ITC Says Yes to ResMed’s Request to Investigate Manufacturer

In response to a legal action initiated by ResMed, the International Trade Commission (ITC) agreed to investigate Chinese medical device manufacturer BMC Medical Co Ltd, and its distributors, Florida-based 3B Medical Inc and 3B Products LLC. ResMed also filed suit in federal court against BMC in May, asserting patent infringement by:

  • The RESmart CPAP and RESmart Auto CPAP devices, and
  • The Willow nasal pillows patient interface and the iVolve nasal mask.

The ITC’s decision stems from an early August amended complaint in U.S. federal court aimed to stop infringement of ResMed patents. ResMed specifically asked the ITC to stop the importation and sales of these products in the United States. ResMed wants the court to halt the infringement and award damages against BMC and 3B.

“We’re encouraged by the ITC’s action to investigate this case against BMC,” said ResMed Global General Counsel and Chief Administrative Officer David Pendarvis. “For more than two decades, ResMed has generated significant advances in innovative products for sleep-disordered breathing therapy We invest over $100 million in research and development each year to fuel these advances and other companies should not be allowed to infringe ResMed’s intellectual property by using our technology.”

Source: ResMed




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CDC Sheds Light on Prescription Drug Use

Newly released data from the Centers for Disease Control (CDC) reports that about 4% of U.S. adults (20 and over) used prescription sleep aids in the past month. The first-person data, collected over a 5-year period from 2005 to 2010, covers prescription sleep aid use among the non-institutionalized U.S. adult population.

Additional findings from the CDC:
• The percentage of adults using a prescription sleep aid increased with age and education. More adult women (5.0%) used prescription sleep aids than adult men (3.1%).
• Non-Hispanic white adults were more likely to use sleep aids (4.7%) than non-Hispanic black (2.5%) and Mexican-American (2.0%) adults.
• Prescription sleep aid use varied by sleep duration and was highest among adults who sleep less than 5 hours (6.0%) or sleep 9 or more hours (5.3%).
• One in six adults with a diagnosed sleep disorder and one in eight adults with trouble sleeping reported using sleep aids.

The CDC points out that no less than a tripling in sleep aid prescriptions from 1998 to 2006 occurred for young adults aged 18–24 (3). Prevalence of use from 2005-2010 was lowest among the youngest age group (aged 20–39) at about 2%, increasing to 6% among those aged 50–59, and 7% among those aged 80 and over.

Broken down by ethnicity and gender, researchers found that prescription sleep aid use in the past 30 days was higher among women (5.0%) than men (3.1%). Non-Hispanic white adults reported higher use of sleep aids (4.7%) than non-Hispanic black (2.5%) and Mexican-American (2.0%) adults. No difference was shown between non-Hispanic black adults and Mexican-American adults in use of prescription sleep aids.

Click here to see key findings additional information from the CDC webiste

Click Here for PDF report

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Narcolepsy: Forgotten No More?


The old diagnostic cliché about “listening for zebras” is well suited to the realm of narcolepsy. Primary care physicians (PCPs) hear the figurative hoof beats of “sleepiness” and naturally gravitate to a host of possible causes before considering narcolepsy.

“PCP docs are thinking chronic fatigue syndrome, auto-immune disorders, sleep apnea, and more,” says Jed Black, MD, a consulting associate professor at Stanford University Medical Center, Stanford Center for Sleep Sciences and Medicine, Palo Alto, Calif. “The list of things that cause fatigue and sleepiness is long, and that is what makes diagnosis difficult.”Factor in the sheer number of patients who complain of sleepiness and it’s no wonder that the far less common ailment of narcolepsy is rarely diagnosed. “If someone has two conditions simultaneously, such as sleep apnea and narcolepsy, then it is really easy to just pick up on the sleep apnea and miss the narcolepsy altogether,” explains Black. “That even happens at highly sophisticated narcolepsy centers such as what we have at Stanford.”

