was hiring over 600 more flight attendants, in addition to working to hire 4,000 workers for other positions.

“The hiring of pilots and within tech ops continues to take place, and we already began ramping up hiring in reservations so more team members will be in place for the holiday season,” it said.

https://www.zerohedge.com/weather/american-cancels-1500-flights-halloween-weekend-denies-denies-any-relation-vaccine-mandate

Sanders working to get prescription drug price provision in social spending bill

 Progressive U.S. Senator Bernie Sanders said on Sunday that he was still working on getting a provision to lower prescription drug prices into the social spending bill pending in the U.S. Congress before a vote by the House of Representatives. 

  President Joe Biden was dealt a setback on Thursday as the House abandoned plans for a vote on an infrastructure bill before his departure to Europe for an international summit with other world leaders, with progressive Democrats seeking more time to consider his call for a separate $1.75 trillion plan to address climate measures, preschool and other social initiatives. 

  A proposal that would allow the U.S. government's Medicare health plan for seniors to negotiate prescription drug prices to make them cheaper was not included in the social spending bill. 

  "I spent all of yesterday on the telephone... We are continuing that effort (to include the prescription drug price provision in the bill)", Sanders told CNN in an interview on Sunday. 

  "It is outrageous that we continue to pay the highest prices in the world for prescription drugs," added Sanders, who has championed that cause for years. 

  Biden had sought to unite his fellow Democrats behind the climate and social spending plan with personal appeals on Thursday, and had pressed for a Thursday vote on the $1 trillion infrastructure bill, another main plank of his domestic agenda. 

  He hoped a framework on the larger measure would convince progressive House Democrats to support the infrastructure bill, but their insistence that the two move together led House leaders to abandon a planned vote. 

  The plan also did not include paid family leave or a tax on billionaires with some constituencies angered by the absence of key Biden administration pledges from the bill. 

https://finance.yahoo.com/news/sanders-working-prescription-drug-price-144254271.html

Moderna says FDA needs more time for review of its COVID-19 shot for adolescents

 Moderna Inc said on Sunday it has been told that the U.S. Food and Drug Administration will require additional time to complete its assessment of the company's COVID-19 vaccine for use in adolescents aged 12 to 17 years.

The FDA informed Moderna that the review may not be completed before January 2022, the company said in a statement, dealing a potential setback to the timing of an emergency use authorization (EUA) for that age group.

Moderna Chief Executive Stephane Bancel told Reuters last week https://www.reuters.com/business/healthcare-pharmaceuticals/exclusive-moderna-covid-19-shot-could-start-being-used-children-teens-within-2021-10-27 that based on conversations with the agency, he believed the vaccine would be authorized for those 12 to 17 in the next few weeks.

The U.S. biotech company said it was told late on Friday that the FDA needed the additional time to evaluate recent international analyses of the risk of a type of heart inflammation called myocarditis after vaccination, a rare side effect that has primarily affected young males.

Moderna said it is conducting its own review of new external analyses on the increased myocarditis risk in those less than 18 years of age as they become available.

Moderna applied for U.S. authorization of its shot for those aged 12 to 17 in June.

Americans of those ages are eligible for the similar COVID-19 vaccine from Pfizer Inc and partner BioNTech SE after it was cleared by the FDA and Centers for Disease Control and Prevention in May.

Moderna also said it will delay filing its request for an EUA for a half strength 50-microgram dose of the vaccine for children ages 6 to 11 while the FDA completes its review of the 12-17 filing.

https://news.yahoo.com/moderna-says-fda-needs-more-165218179.html

Childhood Obesity Is Soaring to New Levels

 As a pediatric endocrinologist in a busy New York City hospital, I am acutely aware of the impact COVID-19 has had on my patients. The physical, emotional, social, and academic costs of the pandemic are evident every time I examine a child diagnosed with the virus. However, I am also deeply aware of another health risk that is threatening the well-being of my patients -- the significant increase in obesity that we have seen in children and teenagers over the past 18 months.

Before COVID-19, obesity affected around 20% of American children 2 to 19 years of age. Now, the numbers are expected to rise much further, with modeling studies predicting at least a 3% to 4% weight gain in children during the pandemic. In my obesity practice, children who had been losing weight before the pandemic are now returning with an average weight gain of 10 to 20 lb.

