miércoles, 31 de julio de 2024
California mulls legalization of psilocybin, MDMA, and other psychedelic drugs to treat PTSD Bernard Wolfson | July 25, 2024
https://geneticliteracyproject.org/2024/07/25/california-mulls-legalization-of-psilocybin-mdma-and-other-psychedelic-drugs-to-treat-ptsd/?mc_cid=7af7c2586b&mc_eid=b73600b7ac
Wade Trammell recalls the time he and his fellow firefighters responded to a highway crash in which a beer truck rammed into a pole, propelling the truck’s engine through the cab and into the driver’s abdomen.
Viewpoint: No indication that COVID summer surge is fading Henry Miller | July 23, 2024
https://geneticliteracyproject.org/2024/07/23/viewpoint-no-indication-that-covid-summer-surge-is-fading/?mc_cid=f064516f7f&mc_eid=b73600b7ac
Like tens of thousands of Americans baking in the summer heat, President Biden is convalescing at home, waiting for the COVID symptoms to pass. It’s that time of year again, in what is likely to become a stressful ritual for many years to come: the summer pandemic surge.
Genetically engineered plastic-eating bacteria could clean up our oceans Henry Miller, Kathleen Hefferon | July 22, 2024
https://geneticliteracyproject.org/2024/07/22/genetically-engineered-plastic-eating-bacteria-could-clean-up-our-oceans/?mc_cid=f064516f7f&mc_eid=b73600b7ac
Spain’s northern coast has been fighting a months-long assault from a ‘white tide’ of plastic pellets dumped by a Dutch-registered ship.
Wound Products, Antimicrobial Resistance, and Commercial Speech: FDA’s Solution in Search of a Problem By Jennifer D. Newberger —
https://www.thefdalawblog.com/2024/07/wound-products-antimicrobial-resistance-and-commercial-speech-fdas-solution-in-search-of-a-problem/?utm_source=rss&utm_medium=rss&utm_campaign=wound-products-antimicrobial-resistance-and-commercial-speech-fdas-solution-in-search-of-a-problem
In November 2023, FDA published a proposed rule regarding wound products containing antimicrobials. From a legal perspective, the reason for the proposed rule is that these wound products are some of the few remaining medical devices that have not yet been classified by FDA. As a result, they have been coming to market through the 510(k) process as Class II medical devices since passage of the Medical Device Amendments, nearly 50 years ago. While it is well within FDA’s right to formally classify the products, the position it is taking in the proposed rule is not based in science or evidence, and raises serious commercial speech concerns.
Draft Guidance on Biosimilars and Interchangeables Tries to Smooth Path for Post-Approval Changes By John W.M. Claud —
https://www.thefdalawblog.com/2024/07/draft-guidance-on-biosimilars-and-interchangeables-tries-to-smooth-path-for-post-approval-changes/?utm_source=rss&utm_medium=rss&utm_campaign=draft-guidance-on-biosimilars-and-interchangeables-tries-to-smooth-path-for-post-approval-changes
There is a growing consensus among legal experts that after Loper Bright, FDA may rely on non-binding guidance to instruct industry with hopes of charting regulatory pathways that avoid litigation. In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy. The top line from FDA for any cGMP-governed industry like these is always going to be that quality matters. But in the biologics and biosimilar industries, maintaining quality can be a very nuanced—if not difficult—process.
The Summit for Women Leaders in Life Sciences Law By Sara M Keup & Véronique Li, Senior Medical Device Regulation Expert —
https://www.thefdalawblog.com/2024/07/the-summit-for-women-leaders-in-life-sciences-law/?utm_source=rss&utm_medium=rss&utm_campaign=the-summit-for-women-leaders-in-life-sciences-law
The American Conference Institute (“ACI”) held its 11th Annual Summit for Women Leaders in Life Sciences Law at the Seaport Hotel in Boston, Massachusetts on July 25th & 26th of last week. Several leading ladies in law at HPM attended the conference and, based on their feedback, gave the annual event an A+ rating. Our very own Director, Anne Walsh, spoke on a panel titled Navigating Today’s Life Sciences M&A Landscape: Charting the Latest Trends and Challenges in Pharma and Biotech Dealmaking. As we are all aware, the M&A landscape is an ever-changing place, so there is always something new to learn. Anne and her fellow panelists engaged the audience with timely and thoughtful insights, each addressing their area of specialty (e.g., FDA, IP, and antitrust).
Funding HAI and Antibiotic Resistance Research
Funding HAI and Antibiotic Resistance Research: AHRQ’s Healthcare-Associated Infections (HAI) Division funds clinical and health services research to develop the knowledge and practical tools used on the frontlines to prevent infections and make care safer. AHRQ is interested in funding research in all clinical settings—acute care, long-term care, and ambulatory care—in accordance with the framework established by the Department of Health and Human Services' National Action Plan to Prevent Health Care-Associated Infections: Road Map to Elimination and the research agenda of the Combating Antibiotic Resistant Bacteria Action Plan.
Causal Mediation of Neighborhood-Level Pediatric Hospitalization Inequities
https://pubmed.ncbi.nlm.nih.gov/38426267/
Community-Level Factors Linked to Pediatric Outcome Inequities
Structural racism seems to be a significant root cause of inequities in child health outcomes, including those at the population level, according to a new AHRQ-funded study in Pediatrics. Researchers found that pediatric hospitalizations increased by more than 6 percent for every 10 percent of the population in a census tract that identified with a “historically marginalized” racial group. This review combined data from nearly 60,000 hospitalizations with community-level factors related to community material deprivation, crime risk, primary language, housing tenure, family composition, hospital access, greenspace, traffic-related air pollution and housing conditions. When they weighted their measurements to account for these systemic inequities, they found that inequities in pediatric hospitalizations disappeared. Researchers concluded that interventions and policies that address such exposures and dismantle racist structures could promote better, more equitable child health outcomes.
National Healthcare Quality and Disparities Reports
National Healthcare Quality and Disparities Reports: Tools for measuring health care quality, including the National Healthcare Disparities and Quality Reports, AHRQ Quality Indicators, and ambulatory clinical performance measures.
Introduction to the AHRQ Data Tools Website - Data Tools Videos
https://datatools.ahrq.gov/data-tools-videos/
New videos from AHRQ provide guidance on the use of AHRQ Data Tools, an interactive resource that allows researchers, policymakers and others to explore data on topics ranging from health insurance coverage to hospital use to disparities in care. An introductory video is complemented by three additional videos that offer more detailed instructions and examples of how to use AHRQ data resources: https://datatools.ahrq.gov/
The Consumer Assessment of Healthcare Providers and Systems (CAHPS®) program provides insights into consumers’ experiences with their care.
The Healthcare Cost and Utilization Project (HCUP) provides data on hospitalizations and emergency department visits.
The Medical Expenditure Panel Survey (MEPS) explores health insurance coverage, healthcare use, and expenditures.
The National Healthcare Quality and Disparities Report (NHQDR) shows opportunities for improving healthcare quality and reducing disparities.
Consumer Assessment of Healthcare Providers and Systems (CAHPS®)
Consumer Assessment of Healthcare Providers and Systems (CAHPS®): The CAHPS program conducts research to support the development and use of patient experience surveys in various health care settings. Surveys identify ways to improve care.
Evidence Mounts That About 7% of US Adults Have Had Long COVID
https://jamanetwork.com/journals/jama/article-abstract/2819957
New data from AHRQ’s Medical Expenditure Panel Survey indicate that about 7 percent of U.S. adults, 17.8 million, have had Long COVID as of early 2023. Hispanic and White adults had higher rates of Long COVID than Asian and Black adults, and women had higher rates than men. Adults who received a COVID-19 booster had lower rates of Long COVID than both unvaccinated adults and adults who received only the primary vaccination series. Adults with obesity or preexisting chronic conditions were also more likely to have had Long COVID than all adults. Researchers said the findings support previously reported estimates. Access a summary of the article published in JAMA.
https://meps.ahrq.gov/mepsweb/
Study Shows Strong Link Between Smoking, Opioid Use
https://meps.ahrq.gov/mepsweb/
A new analysis of data from AHRQ’s Medical Expenditure Panel Survey (MEPS) revealed a strong link between smoking and opioid use, emphasizing the need for integrated treatment programs. Data from 2013 to 2021 from MEPS and the Centers for Disease Control and Prevention’s National Health Interview Survey show that although only 37 percent of the population has ever smoked, smokers account for 69 percent of annual prescription opioid use. Heavy smokers, just 12 percent of the population, collectively use as many opioids as the 63 percent who never smoked. Smokers also report higher rates of chronic pain, severe work limitations due to pain and poor mental health. The authors, published in the American Journal of Preventive Medicine, suggested that combining smoking cessation with substance abuse treatment could be crucial in addressing the opioid epidemic. Access the abstract.
https://pubmed.ncbi.nlm.nih.gov/39025246/
National Center for Health Statistics
https://www.cdc.gov/nchs/nhis/index.htm
Multidisciplinary approaches optimize contract drug discovery Inotiv Learn how a US company is changing the paradigm for contract research, combining disease pharmacology, toxicology, and pathology to optimize drug development
Multidisciplinary approaches optimize contract drug discovery
Inotiv
Learn how a US company is changing the paradigm for contract research, combining disease pharmacology, toxicology, and pathology to optimize drug development
https://www.selectscience.net/article/multidisciplinary-approaches-optimize-contract-drug-discovery?utm_campaign=DDNews%20Special%20Offers%20and%20Promotions&utm_medium=email&_hsenc=p2ANqtz-_lF4GUCMdWlv1LQ9H0nzqKBgrUjVL-qh8Coax6Q-C2HAi-nZb9jRTURPz5VPSfrHkZzrey5rREcKQQbhT5QOGj6cVZ5A&_hsmi=317945909&utm_content=317945909&utm_source=hs_email
martes, 30 de julio de 2024
Disability, Equity, and Mental Health Research Webinar Series
https://www.eventbrite.com/e/disability-equity-and-mental-health-research-webinar-series-tickets-933421457707?aff=oddtdtcreator
Transforming Mental Health Disability Research Through Lived Experience Leadership and Co-Production
Date/Time: August 8, 2024, 1:00–2:30 p.m. ET
Location: Virtual
This webinar will introduce a range of approaches to meaningfully integrate individuals with lived experiences of psychiatric disabilities into mental health research.
