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COPD Foundation Release: FDA Approves First COPD Biomarker

The COPD Foundation is extremely pleased to announce that a new clinical biomarker, plasma fibrinogen, has been approved for use in interventional clinical trials in patients with chronic obstructive pulmonary disease, the nation’s 3rd leading cause of death. This is the first COPD biomarker to receive qualification by the U.S. Food and Drug Administration (FDA) and is the result of six years of work by the COPD Biomarker Qualification Consortium (CBQC).

“Individuals working in the pharmaceutical industry, universities and the patient community have spent several million dollars and countless hours assembling and analyzing data that has led to the FDA’s monumental decision to approve this first COPD biomarker. Ultimately this clinical biomarker will enable future drug development to benefit patients.”

The CBQC, which includes representatives and resources from university and government research, pharmaceutical and patient communities, was created by the COPD Foundation in 2010, with encouragement from the FDA and the National Heart, Lung and Blood Institute, to develop a “biomarker qualification process” for COPD. Biomarkers are medical processes that researchers use to measure disease severity or to determine if a new drug or treatment is effective. Being able to use a biomarker qualified by the FDA assures drug developers that any potential new drug applications will not be rejected simply because of how the drug’s efficacy was measured or how patients were selected.

“This is a major triumph and, on behalf of the entire COPD community, I extend a heart-felt thank you to the FDA and congratulate the CBQC on its commitment and tireless leadership that allowed us to reach this significant milestone,” said John W. Walsh, co-founder and president of the COPD Foundation. “Individuals working in the pharmaceutical industry, universities and the patient community have spent several million dollars and countless hours assembling and analyzing data that has led to the FDA’s monumental decision to approve this first COPD biomarker. Ultimately this clinical biomarker will enable future drug development to benefit patients.”

COPD causes serious long-term disability and as many as 24 million Americans have the disease, but approximately half of them remain undiagnosed. On average, one American dies from COPD every 4 minutes yet in the last 3 decades, only one new class of drug has been approved for COPD.

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In old age, current and former smokers face early lung disease

There may be 35 million older Americans with undiagnosed lung disease due to cigarette smoking, a new study suggests.

They don't meet the criteria for a diagnosis of chronic obstructive pulmonary disease (COPD), but they still suffer significant lung disease and impairment, the researchers report in JAMA Internal Medicine.

"We think we can increase their quality of life by treating them before they get worse," said Dr. James Crapo, the study's senior author from National Jewish Health in Denver.

Currently, about half of U.S. residents age 49 and older are current or former cigarette smokers, the researchers write.

About one in five U.S. adults currently smoke.

COPD, the third leading cause of death in the U.S., is often related to smoking, they add. The disease worsens with age and makes it more and more difficult to breathe.

Typically, the condition is diagnosed through spirometry, which measures lung function. But Crapo points out that lung function can be impaired to lesser degrees before people qualify for a COPD diagnosis.

For the new study, the researchers looked at data from people across the U.S. that had been gathered through spirometry, CT imaging scans of the chest, a walking test and questionnaires.

The researchers compared 4,388 people with normal spirometry tests to 794 people with mild COPD and 108 people who never smoked.

Overall, about 54 percent of people who had normal spirometry scores had signs of lung disease or impairment, the researchers found.

"I think to say they don’t have the disease is wrong," Crapo said.

Compared to the never smokers, those with normal spirometry but impaired lung function had worse quality of life scores, more trouble walking and evidence of airway thickening and emphysema on their CT scans.

The researchers suggest the current diagnostic criteria for COPD may not be picking up everyone with lung disease. Also, the criteria might not detect disease that is progressing in younger smokers.

"We don’t know how to prevent it yet, but the first step is identifying it early," Crapo said. "Then, trying to stop it from progressing."

For now, Crapo said old Americans may qualify for a free CT scan of their chest through Medicare, the public insurance program for older and disabled Americans.

While that scan can help doctors look for cancer, Crapo said it also reveals signs of COPD, such as thickening air walls.

"If you’re one of those people who smoked heavily in...

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 Level of e-cigarette power contributes to potentially hazardous effects

The higher the power of an e-cigarette, the higher the concentrations of potentially hazardous substances the device produces, including acetaldehyde, acrolein, and formaldehyde.

Those are among the findings presented at an international conference of the American Thoracic Society by lead study author Dr. Daniel Sullivan, an internal medicine resident at the University of Texas Southwestern Medical Center. During his previous training at the University of Alabama, Birmingham, Dr. Sullivan and his associates used a variety of methods including liquid chromatography–mass spectrometry and enzyme-linked immunosorbent assay (ELISA) to study components and nicotine formulations typical of e-cigarette users.

Under some test conditions, formaldehyde levels were comparable to those seen in traditional tobacco cigarettes, he said in a video interview.

 

 

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Study shows cost-effective expert recommended asthma test underutilized by physicians

Researchers from the University of Texas Medical Branch at Galveston have found, for the first time, that spirometry was underutilized for asthma diagnosis and management in U.S. adults from 2001 to 2011, despite it's accuracy, cost effectiveness and the publication of national guidelines advocating its use.

