Does the FDA Understand Diabetes?
The FDA would like to gain a better understanding of specific diseases.
Over the next five years they plan to conduct at least twenty patient meetings on a wide variety of diseases such as sickle cell, Parkinson’s, fibromyalgia, chronic fatigue syndrome, narcolepsy, and a handful more. But diabetes isn’t on the list… yet.
I don’t get it… Do they feel they understand diabetes well enough already?
DiaTribe, one of my absolute favorite organizations ever, has started an online petition to make the FDA aware of our desire for diabetes to be on the list (arguably, it should already be on the list)....
Source: Scott's Diabetes Blog - September 4, 2013 Category: Diabetes Authors: Scott K. Johnson Tags: Blog Posts Source Type: blogs
Nuvigil: Not Better Than Placebo for Depression Symptoms in Bipolar
Millions of people around the world rely on antidepressants in the treatment of clinical depression and, to a lesser extent, bipolar disorder. Over a dozen such medications exist, and many are also available in generic form.
But for reasons that scientists can’t yet adequately explain, some people don’t respond to many antidepressant drugs. And the drugs they do respond to may carry unwanted side effects that make taking the drug for any length of time downright challenging.
So drug companies are constantly looking for new drugs, new uses for old drugs, and new formulations of old drugs to help improve their b...
Source: World of Psychology - August 31, 2013 Category: Psychiatrists and Psychologists Authors: John M. Grohol, Psy.D. Tags: Antidepressant Bipolar Depression Disorders General Medications Research Sleep Stimulants Antidepressant Drugs armodafinil Batting Average Clinical Depression Depression Symptoms Depressive Symptoms Endpoints Excessive Slee Source Type: blogs
5 Steps to Improve Sleep & Emotional Vulnerability
Most of us don’t need science to tell us that sleep and emotion are closely linked. Spend a couple nights with interrupted sleep or talk to any parent of a newborn and the connection is quite clear.
The connection appears not just in everyday life. In certain physical and mental disorders sleep disturbance and emotion dysregulation are hallmark symptoms. Symptoms of one rare disorder, cataplexy, which often co-occurs with the sleep disorder, narcolepsy for example, include sudden muscle weakness when a person experiences strong emotion, such as anger or fear, or exhilaration.
Lack of adequate sleep also is commonly l...
Source: World of Psychology - July 18, 2013 Category: Psychiatrists and Psychologists Authors: Christy Matta, MA Tags: Anger Anxiety and Panic Bipolar Brain and Behavior Depression Disorders General Habits Happiness Health-related Mental Health and Wellness PTSD Self-Help Sleep Stress Adequate Sleep Cataplexy Circadian Rhythm Dysregulat Source Type: blogs
How to Fall Asleep in Less Than 30 Seconds
Does it take you a while to fall asleep at night? Do you find your mind dwelling on various thoughts before you’re able to finally drift off and relax into sleep? Do you find that you just aren’t sleepy enough when it’s time for bed?
Realize that if it takes you 15 minutes on average to fall asleep each night, that’s more than 91 hours per year that you’re wasting. This is the equivalent of spending more than two 40-hour workweeks just lying in bed waiting to fall asleep.
And if you have insomniac tendencies and take more than an hour to fall asleep each night, you’re spending more than ...
Source: Steve Pavlina's Personal Development Blog - July 10, 2013 Category: Life Coaches Authors: Steve Pavlina Tags: Productivity Sleep Time Management Source Type: blogs
Another New EH Blogger: Sleeping With MS
Last week I wrote about a new MS blogger joining our Everyday Health community. In that post about David Lyon’s new blog, MS Fitness Challenge, I mentioned that there would be more to come… Well today we announce another new MS blog on the site.
Husband and wife team, Brad Mann & Robynn Mann have posted their first blog called Sleeping With MS. Catchy title, you say… and then you read that Brad not only has multiple sclerosis, but also narcolepsy and other sleep disorders.
Brad and Robynn will be tag-teaming the writing so we’ll get both sides of the story from this couple raising two daughters and two so...
