FDA Social Media Rules Impractical, say Pharma Groups


Should pharma companies be held legally responsible for social media content on their products posted by third parties or on third-party websites? To what extent would it discourage them from interacting with consumers via social media? Would this then deny consumers correct information about their products?


Pharmaceutical groups have raised unanimous concerns on FDA’s draft social media guidance released in June 2014. (see http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM401087.pdf ). They fear it holds them accountable for misinformation about their products posted online by third parties over whom they have little or no control.


The Pharmaceutical Research and Manufacturers of America urged the FDA to limit the manufacturers’ accountability for online content to the extent it was developed or posted by or on behalf of the manufacturer. The also called for clear guidelines to correct misleading third-party information regarding their products’ off-label uses (including permission to link to any FDA-compliant site while doing so).


The Biotechnology Industry Organization pointed out the lack of clarity in FDA’s interpretation of the influence or control pharma companies were expected to have. It called for FDA to provide greater flexibility to manufacturers to correct misinformation on social media, including “broad protection under the First Amendment”.


The Medical Information Working Group asserted that pinning such responsibility on manufacturers would be “impermissibly broad” and beyond FDA’s statutory authority. They termed this impracticable in today’s social media context, where interactive communication and user-generated content are unpredictable.


Source: The Hill

The post FDA Social Media Rules Impractical, say Pharma Groups appeared first on Sleep Diagnosis and Therapy.

Sleep Apps in the Spotlight


Another sign that sleep health is going more mainstream every day is the proliferation of smart phone applications (apps) being designed for the consumer market. Hayley Tsukayama, consumer technology beat reporter for The Washington Post, writes that there are “dozens” of sleep apps in Apple and Google’s app stores.


Some offer meditation tips or even play soothing white noise. “Perhaps most intriguing of all, there’s also a whole class of apps devoted to sleep analysis,” she writes, “and apps that you leave up on your phone’s screen while you snooze that monitor your sleep based on your movements and the sounds from the room.”


Tsukayama tried four of these apps over a period of a few weeks: Sleep Cycle, SleepBot, Pillow and Sleep Time. All are sleep-tracker and alarm apps, which are designed to help track sleep, as well as read sleep patterns, to wake up at the best possible time. To use them, “just call them up on your phone, keep the phone on and plugged in so the app can register your movement, and make your way to dreamland.”


Tsukayama concludes that “I did learn some things about my sleep patterns that were useful. For one, no matter how early I try to go to bed, I found it’s rare that I actually fall asleep before midnight…I found out that I tend to wake up every hour or so unless I’ve had a good workout that day, in which case I sleep a lot better.”


Source: Washington Post

The post Sleep Apps in the Spotlight appeared first on Sleep Diagnosis and Therapy.

No Sedative Needed: Researchers Discover “Sleep Promoting Circuit” in the Brain


Researchers at the University of Buffalo and Harvard have located what they call a “sleep-promoting circuit located deep in the primitive brainstem” that regulates deep sleep. According to the article titled “The GABAergic parafacial zone is a medullary slow wave sleep–promoting center”, this is only the second “sleep node” identified in the mammalian brain.


Published online in Nature Neuroscience, the study demonstrates that fully half of all of the brain’s sleep-promoting activity originates from the parafacial zone (PZ) in the brainstem. The brainstem is a primordial part of the brain that regulates basic functions necessary for survival, such as breathing, blood pressure, heart rate and body temperature. Click Here for Article Preview


“The close association of a sleep center with other regions that are critical for life highlights the evolutionary importance of sleep in the brain,” says Caroline E. Bass, assistant professor of Pharmacology and Toxicology in the UB School of Medicine and Biomedical Sciences and a co-author on the paper.


The researchers reportedly found that a specific type of neuron in the PZ that makes the neurotransmitter gamma-aminobutyric acid (GABA) is responsible for deep sleep. They used a set of innovative tools to precisely control these neurons remotely, in essence giving them the ability to turn the neurons on and off at will.


“These new molecular approaches allow unprecedented control over brain function at the cellular level,” says Christelle Ancelet (in Science Daily), postdoctoral fellow at Harvard School of Medicine. “Before these tools were developed, we often used ‘electrical stimulation’ to activate a region, but the problem is that doing so stimulates everything the electrode touches and even surrounding areas it didn’t. It was a sledgehammer approach, when what we needed was a scalpel.”


“To get the precision required for these experiments, we introduced a virus into the PZ that expressed a ‘designer’ receptor on GABA neurons only but didn’t otherwise alter brain function,” explains Patrick Fuller, assistant professor at Harvard and senior author on the paper. “When we turned on the GABA neurons in the PZ, the animals quickly fell into a deep sleep without the use of sedatives or sleep aids.”


