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-/

Pfizer’s Bourla on Drug Pricing: 'We Have a Problem Here'

 Albert Bourla, chief executive officer of Pfizer, argued at the Yahoo Finance’s All Markets Summit this week that politicians were approaching the problem of drug pricing the wrong way — as usual.

The Biden Administration in August released a plan to decrease prescription drug costs covered by the Medicare program. One of the components of the plan was to allow Medicare to be able to negotiate to secure the best prices, which is currently prohibited by law. The plan also calls for drug companies that raise prices “faster than inflation” to pay a penalty and to cap the amount Medicare beneficiaries pay out-of-pocket for prescription drugs each year.

At the time, President Biden said, “Right now, we pay the highest prescription drug cost prices of any developed nation in the world — the highest. My Build Back Better Plan is going to lower prescription drug costs by finally giving Medicare the power to negotiate the prices of drugs they purchase for the American people, saving Americans hundreds of billions of dollars.”

Those initiatives were dropped from the plan after key Democrats objected to it.

“The issue of drug pricing is a real issue in the U.S.,” Bourla said. “But it is not the issue that some people think and present.”

A report issued by the RAND Corporation in January 2021 noted that U.S. prescription drug prices are higher than in other countries, with U.S. prices averaging 2.56 times more than what is reported in 32 other countries.

Bourla noted, “We have a problem here. The Americans are paying for their medicines like they don’t have insurance, although they do have insurance. And this needs to change. This needs to make sure that this will not be the case moving forward. I’m sure if they have to pay less, that will be a cost and the system will have to absorb the cost. Who is paying for that cost?”

Bourla’s rationale is that prescription drug prices are only a small portion of overall U.S. health care spending. Medicines represent 12% of costs to the system. “This is how much the employer, this is how much Medicare pays to us in terms of how much it pays to hospitals, physicians, everybody else. So by definition, this cannot be the big problem when we are 12%.”

He also pointed out that drug prices have been going down. Pfizer cited a 5% drop in net pricing of drugs in the U.S., a consistent trend.

“I’m sure the patients taking our medicines didn’t experience this -5%,” Bourla said. “They experience 2, 3, 5, 10, 20% sometimes increases in how much they have to pay … for the cost of the medicine. The two are not connected.”

But according to the Government Accountability Office (GAO), prescription drug spending has increased. The 12% figure is up from 7% in the 1990s. And a report by the IQVIA Institute for Human Data Science cited U.S. patients paying $67 billion out of pocket for prescriptions at retail pharmacies in 2019. That raises a question as to whether people are under-insured, uninsured, or insurance companies are not paying for drugs.

“Where we disagree,” Bourla said, “is policies that will take all the money from the pharmaceutical industry and move them to the black hole of the federal budget to do other things. This is not the issue right now. The issue is the out-of-pocket costs of patients, which are very, very high. That’s what we need to address.”

https://www.biospace.com/article/pfizer-s-bourla-on-drug-pricing-in-us-we-have-a-problem-here-/

TPD Summit 2021 – degrader validation for Nurix

 That an entire meeting now exists on protein degradation should awaken investors to what an important area of research this is. The young biotech Nurix yesterday became a beneficiary, reporting very early findings validating its lead clinical asset, NX-2127, a degrader of BTK. Of course, BTK inhibition is a hugely competitive approach in leukaemia, but Nurix argues that selective degradation of this kinase, rather than its mere inhibition, comprises a novel approach, avoiding downstream mutations and yielding effects lasting years. So far the oestrogen receptor has provided the biggest stage for degradation, courtesy of the Serds, and just last week Radius’s elacestrant scored in a phase 3 breast cancer trial, while today Sanofi revealed another delay to its rival, amcenestrant. Nurix told yesterday’s Targeted Protein Degradation Summit that NX-2127 had now been given to six patients, and caused 80-90% BTK degradation. All the patients had failed at least one BTK inhibitor, and partial response has been seen in a subject with the troublesome C481R mutation. Despite these being mere early hints Nurix climbed 17% to hit a market cap of $1.5bn, possibly driven by hope that degradation could take BTK into the hitherto untrodden ground of lymphoma.

Source: Targeted Protein Degradation Summit.

https://www.evaluate.com/vantage/articles/news/snippets/tpd-summit-2021-degrader-validation-nurix

26 FDNY firehouses out of service over vaccine mandate staff shortage

 The FDNY shuttered 26 fire companies citywide on Saturday due to staff shortages caused by the COVID-19 vaccination mandate, according to furious elected officials, who ripped the move as “unconscionable” — and could have catastrophic consequences.

The shutdown came amid a pitched battle between City Hall, which on Monday will start enforcing a mandate that all city workers have at least one dose of the COVID-19 vaccine, and jab-resisting firefighters, many reportedly saying they were already sick with the coronavirus and therefore have “natural immunity.”

Nicole Malliotakis (R-SI, Brooklyn) said 26 companies shuttered — five in her district — and laid the blame on  Mayor de Blasio.

“If someone dies due to a slower emergency response, it’s on Bill de Blasio and his overreaching mandates. I hope this fool fixes it ASAP!” she tweeted. Some residents rallied outside of the Ladder Company 149 in Dyker Heights to support the firefighters.

