Does This Email Message from KVK Tech Violate FDA Regulations?
Today, I received an email message from KVK Tech - a generic drug manufacturer located in my my hometown of Newtown, PA - regarding a gift to Stanford ' s Department of Bariatric and Minimally Invasive Surgery (see below; ignore that the email has the wrong date on it - you can ' t expect a drug company to have good copy editors, can you?). It talks about obesity in the U.S.At the end of the email, in the " About KVK Tech " section, it mentions that it manufactures and distributes Lomaira, which is a drug to treat obesity. Unfortunately, KVK Tech does not mention the Important Safety Information (ISI) whenever a drug compa...
Source: Pharma Marketing Blog - September 28, 2017 Category: Pharmaceuticals Tags: FDA KVK Tech Obesity drugs regulations Source Type: blogs
The Cost of Public Reporting
ANISH KOKA MD
In an age where big data is king and doctors are urged to treat populations, the journey of one man still has much to tell us. This is a tale of a man named Joe.
Joseph Carrigan was a bear of a man – though his wife would say he was more teddy than bear. He loved guitar playing, and camp horror movies. Those who knew him well said he had a kind heart, a quick wit and loved cats.
I knew none of these things when I met Joe in the Emergency Department on a Sunday afternoon. I had been called because of an abnormal electrocardiogram – the ER team was worried he could be having a heart attack. ...
Source: The Health Care Blog - September 18, 2017 Category: Consumer Health News Authors: anish_koka Tags: Uncategorized Source Type: blogs
The High Cost of Public Reporting
ANISH KOKA MD
In an age where big data is king and doctors are urged to treat populations, the journey of one man still has much to tell us. This is a tale of a man named Joe.
Joseph Carrigan was a bear of a man – though his wife would say he was more teddy than bear. He loved guitar playing, and camp horror movies. Those who knew him well said he had a kind heart, a quick wit and loved cats.
I knew none of these things when I met Joe in the Emergency Department on a Sunday afternoon. I had been called because of an abnormal electrocardiogram – the ER team was worried he could be having a heart attack. ...
Source: The Health Care Blog - September 18, 2017 Category: Consumer Health News Authors: anish_koka Tags: Uncategorized Cardiac surgery High-risk Quality Reporting Source Type: blogs
Jellybean 074 with Professor Lars Lundell
LITFL • Life in the Fast Lane Medical Blog
LITFL • Life in the Fast Lane Medical Blog - Emergency medicine and critical care medical education blog
Lars Lundell is a Legend of Scandinavian Surgery. From small beginnings in rural Sweden to the biggest issues in bariatric surgery, Lars has plenty to say. This one has controversy, criticism, care, laughter and a lot of rat surgery.
Professor Lars Lundell. Professor of Surgery Karolinska University Hospital Stockholm. What this man doesn’t know about the oesophagus is probably not worth knowing. What he knows about so many other things is worth knowing. Professor Lunde...
Source: Life in the Fast Lane - August 31, 2017 Category: Emergency Medicine Authors: Doug Lynch Tags: JellyBean ASM CICM CICMxJellyBean Lars Lundell Source Type: blogs
How Could The 21st Century Cures Act And The Joint Commission Improve Eating Disorder Care?
Approximately 30 million individuals have experienced a diagnosable eating disorder at some point in their life. People with an eating disorder are more likely to have comorbid physical and psychological conditions, higher annual health care costs, and experience reduced quality of life. Moreover, eating disorders are among the deadliest of psychological conditions, with anorexia nervosa in particular having an especially high mortality rate. While the burden is significant, there has long been a lack of access to eating disorder prevention, identification, and intervention services.
Parity of behavioral health care with g...
Source: Health Affairs Blog - June 28, 2017 Category: Health Management Authors: Morgan Shields Tags: Featured Following the ACA Insurance and Coverage Payment Policy Public Health 21st Century Cures Act American Health Care Act eating disorder treatment Essential Health Benefits The Joint Commission Source Type: blogs
Lifestyle change: “I know what to do, I just need to do it…but how?”
I hear this nearly every day in my primary care clinic. Many of my patients are overweight or obese, which mirrors the national trend: two out of three adults in the US are overweight or obese. Many of these folks suffer from medical issues such as low back, hip, knee, and foot pain; asthma; obstructive sleep apnea; fatty liver; type 2 diabetes; high blood pressure; high cholesterol; or depression. We know that these conditions often improve with weight loss. So, I often recommend weight loss as a first step in treatment, and the usual approach is through lifestyle change.
Lifestyle change programs for weight loss have bee...
Source: Harvard Health Blog - June 23, 2017 Category: Consumer Health News Authors: Monique Tello, MD, MPH Tags: Behavioral Health Exercise and Fitness Healthy Eating Prevention Source Type: blogs
The Tower Of Babel In Clinical Research: PCORnet ’s Common Data Model Cracks The Foundation
Across all medical specialties, there is a severe lack of high-quality clinical evidence, in part because the gold standard for evidence is large-scale randomized controlled clinical trials. Such trials are on an unsustainable cost trajectory, as they require expensive, stand-alone data capture infrastructures. Furthermore, they typically enroll highly selected populations that are not necessarily representative of real-world patients. Although the emergence of the electronic health record (EHR) holds great promise for generating much-needed evidence, medical research lags far behind other industries in its ability to use ...