Source: Nature.com

The post No Sedative Needed: Researchers Discover “Sleep Promoting Circuit” in the Brain appeared first on Sleep Diagnosis and Therapy.

Could Sleep Apnea Screening before Surgery Prevent Complications?


Canadian researchers have found that treating sleep apnea before surgery reduces the chance of developing serious cardiovascular complications such as cardiac arrest or shock.


According to the study “A Matched Cohort Study of Postoperative Outcomes in Obstructive Sleep Apnea: Could Preoperative Diagnosis and Treatment Prevent Complications?” published in Anesthesiology, the study compared postoperative outcomes in 4,211 patients with OSA, who were diagnosed by sleep study either before or after surgery, with a matched control group of patients who did not have the condition. Those who were diagnosed with OSA prior to surgery were prescribed treatment with CPAP therapy.


“OSA is a common disorder that affects millions and is associated with an increased risk of surgical complications, but the condition often goes unrecognized,” said Thomas Mutter, MD, lead author, department of anesthesia and perioperative medicine, University of Manitoba, Winnipeg, Canada. “As many as 25 percent of surgical patients may have OSA, but the vast majority of these patients aren’t treated or don’t know they have the disorder.”


Medical Press reports that although patients with untreated OSA were at an increased risk of developing cardiovascular complications, patients who were diagnosed and treated with CPAP therapy before surgery were less than half as likely to experience cardiovascular complications such as cardiac arrest or shock.


Additionally, researchers found that respiratory complications were twice as likely to occur in patients with OSA, compared to patients without the condition, regardless of when patients were diagnosed or if CPAP therapy was prescribed.


Click Here to Read Article

The post Could Sleep Apnea Screening before Surgery Prevent Complications? appeared first on Sleep Diagnosis and Therapy.

Sexomnia Defense Earns Acquittal in Rape Case


ABC News is reporting that a Swedish man who was convicted of rape had his charges overturned after an appeals court found the man could have been asleep during the attack. The court cited “sexomnia” as a reason he should be released.


“Mikael Halvarsson was acquitted of rape this month after experts said he was asleep during the attack and had no memory of the incident, according to a translated court ruling from the Sundsvall appeals court in Sweden,” writes Gillian Mohney of ABC News. “Halvarsson was accused after the victim woke up as Halvarsson allegedly assaulted her on April 2, 2014. They had been sleeping in the same bed, but they each had their own blanket, according to the translated court documents, which also noted that she called the police the next morning, and they found Halvarsson still asleep in her bed when they arrived.”


Halvarsson’s previous girlfriend reportedly testified that he had previously tried once to have sex with her when she was sleeping. His mother also confirmed that he had disturbed sleeping patterns before.


Dr. Kingman Strohl, a professor of medicine and director of research at the Sleep Center at Case Medical Center in Cleveland, told ABC that “sexomnia” was an actual medical diagnosis that includes unintentional sexual behaviors during sleep. “Usually people are very scared and also quite confused as to what’s going on,” Strohl said of patients who report sexomnia. “We look for signs” of the behavior in the patient’s past, he said. That it has “gone on before and occurs in context of sleep walking and sleep talking.”


Source: ABC news

The post Sexomnia Defense Earns Acquittal in Rape Case appeared first on Sleep Diagnosis and Therapy.

SomnoMed Granted U.S. Medicare Approval for Sleep Device


SomnoMed’s new SomnoDent® Herbst Advance Classic and Flex oral appliances received CMS approval this week and were allocated the HCPCS Code of E 0486 for DME billing, allowing for a U.S. Medicare reimbursement.

SomnoMed’s shares are expected to trade higher on the news.


Medicare patients can now apply for specified reimbursement for the device and their treatment from now on. The SomnoDent Herbst Advance devices were officially launched in the U.S. this month through SomnoMed’s network of sleep dentists.


Devices will also be available to the market through SomnoMed’s U.S. and Canadian licensees. Patents were lodged for the SomnoDent Herbst Advance earlier this year in core markets. The products feature new components, which are designed to make fitting and titration of the device easier and more precise for dentists and patients.


A press release issued by SomnoMed predicts that Medicare approval for the device will drive further sales as the cost to the end consumer is significantly reduced or eliminated.


Source: Proactive Investors

The post SomnoMed Granted U.S. Medicare Approval for Sleep Device appeared first on Sleep Diagnosis and Therapy.

Sleeping Habits of Geniuses


Out of 26 historical geniuses, a whopping 22 got seven or more overnight hours of slumber. Perhaps toiling over “too many notes,” the genius with the fewest hours (5) was Mozart. Meanwhile, Sigmund Freud (cocaine!) racked up just 6 hours of sleep on average.


At the top of the scale, clocking in at a healthy 9 hours, were B.F. Skinner, Flannery O’Connor, and William Styron. American icon Benjamin Franklin, renowned for such “health” habits as naked air baths, clocked in at a respectable seven hours.