Spirometry is a common test that allows physicians to determine how well a person's lungs work by measuring how much air is inhaled and exhaled as well as how quickly the air is exhaled. This test plays a vital role in the diagnosis and management of asthma by providing accurate measurements of air volumes and flows.

The Choosing Wisely initiative of the American Board of Internal Medicine Foundation helps physicians and patients work together to make appropriate, effective and cost-effective health care choices.

Asthma affects about 8 percent of U.S. adults, which cost $56 billion in medical care in 2007. The Choosing Wisely initiative recommends spirometry for diagnosis and follow-up asthma care because it's effective and costs about $42. On the other hand, unnecessary use of an inhaler can cost $200 to $300 a month. An emergency room visit for an asthma episode can total $3,500. Health care use, including emergency department visits and hospitalizations are linked with how well asthma is controlled. Thus, when used in the diagnosis and management of asthma at the recommended times, spirometry should prevent needless expense.

This study evaluated trends, from 2001 to 2011, in the use of spirometry in patients within a year of when they were diagnosed with asthma. The findings are detailed in the American Journal of Medicine.

In all, 134,208 asthma patients were included in the study. Only 48 percent had spirometry performed within one year of diagnosis. Younger patients, males and those residing in the Northeast were more likely to receive spirometry. Eighty percent of patients cared for by specialists received spirometry, while only 23 percent of those cared for by primary care physicians underwent the test. However, even without spirometry, close to 80 percent of patients were prescribed asthma drugs.

"Physicians must be educated about the usefulness of spirometry and given evidence of its medical and monetary value," said Dr. Kristin Sokol, assistant professor of pediatrics in the division of allergy and immunology. "As the Choosing Wisely initiative implies, the underuse of spirometry may lead to misdiagnosis or under...

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Nudging Smokers

In the Issue of the New England Journal of Medicine an investigation of the role of financial incentives and nudges in promoting smoking cessation, with particular emphasis on the importance of loss aversion and pre-commitment is explored.

In the past 40 years, we have seen a revolution in thinking about thinking.  The central idea is that human beings depart, in systematic ways, from standard economic approaches to rationality. Because the departures are systematic and predictable, they can be taken into account by researchers, clinicians, and others who want to improve health and reduce premature mortality.

Behavioral scientists have shown, for example, that people are “loss averse”; they tend to dislike losses more than they like corresponding gains. A 5-cent tax on the use of a grocery bag is likely to have a much greater effect than a 5-cent bonus for bringing one’s own bag. People also suffer from “present bias”: they tend to focus on the short term and sometimes see the future as a kind of foreign country (and their future selves as strangers). Most people tend to be unrealistically optimistic, at least about their own prospects. People are sometimes aware of their own biases and are willing to pre-commit to courses of action that will counteract them.

These and related findings help to explain preventable health problems and also suggest a wide range of potentially promising interventions. Some such interventions involve economic incentives, in the form of subsidies and penalties. Others involve “nudges,” in the form of choice-preserving interventions that do not impose any such incentives; information, warnings, reminders, and default rules are examples of nudges. Still other interventions combine the two, as with nudges designed to encourage people to enter programs that impose economic incentives.

In this issue of the Journal, Halpern and his colleagues investigate the role of financial incentives and nudges in promoting smoking cessation, with particular emphasis on the importance of loss aversion and pre-commitment. They explore two kinds of interventions for CVS Caremark employees and their relatives and friends. The first is a “deposit program,” in which smokers deposit $150, which they can get back if they stop smoking, along with $650 extra. The second is a “reward program,” in which people receive $800 if they stop smoking. Halpern et al. are interested above all in two questions. First, when will...

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Market Forecast 2014-2024: Asthma and COPD Therapies

MD Spiro prides itself on not only offering incredible spirometry products for your practice, but also prides itself on providing articles and industry updates for our customers.  Below is a new study showing you trends, R&D progress, and predicted revenues in Asthma and COPD Therapies.

So where’s the asthma and COPD therapies market heading? Visiongain's brand new report shows you potential revenues to 2024, assessing data, trends, opportunities and prospects there.

This 335-page report provides 264 tables, charts, and graphs. Discover the most lucrative areas in the industry and the future market prospects. This new study lets you assess forecasted sales at overall world market and national level. You will see financial results, interviews, trends, opportunities, and revenue predictions. Much opportunity remains in this growing pharma market.

