Respiratory / Asthma

Tuberculosis Bacillus Hides From The Immune System In Its Host's Fat Cells

2007-05-07T11:04:00.001-07:00

A team from the Institut Pasteur has recently shown that the tuberculosis bacillus hides from the immune system in its host's fat cells. This formidable pathogen is protected against even the most powerful antibiotics in these cells, in which it may remain dormant for years. This discovery, published in PLoS ONE, sheds new light on possible strategies for fighting tuberculosis. Attempts to eradicate the bacillus entirely from infected individuals should take these newly identified reservoir cells into account.

Mycobacterium tuberculosis, the bacillus responsible for tuberculosis can hide, in a dormant state, in adipose cells throughout the body. The bacterium is protected in this cellular environment, to which the natural immune defences have little access, and is inaccessible to isoniazid, one of the main antibiotics used to treat tuberculosis worldwide. These results were obtained by Olivier Neyrolles* and his colleagues from the Mycobacterial Genetics Unit directed by Brigitte Gicquel at the Institut Pasteur, in collaboration with Paul FornÃ¨s, a pathologist from HÃ´pital EuropÃ©en Georges Pompidou. They raise questions of considerable importance in the fight against tuberculosis.

Tuberculosis kills almost two million people worldwide every year and is considered by the World Health Organisation to represent a global health emergency. However, the bacillus is much more prevalent in the world's population than the statistics would lead us to believe, because only 5 to 10% of those infected actually develop tuberculosis. The bacillus may be present in a significant proportion of the population, remaining in a "dormant" state in the body, sometimes for years, and may be "reactivated" at any time. The risk of rea ctivation is particularly high in immunocompromised individuals, such as those infected with AIDS: the HIV virus and the tuberculosis bacillus make a formidable team, with each infectious agent facilitating the progression of the other.

Neyrolles' team first demonstrated, in cell and tissue cultures, that adipose cells served as a reservoir for Mycobacterium tuberculosis, and that this protected the bacillus against isoniazid. They then investigated whether the pathogen was present in adipose cells in humans. They did this by testing for traces of the genetic structure of the bacillus in samples from people considered not to be infected. Analyses were carried out on samples from deceased subjects from Mexico, where tuberculosis is endemic, and from Parisian districts reporting very few cases of tuberculosis.

The bacterium was detected in the adipose tissue of about a quarter of these people, all of whom were unaware they were infected, in both Mexico and France. These results suggest that the bacillus responsible for tuberculosis can remain protected in the adipose tissue of the body in the absence of any sign of disease.

This work has important implications for the prevention of this disease. It helps to explain how, many years after first testing positive for tuberculosis, people with no trace of the microbe in the lungs may develop some form of tuberculosis attacking the lungs, bones or genitals. It also suggests that isoniazid treatment, prescribed to the close friends and family of patients as a preventative measure, may in some cases not provide sufficient protection against the disease. This is particularly important for immunocompromised patients and for people with AIDS, for whom a secondary infection with tuberculosis bacillus may have very serious consequences.

This work highlights the importance of the search for new targeted therapeutic weapons, such as new antibiotics, which must be able to reach the dormant bacillus that has been hiding in adipose cells without our knowing it.

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Disclaimer

The following press releases refer to a selection of the upcoming articles in PLoS ONE. They are contributed by the article authors and/or their institutions. The opinions expressed do not necessarily reflect the views of the staff or the editors of PLoS ONE.

* Olivier Neyrolles belongs to URA 2172, CNRS,

Citation: Neyrolles O, HernÃ¡ndez-Pando R, Pietri-Rouxel F, FornÃ¨s P, Tailleux L, et al. (2006) Is Adipose Tissue a Place for Mycobacterium tuberculosis Persistence? PLoS ONE 1(1): e43. doi:10.1371/journal.pone.0000043

PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT: http://dx.doi.org/10.1371/journal.pone.0000043

Contact: Bruno Baron
Public Library of Science

Faropenem Phase III Clinical Trial Stopped To Consider Exclusion Of Ketek Comparator

2007-05-07T10:04:00.001-07:00

Replidyne, Inc. (Nasdaq: RDYN), reported today that the current phase III clinical trial comparing faropenem medoxomil (faropenem) to placebo and Ketek (telithromycin) in patients being treated for acute exacerbation of chronic bronchitis (AECB) is being temporarily stopped to consider the exclusion of the Ketek arm in the study. This decision has been made in response to the findings from the December 14 and 15, 2006 joint Advisory Committee meeting of the FDA's Anti-Infective Drug and Drug Safety and Risk Management committees that considered the benefit risk of Ketek for the indication of AECB. The Advisory Committee recommended to the FDA that the risks of Ketek outweigh the benefits of using the drug for the treatment of patients with AECB in a 17 to 2 vote.

"We believe that stopping enrollment in this trial to consider the inclusion of Ketek in the study is the appropriate and responsible action at this time to consider the new scientific evidence presented at the recent FDA Advisory Committee meeting," said Kenneth J. Collins, President and Chief Executive Officer of Replidyne. "While this action will cause a delay in obtaining the results from this AECB study we do not expect that it will impact the total time to complete the clinical program required to support the overall submission for the adult respiratory indications of Acute Bacterial Sinusitis (ABS), Community Acquired Pneumonia (CAP) and AECB. This action today will not impact the development of our pediatric clinical program for faropenem."

The phase III clinical trial for AECB is designed to compare faropenem to placebo and Ketek, an approved ketolide antibiotic. The primary objective of the study is to demonstrate superiority of faropenem to placebo. The additional comparison to Ketek represented a secondary analysis and was initially included primarily for commercial competitive reasons.

About Faropenem Medoxomil

Replidyne's lead product candidate, faropenem medoxomil (faropenem), is a novel oral community antibiotic under development for the treatment of respiratory and other community infections. Faropenem is a member of the penem sub-class within the beta-lactam class of antibiotics. Beta-lactams are generally characterized by their favorable safety and tolerability profiles, as well as their broad spectrum of activity, and as a result are typically first-line therapy in many respiratory and skin infections in adult and pediatric patients.

About Replidyne, Inc.

Replidyne is a biopharmaceutical company focused on discovering, developing, in-licensing and commercializing innovative anti-infective products. In February 2006, Replidyne entered into a partnership agreement with Forest Laboratories to develop and commercialize faropenem medoxomil in the US. An IND for Replidyne's second drug candidate, REP8839, was submitted to the FDA in May 2006. REP8839 is a topical anti-infective product under development for the treatment of skin and wound infections, and the prevention of S. aureus infections, including multiple antibiotic-resistant S. aureus (MRSA) infections, in hospital settings. Replidyne is also pursuing the development of other novel anti-infective products based on its in-house discovery research.

Safe Harbor

This press release contains plans, intentions, objectives, estimates and expectations that constitute forward-looking statements about Replidyne, Inc. that involve significant risks and uncertainties. Actual results could differ materially from those discussed due to a number of factors including, the success and timing of pre-clinical studies and clinical trials; the Company's ability to obtain and maintain regulatory approval of product candidates and the labeling under any approval that may be obtained; plans to develop and commercialize product candidates; the loss of key scientific or management personnel; the size and growth of the potential markets for the Company's product candidates and the Company's ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of Company estimates regarding expenses, future revenues and capital requirements; the Company's ability to obtain and maintain intellectual property protection for our product candidates; the successful development of the Company's sales and marketing capabilities; the success of competing drugs that are or become available; and the performance of third party manufacturers. These and additional risks and uncertainties are described more fully in the Company's Form S-1 and most recent periodic report filed with the SEC under the Securities Exchange Act of 1934. Copies of filings made with the SEC are available through the SEC's electronic data gather analysis and retrieval system (EDGAR) at http://www.sec.gov. All forward-looking statements made in the press release are made as of the date hereof and the Company assumes no obligation to update the forward-looking statements in the document.

Replidyne, Inc.
http://www.replidyne.com

Adams Respiratory Therapeutics Seeks Approval For New Prescription Cough Suppressant

2007-05-07T09:04:00.001-07:00

Adams Respiratory Therapeutics, Inc. (Nasdaq: ARxT) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for 600 mg and 1200 mg oral solid extended-release guaifenesin combination products for the treatment of cough. This new drug represents the first prescription product in Adams' current portfolio of respiratory products.

"This NDA filing is an important milestone for Adams," said president and CEO Michael J. Valentino. "Upon FDA approval of the NDA, this new drug will be our first prescription product offering and will move us closer to our vision of becoming a pre-eminent specialty pharmaceutical company, with leading products in both the over-the-counter and prescription respiratory drug markets. Secondly, it exemplifies our core strategy to build upon our successful guaifenesin business, utilizing our patented extended-release technology platform. Finally, it demonstrates our internal capabilities and technical know-how as a company to develop our own brand name prescription products." Adams has two other guaifenesin-based combination products currently under development in addition to the ongoing clinical program for erdosteine, a mucoregulator product, currently in Phase IIb.

At this time, Adams is not disclosing the name of the second active ingredient in the combination product for competitive reasons. However, the prescription market for products that treat cough is significant. Approximately 24 million prescriptions are written by physicians in the United States every year for the treatment of cough caused by the common cold, chronic bronchitis and other respiratory disorders, according to IMS Health. In addition, cough is among the most common reasons for a doctor visit, as reported by Dr. Peter Dicpinigaitis, a leading physician in the field of cough, and Fellow of the American College of Chest Physicians.

About Adams Respiratory Therapeutics, Inc.

Adams is a specialty pharmaceutical company focused on the late-stage development, commercialization and marketing of over-the-counter and prescription pharmaceuticals for the treatment of respiratory disorders.

Forward-Looking Statements

This press release contains certain "forward-looking" statements, including the Company's belief and anticipation that the FDA will approve the NDA. Such forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Factors that could cause actual results to differ materially include, among others, the FDA's denial of the NDA and other risk factors set forth Item 1A. Risk Factors in the Company's Annual Report on Form 10-K for the fiscal year ended June 30, 2006. Except to the extent required by applicable securities laws, Adams is not under any obligation to (and expressly disclaims any such obligation to) update its forward-looking statements, whether as a result of new information, future events, or otherwise. All statements contained in this press release are made only as of the date of this presentation.

Adams Respiratory Therapeutics, Inc.
http://www.adamsrt.com

HHS Pandemic Influenza Implementation Plan, USA

2007-05-07T08:04:00.001-07:00

STATEMENT BY SECRETARY LEAVITT

When the U.S. Department of Health & Human Services released the Pandemic Influenza Strategic Plan Part I, a year ago, I noted: â€œWe are better prepared today than we were yesterday, and we will be better prepared tomorrow than we are today.â€ Indeed, we are better prepared this year than we were one year ago - and, by continuing to implement the plans we have outlined, we will continue to improve our readiness into the future.

Since the release of our report last November, Congress has allotted $5.5 billion to support our preparation efforts, and our progress has been unprecedented. HHS, for example, has conducted pandemic flu summits in every state and territory, engaging state, local and tribal leaders and community representatives in preparation for an effective response to a pandemic. We are building our vaccine production capacity by investing in new technology, while continuing to grow our stockpile of medical interventions and supplies needed for response. We launched http://www.pandemicflu.gov, a cross-governmental internet resource used by millions of Americans seeking planning and guidance tools to increase their personal and community preparedness. In addition, we facilitated and subsidized state purchase of antiviral drugs and provided millions of dollars to states to enhance their efforts to develop an exercise preparedness plan.

This substantial commitment and investment has taken us a long way down the path of preparedness - but this should not make us complacent. Though it has not yet achieved sustained transmission between humans, the H5N1 strain of avian influenza has reached dozens of countries and claimed more than one hundred-fifty lives. A pandemic remains a serious local and global threat, and there is more work to be done to prepare for it.

Preparation is a continuum. We remain fortunate that we have not yet been faced with a pandemic and can use this time to prepare. If we continue to be vigilant in our commitment to preparedness, we will be better prepared to limit the severity and duration of a pandemic. We have an opportunity to be the first generation in history to be prepared for a pandemic and to save millions of lives in this country and around the world as a result. We must renew our commitment to seize this opportunity.

Sincerely,

Michael O. Leavitt

PREFACE

An influenza pandemic has the capacity to affect individuals and disrupt society on multiple levels. Pandemic influenza preparedness is a public health priority and a shared responsibility of the U.S. Department of Health and Human Services (HHS), the World Health Organization (WHO), and other Federal and non-Federal stakeholders across the country and abroad. The global nature of an influenza pandemic compels Federal, State, local, and tribal governments, communities, corporations, institutions, families, and individuals to learn about, prepare for, and collaborate in efforts to slow, mitigate, and recover from a pandemic. The development, refinement, integration, exercise, and communication of pandemic influenza plans by all stakeholders are critical components of preparedness. To this end, the Federal Government has developed the following documents to guide the Nation's pandemic influenza preparedness planning and response activities:

-- National Strategy for Pandemic Influenza: On November 1, 2005, the President released the National Strategy for Pandemic Influenza, which provides a framework for the U.S. Government's pandemic influenza preparedness and response efforts. (click here.)
-- The National Strategy for Pandemic Influenza Implementation Plan: The White House Homeland Security Council (HSC) released the National Strategy for Pandemic Influenza Implementation Plan in May 2006. This Implementation Plan provides a common frame of reference for understanding the pandemic threat and summarizes key planning assumptions to set a framework for effective action. It also proposes that Federal Departments and Agencies take specific coordinated steps to achieve the goals of the National Strategy, and outlines expectations for Federal and non-Federal stakeholders in the U.S. and abroad. This plan directs all Federal Departments to develop a pandemic influenza plan. (click here.)

-- HHS Pandemic Influenza Plan: On November 2, 2005, HHS released Parts 1 and 2 of the HHS Pandemic Influenza Plan, which serves as a strategic blueprint for all HHS pandemic influenza preparedness planning and response activities. (click here) The Plan builds on the actions and expectations set out in the National Strategy and its Implementation Plan, and updates the August 2004 draft HHS Pandemic Influenza Preparedness and Response Plan. The Plan integrates the changes made in the 2005 WHO classification of pandemic phases and its concomitant expansion of international guidance. It also is consistent with the National Response Plan (NRP) published in December 2004. It includes:

- The HHS Strategic Plan (Part 1): Part 1 outlines Federal plans and preparation for public health and medical support in the event of a pandemic. It identifies the key roles of HHS and its agencies during a pandemic, and provides planning assumptions for Federal, State, and local health and public health operations plans.

- Public Health Guidance for State and Local Partners (Part 2): Part 2 provides detailed guidance to State and local health departments in 11 key areas. Parts 1 and 2 will be regularly updated and refined, and will serve as tools for continued engagement with all stakeholders, including State and local partners.

- HHS Implementation Plan (Part 3): This document implements the strategy laid out in Parts 1 and 2 and itemizes the specific roles and responsibilities of each of HHS' operational and staff divisions in planning for and responding to a pandemic. This document identifies specific steps that operationalize and implement the actions and expectations outlined for HHS in the HSC National Strategy for Pandemic Influenza Implementation Plan. In addition, it identifies additional actions that are required for successfully accomplishing the activities laid out in both the National Strategy and the HHS Strategic Plan. This plan itemizes the specific roles and responsibilities of each HHS operational and staff division in preparing for a pandemic, not necessarily responding to one. The HHS Implementation Plan is divided into two parts as follows:

1. Part I discusses Department-wide issues such as international activities, international and domestic surveillance, public health interventions, the medical response, vaccines, antiviral drugs, diagnostic devices and personal protective equipment (PPE), communications, and State and local preparedness, all of which require coordination of efforts across HHS operational divisions. It details the specific steps needed to meet the challenges of a pandemic response and the critical capabilities as identified in both the National Strategy Implementation Plan and the HHS Strategic Plan.

2. Part II includes detailed continuity of operations plans that ensure that the essential functions of each HHS operating division are identified and maintained in the presence of an expected decrease in staffing levels during a pandemic event.

The HHS Implementation Plan is a dynamic document that will be reviewed and revised as needed as HHS efforts in pandemic preparedness mature. The plan will be tested to identify preparedness weaknesses and to promote effective implementation. Throughout this process, the pandemic influenza response will be optimized by effectively engaging partners and stakeholders during all phases of pandemic planning and response.

