viernes, 31 de mayo de 2024

After grilling an NIH scientist over covid emails, Congress turns to Anthony Fauci

https://www.news-medical.net/news/20240531/After-grilling-an-NIH-scientist-over-covid-emails-Congress-turns-to-Anthony-Fauci.aspx

The chicken and egg problem of fighting another flu pandemic

https://www.news-medical.net/news/20240531/The-chicken-and-egg-problem-of-fighting-another-flu-pandemic.aspx

H.E.L Group extends sales and support with appointment of specialist distributors

https://www.news-medical.net/news/20240531/HEL-Group-extends-sales-and-support-with-appointment-of-specialist-distributors.aspx

Discover how SciY empowers scientists

https://www.news-medical.net/news/20240531/Discover-how-SciY-empowers-scientists.aspx

D.C. Circuit Sides with Manufacturers in Latest 340B Contract Pharmacy Case By Sophia R. Gaulkin & Alan M. Kirschenbaum —

https://www.thefdalawblog.com/2024/05/d-c-circuit-sides-with-manufacturers-in-latest-340b-contract-pharmacy-case/?utm_source=rss&utm_medium=rss&utm_campaign=d-c-circuit-sides-with-manufacturers-in-latest-340b-contract-pharmacy-case

Medicaid spending and utilization of gene and RNA therapies for rare inherited conditions. Ilina C Odouard et al. Health Aff Sch 2024 2(5) qxae051

https://phgkb.cdc.gov/PHGKB/phgHome.action?action=update

10 Things to Know about CDER’s Pharmaceutical Quality Functions

https://www.fda.gov/drugs/things-know-about/10-things-know-about-cders-pharmaceutical-quality-functions-0

NIST Reports First Results From Age Estimation Software Evaluation

https://www.nist.gov/news-events/news/2024/05/nist-reports-first-results-age-estimation-software-evaluation A new study from the National Institute of Standards and Technology (NIST) evaluates the performance of software that estimates a person’s age based on the physical characteristics evident in a photo of their face. Such age estimation and verification (AEV) software might be used as a gatekeeper for activities that have an age restriction, such as purchasing alcohol or accessing mature content online. Age estimation has become an enabling technology in age assurance programs recently included in legislation and regulation both inside and outside the United States. These programs aim to permit only those in certain age groups to access social media chat rooms or to buy certain products both online and in the physical world and can be an important part of efforts to protect children online.

Supplemental Items for Hospital SOPS

Supplemental Items for Hospital SOPS: AHRQ has developed supplemental items that can be added to the Hospital SOPS to assess content in areas not covered by the core questions.

Hospital Survey on Patient Safety Culture

Hospital Survey on Patient Safety Culture: The Hospital SOPS asks providers and staff for their opinions about the culture of patient safety in their hospitals.

Associations between patient safety culture and workplace safety culture in hospital settings

https://pubmed.ncbi.nlm.nih.gov/38698405/ The safety culture of hospital providers and staff is fundamentally linked to patient safety culture, according to an AHRQ study published in BMC Health Services Research. Researchers reviewed nearly 6,700 responses to AHRQ’s Surveys on Patient Safety Culture® (SOPS®) Hospital Survey 2.0 and the SOPS Hospital Workplace Safety Supplemental Item Set. The largest number of associations between survey measures were overall support from hospital leaders; being able to report workplace safety problems without negative consequences; and overall rating on workplace safety. The study underscores the essential role of fostering robust safety cultures in healthcare to enhance safety and well-being for both staff and patients, researchers concluded.

Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program

https://www.fda.gov/science-research/clinical-trials-and-human-subject-protection/support-clinical-trials-advancing-rare-disease-therapeutics-start-pilot-program?utm_medium=email&utm_source=govdelivery

Transforming Healthcare to Improve the Health and Well-Being of Older Americans

Transforming Healthcare to Improve the Health and Well-Being of Older Americans: Blog on AHRQ's Special Emphasis Notice to announce its strong interest in funding health services research to improve care quality for older adults.

UV Disinfection Lights Can Cause Indoor Air Pollution

https://www.nist.gov/news-events/news/2024/05/uv-disinfection-lights-can-cause-indoor-air-pollution For most people, a smelly bathroom is something to avoid. But when the ventilation stopped working in his lab’s hallway bathroom, indoor air expert Michael Link smelled opportunity. At the National Institute of Standards and Technology (NIST), Link and his colleague Dustin Poppendieck study air sanitizers that use ultraviolet light (UV). These devices kill pathogens such as those that cause the flu and COVID-19, but they can also cause unintended chemical reactions in the air.

Rare Disease Endpoint Advancement Pilot Program

https://www.fda.gov/drugs/development-resources/rare-disease-endpoint-advancement-pilot-program?utm_medium=email&utm_source=govdelivery CBER and the Center for Drug Evaluation and Research (CDER) began accepting submissions to the Rare Disease Endpoint Advancement (RDEA) Pilot Program in September 2023. This innovative Pilot aims to accelerate rare disease drug development by fostering collaboration between sponsors and the FDA throughout the novel efficacy endpoint development process. The FDA welcomes RDEA submissions on a quarterly basis, with up to one eligible proposal selected per quarter. The deadline for submitting applications this quarter is June 31, 2024. For more information about the Program, visit Rare Disease Endpoint Advancement Pilot Program. Additionally, for guidance on submitting proposals to CBER, visit Submission Deadlines and Process | Rare Disease Endpoint Advancement Pilot Program. If you would like to connect with the FDA RDEA team, please email RDEA.Meetings@fda.hhs.gov. Submission Deadlines and Process | Rare Disease Endpoint Advancement Pilot Program https://www.fda.gov/drugs/development-resources/submission-deadlines-and-process-rare-disease-endpoint-advancement-pilot-program?utm_medium=email&utm_source=govdelivery

Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule JUNE 26, 2024

https://www.fda.gov/drugs/news-events-human-drugs/rx-drug-promotion-and-clear-conspicuous-and-neutral-final-rule-06262024?utm_medium=email&utm_source=govdelivery he webinar will provide background information on prescription drug promotion, including different categories and types of promotion, as well as regulatory requirements for each. Interested parties will then learn about the clear, conspicuous, and neutral (CCN) final rule, including the five standards associated with the rule and the rule’s compliance date. Finally, the speaker will note available FDA resources to assist firms in complying with the CCN final rule and applicable requirements for prescription drug promotion. The information presented can be used to gain a general understanding about prescription drug promotion and applicable requirements. In addition, participants will utilize the information to understand the effect the final rule has on DTC prescription drug advertising in TV or radio format. Attendees will be able to apply the information to help ensure the presentation of the major statement in their ads complies with the CCN rule.

National Advisory Council (NAC) Meeting Agenda

National Advisory Council (NAC) Meeting Agenda: National Advisory Council (NAC) Meeting Agenda

ICH Announces the Availability of a Final Guideline and Questions and Answers Document on Drug Interaction Studies (M12)

https://database.ich.org/sites/default/files/ICH_M12_Step4_Q%26As_2023_0521.pdf?utm_medium=email&utm_source=govdelivery On May 22, 2024, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced the availability of a final guideline on Drug Interaction Studies (M12) as well as an M12 Question and Answers document (M12 Q&A). The guideline provides recommendations to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies during the development of a therapeutic product. In response to questions posted during the ICH M12 comment period, the M12 Q&A was developed to provide clarity around some of the concepts related to evaluation of drug interaction covered in the M12 guideline. In clinical practice, patients are often prescribed more than one drug, which can result in a DDI. Some patients, in particular fragile older patients or patients with serious or multiple health issues, can be prescribed a large number of different drugs (i.e., polypharmacy). Hence, it is important to consider an investigational drug’s potential to interact with other drugs. While regional guidelines for investigations of DDIs have been available for decades, some differences have remained despite harmonization initiatives. This ICH guideline aims to harmonize recommendations for in vitro and clinical evaluation of DDIs. The scope of the guideline is limited to pharmacokinetic interactions, with a focus on metabolic enzyme- and transporter-mediated interactions. These aspects in general apply to the development of small chemical molecules. DDI evaluation of biologics is covered briefly, with focus on monoclonal antibodies and antibody-drug conjugates. Recommendations are provided on how to investigate interactions mediated by inhibition or induction of enzymes or transporters, both in vitro and in vivo, and on how to translate the results to appropriate treatment recommendations. The guideline also includes recommendations on how to address metabolite-mediated interactions. The use of model-based data evaluations and DDI predictions are also covered. https://database.ich.org/sites/default/files/ICH_M12_Step4_Guideline_2024_0521_0.pdf?utm_medium=email&utm_source=govdelivery ICH’s goal is to foster development of uniform, scientifically driven, international standards to improve the efficiency of new drug development and promote public health by, among other things, preventing duplication of clinical trials and minimizing the use of animal testing. To learn more about ICH, visit the organization’s website, and to learn more about ICH’s published and working-in-progress guidelines, visit the Guideline Database. https://www.ich.org/page/ich-guidelines?utm_medium=email&utm_source=govdelivery

NIAAA Releases Strategic Plan for Fiscal Years 2024-2028

https://www.niaaa.nih.gov/about-niaaa/strategic-plan-fiscal-years-2024-2028 The National Institute on Alcohol Abuse and Alcoholism (NIAAA) has released Advancing Alcohol Research to Promote Health and Well-Being, the institute’s strategic plan for fiscal years 2024-2028. The plan charts a course for the next five years and outlines the goals and priorities that will guide NIAAA’s research through a dynamic balance of basic, translational, and clinical research relevant to NIAAA’s mission. “For more than 50 years, NIAAA has been at the forefront of cutting-edge alcohol research,” said NIAAA Director George F. Koob, Ph.D. “Guided by this new strategic plan, I am optimistic that NIAAA-supported research will pave the way for future breakthroughs that will help more Americans live healthier, more productive lives.” The new strategic plan seeks to advance many long-held NIAAA research and research training priorities, such as preventing alcohol misuse at all ages, enhancing the diagnosis of alcohol use disorder (AUD), fetal alcohol spectrum disorders (FASD), and other alcohol-associated pathologies, improving treatment for these conditions, and addressing health disparities in alcohol misuse and related consequences. Highlights also include: Diversity, equity, inclusion, and accessibility in the alcohol research enterprise Women’s health research Whole-person health and integrated health approaches Data science (e.g., artificial intelligence) and data management Translation and back translation of research findings Social determinants of health in the context of risk and resilience Social media impact on alcohol-related behaviors and outcomes, and social media as a tool for innovating interventions Developed by NIAAA leadership and staff, with input from external researchers, advocacy groups, professional societies, and interested individuals, the strategic plan considers the long-term priorities of the field while remaining flexible to adapt to emerging public health needs and scientific opportunities.

