HCPLive Crisis Point takes an in-depth look at the obesity crisis, beginning with the process of medical diagnosis and who is impacted the most by the disease.

Defining the Scope of the Obesity Crisis

Dr. Castro and Dr. Rizzo discuss the evolving world of monoclonal antibodies for severe asthma. Plus, the ALA team discusses September's annual Asthma Peak Week, and what it means for reopening schools.

ALA Discusses Severe Asthma Biologics with Mario Castro, MD, MPH

Listen to an expert discuss the heterogenous, and potentially fatal, lysosomal storage disorder.

The Rare Disease Report Podcast: Niemann-Pick Disease

The study author joins to highlight new ADA 2021 findings showing rivaroxaban's benefit for a subpopulation of diabetic patients.

VOYAGER PAD, Revisited with Marc Bonaca, MD, MPH

On this episode of Coping After COVID, Dr. Craig Chepke discusses the challenges for schizophrenia patients.

 Coping After COVID: A Troubling Time for Schizophrenia Patients

Brett King, MD, PhD highlights the efficacy, safety, and overall potential of the small molecule drugs for dermatologic diseases.

The Promise of Janus Kinase Inhibitors 

New data from China indicated an association between increased physical activity and improved childhood 

, with body mass index (BMI) status exhibiting a negative effect on the association.

In previous studies, BMI and physical activity had been linked to several asthma symptoms and disease control, with increasing data suggesting that physical activity positively impacting asthma prevalence.

In asthmatic adults, weight loss and improved asthma control were reported when participants engaged in more physical activity.

, various studies had been conducted regarding different levels of physical activity, though few had considered the interrelationship among physical activity, BMI, and childhood asthma control.

As such, Zeyi Zhang, MD, School of Nursing and Rehabilitation, Cheeloo College of Medicine at Shadong University, and fellow investigators evaluated the association between physical activity and childhood asthma control, and estimated the potential mediating or modifying role of BMI status.

Zhang and colleagues enrolled 303 children aged 5-14 years with asthma who attended the pediatric respiratory outpatient of 4 individual hospitals in Jinan, China.

Each participant was given a 6-item questionnaire that measured frequency and participation of physical activity over the course of a week’s time.

Questions included “How often a week do you participate in vigorous PA such as running, swimming, soccer, basketball, badminton, rope skipping, etc.”, “How often a week do you participate in moderate PA such as jogging, cycling, ping‐pong, Tai Chi, dancing, etc.”, “How often a week do you participate in brisk walking training”, and the duration of each activity.

The BMI of each participants were measured using the children’s height and weight.

The Chinese version of the Childhood Asthma Control Test (C-ACT) was applied to children and parents to adequately measure asthma control.

Multiple linear regression was used to determine the association of physical activity and childhood asthma control. To assess the effect modification by BMI status, physical activity‐by‐BMI interaction was fitted in the multiple linear regression model. Stratified analyses were also performed for each BMI status.

The team reported that a positive association between continuous physical activity level and childhood asthma control assessed by C‐ACT after adjustment for covariates (B = 0.144, p = .012, Table 2), and a similar result was observed when physical activity was fitted with categorized variable, which indicated that children with higher physical activity levels had better asthma control than their inactive participants.

There was no physical activity level by BMI status interaction effect on children asthma control with adjustment for covariates.

Surprisingly, observation of the regression coefficient in the study found a positive association between physical activity level and BMI.

Though the team said this finding contradicted their hypothesis, they believed it was possibly due to a reverse causation where children who are overweight are already engaged in a physically active lifestyle due to body image recognition and health education.

Overall, Zhang and colleagues observed that physical activity should be encouraged to improve asthma control in children.

“Moreover, PA as a modifiable factor may have a role in the treatment for asthma‐obesity children,” the team wrote. “Additionally, our findings underscore mechanisms other than weight loss, by which increased PA and improved childhood asthma control are correlated.”

“Physical activity and childhood asthma control: Mediation and moderation role of body mass index,” 

was published online in Pediatric Pulmonology.

Articles

Though previous studies have measured different levels of physical activity, few before this have considered the interrelationship involving body mass index and childhood asthma control.