Timeline Sleeping Habits of Geniuses










Source: NY Magazine














The post Sleeping Habits of Geniuses appeared first on Sleep Diagnosis and Therapy.

ResMed announces its AirView compliance management platform (previously EasyCare Online) is now securely connected to Fairview Health Services Epic EHR system, enabling up to date delivery of sleep apnea patient data for use by Fairview’s medical staff


Launched in June 2014, the integration of this data supports streamlined workflow, reduced cost, improved quality and responsiveness of therapy, and automated access to data for analytical and clinical outcome decision support.


Data generated by PAP devices, such as the ResMed S9 series and AirSense™ 10 series, enables medical professionals to remotely monitor patient therapy compliance to take appropriate action based on specific outcomes. With ResMed’s AirView connection to Fairview’s Epic EHR, clinicians now have access to patient PAP therapy data within their EHR system, eliminating the need to log in to multiple patient management systems to view patient outcomes.


Key features enabled with this solution include:

• boarding of sleep therapy patients from the EHR into the ResMed AirView patient management system;

• daily updating of PAP therapy effectiveness data from the patient’s home directly into the EHR via AirView;

• sleep health therapy management workflow and tracking tools embedded in the EHR, displaying key patient PAP metrics for various time intervals, customized to meet the needs of Fairview clinicians; and

• creation of a secure patient data warehouse to support advanced analytics such as the impact of sleep apnea on comorbid conditions.


“The healthcare system is under significant pressure to drive down the cost of care while still delivering exceptional patient outcomes,” said Raj Sodhi, Vice President, Healthcare Informatics at ResMed. “Sleep apnea represents one area where technology integration can play a key role in making that happen.”


Source: ResMed News

The post ResMed announces its AirView compliance management platform (previously EasyCare Online) is now securely connected to Fairview Health Services Epic EHR system, enabling up to date delivery of sleep apnea patient data for use by Fairview’s medical staff appeared first on Sleep Diagnosis and Therapy.

Second US Hospital Offers Neurostim Device to Treat OSA


WellStar Paulding Hospital is the first hospital in Georgia, and became the second in the U.S. to offer a new procedure to address sleep apnea. As part of WellStar Health System, Paulding Hospital will offer “Inspire Therapy” for moderate to severe obstructive sleep apnea in patients who are unable to use traditional treatments such as CPAP.


Inspire Therapy is a fully implanted neurostimulation device, much like a cardiac pacemaker. When activated, Inspire Therapy senses breathing patterns and delivers mild stimulation to key airway muscles, which keeps the airway open during sleep.


“WellStar is breaking new ground with innovative treatments for sleep apnea,” said Patrick Melder, MD, co-medical director, WellStar Sleep Program. ”This new treatment provides more options for patients who struggle with traditional treatments.  In contrast to other surgical options to treat sleep apnea, Inspire Therapy does not require removal or permanent alteration of facial or airway anatomy. As such, the procedure is less invasive, less painful and results in a quicker recovery.”


WellStar Health System is the largest not-for-profit health system in Georgia and serves a population of more than 1.4 million residents in five counties.


Source: Wellstar Health

The post Second US Hospital Offers Neurostim Device to Treat OSA appeared first on Sleep Diagnosis and Therapy.

Excessive Sleepiness More Prevalent in Shift Workers


A recent study of workers demonstrated that the prevalence of excessive daytime sleepiness (EDS) was higher in shift workers than in non-shift workers. As for obstructive sleep apnea, there was no difference in prevalence between shift and non-shift.


As published in Sleep Disorders and summarized by the National Institutes of Health, the study calls sleep deprivation and sleepiness “the most important health problem in our modern society among shift workers.”


The objective of the study was to investigate the prevalence of sleep disorders and their possible effects on work performance in two groups of shift workers and nonshift workers. Data were collected by PSQI, Berlin questionnaire, Epworth Sleepiness Scale, Insomnia Severity Index, and RLS Questionnaire.


A self-administered questionnaire was submitted to all workers employed in a textile factory. A total of 225 shift workers and 245 non-shift workers participated in this study. All the participants were informed about the objectives of the study and the methods used during the survey. Each participant received the questionnaire and completed it during the work hours.


“It is necessary to say that the relation between the quality of sleep and occupational performance is two-sided,” write researchers. “On one hand, low quality of sleep can result in poor work performance and work accidents. On the other hand, problems occurring while working can culminate in sleep disorders. Knudsen et al. in their study showed that the workers who had work accidents resulting in work absence in the recent past year were more prone to insomnia disorder and poor sleep quality.”


Click Here for Pubmed Abstract 

The post Excessive Sleepiness More Prevalent in Shift Workers appeared first on Sleep Diagnosis and Therapy.