Community health centers provide much more for their clientele then just medical advice and health care.

Because of the low income demographic often served at these facilities, health centers also serve as a place people can go to connect them to a world of different opportunities, from literacy and education programs to employment possibilities.

However, even in good times these centers can struggle financially. Factor in the ongoing coronavirus disease 2019 (COVID-19) pandemic might be creating an exceptionally difficult time for health centers across the country.

Larry McReynolds, Executive Director, Family Health Centers at NYU Langone, explained in an interview with 

, how health centers were able to weather the initial storm and switch to telemedicine to help maintain services.

“Well, it's certainly been very challenging, but I am very encouraged that health centers for the most part, were able to move from an in person face to face model to a virtual model very, very quickly,” he said.

Health centers generate $12.6 billion in economic benefits for low-income, rural and inner city communities and create 143,000 jobs, while serving over 24 million patients in 6000 of in America’s most economically challenged neighborhoods.

The overall goal of health centers across the country is to increase access to care and reduce health disparities. This could mean serving patients who either do not have insurance or have insurance that other institutions do not want to take.

Health centers generally serve a high proportion of Medicaid recipient, as well as a large number of uninsured individuals. McReynolds said these patients can come with multiple social economic issues, including unstable housing, low literacy levels, low education levels, low income levels, and food insecurities.

“They need to be able to go to a place that doesn't ask the first question of ‘what's your insurance’ in order to get in the door to see a doctor,” he said. “So, health centers have a sliding fee scale, so that even the poorest of individuals can have access to care to see a doctor for very little or no money.”

Those factors in normal times make it very difficult for health centers to even break even. However, the COVID-19 pandemic has made the situation even more untenable and difficult for health centers across the country.

McReynolds said one of the unfortunate byproducts of the situation is the NYU Langone Health Center was forced to lay off some workers, which more than 85% of health centers across the country were forced to do.

However, as case numbers began to improve, McReynolds said, Langone was able to rehire some of the laid off workers.

Like traditional doctor’s offices and hospitals, McReynolds said one of the tools health centers have successfully utilized during the ongoing pandemic has been telemedicine services. The popularity of these telehealth programs can be seen in Langone’s behavioral health programs, where McReynolds estimated a 130% increase in productivity from where they were before the pandemic.

Another service offered at the health center is a school-based program, with programs in more than 63 schools across New York City. However, the mass school closings forced the health center to temporarily halt their own programs.

“And so, it really just kind of compounded this disparity problem that COVID adversely affects Hispanics and blacks in infection rates and mortality,” McReynolds said. “And now the services that are designed to help those folks had to lay people off. So that's a very big challenge for fragile organizations that serve fragile populations.”

McReynolds also expects, should a vaccine gain FDA approval, that health centers will have a role in administering it to the public.

McReynolds said there have been a number of new pilot programs tried in an effort to reduce the burden on emergency room visits in favor of community health centers.

“The most successful pilot that I think will stay in place is that there will be community health workers or case workers and emergency rooms that will help those people that showed up to the emergency room when it wasn’t a real emergency and connect them with the primary caregiver in the community.”

Since the pandemic began, there have been an increase in the type of patients needing care, including cardiovascular issues, psychiatric conditions, sleep problems, and substance abuse.

While there are certainly financial worries, to compound what might be an increase in people needing medical assistance, Reynolds said there will always be a role for community health centers.

“I think that the biggest challenge is to, to reach out to patients to let them know that we're here for you regardless,” he said. “Regardless of if you just lost your job and now you don't have insurance anymore because there's 40 million newly unemployed people.

“We're here for you, regardless of whatever your health condition is,” he added. “It's really building on that trust factor of getting the patient to trust us and they have always trusted us because we don't judge them based on income or citizenship or language or anything.”

Articles

National Health Center Week kicks off on August 9.

COVID-19 Only Adding to the Challenges Health Centers Face

Recent study findings demonstrate the efficacy of dupilumab in significantly reducing severe exacerbation rates in patients with uncontrolled, persistent eosinophilic asthma.

Ian Pavord, FRCP, FMedSci, and colleagues conducted meta-analyses of dupilumab compared with standard of care on annualized severe exacerbation rates in patients with eosinophilic asthma. Dupilumab, a monoclonal antibody, blocks the shared receptor component for interleukin (IL)-4 and IL-13, drivers of type 2 inflammation in multiple diseases.