Forecasts from 2014-2024 and other analyses show you commercial prospects
Besides revenue forecasting to 2024, our new study provides you with recent results, growth rates, and market shares. There you find original analyses, with business outlooks and developments. Discover qualitative analyses (including SWOT and Porter's Five Forces Analysis), company profiles and commercial developments. Read the full transcripts of six exclusive expert opinion interviews from industry specialists informing your understanding and allowing you to assess prospects for investments and sales, including:

-    Clive Page, Professor of Pharmacology, King's College London
-    Monica Fletcher, Chief Executive, Education for Health
-    Daphne Tsitoura, Senior Medical Director, GSK
-    Barbara Yawn, Director of Research, Olmsted Medical Center
-    Ahmed Wagih, Product Manager, Respiratory Franchise, GSK

Discover sales predictions for the world market and submarkets

Along with revenue prediction for the overall world market, you see forecasts to 2024 for the following submarkets:
-    Bronchodilator monotherapy – SABAs, LABAs, anticholinergic drugs
-    Anti-inflammatory drugs – inhaled corticosteroids, anti-leukotrienes, monoclonal antibodies
-    Combination drugs.

Our investigation discusses what stimulates and restrains business. You find dynamics of the industry and assess its potential sales, seeing agents likely to achieve the most success.

See revenue forecasts for products
How will leading drugs and promising products currently in development perform to 2024 at world level? Our study...

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Nationwide Climate Change Initiative Targets COPD and Asthma

Today, is Earth Day.  A statement released by the White House outlines an initiative to combat the health-related effects of climate change, with an emphasis on chronic obstructive pulmonary disease (COPD) and asthma.   

“The Centers for Disease Control and Prevention (CDC) is releasing an Adaptation in Action Report highlighting successful actions state and local leaders are taking to reduce the health impacts of climate change in New York City (NYC), San Francisco, ME, MN, AZ, MI, CA and NY. The CDC is also releasing a Health Care Facilities Toolkit illustrating best practices for promoting resilient health care infrastructure,” the Office of the Press Secretary announced.

In their statement, the White House claimed climate change is not only to blame for extreme weather but also for affecting the quality of life of Americans with pulmonary conditions. Furthermore, they highlighted the poor, children, elderly, and sick as other groups that are especially vulnerable to climate change’s effects.

Extending the Climate Data Initiative — a measure launched in March 2014 which made data on climate change available to prepare communities and businesses — the White House announced they are initiating the “Health Resilience” portion of the plan which would make more than 150 meta-tagged health-related datasets public.    

“The new theme aims to empower America’s people, communities, and health sector to more effectively plan, prepare, and strengthen their resilience to the health-impacts of climate change,” the White House announced.   
As a part of the Initiative, Propeller Health reported they are building an Asthma Risk Map that will allow Americans to gauge their COPD and asthma exacerbations in relation to the weather. The digital respiratory health company claimed this program will gather data through the use of “sensors [which] collect crowd-sourced data on the time and location of inhaled medication use. Using predictive spatial modeling techniques and open government data resources, Propeller will identify areas in US cities where the impacts of climate change will be felt most acutely by people with chronic respiratory disease over the next 10 to 100 years and beyond.” 

Moreover, Propeller Health announced they will also include modifiable factors such as air pollution and transportation to help ascertain which interventions would effectively mitigate COPD- and asthma-related symptoms.

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Testing for Inhaled Insulin

Diabetics now have a new option thanks to the breakthrough new medication AFREZZA®, an inhaled insulin now available by prescription. 

The labeling for AFREZZA®, mandates spirometry testing (specifically FEV1) to rule out chronic lung disease prior to initiating therapy, six months after initiation and every year thereafter1. 

MD Spiro offers a number of spirometer options and the expertise to easily integrate spirometry into your practice. From the non-reimbursable, PulmoLife at $195 to the full featured MicroLab at $2,295, Micro Direct has a spirometer designed to meet your needs. 
 
American Thoracic Society (ATS) Coding Recommendations

To aid in the coding for spirometry testing, the ATS has determined the appropriate ICD-9 codes and CPT codes. The following table lists examples of how to record these diagnosis and billing codes:

Spirometry prior to initiation of therapy  94010*  V72.85 + code for underlying condition (diabetes) as additional diagnosis Spirometry after first 6 months of therapy  94010*  V58.83 + V58.67 + code for underlying condition (diabetes) as additional diagnosis  Annual spirometry testing 94010*  V58.83 + V58.67 + code for underlying condition (diabetes) as additional diagnosis 

* It may also be appropriate to append this code with the “-32” modifier indicating that the test is “mandated” by the FDA as part of the labeling restrictions for inhaled insulin.2

For additional information, call us today at 800-588-3381.

References:
a All Current Procedural Terminology (CPT) 5-digit number codes, descriptions, number modifiers, instructions, guidelines and other material are Copyright © 2014 American Medical Association. All rights reserved. 
1. This information is not a substitute for medical advice and does not provide a complete summary of AFREZZA® or any inhaled insulin product or address all considerations in making treatment decisions regarding their use. Always refer to the complete product information provided by the manufacturer. 
2. Modifier minute: modifier 32. American Academy of Professional Coders website. http://news.aapc.com/index.php/2013/04/modifier-minute. Accessed December 22, 2014. 

AFREZZA® is a registered trademark owned by MannKind Corporation. 
Micro Direct, Inc./MD Spiro is not sponsored by nor has any affiliation with Sanofi, US, Inc., MannKind or the AFREZZA® trademark.
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