Medical Device Sterilization Town Hall: Sterilization Open Q&A JUNE 12, 2024

https://www.fda.gov/medical-devices/medical-devices-news-and-events/medical-device-sterilization-town-hall-sterilization-open-qa-06122024?utm_medium=email&utm_source=govdelivery Save the Date: Medical Device Sterilization Town Hall – Sterilization Open Q&A Join the U.S Food and Drug Administration (FDA) on June 12, 2024, for the Medical Device Sterilization Town Hall: Sterilization Open Q&A. During this town hall, we will discuss questions we’ve received in the medical device sterilization mailbox and host a question-and answer session. We encourage attendees to submit questions to MedicalDeviceSterilization@fda.hhs.gov by 4:00 PM ET on Wednesday, June 5, 2024. There will be an opportunity to ask questions live during the town hall. Date: June 12, 2024 Time: 2:00 - 3:00 PM ET Location: Virtual

jueves, 30 de mayo de 2024

National Prevention Week Kickoff Celebration

Drug Overdose Deaths Among Persons Aged 10–19 Years — United States, July 2019–December 2021

https://www.cdc.gov/mmwr/volumes/71/wr/mm7150a2.htm?utm_source=SAMHSA&utm_campaign=b3f7e55c19-EMAIL_CAMPAIGN_2024_05_30_01_09&utm_medium=email&utm_term=0_-b3f7e55c19-%5BLIST_EMAIL_ID%5D#:~:text=During%20July%202019%E2%80%93December%202021%2C%20a%20total%20of%201%2C808%20adolescent,May%202021%20(Figure%201)

FentAlert Challenge Winners

https://www.samhsa.gov/about-us/who-we-are/offices-centers/csap/fentanyl-awareness-youth-challenge/winners?utm_source=SAMHSA&utm_campaign=b3f7e55c19-EMAIL_CAMPAIGN_2024_05_30_01_09&utm_medium=email&utm_term=0_-b3f7e55c19-%5BLIST_EMAIL_ID%5Dhttps://www.samhsa.gov/about-us/who-we-are/offices-centers/csap/fentanyl-awareness-youth-challenge/winners?utm_source=SAMHSA&utm_campaign=b3f7e55c19-EMAIL_CAMPAIGN_2024_05_30_01_09&utm_medium=email&utm_term=0_-b3f7e55c19-%5BLIST_EMAIL_ID%5D

FentAlert Challenge: Youth Innovators Advancing Fentanyl Overdose Prevention Webinar Thursday, June 13, 2024, 2 - 3 p.m. ET

https://us02web.zoom.us/webinar/register/WN_BiC14CmdSqSAGdDhZMqT1g?utm_source=SAMHSA&utm_campaign=b3f7e55c19-EMAIL_CAMPAIGN_2024_05_30_01_09&utm_medium=email&utm_term=0_-b3f7e55c19-%5BLIST_EMAIL_ID%5D#/registration Summer is often a time of substance use initiation for youth and young adults. The serious threat of fentanyl in our communities looms large and it is important to focus on prevention messaging during this time of year. From 2019 to 2021, overdose deaths among adolescents aged 10-19 increased. About 90% of these deaths involved opioids and 84% involved illicitly manufactured fentanyl. Engaging with youth and young adults can provide important insights into how this substance makes its way into our homes, schools, and communities and empower us to do something about it. That’s why SAMHSA is hosting a free webinar, FentAlert Challenge: Youth Innovators Advancing Fentanyl Overdose Prevention, on June 13, 2024, from 2 to 3 p.m. ET. FentAlert Challenge youth and young adult winners will share their strategies to increase awareness, education, and prevention around the dangers of fentanyl. FentAlert Challenge: Empowering Youth for Safer Choices—SAMHSA Fentanyl Awareness Youth Challenge encouraged youth ages 14-18 to develop a community strategy to educate their peers about fentanyl and fake pills—and prevent drug overdose deaths. Six winners and 25 honorable mentions were announced in May during SAMHSA’s National Prevention Week (NPW).

Olmstead Decision & Importance of Behavioral Health Workforce Innovation June 11, 2024, 3 – 4:30 p.m. ETOlmstead Decision & Importance of Behavioral Health Workforce Innovation June 11, 2024, 3 – 4:30 p.m. ET

https://zoom.us/webinar/register/WN_XfYrQbDRQBe42wXe9OJCWw?utm_source=SAMHSA&utm_campaign=267e78e099-EMAIL_CAMPAIGN_2024_05_21_01_54&utm_medium=email&utm_term=0_-267e78e099-%5BLIST_EMAIL_ID%5D&utm_source=SAMHSA&utm_campaign=5f9235b21b-EMAIL_CAMPAIGN_2024_05_29_03_07&utm_medium=email&utm_term=0_-5f9235b21b-%5BLIST_EMAIL_ID%5D#/registration SAMHSA is holding a webinar focusing on how states can help people with mental illness live successfully in the community through behavioral health workforce initiatives. This webinar is part of a series of activities honoring the 25th Anniversary of the historic Olmstead v. L.C. decision in which the U.S. Supreme Court affirmed that the Americans with Disabilities Act ensures the right to receive services in the most integrated setting appropriate to a person’s needs. After the event, a recording will be posted on the State TA Resources page of the SAMHSA website.

SAMHSA-funded 2024 First Episode Psychosis Conference June 5 & 6, 2024, 10 a.m. – 5 p.m. ET

https://mhttcnetwork.org/south-southwest-mhttc-first-episode-psychosis-conference-2024/?utm_source=SAMHSA&utm_campaign=ee4a236fb4-EMAIL_CAMPAIGN_2024_04_18_02_19&utm_medium=email&utm_term=0_-ee4a236fb4-%5BLIST_EMAIL_ID%5D&utm_source=SAMHSA&utm_campaign=5f9235b21b-EMAIL_CAMPAIGN_2024_05_29_03_07&utm_medium=email&utm_term=0_-5f9235b21b-%5BLIST_EMAIL_ID%5D The SAMHSA-funded First Episode Psychosis (FEP) Virtual Conference 2024 will bring together stakeholders with a commitment to improving and growing FEP services in the United States.

Save the Date! SAMHSA’s GAINS Center Webinar: The RED Tool: Identifying and Rectifying Racial and Ethnic Disparities in Treatment Court Programming and Outcomes June 26, 2024, 2:30 – 4 p.m. ETSave the Date! SAMHSA’s GAINS Center Webinar: The RED Tool: Identifying and Rectifying Racial and Ethnic Disparities in Treatment Court Programming and Outcomes June 26, 2024, 2:30 – 4 p.m. ET

https://us06web.zoom.us/webinar/register/WN_8EA6rLorRZuX1I7WA9QnBA?utm_source=SAMHSA&utm_campaign=93f608428a-EMAIL_CAMPAIGN_2024_05_28_05_07&utm_medium=email&utm_term=0_-93f608428a-%5BLIST_EMAIL_ID%5D&utm_source=SAMHSA&utm_campaign=5f9235b21b-EMAIL_CAMPAIGN_2024_05_29_03_07&utm_medium=email&utm_term=0_-5f9235b21b-%5BLIST_EMAIL_ID%5D#/registration Researchers have documented treatment courts’ ability to reduce recidivism among participants; however, one topic of concern has been racial and ethnic disparities in treatment court outcomes. The RED tool is a web-based survey geared to examine treatment courts’ operations and procedures, with an emphasis on probing areas where racial and ethnic disparities may be produced. This webinar will cover a review of research on racial and ethnic disparities in treatment courts, an overview of the RED tool, a summary of key findings from RED tool data, and an introduction to American University’s training and technical assistance approach.

Federal, State, and Local Mental Health Policy Interventions in Response to the Pediatric Mental Health Crisis following the COVID-19 Pandemic

A new journal article in Child and Adolescent Psychiatric Clinics of North America describes the impact of the COVID-19 pandemic on the pediatric mental health crisis in the U.S. and the federal, state, and local policy responses to support the crisis. The article is authored by SAMHSA staff members Billina R. Shaw, M.D., M.P.H., and Nikhil A. Patel, M.D., M.P.H., together with Michelle Durham, M.D., M.P.H., of the University of Houston Tilman J. Fertitta Family College of Medicine. It underscores the need for continued investments in pediatric mental health prevention and treatment to ensure a healthier future for our nation’s youth. Download a copy of the article today (free access until June 27, 2024). https://www.sciencedirect.com/science/article/abs/pii/S1056499324000427?dgcid=author&utm_source=SAMHSA&utm_campaign=5f9235b21b-EMAIL_CAMPAIGN_2024_05_29_03_07&utm_medium=email&utm_term=0_-5f9235b21b-%5BLIST_EMAIL_ID%5D