The investigators obtained data from the phase 3 QUEST and phase 2b studies to identify 3 subgroups of patients with baseline blood eosinophil count, inhaled corticosteroids dose, and number of severe exacerbations that matched the key inclusion criteria of clinical trials of anti-IL-5 biologics. The subgroups of patients had baseline characteristics similar to those of clinical trials for benralizumab (medium-/high-dose inhaled corticosteroid/long-acting β2 -agonist [LABA], eosinophils ≥300 cells/µL, ≥2 previous exacerbations, age at least 12 years old); mepolizumab (high-dose inhaled corticosteroid/LABA, eosinophils ≥150 cells/µL, ≥2 previous exacerbations, age at 12 years old); and reslizumab (medium-/high-dose inhaled corticosteroid/LABA, eosinophils ≥400 cells/µL, ≥1 previous exacerbation, age at least 18 years old).

Pavord and the team pooled the estimates of effect for dupilumab versus standard of care on annualized severe asthma exacerbation rates from the phase 3 and phase 2b studies. They calculated Number Needed to Treat to have 1 less severe exacerbation per year when using dupilumab instead of standard of care.

The team found dupilumab 200 mg and 300 mg every 2 weeks significantly reduced the annualized severe exacerbation rate in all 3 subgroups versus the standard of care. The exacerbation rate ratio for each subgroup was .26 (95% CI, .21-.33), .36 (95% CI, .29-.44), and .29 (95% CI, .23-.36), respectively, which represented a 64-74% relative exacerbation rate reduction.

The Number Needed to Treat was .91 (95% CI, .853-1.005), 1.033 (95% CI, .931-1.18), and 1.107 (95% CI, 1.034-1.228), respectively. These results indicated only 1 patient would need to be treated with dupilumab instead of standard of care to have 1 less severe asthma exacerbation per year.

Overall, the meta-analyses demonstrated dupilumab significantly reduced severe exacerbation rates in subgroups of patients with uncontrolled, persistent eosinophilic asthma.

 by the US Food and Drug Administration in 2018 as an add-on maintenance therapy for adults and adolescents at least 12 years old with an eosinophilic phenotype or with oral corticosteroid-dependent asthma.

Meta-Analyses of Dupilumab Versus Standard of Care in Patients with Uncontrolled, Persistent Asthma

,” was presented as part of the American Thoracic Society annual meeting.

Dupilumab significantly reduces exacerbation rates in patients with asthma compared to standard of care.

Dupilumab Reduces Asthma Exacerbation Rates

GDC-0214 could be a beneficial option for patients with mild 

 by inhibiting various Janus Kinase (JAK) pathways.

In data planned for presentation at the 

American Thoracic Society (ATS) 2020 International Conference

, a team, led by Honglin Chen, Senior Scientific Researcher, Genentech, tested GDC-0214 as a treatment for patients with mild asthma to reduce fractional exhaled nitric oxide (FeNO), a common JAK1-depenendnt IL-4 and IL-13 pathway biomarker.

The Janus Kinase pathway mediates activity for several asthma-relevant cytokines, including IL-4 and IL-13. However, GDC-0214, a potent, small molecule JAK1 inhibitor developed for inhaled delivery, has been safe and effective in past studies involving health volunteers.

In the double-blind, randomized, placebo-controlled, phase 1, proof-of-activity study, the investigators tested inhaled GDC-0214 at multiple dose levels in 36 patients. The team examined patients between 18-65 years old with physician-diagnosed asthma for at least 6 months with FeNO greater than 40 ppb, controlled with as-needed reliever medication.

The study consisted of 4 sequential ascending-dose cohorts mg QD, 4-mg QD, 15-mg QD, and 15-mg BID) with 6-12 patients each.

After receiving 4 days of blinded placebo, the patients were randomized 2-to-1 to GDC-0214 or placebo for an additional 10 days.

The investigators sought primary outcomes of the percent change in FeNO during the active treatment period and assessed pharmacokinetics, safety, and tolerability.

In the study there were 6 participants in each of the first 2 cohorts (1-mg QD; 4- mg QD) and 12 in each of the last 2 cohorts (15-mg QD; 15-mg BID). The mean age was 28 years old, with 54% of the patient population being female.

Overall, patients were diagnosed an average of 17 years prior to enrollment and had a mean FeNO of 93 ppb at baseline.

There were no significant treatment differences observed in the 1 mg and 4 mg dosing groups when compared to placebo, while FeNO was reduced by 23% (18 ppb difference) compared to placebo in the 15 mg QD arm and by 43% (45 ppb difference) in the 15 mg BID dose arm.