Nev Jones, Ph.D., will discuss proven methods of integration and co-creation, including co-production, integration, and co-leadership, and highlight ways in which the NIMH research portfolio would benefit from greater emphasis on and high standards for meaningful inclusion.
NIST Participates in White House Summit on Standards for Critical and Emerging Technology July 29, 2024
https://www.nist.gov/news-events/news/2024/07/nist-participates-white-house-summit-standards-critical-and-emerging
The U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) participated in a summit at the White House last week where representatives of government agencies, industry and standards development organizations discussed the U.S. Government National Standards Strategy for Critical and Emerging Technology (USG NSSCET). This strategy promotes technologically sound standards that help American industry compete internationally on a level playing field and is intended to support and complement existing private sector-led standards activities.
In addition, the Biden-Harris administration has released the USG NSSCET Implementation Roadmap, which includes recommendations and actions for implementing the strategy, along with a fact sheet about the roadmap.
Additive Construction – The Path to Standardization II Registration Extended to August 14, 2024
https://www.nist.gov/news-events/events/2024/08/additive-construction-path-standardization-ii
Interested in standards for Additive Construction?
Join us on August 20th and 21st at the National Cybersecurity Center of Excellence for the 2nd annual in-person, hands-on workshop focusing on standardization for additive construction, or 3D printing with concrete.
Registration closes August 9th so don't delay!
Sponsored by NIST in partnership with the US Army Engineer Research and Development Center (ERDC), the two-day event will drill down on core issues in standards, codes, and design guidelines. Discussions will contribute to the development of a roadmap for standardization of printing and testing methods.
Also, the consortium, Additive Construction by Extrusion (ACE) Consortium, is active on the Federal Register. The Consortium will bring together stakeholders to identify and address gaps in current standards related to materials, methods, structural performance, and engineering design. The Consortium efforts are intended to study the measurement science needs for the successful adoption of ACE by the construction industry, and to identify and propose new standards to address industry needs not met by existing standards. The next meeting will take place at the conclusion of the ACE workshop on the 21st. Followed by ASTM F42.07.07 committee meetings.
AHRQ is pleased to announce the AHRQ QI v2024 software release (July 26) and webinar (August 12).
https://qualityindicators.ahrq.gov/software/qi
Webinar Details and Signup
AHRQ invites you to join a webinar presentation by the AHRQ QI Team on August 12, 2:00 p.m. – 3:00 p.m. EDT to learn about the AHRQ QI v2024 software. The presentation will be followed by a question-and-answer session.
Who Benefits From This Webinar: AHRQ QI software users and anyone interested in learning about updates to the QI software.
How To Attend the Webinar: Register on Zoom
https://ahrq-hhs.zoomgov.com/webinar/register/WN_D8EgM0K9RnGLUvHO4355fA#/registration
The v2024 Quality Indicators Software
The v2024 software calculates risk-adjusted rates based on International Classification of Diseases, 10th Revision/Procedure Coding System coded all-payer 2019, 2020, and 2021 Healthcare Cost and Utilization State Inpatient Databases. The 2021 State Emergency Department Databases were also used to develop the Prevention Quality Indicators in Emergency Department Settings (PQE) module.
The v2024 software release includes:
New: CloudQI Software, including both Patient Safety Indicators and PQE modules, offering enhanced flexibility and capabilities, including multiuser support
New: PQE module, previously released as ED PQI Beta v2023 software, now in production version
Support for fiscal year (FY) 2024 ICD-10-CM/PCS coding and risk adjustment in SAS QI, WinQI, and CloudQI
Risk adjustment models accounting for case-mix, including COVID present on admission as well as a COVID time trend
Indicator refinements
Year 2023 Census-based population estimates for area-level indicator denominators
Detailed information about all changes in the software will be included in the Release Notes and Change Logs, available on the AHRQ QI website.
Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies July 2024
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-pharmacology-considerations-human-radiolabeled-mass-balance-studies?utm_medium=email&utm_source=govdelivery
On July 18, 2024, the FDA announced the availability of a final guidance for industry entitled Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies, replacing the May 2022 draft guidance on this topic. This final guidance describes the FDA’s recommendations regarding clinical pharmacology considerations for conducting human radiolabeled mass balance studies of investigational drugs, including: (1) deciding whether and when to conduct the study, (2) designing the study, and (3) reporting results.
A human radiolabeled mass balance study is a direct method to obtain quantitative information on the absorption, distribution, metabolism, and excretion of the drug in the human body. Data from such studies can help to:
Provide information on which metabolites should be structurally characterized and which metabolites should undergo nonclinical safety assessment or drug-drug interaction (DDI) evaluation
Assess whether renal or hepatic impairment studies or certain DDI studies are recommended for the investigational drug
Assess the extent of absorption of the investigational drug
lunes, 29 de julio de 2024
Sonya Massey’s death: How to prevent more killings of defenseless Black women By Onyeka T. Otugo and Adaira I. LandryJuly 26, 2024
https://www.statnews.com/2024/07/26/sonya-massey-death-prevent-more-killings-black-women/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9Mn-soipjepkoTXT4ebETvLDEhMnTopkf0hRERuf8xMHjr_D5HF64Ssuqmw7WfgGSE8h22k5rTznHC0ZuWlRmGIYNUJA&_hsmi=317667934&utm_content=317667934&utm_source=hs_email
How to prevent tragedies like Sonya Massey’s death
Sonya Massey called 911 on July 6 to report a potential home intruder. “Don’t hurt me,” is what she said to the police when they arrived. “Why would I hurt you? You called us,” is how Deputy Sean Grayson responded minutes before he shot and killed her.
Massey had paranoid schizophrenia, and she was distracted, unsettled, and frightened. What she needed was reassurance, two emergency physicians write in a First Opinion essay. The interaction with police turned quickly from routine to deadly. “As two academic, Black women physicians, we have become familiar with the same speed at which we can turn from ‘pet to threat,’” they write.
Read more on the “pet to threat” phenomenon and the critical need for safe de-escalation tactics and specialized, mental health crisis response teams.
Medical and Educational Indebtedness Among US Health Care Workers
https://jamanetwork.com/journals/jama-health-forum/fullarticle/2821583?utm_term=072624&utm_campaign=ftm_links&utm_medium=referral&_hsenc=p2ANqtz-8C564O1U3pJAcexTgLI-XvB_7pgvYR299sjSrMVF713ifyXGzxXBDLcE4MILtIhVNbzobm7bTbrKcEMDt9ga33hy4pBA&_hsmi=317667934&utm_source=For_The_Media
Health care workers have more medical, educational debt, study says
More and more medical schools are going tuition-free — which is great for doctors, but what about other health care workers? A new study published in JAMA Health Forum found that health care workers overall have more medical and school debt than other workers.
Medical debt among all health care workers tallied $19.8 billion nationally, while educational debt totalled $134.4 billion, according to the study’s analysis of nationally representative survey data from 2018-2021. Medical debt was more common among women than men and among Black health care workers than white ones. School debt was also more common for Black people, and less common for older people.
https://www.statnews.com/2024/07/10/free-medical-school-tuition-bloomberg-johns-hopkins-gottesman-einstein-medicine/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9FxOSdmDDMxLPRwtFmIoXD0IiQ8MhzYCiQCjISwN5B32vJL7FVV8KrkPEpcnr0Th2hlt2zS9zrrEWj5M13Qqj-QaEgRw&_hsmi=317667934&utm_content=317667934&utm_source=hs_email
Why aren’t philanthropists stepping up to support nursing education?
