FTC Again Polices FDA's Laziness With Improper Orange Book Listings for Diabetes, Weight Loss, Asthma and COPD Drugs
Today (April 30, 2024), the U.S. Federal Trade Commission (FTC) announced that it had expanded its campaign against pharmaceutical manufacturers ’ improper or inaccurate listing of patents in the Food and Drug Administration ' s (FDA) Orange Book (see the news release athttps://www.ftc.gov/news-events/news/press-releases/2024/04/ftc-expands-patent-listing-challenges-targeting-more-300-junk-listings-diabetes-weight-loss-asthma for more information). FTC is targeting what it describes as more than 300 " junk " patent listings because the particular patents are legally ineligible to even be listed in the FDA Orange Book.Lis...
Source: Scott's Web Log - May 1, 2024 Category: Endocrinology Tags: 2024 FDA FTC improper listings Orange Book pharma Source Type: blogs
The TAME Trial for Metformin Remains Only Partially Funded
The Targeting Aging with Metformin (TAME) clinical trial has been a feature of the divide between regulators, researchers, and industry in the matter of treating aging as a medical condition for as about as long as the longevity industry has existed. Regulators such as the FDA do not consider aging to be a disease, and they only approve treatments for specific diseases, largely using the World Health Organization's International Classification of Diseases as the basis for what is and is not a disease. The TAME trial came into being as a way to convince the FDA to approve a treatment on the basis of endpoints that approxima...
Source: Fight Aging! - April 30, 2024 Category: Research Authors: Reason Tags: Longevity Industry Source Type: blogs
Lean Digital: How AI Drives Treatment Recommendations for Weight Loss
The first article in this series laid out what we know about body weight and obesity today. The rest of the Lean Digital series will look at some contributions that digital technologies are making toward solutions.
The best contribution that information can make to weight management is to find more effective, personalized treatments: to match the right person to the right treatment, whether it be surgery, drugs, diet, exercise, or some combination. AI is turning up intriguing successes in this endeavor.
I talked to Dr. Ronald Razmi, co-founder and managing director at Zoi Capital and author of the book AI Doctor: The Rise ...
Source: EMR and HIPAA - April 30, 2024 Category: Information Technology Authors: Andy Oram Tags: AI/Machine Learning Analytics/Big Data Clinical Communication and Patient Experience Genomics-Precision Medicine Health IT Company Healthcare IT Telemedicine and Remote Monitoring Andres Acosta apree health Behavior Management Behavi Source Type: blogs
What ’s behind all these assessments of digital health?
By MATTHEW HOLT
A decent amount of time in recent weeks has been spent hashing out the conflict over data. Who can access it? Who can use it for what? What do the new AI tools and analytics capabilities allow us to do? Of course the idea is that this is all about using data to improve patient care. Anyone who is anybody, from John Halamka at the Mayo Clinic down to the two guys with a dog in a garage building clinical workflows on ChatGPT, thinks they can improve the patient experience and improve outcomes at lower cost using AI.
But if we look at the recent changes to patient care, especially those brought on by dig...
Source: The Health Care Blog - April 29, 2024 Category: Consumer Health News Authors: matthew holt Tags: Health Policy Health Tech Matthew Holt cost-effectiveness Diabetes digital health digital therapeutics Livongo MSK Peterson Health Technology Institute Source Type: blogs
Presence of Cardiometabolic Disease Correlates with Accelerated Brain Aging
It is well known that metabolic dysfunction and cardiovascular disease correlate well with an accelerated onset and progression of neurodegenerative conditions. This is particularly evident when considering these conditions in the context of obesity. Age-related diseases are the late stage consequences of a progressive accumulation of cell and tissue damage, and so a lifestyle that accelerates those underlying damage processes will produce a greater incidence of all of the common age-related diseases. Suffering from one form of age-related disease thus implies greater odds of suffering other forms of age-related disease, a...
