Kevin Kunzmann

Balmes discusses the latest annual State of the Air Report, which shows that 131 million Americans are living in areas with failing air quality grades.

2024 State of the Air: Record Highs in US Particle Pollution, with Dr. John Balmes

 What caused the particle pollution spike?


 The health effects of fine particle pollution exposure


 The new EPA particle pollution standard


 Improvements to ozone pollution and the Clean Air Act


 Reflecting on 25 years, and looking ahead


Four in every 10 Americans are now living in an area with unhealthy levels of air pollution, according to a new report that which additionally observed the most severe jump in deadly particle pollution exposure in the last quarter-century.

The 2024 State of the Air—an annual report from the American Lung Association (ALA) that which grades 3-year exposures to smog and air particle pollution—marks the 25th consecutive report from the organization. This latest iteration makes history in showing that approximately 131 million Americans are living in area that which received a failing grade for ≥1 measure of air pollution.

In contextualizing the findings, the ALA acknowledged 3 key factors of influence on this year’s report. The first is that the 2024 State of the Air reports on air quality from 2020 – 2022—recognized primarily as the COVID-19 pandemic era.

“While many people speculated that the changes in behaviors during the pandemic, such as working from home, would result in improved air quality, this report shows that poor air quality continued to impact millions of people during those years,” the ALA wrote in a statement. “Notably, freight and goods movement on heavy-duty trucks, by rail and at ports increased significantly in some regions, adding to increased pollution burdens.”

—many regions have been burdened by the growing threat of wildfires during this time as well.

Lastly, the Environmental Protection Act (EPA) had finalized new regulations designed to target pollution concerns through measures including limits on tailpipe emissions from newly manufactured cars, as well as a stricter standard for particle pollution exposure, in February this year.

“Now, the Lung Association is urging EPA to set long overdue stronger national limits on ozone pollution,” the ALA wrote. “Stronger limits would help people protect themselves and drive cleanup of polluting sources across the country.”

Additionally, the report showed a continued disparity in pollution exposure-related health outcomes among people of color, who are more than twice more likely to live in an area that has a failing grade on all 3 measures of pollution.

 This same population is additionally more susceptible to asthma, diabetes and cardiovascular disease—each chronic condition being associated with worsened outcomes due to air pollution.

The State of the Air report observed the highest rate of persons in counties with unhealthy spikes in short-term particle pollution since 2010: 65 million people.

“In the three years covered by this report, individuals in the U.S. experienced the highest number of days when particle pollution reached ‘very unhealthy’ and ‘hazardous’ levels in the 25 years of reporting the State of the Air,” an ALA statement read. “Short term particle pollution spikes are a clear example of the impacts that climate change is having on health. Changing weather patterns are driving more frequent and severe wildfires, which are delivering dangerous levels of particle pollution to more communities.”

This year’s report also set a record for people living in counties where year-round particle pollution levels are worse than the new standard for national air quality: 90.7 million people in 119 counties. That total increased nearly 5-fold from last year’s report.

Each of Bakersfield, CA; Fresno-Madera-Hanford, CA; Visalia, CA; and Eugene-Springfield, OR, appeared on the lists for top 5 most polluted cities based on short-term and year-round particle pollution.

Perhaps in the lone instance of good news from the 25th State of the Air report is the continued improvement in national ozone pollution. The ALA reported 2.4 million fewer people lived in areas with unhealthy ozone pollution compared to the 2023 report. Though 3 in 10 Americans still live in an area with unhealthy ozone pollution, the organization has seen a “dramatic improvement in ozone pollution” over the last quarter century: approximately three-fourths of all Americans were living in a county with unhealthy ozone pollution rates in 2000.

Additionally, the report cited 5 US cities considered the “cleanest” on the measures of short-term and year-round particle, as well as ozone pollution: Bangor, ME; Johnson City-Kingsport-Bristol, TN-VA; Lincoln-Beatrice, NE; Urban Honolulu, HI; Wilmington, NC.

, ALA chief medical officer Albert Rizzo, MD, discussed the headline findings of the 2024 State of the Air Report with John Balmes, MD, professor of medicine emeritus at the University of California San Francisco, and professor of environmental health sciences emeritus in the School of Public Health at the University of California Berkeley.

Along with discussing the overarching findings of this year’s report, Rizzo and Balmes reviewed the new EPA standards for particle pollution and the positive effect of longer-standing regulations set by the Clean Air Act—which can be contributed to the continued progress in ozone pollution reduction.

Balmes also shares advice on how individuals and organizations alike can become more active participants and advocates in the effort to improve environmental health. He and Rizzo then discuss the new report’s highlight of air quality inequity in the US and the factors that which influence it, before signing off reflecting on the last quarter-century of change in US air quality-related health.