By Tracy R. Vitale and Caroline DorsenJuly 16, 2024
https://www.statnews.com/2024/07/16/philanthropists-step-up-support-nursing-schools/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_5yd3HWg40nqHNkBfun3G6q3pLvplSy9o9y2Y8pdJzeAipERd_0TY0dyuTnD_3lX4rMRe0cz5HcPzqVPRuDji1f662Gw&_hsmi=317667934&utm_content=317667934&utm_source=hs_email
Mark Cuban’s company won’t fix drug costs, but it can still help rectify America’s drug shortages By Ezekiel J. Emanuel and John ConnollyJuly 29, 2024
https://www.statnews.com/2024/07/29/mark-cuban-cost-plus-drug-company-bigger-impact-drug-shortages-not-drug-costs/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--7jnG7vq82-q5MihjBiDKyabWzrVELBNIxyBm3nPiQgqXd9Dkpy2dx0UzcRv06aF_yvhqIw5gLHGzwK0rY6SPUThAV_w&_hsmi=317667934&utm_content=317667934&utm_source=hs_email
We’ve got two big problems with prescription drugs right now: They’re too expensive, and there aren’t enough of the most important ones. Mark Cuban — the billionaire entrepreneur perhaps best known for his assertive presence on the TV show “Shark Tank” — has decided to solve these problems for us through the creation of the Mark Cuban Cost Plus Drug Company. (That’s MCCPDC for short, if that name isn’t rolling off your tongue.)
Cuban claims that the pharmaceutical industry is “the easiest industry I’ve been in to disrupt.” But in a First Opinion essay, industry vet Ezekiel Emanuel and physician John Connolly argue that perhaps Cuban shouldn’t be so confident. His current approach will fail to make a significant dent in drug prices, they write. But by expanding his production forays, they argue, Cuban could make real progress addressing America’s drug shortage issues.
Read more from Emanuel and Connolly about why Cuban’s company can’t save us from high drug prices.
Office of Surveillance and Epidemiology 2023 Annual Report
https://www.fda.gov/media/180347/download?attachment=&utm_medium=email&utm_source=govdelivery
The Center for Drug Evaluation and Research’s Office of Surveillance and Epidemiology (OSE) is pleased to share its 2023 Annual Report.
During 2023, OSE redoubled its commitment to integrating technology in the pursuit of enhancing public health with an emphasis on improving medication safety. A few examples of OSE’s technology milestones included development of:
Machine learning for medical chart review as part of our work with the Sentinel Innovation Center to reduce manual review and streamline operations,
The Information Visualization Platform, built on artificial intelligence, to de-duplicate the FDA Adverse Event Reporting System (FAERS) database and incoming FAERS reports.
OSE also continued to play a significant role in the safety analysis of drugs before and after they are marketed. OSE contributed to 55 novel drug approvals and utilized post marketing data to identify or evaluate 60 Newly Identified Safety Signals for marketed drugs.
View the full OSE 2023 Annual Report for more on OSE’s unwavering commitment to advancing public health.
domingo, 28 de julio de 2024
Facilitating drug development using full-length transmembrane protein platforms
https://www.news-medical.net/whitepaper/20240724/Facilitating-drug-development-using-full-length-transmembrane-protein-platforms.aspx
A crucial step in preclinical drug development is the confirmation of the novel therapeutic molecule's specific binding to the targeted protein. Transmembrane proteins (TPs) like ion channels, transporters, or receptors provide many targets for cancer and other diseases. They are complex, making producing those proteins in suitable amounts much more challenging than their soluble counterparts. This results in a bottleneck in the drug discovery workflow.
Can you develop volatile metabolites from exhaled breath into biomarkers?Can you develop volatile metabolites from exhaled breath into biomarkers?
https://www.news-medical.net/whitepaper/20240726/Can-you-develop-volatile-metabolites-from-exhaled-breath.aspx
The vast number of metabolites produced by physiological processes in the body can be useful biomarkers for a variety of therapeutic applications.
Biomarkers can provide insight into important metabolic processes for health and illness, as well as potential treatment targets. A portion of the metabolites produced in the human body are volatile, known as volatile organic compounds (VOCs), and can be identified in exhaled breath.
Revolutionizing COVID-19 research: The power of the Absorbance 96 plate reader
https://www.news-medical.net/whitepaper/20240724/Revolutionizing-COVID-19-research-The-power-of-the-Absorbance-96-plate-reader.aspx
The Absorbance 96 plate reader has proven to be a flexible workhorse across several scientific areas. It allows researchers to perform a variety of experiments, including ELISA and cell viability assays, expediting discoveries across different domains.
Peri-operative care of transgender and gender-diverse individuals: guidance for clinicians and departments
https://associationofanaesthetists-publications.onlinelibrary.wiley.com/doi/10.1111/anae.16378
New guidelines for treating trans people getting surgery
There’s a major lack of health data on transgender populations — and that has far-reaching effects on all types of care. Surgeons, for example, sometimes ask trans patients to stop taking their hormones for days or weeks before surgery, despite a lack of evidence around how it affects outcomes. Now a working group of experts from the UK have published guidelines for treating trans people getting surgery. In Anaesthesia, they advise that trans patients not stop taking hormones before surgery, unless there’s a specific contraindication.
Other recommendations include using the appropriate name and pronouns for trans patients, offering pregnancy tests to anyone with a uterus regardless of their gender expression, and considering how a patient’s airway may be affected if they’ve received gender-affirming cosmetic procedures on their face or neck.
https://www.statnews.com/2024/01/26/lgbtq-ehr-sexual-orientation-gender-identity-data-cardiology/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9aJO8-s2Jqul9Mm0K1qXS62oNEVqq3TdRoMjK12K-tSHl59cl3grBZlrfDT0wY808qWDA7MTBPIapsz5aPbAajf95qQw&_hsmi=317055438&utm_content=317055438&utm_source=hs_email
An aging geriatrician wonders: Who will care for me? By Jerry H. GurwitzJuly 24, 2024
https://www.statnews.com/2024/07/24/geriatrician-shortage-aging-baby-boomers/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9KtcQYabO3gkTw11zUdY7Wv6Um5Gpt9K4be8giEhVoadHWHsZmMDiTKIBKepowkY9Eb4LHesbs6SjTLfzjPUiogvU5Kg&_hsmi=317055438&utm_content=317055438&utm_source=hs_email
When Jerry H. Gurwitz became one of the first American doctors certified in geriatric medicine over 35 years ago, he thought the new specialty was destined to become a vibrant field of medicine. He was also sure that when he got older, the health care system would be ready to take care of him.
He’s in his late 60s now, and let’s just say things haven’t turned out the way he expected. Despite a growing aging population, the number of medical trainees going into geriatric medicine is shrinking. The U.S. health care system is woefully unprepared to handle the oncoming surge of dementia, impairment, and frailty, Gurwitz argues in a First Opinion essay.
He also asks a question that haunts anyone who has taken care of an elderly loved one: Who will take care of me? It may already be too late to help the system adequately care for aging baby boomers. “I am extremely worried about who will be there to care for me,” he writes. “And if I am worried, you should be too.” Read more.
Prenatal Cannabis Use and Maternal Pregnancy Outcomes
https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2821358?&utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-9qW8pLu_PVtBk28Bob6e8czhFMuv2POgdHOgo_6mOwixp8posf6aJbNJyEUWzVaLxjO3gHVMrOvDjLhuHynkULrR3TUg&_hsmi=317055438&utm_content=317055438&utm_source=hs_email
The health risks of smoking weed while pregnant
As more and more states legalize marijuana, use among pregnant people continues to grow. National guidelines already recommend that pregnant people don’t use cannabis, due to evidence that it’s associated with increases in poor outcomes for the baby, including lower birth weight, preterm birth, and admission to a neonatal ICU. But there’s barely been any research focused on how maternal health is impacted by using cannabis during pregnancy.
A study published this week in JAMA Internal Medicine begins to fill that gap. Analyzing over 316,000 pregnancies within a large northern California health system, researchers found that using cannabis during early pregnancy was associated with a greater risk of gestational hypertension, preeclampsia, placental abruption, and weight gain outside of guidelines. It was also associated with a lower risk of gestational diabetes.
The results indicate the complexity of the issue and the need for more research, the authors write.
https://www.statnews.com/2019/12/23/pregnant-women-providers-how-to-talk-marijuana/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8C-_3VpGS_wR2yM4NwKETAxr1dHSBqH_ocYlzcKtSxpZPigPVuyNVrjms36sYaNHcmzQXgvjn6pTON_2lSQvJpdFqBLg&_hsmi=317055438&utm_content=317055438&utm_source=hs_email
Robotic aid helped improve balance, gait in children with cerebral palsy Timmy Broderick By Timmy Broderick July 24, 2024
https://www.statnews.com/2024/07/24/cerebral-palsy-jama-study-modest-benefit-walking-exoskeleton/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8msFimvG1nWPasb8QFfLLT170snUzZTxLWE_MZ5vadtTL8j6vi2JO6Vyjp-rGdXtAAVSPpTi-aiWWZj9gj7RtyhZZm5A&_hsmi=317055438&utm_content=317055438&utm_source=hs_email
Disability medicine corner: New accessibility legislation and new robot research
STAT’s Timmy Broderick brings us two stories on the disability beat today:
EXCLUSIVE: A key disability rights law might get a refresh: Pennsylvania Sen. Bob Casey will introduce legislation today to strengthen and extend a section of the Rehabilitation Act of 1973 with the goal of improving protections and working conditions for disabled federal employees and boosting accessibility on federal websites. The move comes one month after a federal employee sued the VA because the agency wouldn’t provide her with the tools she needed to do her job. Read more.