Source: Life with MS - July 3, 2013 Category: Other Conditions Authors: Trevis Gleason Tags: MS multiple sclerosis Everyday Health Living with MS MS Blog HIstory ms community Newly diagnosed Source Type: blogs
Pharmalot... Pharmalittle... Good Morning
Good morning, everyone, and welcome to another busy day. As usual, we are scrambling about on the Pharmalot corporate campus in order to deposit the short people at their schoolhouses and sorting out plans for the long weekend coming up. Meanwhile, though, there is much to do. The world has not stopped spinning, of course. So here are some tidbits. Hope your day is a success and do stay in touch...
Wockhardt Says FDA Import Alert Could Hurt $100M In Sales (Business Standard)
J&J To Submit 17 New Drug Applications By 2017 (Dow Jones)
FDA Panel Says Merck Sleeping Pill Is Safe At Low Doses (Bloomberg News)
Glaxo Flu Sh...
Source: Pharmalot - May 23, 2013 Category: Pharma Commentators Authors: esilverman Source Type: blogs
Orexin and Insomnia
If Valium makes you groggy, and Ambien makes you sleepwalk…
A compound that blocks a brain receptor you probably have never heard of may hold the key to the next generation of sleeping pills—and there is always a next generation of sleeping pills.
A new class of hypnotic compounds that serve as antagonists for the neurotransmitter orexin may combat insomnia without the “confusional arousals” that have come to plague some users of zolpidem, otherwise known as Ambien. Sleepwalking, sleep driving, and sleep sex are common among the reports. Orexin is involved in central nervous system arousal. So-called DORAs, or...
Source: Addiction Inbox - May 7, 2013 Category: Addiction Authors: Dirk Hanson Source Type: blogs
FDA: Enhancing Benefit-Risk Assessment in Regulatory Decision Making
Last summer, Congress enacted the Food and Drug Administration Safety and Innovation Act (FDASIA), which included the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). Title I of FDASIA reauthorizes the Prescription Drug User Fee Act (PDUFA), which provides FDA with the necessary user fee resources to maintain an efficient review process for human drug and biologic products. The reauthorization of PDUFA includes performance goals and procedures that represent FDA’s commitments during FY 2013-2017. These commitments are referred to in section 101 of FDASIA.
Section X of these commitments relates ...
Source: Policy and Medicine - April 25, 2013 Category: Health Medicine and Bioethics Commentators Authors: Thomas Sullivan Source Type: blogs
Elizabeth Kolbert: The Science of Sleeplessness : The New Yorker
Nathaniel Kleitman, known as the "father of modern sleep research," was born in 1895 in Bessarabia—now Moldova—and spent much of his youth on the run. First, pogroms drove him to Palestine; then the First World War chased him to the United States. At the age of twenty, he landed in New York penniless; by twenty-eight, he'd worked his way through City College and earned a Ph.D. from the University of Chicago. Soon after, he joined the faculty there. An early sponsor of Kleitman's sleep research was the Wander Company, which manufactured Ovaltine and hoped to promote it as a remedy for insomnia.
Until ...
Source: Psychology of Pain - March 8, 2013 Category: Psychiatrists and Psychologists Source Type: blogs
Pharmalot… Pharmalittle… Good Morning
Good morning, folks, and how are you today? A spot of rain is falling on the Pharmalot corporate campus, where we are doing our best to energize the short people and tend to the usual early-in-the-day to-do list. Of course, the middle of the week only intensifies the need to move quickly. We trust you relate. So join us as we grab another cup of stimulation and dig in for another busy day. As always, here are some items of interest to help you along. Hope your day is smashing and do stay in touch…
FDA OKs Pill For Post-Menopausal Sex Problems (Los Angeles Times)
Allergan Settles Oklahoma Botox Case During Trial (Bloo...