EXECUTIVE SUMMARY

An influenza pandemic has the potential to cause more death and illness than any other public health threat. Although the timing, nature, and severity of the next pandemic cannot be predicted with any certainty, preparedness planning is imperative to lessen the impact of a pandemic. The unique characteristics and events of a pandemic will strain local, State, and Federal resources. For example, it is unlikely that there will be sufficient personnel, equipment, and supplies to simultaneously respond adequately in multiple areas of the country for a sustained period of time. Therefore, the minimization of social and economic disruption will require a coordinated response by the whole country. All governments, communities, and public- and private-sector stakeholders will need to anticipate and prepare for a pandemic by defining their roles and responsibilities, and developing continuity-of-operations plans. To this end, the President directed the Secretary of HHS to initiate a State and local preparedness process. HHS is actively working to help States, tribes, cities, schools, businesses, churches, individuals, and families across the country plan for a pandemic. HHS is collaborating with Governors' offices in every State to hold pandemic summits and exercises. HHS/Centers for Disease Control and Prevention (CDC) have developed checklists to aid in pandemic influenza preparations. These checklists provide specific guidance for State and local planning, businesses, health care providers, community organizations, individuals, and families. (www.pandemicflu.gov)

During a pandemic, and consistent with the National Response Plan (NRP), as head of Emergency Support Function (ESF) #8, Public Health and Medical Services, the Secretary of HHS will lead the Federal public health and medical response efforts. The HHS Pandemic Influenza Plan serves as a blueprint for all HHS pandemic influenza preparedness and response planning. Part 1, the Strategic Plan, describes a coordinated public health and medical care strategy to prepare for, and begin responding to, an influenza pandemic. Part 2, Public Health Guidance for State, Local, and Tribal Partners, provides guidance on specific aspects of pandemic influenza planning and response for the development of State, local, and tribal preparedness plans.

This document, Part 3, the HHS Implementation Plan, operationalizes the strategy described in the White House Homeland Security Council (HSC) National Strategy for Pandemic Implementation Plan by detailing Department-wide HHS pandemic preparedness actions and steps (Part I) and by outlining Agencies' continuity-of-business plans (Part II).

Part 1 - Pandemic Influenza Implementation Plan (PDF - 271 pages, 1.8MB)

Part I of the HHS Implementation Plan identifies eight cross-cutting issues that encompass many of the themes noted in the HHS Strategic Plan and Guidance for State and Local Partners. These themes include infection control, laboratory diagnostics, surveillance, health care planning, and workforce support. Each chapter outlines actions and specific steps the Department will undertake to fulfill the directives of the HSC and accomplish pandemic preparedness. The eight cross-cutting issue chapters are:

-- International Activities

-- Domestic Surveillance

-- Public Health Interventions

-- Federal Medical Response

-- Vaccines

-- Antiviral Drugs

-- Communications

-- State, Local, and Tribal Preparedness

The action steps in these eight chapters are organized by the three pillars identified in the National Strategy for Pandemic Influenza: preparedness and communication; surveillance and detection; and response and containment. The implementation of the HHS action steps is contingent upon the availability of resources.

International Activities

While a novel influenza virus could emerge anywhere in the world at any time, current concern focuses on the continued spread of avian influenza A/(H5N1), which is highly pathogenic in poultry and has caused sporadic cases of severe disease in humans.1,2,3 The emergence and intercontinental spread of avian influenza A/(H5N1) in birds underscores the interrelatedness of all countries and communities with respect to public health emergencies. Chapter 1 emphasizes the need to work in partnership with countries and provide technical assistance to enhance surveillance and response activities in low-resourced countries. International disease-surveillance efforts could permit the identification of the earliest stages of an evolution of avian or animal influenza virus into a human pathogen that is capable of human-to-human spread. The early detection of a pandemic virus will facilitate a rapid and well-orchestrated global public health containment response whose goal is the slowing or limiting of the spread of influenza. Slowing the spread of a pandemic overseas may also allow the United States to implement public health measures that might mitigate the impact of the disease when it arrives on U.S. shores. Continued surveillance, once a pandemic is underway, is important for monitoring and documenting changes in viral characteristics and pathogenesis. The HHS plan focuses on strengthening global surveillance and timely response capacity. It also emphasizes education of, and risk communication to, all stakeholders and partners.

Domestic Surveillance

Continuous surveillance, both domestic and abroad, will provide data on trends in disease activity and virus subtype circulation, and will inform policy and public health decisionmaking in the pre-pandemic and pandemic periods. Initially, domestic surveillance efforts are designed to detect influenza virus types and subtypes, including pandemic strains, circulating in the United States, and will focus on detecting initial cases and clusters of human illness. Early detection of initial cases ensures timely investigation and implementation of public health interventions to limit further spread of disease. Detection of early cases and appropriate laboratory investigation will facilitate the prompt identification of viral characteristics (antiviral susceptibility, antigenicity, transmissibility, and virulence) that can affect medical case management as well as public health response measures. It will also facilitate the development of both pre-pandemic and pandemic vaccines. Early delineation of viral characteristics will increase the likelihood that a vaccine could be available in a timely manner. Early identification of cases will also maximize the chances of delaying the spread of the pandemic across the country.

Surveillance requires that laboratory systems are in place to characterize viral subtypes, enable detection and investigation of suspected cases in a community, and detect sentinel increases in disease activity. Surveillance data will direct decisions on vaccine development, antiviral drug use, and the implementation and continuation of public health interventions, including diagnostic devices and personal protection equipment (PPE) use, to limit the spread of disease. Ongoing surveillance and the generation of real-time data can also help monitor the progression of a pandemic and the effectiveness of various interventions. Surveillance data may be used by researchers to model and project the trajectory of a pandemic.

HHS activities concentrate initially on continuing to build laboratory and epidemiologic capacity for surveillance and response; and on establishing comprehensive, integrated, timely, and sensitive surveillance systems; by building on existing systems and by initiating new systems where gaps currently exist. In addition, current HHS activities will support the faster development and deployment of new virus detection products. These rapid diagnostics may cut the time needed to confirm a human infection. If used at the point of care, rapid diagnostics could allow early recognition of infected individuals and promote the timely institution of appropriate medical care and public health measures.

Public Health Interventions

At the start of a pandemic, a vaccine may not be widely available, and the supply of antiviral drugs may be limited. Public health interventions, such as containment strategies (isolation of infected individuals and social distancing measures), could delay the introduction and/or spread of a novel, pandemic influenza virus in the United States. In the absence of available drugs, and before a pandemic vaccine is produced, public health interventions are the main defense mechanism against viral infection. The specific interventions implemented will depend on the pandemic phase. For example, early in a pandemic that emerges overseas-before the virus is detected in the United States-local containment strategies and travel-related actions (travel advisories and precautions, including entry and exit screening of persons arriving from infected countries or regions) could impede the establishment of the pandemic virus in this country. Later, after the virus is widespread in the United States, public health interventions such as closing schools, restricting public gatherings, quarantining exposed persons, isolating infected persons, and telecommuting or working from home could reduce the number of people infected with the virus. During this time, public health interventions that retard the spread of infection could mitigate the disruptive impact of a pandemic until such medical interventions became available. The HHS Plan outlines steps to develop recommendation protocols to implement and evaluate public health interventions throughout a pandemic cycle.

Federal Medical Response

An influenza pandemic will place extraordinary demands on the U.S. health care system. Efficient use of existing medical resources and expedient deployment of Federal medical assets, including personnel, are crucial in addressing the medical surge requirements imposed by a pandemic. Because the provision of health care is almost entirely a local responsibility, planning at the State and local level is essential for pandemic preparedness. Integration of the medical response across the local, State, and Federal levels becomes critical to optimize the use of scarce medical resources. HHS is working with its State, local, and tribal partners to increase surge capacity of medical materiel and personnel.

For the most efficient use of medical resources, effective response plans must be developed and tested at all levels. Plans must include a functional command structure consistent with the National Incident Management System (NIMS), a regional approach to the stockpiling and distribution of medical materiel, and a schedule of exercises for evaluating the effectiveness of the plans. Guidelines must be developed and disseminated to all partners. These guidelines should offer approaches for the allocation of scarce resources and the altering of medical care such that scarce resources are applied to benefit the greatest number of those in need. The success of the medical response to an influenza pandemic will be determined by how medical providers and facilities can implement interventions that enable them to meet the increased medical demands that result from a pandemic.

The HHS Implementation Plan describes specific steps to develop deployment strategies for Federal medical resources, including personnel, and steps to develop guidelines for the health care system to augment surge capacity, distribute medical resources, institute appropriate infection control measures, and review/modify standards of care without compromising clinical outcome.

Chapter 4, Federal Medical Response, primarily addresses the Federal medical response, and also addresses integrated planning across all jurisdictions. For additional preparedness guidance for State and local partners, see Part 2 of the HHS Pandemic Influenza Plan (Public Health Guidance for State and Local Partners) and Chapter 8, State, Local, and Tribal Preparedness, of this plan.

Vaccines

Historically, vaccination has been the most effective measure for minimizing the morbidity and mortality associated with influenza. Vaccines may also limit virus spread, and thus, the course of a pandemic. Since a pandemic vaccine can only be made once a pandemic virus is identified and isolated, it cannot be available during the early phases of a pandemic. Therefore, a pre-pandemic vaccine based on novel influenza viruses with pandemic potential that are known to be in circulation, and for which a vaccine has already been developed and stockpiled, may provide partial protection or immunologic priming of persons at high risk during the early phases of a pandemic.

When a pandemic is declared and a specific vaccine against the pandemic virus becomes available, its distribution and delivery will be a major focus of the pandemic response. Vaccines produced for a pandemic virus must be safe, produced in large quantities, delivered quickly, and be effective for the largest number of individuals possible to minimize mortality and morbidity. Thus, the rapid production and clinical evaluation of a pandemic vaccine and the tracking of its use and distribution, particularly if two or more doses are required, is an urgent priority of HHS pandemic planning and response preparations. HHS is currently working with private industry to increase the U.S. vaccine production capacity. The HHS Plan describes specific action steps HHS will take to facilitate vaccine development, production, and distribution. The Plan also identifies steps HHS will take to track vaccine efficacy and adverse events. Antiviral Drugs.

If used appropriately, antiviral drugs may limit the spread of influenza, reduce its morbidity and mortality, and thereby diminish the demands placed on the U.S. health care system during a pandemic. However, the susceptibility of the pandemic influenza virus strain to antiviral agents cannot be determined until the pandemic virus strain emerges. Assuming susceptibility, antivirals may also be used in attempts to contain small disease clusters and potentially slow the introduction and spread of the infection in and between communities. Indiscriminate use of antiviral drugs in a pandemic could deplete national and local supplies. Therefore, a comprehensive approach for the appropriate distribution and use of antiviral stocks is an essential component of HHS pandemic preparedness. The HHS Implementation Plan outlines the steps to facilitate the development, licensure/approval, production, and availability of pandemic influenza countermeasures. It also provides guidance for evaluating antiviral efficacy and developing prioritization, allocation, and distribution strategies for antiviral stockpiles.

Communications

Another critical component of HHS preparedness for an influenza pandemic is a clear communications strategy and campaign that informs the public and other stakeholders about this potential threat and provides a solid foundation of information upon which future actions can be based. To be effective, this strategy should be based on scientifically derived risk-communications principles that are developed before, during, and after an influenza pandemic. The HHS Plan outlines a communications strategy and campaign that effectively provides reliable information and guides the public-including individuals and families, the news media, health care providers, and other groups-in responding to outbreak situations appropriately by adhering to public health measures and undertaking actions that protect individuals and family members.

HHS is currently developing communications and outreach materials, messages, and procedures for implementing communications plans. In addition, HHS is developing strategies for health care providers and the public to address any psychosocial concerns. During a pandemic, HHS will provide accurate and timely information on the pandemic to the public. It will also monitor and evaluate its interventions, and will communicate lessons learned to health care providers and public health agencies on the effectiveness of clinical and public health responses.

State, Local, and Tribal Preparedness

An effective pandemic response requires planning and coordination among all levels of Government and all stakeholders. The country's success in responding to and recovering from a pandemic necessarily depends on preparedness by the State, local and tribal jurisdictions. State, local and tribal leaders will be responsible for conducting surveillance, epidemiologic investigation, disseminating information, implementing containment measures, and distributing countermeasures (vaccine and antiviral drugs). In addition, the provision of health care is almost entirely a local responsibility that is shared by both private and public sector entities. Planning for the preservation of societal functioning is also a critical local function.

Moreover, for pandemic influenza preparedness to be effective, it must be a multidisciplinary effort, engaging all stakeholders, including traditional public health and health care partners, as well as other sector partners, such as the business community, public safety and law enforcement, emergency management, education, transportation, social services, mental health and substance abuse services, public utilities, and community- and faith-based organizations. The duration, scope, and scale of the event will challenge infrastructure across most, if not all, sectors. Multi-sectored mutual aid agreements among local jurisdictions may aid in addressing the duration, scope, and scale of the pandemic.

In FY06, the U.S. Congress appropriated $350 million as part of an emergency supplemental appropriation to fund local and State preparedness. HHS is currently working with its State, local, and tribal partners to increase the health care surge capacity of medical materiel and personnel. With State Governors, HHS is co-hosting pandemic summits and exercises in every State. In addition, HHS has developed checklists to aid in community-level pandemic influenza preparations. These checklists provide specific guidance for State and local planning authorities, businesses, health care providers, community organizations, and individuals and families.

The HHS Implementation Plan addresses cross-cutting preparedness issues for which the Department will provide further assistance for State, local and tribal pandemic preparedness. This assistance includes the development of guidelines and operational plans for the distribution of available supplies of pandemic vaccine and antiviral drugs.

Part II

HHS provides and operates many essential services and programs for individuals across the United States. Disruption of business and community operations by a pandemic can seriously jeopardize the health and well-being of many Americans. Part II provides detailed continuity of operations plans for the Office of the Secretary (OS) and HHS agencies, including:

-- The Administration for Children and Families (ACF)
-- The Agency for Health care Research and Quality (AHRQ)
-- The Agency for Toxic Substances and Disease Registry (ATSDR)
-- The Administration on Aging (AOA)
-- The Centers for Disease Control and Prevention (CDC)
-- The Centers for Medicare and Medicaid Services (CMS)
-- The Food and Drug Administration (FDA)
-- The Health Resources and Services Administration (HRSA)
-- The Indian Health Service (IHS)
-- The National Institutes of Health (NIH)
-- The Substance Abuse and Mental Health Services Administration (SAMHSA)

In Part II, each HHS agency and the OS identify essential activities, programs, and personnel, and provide strategies to continue departmental operations in the face of significant absenteeism during a pandemic. Agencies' plans also include leadership succession, plans for the delegation of authority, and options and procedures for alternate worksites. In addition, each plan includes steps to protect the workforce (and the agency's customers) during a pandemic. Finally, each agency outlines its role and responsibilities in a coordinated inter-agency/departmental response to a pandemic.

Given its critical mission, HHS will occupy a central position in any Federal pandemic influenza response. However, a robust, comprehensive response consistent with the National Response Plan requires coordination across Federal Departments and with international partners of the United States. Moreover, an effective pandemic response that preserves human lives and societal infrastructure requires collaboration with all State, local, and tribal partners. This HHS Implementation Plan provides definitive guidance and action steps to maximize our collective efforts in preparing for and responding to pandemic influenza.

Footnotes

1 Chotpitayasunondh T, Ungchusak K, Hanshaoworakul W, Chunsuthiwat S, Sawanpanyalert P, Kijphati R, Lochindarat S, Srisan P, Suwan P, Osotthanakorn Y, Anantasetagoon T, Kanjanawasri S, Tanupattarachai S, Weerakul J, Chaiwirattana R, Maneerattanaporn M, Poolsavathitikool R, Chokephaibulkit K, Apisarnthanarak A, Dowell SF. Human disease from influenza A (H5N1), Thailand, 2004. Emerg Infect Dis. 2005 Feb;11(2):201-9.

2 Beigel JH, Farrar J, Han AM, Hayden FG, Hyer R, de Jong MD, Lochindarat S, Nguyen TK, Nguyen TH, Tran TH, Nicoll A, Touch S, Yuen KY; Writing Committee of the World Health Organization (WHO) Consultation on Human Influenza A/H5. Avian influenza A (H5N1) infection in humans. N Engl J Med. 2005 Sep 29;353(13):1374-85. Review.