A poster presentation at SLEEP 2013, the annual meeting of the Associated Professional Sleep Societies LLC in Baltimore, entitled High Rates of Medical Comorbidity in Narcolepsy: Findings from the Burden of Narcolepsy Disease (BOND) Study of 9,312 Patients in the United States”, showed that the consequences of missed diagnoses can be high. Black and six co-authors determined that narcolepsy patients had significantly higher frequencies of respiratory, musculoskeletal, endocrine, and circulatory conditions across a 5-year period when compared with control subjects.

As part of the Burden of Narcolepsy Disease (BOND) study, the poster helped to demonstrate that people with narcolepsy face significant health and economic burdens. In addition to the comorbidities, sufferers generated more than twice the mean annual medical costs compared with the general population.

No Small Task
Far beyond the simple data collected at clinics, Black and his colleagues gained access to a huge database that admittedly took a long time to sift. For Black, who also serves as vice president of Sleep Medicine at Jazz Pharmaceuticals, the task involved multiple validations of the data. Ultimately, he believes the conclusions were “relatively representative of the insured population.”

Black reports a “lot of interest” thus far in the research, a reaction that amounts to pent up demand for a frequently misunderstood condition. With additional hard numbers to back up the serious effects of narcolepsy, Black expects the poster to spark follow-up research by academics and commercial interests.

Many who observed the poster’s conclusions did not expect the economic consequences, and Black puts himself in this group. “I was incredibly surprised,” says Black. “We know that there is an increased risk for certain comorbid conditions. We know they have to be getting medication and seeing their docs occasionally, but what really surprised me were the inpatient hospital costs and the ER department costs. Every aspect of health care utilization increased.”

The sheer breadth of comorbidities also took researchers by surprise, with Black reporting that he and his colleagues expected to see things such as sleep apnea and depression—even anxiety disorders—but narcolepsy touched even more than that. “Across almost all of the major diagnostic categories there are significant increases in comorbidity, and that I did not expect,” he says. “That lead me to think, ‘Ok something is systematically wrong with the data here,’ and so we went through and did a number of internal evaluations just to convince ourselves that there was not some systematic bias within the data set.
However, the information is solid.”

“Infinite” Follow-Up Possibilities
Despite the sizable work completed by the BOND studies, the University-of-Utah-educated Black confirms that there is still an “infinite” amount of work to be done to better understand narcolepsy. “I think the next step for us is to do a regression analysis to find certain associations within the database,” adds Black, who completed his internship at Yale and his Fellowship at Stanford. “We also want to do a full characterization of the comorbidities.”

The loss of hypocretin is the known cause of narcolepsy and/or cataplexy, but still more can be known. “It’s particularly the loss of hypocretin cells in the brain,” says Black. “Are there some other variety of secondary effects there that lead to health consequences? There are many ways to look at it, and it’s almost overwhelming to think about the process required to start something up and gain these answers.”

The prospect is daunting, but Black believes additional basic research is necessary to counter what he calls the “very low knowledge” level among PCPs and non-sleep specialists when it comes to narcolepsy.

“It’s fair to say the overwhelming majority of primary care docs know that narcolepsy is a condition of sleepiness, and that’s all they know about it,” says Black. “They know it’s pathological sleepiness that can be severe, but if someone comes in who is sleepy, they don’t know how to differentiate it from anything else. They have no capacity to make the narcolepsy diagnosis, and therefore it goes unrecognized. We need to change this, and we can through additional education and research.”

Black Narcolepsy Poster2 2 2 Narcolepsy: Forgotten No More?
Narcolepsy As Defined by The Burden of Narcolepsy Disease (BOND) StudyNarcolepsy is a serious, chronic disorder of the central nervous system characterized by symptoms of excessive daytime sleepiness (EDS), muscle weakness (cataplexy), disrupted nighttime sleep, hypnagogic hallucinations and sleep paralysis. People with narcolepsy experience abrupt shifts between wakeful and REM-like states that are thought to be caused by a loss or impairment of hypocretin-producing neurons in the hypothalamus. The disorder affects approximately one in 2,000 Americans, yet approximately 50 percent of patients remain undiagnosed. Symptoms of narcolepsy often start between the ages of 15 and 25.