In fact, the signs I'm seeing suggest we are facing a dangerous collision between the COVID-19 pandemic and a surging obesity epidemic. Obesity and overweight have soared among my patients due to a number of factors directly related to the pandemic, including less access to physical education at school, a drop in extracurricular sports activities, and fewer healthy food choices because of financial challenges and shopping restrictions. The pandemic also exacerbated an already existing mental health crisis in youth, with an increase in emotional eating among children who are experiencing greater anxiety and depression.

If we do not urgently address the obesity epidemic, the pandemic's impact on the health of children with overweight and obesity will remain, with potential long-term consequences for our nation's wellbeing.

Adolescent Obesity Has More Than Tripled Over the Past 30 Years

While the spike in pediatric obesity during the pandemic is especially severe, it's part of a long-term trend. In September 2021, the CDC released results of a study that found that 22% of children and adolescents had obesity last August, up from 19% one year prior. The study showed that children with healthy weight were gaining an average of 3.4 lb per year before the pandemic but gained 5.4 lb per year during the pandemic. For children with obesity, the expected annual weight gain rose from 6.5 to 12 lb after the pandemic began, and from 8.8 lb to 14.6 lb in those with severe obesity.

Over the past 30 years, the childhood obesity rate has more than doubled in kids ages 2 to 5 years, tripled in youth ages 6 to 11, and more than tripled among adolescents ages 12 to 19. In fact, pediatric overweight and obesity affects more than 30% of children, and it is the most common chronic disease of childhood. Looking at the long-term consequences of this disease, children with obesity are more likely to become adults with obesity and all of its associated health problems, including type 2 diabetes, stroke, and ischemic heart disease later in life.

Physicians Must Take Steps to Address Our Dual Crises

Programs promoting nutritional and lifestyle resources and getting kids active again are vital to supporting children and their families during this collision between the obesity epidemic and the COVID-19 pandemic. At my practice, we converted our weight program from in-person to a virtual format last summer to continue providing group nutritional education and physical activity opportunities for our patients. We engage children in cooking and physical activity demonstrations, with a focus on promoting healthy weight by maintaining a balanced diet and finding safe opportunities for exercise.

When discussing healthy food options, we highlight foods with a lower glycemic index to promote more stable blood sugar levels. These foods include nuts, beans, high-fiber fruits such as pears, berries, and apples, and whole-grain breads. We encourage carbohydrate choices that provide vitamins, minerals, and fiber, and discourage high-calorie sugary drinks. We stress the importance of family support. Encouraging children as they try new foods and helping them enjoy balanced meals opens up the entire family to healthier dietary choices.

Physicians also have an important role to play in advancing initiatives that support healthier outcomes for children and their families. Pediatricians are particularly well positioned to discuss diet, nutrition, and exercise with patients or their parents. Government plays a part too -- we need national health policies that will provide guidance and resources to families and schools. These recommendations must include support for increased funding for healthy meals, physical activity opportunities, and access to healthcare services for families in need. And finally, we must ensure access to COVID-19 vaccines for children who are eligible, and for younger kids once they're authorized. Helping children stay in school will support their physical and emotional wellbeing and health.

As physicians, we serve as advocates for the health of our patients, today and tomorrow. If we intervene early to prevent the health complications caused by obesity and overweight, we can help give children a healthier future. Staying up to date on the latest pediatric-focused obesity resources and research can help.

Marisa Censani, MD, is a pediatric endocrinologist and the director of the Pediatric Obesity Program in the Division of Pediatric Endocrinology at Weill Cornell Medicine and NewYork-Presbyterian Hospital. She currently serves on the Board of Trustees of the Obesity Medicine Association (OMA) and is co-author of OMA's Pediatric Obesity Algorithm.

https://www.medpagetoday.com/opinion/second-opinions/95339

Some mental health conditions are now eligible for COVID boosters

 People with some mental health conditions, including schizophrenia and mood disorders such as depression, are eligible for boosters of COVID-19 vaccines, according to updated guidance by the US Centers for Disease Control and Prevention.

In addition to depression, other mood disorders include bipolar disorder and seasonal affective disorder. Additional lung and liver diseases and tuberculosis were also added to the list of qualifying conditions, the CDC announced on Twitter last week. 

Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the US Food and Drug Administration's vaccine advisory panel, told The New York Times that the change means about 85% of American adults are now eligible for COVID-19 boosters. 

"The door just keeps getting wider and wider," Offit told The Times. 

The country's booster rollout program prioritizes people who may benefit from the increased protection a booster shot of COVID-19 vaccine could bring. That includes people with underlying medical conditions that may increase risk for severe COVID-19 disease. The COVID-19 vaccines remain effective at protecting against severe disease, hospitalization and death. 

According to the CDC's summary of its updates on underlying medical conditions, people with some mental health conditions were added to the list in September 2021 because research shows they're more at risk for hospitalization and death from COVID-19. 

One systematic review referenced by the CDC found that the highest COVID-19 mortality rate among people with mental health conditions was in those with bipolar disorder and schizophrenia. People with anxiety disorders weren't at an increased risk of death from COVID-19. 

Other adults eligible for a booster in the US currently include adults age 65 or older, everyone who received Johnson & Johnson's vaccine, people who live in long-term care facilities, and adults at risk of COVID-19 because of their work or setting. Immunocompromised people are also eligible for a third (and in some cases, fourth) shot.

The CDC's recommendation on whether you need a booster varies in strength, and depends on your individual circumstances. Adults age 50 or older with a medical condition "should" get a booster, while people with the same condition but who are aged 18 to 49 "may" get one if they choose, for example.

https://www.cnet.com/health/medical/people-with-some-mental-health-conditions-are-now-eligible-for-covid-boosters/

San Diego EDs Deluged With Patients After Cyberattack

 A 2021 ransomware attack on a massive Southern California health system sent a sudden flood of critical patients to two large academic emergency departments (EDs), leading to overcrowding that providers struggled to keep pace with, a researcher reported.

The pair of EDs at the University of California San Diego (UCSD) saw their average daily emergency medical services (EMS) arrivals rise by nearly 60% year-to-year during the worst week of the cyberattack on the Scripps Health system of clinics and hospitals, said Christian Dameff, MD, of UCSD, in presentations at the American College of Emergency Physicians annual meeting.

The cyberattack began around May 1 and targeted Scripps Health, a $2.9-billion nonprofit system that provides about a third of patient care in the San Diego region. The 700,000-patient system has about 3,000 physicians and five hospitals.

In their retrospective analyses, Dameff and colleagues noted that in the 3 weeks leading up to the cyberattack, a mean of 69-71 patients were transported to the hospital EDs each day. In the initial days of the attack (May 2-8), the number grew to 116.

Such a large and instant influx of patients was unprecedented, even during the COVID-19 pandemic, noted Gary M. Vilke, MD, of UCSD Health. "Usually it ramps up, like in flu seasons when the census will go up 15%-20%, instead of seeing an extra 100 patients a day overnight."

"I've been with UCSD for 30 years, and it's not something I've seen before," he told MedPage Today.

Local media reported that during the attack, electronic health records were unavailable; imaging results couldn't be viewed; critical patients were diverted elsewhere; and patients couldn't make urgent appointments or reach physicians. UCSD hospitals had to implement emergency procedures to get extra staff on board.

At the time of the attack, Scripps Health said very little publicly about the situation. Network systems were restored by May 26, and Scripps said that it began "notifying individuals whose information may have been involved in a recent cybersecurity incident," according to a June 1 statement. The attack cost the health system $112.7 million through the end of June, mostly from lost revenue, according to Fierce Healthcare. In September, lawyers for a patient with cancer filed legal action to bring a class action lawsuit against the health system for negligence and breach of contract, according to the San Diego Union Tribune.

"It was a pretty big shock to the system. Patients tended to be sicker, with things like strokes and heart attacks," Dameff told MedPage Today. During a July House Energy & Commerce hearing on the growing ransomware threat to critical infrastructure, Dameff stressed that "healthcare is not prepared to defend or respond to ransomware threats," according to SC Media, but also noted that healthcare delivery organizations could put paper processes in place to maintain and manage patient care within hours of an event, which is how a Florida health system handled a June 2021 cyberattack.

Dameff's group reported that the average daily census grew to 281 over the cyberattack period versus 174-229 patients during the same week over the previous 5 years. In 2020, the average daily census for that week was 179. The differences were statistically significant for each year compared to 2021.

