FDA Agency Update December 2015
As 2015 comes to a close for the FDA, it remains an agency in transition. The agency should soon see a new commissioner and may be the subject of legislative overhauls. We have recently reported on the FDA's new patient engagement advisory committee, anticipated biosimilars naming guidance, PDUFA reauthorization, and continued issuance of warning letters.
FDA funding, drug approvals: key concerns
RAPS reported FDA Acting Commissioner Ostroff's recent comments, describing the importance of biomarkers in drug development, inspection policies, and patient-centric approaches. With so much talk of FDA reform, his comments on ...
Source: Policy and Medicine - December 3, 2015 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Antibiotic Scorecard: 1 Easy Way to Change the World for Your Child
Your choice of chain restaurants could help make a profound difference. Thanks to the help of some impressive organizations, we now have an antibiotic Scorecard to help us along the way.
Antibiotic overuse is resulting in a crisis of antibiotic resistance and is changing the microbiome of our children – the vibrant microscopic world that lives on, in, and around their growing bodies.
Antibiotic overuse makes all of us less safe, and children are among the most vulnerable. Already, more than 2 million Americans get an antibiotic-resistant infection each year. Around 23,000 people will die from these infections.
Many peopl...
Source: Conversations with Dr Greene - September 15, 2015 Category: Child Development Authors: Dr. Alan Greene Tags: Dr. Greene's Blog Uncategorized Eating & Nutrition Source Type: blogs
Antibiotic Scorecard: 1 Easy Way to Change the World for Your Child
Your choice of chain restaurants could help make a profound difference. Thanks to the help of some impressive organizations, we now have an antibiotic Scorecard to help us along the way.
Antibiotic overuse is resulting in a crisis of antibiotic resistance and is changing the microbiome of our children – the vibrant microscopic world that lives on, in, and around their growing bodies.
Antibiotic overuse makes all of us less safe, and children are among the most vulnerable. Already, more than 2 million Americans get an antibiotic-resistant infection each year. Around 23,000 people will die from these infections.
Many peopl...
Source: Conversations with Dr Greene - September 15, 2015 Category: Child Development Authors: Alan Greene MD Tags: Dr. Greene's Blog Uncategorized Eating & Nutrition Source Type: blogs
Research and Reviews in the Fastlane 099
This study took a sample from healthy pregnant patients (n=760) at different stages of gestation. They found, unsurprisingly, that d-dimer increases with gestational age, congruent with limited prior literature. They propose a continuous increasing d-dimer in pregnancy. With PE experts such as Dr. Kline proposing gestation adjusted d-dimer, this is a research space to watch.
Recommended by: Lauren Westafer
Systems and administration
Del Portal DA, et al. Impact of an Opioid Prescribing Guideline in the Acute Care Setting. J Emerg Med 2015. PMID: 26281819
As many EDs implement voluntary opioid prescribing guidelines, this...
Source: Life in the Fast Lane - September 9, 2015 Category: Emergency Medicine Authors: Nudrat Rashid Tags: Anaesthetics Cardiology Education Emergency Medicine Haematology Intensive Care critical care literature R&R in the FASTLANE recommendations research and reviews Source Type: blogs
How coordinated care can reduce hospital-acquired infections
It was a week into my elderly patient’s hospital admission when he began to have fever and profuse diarrhea, some 10 to 12 bowel movement a day. The diagnosis was not hard to make: a stool test showed he had C. difficile.
Another patient, a thin women in her late 40s who had become paraplegic after a gunshot wound decades ago, came in from a nursing home when her urinary catheter became clogged. She had high fevers and an infection caused by antibiotic-resistant bacteria called CRE (carbapenem-resistant Enterobacteriaceae).
The irony of modern health care is this: Hospitals and nursing homes, the pillars of our healt...
Source: Kevin, M.D. - Medical Weblog - September 6, 2015 Category: Journals (General) Authors: Manoj Jain, MD, MPH Tags: Conditions Hospital Infectious disease Source Type: blogs
Moving From Spaced Repitition to Spaced Learning
This article proposed a strategy that revolves around the cognitive technique known as spaced repetition. Spaced repetition takes advantage of time and reinforces one’s knowledge the moment before one forgets it. This technique involves reviewing material according to a schedule determined by a temporal relationship known as the “spacing effect”.
Although beneficial, spaced repetition requires time and as a result, is not without its own limitations. Spaced repetition can help students remember what they learn, but it will not help students deepen their understanding or teach them things they don’t already kno...