3 Hien TT, de Jong M, Farrar J. Avian influenza-a challenge to global health care structures. N Engl J Med. 2004 Dec 2;351(23):2363-5.

Part 1 - Pandemic Influenza Implementation Plan (PDF - 271 pages, 1.8MB)

Part 1 - Overview (PDF - 11 pages, 178KB)

Asthma Medicine Halts Pancreatic Cancer Cell Growth

2007-05-07T07:04:00.001-07:00

A common asthma drug reduced pancreatic cancer cell growth in laboratory experiments and animal tests, a new study reports.

A protein called S100P is found in excess amounts in some cancers and is important for pancreatic cancer cell growth and survival. This protein also activates a cell surface protein receptor called RAGE that plays a role in Alzheimer disease, diabetes, and cancer.

A drug called cromolyn, an allergy and asthma treatment, has been shown to bind to proteins similar to S100P. To test cromolynâ€™s effects on S100P in pancreatic cancer cells, Thiruvengadam Arumugam, Ph.D., Vijaya Ramachandran, Ph.D., and Craig D. Logsdon, Ph.D., of the University of Texas M. D. Anderson Cancer Center in Houston, conducted experiments with the drug in tissue cultures and in mice with implanted pancreatic cancer.

They found that cromolyn bound to S100P, halted the activation of RAGE, and slowed cancer cell growth and survival in cell lines. In mice, the drug slowed pancreatic tumor growth and improved the effectiveness of gemcitabine, a chemotherapy drug used to treat pancreatic cancer.

"Together, these data support the further investigation of cromolyn as a possible treatment for pancreatic cancer," the authors write.

Contact: Scott Merville, M. D. Anderson Cancer Center External Communications

###

Other highlights in the December 20 JNCI

Note: The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the National Cancer Institute. Attribution to the Journal of the National Cancer Institute is requested in all news coverage. Visit the Journal online at http://jncicancerspectrum.oxfordjournals.org/.

Contact: Andrea Widener
Journal of the National Cancer Institute

WFP Resumes Programs Providing Food To People With TB, HIV In Cambodia After Receiving Aid From Spain, U.S.

2007-04-16T18:12:00.001-07:00

The World Food Program has resumed its programs providing people living with HIV and tuberculosis in Cambodia with access to food after receiving aid from Spain and the U.S., the agency said on Thursday, the AP/International Herald Tribune reports (AP/International Herald Tribune, 2/8). Thomas Keusters, country director for WFP's Cambodia office, said recently that WFP had been "forced to suspend" the programs because of funding shortages. The programs distribute food rations to 18,000 people with TB and 70,000 people with HIV. They also ensure that HIV-positive people and people with TB needing medicine are connected with food distribution points. "The sick need food first before taking medicines," Haidy Ear-Dupuy -- advocacy manager at the Phnom Penh, Cambodia, office of World Vision -- said, adding, "You cannot take medication on an empty stomach. You must maintain a balance" (Macan-Markar, Inter Press Service, 2/6). WFP in a statement on Thursday said that Spain has provided about $650,000 and that the U.S. has provided 6,100 tons of legumes, as well as 2,370 tons of vegetable oil, for a period of three years. WFP three weeks ago announced that it needed at least $10 million to run its programs in Cambodia through July (AP/International Herald Tribune, 2/8). Keusters said WFP welcomed the donations but added that more "urgent donations" are needed (Agence France-Presse, 2/8). HIV prevalence in Cambodia is 1.6%, the highest in Southeast Asia, according to Inter Press Service (Inter Press Service, 2/6).

"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Slow-Release Morphine Reduces Level Of Intractable Cough

2007-04-16T16:52:00.001-07:00

Slow-release morphine helped a group of patients with long-term, treatment-resistant chronic cough reduce their daily cough score levels by 40 percent.

The research results appear in the second issue for February 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.

Alyn H. Morice, M.D., of the Department of Academic Medicine at the University of Hull and Castle Hill Hospital in East Yorkshire, United Kingdom, and six associates enrolled 27 patients with intractable cough in an eight-week, randomized, double-blind, placebo-controlled study to test the use of slow-release morphine sulfate versus a placebo on their cough. Each phase lasted four weeks.

Morphine, derived from opium, is used in medicine as an analgesic, light anesthetic or a sedative. Although opiates have been long advocated for the suppression of cough, there are few trial data to support this recommendation. In fact, prior to this research, the use of opiates in intractable chronic cough had never been studied.

"Although acute cough is benign and self-limiting, chronic persistent cough can have a devastating effect on the quality of life of sufferers," said Dr. Morice. "This research provides evidence for the use of opiates in chronic cough."

The investigators found a "rapid and highly significant reduction by 40 percent in daily cough scores was noted by patients on slow-release morphine sulfate."

Patients responded quickly to treatment starting at five milligrams twice daily. The researchers found patients benefited the most by day five of treatment, and that this response was sustained through the remainder of the four-week period. The authors noted that the rapid response to morphine was in contrast to the absence of any effect of placebo.

The 27 participants, 18 of whom were female, were recruited from a hospital cough clinic. All had endured a chronic, persistent cough for more than three months. Their average age was 55.

During each four-week interval, patients made three visits to a clinical trial center, where they filled out a quality-of-life questionnaire on the impact of chronic cough on activities of daily living. A spirometric lung test was performed at the first visit, and lung function was measured on each subsequent visit.

In addition, each participant assessed their cough severity daily, rating it from 0 to 9 on a record card. Participants could not use other cough remedies, including over-the-counter products, during the eight-week study period.

According to the authors, one-third of the participants increased their dose of morphine sulfate from 5 mg to 10 mg twice daily during the first month; 11 percent did so in the second month; and a further 22 percent joined them in the third month. By the end of the study, two-thirds of the patients had increased their dose to 10 milligrams.

"The optimum dose in the suppression of chronic cough lies between 5 and 10 mg twice daily," said Dr. Morice, who added that the most common side effects were constipation (40 percent) and drowsiness (25 percent).

The investigators believe that the risk-benefit ratio makes low-dose morphine sulfate a credible therapeutic option for patients with chronic cough who fail other specific treatments.

Founded in 1905, the American Thoracic Society is the world's leading medical association dedicated to advancing pulmonary, critical care and sleep medicine. The Society has more than 18,000 members who prevent and fight respiratory disease around the globe, through research, education, patient care and advocacy.

American Thoracic Society
61 Broadway, 4th Floor
New York, NY 10006-2755
http://www.thoracic.org
See you at ATS 2007-the 103rd International Conference, May 18-23 San Francisco, CA

Drug Reduces Unscheduled Trips To Doctor For Childhood Asthma Attacks

2007-04-16T16:12:00.001-07:00

Young children with attacks of sporadic, recurring asthma who were treated with the prescription drug montelukast by their parents had fewer unscheduled trips to the doctor, missed less days from school or childcare, and caused their parents to take fewer days off work for their care.

Results from this multi-center, randomized, double-blind and placebo-controlled trial appear in the second issue for February 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.

Colin F. Robertson, M.D., of the Department of Respiratory Medicine at Royal Children's Hospital in Melbourne, Australia, and eight associates studied 202 children, ages 2 to 14, who were given either montelukast or placebo by their parents when needed for one year. All of the children had intermittent, doctor-diagnosed asthma.

By the end of the year-long study, the patients treated with montelukast had 163 unscheduled health resource visits for their illness, as compared with 228 in the placebo group.

"Symptoms were reduced by 14 percent, nights awakened by 8.6 percent, days off from school or childcare by 37 percent and parent time off from work by 33 percent," said Dr. Robertson.

In asthma, children's airways become chronically inflamed, with various stimuli causing episodes of airway obstruction and breathing difficulties. The disease is the most common chronic disorder of childhood and affects an estimated 6.2 million children under age 18 in the U.S.

Intermittent asthma is the most common pattern of the disease in children, accounting for attacks in 75 percent of affected youngsters.

Montelukast sodium, a specific leukotriene receptor antagonist that has been shown to be effective in children, is used to prevent mild, persistent asthma. It reduces the swelling and inflammation that tend to close airways, and relaxes the walls of the bronchial tubes, allowing more air to pass through to the lungs.

"Acute episodes of asthma in young children place a significant burden on healthcare resources," said Dr. Robertson. "Admission to the hospital for asthma in children aged 0 to 4 years is five times more common, and for those aged 5 to 14 years, twice as common as for adults who have asthma."

The study was designed to evaluate parent-initiated therapy with montelukast at the onset of each upper respiratory infection or asthma symptom. Treatment continued for a minimum of seven days or until symptoms had resolved for 24 hours.

"A key component of the study was the impact of asthma on the family, as measured by days absent from school or childcare, nights of disturbed sleep, and the number of parent days lost from work," said Dr. Robertson. "Furthermore, the strategy of parent-initiated therapy required children on average to take the study drug only 30 days per year, rather than 365, providing a further cost-benefit for the family."

The authors noted that there was no significant reduction in specialist care, hospitalizations, duration of episodes, or use of beta-agonists and prednisolone as a result of montelukast study.

An analysis of cost showed that the use of montelukast resulted in a savings of $124 Australian dollars - about $96 U.S. dollars - or 29 percent less per treated episode than the placebo controlled arm of the trial.

Founded in 1905, the American Thoracic Society is the world's leading medical association dedicated to advancing pulmonary, critical care and sleep medicine. The Society has more than 18,000 members who prevent and fight respiratory disease around the globe, through research, education, patient care and advocacy.

American Thoracic Society
61 Broadway, 4th Floor
New York, NY 10006-2755
http://www.thoracic.org
See you at ATS 2007-the 103rd International Conference, May 18-23 San Francisco, CA

Animal Testing Reduced By Soft-Cell Approach

2007-04-16T14:51:00.000-07:00

The new in-vitro technique pioneered by Dr Amanda Hayes and her UNSW colleagues, Shahnaz Bakand and Chris Winder, directly exposes human cells to airborne toxicants and measures cytotoxic effects. The cells are grown on a porous polyester membrane inside a small diffusion chamber and then exposed to selected toxic air pollutants. After as little as one hour's exposure, they can study cell growth and metabolism, and a range of routine toxicological endpoints.

Importantly, the toxic measurements obtained by the in vitro method, such as the amount of a contaminant needed to inhibit cell growth, mirror well-established lethal values obtained from animal studies - a long-established method in toxicological studies. "In-vitro toxicity tests can improve the scientific, economic, and ethical value of research and play a significant role in the screening of toxic chemicals and the replacement of animals," Dr Hayes says.

This research earned Hayes and her colleagues the 2006 Australian Museum Voiceless Eureka Prize for Research. This prize rewards scientists for work that has reduced the use of animals or animal products in laboratory-based research, education and testing.

Many industrial and environmental air pollutants are already known to have adverse health effects on the respiratory system of workers. Increasingly, new formulations are using tiny nanoparticles and ultrafine particulates in cosmetics, pharmaceuticals and petrochemical products. Little is known about their toxicity and safety to human health but this new category of pollutants poses possible dangers, both medically and environmentally, especially if they get airborne.

Most nanoparticles have a high surface area-to-mass ratio that can make the particles very reactive or catalytic. Being so small, they may also be able to pass through cell walls in organisms, and their reactions inside the body are relatively unknown.

"These tiny new substances are the tip of a huge chemical iceberg," says Hayes, Manager of the Chemical Safety and Applied Toxicology Laboratories at the University of New South Wales.

"Worldwide, there are millions of known chemicals, of which more than 100,000 chemical compounds are in commercial use in an unknown but extremely large number of chemical mixtures.

"Continued conventional animal toxicity testing of this large number of chemicals is simply unachievable from a scientific and economic standpoint," says Dr Hayes. "It's also unethical, given that in Australia alone, more than a million dogs, cats, rabbits, sheep, cattle, pigs and mice are used each year for toxicological testing and research." This is a drop in the ocean, compared with the animal death toll in the rest of the world.

In many inhalation studies, the toxicity of airborne chemicals is tested on laboratory animals by placing them in enclosed chambers and subjecting them to increasing concentrations of the test compounds for specified times until half of the test animals are killed. One type of test commonly used where this occurs is the LD50 test, where LD stands for lethal dose.

This heavy reliance on animal data in toxicology has long been a concern of the scientific community. Predicting the biological activities of toxic chemicals in humans by using animal data always poses uncertainty due to differences between animals and humans.

In a series of published experiments, the UNSW team has demonstrated the feasibility of their in vitro technique for:

* formaldehyde, an industrial contaminant linked to human cancer;

* nitrogen dioxide, a lung irritant that causes inflammation, pulmonary oedema, and pneumonia;

* fire combustion products, including cyanide, hydrogen sulphide, and ammonia; and,

* the volatile organic compounds (VOCs) xylene and toluene, found in solvents used by the printing, painting, and petrochemical industries.

The in vitro method "opens new possibilities for toxicity testing of industrial chemicals, environmental contaminants, workplace airborne contaminants, and fire combustion products", says Dr Hayes.

The technique has several advantages over conventional tests:

* The use of human cells (as opposed to animal cells) generates data representative of direct human chemical exposure.

* A number of human cell types such as lung, skin and liver can be used to represent target organs that are more likely to be significantly exposed or affected by air pollutants. As the respiratory system is both a site of toxicity for pulmonary toxicants, and a pathway for inhaled chemicals to reach other organs, relevant airway cells and lung cells are a major focus for inhalation studies.

* The advantage of using human cell lines and cultures is that the researcher can study toxicity mechanisms at the molecular/cellular level at an earlier stage specifically for individual chemicals, depending on their site of action within the human body without using animals. For example, when assessing the toxicity of formaldehyde, which is known to have a toxic effect on the liver, liver type cells such as hepatocytes can be chosen.

* The in vitro technique is cheap and portable, so scientists can measure immediate toxicity events, rather than waiting for toxicity to be expressed as organ or organism failure many months or even years down the track from initial exposure.

* The application of in vitro methods could open new possibilities for toxicity testing of industrial chemicals, occupational and environmental contaminants, combustion products and respiratory therapeutics and lead to a better understanding of the interactions between chemical exposure and toxic effects of single chemicals and chemical mixtures.

###

Contact: Dr Amanda Hayes
University of New South Wales

Medicsight Plc Receives Canadian Medical Device Licenses For ColonCAD API And LungCAD API

2007-04-16T14:12:00.001-07:00

MGT Capital Investments, Inc. (Amex: MGT), an investment company focused on the health care information technology sector, announced today that its subsidiary, Medicsight plc, was granted medical device licenses from the Therapeutic Products Directorate (TPD) of Health Canada to begin marketing and selling Medicsight ColonCAD API and Medicsight LungCAD API.

David Sumner, chief executive officer of Medicsight plc, commented, "We are extremely pleased to receive Canadian medical device licenses for our colon and lung CAD products. These approvals build on Medicsight's recent ColonCAR(TM) market release in the United States and Europe and expands the addressable market of our CAD products for the Company and its distribution partners."

Mr. Sumner continued, "Medicsight's ColonCAD addresses many of the difficulties faced by radiologists and has been designed to help unlock the full potential of virtual colonoscopy. Our LungCAD is designed to allow radiologists to detect and segment lung nodules at early stage, enhancing treatment options and disease management. For these reasons we believe that our products will be well received by the Canadian market and we will continue to work diligently to bring this important software to radiologists around the globe."

Medicsight's CAD products are designed to be seamlessly integrated into either 3D workstations or Picture Archiving Systems (PACS) and assist radiologists in the identification of potentially fatal lesions found in the lung and polyps found in the colon. Medicsight's CAD products are designed to improve radiologist workflow and productivity.

Medicsight ColonCAD API is an image-analysis software tool designed to be used with CT (computed tomography) colonography (virtual colonoscopy) to assist radiologists in detecting and measuring potential colorectal polyps. ColonCAD has been developed using one of the world's largest CT scan databases of verified CT colonography data.

Medicsight LungCAD API is a medical imaging software tool designed to assist radiologists in the evaluation of pulmonary nodules on CT scans of the lung. Developed using one of the world's largest and most population-diverse CT scan databases, the product aims to assist radiologists in detecting lesions in the lung, such as nodules, while providing valuable information to the radiologist to assess patient images more effectively.

About MGT Capital Investments, Inc.