Source: Fight Aging! - April 29, 2024 Category: Research Authors: Reason Tags: Medicine, Biotech, Research Source Type: blogs
Lean Digital: How Apps and Services Can Help Control Weight
Is anyone not obsessed with weight? The health care field certainly is. Researchers have found ties between high body weight and an oversized list of unhealthy conditions. Payers have invested enormous amounts of money in decreasing individuals’ body weights. A Congressional bill would promote behavioral therapy for obesity and extend Medicare coverage for drugs treating obesity.
And yet weights continue to rise around the world, and the phenomenon starts at very young ages.
The rapidly expanding use of GLP-1 drugs has been life-altering for many, but brings its own disappointments: They’re extremely expensive, req...
Source: EMR and HIPAA - April 29, 2024 Category: Information Technology Authors: Andy Oram Tags: AI/Machine Learning Analytics/Big Data Communication and Patient Experience Health IT Company Healthcare IT Telemedicine and Remote Monitoring Behavior Management Behavioral Change GLP-1 Healthcare Motivation Lean Digital Weight Loss S Source Type: blogs
A Progressive Failure of Glucose Regulation in the Aging Brain
There has long been a school of thought on Alzheimer's disease that consideres it a form of diabetes, in which dysregulated glucose metabolism features prominently. This dysregulation certainly occurs; the study noted here isn't the only one to show that the aging brain no longer manages glucose adequately. The question is whether this mechanism is important relative to all of the other processes thought to contribute to the pathology of Alzheimer's disease and other neurodegenerative conditions, and where it fits in a chain of cause and consequence. Finding ways to demonstrate the relative importance of different mechanis...
Source: Fight Aging! - April 29, 2024 Category: Research Authors: Reason Tags: Daily News Source Type: blogs
A hypothetical case of medical malpractice. This can be you.
A patient presents to the emergency room of a major local hospital with ulcers on the heels of both feet. The patient is more than 40 years old, smokes, and has hypertension but is not a diabetic. It is determined that the patient has peripheral artery disease. The patient is admitted to Dr. X’s service.
Read more…
A hypothetical case of medical malpractice. This can be you. originally appeared in KevinMD.com. (Source: Kevin, M.D. - Medical Weblog)
Source: Kevin, M.D. - Medical Weblog - April 28, 2024 Category: General Medicine Authors: Howard Smith, MD Tags: Physician Malpractice Surgery Source Type: blogs
Fight Aging! Newsletter, April 29th 2024
In conclusion, we assigned stemness scores to human samples and show evidence of a pan-tissue loss of stemness during human aging, which adds weight to the idea that stem cell deterioration may contribute to human aging.
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The Role of Immune Aging in Neurodegenerative Conditions
https://www.fightaging.org/archives/2024/04/the-role-of-immune-aging-in-neurodegenerative-conditions/
The research community has come to see chronic inflammation and other age-related immune system dysfunctions as an important aspect of neurodegenerative conditions. Inflammation in the short term is n...
Source: Fight Aging! - April 28, 2024 Category: Research Authors: Reason Tags: Newsletters Source Type: blogs
The Challenges Inherent in Understanding a Fast-Moving, Developing Field
This messy popular science article is an essay length expression of futility on the part of a journalist who accepts that he is not equipped to understand the field of aging research and the longevity industry that has arisen in the past decade. One can talk to the talking heads, but they will all say something different. One can look for proof of efficacy for specific approaches, and find only contradictory data, or only compelling animal data, or only small effect sizes, and a lack of the sort of certainty that arises from large human trials. Those trials are still in the future for near every approach to the treatment o...
Source: Fight Aging! - April 25, 2024 Category: Research Authors: Reason Tags: Healthy Life Extension Community Source Type: blogs
Ozempic And Other Weight Loss Drugs Will Only Work With Digital Health
Weight loss injections are now widely used as miracle drugs for effortless skinniness. But without digital health, they just won’t work in the long run. The U.S. Food and Drug Administration, the FDA, approved Wegovy, a semaglutide injection for chronic weight management in adults with obesity or overweight with at least one weight-related condition for use in addition to a reduced calorie diet and increased physical activity in 2021.