The investigators also found higher plasma exposures, which reflects higher lung concentrations, correspond with greater FeNO reductions.

There were no dose-limiting adverse events, serious adverse events, or treatment discontinuations. The most common adverse events in the study were asthma symptoms, upper respiratory tract infections, and headache.

There were also no major imbalances in adverse events or laboratory finding between the different treatment groups.

“Treatment with inhaled JAK inhibitor, GDC0214, for 10 days resulted in a dose-dependent reduction in FeNO in patients with mild asthma, and was found to be well tolerated, without evidence of systemic toxicity,” the authors wrote.

Findings of a new study demonstrate very 

 is associated with a 17% in asthma-related hospital admissions.

Furthermore, Amir Sapkota, PhD, and a team of investigators found the late onset of spring was associated with a 7% increase in hospital admissions for asthma.

Inhaled JAK Inhibitor GDC-0214 Reduces Exhaled Nitric Oxide in Patients with Mild Asthma

In a study presented virtually at ATS 2020, investigators find 15 mg of the study drug resulted in a 43% decrease in FeNO.

GDC-0214 Well-Tolerated for Patients with Mild Asthma

A new study from the US Center for Disease Control and Prevention (CDC) identified and characterized pathologies potentially linked to 

e-cigarette or vaping product use-associated lung injury (EVALI)

. Through tissue samples of both biopsies and autopsies from suspected EVALI patients, they found an association between e-cigarette/vaping use and acute or subacute lung injuries.

The investigators, led by Sarah Reagan-Steiner, MD, and colleagues, also noted previous shortcomings of systematic characterization in autopsy findings.

The biopsy (n = 10) and autopsy (n = 13) tissues submitted for analysis were from individuals either with a history of smokeless tobacco product use or respiratory, gastrointestinal, or constitutional-related symptoms. Other tissues came from those who had shown pulmonary infiltrates or opacities on their chest imaging or who had a sudden death from an undetermined cause.

The investigators supplemented their review process with patient medical records, evaluated histopathology, and a performance of infectious disease testing as necessary.

A total of 21 out of the 23 samples met the surveillance case definitions for EVALI. Reagan-Steiner and colleagues found that evidence of acute to subacute lung injuries, including diffuse alveolar damage or organizing pneumonia, were present in all 10 lung biopsies. They also found these similar patterns to be present in 9 (69%) of the autopsy cases.

The additional autopsies that did not follow these patterns revealed other pulmonary pathology not necessarily consistent with EVALI. These included bronchopneumonia, bronchoaspiration, and chronic interstitial lung disease.

Thus, they acknowledged a link between acute lung injury patterns in both biopsies and autopsies in suspected EVALI cases.

“Acute to subacute lung injury can have numerous causes,” they suggested, “however, if it is identified in an individual with a history of e-cigarette, or vaping, product use, and no alternative cause is apparent, a diagnosis of EVALI should be strongly considered.”

Nevertheless, Reagan-Steiner and team concluded, a thorough review of autopsy tissues in EVALI-suspected deaths can also help identify alternative, EVALI-unrelated diagnoses.

Although the use of e-cigarettes among US adults has increased over the past few years, long-term health implications due to use is still largely unclear and under-analyzed.

 presented in March at the American College of Cardiology (ACC) 2020 Scientific Sessions, a survey of 930,000 US adults found a near doubling of smokeless tobacco product usage from 2016-2018. With the relative novelty of such products, it becomes all the more necessary for investigators to analyze vaping and e-cigarette prevalence and any related health risks.

led by Denitza P. Blagev, MD, suggested a link between longer time spent in hospitals due to EVALI and readmission risk. According to their analysis, patients with longer hospitalizations were likely to experience readmission 30 days following discharge, though this link was not reflected in time spent in the ICU.

Although much is still unknown about EVALI and its implications, many such studies have sought to better understand its links to overall patient/user health.

Pathological findings in suspected cases of e-cigarette, or vaping, product use-associated lung injury (EVALI): a case series

A new case study  assesses biopsy and autopsy tissues to characterize pathological patterns in suspected EVALI cases .

Autopsies, Biopsies Link Lung Injuries to E-Cigarette Use  

This article, "FDA Accepts Aducanumab for Review as Alzheimer Disease Treatment," was originally published in NeurologyLive.