News

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Obesity Management

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Increased Physical Activity Improves Asthma Control in Pediatric Patients

Following lengthy testimony, the Vaccines and Related Biological Products Advisory Committee has voted against the 

 of the Pfizer-BioNTech COVID-19 vaccine booster dose by a count of 16-2.

The committee was asked to make a decision looking at the clinical trial C4591001, which compromised 329 participants, and determining if the safety and effectiveness of the data would support approval.

The booster dose represents a single shot of the 0.3 mL approximately 6 months after the second dose in individuals 16 years and older.

vote against recommending the approval of a booster dose

 for people 16 years and older, the VRBPAC decided to create a new question to vote on an Emergency Use Authorization (EUA) for a booster dose for people 65 years and older and those deemed high risk of COVID-19.

Based on the totality of scientific evidence available including the safety and effectiveness data from clinical trial C4591001 do the known and potential benefits outweigh the known and potential risks of a Pfizer-BioNTech COVID-19 Vaccine booster administered at least 6 months after completion of the primary series for use in:

Individuals at high risk of severe COVID-19

Committee members voiced their concerns about the lack of data to feel comfortable with having such a large amount of the American population eligible for the booster dose.

After the second vote, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Research and Evaluation, asked the committee for their opinion on health care workers and the booster dose.

They decided to pose a poll question to the committee about this group. The specific question was: should healthcare workers or others at high risk for occupational exposure be included in this EUA?

The committee voted 18-0 in favor of including healthcare workers.

The earlier meeting mainly centered on the effectiveness of the vaccine after several months and whether or not the booster is necessary to combat the Delta variant.

Sarah Oliver, MD, MSPH, Centers for Disease Control and Prevention Division of Viral Disease, National Center for Immunization and Respiratory Diseases, discussed vaccine rates, hospitalizations, and vaccine effectiveness.

To date, 380 million total vaccine doses administered, and the breakout in terms of the percentage of the population fully vaccinated for ages is the following:

From January-July 2021, COVID-19 hospitalization rates were 23 times higher in the unvaccinated in the 18-49 age group; 22 times higher in the unvaccinated in the 50-64 age group; and 13 times higher in the unvaccinated in those aged 65 years and older.

The vaccines’ effectiveness dropped considerable from the plus 90% range prior to the emergence of the Delta variant to dropping several percentage points after that strain became the predominant variant.

During the meeting, 2 Israeli investigators presented data regarding how that country dealt with an increase of COVID-19 and their booster strategy in order to try to stop it.

Sharon Alroy Preis, MD, MPH, MBA, director of Public Health Services, Ministry of Health, Israel during her presentation said Israel was vaccinated earlier than most other countries and up to 3 months before.

In the summer they saw a 10 fold increase in 1 month.

Their booster data they reported showed the following:

Ron Milo, PhD, Professor, Weizmann Institute, Israel, said there was “significant protection” with booster doses.

He explained that if VE after waning is 50 for infection and increases 10-fold it become 95%. If VE after waning is 80 for infection and increases 10-fold it becomes greater than 97%.

When asked about follow-up booster doses, Preis said it was too early to determine if people will need to be vaccinated every 6 months.

William C. Gruber, MD, senior vice president, Vaccine Clinical Research and Development Pfizer, presented for the company and said that immunity waned 6-8 months after the second dose when Delta variant is the predominant strain. In addition, a retrospective study showed that vaccine effectiveness (VE) decreased primarily due to waning vaccine induced immunity rather than due to Delta escaping vaccine protection.

Joohee Lee, MD, from the FDA, said the breakthrough infections happened more frequently to those who were vaccinated earlier than later. During her presentation Lee noted that immunogenicity data to support the effectiveness of the booster dose against the Delta variant are limited to exploratory analysis in a small number of participants using non-validated assays.

In the afternoon session during the public hearing people making presentations were mostly skeptical against the idea of a booster. More than a few were complaining over the size of the number of participants (329), the very small amount people who were 65 and older (12 participants), and the limitations on the Pfizer and Israel data.

After the public comment, there was a question and answer period and a discussion amongst the committee members. Paul Offit, MD, commented that he might be reluctant to vote yes for everyone 16 years or older, but would be open to voting for those 65 years and older.