High rates of medical comorbidity in narcolepsy: Findings from the Burden of Narcolepsy Disease (BOND) study of 9,312 patients in the United States; Black J, et al, SLEEP 2013.

Black Narcolepsy Poster2 2 2 Narcolepsy: Forgotten No More?
High rates of medical comorbidity in narcolepsy: Findings from the Burden of Narcolepsy Disease (BOND) study of 9,312 patients in the United States; Black J, et al, SLEEP 2013.

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Apnea Risk Linked to Gestational Diabetes

The Endocrine Society’s Journal of Clinical Endocrinology & Metabolism (JCEM) is reporting that women diagnosed with gestational diabetes are nearly seven times more likely to have obstructive sleep apnea than other pregnant women. The new study, summarized in the Medical Press, also reiterates the comorbidities of stroke and cardiovascular disease associated with sleep apnea.

Clinically speaking, gestational diabetes causes glucose levels in the bloodstream to rise above normal levels. This form of diabetes occurs during pregnancy, typically in the second trimester.

“It is common for pregnant women to experience sleep disruptions, but the risk of developing obstructive sleep apnea increases substantially in women who have gestational diabetes,” said Sirimon Reutrakul, MD, who conducted the research at Rush University Medical Center in Chicago. “Nearly 75 percent of the participants in our study who had gestational diabetes also suffered from obstructive sleep apnea.”

Sleep labs may wish to consider the apnea connection to gestational diabetes as yet another way to expand the patient base by working with nearby maternity wards. “Based on these findings, women who have gestational diabetes should be considered for evaluation for obstructive sleep apnea,” said Reutrakul, “especially if other risk factors such as hypertension or obesity are present, and women already diagnosed with sleep apnea should be monitored for signs of gestational diabetes during pregnancy.”

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CPAP as Possible Alternative Asthma Treatment?

Add asthma to the growing list of diseases that may be helped by CPAP. The Cleveland Plain Dealer reports that CPAP machines could indeed become an alternative treatment for those with asthma.

No less than The American Lung Association has launched a national study to explore the question. The study is reportedly looking for nonsmokers with asthma who are willing to try CPAP machines for four months to see if their symptoms improve, and if so by how much. Those who enroll must be between the ages of 15 and 60.

“If CPAP is found to be effective, this will introduce an entirely new way to treat asthma without medication,” said Dr. Robert Wise, director of the American Lung Association’s 18 research centers across the country.

The study hopes to enroll 192 people in the study. According to reporter Diane Suchetka, many people with asthma are eager to stop taking medication because of its high cost, inconvenience, and long-term side effects, such as cataracts.

Those who wish to inform patients about the study can point them to The potential for CPAP is huge in the asthma realm, considering that 26 million Americans have asthma.

Of those, about 7 million are children, according to American Lung Association. The disease is responsible for almost 11 million doctor visits and 440,000 hospital visits a year.

Source: American Lung Association

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Combined Impact of OSA in patients with COPD

The mortality rate for humanity may indeed be 100%, but a new study suggests that CPAP therapy can help people who have both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). A wrapup in this week’s Medical Press calls the phenomenon “the overlap syndrome.”

This study adds to the growing body of literature regarding the combined impact of OSA in patients with COPD,” said lead author and principal investigator Michael L. Stanchina, MD, clinical assistant professor of medicine at the Alpert Medical School of Brown University and physician at Rhode Island Hospital in Providence, R.I. “We have shown that more time on CPAP in patients with the overlap syndrome was associated with a reduced risk of death, after controlling for common risk factors.”