The US Food and Drug Administration (FDA) has accepted a biologics license application with priority review for aducanumab, an investigational 

There is currently a Prescription Drug User Fee Act target action date set for March 7, 2021.

Although the review is already on an accelerated track, the agency said it would act even earlier if the circumstances warrant it.

“The FDA’s acceptance of the aducanumab BLA with Priority Review is an important step in the path to potentially having a treatment that meaningfully changes the course of Alzheimer’s disease,” Michel Vounatsos, chief executive officer at Biogen, said in a statement. “We believe that aducanumab marks the beginning of a new era of potential treatments for Alzheimer disease that will inspire even more discovery and innovation to bring hope to those affected by this devastating disease.”

The FDA also stated that it intends to soon hold an advisory committee meeting related to the application for the investigational human monoclonal antibody.

If approved, aducanumab, previously known as BIIB037, would become the first treatment for reducing clinical decline in Alzheimer disease through its mechanism of selectively targeting aggregated forms of amyloid-beta, including both soluble oligomers and insoluble fibrils.

The drug has faced an interesting journey on its road to the FDA. Data from the identical, phase 3 EMERGE and ENGAGE clinical trials have been the subject of much debate after an initial 

 completed in March 2019showed that the drug missed its primary end point.

However, results of an additional analysis of the EMERGE dataset announced in October 2019 reportedly showed 

 on the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score, with P values of .010 or .031 based on cutoff dates.

This analysis included an additional 3 months of data from patients who received a high dose of the drug.

At the time, Biogen said that although ENGAGE failed to meet its end points, data from patients in that trial who achieved sufficient exposure to high-dose aducanumab supported the findings from the EMERGE trial.

Notably, a 22% reduction in clinical decline was observed at the 78-week cutoff in the intent to treat population in EMERGE who received high-dose aducanumab, with a similar reduction seen in the opportunity to complete population.

Those treated with the drug also showed a consistent reduction in clinical decline as measured by prespecified secondary endpoints, including the Mini Mental State Exam (18% vs placebo; 

= .05), the Alzheimer’s Disease Assessment Scale-Cognitive Subscale 13 Items (27% vs placebo; 

 = .01), and the Alzheimer’s Disease Cooperative Study-Activities of Daily Living Inventory Mild Cognitive Impairment Version (40% vs placebo; 

In addition, imaging showed that both low- and high-dose aducanumab were associated with reduced amyloid plaque deposit burden at weeks 26 and 78 compared with placebo (

Earlier this year, the FDA gave the go-ahead for a 

 of aducanumab in order to demonstrate long-term safety and tolerability in a targeted enrollment of 2400 patients from 4 previous clinical trial programs in the aducanumab development program.

Investigators found a 22% reduction in clinical decline at the 78-week cutoff in the intent to treat population in EMERGE who received high-dose aducanumab, with a similar reduction seen in the opportunity to complete population. 

FDA Sets PDUFA Date on Aducanumab for Alzheimer Disease

Manipulative techniques are not effective for chronic low back pain among relatively young individuals. 

Manipulative Therapy Ineffective for Chronic Low Back Pain

Firmicutes bacteria can help produce metabolites that maintain intestinal barriers and mucosal immunity. 

SER-287 Shows Efficacy in Treating Ulcerative Colitis in Early Phase Trial

Older, white patients and those who use linagliptin are at a higher risk of bullous pemphigoid.

DDP-4 Inhibitors Increase Risk of Bullous Pemphigoid

New findings suggest differing chronic lung diseases are associated with varying risk factors among COVID-19 patients.

Older, Male Asthmatics at Greater COVID-19 Severity Risk

It is important for clinicians considering prescribing denosumab treatment to counsel patients before its initiation on the importance of not delaying or discontinuing injections.

Denosumab Doses Must Be Delivered On Time for Patients With Osteoporosis

Approximately 5% of the 13,000 TBI patients examined died during the course of the study.

High Variability Found in Mortality from Traumatic Brain Injuries

Canakinumab Beneficial in Treating Osteoarthritis

The level of distress for adults in the UK rose from 18.9% in 2018-19 to 27.3% in April.

Lockdown Orders Impacting Mental Health in the UK

Podcasts

World-leading virologist and AIDS researcher David Ho, MD, joins the inaugural podcast episode.

COVID-19 Complications & Searches for a Cure with Dr. David Ho

The fast-acting therapy has been long-discussed for its unique benefits to severe patients—as well as notable concerns surrounding its administration.

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