Supplemental Research Bulletin — Climate Change and Behavioral Health

https://www.samhsa.gov/dtac/disaster-behavioral-health-resources/supplemental-research-bulletin?utm_source=SAMHSA&utm_campaign=35a9599ef9-EMAIL_CAMPAIGN_2024_05_24_08_48&utm_medium=email&utm_term=0_-35a9599ef9-%5BLIST_EMAIL_ID%5D&utm_source=SAMHSA&utm_campaign=5f9235b21b-EMAIL_CAMPAIGN_2024_05_29_03_07&utm_medium=email&utm_term=0_-5f9235b21b-%5BLIST_EMAIL_ID%5D In recent years, weather-related disasters have grown more frequent and intense and the climate more variable. These trends have greater and longer-lasting effects on some populations than others. This Supplemental Research Bulletin reviews the mental health and substance use-related (behavioral health) effects of climate-related disasters on individuals and communities. It explores the connections between extreme weather and behavioral health issues and conditions and ways to foster resilience in impacted communities. Please also download and share this infographic with your colleagues and communities to raise awareness of the impact of weather-related disasters. https://www.samhsa.gov/sites/default/files/dtac-taking-action-building-a-more-resilient-world.pdf?utm_source=SAMHSA&utm_campaign=35a9599ef9-EMAIL_CAMPAIGN_2024_05_24_08_48&utm_medium=email&utm_term=0_-35a9599ef9-%5BLIST_EMAIL_ID%5D&utm_source=SAMHSA&utm_campaign=5f9235b21b-EMAIL_CAMPAIGN_2024_05_29_03_07&utm_medium=email&utm_term=0_-5f9235b21b-%5BLIST_EMAIL_ID%5D

Social Determinants of Health: Their Impacts on Disparities, Discriminatory Practices, and the Need to Develop and Deliver Services Grounded in Equity — Webinar Friday, June 14, 2024 9 a.m. ET

https://attcnetwork.org/event/social-determinants-of-health-their-impacts-on-disparities-discriminatory-practices-and-the-need-to-develop-and-deliver-services-grounded-in-equity-new-england-region-1-2/?utm_source=SAMHSA&utm_campaign=5f9235b21b-EMAIL_CAMPAIGN_2024_05_29_03_07&utm_medium=email&utm_term=0_-5f9235b21b-%5BLIST_EMAIL_ID%5D This training will introduce participants to how the social determinants of health have contributed to disparities and marginalization in the U.S. and how institutionalized forms of racism, discrimination and disparities impact individuals, families, and entire communities. The training will also describe strategies and techniques grounded in social justice that build healthy Social Determinants of Health, which in turn build and sustain equity.

Zeroing in on Xylazine — Webinar Monday, June 10, 2024 12 p.m. ET

https://opioidresponsenetwork.org/events/?utm_source=SAMHSA&utm_campaign=5f9235b21b-EMAIL_CAMPAIGN_2024_05_29_03_07&utm_medium=email&utm_term=0_-5f9235b21b-%5BLIST_EMAIL_ID%5D This training will provide knowledge regarding xylazine, a CNS depressant, which has been linked to an increasing number of overdose deaths in the U.S. This training will discuss the physiologic effects of xylazine, manifestations of xylazine intoxication, overdose, communicable infections associated with xylazine use, and wound care for persons injecting xylazine.

Resilient Leadership in Infant & Early Childhood Mental Health — Webinar Series Monday, June 10, 2024 10:30 a.m. ET

https://nttacmentalhealth.org/events/resilient-leadership-in-infant-early-childhood-mental-health/?utm_source=SAMHSA&utm_campaign=5f9235b21b-EMAIL_CAMPAIGN_2024_05_29_03_07&utm_medium=email&utm_term=0_-5f9235b21b-%5BLIST_EMAIL_ID%5D In today’s rapidly evolving landscape of infant and early childhood mental health (IECMH), resilient leadership is more crucial than ever. Resilient leadership encompasses the ability to remain calm, clearheaded, and principled despite increasing anxiety and escalating change. Join us for a transformative two-part training session on “Resilient Leadership,” where we explore the essential principles and strategies for thriving in uncertain environments. The second part of the training takes place on Monday, June 24, 2024 at 10:30 a.m. ET.

How to Write Successful Grants in Prevention — Webinar Series Monday, June 3, 2024, 12 p.m. ET

https://pttcnetwork.org/event/writing-a-winning-proposal-narrative/?utm_source=SAMHSA&utm_campaign=5f9235b21b-EMAIL_CAMPAIGN_2024_05_29_03_07&utm_medium=email&utm_term=0_-5f9235b21b-%5BLIST_EMAIL_ID%5D This webinar focuses on the key parts of a strong grant proposal narrative in the field of prevention. Participants will learn how to write a compelling problem statement that describes the problem they aim to solve using data gathered from their local community, write a strong project description that outlines the evidence-based and/or evidence-informed activities of the grant, draft a strategy for evaluation that demonstrates how to show the impact of the proposed project, and propose a project budget. The next webinar in this series, Analyzing & Learning From Real-World Examples, takes place on June 10, 2024, 12 p.m. https://pttcnetwork.org/event/learning-from-real-world-examples/?utm_source=SAMHSA&utm_campaign=5f9235b21b-EMAIL_CAMPAIGN_2024_05_29_03_07&utm_medium=email&utm_term=0_-5f9235b21b-%5BLIST_EMAIL_ID%5D

miércoles, 29 de mayo de 2024

Patient Safety and Artificial Intelligence: Opportunities and Challenges for Care Delivery. May 29, 2024

https://psnet.ahrq.gov/issue/patient-safety-and-artificial-intelligence-opportunities-and-challenges-care-delivery

Updates on Arts-Based Interventions and Integrative Health

https://www.nccih.nih.gov/research/blog/updates-on-arts-based-interventions-and-integrative-health?nav=govd Music, dance, and the visual arts have long played key roles in human experience. They move us, lift our moods, challenge us to think, and help us communicate. And a growing body of research suggests that they may also help promote our physical and mental health. Here at the National Center for Complementary and Integrative Health (NCCIH), we have an ongoing interest in research on the arts and their potential benefits for health and wellness. In this post, I want to share information with you about three exciting developments in this field: a new book to add to your reading list, a research funding opportunity, and a challenge for the music and health research community.

Friday, June 28 2024 Annual Force-Based Manipulation Investigator Meeting

https://www.eventbrite.com/e/2024-annual-force-based-manipulation-investigator-meeting-tickets-856235502437?aff=oddtdtcreator This meeting will provide opportunities to share advances across three National Institutes of Health (NIH)-funded force-based manipulation research networks, promote collaboration, and avoid duplication of network efforts. The meeting’s open session will featured updates from the trans-network scientific working groups and a keynote presentation by Valeria Vásquez, Ph.D., associate professor at McGovern Medical School at UTHealth Houston.

Technical Assistance and Teaming Webinar: REsearch Across Complementary and Integrative Health Institutions (REACH) Virtual Resource Centers Date: June 18, 2024 - 2:00 p.m. ET to 3:30 p.m. ET

https://www.nccih.nih.gov/news/events/technical-assistance-and-teaming-webinar-research-across-complementary-and-integrative-health-institutions-reach-virtual-resource-centers?nav=govd This webinar will include an overview of the REsearch Across Complementary and Integrative Health Institutions (REACH) Virtual Resource Centers (U24 Clinical Trial Not Allowed) funding opportunity from the National Center for Complementary and Integrative Health (NCCIH). See NOT-AT-24-037: Notice of Intent to Publish a Funding Opportunity Announcement for REsearch Across Complementary and Integrative Health Institutions (REACH) Virtual Resource Centers (U24 Clinical Trial Not Allowed) The first portion of the webinar is the technical assistance portion of the event. It will include information on the goals and purpose of the request for applications (RFA) as well as review considerations. There will be a questions and answers opportunity thereafter. Following the technical webinar will be a teaming activity opportunity to engage and provide potential applicants with an opportunity to network with potential complementary and integrative health institution partners.

Complementary and Integrative Interventions To Prevent and Mitigate the Effects of Endocrine-Disrupting Chemicals Date: June 10, 2024 to June 11, 2024

https://www.nccih.nih.gov/news/events/complementary-and-integrative-interventions-to-prevent-and-mitigate-the-effects-of-endocrine-disrupting-chemicals?nav=govd NCCIH is partnering with the National Institute of Environmental Health Sciences (NIEHS) to hold a 2-day workshop to stimulate discussion about and interest in researching ways to reduce and mitigate the effects of endocrine-disrupting chemicals (EDCs) in people who have been exposed. Spanish-language interpretation will be provided for those who indicate the need.

2024 NCCIH Cannabinoid Research Principal Investigators Meeting: Exploring the Mechanisms Underlying Analgesic Properties of Minor Cannabinoids and Terpenes Date: June 4, 2024 - 09:00 a.m. ET to 5:00 p.m. ET

https://www.nccih.nih.gov/news/events/2024-nccih-cannabinoid-research-principal-investigators-meeting-exploring-the-mechanisms-underlying-analgesic-properties-of-minor-cannabinoids-and-terpenes?nav=govd This meeting is aligned with NCCIH’s mission to support research on the fundamental science, safety, and usefulness of complementary and integrative health approaches. Specifically, minor cannabinoids and terpenes from natural products are part of complementary interventions supported by NCCIH. The meeting is also aligned with NCCIH’s strategic goals of advancing understanding of natural product’s basic biological mechanisms of action and improving care for hard-to-manage symptoms, such as pain. This meeting will be livestreamed through NIH VideoCast and available for viewing after the event. Prior to the event, NCCIH will send a link to those who register.

Veterans With Chronic Pain Value Discussions With Health Care Providers About Natural Products

https://www.nccih.nih.gov/research/research-results/veterans-with-chronic-pain-value-discussions-with-health-care-providers-about-natural-products?nav=govd Veterans value discussions with health care providers about natural products (NPs); however, the perception among some veterans that providers are biased against these products negatively affects patient-provider relationships, according to a new study by researchers from the San Francisco VA Health Care System and other collaborating institutions, published in the Journal of General Internal Medicine. The findings of this study, which was funded by a collaborative agreement through the National Institutes of Health’s National Center for Complementary and Integrative Health and the Office of Dietary Supplements, indicate that providers engaging in conversations about NPs with curiosity and respect can reinforce patient-provider relationships.