A new robotic aid improved balance and gait for kids with cerebral palsy: Walking can be taxing for kids with cerebral palsy, but new research from a team in South Korea found that a robotic exoskeleton helped to modestly improve children’s gait, balance, and motor functioning. Read more on the growth of robotic-assisted gait training in rehabilitative medicine.
Neural circuit basis of placebo pain relief
https://www.nature.com/articles/s41586-024-07816-z?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8q1heDIAc7E5_oItSd9U6M8YQExSlSxgDWf6A2OX1Tv9uvJoRzDZaLfNMPOtONkkf4yYg4mQO1kxhjuQLtZjwKJpuuIA&_hsmi=317386118&utm_content=317386118&utm_source=hs_email
Hot mice unlock the brain's secret to pain placebos
The placebo effect is mysterious and often pesky in clinical trials, but new research in Nature offers new evidence for which brain circuit is responsible for the placebo effect in treating pain.
A team led by researchers from the University of North Carolina conditioned mice to expect pain relief by putting them in a chamber with two rooms: one with a hot floor and one with a comfortably warm floor. They induced the placebo effect by making both chambers hot, but mice kept crossing into the one they had been conditioned to expect to be less hot. By studying their brains, researchers pinned down which specific neurons seemed to be responsible for convincing the mice that they were experiencing pain relief. Injecting the mice with naloxone, an opioid receptor antagonist, got rid of the placebo effect, suggesting the brain’s natural opioid system is involved with modulating those neurons.
Though there’s still more work to be done, researchers noted that their results indicate that the pathway they identified could be tackled by new pain-relieving interventions like drugs or cognitive behavioral therapies.
Online Search Interest in Gynecologists After the Release of the Film Barbie
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2821491?resultClick=3&utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8BqKoSMn7cUYuEu2cEFECXfPSicxgbNIjuJs04j5eQEzjit7ge4v2_z4CVDezQgPHBFX4SuBC4bz5lUiwMSnd8i7EFSQ&_hsmi=317386118&utm_content=317386118&utm_source=hs_email
Barbie, the SEO queen of gynecology
Last summer’s Barbie movie spawned endless memes (that even the American Medical Association got in on), songs of the summer from Billie Eilish and Dua Lipa, and a shortage of hot pink paint. But did the iconic last scene — Barbie’s very enthusiastic declaration, “I’m here to see my gynecologist” — birth a renewed interest in getting Pap smears?
Other high-profile medical mentions — such as Katie Couric’s televised colonoscopy and Angelina Jolie’s breast cancer essay in the New York Times — led to increases in colonoscopies and genetic testing, so researchers in JAMA Network Open wondered if Barbie did the same thing.
Looking at online search trends, researchers reported that while searches for “gynecologist” and “gynecologist definition” spiked 51% and 154%, respectively, at the time of the Barbie movie’s release, there was no change in searches for gynecologist appointments. It wasn’t clear to researchers whether people needing the definition of a gyno were the same people who require gynecologic care, but the trend overall suggested that an increased awareness didn’t translate to an increase in people seeking out appointments.
Kamala Harris’ views on health care were shaped by her mother, cancer researcher Shyamala Gopalan By Rohan RajeevJuly 26, 2024
https://www.statnews.com/2024/07/26/shyamala-gopalan-breast-cancer-researcher-kamala-harris-mom/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-8N9yQfCqgyEZVfp-L6GvbuOAlmUAnkjxELtIAdsu0rO_HhPa9nTyCPOIObRR0XG8_DxOae3RO75lEz_VtCTarpzaQ3lA&_hsmi=317386118&utm_content=317386118&utm_source=hs_email
This past Mother’s Day, Kamala Harris posted a picture of herself and her sister in brightly colored coats, standing next to their mother on a sidewalk. “My mother, Dr. Shyamala Gopalan, had two goals in life: to cure breast cancer and to raise my sister and me,” she wrote.
Gopalan was best known for her research on the relationship between progesterone receptors and breast cancer. She worked at institutions including McGill and Lawrence Berkeley National Lab, served on the President’s Special Commission on Breast Cancer under Clinton, and peer reviewed for the NIH before her death in 2009 from colon cancer.
It’s uncertain what the future of Biden’s Cancer Moonshot and the NIH might be under an administration change. With Harris as the likely Democratic presidential nominee, it’s interesting to see what she has said about her mom, health care, and thinking like a scientist, even as a policymaker. Go deeper with this story from STAT’s Rohan Rajeev.
https://www.statnews.com/2023/10/05/cancer-moonshot-biden-questions/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_b8JMmrqqTAZ30cx-A-qhl9QucBtRwh-xUpZEcLOvoHfE-407wO8zphYHT35baOMefgmnEjvPTfnglSUFTOAwzkrgs2w&_hsmi=317386118&utm_content=317386118&utm_source=hs_email
Can the National Institutes of Health navigate multiple storms and rebuild its bipartisan support?
By Nick ManettoJuly 3, 2024
https://www.statnews.com/2024/07/03/can-the-national-institutes-of-health-navigate-multiple-storms-and-rebuild-its-bipartisan-support/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--ZrI3J3rwFSnHG87ZCsGvW6Gz1nJyQByBMPiKXj8GM99iMNoCmFXv1JfdRFGjTAEiM7KOGlWyjGdUeW68K0Oc3YDCryg&_hsmi=317386118&utm_content=317386118&utm_source=hs_email
National Trends in Suicide Among Asian American or Pacific Islander Youth
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2821492?resultClick=3&utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_EgNIJYgqB4f1k1yCZc8KA9Dm6COvPwmE6d9nSWINRyiBZ271O5Np35uVqoI8RqqEREEpjEBcE47QQwyMvtUvfYM11AQ&_hsmi=317386118&utm_content=317386118&utm_source=hs_email
The striking increase in suicides among Asian-Americans
Recent U.S. data showed that while suicide rates decreased for young white people in 2018 and 2019, rates went up for Asian-American or Pacific Islander youths. In a recent JAMA Network Open study, researchers examined suicide trends in Asian-Americans ages 10 to 19 years old more closely.
Looking at codes for causes of death in a data set ranging from 1999 to 2021, researchers found that suicide rates started rising for girls in 2004, peaking at nearly 3 per 100,000 people in 2020. For boys, the rates began rising in 2009 and peaked at 8 per 100,000 people in 2019.
The authors couldn’t explain what was causing the increases, but suggested this upward trend might have stemmed from economic hardships in Asian-American households during the Great Recession, as well as increased exposure to sexism and racism — especially for Asian-American women and girls — with the proliferation of social media.
Breast cancer study reveals a paradox of mastectomy Angus Chen By Angus Chen July 25, 2024
https://www.statnews.com/2024/07/25/breast-cancer-study-reveals-double-mastectomy-paradox/?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--vqGS4CUnlub-aGB7hFmz27IAd7UJF8E3hXthNEOm_PP41di-bu5TeWnwC-751md_pjPpGu9qZADdkplbqu81vAiPX_w&_hsmi=317386118&utm_content=317386118&utm_source=hs_email
A paradox of mastectomy for breast cancer patients
Weighing treatment options for breast cancer is an agonizing choice. New research published in JAMA Oncology affirms the prevailing knowledge that excising the cancerous lump, getting a single mastectomy, or a double mastectomy all return about the same rate of survival: over 80% over 20 years of followup.
However, STAT’s cancer reporter Angus Chen writes, the new study turns up a puzzling finding: Survivors who ended up developing a second breast cancer in their opposite, or contralateral, breast had a higher risk of death from breast cancer, even though people who got a double mastectomy died at the same overall rates.
“That seems like a paradox,” said Steven Narod, a breast cancer researcher and physician at Women’s College Hospital in Toronto and the lead author on the study. “If you get a contralateral breast cancer, your risk of dying goes up. But preventing it doesn’t improve your survival.”
Read more from Angus, including possible explanations for the conundrum.
CDC Confirms Three Human Cases of H5 Bird Flu Among Colorado Poultry Workers
https://www.cdc.gov/media/releases/2024/s0725-three-human-cases-of-h5-bird-flu.html?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_2cSYQDxgi-u25PK5jT8OhT6ON4dxywGgKgQJA-6h7D5koPyGYWnmlC-kD4OnYT4thXIQlpc7sago7vsRkvWTyNPHW8A&_hsmi=317386118&utm_content=317386118&utm_source=hs_email
Bird flu cases in humans now total 13 in U.S.
The number of confirmed human infections with the bird flu virus associated with the ongoing outbreak in dairy cattle has risen to 13, the Centers for Disease Control and Prevention announced Thursday, as it confirmed three additional cases in Colorado. They are currently designated simply as H5 and not H5N1 because CDC labs are still working on typing the neuraminidase, the N number in the virus’ name, STAT’s Helen Branswell reports.