MGT Capital Investments is an investment company with two direct subsidiaries that focus solely on the dynamic and consolidating HCIT sector. The first subsidiary, Medicsight plc, is a leading developer of computer-aided detection (CAD) and computer assisted reader (CAR) software solutions that are validated using one of the world's largest databases of verified CT scan data. Medicsight's CAD and CAR products help clinicians identify, measure, and analyze suspicious pathology, such as colorectal polyps and lung lesions. MGT Capital Investments has invested in and controls a second subsidiary, Medicexchange plc, which operates Medicexchange.com, an online multi-vendor sales channel for diagnostic, treatment and surgery planning solutions for cardiac, thoracic, breast imaging, orthopedic, and gastro intestinal imaging. Medicexchange.com provides these solutions in a low-cost, on-demand and downloadable format, enhancing access to information and products for medical imaging professionals. Additional information can be found at http://www.mgtci.com.

All forward-looking statements are made pursuant to the 'safe harbor' provisions of the Private Securities Litigation Reform Act of 1995. Forward- looking statements are based on current management expectations that involve risks and uncertainties that may result in such expectations not being realized. Potential risks and uncertainties include, but are not limited to, the risks described in company filings with the Securities and Exchange Commission.

MGT Capital Investments, Inc.
http://www.mgtci.com

Intense Cessation Treatment Proves Successful In High-Risk Smokers

2007-04-16T12:46:00.001-07:00

Hospitalized patients who undergo structured treatment to quit smoking are significantly more likely to remain smoke-free, says a new study. New research published in the February issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians (ACCP), suggests that high-risk smokers with acute cardiovascular disease are three to four times more likely to quit smoking when treated with an intensive smoking cessation program.

"Smoking is the greatest risk factor for patients with heart disease," said author Syed M. Mohiuddin, MD, FCCP, Creighton University Cardiac Center, Omaha, NE, "and our study showed that intense treatment intervention not only succeeded in getting patients to quit smoking, but it reduced hospitalizations and mortality, as well."

From January 2001 to December 2002, Dr. Mohiuddin and colleagues gathered 209 patients who were admitted to the coronary care unit at the Creighton University Cardiac Center, suffering from unstable angina, heart attack, or severe coronary heart disease. All of the patients were self-identified smokers and agreed to undergo smoking cessation intervention. Patients were then randomized into two groups: the intensive intervention group (109) and the usual care group (100).

Prior to hospital discharge, all patients received approximately 30 minutes of counseling and were given self-help materials. Treatment in the intervention group also included a minimum 12 weeks of behavior modification counseling, coupled with individualized pharmacotherapy. This included nicotine replacement therapy and/or bupropion at no cost to the patient. However, patients in the usual care group did not receive anything beyond the initial inpatient counseling session.

"The intensive component of tobacco cessation therapy was started while patients were hospitalized but continued after release," said Dr. Mohiuddin, "making the outpatient portion of this program the most significant element."

All participants returned at 3, 6, 12, and 24 months, during which follow- up medical histories and expired carbon monoxide levels were obtained. Patients who reported having not smoked during the previous evaluation period and who were confirmed by a negative expired carbon monoxide were classified as "abstinent." Those patients who were confirmed as not smoking by their expired carbon monoxide at every visit were classified as "continuously abstinent."

Compared with the usual care group, patients in the intensive treatment group had significantly higher quit rates at all follow-up time intervals. At the two-year follow-up, 39 percent of the intensive treatment group was continuously abstinent, compared with only 9 percent of the usual care group. Additionally, treatment was shown to reduce the risk of hospitalization by nearly half. Researchers also found that those in the control group were four times as likely to die than were patients in the intervention group.

"Cessation of smoking results in an almost immediate improvement in the risk of heart attack," said Dr. Mohiuddin, "and our study proves that intense smoking cessation treatment in high-risk patients is successful and that it saves lives."

"Smoking clearly links patients with cardiovascular disease to adverse outcomes," said Mark J. Rosen, MD, FCCP, President of the American College of Chest Physicians. "It's never too late to quit smoking and all patients who smoke should work with their doctors to find the quit method that works best for them."

CHEST is a peer-reviewed journal published by the ACCP. It is available online each month at http://www.chestjournal.org. The ACCP represents 16,500 members who provide clinical respiratory, sleep, critical care, and cardiothoracic patient care in the United States and throughout the world. The ACCP's mission is to promote the prevention and treatment of diseases of the chest through leadership, education, research, and communication. For more information about the ACCP, please visit the ACCP Web site at http://www.chestnet.org.

American College of Chest Physicians
http://www.chestnet.org

Sanofi-Aventis Announces Update To U.S. Prescribing Information For Ketek(R) (Telithromycin)

2007-04-16T12:06:00.001-07:00

Sanofi-aventis today announced that the U.S. Food and Drug Administration (FDA) has approved revisions to the US Prescribing Information for Ketek(R) (telithromycin).

These revisions follow discussions with the FDA and are based on recommendations of a FDA Joint Advisory Committee meeting of the Drug Safety and Risk Management Advisory Committee and Anti-infective Drug Advisory Committee held in December 2006. The revisions include:

- A boxed warning to alert physicians and patients that the use of the drug is contraindicated in patients with myasthenia gravis (a rare autoimmune disease),

- Updated warnings about possible visual disturbances and loss of consciousness (syncope).

- Deletion of the indications for acute exacerbation of chronic bronchitis (AECB) and acute bacterial sinusitis (ABS).

Ketek(R) remains indicated in patients with mild to moderate community- acquired pneumonia (CAP) caused by susceptible pathogens, including multidrug- resistant Streptococcus pneumoniae (MDRSP).

Ketek(R), when used as directed in its approved indication continues to be an important option in the anti-infective armamentarium and helps to satisfy a medical need.

Ketek(R) is currently approved and marketed in over 50 countries. Since its launch, it is estimated that 28 million patients have been treated with Ketek(R) worldwide.

MORE INFORMATION

In consultation with the FDA, sanofi-aventis has prepared a Medication Guide to be distributed to patients along with every prescription of Ketek. The Medication Guide communicates the rare but potentially serious adverse events associated with the use of Ketek.

In the U.S., sanofi-aventis will inform healthcare professionals about the revisions to the U.S. prescribing information through a "Dear Healthcare Professional" letter, sales force educational communications to healthcare professionals and the posting of the updated prescribing information and Medication Guide on the company and product Web sites (http://www.sanofi- aventis.us and http://www.Ketek.com).

Sanofi-aventis will also be contacting several patient organizations concerned with myasthenia gravis to ensure these parties have the most updated information regarding the label change of Ketek.

Additional information regarding the Medication Guide and update to the Ketek prescribing information can be found on the FDA Web site.

About Ketek

Ketek is contraindicated in patients with myasthenia gravis. There have been reports of fatal and life-threatening respiratory failure in patients with myasthenia gravis associated with the use of Ketek.

KETEK tablets are indicated for the treatment of community-acquired pneumonia (of mild to moderate severity) due to Streptococcus pneumoniae, (including multi-drug resistant isolates [MDRSP*]), Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae, for patients 18 years old and above.

MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are isolates resistant to two or more of the following antibiotics: penicillin, 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

KETEK is contraindicated in patients with myasthenia gravis. Exacerbations of myasthenia gravis have been reported in patients and sometimes occurred within a few hours of the first dose of telithromycin. Reports have included fatal and life-threatening acute respiratory failure with a rapid onset and progression.

KETEK is contraindicated in patients with previous history of hepatitis and/or jaundice associated with the use of KETEK tablets, or any macrolide antibiotic.

KETEK is contraindicated in patients with a history of hypersensitivity to telithromycin and/or any components of KETEK tablets, or any macrolide antibiotic.

Concomitant administration of KETEK with cisapride or pimozide is contraindicated.

Acute hepatic failure and severe liver injury, in some cases fatal, have been reported in patients treated with KETEK. These hepatic reactions included fulminant hepatitis and hepatic necrosis leading to liver transplant, and were observed during or immediately after treatment. In some of these cases, liver injury progressed rapidly and occurred after administration of a few doses of KETEK.

Physicians and patients should monitor for the appearance of signs or symptoms of hepatitis, such as fatigue, malaise, anorexia, nausea, jaundice, bilirubinuria, acholic stools, liver tenderness or hepatomegaly. Patients with signs or symptoms of hepatitis must be advised to discontinue KETEK and immediately seek medical evaluation, which should include liver function tests. If clinical hepatitis or transaminase elevations combined with other systemic symptoms occur, KETEK should be permanently discontinued.

Ketek must not be re-administered to patients with a previous history of hepatitis and/or jaundice associated with the use of KETEK tablets, or any macrolide antibiotic.

In addition, less severe hepatic dysfunction associated with increased liver enzymes, hepatitis and in some cases jaundice was reported with the use of KETEK. These events associated with less severe forms of liver toxicity were reversible.

Telithromycin has the potential to prolong the QTc interval of the electrocardiogram in some patients. QTc prolongation may lead to an increased risk for ventricular arrhythmias, including torsades de pointes. Thus, telithromycin should be avoided in patients with congenital prolongation of the QTc interval, and in patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (e.g., quinidine and procainamide) or Class III (e.g., dofetilide) antiarrhythmic agents.

Cases of torsades de pointes have been reported post-marketing with KETEK. In clinical trials, no cardiovascular morbidity or mortality attributable to QTc prolongation occurred with telithromycin treatment in 4780 patients in clinical trials, including 204 patients having a prolonged QTc at baseline.

KETEK may cause visual disturbances particularly in slowing the ability to accommodate and the ability to release accommodation. Visual disturbances included blurred vision, difficulty focusing, and diplopia. Most events were mild to moderate; however, severe cases have been reported.

There have been post-marketing adverse event reports of transient loss of consciousness including some cases associated with vagal syndrome.

Because of potential visual difficulties or loss of consciousness, patients should attempt to minimize activities such as driving a motor vehicle, operating heavy machinery or engaging in other hazardous activities during treatment with KETEK. If patients experience visual disorders or loss of consciousness while taking KETEK, patients should not drive a motor vehicle, operate heavy machinery or engage in other hazardous activities.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including KETEK, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C difficile, and surgical evaluation should be instituted as clinically indicated.

Therapy with simvastatin, lovastatin, or atorvastatin should be suspended during the course of KETEK treatment. Concomitant treatment of KETEK with rifampin, a CYP 3A4 inducer, should be avoided.

Most adverse events were mild to moderate and included diarrhea, nausea, headache, dizziness, and vomiting.

About sanofi-aventis

Sanofi-aventis is one of the world's leading pharmaceutical companies. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven major therapeutic areas: cardiovascular, thrombosis, oncology, metabolic diseases, central nervous system, internal medicine and vaccines. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Forward Looking Statements

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FDA Revises Label Warnings On The Antibiotic Ketek

2007-04-16T11:18:00.001-07:00

The US Food and Drug Administration (FDA) has revised the label warnings on the antibiotic Ketek, to improve safe use by patients. Ketek is the brand name of Telithromycin and is manufactured by Sanofi-Aventis.

The FDA has removed approval of the drug for treatment of acute bacterial infections associated with sinusitis and chronic bronchitis. Ketek retains FDA approval for treatment of community acquired pneumonia of "mild to moderate severity" but it will carry a black box label, the most severe level of warning issued by the FDA.

The new label will warn that patients with the muscle weakness autoimmune disease myasthenia gravis should not take the drug. It will also carry a stronger warning about potential side effects such as "visual disturbances" and "loss of consciousness".

This is the second time that Ketek's label has changed in the last 12 months. In June last year the label was strengthened to point out the danger of hepatic toxicity ( a rare but severe symptom of liver disease).

Dr Steven Galson, Director at the Center for Drug Evaluation and Research said the "Action is the result of comprehensive scientific analysis and thoughtful public discussion of the data available for Ketek, and includes important changes in the labeling designed to improve the safe use of Ketek by patients and give healthcare providers the most up-to-date prescribing information."

A new patient information leaflet will also accompany the prescription, explaining the drug's safe use and risks.

These changes reflect the advice given out in December last year by the FDA's Anti-Infective Drugs and Drug Safety and Risk Management Advisory Committees.

The committees pointed out that since the drug was approved in April 2004, new evidence shows that the balance of risks versus benefits has changed. Much of this relates to cases of liver damage, disturbed vision and loss of consciousness.

Dr John Jenkins, Director at the FDA's Center for Drug Evaluation and Research, Office of New Drugs, said that the new benefits versus risk assessment does not support the use of Ketek for self-limited and less serious illnesses such as sinusitis and bronchitis.

But he said the drug will continue to be "approved for community-acquired pneumonia of mild to moderate severity, which is a more serious illness that generally does not resolve without antibiotic therapy."

According to reports by the Associated Press the FDA's handling of Ketek is under Senate investigation. Also, today is the day that the House of Representatives Subcommittee on Oversight and Investigations is hearing witness statements on "The Adequacy of FDA Efforts to Assure the Safety of the Drug Supply", which according to a Bloomberg press report yesterday includes "irregularities in the approval of Ketek".

The drug has a somewhat tortuous pharmacological history. A group of antiobiotics called macrolides was developed to treat people allergic to penicillin. But then some bacteria became macrolide resistant. Enter the Ketolides - developed to defeat the macrolide-resistant bacteria that cause respiratory infections.

Telithromycin (the generic name for Ketek) is a ketolide antibiotic with a similar structure to one of the macrolides - Erythromycin. It works by stopping the bacteria from being able to produce protein which limits the spread of the colony in the respiratory tract.

Telithromycin is metabolized mostly in the liver and has a half life in the body of about 10 hours.

Click here for more information on Telithromycin from the FDA.

Click here for more information on Telithromycin from wikipedia.

Written by: Catharine Paddock
Writer: Medical News Today

Survival In Asbestos-Related Cancer Improved By Chemo Combination

2007-04-16T11:06:00.001-07:00

People with mesothelioma - a form of cancer associated with asbestos exposure - have a higher survival rate when treated with a combination of two cancer drugs, a large multicenter study finds.

Mesothelioma, a rare but aggressive form of cancer that occurs in the lining of the lungs, heart and abdomen, is associated with exposure to asbestos. There is no known cure.

In the study, patients receiving pemetrexed and cisplatin - along with the vitamin supplements folic acid and B12 - survived nearly three months longer than patients getting cisplatin alone.

Researchers led by John Green, M.D., at the Clatterbridge Center for Oncology in England, reviewed a study of 448 patients with advanced mesothelioma who were treated with either the single drug or the combination.

"Pemetrexed used in combination with cisplatin significantly increases the length of survival, when compared with cisplatin alone," the researchers say. "Further research is needed into the optimum treatment regimen for pleural mesothelioma."

The review appears in the current issue of The Cochrane Library, a publication of The Cochrane Collaboration, an international organization that evaluates medical research. Systematic reviews draw evidence-based conclusions about medical practice after considering both the content and quality of existing medical trials on a topic.

The researchers examined data from a clinical trial of 20 treatment centers in Europe, the Americas, Australia and Asia. Eighty-one percent of the patients were men, with an average age of 61. Patients who received the combination treatment survived an average 2.8 months longer.

Patients receiving both medications also reported improved quality of life in terms of fatigue, loss of appetite, pain and cough.

During the early stages of the trial, patients receiving pemetrexed had serious symptoms of toxicity, including drug-related death. Other side effects included blood cell abnormalities, nausea and diarrhea, which decreased in both incidence and severity after the vitamins were added to the treatment. People who work trades such as shipbuilding, railway engineering, construction work and asbestos manufacture have higher rates of mesothelioma than the general public. The cancer may take 10 to 60 years to develop, and the risk does not diminish after exposure to asbestos has stopped. Family members of people exposed to asbestos at work also have an increased risk of developing mesothelioma from asbestos fibers carried home on the clothes of the people they live with.

Daniel Baram, M.D., a pulmonologist at the Lung Cancer Evaluation Center at the State University of New York, said, "Most cases [of mesothelioma] are still from pre-OSHA workplace improvements. I suspect that modern asbestos abatement precautions will avoid most, if not all, future cases. The latency is over 30 years, so we are still diagnosing cases with exposure during World War II and the '40s and '50s."

Mesothelioma is difficult to diagnose, Green said, because "there is a lag of many years between exposure and asbestosis, which is a nonmalignant condition, and a greater lag before the development of overt malignancy."