KFF Introduces Health Policy 101—A Primer on U.S. Health Policy

https://www.kff.org/health-policy-101/?utm_campaign=KFF-Health-Policy-101&utm_source=general%20email&utm_medium=email&utm_term=landing_page A new KFF resource—Health Policy 101—explains the basics on a wide range of topics about health programs and policy in the United States, such as Medicare and Medicaid, the Affordable Care Act, health care costs and affordability, women’s health issues, and the politics of health care. Health Policy 101 chapters are available online and can be downloaded in PDF format. The "101" was created to serve as a mini "textbook" for faculty and students interested in health policy. Dr. Drew Altman, KFF’s president and CEO, is the editor of the 101 series. CONTACT: Mikhaila Richards | 202.654.1328 | MRichards@kff.org

Variation in Use of Dental Services by Children and Adults Enrolled in Medicaid or CHIP Elizabeth Williams and Robin Rudowitz Published: May 29, 2024

https://www.kff.org/medicaid/issue-brief/variation-in-use-of-dental-services-by-children-and-adults-enrolled-in-medicaid-or-chip/?utm_campaign=KFF-Medicaid&utm_medium=email&_hsenc=p2ANqtz--O9hLM7hY6_1HKODkEddtN34O2wzTwnWxHRONhOLJakKikBdK94RZXFIrZOjguOPdpk3yubhH7QMNo5xiKdTqX14Hb2Q&_hsmi=309119843&utm_content=309119843&utm_source=hs_email A new KFF brief analyzes how Medicaid dental coverage and service use varies for children and adults as well as by race/ethnicity, state, and rural/urban regions, including how different barriers and coverage policies impact access to oral health care. Among adults with Medicaid, use of dental services is higher in states with extensive dental coverage. Meanwhile, service use among children varies substantially by state, even though all state Medicaid programs are required to cover their dental services. Overall, Medicaid enrollees have low rates of dental service use, which could indicate barriers to care, such as a lack of available dental providers in general or that accept Medicaid. CONTACT: Tammie Smith | 202.654.1410 | TammieS@kff.org

Antimicrobial resistance: an enormous, growing, and unevenly distributed threat to global health

https://www.thelancet.com/infographics-do/antibiotic-resistance-series-2024?dgcid=hubspot_email_conferencealerts_lancetamr24&utm_campaign=conferencealerts&utm_medium=email&_hsenc=p2ANqtz-_E-RzBcsQ791U3ZSxbZPbvSzCVhlFK7DhW0LjaeW_aRJ8CrsH4OIyKGrCGgH5ZHy4n74oGYbQneFvPy4MsoFO21UOBAA&_hsmi=309014326&utm_content=309014326&utm_source=hs_email Each year, an estimated 7·7 million deaths are associated with bacterial infections, 1·27 million of which are caused by bacterial pathogens resistant to the antibiotics available to treat them.

The Lancet Series on Antimicrobial Resistance: The need for sustainable access to effective antibiotics

https://www.thelancet.com/series/antibiotic-resistance?dgcid=hubspot_email_conferencealerts_lancetamr24&utm_campaign=conferencealerts&utm_medium=email&_hsenc=p2ANqtz-9-i8dhyp1g5DjUbxJAgIqLXqYT2ezkDIcmigcC6JeyhpuE3khan-QrJPrHr6m784RAtqAbYRg4FCr7ZkHn_z5ZPFUGzQ&_hsmi=309014326&utm_content=309014326&utm_source=hs_email

Antimicrobial Resistance: a silent pandemic

Health insurers boast to investors about using AI, but they’d rather not talk about it Brittany Trang By Brittany Trang May 29, 2024

Health insurers boast to investors about using AI, but they’d rather not talk about it Brittany Trang By Brittany Trang May 29, 2024 https://www.statnews.com/2024/05/29/health-insurers-artificial-intelligence-ai-use-cases-transparency/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-966qnDaEuRA9KCXL8_TVX8KNAS0I53l3gIF-NGQOkjUcc48IssXXzaatv6emywwcFR3wvtH5kTZHwyV4-YFBUb9xaYNQ&_hsmi=309132552&utm_content=309132552&utm_source=hs_email Health insurers boast to investors about using AI, but kept quiet when STAT reached out Health insurers are telling shareholders that they are ramping up the use of artificial intelligence and hiring talent to implement the technology across their organizations, STAT’s Brittany Trang reports. A review of regulatory filings from publicly-traded insurers showed several — including Elevance, Molina, and Cigna — investing in AI with the goal of saving money. (Elevance has hired nearly 500 people to work exclusively on AI.) The expansion comes at the same time the health insurance industry is lobbying Congress to minimize regulation of AI in health care. And all five of the insurers that Brittany contacted declined to elaborate on how they are using AI — a lack of transparency that poses problems for an industry that has already been slammed by lawmakers for using AI to guide patient care. Read more on what we know about insurers’ AI ambitions. Senate Democrats push for stronger rules around AI in Medicare Advantage Bob Herman Casey Ross By Bob Herman and Casey Ross Feb. 8, 2024 https://www.statnews.com/2024/02/08/medicare-advantage-senate-democrats-ai-algorithms-unitedhealth/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--iFzoquaOzNioPF5p9VWdkEwYl9CbXtDatA_aKDENESkQJOz6zKQJV1sTJbEnBHA8asxAuMHK1FCVuGMqU1Q_kIUPQbw&_hsmi=309132552&utm_content=309132552&utm_source=hs_email

What we know about extreme heat’s health impacts after the hottest summer on record Theresa Gaffney By Theresa Gaffney May 14, 2024

https://www.statnews.com/2024/05/14/hottest-summer-2000-years-nature-study-climate-change-effects-health/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8WP2SC69rJKH40Q_mf3WRm7tpot0-L7Kmxw2mK5qMDKmrcc5m5Bz8-Mg388FIhP-EpsHqr56BoC6mDUqkUXd1ZrIV_sQ&_hsmi=309132552&utm_content=309132552&utm_source=hs_email Heat waves are linked to early deliveries, per study Heat waves are becoming more frequent and more intense across the world, and as temperatures rise, so do health risks. It can be especially dangerous for those with cardiovascular or chronic diseases — and several studies have identified an increased risk of preterm delivery and stillbirth after heat exposure. STAT’s Nalis Merelli reported yesterday on a new study that confirms the link to early deliveries at a massive scale. The research, published last week in JAMA Network Open, looked at more than 53 million singleton births that occurred in the 50 most populous U.S. cities during the hottest months of the year between 1993 and 2017. After a heat wave, preterm births increased by 2% and early births by 1%. But the effects were uneven: Mothers who were 29 or younger, had a lower level of education, and belonged to a minority ethnic or racial group saw a 4% increase in preterm births, and a 3% increase in early deliveries. Heat waves associated with increased risk of preterm birth in the U.S. Annalisa Merelli By Annalisa Merelli May 28, 2024 https://www.statnews.com/2024/05/28/extreme-heat-increased-risk-preterm-delivery-stillbirth-study-says/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8Z-QV9l0U9wTdnqKRBv--_GToBzoQ3oWWM_7plrJOY3sqwTbxOjM636lK9yGG-Q4uXsvMznpS34OfdrCTPBsDZh7PgNQ&_hsmi=309132552&utm_content=309132552&utm_source=hs_email

Saving rural psychiatry services will require higher Medicaid payments By Nadir Al-SaidiMay 29, 2024

https://www.statnews.com/2024/05/29/rural-psychiatrists-higher-medicaid-payments/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9XWXaYmy-5dexDscvmxryYnC9lEHAF3h8gCBipGINOFsqYaCHYF9wBfJbQZ4m3VDksI6lJqns1h7jCF4BuhYnyHL0s8A&_hsmi=309132552&utm_content=309132552&utm_source=hs_email This is an easy one, according to First Opinion contributor Nadir Al-Saidi: higher Medicaid payments. Al-Saidi’s father runs the only private psychiatric practice in their rural Michigan town, and is the sole psychiatrist contracted at the local hospital. “If there were ever to be an empty bed in the stress unit my psychiatrist dad manages, I’m certain he would admit himself,” he writes. Having a highly Medicaid-dependent patient panel makes it almost impossible for a psychiatrist to financially support a practice, he argues. Instead, most choose to practice in urban settings where more people are covered by private insurance enrollment, making the business more lucrative.

Failing to address mental health inequities will cost the U.S. $14 trillion

Failing to address mental health inequities will cost the U.S. $14 trillion By Daniel Dawes, founding dean of the School of Global Health at Meharry Medical College, which is an HBCU. Author of the recent report, “The Projected Costs and Economic Impact of Mental Health Inequities in the United States.” https://www.statnews.com/sponsor/2024/05/15/failing-to-address-mental-health-inequities-will-cost-the-u-s-14-trillion/