The cases — one of which Colorado had previously announced as a “presumptive positive” — are in people who were culling infected poultry on a farm in the state. Genetic analysis of the virus in that poultry outbreak shows that it is similar to the virus circulating in cows; it’s believed this is one of several instances where H5N1 in cow herds has spilled over into nearby poultry operations. Of the 13 human cases, 10 have been detected in Colorado, which also has the highest number of reported infected dairy herds — 51, according to the state's Department of Agriculture. Michigan and Texas have reported two and one human case, respectively.
https://ag.colorado.gov/animal-health/reportable-diseases/avian-influenza/hpai-in-dairy-cattle?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz-_xieJZ45QFF2lftALeMiK7eGtfW7hvbz_3hocy0Tu_1tegkkdNQ1k6geJaECoVRmfKNvG_zsF1aUv9CtME5z3KKAawCQ&_hsmi=317386118&utm_content=317386118&utm_source=hs_email
What the Election Could Mean for the Mexico City Policy and U.S. Foreign Aid
This analysis outlines the potential reach of a prominent conservative proposal — widely seen as a blueprint for another Trump administration — that recommends expanding the Mexico City Policy to include virtually all U.S. foreign assistance. It looks at the amount of funding, the number of organizations, the range of foreign assistance sectors, and other variables that could be affected should the proposal be implemented.
https://www.kff.org/global-health-policy/
The Global HIV/AIDS Epidemic Published: Jul 25, 2024
https://www.kff.org/global-health-policy/fact-sheet/the-global-hiv-aids-epidemic/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz--5h9FFnfqpid2S-UxOId1Fq4qek-64s1pe45-QO5bTyspJMIBmI-hJ7zn9N6hNRRpdi3ipMQv_-mWiOEpavkam6M0Hjw&_hsmi=317468616&utm_content=317468616&utm_source=hs_email
The Global HIV/AIDS Epidemic
Published: Jul 25, 2024
Key Facts
HIV, the virus that causes AIDS (acquired immunodeficiency syndrome), is one of the world’s most serious health and development challenges. Approximately 40 million people are currently living with HIV, and tens of millions of people have died of AIDS-related causes since the beginning of the epidemic.
Many people living with HIV or at risk for HIV infection do not have access to prevention, treatment, and care, and there is still no cure.
In recent decades, major global efforts have been mounted to address the epidemic, and despite challenges, significant progress has been made in addressing HIV. Current global health goals are to end AIDS as a public health threat by 2030.
The U.S. government (U.S.), through PEPFAR (the President’s Emergency Plan for AIDS Relief), is the single largest donor to international HIV efforts in the world, including the largest donor to the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund). PEPFAR, which now spans over 50 countries, has directed approximately $120 billion toward HIV prevention, care, and treatment efforts since it launched in 2003.
U.S. International Family Planning & Reproductive Health: Requirements in Law and Policy Published: Jul 26, 2024
https://www.kff.org/global-health-policy/fact-sheet/u-s-international-family-planning-reproductive-health-requirements-in-law-and-policy/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz--WavOYZ9U86ptEi_s8MNyxTEshBkT_olR5N080VY3w7RjEgj3E5zJ3XKmgEhiFPXRcvINRCiJj85RCBsNw2cZ_eSgPXg&_hsmi=317468616&utm_content=317468616&utm_source=hs_email
This fact sheet summarizes the major statutory requirements and policies pertaining to U.S. global family planning/reproductive health (FP/RH) efforts over time and identifies those currently in effect. These laws and policies collectively serve to direct how U.S. funds are spent, to where and which organizations funds are provided, and generally shape the implementation and define the scope of U.S. global FP/RH activities. It includes U.S. laws and annual requirements enacted by Congress through appropriations bills (statutory provisions) as well as executive branch policies and guidance specific to FP/RH (policy provisions). Each category lists provisions in chronological order.
Donor Government Funding for HIV in Low- and Middle-Income Countries in 2023 Adam Wexler, Jennifer Kates, Stephanie Oum, and Eric Lief Published: Jul 22, 2024
https://www.kff.org/global-health-policy/report/donor-government-funding-for-hiv-in-low-and-middle-income-countries-in-2023/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz-_UrbegzltDqwEhljihNYJihy31K0zhOv74MuJKDW6dm3eglKtdhyY9vmlDYLOMgDWW8fkr2s3aAWk199KAnhSlEclOWg&_hsmi=317468616&utm_content=317468616&utm_source=hs_email
This report, Donor Government Funding for HIV in Low- and Middle-Income Countries in 2023, tracks funding levels of the donor governments that collectively provide the bulk of international assistance for AIDS through bilateral programs and contributions to multilateral organizations. The new report, produced as a partnership between KFF and UNAIDS, provides the latest data available on donor funding disbursements based on data provided by governments. It includes their bilateral assistance to low- and middle-income countries and contributions to the Global Fund to Fight AIDS, Tuberculosis and Malaria as well as UNITAID.
What are the Consequences of Health Care Debt Among Older Adults? Alex Cottrill, Tricia Neuman, Lunna Lopes, and Liz Hamel Published: Jul 26, 2024
https://www.kff.org/medicare/issue-brief/what-are-the-consequences-of-health-care-debt-among-older-adults/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz--_LPCNZRh0pInj3-D24TR_Yy9fLMLl_BkhnLDW3LKnV6EzJvnXFRQq8w_G_xtmlThBccQ3VEHtIIo7P2lJ_sHXgc3zgw&_hsmi=317468616&utm_content=317468616&utm_source=hs_email
Health care debt is a widespread problem in the United States, garnering the attention of some policymakers and emerging as a potential campaign issue. A 2022 KFF survey found that 2 in 5 US adults (41%) of all ages report some form of debt due to medical or dental bills for their own or someone else’s care. Nearly three-quarters of adults say they are worried about affording unexpected medical bills or the cost of health care services, higher than the shares who report worrying about affording other household expenses. The Medicare program, which provides health insurance coverage to 66 million people, most of whom are older adults ages 65 or older, helps to cover the cost of medical care for those who qualify, yet health care cost-related problems among Medicare-age adults are not uncommon and leave many exposed to debt, with potentially serious and long-lasting health and financial consequences.
What the FTC’s New Protections From Non-Compete Agreements Mean in a Mostly Non-Profit Hospital Industry Michelle Long, Matthew Rae, and Kaye Pestaina Published: Jul 24, 2024What the FTC’s New Protections From Non-Compete Agreements Mean in a Mostly Non-Profit Hospital Industry Michelle Long, Matthew Rae, and Kaye Pestaina Published: Jul 24, 2024
https://www.kff.org/policy-watch/what-the-ftcs-new-protections-from-non-compete-agreements-mean-in-a-mostly-non-profit-hospital-industry/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz--dHzn4v8SeOYk0CSKeCl_uKvIk7BjNIbuMG3IXvIcDmijju2sZlOHKG4ZaiOmVG30MioNxeuxOLpqzrlMD3XVZK2ZCCg&_hsmi=317468616&utm_content=317468616&utm_source=hs_email
In April 2024, the Federal Trade Commission (FTC) approved a final rule barring employers’ use of non-compete clauses in certain employment contracts. Non-compete clauses are used in many industries to prevent employees from taking a job with a competitor or starting a related business within a certain amount of time or distance. The FTC estimates that one in five workers (about 30 million) are subject to a non-compete clause. The regulation, which is set to take effect in September 2024, already faces multiple legal challenges, and possibly more to come, with plaintiffs claiming that the FTC exceeded its regulatory authority. Plaintiffs in of those cases were granted a preliminary injunction in July 2024, enjoining the FTC from enforcing the rule against them while the case makes its way through the courts.
Democratic Women Voters See Vice President Harris As Trusted Messenger on Abortion Policy Ashley Kirzinger, Isabelle Valdes, and Liz Hamel Published: Jul 23, 2024
https://www.kff.org/womens-health-policy/poll-finding/democratic-women-voters-see-vice-president-harris-as-trusted-messenger-on-abortion-policy/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz-8WxrFwn0Lt1FFAJdlEiu8x-MZxFWM6hUZ-ZDaiU1QXJGeXLv-YLBL5h6qeVCNEQzPAWe4QoHHR3oxN3na1cxd6Kph3JQ&_hsmi=317468616&utm_content=317468616&utm_source=hs_email
Long before President Biden announced his decision to withdraw from the 2024 presidential race, Vice President Kamala Harris has been the administration’s voice on abortion rights. As part of her “Fight for Reproductive Freedoms” tour earlier this spring, V.P. Harris was the first sitting U.S. vice president1 to visit an abortion provider and she has consistently criticized Republican efforts to limit access to reproductive health care.