As the committee was deliberating over the data and had their questions answered, some members seemed more inclined to want more data and that the current evidence did not confirm the need for a booster dose.

This discussion led to the vote and the aforementioned result.

The VRBPAC voted 16-2 against the booster dose because of unclear evidence regarding the need.

Infectious Disease

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FDA Panel Advises Against Pfizer-BioNTech COVID-19 Booster Dose

Connor Iapoce is an assistant editor for 

 and joined the MJH Life Sciences team in April 2021. He graduated from The College of New Jersey with a degree in Journalism and Professional Writing. He enjoys listening to records, going to concerts, and playing with his cat Squish. You can reach him at 

Earlier this year, the US Food and Drug Administration (FDA) expanded the label for sacubitril/valsartan in patients with 

with left ventricular ejection fraction (LVEF) lower than normal.

As a result, investigators in a recent study projected the number of newly eligible treatment candidates for sacubitril/valsartan under the expanded FDA labeling, as well as the number needed to treat (NNT) to prevent worsening events of heart failure.

The team, led by Scott D. Solomon, MD, Division of Cardiovascular Medicine, Brigham and Women’s Hospital, Harvard Medical School, observed an expanded FDA label is expected to show substantial increase in the potential HF population eligible for sacubitril/valsartan and may prevent up to 180,000 worsening HF events.

In order to estimate the prevalence of HF, self-reported data from the National Health and Nutrition Examination Survey (NHANES) from 2015 - 2018 was used in the study.

Moreover, to determine the eligible cohort for sacubitril/valsartan, investigators excluded patients with a systolic blood pressure (SBP) lower than 100 mm Hg or an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2.

Investigators determined newly eligible patients with HF at higher LVEF ranges based on 4 LVEF cutoffs to define lower than normal: 41% - 50%, which covers HF with mid range ejection fraction; 41% - 55%, in which the upper limit of the confidence interval of treatment effect is entirely confined to the region of benefit in pooled analysis of PARAGON-HF and PARADIGM-HF trials; 41% - 57%, which was the median LVEF value in the PARAGON-HF trial; 41% - 60%, which is the nearest 5-point integer.

The PARAGON-HF trial was a global randomized clinical trial (RCT) that examined sacubitril/valsartan against an active comparator valsartan among adults 50 year and older with symptomatic HFpEF with LVEF of 45% or more.

In order to determine the total burden of HF events, investigators used 3 end points of interest including total HF hospitalizations, total HF hospitalizations and cardiovascular death, and total HF hospitalizations and urgent HF visits and CV death.

Lastly, main outcomes of the study included the number of worsening HF events prevented or postponed if eligible patients were treated with sacubitril/valsartan for 3 years. Data was analyzed from February - June 2021.

Data on the prevalence of self-reported HF among US adults show an estimate of 5,604,076 (95% CI, 4,674,944 - 6,533,208).

Following the use of exclusion criteria, the study identified a total of 4,682,098 individuals (95% CI, 3,890,581 - 5,473,615) with HF. The analyzed demographics show a mean age of 66.3 years, 42.6% women (n = 1,995,037), and 16.0% (n = 748,045) were Black.

Investigators noted 45.4% of patients with HF (n = 2,124,182) would have previously met LVEF criteria for prior HF with reduced ejection fraction indication.

Further, under the expanded label, eligibility ranged from additional 14% (if LVEF ≤50%) to 39% (if LVEF ≤60%).

As a result, the potential number of adults projected to be newly eligible had a range from 643,161 (95% CI, 534,433 - 751,888; LVEF, 41% - 50%) to 1,838,756 (95% CI, 1,527,911 - 2,149,601; LVEF, 41% - 60%).

Within the PARAGON-HF trial (n = 4796), the 3-year NNT was 20 for total HF hospitalizations, 19 for total HF hospitalizations and CV death, and 17 for total worsening HF events and CV death.

In addition, across all LVEF ranges, the 3-year NNT ranged from 7 - 12 in all 3 end points of interest.

Following this, the implementation of sacubitril/valsartan among newly eligible patients with HF would prevent up to 69,268 worsening HF events (95% CI, 57,558 - 80,978; LVEF, 41% - 50%) to 182,592 worsening HF events (95% CI, 151,725 - 213,460; LVEF, 41% - 60%).

