US DEPARTMENT OF VETERANS AFFAIRS

DiMe and CTA launch CHcc project to advance connected health tech, focusing on sustainable hospital-at-home ecosystems and addressing industry fragmentation. Partners include healthcare, tech, patient orgs, and government entities.

Simufilam fails to meet primary endpoints in phase 3 ReThink-ALZ study for Alzheimer's disease, leading to discontinuation of ReFocus-ALZ. A new phase 2a study evaluates lamotrigine's potential in dementia with Lewy bodies, set to complete in early 2025. Hearing loss identified as an independent risk factor for Parkinson disease, suggesting potential for intervention.

Hearing loss is an independent risk factor for Parkinson disease (PD), with mild hearing loss increasing PD incidence. Hearing aids within 2 years of audiogram significantly reduce PD risk. The study, published in JAMA Neurology, used data from over 3 million US veterans and found a hazard ratio of 1.26 for PD risk associated with hearing loss.

Sarah Abramowitz's research on polygenic risk scores (PRSs) variability in predicting coronary artery disease (CAD) risk was published in JAMA and presented at the AHA Scientific Sessions. The study found significant individual-level variability across PRSs, suggesting caution in their use for personalized medicine.

Clinicians discussed BTK inhibitor use in CLL, follicular lymphoma, and MCL, focusing on frontline management, sequencing therapies, and managing AEs. They debated treatment options, including BTK inhibitor monotherapy vs. venetoclax and obinutuzumab, and the efficacy of newer BTK inhibitors like acalabrutinib and zanubrutinib. The panel also addressed real-world data on therapy switching and the impact of BTK inhibitors on vaccine responses.

46 polygenic risk scores (PRSs) for coronary heart disease (CHD) with similar population-level performance produced discordant individual-level risk estimates, with 20% of participants having PRSs in both the top and bottom 5th percentile at least once. This variability suggests that CHD PRSs with similar population-level characteristics may not provide consistent individual risk estimates, emphasizing the need for refined statistical methods and strategies to communicate uncertainty in clinical implementation.

President Biden's EO 14117 aims to prevent countries of concern from accessing US government-related or bulk sensitive personal data. The DOJ proposed rule identifies six countries of concern and defines sensitive personal data into six categories with four tiers of sensitivity, each with numerical thresholds. Exemptions and penalties are also proposed, with public comment open until November 29, 2024.

CMS approved 40% of TPTP applications, including all FDA-designated breakthrough devices. Approved devices often lacked generalizability to Medicare beneficiaries, used surrogate markers, or did not meet all primary end points. Strengthening premarket clinical evidence requirements could improve clinical decision-making and care for Medicare beneficiaries.

The US Department of Veterans Affairs (VA) is using 3D printing to create patient-specific, FDA-cleared radiotherapy boluses (RTB) for veterans, improving radiation therapy precision and outcomes. VA’s Office of Advanced Manufacturing (OAM) and 3D Systems collaborated on a five-phase development process, producing 21 personalized boluses since April 2023. Clinicians report the RTB fits perfectly, enhancing treatment effectiveness. VA plans to expand RTB access to more radiation oncology sites.