Source: Health Affairs Blog - June 6, 2017 Category: Health Management Authors: Lesley H. Curtis Tags: Costs and Spending Featured Health IT Quality big data clinical research clinical trials Common Data Model PCORI PCORnet Source Type: blogs
Bariatric surgery reduces the risk of atrial fibrillation
(Source: Notes from Dr. RW)
Source: Notes from Dr. RW - May 22, 2017 Category: Internal Medicine Tags: cardiovascular Source Type: blogs
Procrustes
Crossposted fromTheFatLadySingsThis morning I read Ragen Chastain ’s latest post, They Want Fat People to Swallow Balloons Now about yet another invasive, potentially lethal weight loss device called Obera. As Ragen explains, Obera is a silicon balloon inserted into the stomach and left in place for 6 months and is promoted as non-surgical, non-invasive (though how having to be sedated in order to have the balloon inserted qualifies as non-invasive beats me), non-permanent, and no incisions. The “non-permanent” part is c orrect because as with any such effort the weight loss is not permanent. If you go to their...
Source: Jung At Heart - April 10, 2017 Category: Psychiatry & Psychology Source Type: blogs
Bringing on-demand rideshare to medical transport. Interview with Veyo ’ s CEO
Uber and Lyft have transformed (and largely destroyed) the taxi industry. Now startup companies like Veyo are applying similar approaches to the medical transportation field. I interviewed Veyo’s CEO, Josh Komenda to get his take.
1.How is non-emergency medical transportation (NEMT) defined? What’s included? How big is it?
Non-Emergency Medical Transportation (NEMT) is a transportation benefit for Medicaid or Medicare members who need to get to and from medical services, but have no means of transportation. NEMT provides eligible patients with trips that are non-emergency in nature, meaning there is no i...
Source: Health Business Blog - March 9, 2017 Category: Health Management Authors: dewe67 Tags: Entrepreneurs Patients Podcast Technology medical transportation NEMT rideshare Source Type: blogs
Medtronic ’s Signia Surgical Stapler Measures Tissue Strength to Perfect Staple Lines
Medtronic is releasing a new advanced surgical stapler, the Signia Stapling System, which sports sensors that detect the tissue being worked and adjust its speed to produce optimal staple lines.
The company’s Adaptive Firing technology measures how much force it takes a staple to penetrate through tissue, controlling in real-time the speed of the stapler. The tissue sensing data and status of the stapler, including the battery charge, is displayed on a color screen at the back of the device.
The device is completely powered, including its rotation, articulation, and opening and closing of the jaw.
“In my exper...
Source: Medgadget - February 16, 2017 Category: Medical Equipment Authors: Editors Tags: Ob/Gyn Surgery Thoracic Surgery Urology Vascular Surgery Source Type: blogs
Study: Brain scans mapping language and memory areas can help guide epilepsy-related surgeries
—Language task fMRI and resting-state fMRI data from a presurgical patient with left temporal lobe epilepsy. Copyright Bradley Goodyear, Einat Liebenthal and Victoria Mosher.
Can brain scans help doctors navigate epilepsy surgery? (UPI)
“…When medication doesn’t effectively control epilepsy, surgery may be recommended. Doctors can remove the part of the brain that triggers seizures or use certain procedures to control seizure activity.
Before surgery, however, the brain must be “mapped” to ensure the regions responsible for language and memory aren’t damaged during the procedure, the study authors explained...
Source: SharpBrains - January 13, 2017 Category: Neuroscience Authors: SharpBrains Tags: Cognitive Neuroscience Health & Wellness 2011 SharpBrains Summit bariatric-surgery epilepsy functional MRI presurgical seizures Source Type: blogs
Why doctors are rebelling against saving lives
When I was in medical school, “real” doctors saved lives. Period.
Specialists who focused on a patient’s quality of life, (the plastic surgeons, bariatric surgeons, holistic practitioners, infertility experts, etc.) were considered sellouts. (We won’t even consider the med school status of future psychiatrists.)
We disparaged these doctors because they could be saving lives and chose not to, because they were often paid (God forbid) out-of-pocket by their patients, and because they actively self-promoted themselves to the public (another doctor no-no). These “greedy” docs were scorned as entrepreneurs in a prof...
Source: Kevin, M.D. - Medical Weblog - December 23, 2016 Category: Journals (General) Authors: < a href="http://www.kevinmd.com/blog/post-author/michael-breen" rel="tag" > Michael Breen, MD < /a > Tags: Physician Primary care Source Type: blogs
Coronary artery disease: Primary care and prevention – 5
Previous
Statin for primary prevention
Very high lipid levels of the order of LDL cholesterol above 190 mg/dL calls for usage of statins for primary prevention. High intensity statins can be considered in this scenario as in acute coronary syndrome. When the LDL cholesterol level is between 70-189 mg/dL, primary prevention with moderate intensity statin may be considered if they are diabetic and have significant other risk factors for CAD. It is reasonable to measure SGPT/ALT levels before initiating statins and while on treatment so that values above 3 times the upper limit are not reached. Caution is advised in those abo...
Source: Cardiophile MD - December 21, 2016 Category: Cardiology Authors: Prof. Dr. Johnson Francis, MD, DM, FACC, FRCP Edin, FRCP London Tags: Cardiology Source Type: blogs