Click here to read the full 2024 State of the Air Report from the ALA.

Lungcast is a monthly respiratory news podcast series hosted by Al Rizzo, MD, chief medical officer of the ALA, and produced by HCPLive.

American Lung Association. State of the Air 2024 Report. Published April 24, 2024. https://www.lung.org/getmedia/dabac59e-963b-4e9b-bf0f-73615b07bfd8/State-of-the-Air-2024.pdf

American Lung Association. 2024 ‘State of the Air’ Report Reveals Most ‘Hazardous’ Air Quality Days in 25 Years. Press release. Published April 24, 2024. https://www.lung.org/media/press-releases/sota-2024

Kunzmann K. Poor Air Quality Across the US: What You Need to Know. 

. Published June 8, 2023. https://www.hcplive.com/view/poor-air-quality-across-the-us-what-you-need-to-know

Podcasts

2024 State of the Air: Record Highs in US Particle Pollution, with John Balmes, MD

 Monday night, the US Food and Drug Administration (FDA) issued a complete response letter (CRL) to Abeona Therapeutics for the company’s biologic license application (BLA) for prademagene zamikeracel (pz-cel).

 The novel cell-based therapy is under development for the treatment of 

recessive dystrophic epidermolysis bullosa (RDEB)

, a rare, inherited, debilitating skin disease associated with severe outcomes including increased risk of skin cancer and death.

Abeona stated on Monday the CRL entailed an FDA request for additional information regarding Chemistry Manufacturing and Control (CMC) requirements being “satisfactorily resolved” prior to a potential approval for pz-cel. The company stated they submitted plans to the FDA with the commitment to provide the relevant CMC data prior to a potential BLA approval.

“The information needed to satisfy the CMC requests in the CRL pertains to validation requirements for certain manufacturing and release testing methods, including some that were captured in the observations during the FDA’s pre-license inspection,” they wrote. “The CRL did not identify any deficiencies related to the clinical efficacy or clinical safety data in the BLA, and the FDA did not request any new clinical trials or clinical data to support the approval of pz-cel.”

Abeona chief executive officer Vish Seshardri expressed surprise and disappointment with the CRL, but said the company is working to remediate the issue all the same.

“We are already hard at work generating the additional CMC information, and we expect that all of FDA’s requests will be addressable in a reasonable timeframe,” Seshandri said in a statement. “We anticipate completing the BLA resubmission in the third quarter of 2024 with necessary updates to fully satisfy all the deficiencies outlined in the CRL.”

spoke with a trio of experts regarding pz-cel, its supporting phase 3 data from the VIITAL trial, and the novel therapy’s potential role in the treatment of RDEB.

Joyce Teng, MD, PhD, professor of dermatology at Stanford University, explained how the use of genetically corrected cells derived from patients could create for the opportunity to provide a “true, personalized approach” to managing RDEB. “The genetically corrected keratinocytes will be growing into a sheet of skin without the genetic defect, then grafted back onto the individual where the initial cells were derived from, to correct the area where the disease is affected,” Teng said.

That said, skin graft procedures with pz-cel will have to be performed in skilled tertiary centers, she explained.

“But the advantage of that kind of approach to some of these data are already in the public domain—that the durability of these skin grafts are quite good compared to other products,” Teng said. “It can probably tailor to patients that have, for instance, a chronic wound in a particular location of their body that's really, really difficult to heal.”

The potential application of pz-cel to treat patients with RDEB comes at a time when gene therapy beremagene geperpavec (B-VEC; VYJUVEK) was recently approved to treat DEB; Amy Paller, MD, chair of dermatology at Northwestern Medicine, discussed with 

“Aging, older individuals and those maybe a little bit slower in general to heal, those who have more of these larger (wound) areas, maybe are really who we would more readily designate for these (pz-cel) transplants,” Paller said. “And obviously, there may be those who can't be putting on (the topical) every week, because it's complicated, right?”

Paller explained that patients will experience more inflammation and a slower healing process as they age; the properties of pz-cel’s clinical benefit may be especially pronounced in the older RDEB patient population.

“The deficiency in type VII collagen affects both the adhesive properties of skin—because it is a major component of the anchoring fibrils...but also collagen VII can be involved as an extracellular matrix component that cells can migrate on,” Paller said. “There's so many reasons why it's problematic.”

In the event the BLA is eventually approved by the FDA, there will likely be a rollout phase to ensure the grafting procedure is handled optimally, explained investigator Peter Marinkovich, MD, director of the Stanford Bullous Disease and Psoriasis Clinics.