The team concluded the expanded FDA label may increase the HF population eligible for sacubitril/valsartan by up to 1.8 million individuals.

“If prior implementation barriers to sacubitril/valsartan are swiftly overcome, population-level impact on worsening HF events in this high-risk population is certainly possible with a favorable safety/efficacy margin for most individuals,” investigators wrote. “However, challenges based on access, cost, and therapeutic inertia should not be underestimated.”

Potential Implications of Expanded US Food and Drug Administration Labeling for Sacubitril/Valsartan in the US

The potential number of adults projected to be newly eligible for treatment had a range from 643,161 (LVEF, 41% - 50%) to 1,838,756 (LVEF, 41% - 60%). 

Cardiology

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Expanded FDA Label Increases Sacubitril/Valsartan Eligibility in Heart Failure Care 

. The US Pain Foundation shared that staggering statistic in a video they released in honor of 

 aims to allow a glimpse into the life of someone who experiences chronic pain. In the video, 5 people are featured sharing their personal experiences with chronic pain.

“The pain is like the beginnings of an F5 hurricane or a tornado,” Cheryl from Lake Louise, AK, said. “It starts off small but as it goes along it picks up debris, right, and starts to destroy things.”

Twenty million Americans live with “high-impact pain” or pain that significantly impacts their life. Another statistic that’s shared in the video. Despite how prevalent pain is, individuals often have difficulty finding the care they need.

The #PainCounts initiative is striving to improve the level of understanding surrounding chronic pain. Many face stigmatization due to the lack of understanding from the public, the health care system, and insurance providers.

The National Institutes of Health (NIH) dedicate less than 2% of funding to pain research and as of 2018, 96% of medical schools in the US did not require students to take courses on pain medicine, according to “

“At one point, I was so depressed,” Millie, from Rochester, NY, said in the video. “I had depression and anxiety, I wouldn’t get out of bed.”

Unfortunately, pain and depression can often feed off of each other. An especially harrowing statistic shared in the video stated that 10% of all suicides involve someone with chronic pain.

The US Pain Foundation is seeking to change this by partnering with Sunbeam for 

. The goal is a higher understanding, more research, better training and less stigma. 

Videos

The US Pain Foundation starts off September strong for Pain Awareness Month by releasing a touching video that gets personal about chronic pain. 

Acute Pain

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Pain

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Chronic Pain

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The US Pain Foundation Sets September Initiative for Awareness with #PainCounts

. Prior to joining MJH Life Sciences in 2019, he worked as a digital reporter covering nanotechnology, life sciences, material science and more with 

. He graduated with a degree in journalism from Temple University in 2008 and began his career as a local reporter for a chain of weekly newspapers based on the Jersey shore. When not working, he enjoys going to the beach and enjoying the shore in the summer and watching North Carolina Tar Heel basketball in the winter.

 (HBV) is useful in areas of high prevalence, it is not as cost effective in areas like the US where the prevalence is low.

However, utilizing machine learning technology could help identify high-risk individuals.

A team, led by Nathan S. Ramrakhiani, Division of Gastroenterology and Hepatology, Stanford University Medical Center, identified patients with HBV using a newly developed logistic regression and machine learning that leverages demographic data from a population-based data.

While affecting more than 290 million patients worldwide, only 10% of individuals with chronic hepatitis B virus have been officially diagnosed. Even thought for the last 2 decades guidelines have called for screening high-risk individuals, cases still remain underreported.

In the study, the investigators identified patients with data on hepatitis B surface antigen (HBsAg), birth year, sex, race and ethnicity, and birthplace using 10 cycles from the National Health and Nutrition Examination Survey (NHANES) between 1999-2018. The median birth year for the patient population was 1973

The participants were divided into 2 separate cohorts: training (cycles 2, 3, 5, 6, 8, 10; n = 39,119) and validation (cycles 1, 4, 7, 9; n = 21,569).

Next, the investigators developed and tested the new logistic regression and machine learning models.

The primary outcome for the logistic regression model was HBV infection, which was defined as positive HBsAg with demographic variables as primary predictors. Both univariable and multivariable logistic regression were in the training set.