The study “Impact of CPAP Use and Age on Mortality in Patients with Combined COPD and Obstructive Sleep Apnea: The Overlap Syndrome” published in the current issue of the Journal of Clinical Sleep Medicine, concerned a post hoc analysis of 10,272 outpatients. According to a Medical Press report, Stanchina’s team identified a study sample of 3,396 patients from 2007-2010 who had COPD or OSA.

This sample included 227 overlap syndrome patients who had both COPD and OSA. All patients in the overlap group were treated with CPAP therapy, and objective treatment compliance data were collected for the first one to three months of use. Seventeen patients with the overlap syndrome died.

Multivariate analysis revealed that hours of CPAP use at night is an independent predictora of mortality (hazard ratio = 0.71) in patients with COPD and OSA. Results show that overlap syndrome patients who use CPAP have a significantly higher survival than those who do not. Even minimal use of CPAP was associated with some reduction in the risk of death, and this benefit increased with more nightly hours of CPAP therapy.

“We were most surprised to find that any level of CPAP use in this cohort, over no use, was associated with some mortality benefit,” said Stanchina.

Click here to read abstract

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FDA Scrutinizes Effects of Sleep Drugs

The NY Times jumped into the sleep-related media fray with a feature that addressed the flip side of sleep—waking up. Reporter Katie Thomas reports that the FDA is taking heightened interest in the issue thanks to new evidence that suggests the effects of well-known sleep drugs could persist into the day.

Of particular interest is a possible link between sleep drugs and car accidents. With studies showing about 60 million prescriptions for sleep aids in the United States last year, the problem (if it exists) could be widespread.

The NY Times points out that relative newcomers such as Intermezzo from Purdue Pharma could help pave the way for appropriate dosing guidelines. In 2011, the FDA recognized gender variability when it approved the sleep drug Intermezzo, which treats patients who wake up in the middle of the night.

Women get a lower dose of Intermezzo (active ingredient Zolpidem) and all users are warned to only take the drug if they have four hours or more of bedtime left. “The agency’s experience with Intermezzo,” writes Thomas, “along with other research, led it to order in January that the dosage for all drugs containing zolpidem — the active ingredient in Intermezzo, as well as Ambien and related generic sleep drugs — be halved for women.”

Despite the increased scrutiny for sleep drugs, the NY Times highlighted the inherent paradox of the sleep drug/sleepiness situation. “What we have to weigh here is that people who don’t sleep well are a hazard on the road because they do fall asleep while driving,” said Robert Voas, a senior research scientist at the Pacific Institute for Research and Evaluation and an expert on driving safety in the Times article. “There’s risks on both sides.”

Source: NY Times

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ResMed Announces Record Financial Results for the Quarter and Nine Months Ended June 30, 2013

San Diego – ResMed Inc. (NYSE: RMD)  announced record revenue and income for the quarter ended June 30, 2013. Revenue for the quarter ended June 30, 2013 was $414.6 million, an 11% increase (also an 11% increase on a constant currency basis) over the quarter ended June 30, 2012.  For the quarter ended June 30, 2013, GAAP income from operations was $86.2 million, while GAAP net income was $73.0 million or $0.50 per diluted share.  These results were impacted by a $24.8 million ($17.7 million, net of tax) charge for our previously announcedSydney University education, research and settlement expenses.  For the quarter ended June 30, 2013, non-GAAP operating income and non-GAAP net income were $110.9 million and $90.7 million, an increase of 24% and 18%, respectively, compared to the quarter ended June 30, 2012 (non-GAAP measures exclude the impact of the charge forSydney University education, research and settlement expenses, as described below).  Non-GAAP diluted earnings per share for the quarter ended June 30, 2013 were $0.62, an increase of 17% compared to the quarter ended June 30, 2012.