Semaglutide was originally used for the treatment of type 2 diabetes, and was found to have a major lucky side effect: being very effective in assisting weight loss. Semaglutide inject...
Source: The Medical Futurist - April 23, 2024 Category: Information Technology Authors: Andrea Koncz Tags: Digital Health Research weight management weight loss Ozempic Wagevy Source Type: blogs
MCQ on Type 1 Diabetes Mellitus
All of the following are true regarding type 1 diabetes mellitus except:
A. Accounts for about 10% of all cases of diabetes mellitus
B. First peak of presentation occur at 5 to 7 years of age
C. Can occur between 1 and 2 years in high risk groups
D. In all populations, females are significantly more affected
Correct answer: D.
Type 1 diabetes mellitus is slightly more common in boys and men. (https://www.ncbi.nlm.nih.gov/books/NBK441918/) (Source: Cardiophile MD)
Source: Cardiophile MD - April 20, 2024 Category: Cardiology Authors: Johnson Francis Tags: General Cardiology Source Type: blogs
The Evolution of Healthcare at Home, the Technology Driving this Change, and It ’ s Impact on the World of Healthcare
The world of healthcare is ever-evolving, especially when new technology is being adopted. One such new area is healthcare at home. Although we were forced into fully remote operations with COVID-19, we have been making modifications along the way and have discovered how beneficial it can be to our organizations and our patients. To make further strides though, we have to understand where we’ve come from, where we are now, and how it is making an impact. So let’s take a deeper look into healthcare at home to see how it has evolved over time, the technology that is driving this change, and how it is impacting ou...
Source: EMR and HIPAA - April 19, 2024 Category: Information Technology Authors: Grayson Miller Tags: Communication and Patient Experience Health IT Company Healthcare IT Telemedicine and Remote Monitoring Academy Medtech Ventures Alaina Victoria Brenden Hayden Cara Lunsford Carrie Nelson Cindy Gaines Digital Communication Discern He Source Type: blogs
From Patent To Product: The Speed Of The Digital Health Evolution
We’re bombarded with mindblowing headlines of new medical miracles every day. BCI helps paralysed patients talk again! Robots in the stomach! Micro-organs on organ-on-chip technologies! But it is almost impossible to see through the hype and know if and when these will yield actual, patient-ready solutions. So let’s get into this maze and decipher how a new, revolutionary medical technology develops from an ingenious idea to a market-ready product with two real-life examples: the artificial pancreas and wireless ECG.
In early April, the UK’s NHS rolled out an artificial pancreas (APS) for Type 1 diabetes patients,...
Source: The Medical Futurist - April 16, 2024 Category: Information Technology Authors: Andrea Koncz Tags: TMF artificial intelligence digital health Innovation patent analysis Medicine Source Type: blogs
If data is the new oil, there ’ s going to be war over it
By MATTHEW HOLT
I am dipping into two rumbling controversies that probably only data nerds and chronic care management nerds care about, but as ever they reveal quite a bit about who has power and how the truth can get obfuscated in American health care.
This piece is about the data nerds but hopefully will help non-nerds understand why this matters. (You’ll have to wait for the one about diabetes & chronic care).
Think about data as a precious resource that drives economies, and then you’ll understand why there’s conflict.
A little history. Back in 1996 a law was passed that was supposed to ma...
Source: The Health Care Blog - April 15, 2024 Category: Consumer Health News Authors: matthew holt Tags: Health Policy Health Tech The Business of Health Care 21st Century Cures Act Carequality Data Epic HIPAA Integritort Joe Biden Judy Faulkner MDPortals Novellia Particle Health Reveleer TEFCA Source Type: blogs