"There is no way of diagnosing the premalignant phase during the latent period of 15 to 20 years," Green added. "Many of these patients smoke and are in economically disadvantaged communities. Many individuals have moved away from heavy industries and may not admit or know they were exposed to asbestos as young men, with similar issues for their partners."

According to the U.S. Environmental Protection Agency, 10 percent to 15 percent of schools and other public buildings in the United States contain asbestos insulation.

Although safety measures for working with asbestos have been in place since the 1970s, mesothelioma is projected to account for 65,000 deaths between 2001 and 2050 worldwide, peaking between 2012 and 2015, according to background information in the review.

It is a personal matter as to whether the survival increase for patients receiving the two drugs is worthwhile, Baram said. "It depends in large part on the patient. A 2.8-month mean survival increase means that some patients may get even more than that, though some people will get less. Many, if not most, patients when faced with a disease with a very bad prognosis are often willing to undergo aggressive therapy, although the toxicity is serious and potentially life-threatening."

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By Lise Millay Stevens, Contributing Writer
Health Behavior News Service

Green J, et al. Pemetrexed disodium in combination with cisplatin versus other cytotoxic agents or supportive care for the treatment of malignant pleural mesothelioma. Cochrane Database of Systematic Reviews 2007, Issue 1.

The Cochrane Collaboration is an international nonprofit, independent organization that produces and disseminates systematic reviews of health care interventions and promotes the search for evidence in the form of clinical trials and other studies of interventions. Visit http://www.cochrane.org/ for more information.

Contact: Lisa Esposito
Center for the Advancement of Health

New York Mayor Urges Federal Government To Pay For Sept 11 Health Care

2007-04-16T10:09:00.001-07:00

New York Mayor Michael Bloomberg called on the US government to inject 1 billion dollars into a Sept 11 victims' compensation fund that closed in 2004. He said the City cannot afford to foot the bill for the claims that will come forward from people with health problems emerging years after the collapse of the World Trade Centre.

Bloomberg says that the City's bill for dealing with the health problems caused by Sept 11 will cost nearly 400 million dollars a year and it can't afford to do this without federal support.

A recent report commissioned by the mayor says that the city has spent over 2 billion dollars in the last five years on diagnosing and treating citizens with health issues arising out of the trade centre collapse.

He said they could not afford to provide the care that people deserved in the longer term.

He also asked for 150 million dollars a year to support people with physical and mental health problems arising directly from Sept 11.

According to the 80 page report by the World Trade Center Health Panel set up by the Mayor, over 400,000 citizens who were exposed to the toxins in the smoke and dust which lingered for weeks while the twin towers burned qualify for health monitoring. Some 71,000 of them have registered with a scheme that will monitor their health for the next 20 years.

Many of the people who fell ill had mental health and lung problems.

Following the recommendations of the Health Panel, the Mayor held a briefing at a City Hall, where he said that the federal government should as a minimum fund these essential needs and that anything less would be "turning their backs on those who responded with courage and suffering".

US Representative and Manhattan Democrat Jerrold Nadler, and New York Democrat and Senator Hillary Clinton have brought in legislation to give New York funds towards the clean up operation and for treating people with illnesses caused by the dust and toxins arising from the burning aftermath of the towers.

The Mayor said that one of the research programmes the City would establish is to track the progress of cancer and other diseases being diagnosed in uniformed and civilian first responders, including 34,000 police officers and several thousand firefighters.

Another programme would double the diagonostic and treatment capacity to 12,000 patients at Bellevue Hospital for immigrants and residents of Chinatown.

Mayor Bloomberg said if victims aren't compensated for the injuries and illnesses they suffer as a result of helping with the clear up, one might question whether people would be so willing to come forward so selflessly should another disaster occur.

He said the the first responders were "responding to an act of war against this nation," and that meant federal government had a clear responsibility to meet here.

Federal funds amounting to 20 billion dollars in the form of aid and tax concessions have been awarded for the rebuilding of the lower Manhattan area. President Bush has also allocated 25 million in his recent budget to pay for health care for emergency workers.

The World Trade Center Health Panel said the current federal plans for supporting the health care of the people affected by Sept 11 were "modest and short term". They are suggesting the focus needs to be on the longer term too.

The September 11th Fund Home Page.

Written by: Catharine Paddock
Writer: Medical News Today

Why Only Some Cystic Fibrosis Patients Respond To Treatments That Prevent The Generation Of Truncated Proteins

2007-04-16T09:17:00.001-07:00

Individuals with the genetic lung disorder cystic fibrosis (CF) lack any functional CFTR protein because their genes that encode this protein carry a mutation. One mutation (the W1282X mutation) that results in CF does so because it causes the cellular machinery that converts the initial product of a gene (mRNA) into a functional protein to prematurely stop making CFTR protein. Agents (such as gentamicin) that enable the protein-generating machinery to ignore such mutations have shown benefit in some, but not all, CF patients with the W1282X mutation. In a study that appears online in advance of publication in the March print issue of the Journal of Clinical Investigation, researchers from The Hebrew University of Jerusalem, Israel, describe a potential molecular explanation for the distinct responsiveness of patients with Cf to treatment with gentamicin.

Batsheva Kerem and colleagues found that CF patients with the W1282X mutation who responded to treatment with gentamicin expressed more nonsense CFTR mRNA than patients who did not respond to treatment. Further analysis showed that different cell lines from CF patients with the W1282X mutation had distinct abilities to destroy nonsense mRNA. Inhibiting the destruction of nonsense mRNA in these cell lines increased the amount of nonsense CFTR mRNA present, making them more susceptible to the ability of gentamicin to induce the production of functional CFTR protein. This study suggests that the ability of an individual's affected cells to destroy nonsense mRNA determines how responsive CF patients with the W1282X mutation are likely to be to treatment with gentamicin. Such observations might also extend to other genetic disorders in which mutations causing the cellular machinery to prematurely stop making protein have been identified, such as Duchenne muscular dystrophy.

TITLE: Nonsense-mediated mRNA decay affects nonsense transcript levels and governs response of cystic fibrosis patients to gentamicin

AUTHOR CONTACT:
Batsheva Kerem
The Hebrew University of Jerusalem, Jerusalem, Israel.

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JCI table of contents -- February 8, 2006

Contact: Karen Honey
Journal of Clinical Investigation

Astrazeneca Launches A Smarter Approach To Asthma Management In Europe

2007-04-16T09:06:00.001-07:00

AstraZeneca today announced that 37 countries to date have received approval of Symbicort® Maintenance And Reliever Therapy (Symbicort SMART®), and that a period of world wide launches will now be initiated. This new, smarter approach to asthma is the first to provide patients with both asthma maintenance and reliever therapy together in just one inhaler.

With the Symbicort SMART management approach, patients receive inhaled corticosteroid (ICS) and long acting bronchodilator (LABA) with every inhalation. Thus, with Symbicort SMART it is possible to treat the underlying inflammation with every inhalation, even when used for rapid symptom relief, making it a more effective way to manage asthma. A separate SABA (short acting bronchodilator) inhaler is therefore no longer needed. Symbicort SMART has been proven to reduce exacerbations by 39% compared with salmeterol / fluticasone combination and a separate reliever medication.1

The Symbicort SMART treatment approach is possible only because Symbicort combines two components in one inhaler: budesonide, an ICS to provide an anti-inflammatory effect in the airways, and formoterol, a unique bronchodilator that is both rapid in effect and long lasting (LABA). The other LABA available for maintenance treatment of asthma, salmeterol, does not have the properties that enables it to be used in this way. Consequently, Seretide™ (salmeterol/fluticasone) can not be used in the same way as Symbicort SMART. Patients on Symbicort SMART receive a maintenance dose in line with normal practice to establish asthma control and can then take additional inhalations 'as needed' if symptoms occur, to provide both rapid symptom relief and increased asthma control in the longer term.

"We know that patients tend to over-rely on their symptom relief inhaler when experiencing a worsening of their symptoms," comments Professor Claus Vogelmeier, Professor of Medicine and Head of Pulmonary Division, Marburg University Hospital Germany, and speaker at the official Symbicort SMART launch event in Lund. "Although patients consistently adjust their medication in response to asthma variations, often the adjustment in maintenance therapy is delayed in response to an exacerbation. With Symbicort SMART, physicians can be sure that patients are receiving their anti-inflammatory treatment with every inhalation, ensuring their asthma is better controlled."

The Symbicort SMART approach is recognised by the Global Initiative for Asthma (GINA) who recently announced revised international treatment guidelines on best practice in the prevention and treatment of asthma. The guidelines support the need for a new management approach - Symbicort SMART.2

"Previous editions of the GINA Guidelines have perhaps led to an impression that mild asthma could be equated to mild symptoms and severe asthma to severe symptoms, which we know is not the case," comments Dr Paul O'Byrne, McMaster University, Ontario, Canada and Chair of the GINA Executive Committee. "Asthma is a variable disease and the GINA Committee felt that a treatment approach based upon effective control of symptoms and exacerbations would better reflect the natural course of the disease. The result will be improved outcomes by allowing treatment to be rapidly increased when symptoms first appear and then brought back down again when control is achieved, and thus let the dosing respond quickly to the patients' asthma control status."

Symbicort SMART has been tested extensively in a wide clinical trial program involving over 14,000 patients with persistent asthma. These studies consistently show that Symbicort SMART, irrespective of asthma severity, reduces the risk of patients developing potentially life-threatening asthma attacks compared with traditional treatment approaches such as fixed dosing with either higher doses of ICS plus a short-acting bronchodilator (SABA) or with an ICS/LABA combination therapy plus a SABA. 1, 3-7

In the EU, Symbicort SMART is licensed for use in adults with a need for ICS / LABA combination treatment. National launches are expected throughout the EU over the coming months.

"We are delighted to announce the launch of Symbicort SMART in Europe," said Dr John Patterson, Executive Director, Development for AstraZeneca. "This new treatment approach will simplify asthma management and has the potential to improve the lives of a great many asthma patients. We now have a management approach that provides the reassurance of instant relief when needed and in the same breath treats the underlying disease for the long term. This is a significant step forward for asthma patients."

To date, Symbicort has been effectively and widely used as a traditional maintenance treatment for asthmatics across the world. With the advent of today's launch of Symbicort SMART, Symbicort is the first maintenance therapy to als

o be proven effective and licensed for maintenance and reliever therapy in one inhaler. AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the world's leading pharmaceutical companies with healthcare sales of $26.47 billion and leading positions in sales of gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infection products. AstraZeneca is listed in the Dow Jones Sustainability Index (Global) as well as the FTSE4Good Index.

For further updates, news and information on Symbicort, please visit
http://www.astrazenecapressoffice.com

References

1. Kuna P, Peters MJ, Buhl R. Budesonide/formoterol as maintenance and reliever therapy reduces asthma exacerbations versus a higher maintenance dose of budesonide/formoterol or salmeterol/fluticasone. Abstract presented at the ERS Congress 2006.

2. The Global Initiative for Asthma (GINA). GINA Report, Global Strategy for Asthma Management and Prevention, published November 2006. www.ginasthma.com

3. Rabe K, Atienza T, Magyar P et al. Reduction in asthma exacerbations with budesonide in combination with formoterol for reliever therapy: a randomised, controlled, double-blind study. Lancet 2006;368: 744-53.

4. Vogelmeier C, D'Urzo A, Pauwels R, Merino JM, Jaspal M, Boutet S, Naya I, Price D. Budesonide/formoterol maintenance and reliever therapy: an effective asthma treatment option? Eur Respir J 2005; 26(5): 819-828.

5. O'Byrne P, Bisgaard H, Godard P, Pistolesi M, Palmqvist M, Zhu Y, EkstrГ¶m T, Bateman E. Budesonide/Formoterol Combination Therapy as Both Maintenance and Reliever Medication in Asthma. American Journal of Respiratory and Critical Care Medicine 2005; 171(2): 129-136.

6. Scicchitano R, Aalbers R, Ukena D, Manjra A, Fouquert L, Centanni S, Boulet L-P, Naya IP, Hultquist C. Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Current Medical Research and Opinion 2004;20(9):1403-18.

7. Klaus F. Rabe, Emilio Pizzichini, BjГ¶rn StГ¤llberg, Santiago Romero, Ana M. Balanzat, Tito Atienza, Per Arve Lier, and Carin Jorup, Budesonide/Formoterol in a Single Inhaler for Maintenance and Relief in Mild-to-Moderate Asthma: A Randomized, Double-Blind Trial, Chest, Feb 2006; 129: 246 - 256

Symbicort SMART -- Symbicort SMART improves daily symptom control and reduces asthma attacks while patients only need one inhaler*. A separate short-acting bronchodilator is no longer needed. Patients prescribed Symbicort SMART, take a maintenance dose of Symbicort every day in line with normal practice to establish asthma control and take additional inhalations 'as needed' of Symbicort if symptoms occur, to provide both rapid symptom relief and improved asthma control. *not indicated for prophylactic use before exercise

-- Symbicort SMART successfully completed the European Union Mutual Recognition Procedure (MRP) in October 2006

-- Symbicort SMART is currently approved in 37 countries worldwide

-- Symbicort is currently approved in more than 90 countries; sales were $585 million in the first half 2006 (up 24 percent on 2005 figures) and have now reached more than five million treatment years

-- Symbicort received FDA approval in the US in July 2006 for maintenance treatment of asthma (in patients from 12 years of age)

Asthma -- Asthma is a chronic inflammatory condition of the airways characterised by reversible airway obstruction. It is a variable condition that can change both daily and seasonally

-- Most asthma patients require maintenance treatment with an inhaled corticosteroid (ICS), which suppresses the underlying airway inflammation, and a bronchodilator, which relaxes the smooth muscle of the airways.

High Rates Of Latent TB Infection Found In Russian Health Workers

2007-04-16T08:15:00.001-07:00

Testing for tuberculosis has revealed that nearly 40% of the doctors in one Russian city have latent infection, with even higher levels in those who work in TB clinics. The research has been published in PLoS Medicine.

TB disease is a growing problem worldwide. Russia is one country where it is particularly common. Although up to a third of the world's population are infected with the bacterium that causes the disease, in most people the infection remains 'latent'. It is important to detect latent infection in order to reduce the spread of the infection and to hold back the rise in the number of active cases. Working in Samara City in the Russian Federation, researchers from Queen Mary College, UK and colleagues in Samara, tested both health workers and students for latent TB. All the health staff, including students, were found to have higher rates of infection than other people in Samara. The 47% infection rate found in staff in TB clinics was ten times higher than that in the population at large.

The study authors say that, although more research is first needed, it may be necessary to conduct regular occupational health screening for latent infection followed by treatment where appropriate. However, even this may not be effective in controlling rates of active infection, as resistance to TB drugs is so common.

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Everything published by PLoS Medicine is Open Access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.

Note: The test used by the researchers was not the 'traditional' tuberculin skin test, as this is not reliable when used with people who were given the 'BCG' vaccination for TB early in life, which is common in Russia as in many other countries. The new 'IFN-gamma' test gave good results and the researchers recommend that it be used in further research of this kind.

Citation: Drobniewski F, Balabanova Y, Zakamova E, Nikolayevskyy V, Fedorin I (2007) Rates of latent tuberculosis in health care staff in Russia. PLoS Med 4(2): e55.

PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT

CONTACT:

Francis Drobniewski
Barts and the London School of Medicine and Dentistry
Queen Mary College
University of London
2 Newark Street
London, E1 2AT United Kingdom

Contact: Andrew Hyde
Public Library of Science

Ethiopians With TB Must Overcome Barriers To Complete Treatment

2007-04-16T08:06:00.001-07:00

One in five Ethiopians treated for tuberculosis fails to complete the length course of drugs required, according to a study by Ethiopian and Norwegian researchers, published in PLoS Medicine. The research has made clear some of the difficulties that patients must overcome in order to succeed in completing a course of treatment. People who cannot easily travel to a treatment centre are the most likely to 'default'.

Tuberculosis is one of the world's leading causes of death and the number of cases is increasing. Ethiopia is one of the worst affected countries. The treatment recommended by the World Health Organization (WHO) can be very effective for most patients but it does involve taking drugs for at least six months. Patients may find it difficult to complete the full treatment, although it helps to have a system where trained observers help make sure that each patient takes all the necessary pills. WHO promotes this approach - known as DOTS (directly observed treatment short course) - and says national programs should aim for a treatment completion rate of at least 85%. Ethiopia was already known to have made good progress towards this goal during the 1990s. However, the researchers wanted to know why those people still not completing treatment were failing to do so.