The take-home message from the studies is that "We should be discussing cyberattack impacts on regions, and developing regional preparedness plans," Dameff stressed, adding that tabletop simulations of cyberattacks should be routine, and hospitals need to talk to each other about plans to handle critical patients.

"There's a uniqueness to cyberattacks," he said. "You know when a hurricane is going to hit and you can prepare. With cyberattacks, you don't. And cyber attackers can be sneaky and hit you again; hospitals can be ransomed more than once."

Michael Johnson, a cybersecurity specialist at the University of Minnesota Technological Leadership Institute in Minneapolis, told MedPage Today cyberattacks are going to continue to be a major problem.

"I don't see [cyberattack incidents] dropping any time soon, and even stabilization in the near term is unlikely," he said. "Hospitals in particular are very enticing targets for cyber activity, both from a data theft perspective and a ransomware perspective."

"Healthcare data has become some of the most valuable data to monetize by the hackers, even more valuable than the average set of financial data," added Johnson, who was not involved in the study. "And disruption to systems like emergency healthcare increases the chance the ransom will be paid in the hope that the hospital can resume normal operations as quickly as possible."

https://www.medpagetoday.com/meetingcoverage/acep/95357

Kymera Study Validates IRAK4 as Viable Protein Degradation Target

 Kymera Therapeutics announced positive interim results from its Phase I placebo-controlled trial of targeted protein degradation for anti-inflammation.

At this week’s 4^th Annual Targeted Protein Degradation Summit, Kymera presented data from a Single Ascending Dose portion of a Phase I study demonstrating robust IRAK4 degrader activity of their drug candidate, KT-474.

KT-474 targets and degrades IRAK4, which is a previously “undruggable” target implicated in several inflammatory and immune diseases like arthritis and Alzheimer’s Disease. Previous anti-inflammatory therapies have aimed to block single downstream cytokines, which is not sufficient to prevent disease symptoms.

Out of 57 healthy volunteer patients, randomly sorted into placebo or a single KT-474 dose, robust IRAK4 reduction was seen for up to six days. Mean reduction, as measured in peripheral blood mononuclear cells, was measured to be 93-96% at the three highest dosage levels, achieved at 48 hours after dosing. Additionally, KT-474 was well-tolerated with no serious adverse events reported, although with some probable side effects noted to be headache and nausea.

Kymera was able to demonstrate for the first time proof-of-biology ex vivo (outside of the body) using whole blood from one of their KT-474 treated patient cohorts. After stimulating the whole blood with R848 or LPS, which ordinarily would induce pro-inflammatory cytokines, levels of these inflammatory cytokines (ex. IL6, IL10, TNF-alpha) were significantly decreased from baseline in the KT-474 treated whole blood samples.

“Importantly, we have now shown that IRAK4 knockdown of ≥ 85% in vivo in circulating PBMC leads to profound TLR/IL-1R pathway inhibition, as demonstrated by up to 97% suppression of ex vivo response of whole blood to TLR agonists,” explained Dr. Jared Gollob, MD, chief medical officer of Kymera.

These proof-of-biology results validated the protein degrader activity of KT-474 in targeting IRAK4 as a master regulator of inflammatory cytokines. This confirms the efficiency of the drug to inhibit multiple pro-inflammatory cytokines, as opposed to just one.

“The proof-of-mechanism and proof-of-biology that have been achieved with just single doses of KT-474 attest to the potency of this drug and validates the strategy of targeting IRAK4 with a degrader to maximize blockade of TLR/IL-1R signaling,” said Kymera President and CEO Dr. Nello Mainolfi, Ph.D..

Kymera is currently conducting a multiple ascending dose trial as another part of its KT-474 study, with results expected by the end of 2021. Following this, the company plans to evaluate the therapeutic profile of KT-474 in an open-label cohort of patients with hidradenitis suppurativa, a skin condition characterized by painful bumps under the skin, and atopic dermatitis.

“The potent, broad effect of IRAK4 knockdown observed on multiple different proinflammatory cytokines implicated in a variety of autoimmune inflammatory diseases highlights the potential for KT-474 to be a best-in-class oral anti-inflammatory drug, especially in a shifting external landscape for safe, broadly active small molecule anti-inflammatory agents,” Mainolfi said.

https://www.biospace.com/article/kymera-study-validates-irak4-as-viable-protein-degradation-target-/