Source: ResMed News Website

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Understanding the Causes of Sleep Disorders in Veterans

A veteran-centric integrative care company based in Virginia has released their own nationwide veteran sleep survey results. The survey was conducted in conjunction with the Center of Behavior and Health at the Johns Hopkins School of Medicine and VetAdvisor LLC. The purpose of the survey is to help researchers understand the causes of veteran sleep disorders, enhance overall understanding of these disorders, and determine the potential benefits of behavioral sleep coaching and consumer sleep monitoring devices in their treatment. A sleep coach is a wellness advisor who is an expert in sleep issues and their impact on veterans and military personnel.

View copy of the report


Two thousand, eight hundred and sixty six volunteers completed the VSS (11.5% female, 80% white, 11% Black, 1.3% Asian, 3% other, 6% Hispanic/Latino). The mean age was 54 years (SD=13.3, ranging from 18 to 96). The five branches of the military were represented [Army, 56%; Navy, 16%, Marines, 10%, Air Force 16%, Coast Guard, 1%). Seventy two percent of respondents reported having been deployed to a combat zone and 53% reported participating in combat operations. Fourteen percent were officers.

The average amount of veteran participant sleep was 5.6 hours. 76% of veterans report that they do not typically get enough sleep. Even more alarming, 91% of the veterans surveyed reported often feeling tired, fatigued or sleepy during the day. “Having trouble falling or staying asleep” was by far the most frequent reason cited by veterans as a cause of not getting enough sleep (70%). Other common reasons included: “sleep is poor quality” (53%), “being too busy with work or family responsibilities” (13%), “being a night owl” (12%), and “liking to watch television late at night” (8%).

Importantly, 74.3% of respondents reported meeting general clinical criteria for insomnia (i.e., trouble falling asleep or staying asleep, 3 or more nights per week for at least a month with at least some significant sleep-related daytime symptoms). In the general population, the prevalence of chronic insomnia is 10-15%. Veterans who had actively engaged in combat were also more likely to report insomnia than those who had not actively engaged in combat (78.7% vs. 69.2%)

The two most common reasons for sleep disruption were: 1) experiencing mental alertness/thoughts won’t slow down and 2) pain. While factors associated with normal daily living such as financial stress and worrying about daily concerns appeared to contribute to sleep disruption in both groups equally, the factors associated with trauma such as nightmares or feeling the need to be “on guard” were much higher in the active combat engagement group. Not surprisingly, when veterans were asked to rate the factor with the single greatest impact on their sleep, the groups differed as well. For those actively engaged in combat, the top 3 reasons in order were: 1) mental alertness/thoughts won’t slow down (15.7%), 2) pain (12.2%), and 3) nightmares/dreams (10.7%). For those not engaging in combat the top three reasons were: 1) pain (18.7%), 2) mental alertness/thoughts won’t slow down (15.3%), and 3) worrying about daily concerns (6.9%).

Source: myvetadvisor

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Add Increased Risk of Open-Angle Glaucoma to the List of Possible Sleep Apnea Consequences

A recent study “Obstructive Sleep Apnea and Increased Risk of Glaucoma” published in the journal of the American Academy of Ophthalmology summarizes that people with sleep apnea are far more likely to develop glaucoma compared to those without the sleep condition.

Conducted by researchers at Taipei Medical University, using a nationwide, population-based dataset to examine the prevalence and risk of the most common form of glaucoma among patients with the most common form of sleep apnea. The researchers reviewed National Health Insurance medical records for 1,012 patients aged 40 and older throughout Taiwan who were diagnosed with obstructive sleep apnea between 2001-04, comparing them to 6,072 matched-cohort control patients. They determined that the risk of developing open-angle glaucoma within five years of an obstructive sleep apnea diagnosis was 1.67 times higher in those who had sleep apnea compared to the control subjects.

Click here for Abstract

This study determined that obstructive sleep apnea is not simply a marker for poor health, but is actually an independent risk factor for open-angle glaucoma. The relationship between the two conditions is significant, given the large numbers of people worldwide who suffer from them.

Source: American Academy of Ophthalmology

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