They studied over 400 patients diagnosed and registered for treatment in a hospital in Hossana Hospital in southern Ethiopia over a two-year period. Using questionnaires they recorded information about the patients' circumstances. They recorded who completed or failed to complete treatment and analysed their data to determine which factors were most closely associated with failure to complete.

The overall completion rate was 80% (i.e. 20% failed to complete), still some way short of the WHO target. The patients who needed to use public transport, which is expensive for many Ethiopians, in order to reach a treatment centre were the most likely to fail to complete. This was despite the fact most of the patients in the study lived in less remote areas than the majority of southern Ethiopians. Other factors were also noted; for example people aged over 25 were less likely to finish their treatment.

The researchers concluded that it will be necessary for the Ethiopian government to continue to expand its efforts to improve access to treatment centres for patients with TB.

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Everything published by PLoS Medicine is Open Access: freely available for anyone to read, download, redistribute and otherwise use, as long as the authorship is properly attributed.

Citation: Shargie EB, LindtjГёrn B (2007) Determinants of treatment adherence among smear-positive pulmonary tuberculosis patients in southern Ethiopia. PLoS Med 4(2): e37.

PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT

CONTACT:

Estifanos Shargie
Centre for International Health,
University of Bergen
Bergen, Norway

About PLoS Medicine

PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org/

About the Public Library of Science

The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical literature a freely available public resource. For more information, visit http://www.plos.org/

Contact: Andrew Hyde
Public Library of Science

Spray Drying Technique Created For TB Vaccine

2007-04-16T07:09:00.001-07:00

Bioengineers and public health researchers have developed a novel spray drying method for preserving and delivering the most common tuberculosis (TB) vaccine. The low-cost and scaleable technique offers several potential advantages over conventional freezing procedures, such as greater stability at room temperature and use in needle-free delivery. The spray drying process could one day provide a better approach for vaccination against TB and help prevent the related spread of HIV/AIDS in the developing world.

The research team led by Yun-Ling Wong, a graduate researcher in bioengineering, and David Edwards, Gordon McKay Professor of the Practice of Biomedical Engineering, both at the Harvard School of Engineering and Applied Sciences, and Barry R. Bloom, Dean of the Harvard School of Public Health and Joan L. and Julius H. Jacobson Professor of Public Health, was sponsored in part by the Bill and Melinda Gates Foundation. The work appeared in the February 13 edition of the Proceedings of the National Academy of Sciences.

"With the increasing incidence of tuberculosis and drug resistant disease in developing countries due to HIV/AIDS, there is a need for vaccines that are more effective than the present Bacillus Calmette-GuГ©rin (BCG) vaccine," said Wong. "An optimal new vaccine would obviate needle injection, not require refrigerated storage, and provide a safe and more consistent degree of protection."

BCG, while the most widely administered childhood vaccine in the world, with 100 million infant administrations annually, is presently dried by freezing - or lyophilization - and delivered by needle injection. The commercial formulation requires refrigerated storage and has shown variable degrees of protection against tuberculosis in different parts of the world. Because of such limitations, public health experts and physicians have long seen a need for alternatives to the traditional BCG vaccine and current treatment strategies.

"The breakthrough for developing the spray drying process involved removing salts and cryoprotectants like glycerol from bacterial suspensions," explains Edwards. "This is counter to conventional thinking: that bacteria be dried in the presence of salts and cryoprotectants. While these substances are generally required for normal storage and freezing protocols, in the case of evaporative drying as occurs in spray drying, salt and cryoprotectants act like knives that press on the bacterial membrane with great force and inactivate the bacteria. By removing these, we managed to save the bacteria and achieve better stability."

The spray drying process developed for the BCG vaccine is similar to the way manufacturers prepare powdered milk. In fact, Edwards' first exposure to the spray drying process occurred when he was working with a spray dryer to produce highly respirable drug aerosols in a food science lab. While spray drying of small and large molecules is common in the food, cosmetic and pharmaceutical industries, the method has not been commonly used for drying cellular material. Most important, the new technique enables the BCG vaccine, and potentially other bacterial and viral based vaccines, to be dried without the traditional problems associated with standard freezing.

"Unlike traditional freezing techniques, spray drying is lower cost, easily scaleable for manufacturing, and ideal for use in aerosol (needle free) formulations, such as inhalation," says Wong. "Its greater stability at room temperature and viability ultimately could provide a more practical approach for creating and delivering a vaccine throughout the world."

Edwards, an international leader in aerosol drug and vaccine delivery, sees great promise for the advance, which he and his colleagues hope to develop in the next few years for better vaccination approaches for diseases of poverty through the international not-for-profit Medicine in Need (Mend), based in Cambridge, Paris, and Cape Town, South Africa.

"With the emergence of multidrug and extremely drug resistant TB, we hope this breakthrough is one more step to help us develop a stable vaccine to stem the tide of disease," says Bloom. "Better vaccination against TB can go a long way to addressing the current developing world health care crisis, with TB alone presently taking the lives of more than 2 million people a year. And we believe this method could also be used to improve delivery of many other vaccines."

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Wong, Edwards, and Bloom's co-authors included Samantha Sampson and Sunali Goonesekera (Harvard School of Public Health); Willem Andreas Germishuizen (Harvard School of Engineering and Applied Sciences); Giovanni Caponetti (Eratech), Jerry Sadoff (Aeras Global TB Vaccine Foundation). The work was supported by a Grand Challenge Grant from the Bill and Melinda Gates Foundation and with a grant from the National Institutes of Health.

Contact: Michael Patrick Rutter
Harvard University

Statement On The Passing Of Congressman Charlie Norwood (R-GA), By John Kirkwood, American Lung Association President & CEO

2007-04-16T07:04:00.001-07:00

The American Lung Association's volunteers and staff wish to express our deepest condolences to family of U.S. Congressman Charlie Norwood, DDS (R-GA), who died today after a long battle with idiopathic pulmonary fibrosis and lung cancer. A long-time champion for all patients, Representative Norwood inspired lung disease patients across the country when he returned to Congress following his lung transplant in 2004. American Lung Association staff and volunteers fondly remember Representative Norwood's keynote speech to our national conference in May 2002.

Idiopathic pulmonary fibrosis is a form of interstitial lung disease. When a person has idiopathic pulmonary fibrosis, the lung is affected in three ways. First, the lung tissue is damaged in some known or unknown way. Second, the walls of the air sacs in the lung become inflamed. Finally, scarring (or fibrosis) begins in the interstitium (or tissue between the air sacs), and the lung becomes stiff. The American Lung Association supports an array of research into the basic cellular and molecular processes that underlie the inflammatory response in the lungs that precedes pulmonary fibrosis. Our researchers are also examining new ways to prevent the lung scarring that follows this type of inflammation and are looking for new treatments for lungs damaged excess scar tissue formation.

Lung cancer is the number one cancer killer in the U.S., and the American Lung Association is committed to funding vital research to help fight this devastating disease including our Lung Cancer Discovery Award which is specifically directed at developing improved treatments. Lung cancer may also be the most tragic cancer because in most cases, it might have been prevented. Nearly 90 percent of lung cancer cases are caused by smoking. The more time and amount you smoke, the greater your risk of lung cancer. But if you stop smoking, the risk of lung cancer decreases each year as normal cells replace abnormal cells.

About the American Lung Association

Beginning our second century, the American Lung Association is the leading organization working to prevent lung disease and promote lung health. Lung disease death rates continue to increase while other leading causes of death have declined. The American Lung Association funds vital research on the causes of and treatments for lung disease. With the generous support of the public, the American Lung Association is "Improving life, one breath at a time." For more information about the American Lung Association or to support the work it does, call 1-800-LUNG-USA ( 1-800-586-4872) or log on to http://www.lungusa.org.

EPA Rule Slashes Toxics From Gasoline, Vehicles, And Portable Fuel Containers - USA

2007-04-16T06:14:00.001-07:00

Toxic fumes from gasoline, vehicles and fuel containers will decrease significantly, further reducing health risks under tough new standards signed today by EPA Administrator Stephen L. Johnson. By 2030, EPA's new Mobile Source Air Toxic (MSAT) regulations and fuel and vehicle standards already in place will reduce toxic emissions from cars to 80 percent below 1999 emissions.

"Americans love their cars. By clearing the air from tons of fuel and exhaust pollution, President Bush and EPA are paving the road toward healthier drivers and a cleaner environment," said EPA Administrator Stephen L. Johnson.

The MSAT rule toughens benzene standards for gasoline, sets hydrocarbon emissions standards for cars at cold temperatures and tightens fuel containers to prevent the evaporation of harmful fumes.

Once the new standards are fully implemented in 2030, they are expected to reduce emissions of mobile source air toxics annually by 330,000 tons, including 61,000 tons of benzene. EPA estimates annual health benefits from the particulate matter reductions of the vehicle standards to total $6 billion in 2030. The estimated annual cost for the entire rule is about $400 million in 2030.

The new MSAT standards will take effect in 2011 for gasoline, 2010 for cars, and 2009 for fuel containers.

Click here for a copy of this final rule

http://yosemite.epa.gov

Respiratory Research About To Experience Influx Of Talented Young Scientists, UK

2007-04-16T06:06:00.001-07:00

The field of respiratory research is about to experience an influx of talented young scientists. Twenty-one PhD students will soon begin research projects that address the role of factors as diverse as fungi, viral infection, immune system reactions and the influence of maternal diet on the serious respiratory disorders asthma, chronic obstructive pulmonary disease (COPD) and other conditions.

The research awards have been made in response to the growing number of people in the UK who suffer from respiratory disease. The medical research charities Asthma UK, the British Lung Foundation and the British Thoracic Society (with the Morriston Davies Trust) have joined together with the Medical Research Council to fund the studentships.

They hope that by encouraging young scientists to study conditions that affect the respiratory system, there will be a greater capacity to develop treatments and knowledge of these illnesses in the future.

The funding collaboration was prompted by the report of a workshop attended by clinicians, scientists, research charities and other research funders in October 2005. The report reviewed the current standing and future of respiratory medicine research in the UK.

Professor Stephen Holgate, Chair of the UK Respiratory Research Strategy Committee, said: "More and more people in the UK are becoming ill as a result of respiratory conditions. Two major disease areas, lung cancer and lung fibrosis, were still under-represented in the research applications but this simply highlights why it is so important that we encourage young scientists to begin their careers in respiratory research, build their knowledge and find out more about how and why these conditions are on the rise so that we can offer effective treatments in the future. All of the funding partners believe the collaboration is a fantastic opportunity to strengthen respiratory research."

Twelve awards will be available in 2007 and a further nine in 2008. Students all over the UK will carry out a three or four year research project and receive training in research methods and key personal skills. The first awards have been made to scientists in Aberdeen, Edinburgh, Southampton, Manchester, Nottingham, Leicester, Glasgow, Leeds, Sheffield and London.

http://www.asthma.org.uk

Hospital Performance Measures May Not Accurately Reflect Quality Of Care Or Predict Patient Outcomes

2007-04-16T03:39:00.001-07:00

A comparison of hospitals with high and low Medicare performance measures found little difference in the rate of death for three common conditions at the hospitals, indicating that the measures may not accurately reflect patient outcomes, according to a study in the December 13 issue of JAMA.

In the United States, quality of care delivered in hospitals is often variable. Because it is assumed that measuring quality of care is a key component in improving care, quality measurement has an increasingly prominent role in quality improvement, according to background information in the article. These measures can provide an incentive to improve the quality of the care delivered and to influence consumer choice of hospitals and health care plans. While some research has documented an association between higher adherence to care guidelines and better outcomes of patients who receive that care, to date there has been limited evidence demonstrating that hospitals that perform better on process measures also have better overall quality.

Rachel M. Werner, M.D., Ph.D., of the Philadelphia Veterans Affairs Medical Center, Philadelphia, and Eric T. Bradlow, Ph.D., of the University of Pennsylvania, Philadelphia, conducted a study to determine whether certain quality measures are correlated with and predictive of hospitals' risk-adjusted death rates. The researchers analyzed data from Hospital Compare, a website of the Centers for Medicare & Medicaid Services (CMS) that reports results of hospital performance measures. This study included data on hospital care between Jan. 1 and Dec. 31, 2004, for heart attack, heart failure, and pneumonia at acute care hospitals included on the Hospital Compare website. Ten process performance measures were compared with hospital risk-adjusted death rates, which were measured using Medicare Part A claims data. A total of 3,657 acute care hospitals were included in the study based on their performance reported in Hospital Compare.

Across all heart attack performance measures, the absolute reduction in risk-adjusted death rates between hospitals performing in the 25th percentile vs. those performing in the 75th percentile was 0.005 for inpatient death, 0.006 for 30-day death, and 0.012 for death at 1-year. For the heart failure performance measures, the absolute death reduction was smaller, ranging from 0.001 for inpatient death to 0.002 for 1-year death. For the pneumonia performance measures, the absolute reduction in death ranged from 0.001 for 30-day death to 0.005 for inpatient death.

"Our study suggests that in the case of hospital performance, the CMS's current set of performance measures are not tightly linked to patient outcomes. These findings should not undermine current efforts to improve health care quality through performance measurement and reporting. However, attention should be focused on finding measures of health care quality that are more tightly linked to patient outcomes. Only then will performance measurement live up to expectations for improving health care quality," the authors conclude.

(JAMA. 2006;296:2694-2702.)

Dr. Werner was supported by a career development award from the Department of Veterans Affairs. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Commentary: Performance Measures and Clinical Outcomes

In an accompanying commentary, Susan D. Horn, Ph.D., of the Institute for Clinical Outcomes Research, Salt Lake City, discusses the findings concerning hospital performance measures.

Dr. Horn notes, "The results of this study raise questions about the appropriateness of using Hospital Compare performance measures as the basis either for pay-for-performance systems or for consumers to identify better-quality hospitals. If performance measures are not strongly associated with better outcomes, why should clinicians and health care centers be required to collect and submit the data, and why would payers and consumers want to act on them""

"As the study by Werner and Bradlow illustrates, current simplistic process measures based on randomized controlled trials (RCTs) do not necessarily provide a meaningful basis for consumers to choose one clinician or hospital over another, or for clinicians or hospitals to improve their outcomes. In the real world where multiple clinical variables and patient factors affect outcomes, RCTs and comprehensive observational studies both have a role to play in improving patient care: the effects of RCTs in clinical practice can be examined in observational studies and observational studies can be progenitors [originators] for new RCTs. Patients, physicians, and policymakers will all benefit from efforts to evaluate rigorously and further understand the relationship between performance measures and clinical outcomes."

(JAMA. 2006;296:2731-2732.)

Dr. Horn reports that she in an employee, officer, shareholder, and founder of International Severity Information Systems Inc., which provides products and services to facilitate studies on practice-based evidence for clinical improvement.

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Contact: Judi Cheary
JAMA and Archives Journals

FDA Approves Cyanokit(R) For Treatment Of Cyanide Poisoning

2007-04-16T03:34:00.001-07:00

EMD Pharmaceuticals and Dey, LP, U.S. Affiliates of Merck KGaA of Darmstadt, Germany, jointly announced today that the U.S. Food and Drug Administration (FDA) has approved Cyanokit(R) (hydroxocobalamin for injection), for the treatment of known or suspected cyanide poisoning.

EMD Pharmaceuticals completed the submission of a New Drug Application (NDA) for Cyanokit(R) (hydroxocobalamin for injection) to the FDA in June of 2006. Dey, LP is located in Napa, CA and will market Cyanokit in the US market. Dey, LP expects Cyanokit to be available early in 2007.

Cyanokit's unique mechanism of action makes possible its use in a pre- hospital or hospital setting. It is the first cyanide antidote to be approved in the United States in several decades.

In the U.S., cyanide poisoning is primarily caused by smoke inhalation during closed space structural fires. Additional causes may include accidental or intentional ingestion or exposure during industrial accidents or a terrorist attack involving cyanide.