“You want to have very good EB surgeons and anesthesiologists who understand EB patients, who know how to manage their fragile airways effectively to try to minimize the risk,” he explained. “And then you also want the patients to be hospitalized and treated during their medical care by people who are familiar with EB, who will handle the skin gently and not incur blistering and try to give the patient as good a hospital experience as possible. “

Stansfield N. FDA Issues CRL for Abeona's Epidermolysis Bullosa Gene Therapy Pz-Cel. 

. Published April 22, 2024. https://www.cgtlive.com/view/fda-issues-crl-abeona-epidermolysis-bullosa-gene-therapy-pz-cel

Abeona. Abeona Therapeutics Provides Regulatory Update on Pz-cel. Press release. Published April 22, 2024. https://investors.abeonatherapeutics.com/press-releases/detail/276/abeona-therapeutics-provides-regulatory-update-on-pz-cel

Kunzmann K. Comparing New Therapies for Dystrophic Epidermolysis Bullosa. 

. Published March 6, 2024. https://www.hcplive.com/view/comparing-therapies-dystrophic-epidermolysis-bullosa

Kunzmann K. Amy Paller, MD: What Pz-cel, B-VEC Each Bring to Recessive DEB. 

. Published March 6, 2024. https://www.hcplive.com/view/amy-paller-pz-cel-b-vec-recessive-deb

Kunzmann K. The Prospect of Pz-cel in RDEB Treatment, with Peter Marinkovich, MD. 

. Published March 6, 2024. https://www.hcplive.com/view/pz-cel-rdeb-treatment-peter-marinkovich-md

Articles

Abeona's pz-cel is up for indicated use to treat patients with recessive dystrophic epidermolysis bullosa.

FDA Issues CRL to Abeona for Potential RDEB Cell Therapy

Situations when hospitalized patients remain in the emergency department (ED) for ≥24 hours are more frequently associated with instances of patient discrimination and risk of care dissatisfaction, according to new findings.1

2024 American College of Physicians (ACP) Internal Medicine Meeting

 in Boston, MA, this week, investigators from Harvard Medical School reported that ED boarding time may significantly impact the quality of care and treatment provided to patients. What’s more, the findings suggest the effect may be more severe for patients of marginalized races or ethnicities.

Led by Rose McKeon Olson, MD, MPH, of the division of global health equity at Brigham Women’s Hospital, the investigators sought to determine whether prolonged ED boarding is linked to increased risk of perceived discrimination and patient dissatisfaction, stratified by patient racial and ethnic background. As they noted, US EDs and hospitals have experienced “critical overcrowding and capacity challenges,” a trend exacerbated by the COVID-19 pandemic.

“ED boarding is associated with adverse health outcomes,” they wrote. “Its effect on discrimination is unknown.”

The team conducted a random-sample survey at a large urban academic hospital from June 2023 – January, assessing hospitalized patients admitted to internal medicine care. Patients were stratified 1:1 as either identifying as non-Hispanic White, or being from a marginalized racial or ethnic background.

Length of boarding in the ED was stratified into 3 durations: <4 hours (reference group), 4 - <24 hours, and ≥24 hours. Olson and colleagues assessed for racial discrimination based on the Discrimination in Medical Settings Scale, and patient dissatisfaction based on the Adapted Picker Patient Questionnaire.

Their final analyses included 525 patients; 274 (52.7%) were from a marginalized race or ethnicity, and the rest were White. Mean patient age was 60.6 years old; 300 (57.1%) were female). Approximately 90% spoke English, and patients primarily had private insurance (47.2%), followed by Medicare (42.1%).

Patients were primarily onboarded in 4 - <24 hours at the ED (n = 202 [38.5%]), followed by ≥24 hours (n = 188 [35.8%]). Only one-fourth of patients were boarded within 4 hours. Such rates were consistent across both White and marginalized race / ethnicity cohorts.

Olson and colleagues reported that patients who were boarded for ≥24 hours were nearly twice as likely to report discrimination per questionnaire results (odds ratio [OR], 1.84; 95% CI, 1.05 – 3.24). Among the patients from marginalized racial / ethnic backgrounds, the risk was even more severe (OR, 2.18; 95% CI, 1.04 – 4.57; 

 = .04). Among White patients, the outcome was insignificant (OR, 1.37; 95% CI, 0.55 – 3.40; 

The investigators additionally observed that patients who were boarded ≥24 hours were 77% more likely to report dissatisfaction with their care (OR, 1.77; 95% CI, 1.02 – 3.08; 

“Hospitalized patients who board in the ED 24 hours or longer experienced more discrimination and dissatisfaction with their care,” the team wrote. “Despite similar lengths of boarding time, marginalized races and ethnicities were more likely to report discrimination during prolonged ED boarding.”

