The E-cigarette or Vaping Product Use-Associated Lung Injury Epidemic: Pathogenesis, Management, and Future Directions: An Official American Thoracic Society Workshop Report.

E-cigarette or vaping product use-associated lung injury (EVALI) is a severe pulmonary illness associated with the use of e-cigarettes or vaping products that was officially identified and named in 2019. This American Thoracic Society workshop was convened in 2021 to identify and prioritize research and regulatory needs to adequately respond to the EVALI outbreak and to prevent similar instances of disease associated with e-cigarette or vaping product use. An interdisciplinary group of 26 experts in adult and pediatric clinical care, public health, regulatory oversight, and toxicology were convened for the workshop.

The Evolution of Vigilance and Its Atrophy Preceding the COVID-19 Global Pandemic.

Introduction: Recent infectious outbreaks preceding the COVID-19 crisis resulted in the evolution of vigilance for preparedness against the next pandemic. This vigilance was maintained to varying degrees in different jurisdictions.

Objective: To evaluate the evolution of vigilance following previous epidemics and pandemics and the subsequent atrophy of vigilance prior to the COVID-19 global pandemic.

Unsubstantiated health claims for COVID-19 infections are led by cannabidiol: return of snake oil medicine.

Background: The United States Food and Drug Administration (FDA) monitors, inspects, and enforces the promotion of products by companies that claim to mitigate, prevent, treat, diagnose, or cure COVID-19. The introduction of COVID-19-related diagnostics and therapeutics during the pandemic has highlighted the significance of rigorous clinical trials to ensure safety and efficacy of such interventions. The objective of this report is to provide a descriptive review of promotional violations of health products for COVID-19 infection.

How the Global COVID-19 Pandemic Brought Drug and Vaccine Development into the Public Mainstream.

Pharmaceutical development was at the forefront of efforts to prevent infection with the SARS-CoV-2 virus as well as to treat its often-devastating effects. Drug development, and its multifaceted and multi-disciplined activity toward effective vaccines and drugs, became part of everyday news. I review several key areas of vaccine and drug development that were brought into the public mainstream over the evolution of the pandemic.

The Emergency Use Authorization of Pharmaceuticals: History and Utility During the COVID-19 Pandemic.

The Emergency Use Authorization (EUA) originated in 2004 because of the need for emergency medical countermeasures (MCMs) against potential bioterrorist attacks. The EUA also proved useful in dealing with subsequent pandemics and has emerged as a critical regulatory pathway for therapeutics and vaccines throughout the Coronavirus Disease 2019 (COVID-19) pandemic. With the EUA process in the USA, we witnessed emergency authorizations, their expansions, as well as withdrawal of previously authorized products, which exemplifies the dynamic nature of scientific review of EUA products.

Compliance With Cannabis Act Regulations Regarding Online Promotion Among Canadian Commercial Cannabis-Licensed Firms.

Importance: As global jurisdictions shift toward cannabis legalization, 2 areas of public health importance relate to exposure to youth and to truthful promotion. Although Canada's Cannabis Act specifies many prohibitions related to cannabis promotion, no systematic monitoring or enforcement among licensed firms exists. Compliance with marketing regulations has effects beyond Canadian citizens because of the global outreach of websites and social media.

Drug Advertising Violations: A Longitudinal Trend Analysis of FDA Enforcement Letters from 2005 to 2019.

Introduction: In the United States, all pharmaceutical promotional activities must comply with regulatory standards set by the Food and Drug Administration (FDA); failure to comply may lead to receiving an FDA enforcement letter. Letters include details of the specific advertisement in violation, as well as the action that is required by the company to rectify the non-compliant promotion.

Objectives: The aim of this study was to determine trends in enforcement letters from the FDA to parties responsible for pharmaceutical promotion violations from 2005 to 2019.

Please don't call it medical marijuana unless it is; but it probably isn't.

The drug development process of demonstrating an agent is safe, effective and pure has, with rare exception, proven an exemplary path in translational research. The basic science, the clinical trials and the chemistry, manufacturing and control have served public health well. This carefully regulated approach forms the basis of a drug label with data from these studies also used to convey risk and benefit to prescribing physicians through the channels of medical literature and drug promotion by the industry.