Household Water Lead and Hematologic Toxic Effects in Chronic Kidney Disease

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2818894?guestAccessKey=9dd9b616-a925-47e2-842c-f8818012b31a&utm_term=052824&utm_campaign=ftm_links&utm_medium=referral&_hsenc=p2ANqtz-9e32GfOu2APltlmmAc6LuBvPTIw7AFn4QC9p4a5gsnskoEA9_Fc9iF_L0m13NvmYq5GEad2t9dqLRqR_TIlNxAczGNzg&_hsmi=309132552&utm_content=tfl&utm_source=For_The_Media Even common levels of lead could be dangerous for kidney patients A first-of-its-kind study published yesterday in JAMA Internal Medicine analyzed how common household levels of lead contamination in the U.S. water supply may affect people with chronic kidney disease. Lead poisoning is common in the U.S., and people with chronic kidney disease are particularly vulnerable. So when patients receive dialysis, which helps filter the blood, their home water supply is typically tested for toxins to ensure safe treatment. The researchers found that, among more than 6,400 chronic kidney disease patients, 12% had measurable lead in their home drinking water. To quantify the impact of contamination, researchers measured exposure against the patients’ dosage level of an anemia treatment, a proxy for the toxic effect lead has on the blood. Of patients with measurable lead in their water, a higher category of lead contamination was linked with 15% higher risk of using the maximum dose of that treatment. The results indicate, the authors write, that that even common levels of lead could have negative health effects for vulnerable individuals.Even common levels of lead could be dangerous for kidney patients A first-of-its-kind study published yesterday in JAMA Internal Medicine analyzed how common household levels of lead contamination in the U.S. water supply may affect people with chronic kidney disease. Lead poisoning is common in the U.S., and people with chronic kidney disease are particularly vulnerable. So when patients receive dialysis, which helps filter the blood, their home water supply is typically tested for toxins to ensure safe treatment. The researchers found that, among more than 6,400 chronic kidney disease patients, 12% had measurable lead in their home drinking water. To quantify the impact of contamination, researchers measured exposure against the patients’ dosage level of an anemia treatment, a proxy for the toxic effect lead has on the blood. Of patients with measurable lead in their water, a higher category of lead contamination was linked with 15% higher risk of using the maximum dose of that treatment. The results indicate, the authors write, that that even common levels of lead could have negative health effects for vulnerable individuals. Half of US population exposed to adverse lead levels in early childhood https://www.pnas.org/doi/10.1073/pnas.2118631119?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8U_xjixds7kc1yu_RCWfhs_dJgPEOA12gGPH4xvbBstlpFrqZbWqCzblR12e7Q3nrR34-ZGIiRla7jZib090mV287-IQ&_hsmi=309132552&utm_content=309132552&utm_source=hs_email

New obesity drugs are seemingly everywhere. Black Americans feel left out By Anissa Durham

New obesity drugs are seemingly everywhere. Black Americans feel left out By Anissa Durham https://www.statnews.com/2024/05/29/ozempic-wegovy-black-americans-access-body-image/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--Apw45VVcsQDANE8fQs2s1Y7ZHeIK6a-W433TvqPvXMsAPyRL4_Ok-xaEfbghCxzAtJg81ACfRmYHYOkvLkD2qpQRzZw&_hsmi=309132552&utm_content=309132552&utm_source=hs_email May 29, 2024 STAT has reported for over a year on how GLP-1 drugs are transforming the treatment of obesity in the U.S. But amid all the hubbub — as the drugs are touted for treating obesity, heart health, and down the line, maybe even conditions like addiction — many Black Americans worry that their community is being left behind. They say, too, that the public’s obsession with the drugs serves as a reminder of how Black bodies are policed and judged by society. Black Americans have long experienced higher than average rates of chronic disease, for reasons that include disparities in income and education; reduced access to health insurance, housing, and healthy food; and racism-related stress. Despite this burden, experts say that Black patients don’t have equal access to GLP-1s. Read more from STAT contributor Annisa Durham. In another story, Durham, a health data reporter for Word In Black, interviewed 14 Black people about how they view their bodies. Eleven of those people are women, as it became clear to Durham during reporting that Black women’s bodies are policed, surveilled, and judged more often than anyone else. They spoke with brutal honesty as they shared their journeys with weight loss, and their encounters with family and a medical system rooted in anti-Blackness. Black voices, Black bodies: Life in the age of Ozempic By Anissa Durham https://www.statnews.com/2024/05/29/ozempic-black-voices-black-bodies-weight-stigma/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--RXNK7epamExoaWJeV2O3Aqon3RHJY-Qvj36cMw7_zh_zVby5brzdJ4BHhhlD9I3Kuum-zG04O6TgpA9nbbYRzjnCKJQ&_hsmi=309132552&utm_content=309132552&utm_source=hs_email May 29, 2024

Biotechs turn to gene silencing for obesity drugs that can last longer than Wegovy

https://www.statnews.com/category/the-obesity-revolution/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9vgqfFRxLtSo4CAMzSE9qS1b9ztTWDRNE5N_PrFcooS76RK-glR9nSeaVB-XZPE_WtCuYcViohbjm73-boua-cuQlp3A&_hsmi=309132552&utm_content=309132552&utm_source=hs_email

SAMHSA’s GAINS Center Webinar: The RED Tool: Identifying and Rectifying Racial and Ethnic Disparities in Treatment Court Programming and Outcomes June 26, 2024, 2:30 – 4 p.m. ET

https://us06web.zoom.us/webinar/register/WN_8EA6rLorRZuX1I7WA9QnBA?utm_source=SAMHSA&utm_campaign=93f608428a-EMAIL_CAMPAIGN_2024_05_28_05_07&utm_medium=email&utm_term=0_-93f608428a-%5BLIST_EMAIL_ID%5D#/registration Researchers have documented treatment courts’ ability to reduce recidivism among participants; however, one topic of concern has been racial and ethnic disparities in treatment court outcomes. It is paramount that treatment court professionals and administrative offices of the court understand the factors that contribute to racial and ethnic disparities in treatment court programs and be equipped to address them. Faculty and staff in the School of Public Affairs at American University (AU) developed the Racial and Ethnic Disparities (RED) Program Assessment Tool (RED tool) to assist treatment courts in identifying and addressing disparities in their programs. The RED tool is a web-based survey geared to examine treatment courts’ operations and procedures, with an emphasis on probing areas where racial and ethnic disparities may be produced. This webinar will cover a review of research on racial and ethnic disparities in treatment courts, an overview of the RED tool, a summary of key findings from RED tool data, and an introduction to AU’s training and technical assistance approach.

10 Things to Know about CDER’s Pharmaceutical Quality Functions

https://www.fda.gov/drugs/things-know-about/10-things-know-about-cders-pharmaceutical-quality-functions?utm_medium=email&utm_source=govdelivery Pharmaceutical quality provides the confidence that a patient’s next dose of medicine is safe, effective, and available when it’s needed. When CDER receives a prescription drug application for approval, we evaluate whether the drug can be made to consistently meet quality standards. Pharmaceutical quality is about more than just the quality of the drug itself. It includes the manufacturing facilities and the processes used to manufacture the drug. Some of CDER’s pharmaceutical quality functions occur before a prescription drug is approved and reaches patients. CDER also monitors drugs on the market and the facilities making them to ensure continued quality.

Building support infrastructure so scientists can focus on research

https://www.fic.nih.gov/?utm_source=funding-news&utm_medium=email&utm_campaign=funding-news

This Week in CDRH May 29, 2024

https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrhnew-news-and-updates

martes, 28 de mayo de 2024

Platform Technology Designation Program for Drug Development MAY 2024

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/platform-technology-designation-program-drug-development?utm_medium=email&utm_source=govdelivery Today, FDA issued the “Platform Technology Designation Program for Drug Development” draft guidance. The platform technology designation program was added to the Federal Food, Drug, and Cosmetic Act by the PREVENT Pandemics Act. This program is intended to result in efficiencies in drug or biological product development, manufacturing, and review processes for drugs and biological products incorporating designated platform technologies. Today’s guidance outlines how a well-understood and reproducible technology in an FDA-approved drug or biological product may be eligible for a platform technology designation. There are several potential benefits for a drug company that receives a platform technology designation, including having early and additional interactions with FDA to discuss the use of a platform technology and leveraging information previously submitted in support of the designation in subsequent submissions from the same sponsor, such as new drug or biologics license applications. Read the guidance for the complete eligibility factors for receiving a platform technology designation, the potential benefits of receiving a designation, how to leverage data from designated platform technologies, how to discuss a planned designation request as part of a milestone meeting, the recommended content of a designation request submission, and the review timelines for a designation request.

NIST Launches ARIA, a New Program to Advance Sociotechnical Testing and Evaluation for AIv

https://www.nist.gov/news-events/news/2024/05/nist-launches-aria-new-program-advance-sociotechnical-testing-and The National Institute of Standards and Technology (NIST) is launching a new testing, evaluation, validation and verification (TEVV) program intended to help improve understanding of artificial intelligence’s capabilities and impacts. Assessing Risks and Impacts of AI (ARIA) aims to help organizations and individuals determine whether a given AI technology will be valid, reliable, safe, secure, private and fair once deployed. The program comes shortly after several recent announcements by NIST around the 180-day mark of the Executive Order on trustworthy AI and the U.S. AI Safety Institute’s unveiling of its strategic vision and international safety network.

Co-sponsored Public Workshop - Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Life Cycle

Co-sponsored Public Workshop - Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Life Cycle JUNE 26 - 27, 2024 Co-sponsored Public Workshop: Using Patient-Generated Health Data in Medical Device Development The U.S. Food and Drug Administration (FDA) is announcing a co-sponsored public workshop with the Digital Medicine Society (DiMe), Using Patient-Generated Health Data in Medical Device Development: Case Examples of Implementation Throughout the Total Product Life Cycle. The purpose of this public workshop is to illustrate how patient-generated health data (PGHD) can promote medical device innovation throughout the total product life cycle. Patients, industry sponsors, regulators, and researchers will share their perspectives on how using PGHD can help advance remote clinical trial data collection and support clinical outcome assessments. Workshop Date: June 26-27, 2024, from 11:00 a.m. – 3:00 p.m. (ET) Location: The workshop will be webcast. Registration Deadline: June 25, 2024, by 4:00 p.m. (ET) https://www.fda.gov/medical-devices/medical-devices-news-and-events/co-sponsored-public-workshop-using-patient-generated-health-data-medical-device-development-case?utm_medium=email&utm_source=govdelivery

Personalizing Care for Breast Cancer: The Precision Medicine Approach

https://www.medscape.org/viewarticle/1000564_sidebar5?sso=true&uac=148436CN&src=mkmcmr_driv_cust_mscpedu_honc_240528-1000564-es_lang-honc

How the media portrayed a study: “High Levels of Glyphosate Found in Sperm” – What data actually show: Almost no chemical traces and no effect on sperm Kevin Folta | May 28, 2024

https://geneticliteracyproject.org/2024/05/28/how-the-media-portrayed-a-study-high-levels-of-glyphosate-found-in-sperm-what-data-actually-show-almost-non-chemical-trace-and-no-effect-on-sperm/?mc_cid=cabaeb9614&mc_eid=b73600b7ac

Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development MAY 29 - 30, 2024

https://www.fda.gov/drugs/news-events-human-drugs/regulatory-education-industry-redi-annual-conference-2024-innovation-medical-product-development?utm_medium=email&utm_source=govdelivery

HHS Secretary Xavier Becerra Issues Statement on the National Institutes of Health Request for Information

https://www.hhs.gov/about/news/2024/05/21/hhs-secretary-xavier-becerra-issues-statement-national-institutes-health.html?utm_source=news-releases-email-A&utm_medium=email&utm_campaign=may-28-2024&utm_content=release-3&j=2369319&sfmc_sub=6992026&l=69_HTML&u=55839762&mid=100038678&jb=1002 The Biden-Harris Administration is committed to lowering healthcare costs, promoting innovation, and ensuring that taxpayer investments result in advancements in biomedical research accessible to everyone across the country.