"We are very pleased with the FDA's decision to approve Cyanokit," said Christy Taylor, Senior Vice President of Marketing, Sales and Business Development for Dey, LP. "Treating cyanide poisoning as soon as possible after exposure is critical to survival. Emergency responders will now have a way to treat people for cyanide poisoning immediately at the scene of a fire, accident or other emergency as well as in the emergency department of a hospital. We anticipate that the availability of Cyanokit will have a significant impact on the survival of those who are affected by cyanide poisoning."

Cyanokit Exhibited Positive Safety, Efficacy Profiles

The FDA approval is supported by efficacy studies in animals and safety studies in healthy adults. These studies demonstrated that Cyanokit is safe and effective in treating cyanide poisoning from smoke inhalation and other causes.

At the American College of Emergency Physicians 2005 Research Forum, investigators Frederic Baud, MD, Medical and Toxicological Critical Care Department, Lariboisiere Hospital, Paris, France and Stephen W. Borron, MD, FACEP of The University of Texas Health Science Center at San Antonio presented the results of several studies including a prospective open-label study(1) carried out in 69 subjects who had been exposed to smoke inhalation from fires. Subjects were over 15 years of age, presented with soot in the mouth or nose and expectoration, and had altered neurological status. The median Cyanokit dose was 5.0 g with a range from 4.0 to 15.0 g.

Fifty of 69 patients, or 73 percent of subjects, survived following treatment with Cyanokit and supportive care. Of the 19 subjects who did not survive, 13 subjects were in initial cardiac arrest at the scene.

Of the 42 subjects with pretreatment cyanide levels considered to be potentially toxic, 28 (67 percent) survived. Of the 19 subjects whose pretreatment cyanide levels were considered potentially lethal, 11 (58 percent) survived. Of the 50 subjects who survived, 9 subjects (18 percent) experienced long-term neurologic effects from cyanide poisoning at hospital discharge.

A study of 136 healthy adult subjects(2) also was conducted to assess the safety, tolerability, and pharmacokinetics of Cyanokit. Side effects observed with Cyanokit were generally transient and self-limiting. The most frequently occurring adverse reactions were injection site reactions; skin rash; chromaturia (urine discoloration), which was reported in all subjects receiving 5.0 g Cyanokit or greater; and erythema (skin redness), which occurred in most subjects receiving 5.0 g Cyanokit or greater. Elevations in blood pressure were observed in some subjects, generally returning to normal within a few hours after administration. People with known hypersensitivity to hydroxocobalamin and /or Vitamin B12 should not be administered Cyanokit.

"These results show that Cyanokit is safe and effective in treating cyanide poisoning, even in patients with potentially lethal concentrations of cyanide in the blood," says Dr. Stephen W. Borron, one of medical advisors to the safety study. "In addition, the side effects experienced by patients were modest and temporary; no severe adverse events related to Cyanokit treatment were observed. These characteristics of a cyanide antidote are very important in an emergent situation requiring rapid, life-saving treatment."

Smoke Inhalation and Cyanide Poisoning

Fire smoke is a common source of cyanide exposure. Cyanide may be produced by the pyrolysis (incomplete burning) of common synthetic or plastic materials as well as from natural materials such as wood, paper and silk. Cyanide is increasingly recognized as a common and dangerous component of fire smoke, adding to the effects of carbon monoxide as a fire smoke toxicant. In fact, cyanide poisoning and carbon monoxide poisoning most often occur together during a fire. Prompt recognition and treatment of cyanide poisoning with an antidote can save lives.

Cyanokit has been used in France for over 10 years in both pre-hospital and hospital settings to treat cyanide poisoning resulting from smoke inhalation, ingestion and other causes. Although recognized in Europe for many years, only recently has the risk of cyanide exposure in fire smoke gained recognition in the U.S. The U.S. maintains one of the highest fire- related death rates of industrialized countries even though the number of fires has steadily decreased over the past two decades. Smoke inhalation is responsible for up to 80 percent of U.S. fire-related injuries and deaths. According to the United States Fire Administration (USFA), in 2004, the most recent year for which statistics are available:

-- 3,900 civilians and 117 firefighters lost their lives in fires, with an additional 17,785 civilians injured as the result of fire

-- Of all civilian fire-related deaths, 83 percent of them occurred in residences

-- An estimated 20,800 residential structure fires are attributed to mattresses, pillows, and bedding materials, all of which are highly likely to contain synthetic materials that release hydrogen cyanide when they smolder

Cyanide is highly toxic by all routes of exposure and may result in rapid onset of serious effects on the nervous, cardiovascular, and respiratory systems, leading to death within minutes to hours. Exposure to lower concentrations of cyanide may produce headache, confusion, nausea, and vomiting followed in some cases by coma and death. The presence and extent of cyanide poisoning are often initially unknown.

There is no widely available, rapid, confirmatory cyanide blood test. Treatment decisions must be made on the basis of clinical history and/or signs and symptoms of cyanide intoxication. If clinical suspicion of cyanide poisoning is high, Cyanokit should be administered without delay.

About Cyanokit

The active ingredient in Cyanokit, hydroxocobalamin, is a precursor of vitamin B12. Hydroxocobalamin works by binding directly to the cyanide ions, creating cyanocobalamin, a natural form of vitamin B12, which is excreted in the urine. Advantages of this approach are that methemoglobin is not produced and the oxygen-carrying capacity of the victim's blood is not lowered. Therefore, Cyanokit is suitable for use in smoke inhalation victims. The most common side effects seen in clinical trials of hydroxocobalamin are: injection site redness; temporary discoloration of the skin, urine and mucous membranes; and transient elevations in blood pressure.

The initial dose of Cyanokit for adults is 5.0 g, (2 vials) administered by intravenous infusion. Depending upon the severity of the poisoning and the clinical response, a second dose of 5.0 g may be administered up to a total dose of 10.0 g.

Cyanokit has been approved for marketing in France (marketed under the same name by Merck Sante s.a.s.) since 1996 for the treatment of cyanide poisoning.

For full prescribing information, please contact 1-800-429-7751 or visit http://www.dey.com.

About EMD Pharmaceuticals, Inc.

A U.S. Affiliate of Merck KGaA of Darmstadt, Germany, EMD Pharmaceuticals is a specialty pharmaceutical company with a focus on clinical development, regulatory affairs, and business development in support of providing targeted therapies for cancer treatment and other specialty areas, including central nervous system disorders and cyanide poisoning. EMD is headquartered in Durham, N.C. Additional information about EMD is available at http://www.emdpharmaceuticals.com.

About Dey, LP.

A U.S. Affiliate of Merck KGaA of Darmstadt, Germany, DEY, L.P. develops, manufactures, and markets innovative airway, allergy and emergency medications that save and improve lives. The Company puts "patients first" through integrated healthcare delivery solutions, and facilitates efficient, cost- effective partnerships with its customers. DEY is committed to investing in its employees and the communities in which they live. Additional information about Dey, LP is available at http://www.dey.com.

(1) Borron SW et al. "Hydroxocobalamin for Empiric Treatment of Smoke Inhalation-Associated Cyanide Poisoning: Results of a Prospective Study in the Prehosptial Setting" poster presentation presented at the American College of Emergency Physicians 2005 Research Forum.

(2) Uhl W. "Hemodynamic Effects of Hydroxocobalamin in Healthy Volunteers" poster presentation presented at the American College of Emergency Physicians 2006 Research Forum.

EMD Pharmaceuticals; Dey, LP
http://www.emdpharmaceuticals.com

DNA Damage Might Be Caused By Underground Air

2007-04-16T02:48:00.001-07:00

Our everyday environments are full of airborne particles that are harmful to varying degrees when inhaled. Particularly damaging to our cellular DNA are the particles from the underground system in Stockholm, Sweden, according to a new doctoral thesis from Karolinska Institutet.

"Luckily, most of them do not remain in the underground for any length of time," says scientist Hanna Karlsson. "However, particle levels are often very high. My results show that there is every reason to speed up the work being done to clean the air in the underground."

Every year, some 5,300 Swedes die premature deaths from inhaling the microscopic particles of coal, asphalt, iron and other materials that pollute the cityвЂ™s air. These particles, which are the result of incomplete combustion, road surface attrition, etc. could be reduced if the right steps were taken; the problem is that it is not known which particle sources pose the greatest threat to human health.

To build up a picture of which particles are the most harmful, Dr Karlsson has compared how particles from a variety of sources affect cultured lung cells. The results, which are presented in her thesis Particularly harmful particles show that particles from the Stockholm underground are much more damaging to cellular DNA than the other sources tested (e.g. wood smoke and cars).

The airborne particles in the underground system largely comprise iron, and are formed by the abrasion of the train wheels against the rails. The damage is caused when these particles enter the body and form free radicals in the bodyвЂ™s cells. Free radicals are highly reactive molecules that can prove harmful to the cellвЂ™s DNA; although such damage can often be repaired by the cell, it can sometime remains untreated, and this increases the risk of cancer.

Another type of particle that stood out in the studies was that caused by the friction between car tyres and the road surface. The report shows that these particles trigger a powerful inflammatory response (i.e. a general defence reaction in the body). Levels of these particles are particularly high in the spring, when road surfaces dry out and cars are still fitted with studded winter tyres.

"ItвЂ™s a serious problem, as these particles exist in large concentrations in environments that people remain in for long periods," says Dr Karlsson.

Apart from particles from the underground and the roads, the study also examined those released by the combustion of wood, pellets and diesel. None of the other types of particle tested were totally harmless. Modern wood- and pellet-burning boilers gave off much fewer emissions than old ones, but the particles produced were no less harmful.

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Thesis: "Particularly harmful particles" - A study of airborne particles with a focus on genotoxicity and oxidative stress" by Hanna Karlsson, Department of Bioscience and Nutrition, KI.

For further information, please contact:
PhD Hanna Karlsson

Contact: Katarina Sternudd
Karolinska Institutet

Researchers Barcode DNA Of Vast Fungi Collection

2007-04-16T02:36:00.001-07:00

In the storerooms of a Venice, Italy, museum, a University of California, Berkeley, scholar and Italian experts are at work on a rare collection, but the objects aren't Renaissance paintings or the art of ancient glassblowers. Instead, the team is collecting samples from the largest and best preserved collection of fungi in Italy to create an unprecedented DNA database.

These 28,000 samples of fungi that represent 6,000 species - many of which are quite rare - are housed at the Venice Museum of Natural History, a partner with UC Berkeley for this ambitious project. The collection also is one of the largest in Europe.

The project was publicly announced in Italy at the prestigious Venetian Institute of Sciences, Letters and Arts.

"We are building up a huge molecular database that will be available to the entire scientific community," said Matteo Garbelotto, UC Berkeley adjunct associate professor of ecosystem sciences and principal investigator of the project. "In addition to aiding research on the productivity of forests and agricultural ecosystems, this database will greatly aid the diagnosis of plant diseases."

Fungi are a kingdom of organisms that include yeasts, mushrooms and mold. They are essential to most terrestrial ecosystems, channeling nutrients in the soil and making them available for the growth of plants, including trees and agricultural crops. "Without fungi, there would be no forests," Garbelotto pointed out.

A large number of fungi are also plant pathogens and cause serious diseases of crops and trees, especially when transported to new areas of the world through the global trade of goods and movement of people. In addition, some species of fungi can lead to human illness, including pneumonia, skin infections, allergies and asthma.

Garbelotto is perhaps best known for his work in the identification of Phytophthora ramorum, the fungus-like plant pathogen that made its way from Europe to the United States. The pathogen is responsible for sudden oak death, the disease that has caused widespread dieback of tanoaks and coast live oaks in California and southwest Oregon.

"In the case of exotic plant diseases, DNA information may be used, as it is in criminal forensics, to identify possible culprits and to understand how they were introduced," said Garbelotto. "This provides governments with pivotal information needed to avoid repeated introductions of pathogens."

Garbelotto is working with Italian mycologist Giovanni Robich and Luca Mizzan, curator of Marine Biology at the Venice Museum of Natural History, to sort through the samples in the museum, which are being sent to Garbelotto's lab at UC Berkeley for DNA sequencing and analysis.

The Venice Natural History Museum is part of the Musei Civici Veneziani, a network of 11 museums in Venice. It is housed in the Fontego dei Turchi, a Byzantine-style palace on the Grand Canal that dates back to the 12th century. Before it was established as a museum in 1923, it had served as a trading depot for Turkish merchants.

"Often museums are seen as places where people just go and see things," said Garbelotto, who is doing this work during a sabbatical leave from UC Berkeley. "This shows that museums are actually involved in cutting-edge research. Providing a database of this scope is pretty novel."

Museum curator Mizzan said the museum's vast collection of fungi got a kick start when the Venice Society of Mycology formed in the late 1980s to monitor the mycological flora in the Lagoon of Venice and surrounding areas. The collected samples represented over 1,200 species of fungi and formed the foundation of the museum's present collection.

Garbelotto noted that the relatively young age of the samples has been critical to obtaining good quality tissue for DNA analysis. The samples come from throughout Europe, with a significant number representing species found elsewhere in the world.

Rather than sequencing the entire genome of each species, the researchers are focusing on a non-coding region of the ribosomal DNA that is known to be unique in each species. The length of the region varies from around 450 base pairs to 900 base pairs, depending upon the taxa from which it is sampled.

"If you're going to cross-compare species, you've got to amplify the same region," said Sarah Bergemann, the post-doctoral researcher in ecosystem science who is heading the lab analysis work at UC Berkeley. Bergemann is working with Amy Smith, staff research associate at Garbelotto's lab, to process the samples Garbelotto sends from Italy.

"This will be important for people who study the evolutionary characteristics of fungi," said Bergemann. "They'll be able to use our database for cross comparisons. It's also useful for people who study species distribution. For example, if you want to figure out how some species are related to one another, and you know something about their taxonomy, you can go back to their DNA to see if the morphological characteristics match their molecular code."

Without the DNA fingerprint, researchers traditionally need to wait for fungi to fruit or mushroom to identify them. "This can be very limiting because mushrooms are only produced seasonally, with some species only fruiting once every several years," said Garbelotto. "The database we are creating will allow people to identify the fungi present in plants, in the soil and in the air at any time."

The project, which began in April, is expected to be completed by the end of 2007. "We do not know of any similar project in Europe, at least of this dimension," said Enrico Ratti, the museum's scientific director.

"The importance of this project is in the cooperation between different subjects, namely private collectors, a private association, a public municipal museum and a foreign university," said Giandomenico Romanelli, director of the Musei Civici Veneziani. "We think that this is an exemplar model, to be followed in subsequent projects. Furthermore, in our philosophy, natural science collections are public goods that everybody belonging to the scientific community should be able to take advantage of."

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Contact: Sarah Yang
University of California - Berkeley

UCSD Researchers Discover Internal Compass Of Immune Cell

2007-04-16T01:46:00.001-07:00

Researchers at the University of California, San Diego (UCSD) School of Medicine have discovered how neutrophils - specialized white blood cells that play key roles in inflammation and in the body's immune defense against bacteria - navigate to sites of infection and inflammation. These findings could potentially lead to new treatments for serious infections and inflammatory diseases in patients.

The research, reported in the December 15, 2006 issue of the journal Science, describes the elements of the "internal compass" that neutrophils use to detect and migrate towards chemoattractants, markers of infection and inflammation that are released from bacteria and inflamed tissues.

"These findings solve the long-standing puzzle of how neutrophils find their way and move toward sites of injury or infection in the body," said senior author Wolfgang Junger, Ph.D., adjunct professor of surgery at UCSD Medical Center.

His team set out to identify the key mechanisms of signal amplification that must occur in order for neutrophils to detect the low-level activating signals (chemoattractants) sent out by bacteria at injury sites. They found that neutrophils possess a built-in amplification system that is an integral part of the internal compass the cells use to locate the source of chemoattractants. At the core of the amplification system is the chemical adenosine triphosphate (ATP).

The chain of events necessary to direct the neutrophils toward its goal begins when ATP is released from the region of the cell surface closest to the source of chemoattractants. Next, ATP binds to a nucleotide receptor called P2Y2 on the cell surface, a step critical to position the cells in the direction of the source of chemoattractants.

Once this internal compass has been activated, ATP is converted by the cells to adenosine, which in turn activates A3 adenosine receptors concentrated at the front of cells, providing the signal to move toward the source of chemoattractants.