Though the assessment was limited by the single-center cohort and inability to adjust for potential confounders, among other shortcomings, the team believed the findings elucidated some clear needs for follow-up assessment.

Among those ideas, they noted, would be a qualitative study to identify the potentially modifiable drivers of discrimination in the ED, as well as a retrospective chart review to assess additional measures of boarding time outcomes.

McKeon Olson R, Fleurant A, Beauparlant S, Baymon DE, et al. Emergency Department Board Associated with Increased Racial Discrimination and Patient Dissatisfaction. Poster presented at: American College of Physicians Internal Medicine 2024 Meeting. Boston, MA. April 18 – 20, 2024.

Alharthi S, Al-Moteri M, Plummer V, Al Thobiaty A. The Impact of COVID-19 on the Service of Emergency Department. 

. 2021;9(10):1295. Published 2021 Sep 29. doi:10.3390/healthcare9101295

Data presented at ACP 2024 shows non-White patients may be particularly subjected to more risk of discrimination in their care when ED boarding extends past 24 hours.

Longer Emergency Department Boarding Increases Risk of Patient Discrimination, Dissatisfaction

Pre-visit planning showed potential to improve the uptake of pneumococcal vaccination among senior age adults in internal medicine clinic settings, according to new data presented at the 

A team of investigators from the Emory University School of Medicine, led by internist Reema Dbouk, MD, found significantly improved pneumococcal vaccination rates across older adults aged ≥65 years old when applying 2 different methods of intervention informed by pre-visit strategies. The findings suggest a promising and time-efficient role for internal medicine care teams in assuring higher-risk adults are more protected against pneumococcal disease.

Dbouk and colleagues noted that—despite the availability of both 15-valent and 20-valent pneumococcal conjugate vaccine (Prevnar 15, Prevnar 20) for the prevention of pneumococcal disease—vaccination rates were stagnant near 65% among the US population from 2019 – 2021. Notably, vaccination rates are even poorer among minority populations.

“US coverage is only 54% for non-Hispanic (Black persons) and 46% for Hispanic (persons),” investigators wrote. “As of December 2022 in the US, approximately 4.4% of Medicare beneficiaries aged 65 years and older received Prevnar 15 or Prevnar 20.”

Pre-visit planning, they reasoned, has been shown to historically benefit vaccination rates among targeted populations receiving care in ambulatory settings. The team sought to improve pneumococcal vaccination in eligible patients aged ≥65 years old seen in their clinic by 10% overall, and by 15% in minority groups.

The assessed intervention included medical assistants reviewing the vaccination status of patients scheduled for care in the following day and pending vaccination orders when indicated. Providers then reviewed the pending vaccination orders during the patient visit, confirmed patient eligibility, and offered the vaccination to the patient. Once the patient agreed to vaccination, the order was signed and the dose was administered before the end of the care visit.

Dbouk and colleagues ensured medical assistants were comfortable and confident in managing the pre-visit planning by survey, generating an empathy map based on the results that helped inform an instructional resource on how to pre-visit plan pneumococcal vaccinations.

Intervention 1 included a pre-visit planning for 1 physician and medical assistant team, while intervention 2 included pre-visit planning for 3 physician and medical assistant teams. Their baseline data was pneumococcal vaccination rates by provider of patients aged ≥65 years old seen in clinic August – October 2022 (intervention 1) and November 2022 – January 2023 (intervention 2).

The team observed that both interventions were significantly beneficial for improving pneumococcal vaccination uptake in each of overall, Black and White patients aged ≥65 years old. They additionally noted intervention 2 was associated with improved vaccination uptake among Asian patients.

Indeed, investigators concluded the strategy may help to primarily improve vaccination uptake, while also aiding outcomes including the clinic workflow and care team preparation for individual patients.

“Pre-visit planning is a tool that has potential to improve pneumococcal vaccination uptake in the ambulatory setting, and offload sole responsibility for addressing preventive health measures from providers,” they concluded.

Dbouk R, Gray K, Moore MA. Increasing Pneumococcal Vaccination Rates Using Pre-Visit Planning in Patients Age 65 and Older in an Academic Internal Medicine Clinic. Poster presenter at: American College of Physicians Internal Medicine 2024 Meeting. Boston, MA. April 18 – 20, 2024.

Kunzmann K. William Schaffner, MD: Pneumococcal Vaccine Guidelines. 

. Published August 14, 2019. https://www.hcplive.com/view/william-schaffner-md-pneumococcal-vaccine-guidelines

A study presented at ACP 2024 shows benefit with preparing to offer pneumococcal vaccination to incoming patients in an ambulatory setting.