Readout of Federal Interagency Working Group on Arts, Health, and Civic Infrastructure Meeting

https://www.hhs.gov/about/news/2024/05/20/readout-federal-interagency-working-group-arts-health-civic-infrastructure-meeting.html?utm_source=news-releases-email-A&utm_medium=email&utm_campaign=may-28-2024&utm_content=release-1&j=2369319&sfmc_sub=6992026&l=69_HTML&u=55839766&mid=100038678&jb=1002 On Thursday, May 16, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra participated in the second Federal Interagency Working Group meeting on Arts, Health, and Civic Infrastructure.

Biden-Harris Administration Launches New Option to Report Potential Violations of Federal Law and Continue to Promote Patient Access to Stabilizing Emergency Care

https://www.hhs.gov/about/news/2024/05/21/biden-harris-administration-launches-new-option-report-potential-violations-federal-law-continue-promote-patient-access-stabilizing-emergency-care.html?utm_source=news-releases-email-A&utm_medium=email&utm_campaign=may-28-2024&utm_content=release-2&j=2369319&sfmc_sub=6992026&l=69_HTML&u=55839764&mid=100038678&jb=1002 On Tuesday, May 21, 2024, the Centers for Medicare & Medicaid Services (CMS) launched a new option on CMS.gov to allow individuals to file an Emergency Medical Treatment and Labor Act (EMTALA) complaint more efficiently.

Jennifer Newberger Returns to HPM as a Director After Stints with Apple, Abbott Laboratories, and Cognito Therapeutics

https://www.thefdalawblog.com/2024/05/jennifer-newberger-returns-to-hpm-as-a-director-after-stints-with-apple-abbott-laboratories-and-cognito-therapeutics/?utm_source=rss&utm_medium=rss&utm_campaign=jennifer-newberger-returns-to-hpm-as-a-director-after-stints-with-apple-abbott-laboratories-and-cognito-therapeutics

OSIS Workshop: CDER Bioavailability/Bioequivalence Study Sites and Inspections of Good Laboratory Practice JUNE 13, 2024

https://www.fda.gov/drugs/news-events-human-drugs/osis-workshop-cder-bioavailabilitybioequivalence-study-sites-and-inspections-good-laboratory?utm_medium=email&utm_source=govdelivery On June 13, 2024, the FDA’s Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) will host a webinar entitled OSIS Workshop: CDER Bioavailability/Bioequivalence (BA/BE) Study Sites and Inspections of Good Laboratory Practice. In this event, FDA experts will describe the Mission and Vision of the Office of Study Integrity and Surveillance (OSIS), discuss the basic elements needed for a bioanalytical lab to successfully undergo an FDA inspection, provide an overview of compliance programs dealing with inspections of facilities that perform Good Laboratory Practice, Animal Rule, In Vivo Clinical BA/BE, and In Vivo Analytical BA/BE studies, and engage attendees to work through case studies representative of the above programs. Topics Covered: Expectations during BA/BE Inspections – Immunogenicity, Clinical, Clinical Endpoints and Analytical Clinical Programs Overview of Good Laboratory Practice/Animal Rule Compliance Programs and inspections Understanding of the OSIS BA/BE Program that includes BA Studies 505b2, BE studies, In Vitro BE studies and immunogenicity studies Gain a better understanding of reserve sample requirements Dates/Times: June 13, 2024 8:50 AM - 11:25 AM ET Additional Details: Attendance is virtual, and continuing education credits are available. The webinar is free, but registration is required. For more information on this webinar, including specific topics to be covered, agenda, and intended audience, please visit the meeting website. CDER’s SBIA aims to help small pharmaceutical business and industry navigate the wealth of information that FDA offers and assist in understanding human drug product regulation.

CAHPS Home and Community-Based Services Survey

CAHPS Home and Community-Based Services Survey: The CAHPS Home and Community-Based Services Survey is designed to assess the experiences of adult Medicaid beneficiaries who receive long-term services and support from State HCBS programs. These programs provide services for adults with disabilities in both physical and mental areas.

Register for June 6 Webcast: “Participating in the 2023 CAHPS® Home and Community-Based Services Survey Database: What You Need to Know” Date: June 6, 2024 Time: 3:30 - 4:30 p.m. EDT

https://westat.zoomgov.com/webinar/register/WN_DRbeTV1gS9auxTT8TdBp6Q#/registration Registration is open for a free webcast about participating in the 2023 Consumer Assessment of Healthcare Providers and Systems (CAHPS®) Home and Community Based Services (HCBS CAHPS) Survey Database. Speakers will review the HCBS CAHPS Survey and discuss the benefits and steps involved in participating. The database will display results by state and HCBS program types. Voluntary data submission opens August 5 – 23, 2024 to all states and is free. The HCBS CAHPS Survey Database is a joint project between the Agency for Healthcare Research and Quality and the Centers for Medicare & Medicaid Services. Speakers include: Jon Bakdash, Ph.D., Agency for Healthcare Research and Quality Melanie Brown, Ph.D., Centers for Medicare & Medicaid Services (CMS) Amanda Huben, The Lewin Group Joshua Rubin, Westat Dale Shaller, MPA, Shaller Consulting (Moderator)

Olmstead Decision & Importance of Behavioral Health Workforce Innovation June 11, 2024, 3 – 4:30 p.m. ET

https://zoom.us/webinar/register/WN_XfYrQbDRQBe42wXe9OJCWw?utm_source=SAMHSA&utm_campaign=267e78e099-EMAIL_CAMPAIGN_2024_05_21_01_54&utm_medium=email&utm_term=0_-267e78e099-%5BLIST_EMAIL_ID%5D#/registration The Substance Abuse and Mental Health Services Administration (SAMHSA) is holding a webinar focusing on how states can help people with mental illness live successfully in the community through behavioral health workforce initiatives. This webinar is part of a series of activities honoring the 25th Anniversary of the historic Olmstead v. L.C. decision in which the U.S. Supreme Court affirmed that the Americans with Disabilities Act ensures the right to receive services in the most integrated setting appropriate to a person’s needs. The webinar will feature staff from SAMHSA, the U.S. Department of Health and Human Services Office of Civil Rights, and technical assistance providers, along with representatives from state agencies working to promote community integration. During the webinar, the following information will be shared: An overview of states’ obligations under the Olmstead v. LC decision Workforce approaches states have used to support community integration Other best practices for consideration

The Lancet Global Health in conversation with Kara Hanson and Michael Makanga on equitable research funding in global health

https://thelancetglobalhealth.buzzsprout.com/1358155/15068253-kara-hanson-and-michael-makanga-on-equitable-research-funding-in-global-health?utm_campaign=update-langlo&utm_medium=email&_hsenc=p2ANqtz-9BkFawDI_-av1T3vY5R6f5giqibafGVxiSffpUI7-02goYWJBl7u_2oFJycJdc4nPcFzfSihVCzBb60GDyNOyIWMyOBw&_hsmi=308912265&utm_content=308592944&utm_source=hs_email

Facilitating the development of urgently required combination vaccines

https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(24)00092-5/fulltext?dgcid=hubspot_update_feature_updatealerts_langlo&utm_campaign=update-langlo&utm_medium=email&_hsenc=p2ANqtz-_nNbkU0L1oyua-VvIUjG6c_xY9tR1EhZfVX6VRufEJBnp1mJooUu6j-GsjDjwkK0qeQYaJ8dkWASUeNUb8iAdKoeB7rg&_hsmi=308912265&utm_content=308592944&utm_source=hs_email

Understanding deaths from diarrhoea in children younger than 5 years Ashraful Islam Khan,Mohammad Ashraful Amin

https://www.thelancet.com/journals/langlo/issue/vol12no6/PIIS2214-109X(24)X0006-6

Inflation and health: a global scoping review

https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(24)00133-5/fulltext?dgcid=hubspot_update_feature_updatealerts_langlo&utm_campaign=update-langlo&utm_medium=email&_hsenc=p2ANqtz-9z_v67AhP64UnpvfhmexvWgR22AWT5LztZ2CPlARM16TKaFdGnuSKaHZP6rTU_RYavzFj3wexqrG5oHLOnRfiq33HXtw&_hsmi=308912265&utm_content=308592944&utm_source=hs_email

CDRHNew - News and Updates

https://www.fda.gov/medical-devices/medical-devices-news-and-events/cdrhnew-news-and-updates

lunes, 27 de mayo de 2024

AI-based body composition analysis predicts lung cancer treatment outcomes

https://www.news-medical.net/news/20240524/AI-based-body-composition-analysis-predicts-lung-cancer-treatment-outcomes.aspx

Personalized phage therapy successfully treats antibiotic-resistant infections in animals

https://www.news-medical.net/news/20240527/Personalized-phage-therapy-successfully-treats-antibiotic-resistant-infections-in-animals.aspx

Mohs Surgeons Have High Rates of Emotional and Physical Stress Roxanne Nelson

https://www.medscape.com/viewarticle/mohs-surgeons-have-high-rates-emotional-and-physical-stress-2024a10008r6?ecd=mkm_ret_240526_mscpmrk-OUS_ExcNews_etid6524520&uac=148436CN&impID=6524520