In the machine learning model, the investigators determined the demographic factors and birthplace associated with the primary outcome. The model used the training cohort with down-sampling of the controls and 10-fold cross-validation to determine test characteristics of the model.

Using the multivariable logistic regression, the investigators identified several factors that were more commonly associated HBV infections, including birth year 1991 or after (aOR, 0.28; 95% CI, 0.14-0.55; 

 < 0.001), male sex (aOR, 1.49; 95% CI, 1.11-2.01; 

 = 0.0080), Black and Asian/Other vs. White (aOR, 5.23 and 9.13; 95% CI, 3.10-8.83 and 5.23-15.96; 

 <0.001 for both), and being US-born vs. foreign-born (aOR 0.14; 95% CI, 0.10-0.21; 

Machine Learning Model Bests Logistic Regression

Ultimately, the machine learning model was superior, with higher area under the receiver operating characteristic (

) values (0.83 vs. 0.75 in validation cohort, P < 0.001) and better differentiation of high and low risk individuals.

The training cohort showed the AUROC was significantly higher in the machine learning model at 0.90 (95% CI, 0.88-0.92), compared to 0.81 (95% CI, 0.79-0.84) for the logistic model (

In the validation cohort, the AUROC was similarly higher in the machine learning model (0.83; 95% CI, 0.78-0.88 vs. 0.75; 95% CI, 0.70-0.80; P < 0.001).

“Our machine learning model consistently outperformed the logistic regression model, laying the groundwork for what could eventually be a practical and cost-effective HBV screening strategy for low prevalence regions with more “imported” HBV infection such as the United States or Western Europe,” the authors wrote. “We also advocate for additional risk-based screening for populations with specific exposure risks as per professional society and CDC guidelines.”

Optimizing Hepatitis B Virus Screening in the United States Using a Simple Demographics-Based Mode

The machine learning model outperformed a comparison logistic regression model in identifying high-risk patients for HBV. 

Hepatitis C

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, IBS and IBD, Crohn's disease, and more.

Geriatrics

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Machine Learning Model Could Transform Hepatitis B Screenings

Hospitals that use the 3-dose vaccine would spend approximately 37% more on prophylaxis for hepatitis B. 

Two Dose HBV Vaccine Provides Protection, Cost Savings for Hospital Systems

Armand Butera is the assistant editor for 

. He attended Fairleigh Dickinson University and graduated with a degree in communications with a concentration in journalism. Prior to graduating, Armand worked as the editor-in-chief of his college newspaper and a radio host for WFDU. He went on to work as a copywriter, freelancer, and human resources assistant before joining 

. In his spare time, he enjoys reading, writing, traveling with his companion and spinning vinyl records. Email him at 

In this episode of Derm Discussions, vitiligo expert John Harris, MD, PhD, discusses new tactics and therapeutic options in treating inflammatory skin disorders like vitiligo, alopecia areata, and atopic dermatitis.

Vitiligo

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Dermatology

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Internal Medicine

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John E. Harris, MD, PhD: The Current State of Vitiligo and Alopecia Areata Research

The evidence regarding patients with entecavir-treated chronic hepatitis B without maintaining virological response is limited and uncertain.

Maintaining Virologic Response Following HBV Treatment Reduces HCC Risk

The TMIOA Medical Director and Principal Investigator discusses the idea behind hosting a mixed in-person and virtual conference for this year's Heart in Diabetes.

Diabetes

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Yehuda Handelsman, MD: Organizing a Hybrid Cardiometabolic Meeting in 2021

Though the severity of the COVID-19 virus did not differ in participants with different dermatological conditions, their conditions were affected in alternate ways.

Plaque Psoriasis

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Chronic Idiopathic Urticaria

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Inflammation

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COVID-19 Linked to Exacerbations in Skin Diseases

Voxelotor has the potential to decrease long-term problems in pediatric sickle cell disease. 

Sickle Cell

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Latest News

Increased Physical Activity Improves Asthma Control in Pediatric Patients

FDA Panel Advises Against Pfizer-BioNTech COVID-19 Booster Dose

Expanded FDA Label Increases Sacubitril/Valsartan Eligibility in Heart Failure Care

The US Pain Foundation Sets September Initiative for Awareness with #PainCounts

Machine Learning Model Could Transform Hepatitis B Screenings