KFF’s Health Misinformation
https://www.kff.org/health-misinformation-monitor/volume-04/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz-_tZSu-rPwyfp4HTBuy14UKa0CWI5PS0iTwk5G1_KjBaBQxEqjJ8ZX6n2mTvRVyAT8LM6gN0vTkj_YxY0EQ5-nWK7BU3g&_hsmi=317468616&utm_content=317468616&utm_source=hs_email
This is Irving Washington and Hagere Yilma. We direct KFF’s Health Misinformation and Trust Initiative and on behalf of all of our colleagues across KFF who work on misinformation and trust we are pleased to bring you this edition of our bi-weekly Monitor.
KFF Health Misinformation Monitor: July 25
The latest edition of the KFF Health Misinformation Monitor focuses on how ongoing misinformation about the safety and efficacy of COVID-19 vaccines may affect the acceptance of new vaccine recommendations.
Beyond Chevron: How the Court’s Decision Will Change Health Policy Legis...
The Health Wonk Shop: Beyond Chevron – How the Court’s Decision Will Change Health Policy Legislating and Rulemaking
https://www.kff.org/other/event/july-25-virtual-event-beyond-chevron-how-the-courts-decision-will-change-health-policy-legislating-and-rulemaking/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz-9roxxroMfiEjiW9qSEuTrO3ijx3KXymggUoIX7uSfbQmqbuQOx9VcbyjfFM-zRFWM1ZCaYZP0dlxIIulDjDf5JfLFc3Q&_hsmi=317468616&utm_content=317468616&utm_source=hs_email
Published: Jul 25, 2024
Inflation Reduction Act Health Insurance Subsidies: What is Their Impact and What Would Happen if They Expire? Jared Ortaliza, Anna Cord, Matt McGough, Justin Lo, and Cynthia Cox Published: Jul 26, 2024
https://www.kff.org/private-insurance/issue-brief/inflation-reduction-act-health-insurance-subsidies-what-is-their-impact-and-what-would-happen-if-they-expire/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz-8fP4ibxyUDvaA6mBQIRzQTc-ZS__65TdKcjPl1JQPOS0yZpWSJJnJyp2U3LxrqmJBSDYrAIkitlJJPlWQRKrodZQureQ&_hsmi=317468616&utm_content=317468616&utm_source=hs_email
ACA Marketplace Enrollees Will See Steep Increases in Premium Payments in 2026 if Enhanced Subsidies Expire
Without the enhanced subsidies in the Inflation Reduction Act (IRA), Affordable Care Act (ACA) Marketplace enrollees in 12 of the states that use HealthCare.gov would see their monthly premium payments at least double on average, according to a new KFF analysis.
The Role of Health Care in the New Presidential Election Drew Altman Published: Jul 25, 2024
https://www.kff.org/from-drew-altman/the-role-of-health-care-in-the-new-presidential-election/?utm_campaign=KFF-This-Week&utm_medium=email&_hsenc=p2ANqtz-9Dp3QkBr_22oS2GvuEv9Ae259lwxeb3oSGoiO_pKvK90WDQh_EIRWm99qy_IuR7vncwPmbJB7ESJebOMOn9-k_vTSXcQ&_hsmi=317468616&utm_content=317468616&utm_source=hs_email
The Role of Health Care in the New Presidential Election
In his latest column, KFF President and CEO Drew Altman describes the role of health care in the new presidential election with Vice President Harris facing former President Donald Trump. He discusses how health will likely be a consequential factor in the campaign, with abortion and reproductive rights, along with health care costs, taking center stage.
sábado, 27 de julio de 2024
FDA Releases Draft Guidance on Essential Drug Delivery Outputs By Adrienne R. Lenz, Principal Medical Device Regulation Expert —
https://www.thefdalawblog.com/2024/07/fda-releases-draft-guidance-on-essential-drug-delivery-outputs/?utm_source=rss&utm_medium=rss&utm_campaign=fda-releases-draft-guidance-on-essential-drug-delivery-outputs
For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. EPRs were usually requested in the context of design controls, although 21 C.F.R. § 820.30 does not use this term. In various meetings with the Agency and at conferences, FDA was often asked to clarify this term. Are EPRs the same as “Essential Performance” as defined in IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance? Are EPRs design outputs that are essential for the proper functioning of the device that are required to be identified per 21 C.F.R. § 820.30(d)? Are EPRs a new term to describe a subset of design input requirements and specific to combination products?
ACI’s 10th Anniversary Paragraph IV Disputes Master Symposium
https://www.thefdalawblog.com/2024/07/acis-10th-anniversary-paragraph-iv-disputes-master-symposium/?utm_source=rss&utm_medium=rss&utm_campaign=acis-10th-anniversary-paragraph-iv-disputes-master-symposium
The American Conference Institute (“ACI”) is holding its 10th Anniversary Paragraph IV Disputes Master Symposium from October 15-16, 2024, at the Hyatt Regency McCormick Place in Chicago, Illinois. Each fall, leading pharmaceutical patent litigators for brand-name and generic drug companies gather at the Paragraph IV Disputes Master Symposium in Chicago to receive up-to-the-minute information on the latest developments affecting Hatch-Waxman litigation and participate in significant peer-to-peer networking opportunities. Join us to address emerging and growing areas of concern, including the implementation of the Inflation Reduction Act, FTC’s—and now a District Court’s—attack on Orange Book patent listings, and the proposed use of the Bayh Doyle Act.
Other key program highlights this year include:
Examining the Use of Clinical Trials as Prior Art: How to Thread the Needle on Protecting IP and Mandated Disclosures
Patent Rights and Supply Chain Dynamics: Understanding How Developments in India May Affect Hatch-Waxman- Generic and Brand Perspectives
Fireside Chat on Future of FDA Initiatives Affect Small Molecules: Regulatory Initiatives, and Agency Developments for Hatch Waxman Practitioners to Watch
Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will moderate a panel discussion, titled “Fireside Chat on the Future of the FDA: Regulatory Initiatives, and Agency Developments for Hatch Waxman Practitioners to Watch.”
https://www.americanconference.com/paragraph-iv-disputes-master-symposium/?utm_medium=affiliate&utm_source=fdalawblog&utm_campaign=F25_awareness
Join SAMHSA’s PCSS-MOUD Exchange Sessions to Learn about the Implementation of Opioid Use Disorder Treatment in a Variety of Healthcare Settings
https://pcssnow.org/education-training/pcss-moud-exchange/?utm_source=SAMHSA&utm_campaign=331578a771-EMAIL_CAMPAIGN_2024_07_25_01_10&utm_medium=email&utm_term=0_-331578a771-%5BLIST_EMAIL_ID%5D
SAMHSA’s Providers Clinical Support System – Medications for Opioid Use Disorder (PCSS-MOUD) is hosting a four-part learning Exchange Session that address requirements, strategies, and considerations for integrating opioid use disorder treatment in various care settings. Sessions start on August 1 and run each week through August 22 at 3 p.m. ET.
The PCSS-MOUD Exchange sessions will focus on exploring, preparing, implementing, and sustaining treatment services including the use of medications for opioid use disorder (MOUD). Topics such as medication review, patient screening, protocols, clinic workflows, and strategies for treating patients, including addressing treating patients with other heath conditions.
Exchange Session 1 – Explore on August 1, 3 – 4 p.m. ET
https://aaap.zoom.us/webinar/register/WN_poq6FjYOSdCMmqrxa0m5uw?utm_source=SAMHSA&utm_campaign=331578a771-EMAIL_CAMPAIGN_2024_07_25_01_10&utm_medium=email&utm_term=0_-331578a771-%5BLIST_EMAIL_ID%5D#/registration
Review medications for opioid use disorders (MOUD), with a focus on buprenorphine treatment and its various formulations, and strategies for including harm reduction approaches into care. Discuss administrative, clinical and financial considerations, and provide resources for both prescribers and non-prescribers.
Exchange Session 2 – Prepare on August 8, 3 – 4 p.m. ET
https://aaap.zoom.us/webinar/register/WN_yQ1PSbFnTri_9sJ3t1xyzQ?utm_source=SAMHSA&utm_campaign=331578a771-EMAIL_CAMPAIGN_2024_07_25_01_10&utm_medium=email&utm_term=0_-331578a771-%5BLIST_EMAIL_ID%5D#/registration
Review patient screening considerations and discuss how OUD screening can be integrated into current clinic workflows. Discuss the training and certifications required for specific team members to implement MOUD. Highlight the critical role of Champions, and how to strategically select Champions to support MOUD implementation.
Exchange Session 3 – Implement/Sustain on August 15, 3 – 4 p.m. ET
https://aaap.zoom.us/webinar/register/WN_JITGvwLtQBurgMflyIcw6w?utm_source=SAMHSA&utm_campaign=331578a771-EMAIL_CAMPAIGN_2024_07_25_01_10&utm_medium=email&utm_term=0_-331578a771-%5BLIST_EMAIL_ID%5D#/registration
Review considerations for MOUD initiation and follow-up, including lab guidelines, and clinical management of patients with continued use (e.g., fentanyl, novel synthetic opioids), overdose risk, poly-substance use, and comorbid mental health conditions.