Source: Pharmalot - February 27, 2013 Category: Pharma Commentators Authors: Ed Silverman Tags: Uncategorized Allergan AstraZeneca Biosimilars Botox Cystic Fibrosis Elan FDA Flu GlaxoSmithKline Hospira Influenza Menopause Merck Narcolepsy Osphena Pandemrix Royalty Pharma SFDA Shionogi Tredaptive Vertex Pharm Source Type: blogs
UK study confirms GSK flu shot link to rare sleep disorder
Tue Feb 26, 2013 6:30pm EST
* At least 14-fold increased narcolepsy risk after Pandemrix
* Boosted vaccine may have triggered adverse immune response
* GlaxoSmithKline says determined to understand more
* Drugmaker has reports of almost 800 cases across Europe
By Kate Kelland
LONDON, Feb 27 (Reuters) - GlaxoSmithKline's Pandemrix swine flu vaccine has been linked to cases of the rare sleep disorder narcolepsy in children in a scientific study in England that confirms similar findings elsewhere in Europe.
The vaccine, more than 30 million doses of which were given during the H1N1 flu pandemic in 2009-2010, contains a...
Source: PharmaGossip - February 27, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
Diagnosed with narcolepsy
by DOdoc (Posted Sun Feb 24, 2013 10:41 pm)Changing your lifestyle is only one component of treatment. It's FAR from that "simple".The first thing you need to do is STOP trying to manage this on your own or taking advice from people in your life writing papers about it or clicking on links.You NEED to be under the care of an appropriate provider to properly diagnose and then properly treat the condition specific to the individual. There are many, MANY factors that go into proper care and treatment and the most responsible thing to do is find a physician who has experience treating this complicated disorder.Dr. F. (Source: Med Student Guide)
Source: Med Student Guide - February 25, 2013 Category: Medical Students Source Type: forums
8 Damn Good Reasons Not to Get the Flu Shot
Are you thinking about getting the flu vaccine?
Every year the mainstream media war drum beats for you to get vaccinated against the flu. They rarely discuss anything but the benefits of the vaccine.
Why?
Maybe it is because many people are already skeptical about the flu vaccine.
I’m going to be very up front with you here. You rarely hear about the adverse reactions or about the toxic chemicals being injected into you. My goal is to get you to investigate vaccines more closely. Here are eight reasons to question the flu shot.
Let’s begin…
REASON #1: NEUROTOXIC INGREDIENTS
A common urban myth is that the mercury ha...
Source: vactruth.com - February 1, 2013 Category: Health Medicine and Bioethics Commentators Authors: Jeffry John Aufderheide Tags: Jeffry John Aufderheide Top Stories American Academy of Pediatrics (AAP) Centers for Disease Control (CDC) Dr. Gary Goldman Food and Drug Administration (FDA) Thimerosal vaccine ingredients Vaccine Safety Viral Shedding Source Type: blogs
TWiV 217: I just flu in and my arms are shot
On episode #217 of the science show This Week in Virology, Vincent, Alan, Rich, and Dickson review influenza vaccines.
You can find TWiV #217 at www.twiv.tv. (Source: virology blog)
Source: virology blog - January 27, 2013 Category: Virology Authors: Vincent Racaniello Tags: This Week in Virology adjuvant afluria cell culture efficacy egg fluarix flulaval flumist fluvirin H5N1 influenza LAIV narcolepsy pandemic pandemrix TIV vaccine viral virus Source Type: blogs
Off label free speech contd.
U.S. won't pursue case of drug representative and 'off-label' promotion
David Sell, Inquirer Staff Writer
Posted: Friday, January 25, 2013, 3:01 AM
The federal government has decided not to ask the U.S. Supreme Court to overrule a recent appeals court decision that overturned the conviction of a pharmaceutical sales representative who claimed his First Amendment rights were infringed by prosecutors seeking to enforce Food and Drug Administration limits on drug promotion.
Working a territory on Long Island, Alfred Caronia sold Xyrem, a drug approved for narcolepsy, for Orphan Medical Inc., now known as Jazz Pharmaceutical...
Source: PharmaGossip - January 25, 2013 Category: Pharma Commentators Authors: insider Source Type: blogs