The natural history of community-acquired common colds symptoms assessed over 4-years.

Background: The common cold is the most frequently experienced infection among humans, but limited data exist to characterize the onset, duration, severity and intersection of symptoms in community-acquired colds. A more complete understanding of the symptom frequency and burden in naturally occurring colds is needed.

Methodology: We characterized common cold symptoms from 226 cold episodes experienced by 104 male or female subjects.

The MCID of the transition dyspnea index is a total score of one unit.

The Baseline (BDI) and Transition (TDI) Dyspnea Indexes provide interview-based measurements of breathlessness related to activities of daily living. The BDI is a discriminative instrument that includes specific criteria for each of three components at a single point in time. The TDI is an evaluative instrument that includes specific criteria for each of three components to measure changes from a baseline state.

Airway responses to the inhalation of cotton dust and cotton bract extracts.

Background: Exposure to dust in the cotton industry is associated with respiratory dysfunction. Healthy subjects challenged with cotton bract extract (CBE) develop transient airway hyperresponsiveness. CBE, a major component of cotton dust, is potentially an important agent for studying byssinosis.

Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD.

Study Objectives: Pulmonary rehabilitation (PR) improves exercise tolerance in COPD patients. Tiotropium is a once-daily, inhaled anticholinergic bronchodilator that provides sustained 24-h improvements in airflow and lung hyperinflation reduction. We hypothesized that ventilatory mechanics improvements from tiotropium would permit enhanced ability to train muscles of ambulation and therefore augment exercise tolerance benefits of PR.

Meaningful effect size and patterns of response of the transition dyspnea index.

Ths object of this study was to examine validity, meaningful effect sizes, and patterns of response of the Transition Dyspnea Index (TDI) in a clinical trial cohort of chronic obstructive pulmonary disease (COPD) patients. The design was a retrospective analysis of data from a randomized, double-blind placebo-controlled clinical trial. We analyzed fifty clinical investigation sites in United States.

One-Year Evaluation of the Safety and Efficacy of Ipratropium Bromide HFA and CFC Inhalation Aerosols in Patients with Chronic Obstructive Pulmonary Disease.

Introduction: Ipratropium bromide (IB) is an established and effective first-line maintenance treatment for patients with chronic obstructive pulmonary disease (COPD). A new IB metered-dose inhaler (MDI) using hydrofluoroalkane 134a propellant (IB HFA) has been developed as an alternative to the MDI containing chlorofluorocarbon (IB CFC).

Objective: To compare the long-term safety and efficacy of IB HFA and IB CFC in patients with COPD.

A 6-month, placebo-controlled study comparing lung function and health status changes in COPD patients treated with tiotropium or salmeterol.

Background: Tiotropium, a once-daily anticholinergic, and salmeterol represent two inhaled, long-acting bronchodilators from different pharmacologic classes. A trial was designed to examine the efficacy and safety of both compounds with multiple outcome measures, including lung function, dyspnea, and health-related quality of life (HRQoL) in patients with COPD.

Methods: A 6-month, randomized, placebo-controlled, double-blind, double-dummy, parallel-group study of tiotropium, 18 microg once daily via dry-powder inhaler, compared with salmeterol, 50 microg bid via metered-dose inhaler, was conducted in patients with COPD.

Expression of ICAM-1 in nasal epithelium and levels of soluble ICAM-1 in nasal lavage fluid during human experimental rhinovirus infection.

Most rhinovirus serotypes use intercellular adhesion molecule-1 (ICAM-1) as the receptor to enter cells, but ICAM-1 expression has not been detected on normal nasal epithelial cells. During experimental rhinovirus infection, expression of ICAM-1 on nasal epithelial cells was examined with immunohistochemical staining of nasal scrape biopsy specimens, and levels of soluble ICAM-1 in nasal lavage fluid were measured by sandwich enzyme-linked immunosorbent assay technique. Expression of ICAM-1 on nasal epithelial cells increased following inoculation in 20 of 23 infected subjects.