Exchange Session 4 – Implement/Sustain on August 22, 3 – 4 p.m. ET
https://aaap.zoom.us/webinar/register/WN_VKEP49xaSG6gWK35QyOfMg?utm_source=SAMHSA&utm_campaign=331578a771-EMAIL_CAMPAIGN_2024_07_25_01_10&utm_medium=email&utm_term=0_-331578a771-%5BLIST_EMAIL_ID%5D#/registration
Consider approaches to sustain MOUD and ensure continued access to high-quality care for our most challenged patients, including those who are pregnant, youth/adolescents, those with acute or chronic pain, and those electing to taper their dose.
Organized by American Academy of Addiction Psychiatry, each session is a 1-hour. The sessions are designed for physicians, nurse practitioners or other advanced practice nurses, physician assistants, psychologists, licensed counselors, social workers, clinical administrators, and healthcare teams.
PCSS-MOUD is a SAMHSA funded national training, guidance, and clinical mentoring program to enhance the capacity of healthcare and counseling professionals to identify and treat opioid use disorder (OUD). PCSS-MOUD trains health professionals to provide effective, evidence-based, medication treatments to patients with opioid use disorder in primary care, psychiatric care, substance use disorder treatment, and pain management settings.
Credit Designations Available: AMA PRA Category 1 Credit™, Nursing Contact Hours, AAPA Category 1 CME credit, and Interprofessional Continuing Education (IPCE) credit. Note: A Certificate of Attendance which acknowledges 1 hour of participation is also available (0 CE).
Listen to the Latest ‘KFF Health News Minute’ July 23, 2024
https://kffhealthnews.org/news/article/listen-to-the-latest-kff-health-news-minute-2024/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-9rlyMh0TsCHOS9EmBx6mYTKq-DMY9qV2qbSu3etanbVzoMf7aInzI4Sk5X6a2rQI9pj7d1iYDMK2CbQ1clA_9Sk3ef0A&_hsmi=317496382&utm_content=317496382&utm_source=hs_email
Listen to the Latest ‘KFF Health News Minute’
“Health Minute” brings original health care and health policy reporting from the KFF Health News newsroom to the airwaves each week.
Journalists Discuss Abortion in GOP Platform and How Idaho’s Ban Drove Away OB-GYNs July 20, 2024
https://kffhealthnews.org/news/article/on-air-july-20-2024-abortion-gop-platform-covid/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-_pU6KUcy_A1JUd-ZVGYIf96t8Vb2oMasY3f27uSfbWzjbqSiyc71XZRgsy4voHtBAU6fCiN2HKvbwd0oxrKtJDPmKrrw&_hsmi=317496382&utm_content=317496382&utm_source=hs_email
Journalists Discuss Abortion in GOP Platform and How Idaho’s Ban Drove Away OB-GYNs
KFF Health News and California Healthline staff made the rounds on national and local media in the last couple of weeks to discuss topical stories. Here’s a collection of their appearances.
California Forges Ahead With Social Media Rules Despite Legal Barriers By Mark Kreidler July 23, 2024
https://kffhealthnews.org/news/article/california-social-media-regulations-legal-challenges-tech/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz--OHchrYyF4fAp1rjsAjzQHwLMsgc9bGWGFhAwkEJF9fruFUPYPS0DoHLHIb8eRw8OwIUdqxySgHaPVyDkW46WHh7njIg&_hsmi=317496382&utm_content=317496382&utm_source=hs_email
California Forges Ahead With Social Media Rules Despite Legal Barriers
By Mark Kreidler
State lawmakers are advancing two bills aimed at protecting children from the harms of social media, part of a nationwide wave of efforts to address the issue. Yet the bills’ proponents face hurdles in finding an approach that can survive legal challenges from the tech industry.
Why Millions Are Trying FDA-Authorized Alternatives to Big Pharma’s Weight Loss Drugs By Arthur Allen Illustration by Oona Tempest July 23, 2024
https://kffhealthnews.org/news/article/glp1-compounding-pharmacies-wegovy-zepbound-copycat-drugs-shortages/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-9OAtSX9_kVHmQIUuDyocZjV859PuVMTD8w0tDogs0atghiKP596ULUi6G8FS5CMIEVD0_7PxGnrFJv6o6kMwKIJroOtQ&_hsmi=317496382&utm_content=317496382&utm_source=hs_email
Why Millions Are Trying FDA-Authorized Alternatives to Big Pharma’s Weight Loss Drugs
By Arthur Allen Illustration by Oona Tempest
Although Novo Nordisk and Lilly lump together the pharmacies that compound semaglutide and tirzepatide with internet cowboys selling fake drugs, there is a distinction. The FDA has offered Americans little clarity about the vast gray and black markets for the drugs.
Louisiana Reclassifies Drugs Used in Abortions as Controlled Dangerous Substances By Rosemary Westwood, WWNO July 24, 2024
https://kffhealthnews.org/news/article/louisiana-mifepristone-misoprostol-abortion-pills-reclassified-dangerous-controlled-substances/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-9XMNZscBhsXiZH3e1k5V7X8Q-Qzsn-J_UFnGnqvpgmZcbP233FDnboyI6XMyi38GDquY7WS1WGtktb9LSDRsJI3ul1Cg&_hsmi=317496382&utm_content=317496382&utm_source=hs_email
Louisiana Reclassifies Drugs Used in Abortions as Controlled Dangerous Substances
By Rosemary Westwood, WWNO
Louisiana lawmakers have added two drugs commonly used in pregnancy and reproductive health care to the state’s list of controlled dangerous substances, a move that has alarmed doctors in the state.
Rescue From Above: How Drones May Narrow Emergency Response Times By Michelle Andrews July 22, 2024
https://kffhealthnews.org/news/article/drone-emergency-medical-response-times/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz--uDqoDM1f5WuiNAJonts2m7Ri1qtpbZhqJyttBDIkKvCjE0z2siEE0pwvF-eKFvz7vkXh_B_N5YytIl1vBLOX6AIHavg&_hsmi=317496382&utm_content=317496382&utm_source=hs_email
Rescue From Above: How Drones May Narrow Emergency Response Times
By Michelle Andrews
Public safety and health care organizations are using drones to speed up lifesaving treatment during medical emergencies in which every second counts.
Montana Looks To Become Latest State To Boost Nonprofit Hospital Oversight By Katheryn Houghton July 25, 2024
https://kffhealthnews.org/news/article/montana-nonprofit-hospital-community-benefit-standards-oversight/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-_00ZlFr17DxyXoa3Buw23DGazppesK1XSF8vMNK73LqV8HZgRgdVg_ixTCIXO4ipJCMlZmyBQU0MXoq2tT3AA3SfDqww&_hsmi=317496382&utm_content=317496382&utm_source=hs_email
Montana Looks To Become Latest State To Boost Nonprofit Hospital Oversight
By Katheryn Houghton
Montana’s proposal to increase oversight is part of a national trend by states to ensure nonprofit hospitals act as charitable organizations as they claim tax-exempt status. But the state has yet to set standards for how much the hospitals must do.
World-Famous Wall Drug Isn’t Immune From Challenges Facing Rural Pharmacies By Arielle Zionts July 24, 2024
https://kffhealthnews.org/news/article/wall-drug-rural-pharmacies-challenges/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-_fRjNQuka6IT61dpdg9k-Gkv6HmAclwX8A4AOcZE5Jk1n80PRiWxQgzwD4WyJ-XxdjfzxHB1gExSe1kira9gjLdAvo2g&_hsmi=317496382&utm_content=317496382&utm_source=hs_email
World-Famous Wall Drug Isn’t Immune From Challenges Facing Rural Pharmacies
By Arielle Zionts
Even as part of a popular South Dakota tourist attraction, an independent pharmacy serving locals, remote ranchers, and sightseers struggles with staffing and insurer payments.
California Speeds Up Indoor Heat Protections Amid Sweltering Summer Weather By Samantha Young July 24, 2024
https://kffhealthnews.org/news/article/california-indoor-worker-heat-protections-finalized-summer-weather/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-_s07jEwN5xYLCOZXq9nHwGG3_bXTyiQD6CYanBFnkP6vJ7hXlsOfzLr1KNGM9BMvCuTL6xrZU3HLiqyAL1ywyjnhT72Q&_hsmi=317496382&utm_content=317496382&utm_source=hs_email
California Speeds Up Indoor Heat Protections Amid Sweltering Summer Weather
By Samantha Young
Indoor workers who toil in hot jobsites in California gain immediate protection from this summer’s extreme heat. The state’s worker safety chief announced finalized rules Wednesday, capping a years-long push by workers.
Covid Is Still With Us, but the Guidance Has Changed. Here’s What to Know if You’re Exposed. By Tarena Lofton July 22, 2024
https://kffhealthnews.org/news/article/covid-is-still-with-us-but-the-guidance-has-changed-heres-what-to-know-if-youre-exposed/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-9O2eOlkEZ7eoTMFZTQYUtuskXdDx2xp2t2nw66PorZxY6gStSTET8Wy4rb8SGhcU-I0WBX75Nq4W0ikJPWmMGg_l7FBg&_hsmi=317496382&utm_content=317496382&utm_source=hs_email
Covid Is Still With Us, but the Guidance Has Changed. Here’s What to Know if You’re Exposed.