Global Perspectives on the Latest Conference Updates for Antibody-Drug Conjugates in Advanced NSCLC

https://www.medscape.org/viewarticle/1000528?sso=true&uac=148436CN&src=mkmcmr_reeng_recap_mscpedu_activity

Is Mental Illness 'Transmissible'? Alicia Ault May 24, 2024

https://www.medscape.com/viewarticle/mental-illness-transmissible-2024a10009um?ecd=wnl_tp10_daily_240525_MSCPEDIT_etid6542183&uac=148436CN&impID=6542183

Personalizing Care for Breast Cancer: The Precision Medicine Approach

https://www.medscape.org/viewarticle/1000564?sso=true&uac=148436CN&src=mkmcmr_reeng_recap_mscpedu_activity

Study finds human body lice can transmit plague bacteria

https://www.news-medical.net/news/20240526/Study-finds-human-body-lice-can-transmit-plague-bacteria.aspx

Adolescent cannabis use linked to higher risk of psychotic disorders, study finds

https://www.news-medical.net/news/20240526/Adolescent-cannabis-use-linked-to-higher-risk-of-psychotic-disorders-study-finds.aspx

Living Well With Diffuse Lower-Grade Glioma: Strategies for Improving Patient Quality of Life in the Theatre and Beyond

https://www.medscape.org/viewarticle/1001117

Advanced NSCLC: Multidisciplinary and Patient Thoughts on How to Ease the Burden of Care

https://www.medscape.org/viewarticle/999304?sso=true&uac=148436CN&src=mkmcmr_driv_cust_mscpedu_240526-OUS-HONC-999304-cta

domingo, 26 de mayo de 2024

RADx Tech: Advancing COVID-19 Diagnostic Technology

Using AI to repurpose routine CT scans

Using AI to repurpose routine CT scans: A collaborative NIH-funded team is using AI to mine common chest CT scans to predict mortality. Their research identified a collection of cardiac factors that were predictive of death in a large group of patients, potentially setting the stage for improved cardiac screening.

Unobtrusive, implantable device could deepen our understanding of behavioral responses

Unobtrusive, implantable device could deepen our understanding of behavioral responses: Measuring heart rate or body temperature may sound easy, but retrieving the data from small animals with bulky traditional tech is difficult, especially during behavioral tests, which are critical for understanding brain disorders. Thanks to a recent study, the animal data is now in reach.

How ultrasound and microbubbles could deliver immunotherapy to the brain

How ultrasound and microbubbles could deliver immunotherapy to the brain: Malignant primary brain tumors are the leading cause of cancer deaths among children and young adults with few therapeutic options. A preclinical study in Pharmaceutics shows that combining focused ultrasound with microbubbles opened the blood brain barrier to deliver immunotherapy into the brain of a large animal model.

How a vibrating capsule could help curb obesity

How a vibrating capsule could help curb obesity: A team of scientists have developed a noninvasive alternative to current weight-loss options—an oral capsule containing a tiny vibrating motor that is designed to stimulate the stomach to produce the same sense of fullness people experience after eating a large meal. A team of scientists is developing a noninvasive alternative to current weight-loss options—an oral capsule containing a tiny vibrating motor that is designed to stimulate the stomach to produce the same sense of fullness that people experience after eating a large meal. In a preclinical animal study, the researchers found that when pigs were given the vibrating electronic capsule before meals, they had significantly reduced food consumption and slower weight gain compared to when they didn’t receive the treatment.

The Right to Contraception: State and Federal Actions, Misinformation, and the Courts Mabel Felix, Laurie Sobel, and Alina Salganicoff Published: May 23, 2024

https://www.kff.org/womens-health-policy/issue-brief/the-right-to-contraception-state-and-federal-actions-misinformation-and-the-courts/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz--z88pd6yCJ7GTj_H5LamAPEFzdGlWGc_uQYNxcYmNelTRS5s61uVnGJh5HBYwJeauAUdKE8_4NjITAxEML_nzTfSoojg&_hsmi=308617290&utm_content=308617290&utm_source=hs_email

How Many Older Adults Live in Poverty? Nancy Ochieng, Juliette Cubanski, Tricia Neuman, and Anthony Damico Published: May 21, 2024

https://www.kff.org/medicare/issue-brief/how-many-older-adults-live-in-poverty/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz-_MAVhwNu5AmWEgaJ65eQnk06vk-52oPzkAzYSD1z5qHNBReRyk25mUyWQXDG_752Zjjntl3vMKHpAllRpOUPvnIkW8fQ&_hsmi=308617290&utm_content=308617290&utm_source=hs_email

In 2024, A Majority of States Offer Medicare Advantage Plans to Their State Retirees, with 12 Offering Medicare Advantage Exclusively Meredith Freed, Alex Cottrill, Suhanee Patel, Jeannie Fuglesten Biniek, and Tricia Neuman Published: May 22, 2024

https://www.kff.org/medicare/issue-brief/in-2024-a-majority-of-states-offer-medicare-advantage-plans-to-their-state-retirees-with-12-offering-medicare-advantage-exclusively/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz--VeJBM_c2I25UaW0CaLeDOrndZKz3tOHKmQQDvIEoVFoIPIXFez_vbws6qLH9hXEyNPfsLezf_lizCdYjkyjnx-bMmlA&_hsmi=308617290&utm_content=308617290&utm_source=hs_email

The U.S. and the International Health Regulations: Implications of an Amended Agreement Josh Michaud, Anna Rouw, and Jennifer Kates Published: May 21, 2024

https://www.kff.org/global-health-policy/issue-brief/the-u-s-and-the-international-health-regulations-implications-of-an-amended-agreement/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz-8rJtqKcROKXnrZCq8ePL2B0xeTRY86wJjY40SuU6hUE7_DPzwShJ1tlXf16_Z5iWbOnWW0Xp9GYDMstoWFYCCTJW04zw&_hsmi=308617290&utm_content=308617290&utm_source=hs_email

The Lancet Series on Antimicrobial Resistance: The need for sustainable access to effective antibiotics Published: May 23, 2024

https://www.thelancet.com/series/antibiotic-resistance?utm_campaign=tlpr&utm_medium=email&_hsenc=p2ANqtz-93w49O-7d0_4kKppIQyJpKSV9YL9v_Mrze-AloN-bj7ysQEWQXYd6vW4IX9MBkj-GA-ws1LVceCRh-uPGvRWOT4JjfnjMpG3_vsVAPHbGh3F-IbK4&_hsmi=307834864&utm_content=307834864&utm_source=hs_email Access to effective antibiotics is essential to every health system in the world, however, antimicrobial resistance (AMR) threatens this backbone of modern medicine and is already leading to deaths and disease which would have once been prevented. This Series highlights that, although AMR can affect anyone throughout the life course, the very young, very old and severely ill are the ones suffering the most. Through novel modelling data, this Series shows how stopping infections through improved vaccination and water and sanitation can not only prevent a significant proportion of deaths due to AMR in low- and middle-income countries, but also reduce the use of antibiotics to preserve its effectiveness. The Series also addresses how a rethink of drug development is needed to support investment in antibiotic, diagnostics, and vaccine development according to the burden of infection and resistance. Lower drug development costs will also make antibiotics more affordable and accessible. Finally, the authors argue for the need of targets to trigger political commitment and accelerate progress in addressing AMR.

Protecting scientific integrity in an age of generative AI

https://www.pnas.org/doi/10.1073/pnas.2407886121?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8to7S_4xLK9IlR6bDnHz9S97UmME0vOlXb0pojPtr0kQwkYWnHzccmtszJK8qzoKGRPFqskw0WTUj03-KuTbfq6zpCLA&_hsmi=308143698&utm_content=308143698&utm_source=hs_email Scientists call for a strategic council to guide AI use The advent of increasingly powerful AI algorithms has scientists both excited and nervous. Artificial intelligence offers new research opportunities and problem-solving abilities — but it also opens the door to new kinds of ethical violations, as a new editorial in the Proceedings of the National Academy of Sciences points out. The authors discuss five ways to help maintain scientific integrity in the context of AI. Scientists should be accountable for the content or inferences they might draw from generative models, for one, and AI-generated work or data should be clearly documented. AI should also be vetted to avoid causing harm, including perpetuating biases — and to lead the way, the authors suggest the National Academies create a “strategic council on the responsible use of artificial intelligence in science.”v

What clinical real-world data can deliver By Jenna PhillipsMay 22, 2024

https://www.statnews.com/2024/05/22/clinical-real-world-data-patient-experience-impact-research-innovation/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--FOC9fwC-fs--q2sXVUXgg8LfusLTkc7BO5VH4ph4iiGlSHlzWIhZQu4SUZISfpm8bPwNNp2-MmB_eFlJM1W7FawqXfw&_hsmi=308143698&utm_content=308143698&utm_source=hs_email New drugs are entering the clinic faster than ever. The FDA’s Breakthrough Therapy designation program is an example of regulatory innovation that helps speed drugs to market, writes Boston-based health and life sciences consultant Jenna Phillips — but it also means that there’s less time to train clinicians on best practices with a new therapy. In a new First Opinion, Phillips argues that real-world clinical data can offer insights about how to best use new medicines. It can help pinpoint clinician and patient experiences with new drugs: Real-world data on GLP-1 weight loss drugs, for example, shows patients present to the emergency department with side effects like gastrointestinal distress. Read more about how these kind of insights could help health workers improve care.

How AI is advancing cancer care and closing treatment gaps

https://www.statnews.com/sponsor/2024/04/22/how-ai-is-advancing-cancer-care-and-closing-treatment-gaps/ When ChatGPT launched less than two years ago, AI came into popular consciousness in a way that set the world abuzz. But as is often the case with advances in biotechnology, health care has been using artificial intelligence for years to detect disease earlier and interpret diagnostics.