Fire Commissioner Daniel A. Nigro said the department “has not closed any firehouses.

“Irresponsible bogus sick leave by some of our members is creating a danger for New Yorkers and their fellow Firefighters,” Nigro said. “They need to return to work or risk the consequences of their actions.”

No borough or neighborhood was spared, with the shuttered companies ranging from Engine Co. 55 in lower Manhattan, to Engine Co. 234 in Crown Heights, to Engine Co. 231 in Brownsville. Others included Ladder Co. 128 in Long Island City and Engine Co. 158 and Ladder Co. 78 on Staten Island, according to information provided by Malliotakis and Councilman Joe Borelli (R-SI), who cited the Uniformed Firefighters Association. Borelli said the list of 26 came from a FDNY alert dispatched to members.

The FDNY has shut down 26 firehouses across the city due to staff shortages caused by the city’s COVID-19 vaccine mandate.

Daniel William McKnight

FDNY spokesman Jim Long said the closings are not permanent, describing the companies as “temporarily out of service” and the situation as “fluid” since it was shifting firefighters to units where they were needed.

As of late Saturday afternoon, the FDNY could not provide an exact number of closings that the pols said were in effect as of 7:30 am Saturday.

“The situation remains fluid. We hire manpower to get the company back in service or relocate other units to the area for coverage,” Long said.

In anticipation of a shortage of firefighters, NYPD’s Emergency Service Unit has requested the help of volunteer firefighters from Long Island and upstate to back fill the lost positions, according to an email obtained by The Post.

That was little solace to retired electrician Vinny Agro, 63, who lives across the street from now-offline Engine Co. 284 in Dyker Heights, Brooklyn.

The FDNY’s vaccination rate was at 72 percent at the deadline for the vaccine mandate on Friday.

REUTERS/Lloyd Mitchell

“We’re f- -ked. We are going to toast like marshmallows,” he said. “It’s another sad day for New York City.”

A man who lives next door to the firehouse said that he had not seen firefighters for about 24 hours and that they were desperately needed in the neighborhood.

“Most of the houses here are semi-attached frame houses. You throw a match on it, and it goes up real quick,” he said. “You need a quick response . . . it’s scary.”

Fire officials said last week that they were prepared to close as much as 20 percent of the companies citywide.

Saturday’s temporary closures represented 7.6 percent of the city’s 341 engine and ladder companies. But it was still an “unconscionable” number, said Borelli, who chairs the council’s committee on fire and emergency management.

“The firefighters who are unable to work have all been tested within the week and are not COVID positive, and I doubt New Yorkers care about the vaccine status of the person applying defibrillators to their chest,” he said.

Donald Watson, 57, a Downtown Brooklyn resident, said the firefighters were just “looking out for themselves.”

“It’s sad we have to go through this because of COVID,” Watson said. “A lot of them don’t want to take the shot. C’mon. It’s nothing but a shot.”

The FDNY’s vaccination rate stood at 72 percent for firefighters — and 77 percent agencywide — at the end of Friday, the city’s deadline for workers to get at least one dose of the vaccine, according to data from City Hall. Nearly 4,000 FDNY employees remained unvaccinated.

The mandate is expected to be enforced beginning Monday, and 26,600 city workers across all city agencies were still unvaccinated as of Friday night, according to City Hall. Those who don’t have at least one jab will be suspended without pay.

The NYPD stood at 84 percent of personnel vaccinated, and the Sanitation Department was at 77 percent.

The 77th Precinct in Crown Heights, Brooklyn, was slow to respond to calls Friday night as four officers on the 4 p.m.-to-midnight shift called in sick, sources said. Call logs showed response times of more than two hours in some cases.

The FDNY has blamed the shortage on people calling out sick to protest the mandate.

NHLI via Getty Images

“We have contingency plans in place if necessary, and there will not be any shortages in any commands. There will be no reduction in police services,” an NYPD spokeswoman said.

The FDNY has blamed the staffing shortage on firefighters calling out sick, with one insider saying “hundreds” of firefighters have been taking medical leave to protest the mandate.

“It’s definitely a sick-out. It’s a job action,” the insider said. “If they call in sick they have to go to the medical office. The medical office is overwhelmed.”

More than two dozen FDNY members were seen leaving the department’s medical office at the MetroTech center in Downtown Brooklyn Saturday.

A memo sent to members of the Uniformed Fire Officers Association on Friday said it was “still in negotiations” with the Office of Labor Relations “for an extension to the deadline as well as alternate methods of implementation.”

The memo, seen by The Post, advised all members, vaccinated or not, to report for duty when scheduled and make notations in the fire company’s journal about why they were asked to leave.

De Blasio has held firm, saying on Thursday that the city would not extend the jab deadline.

Vaccinations surged statewide this week, with 103,348 doses administered from Friday to Saturday, Gov. Hochul said on Saturday. On Monday, 45,217 doses had been given out in the previous 24 hours.

https://nypost.com/2021/10/30/fdny-firehouses-shuttered-over-vaccine-staffing-shortages/