By Tarena Lofton
President Joe Biden tested positive for covid-19 last week, but his symptoms were reportedly mild. With covid still circulating and putting Americans at risk, KFF Health News reviews the latest safety guidelines from the Centers for Disease Control and Prevention.
The CDC’s Test for Bird Flu Works, but It Has Issues By Arthur Allen and Amy Maxmen July 26, 2024
https://kffhealthnews.org/news/article/bird-flu-test-cdc-flaws/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-80O8CqLkjdtlqS1dbVaaSztNs5lkaPE5vCgUrZU73o0gRHjbXCT__XrHps-vLbs7rtnHszciMgm0aB0tDzNDeoVe_Tcw&_hsmi=317496382&utm_content=317496382&utm_source=hs_email
The CDC’s Test for Bird Flu Works, but It Has Issues
By Arthur Allen and Amy Maxmen
he Centers for Disease Control and Prevention promises better tests are being developed, but the episode points to vulnerabilities in the country’s defense against emerging outbreaks.
Union With Labor Dispute of Its Own Threatened To Cut Off Workers’ Health Benefits By Phil Galewitz Updated July 26, 2024 Originally Published July 26, 2024
https://kffhealthnews.org/news/article/nea-national-education-association-union-threatens-health-insurance-benefit-lockout/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-8iGIGege268wlkSH0w1HLLWIvc9_7ZfE1Z7eX50olzo7wRyrESD0pgZ0UHUMa033lf9PRTLu5tdOTM1cytl8WKYdVbeg&_hsmi=317496382&utm_content=317496382&utm_source=hs_email
Union With Labor Dispute of Its Own Threatened to Cut Off Workers’ Health Benefits
By Phil Galewitz
The National Education Association, the nation’s largest union, told striking workers that their health coverage would be cut off Aug. 1 absent a deal on a new contract. Tensions have mounted after staff disrupted the union’s convention, at which President Joe Biden had been scheduled to speak.
Oregon Senator Proposes Criminal Charges and Fines for Rogue Obamacare Agents By Julie Appleby July 24, 2024
https://kffhealthnews.org/news/article/oregon-senator-proposes-criminal-charges-and-fines-for-rogue-obamacare-agents/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-9gSqPZlbTVWCeL_65fZIdCH7fgDwSHNLa53kb_pMN4YClBlaUriroGPonnd3pip2z3WVde5y9CPSARqioKzmSiAfu6ag&_hsmi=317496382&utm_content=317496382&utm_source=hs_email
Oregon Senator Proposes Criminal Charges and Fines for Rogue Obamacare Agents
By Julie Appleby
Oregon Sen. Ron Wyden introduced legislation intended to curb a growing problem in which consumers, without their consent, are enrolled in Affordable Care Act plans or their coverage is switched.
Harris in the Spotlight Episode 357 July 25, 2024
https://kffhealthnews.org/news/podcast/what-the-health-357-kamala-harris-campaign-health-policy-july-25-2024/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-_2dZa8H2xrvkZLH_LxtjsYmNDif4wdNCeMh1zS-rYH7SZ3OxEyc6m_oE2ViVOVCDV-wBKFSVKaHj6faHmh9e66cxizmQ&_hsmi=317496382&utm_content=317496382&utm_source=hs_email
KFF Health News' 'What the Health?': Harris in the Spotlight
For the 2024 campaign, Joe Biden is out, and Kamala Harris is in. As the vice president makes moves toward the top of the Democratic presidential ticket, health policy is resurging as a campaign issue. Meanwhile, Congress tries — and again fails — to make timely progress on the annual government spending bills as abortion issues cause delays. Alice Miranda Ollstein of Politico, Stephanie Armour of KFF Health News, and Rachel Cohrs Zhang of Stat join KFF Health News’ Julie Rovner to discuss these issues and more. Also this week, Rovner interviews Anthony Wright, the new executive director of Families USA, about his plans for the organization and his history working with Harris on health topics.
Harris, Once Biden’s Voice on Abortion, Would Take an Outspoken Approach to Health By Stephanie Armour and Julie Appleby and Julie Rovner July 21, 2024
https://kffhealthnews.org/news/article/kamala-harris-health-agenda-abortion-womens-health-2024-election/?utm_campaign=KHN%20-%20Weekly%20Edition&utm_medium=email&_hsenc=p2ANqtz-_O5gpQdzfyDV2ahHF0mj1F0xbXWuy0ynNeAqYIhh3_WvUyVd2pQCPMRKXG-qHazJIMs87azir0mwCOght0U0cmISoBPg&_hsmi=317496382&utm_content=317496382&utm_source=hs_email
Harris, Once Biden’s Voice on Abortion, Would Take an Outspoken Approach to Health
By Stephanie Armour and Julie Appleby and Julie Rovner
If she grabs the baton from President Joe Biden to become the new presumptive Democratic presidential nominee, Kamala Harris would widely be expected to take an aggressive stance in support of abortion access — hitting former President Donald Trump on an issue that could undermine his chances of victory.
Department of Commerce Announces New Guidance, Tools 270 Days Following President Biden’s Executive Order on AI
Department of Commerce Announces New Guidance, Tools 270 Days Following President Biden’s Executive Order on AI
For the first time, Commerce makes public new NIST draft guidance from U.S. AI Safety Institute to help AI developers evaluate and mitigate risks stemming from generative AI and dual-use foundation models.
July 26, 2024
https://www.nist.gov/news-events/news/2024/07/department-commerce-announces-new-guidance-tools-270-days-following
The U.S. Department of Commerce announced today, on the 270-day mark since President Biden’s Executive Order (EO) on the Safe, Secure and Trustworthy Development of AI, the release of new guidance and software to help improve the safety, security and trustworthiness of artificial intelligence (AI) systems.
The department’s National Institute of Standards and Technology (NIST) released three final guidance documents that were first released in April for public comment, as well as a draft guidance document from the U.S. AI Safety Institute that is intended to help mitigate risks. NIST is also releasing a software package designed to measure how adversarial attacks can degrade the performance of an AI system. In addition, Commerce’s U.S. Patent and Trademark Office (USPTO) issued a guidance update on patent subject matter eligibility to address innovation in critical and emerging technologies, including AI.
viernes, 26 de julio de 2024
Infant Mortality in the United States, 2022: Data From the Period Linked Birth/Infant Death File
https://www.cdc.gov/nchs/data/nvsr/nvsr73/nvsr73-05.pdf?utm_campaign=morning_rounds&utm_medium=email&_hsenc=p2ANqtz--l_AzmZD-PdbG5HolTVuhKrShCVwM3r4hVWrbbx6v6PefbkertpgR08rBMdINJ78SHW-Q5pu-iKDJlr2q-3o6Oog9BJQ&_hsmi=317225391&utm_content=317225391&utm_source=hs_email
U.S. infant mortality rose 3% in 2022, per CDC
Infant deaths were up 3% in 2022 from 2021, according to new CDC data published today in its National Vital Statistics Report. The rate was 5.61 deaths per 1,000 live births overall, but varied widely by race. Black women lost babies at the highest rate, at 10.9 per 1,000. White women lost babies at a rate of 4.52 per 1,000.
Infant mortality rates measure the number of babies that die before they reach their first birthday. The 3% increase is the first statistically significant increase in two decades, the authors of a provisional report on the numbers said late last year. The number has generally been decreasing over the years, so despite the increase, 2022’s rate is still below where it was back in 2002.
The leading causes of death for infants were the same in 2022 as 2021: congenital malformations and disorders related to short gestation and low birth weight. But there was one cause of death that became more common. Infant deaths due to maternal complications from pregnancy jumped from 30.4 to 33.1 deaths per 1,000 live births.
FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products
https://www.fda.gov/drugs/human-drug-compounding/fda-alerts-health-care-providers-compounders-and-patients-dosing-errors-associated-compounded?utm_medium=email&utm_source=govdelivery
FDA alerts health care providers, compounders and patients of dosing errors associated with compounded injectable semaglutide products
FDA has received reports of adverse events, some requiring hospitalization, that may be related to overdoses due to dosing errors associated with compounded semaglutide injectable products. Dosing errors have resulted from patients measuring and self-administering incorrect doses of the drug and health care providers miscalculating doses of the drug.
FDA encourages health care providers and compounders to provide patients with the appropriate syringe size for the intended dose and counsel patients on how to measure the intended dose using the syringe.
The agency also encourages patients to talk with their health care provider or compounder about how to measure and administer the intended dose of compounded semaglutide.
FDA Approves HPV Tests That Allow for Self-Collection in a Health Care Setting
https://www.cancer.gov/news-events/cancer-currents-blog/2024/fda-hpv-test-self-collection-health-care-setting?cid=eb_govdel
On May 14, the Food and Drug Administration (FDA) expanded the approvals of two tests that detect cancer-causing types of human papillomavirus (HPV) in the cervix. Both tests are used as part of screening for cervical cancer.
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