Biden-Harris Administration Launches New Option to Report Potential Violations of Federal Law and Continue to Promote Patient Access to Stabilizing Emergency Care

https://www.cms.gov/priorities/your-patient-rights/emergency-room-rights/how-to-file-complaint?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--I9LYVoV-oNtTQMO05y8FVs2obRpWT2vwIhXltsSE4Qv8sbfteHAHw1n8qaurrPjFriwmWO81W8m3EVcyOs7SD53ox-g&_hsmi=308143698&utm_content=308143698&utm_source=hs_email With new EMTALA option, CMS will take your complaints Patients can now file complaints directly with the federal government if they were denied emergency care including emergency abortions on a new web portal, the Centers for Medicare & Medicaid Services announced yesterday. The Biden administration has said that such denials of care violate the Emergency Medical Treatment and Labor Act or EMTALA, a law that requires hospitals to provide emergency care to any patient. The new portal is designed to make reporting denials of care easier for patients and help CMS, which enforces the federal law, to investigate patient claims. “We want to make sure that everyone knows their rights and can take action to help make sure the health care system is safe for everyone,” CMS Administrator Chiquita Brooks-LaSure said in a statement. The application of EMTALA to abortions is currently at the center of a Supreme Court case that will weigh whether an exception should be made in certain cases for emergency abortions. EMTALA, a vital health law you’ve never heard of, is in danger By Nicole HuberfeldApril 23, 2024 https://www.statnews.com/2024/04/23/supreme-court-abortion-idaho-emtala-case-could-imperil-emergency-care/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_o_BJPseXN0UEDWubs1TZtXBzc2QdrVxO8tmXu-YU0hC7sULLApjgQoI7msubE_cY6p4W8o8ZjHH8BHNLNTfzovfNn0A&_hsmi=308143698&utm_content=308143698&utm_source=hs_email Biden-Harris Administration Launches New Option to Report Potential Violations of Federal Law and Continue to Promote Patient Access to Stabilizing Emergency Care https://www.hhs.gov/about/news/2024/05/21/biden-harris-administration-launches-new-option-report-potential-violations-federal-law-continue-promote-patient-access-stabilizing-emergency-care.html?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_xbuW0yBXtKbITlrG7S2y6mhR8HSGl21E82X0KCAHksTdA94YA__GLRJkaibQF4KGiFvlwIXwqa7j3yq9psRxo6s6MrA&_hsmi=308143698&utm_content=308143698&utm_source=hs_email Supreme Court judges wrestle with abortion access in emergency cases Sarah Owermohle By Sarah Owermohle April 24, 2024 https://www.statnews.com/2024/04/24/supreme-court-emergency-abortion-access/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9WjQuI3LIArlF3O4A645d6sy-XE4ONnX9v8LRRZ1U9YNrlyRLPH1J5OSf-AnzNFynlZyzWFmv2TfHtF6MViJXjJfCVSg&_hsmi=308143698&utm_content=308143698&utm_source=hs_email

Urgent action needed to achieve viral hepatitis elimination The Lancet Gastroenterology & Hepatology

https://www.thelancet.com/journals/langas/issue/vol9no6/PIIS2468-1253(24)X0005-9

Decolonization and Pathogen Reduction Approaches to Prevent Antimicrobial Resistance and Healthcare-Associated Infections Volume 30, Number 6—June 2024 Perspective

Decolonization and Pathogen Reduction Approaches to Prevent Antimicrobial Resistance and Healthcare-Associated Infections Volume 30, Number 6—June 2024 Perspective Mihnea R. MangaleaComments to Author , Alison Laufer Halpin, Melia Haile, Christopher A. Elkins, and L. Clifford McDonald Author affiliations: Centers for Disease Control and Prevention, Atlanta, Georgia, USA (M.R. Mangalea, A.L. Halpin, M. Haile, C.A. Elkins, L.C. McDonald); United States Public Health Service, Rockville, Maryland, USA (A.L. Halpin) https://wwwnc.cdc.gov/eid/article/30/6/23-1338_article?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_0XtUo5fyxz6O8s7lXivgr40YUwGS6Fr300vQgqbn4brNnfB2flza0FVLFA-d16PSUcULMkPs1VcSEEW6c39r5DAXqyQ&_hsmi=308341219&utm_content=308341219&utm_source=hs_email Fighting antimicrobial resistance, one patient at a time It shouldn’t be shocking, but still: Pretty much every health care building has antimicrobial-resistant bacteria living somewhere inside. Of course, so do we humans, when you consider the bugs residing in our microbiomes. But the danger is higher for hospital patients who might have weakened immunity or open wounds, from trauma or surgery. When the population of microbes living within us expands through greater exposure, that can lead to infections in vulnerable people, particularly when the bacteria are resistant to antibiotics that disrupt the human microbiome and weaken its defenses. Pathogen reduction, which whittles down the number of resistant bacteria colonizing the human microbiome, is the goal described in a new report from the CDC journal Emerging Infectious Diseases. Strategies include giving combined oral antimicrobial drugs to patients before elective colorectal surgery and using anti-staphylococcal treatments for patients undergoing orthopedic surgeries or procedures involving the heart and chest

The oral nucleoside prodrug GS-5245 is efficacious against SARS-CoV-2 and other endemic, epidemic, and enzootic coronaviruses

https://www.science.org/doi/10.1126/scitranslmed.adj4504?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9jWqeqg-oTmGunmuFO8zlQV50oFpZLFWElBXtZR6eAcnSUKDMkRsa9r5Wz3WQ5lD7coxa4iEInR9SyCS_g0NnOzYtv7w&_hsmi=308341219&utm_content=308341219&utm_source=hs_email Gilead's antiviral defused coronaviruses in mice, but human testing is not in the cards Covid-19 is still with us. Despite the success of Covid vaccines and because of waning interest in boosters, we still need antiviral drugs to combat infections. There are downsides to old stand-bys remdesivir (transfused), Paxlovid (rebound risk), and molnupiravir (weakness), so better solutions are needed for people who are unvaccinated, immunocompromised, or otherwise unable to build an antibody response to a vaccine. Scientists testing an experimental drug in mice report success in Science Translational Medicine against a range of coronaviruses for their small molecule obeldesivir. Developed in collaboration with Gilead, the drug was also combined at a different dosage with Paxlovid. The cocktail worked better than obeldesivir alone, but plans to test the molecule in people are on hold. “It’s really hard to test at this stage in the post-pandemic, because the virus causes so little disease,” study author David Martinez told STAT’s Annalisa Merelli. Read more. New antiviral works against coronaviruses in mice, but human testing will have to wait Annalisa Merelli By Annalisa Merelli May 22, 2024 https://www.statnews.com/2024/05/22/new-antiviral-obeldesivir-effective-coronavirus-mers-mice-experiments/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8PTc5IUBMtmhydWFCewi6RtpXIsbTpDu6SaHMgJQ--iKq2SQFaB6EH59e7wUHE35y_CVQ2fml_Udl-39npVOZZfBdECw&_hsmi=308341219&utm_content=308341219&utm_source=hs_email

Addressing health care workers’ trauma can help fight burnout By Sadie ElisseouMay 23, 2024

https://www.statnews.com/2024/05/23/health-care-workers-trauma-fighting-burnout/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--yL4Zw8IUigrWCYpy2hu3fnzhdnDT0zUXRSOAMjG0ouIm2JslNhypl6mPmAIZe3OZ5qYw-0QBZJUiamNTIA8uK2vtHcw&_hsmi=308341219&utm_content=308341219&utm_source=hs_email In health care, trauma is an occupational hazard. Medical professionals witness pain, suffering, injustice, and death, in addition to microaggressions, workplace violence, and moral injury. But for some people, these professional stressors are piled on top of challenging life events, including adverse childhood experiences, primary care physician Sadie Elisseou writes in a First Opinion. Such a history increases the risk of burnout, analogous to the greater risk of PTSD in veterans who have seen combat. “So far, no single framework has been successful in offering a comprehensive strategy to shield health care workers, and the systems they work in, from burnout,” Elisseou says. “Adopting a trauma-informed approach may have a transformative impact on anti-burnout solutions, redirecting the course of the health care crisis.” Read what that recognition and response can entail.

Trauma-Informed Care: A Missing Link in Addressing Burnout

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10455772/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_eQ3-6Rr5gnbClO50ZktYHCJeAH4XcZK4RDQIMVhHumNGxDikkVm2lGQjgBECCq5LDXjVkTnfsA8sIQz1yjWFtuD0N0g&_hsmi=308341219&utm_content=308341219&utm_source=hs_email The Covid-19 pandemic and national movements for health equity have highlighted the impact of trauma on public health as well as on health worker well-being. As burnout rates across healthcare climb, we seek creative and effective solutions. Current anti-burnout strategies focus on much needed systems solutions for employee success; however, they often lack a trauma-informed approach. Trauma is highly prevalent in society at large, and health workers are further exposed to trauma in the course of their professional studies and duties. Common symptoms of burnout may actually be manifestations of traumatic stress. Trauma-informed care (TIC) is a strategic framework and growing social movement for providing quality care to survivors of individual, interpersonal, collective, and structural trauma. Importantly, TIC has practical applications to address our healthcare burnout epidemic. In this perspective piece, an expert describes a trauma-informed lens through which to view burnout solutions using SAMHSA’s 4 Rs of a trauma-informed approach: 1) Realize the widespread impact of trauma, 2) Recognize the signs and symptoms in patients and staff, 3) Respond by integrating knowledge about trauma into practice, and actively 4) Resist re-traumatization. Moving forward, key stakeholders must collaborate to build and refurbish efficient systems alongside a trauma-informed organizational model. TIC can transform the healthcare experience for patients and employees alike by fostering community, empowerment, and healing.

How pharma companies can embrace their responsibility to help people and the planet

https://www.statnews.com/sponsor/2024/05/02/how-pharma-companies-can-embrace-their-responsibility-to-help-people-and-the-planet/ The connection between the climate crisis and lung health is clear, as are the repercussions. As a warming climate worsens air pollution, disrupts habitats, and spawns wildfires and droughts, people will face new onsets and exacerbated symptoms of asthma, allergies, COPD, and bronchitis.