Source: The Health Care Blog - August 17, 2015 Category: Consumer Health News Authors: John Irvine Tags: Uncategorized Learning Medical Education Osmosis Picmonic Spaced Repitition Source Type: blogs
Moving From Spaced Repetition to Spaced Learning
This article proposed a strategy that revolves around the cognitive technique known as spaced repetition. Spaced repetition takes advantage of time and reinforces one’s knowledge the moment before one forgets it. This technique involves reviewing material according to a schedule determined by a temporal relationship known as the “spacing effect”.
Although beneficial, spaced repetition requires time and as a result, is not without its own limitations. Spaced repetition can help students remember what they learn, but it will not help students deepen their understanding or teach them things they don’t already kno...
Source: The Health Care Blog - August 17, 2015 Category: Consumer Health News Authors: John Irvine Tags: Uncategorized Learning Medical Education Osmosis Picmonic Spaced Repitition Source Type: blogs
Protecting Americans from Preventable Infections: Working Together Will Save Lives
By TOM FRIEDEN, MD
“Alone we can do so little; together we can do so much.” Those words spoken by Helen Keller nearly a century ago remain powerful and relevant today.
A new report from the Centers for Disease Control and Prevention (CDC) projects that thousands of lives could be saved every year if health care facilities and public health departments work together to track and stop antibiotic resistance – and if they communicate with each other about these infections to prevent spread from one facility to another.
Even if one health care facility follows all recommended infection control practices, antibiotic-resist...
Source: The Health Care Blog - August 17, 2015 Category: Consumer Health News Authors: John Irvine Tags: THCB CDC CRE Infection Prevention Source Type: blogs
Post #42 A book review - Being Mortal: Medicine and What Matters in the End by Atul Gawande
In his breathtaking book, Being Mortal: Medicine and What Matters in the End, Atul Gawande (one of my favorite authors) elegantly describes three different modalities of patient counseling that doctors employ. The first is the oldest and most traditional approach, a paternalistic relationship. The doctor not only has the knowledge to guide the patient, but also possesses the experience and wisdom to make decisions on their behalf. The second type of relationship is termed "informative." Here the doctor informs you about the facts and figures related to your medical problem, along the lines of a talk...
Source: A Pediatrician's Blog - August 10, 2015 Category: Pediatrics Source Type: blogs
The Cost of Resistance and the Attack of the Microbes
The rise of drug-resistant 'superbugs' could devastate the world economy and pose a deadly threat to all of mankind. (Source: The RAND Blog)
Source: The RAND Blog - August 7, 2015 Category: Health Management Authors: RAND Corporation Source Type: blogs
Regulation, Competition, and “Antibiotic-free” Chicken
In an effort to distinguish itself from competitors, poultry producer Purdue recently ran advertisements touting its “no antibiotics ever” line of chicken products. This is not just another corporate ad campaign; the story goes deeper than that, as the New York Times recently reported. At issue is the definition of what makes poultry “antibiotic free.”
Poultry companies like Purdue and its main competitors, Tyson and Foster Farms, have long used antibiotics important to humans in the raising of chickens. Many scientists have advocated a ban on routine (non-disease) use of antibiotics in the raising of food animals ...
Source: Cato-at-liberty - August 4, 2015 Category: American Health Authors: Peter Van Doren Source Type: blogs
Profit over Safety – Centers for Disease Control Names 271 New Vaccinations
Conclusion
How many vaccinations will be considered to be a sensible number? If all of the vaccinations currently under development are deemed a success, how many of them will be added to the schedule? As there is little research to determine which ingredients are in the vaccinations listed as “under development” by the CDC, many parents are concerned about their toxicity and how best to protect their children.
I will leave you with the wise words of Robert F, Kennedy Jr: “Vaccine industry money has neutralized virtually all of the checks and balances that once stood between a rapacious pharmaceutical industry and ou...
Source: vactruth.com - August 3, 2015 Category: Allergy & Immunology Authors: Christina England Tags: Christina England Logical Top Stories Centers for Disease Control (CDC) PhRMA Robert F. Kennedy Jr. World Health Organization (WHO) Source Type: blogs
Antibiotic misuse and superbugs create the perfect killer
Imagine the United States of America when a simple skin infection from a scrape causes a 10 percent chance of dying. Out of every 1,000 women who give birth, nine will die, and out of the 1,000 infants born, up to 30 percent will die. It is difficult to imagine, but these are the alarming statistics prior to antibiotics in the early 1900’s.
Vast improvements have been made since then in life expectancy and public health. Yet, these advancements are now being set back. Microbes are evolutionary clever, responding to their environment to evade death. In the past, resistance was not as rapid as the pharmaceut...
Source: Kevin, M.D. - Medical Weblog - July 9, 2015 Category: Journals (General) Authors: Jesse O’Shea Tags: Conditions Infectious disease Source Type: blogs