Lead authors Yu Chen, M.D., UCSD postgraduate researcher in surgery and Ross Corriden, UCSD graduate student in biomedical sciences, found that when ATP receptors were blocked, the cells became disoriented, while blocking A3 adenosine receptors slowed down the cell movement toward chemoattractants. The researchers also found that drugs which interfere with the amplification system impair cell migration to inflamed tissues.

"These findings are very important because they suggest that novel classes of anti-inflammatory drugs could be developed to prevent rheumatoid arthritis, inflammatory bowel diseases, asthma, and many other chronic inflammatory diseases," said Junger.

Conversely, drugs that boost these amplification systems and the internal compass could be used to coax neutrophils to migrate to infected wounds to improve wound healing.

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Co-authors contributing to the study were close collaborator Paul Insel, M.D., UCSD professor of pharmacology and medicine; Yoshiaki Inoue, M.D., and Naoyuki Hashiguchi, M.D., UCSD visiting scholars in surgery; Linda Yip, Ph.D., UCSD postgraduate research scientist in surgery; Annelies Zinkernagel, M.D., UCSD visiting scientist in pediatrics; and Victor Nizet, M.D., UCSD associate professor of pediatrics and pharmacy.

The study was funded by grants from the National Institutes of Health and the Department of Defense.

Contact: Debra Kain
University of California - San Diego

Options Improving For Patients With Acromegaly And Gigantism, Says Endocrinology Expert

2007-04-16T01:35:00.001-07:00

Scientific, technological and medical advances made in the past two decades are leading to more definitive diagnoses, earlier and more effective treatment options and better outcomes for patients suffering from a condition called acromegaly, according to an article published in the New England Journal of Medicine and authored by a specialist in endocrinology at Cedars-Sinai Medical Center.

In the article, Shlomo Melmed, M.D., senior vice president for Academic Affairs and director of the Burns and Allen Research Institute at Cedars-Sinai, provides an update on medical progress related to the condition that stems from disorders - usually tumors - of the pituitary gland. He wrote a similar review article 16 years ago, published in the same journal in 1990.

"There have been remarkable advances in the therapy of this disease. Previously, all patients required surgery and/or radiotherapy for management, but now we have a whole new armamentarium of safe drugs that can effectively control the disorder. There also have been advances in diagnosis, such as the development of more sensitive blood assays for hormones," said Melmed, who directs the medical center's Pituitary Center and holds the Helene A. and Philip E. Hixon Endowed Chair in Investigative Medicine.

"Despite the improvements, acromegaly remains a very challenging and very complex disease," he said. "If it occurs before the end of puberty, the patients become giants, suffering from a condition called gigantism. Unfortunately, several studies document a seven- to 12-year gap from symptom onset to time of diagnosis. During this time the children get bigger and their hormones get higher and the tissue damage gets worse. Therefore, the earlier we can diagnose and treat the disease, the more effectively we can control the negative implications."

Acromegaly develops when somatotrophs, cells of the pituitary gland that are responsible for producing growth hormone, proliferate and oversecrete the hormone. The overabundance of growth hormone and the related insulin-like growth factor I (IGF-I), produce a range of effects including abnormal enlargement of the extremities, soft-tissue swelling, joint and spine conditions, protrusion of the jaws, and high blood sugar levels even when fasting. Patients often suffer from such complications as heart and valve disorders, high blood pressure and respiratory dysfunction.

"In addition to the variety of medical conditions, self-image is a major issue for these patients. At Cedars-Sinai, we have support groups in which patients can share their experiences with a professional counselor, and we offer the option of cosmetic surgery, especially for the jaw," said Melmed. "We also have patient days that give patients the opportunity to meet with our physician experts and the coordinators of our support groups."

Nearly all cases of acromegaly are caused by tumors of the pituitary gland. More than 90 percent of patients with acromegaly have a slow-growing type of tumor that is found in adults over 50 years of age. Younger patients usually have a more rapidly growing tumor, and a third type of tumor, commonly encountered by patients in their teens, often causes gigantism.

In general, ideal treatment includes surgery to remove the tumor, followed by medical therapy to manage or reverse any coexisting conditions. In many cases, however, the tumor may have grown too large or is positioned too close to vital structures for complete surgical removal to be possible or practical. Also, not all patients are good candidates for surgery.

Improvements in radiation therapy and radiosurgery, along with advances in computerized imaging systems, have improved targeting of a tumor mass, minimized radiation damage to normal surrounding tissues, and reduced treatment times. Also in the past two decades, new medications have been introduced, working at the cellular and molecular levels to suppress the secretion of growth hormone, interrupt the proliferation of somatotroph cells, and block the synthesis of IGF-I. High cost and temporary, unpleasant side effects continue to be factors, and the medications are not effective in or tolerated by all patients, but new alternatives are currently undergoing clinical trials.

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Cedars-Sinai's Pituitary Center, believed to treat and follow more patients with acromegaly than other centers in the country, combines the expertise of pituitary specialists in neuroendocrinology, neurosurgery, imaging and pathology. Many of the advances made in the field in recent years originated in Cedars-Sinai's research laboratories and clinical trials initiated at the medical center.

The study was supported by grants from the National Institutes of Health and the Helene and Philip Hixon Chair in Investigative Medicine.

Citation: New England Journal of Medicine, Dec. 14, 2006, "Acromegaly."

One of seven hospitals in California whose nurses have been honored with the prestigious Magnet designation, Cedars-Sinai Medical Center is one of the largest nonprofit academic medical centers in the Western United States. For 18 consecutive years, it has been named Los Angeles' most preferred hospital for all health needs in an independent survey of area residents. Cedars-Sinai is internationally renowned for its diagnostic and treatment capabilities and its broad spectrum of programs and services, as well as breakthroughs in biomedical research and superlative medical education. It ranks among the top 10 non-university hospitals in the nation for its research activities and is fully accredited by the Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP). Additional information is available at http://www.cedars-sinai.edu/.

Contact: Sandy Van
Cedars-Sinai Medical Center

New Understanding Of Immune System Creates Unexpected Links In Medicine

2007-04-16T00:41:00.001-07:00

Based on experiments with worms similar to those that infest millions of children in the tropics, researchers see potential for a new way to treat asthma. Parasitic infections and asthma may cause the human immune system to react in some of the same ways, and may one day be cured by manipulating some of the same proteins, according to research published in the journal Science.

To be effective, the immune system must "decide" which cells and chemicals need to be ramped up to best destroy the invader at hand, be it bacterium, virus or worm. In 1986, Tim Mosmann, Ph.D., now director of the David H. Smith Center for Vaccine Biology and Immunology at the University of Rochester Medical Center, led a team that first described a new concept for how the immune system might make such choices: the Th1/Th2 Model. A landmark in immunology, it was a major step toward unraveling the systemвЂ™s complexities. TodayвЂ™s study results show how the model continues to define new players in the immune system and to suggest new treatment approaches.

"The point of the study is that each new detail in our understanding of the immune system creates opportunities to make changes that counter disease," said Mosmann. "These results, while early, suggest that helping the body make more of a newly defined immune chemical may prevent roundworm infection, and that shutting it down may reduce lung damage in asthma."

Part of the immune system is adaptive, pumping out vast numbers of immune cells on the hope that one will be the right shape to link up with, and become activated by, any invader encountered. When one of those immune cells recognizes an invader, it expands into an army of clones specifically selected to attack that organism. One workhorse of the adaptive system is the helper T cell, a white blood cell that secretes protein messengers called cytokines to accelerate the immune response.

According to MosmannвЂ™s model, T cells differentiate into two major sets of helper T cells, Type 1 (Th1) and Type 2 (Th2), each defined by the cytokines they produce. Each profile is more effective at attacking certain invaders, with Th1 responses, for example, better against bacteria that live inside cells. Th2 cytokines include interleukin-4 (IL-4), interleukin-5 (IL-5) and interleukin-13 (IL-13), all of which are useful in immune responses against worms. In a clue to the worm/asthma link, IL-4, IL-5 and IL-13 also trigger mechanisms that cause irreversible damage to the lungs of asthmatic patients.

Study Details

How the mouse immune system reacts to the worms is central to MosmannвЂ™s research because mice and humans share the Th1/Th2 immune system divide, because mouse and human roundworm parasites are relatives, and because roundworm infection remains a major threat in the developing world. His basic research on T cell subsets was funded by the National Institute of Allergy and Infectious Diseases.

More than 15,000 species of parasitic roundworms infect everything from grapes to wasps to cattle. In humans, infection is usually caused by eating undercooked pork or wild game, or by poor hygiene, and brings repeated episodes of diarrhea, anemia and malnutrition. Stranded soldiers were once advised by field manuals to eat a cigarette or drink a tablespoon of kerosene to stun the worms, but modern antihelminthic drugs (e.g. Albendazole, Ivermectin, Thiabendazole) are effective and much safer. Drug treatments, however, do not reach many living in the worst conditions nor do they prevent patients from becoming re-infected. MosmannвЂ™s work could conceivably lead to a vaccine that would confer permanent immunity to worm infection, but such research remains in the future.

Having been exposed to bacteria and parasites since early in evolution, tissues lining the gut and lungs of mice and humans have developed ways to prevent invaders from entering the body. Tissues lining the gut, for example, shed their outer cell layers when exposed to worms. Helper T cells release chemicals that cause gut cells to rapidly divide and reproduce (grow). As new cells are created, older, outer, infested layers die, fall off (shed) and are expelled from the body with solid waste.

Using molecular biology techniques, MosmannвЂ™s team found that roundworm infection led Th2 helper T cells, more than other T cell types, to produce greater amounts of a growth factor, amphiregulin, which triggers cells to divide and grow. The current results define amphiregulin for the first time as an important new player in the immune system, in the Th2 immune profile and perhaps in the many disease processes touched by it.

In the current study, mice were infected with the nematode parasite, Trichuris muris, a relative of the worm that causes trichinosis in humans. After 14 days of infection, the study found increased expression of amphiregulin along with higher levels of Th2 cytokines IL-4 and IL-13.

Researchers confirmed the relevance of amphiregulin in immune responses to the parasites by comparing worm counts in normal mice against mice that had been genetically engineered not to produce amphiregulin. Similar numbers of worm larvae were detected after ten days in both groups, and all mice cleared the parasite by day 19. Worm clearance at day 14, however, was significantly delayed in amphiregulin-deficient mice, as was the shed rate in their gut cells.

More immediate than the potential for an anti-worm vaccine, authors said, is the studyвЂ™s finding for the first time that amphiregulin is a product of Th2 cells, which are known to play key roles in asthma, the chronic disorder that blocks and damages air passages in the lungs of 20 million Americans.

Researchers believe airborne irritants cause Th2 cells to release interleukins, which in turn leads to the release of toxic granules that cause direct tissue damage in the lungs. As the lung tries to heal the damage, growth factors cause the airway walls to thicken, by as much as 300 percent in severe cases. Could amphiregulin be the growth factor that causes permanent thickening of asthmatic airways, restricting airflow more and more as time goes by"

MosmannвЂ™s team has already begun experiments to determine if the production of amphiregulin by the Th2 response in mice also occurs in human helper T cells. After that, researchers are interested in comparing amphiregulin expression levels in the cells of healthy versus asthmatic lungs.

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Contact: Greg Williams
University of Rochester Medical Center

Masimo Rainbow SET Pulse CO-Oximetry Technology Shown Effective And Efficient In Detecting Carbon Monoxide Poisoning In Multiple Clinical Settings

2007-04-16T00:35:00.001-07:00

Masimo, the inventor of Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry, reported that two new independent studies and one case report were presented last week at the 2006 American Association of Respiratory Care (AARC) Congress in Las Vegas, each highlighting the significant clinical benefits to be gained by noninvasively screening patients for carbon monoxide poisoning using the "rapid," "inexpensive" and "reliable" Masimo Rainbow SET Pulse CO-Oximetry technology.

In a study led by Dr. Robert Partridge and Dr. Gregory Jay of Rhode Island Hospital at Brown University Medical School, a team of researchers performed a study to assess baseline carbon monoxide (CO) levels of nearly 5,000 patients presenting to the emergency room. To accomplish this, all pulse oximeters in the emergency department (ED) were replaced with Masimo Rainbow SET Pulse CO-Oximeters and the ED staff began assessing baseline carboxyhemoglobin (COHb) levels of all adult patients as part of the standard triage process. In addition to confirming suspected cases of CO toxicity (COT) from smoke inhalation, there were nine unsuspected cases of COT discovered, in just three months, in patients who presented with non-specific symptoms or unrelated complaints. Toxic COHb levels ranged from 16-33% and were confirmed with an invasive laboratory blood test. If this rate were indicative of all US hospitals, it would equate to as many as 50,000 cases of unsuspected CO toxicity annually.

The study concluded that the use of Masimo Rainbow SET as a noninvasive test for COT can effectively and efficiently be performed at ED triage, and that "unsuspected COT may be identified using noninvasive COHb screening and the prevalence of COT may be higher than previously recognized."

The team from Brown University also presented a case report of a previously healthy 52-year old non-smoking female who was brought to the ED complaining of nausea, headache, dizziness, and feeling cold. The patient had no history of carbon monoxide exposure. The Masimo Rainbow SET device recorded an SpCO level of 33%, which was later confirmed with an invasive laboratory measurement. After interviewing the woman, clinicians learned that her utilities had been shut off and she was running a gas-powered generator in her basement.

In the report, researchers said that since early CO toxicity shares symptoms with other more common illnesses, "physicians must maintain a high index of suspicion to avoid incorrect diagnosis, management and disposition. Unrecognized CO poisoned patients returned to the site of exposure may develop more serious CO toxicity." They added that the noninvasive testing provided by Masimo Rainbow SET technology "is a rapid, inexpensive method for screening large numbers of patients for CO toxicity and identifying unsuspected cases that might otherwise be missed."

Finally, a group of researchers at the Erlanger Health System in Chattanooga, TN used the Masimo Rainbow SET technology to assess CO levels on 136 patients who presented to the outpatient pulmonary lab for arterial blood gas (ABG) draws to evaluate patient's smoking history as well as 21 patients who presented with burns and inhalation injuries in the ED who also received ABGs. As a result of these tests, the researchers concluded that the Masimo Rainbow SET Pulse CO-Oximeter "performed well in both the pulmonary and the Emergency Department environments, with an extremely small bias compared to CO-oximetry measured COHb." They added that based on their study, the technology was "quite reliable at detecting elevated CO levels in patients presenting to the pulmonary lab or emergency department."

About Masimo

Masimo develops innovative monitoring technologies that significantly improve patient care -- helping solve "unsolvable" problems. In 1995, the company debuted Read-Through Motion and Low Perfusion pulse oximetry, known as SET, and with it virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent clinical studies have confirmed that Masimo SET technology allows clinicians to accurately monitor blood oxygen saturation in critical care situations -- establishing the technology as the "gold standard" pulse oximetry and substantially contributing to improved patient outcomes. In 2005 Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, which, for the first time, noninvasively monitors the level of carbon monoxide and methemoglobin in the blood, allowing early detection and treatment of potentially life-threatening conditions. Masimo, founded in 1989, has the mission of "Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications." Additional information about Masimo and its products may be found at http://www.masimo.com.

Evaluation of a New Pulse CO-Oximeter: Noninvasive Measurement of Carboxyhemoglobin in the Outpatient Pulmonary Lab and Emergency Departments. Layne T, Snyder C, Brooks D, Enjeti. Pulmonary Physiology Department, Erlanger Health System, Chattanooga, TN.

Non-Invasive Carboxyhemoglobin Monitoring: Screening Emergency Department Patients for Carbon Monoxide Exposure. Partridge R, Chee KJ, Suner S, Sucov A, Jay G. Department of Emergency Medicine, Rhode Island Hospital, Brown Medical School, Providence, RI.

Unsuspected Carbon Monoxide Toxicity Detected by Non-Invasive Monitoring: A Case Report. Partridge R, Chee KJ, Suner S, Sucov A, Jay GD. Department of Emergency Medicine, Rhode Island Hospital, Brown Medical School, Providence, RI.

Masimo, SET, Signal Extraction Technology, Radical, Radical-7, Rad57, APOD, and Improving and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications are registered trademarks of Masimo Corp. Rainbow, SpCO, SpMet and Pulse CO-Oximeter are trademarks of Masimo Corp.

Masimo Corporation
http://www.masimo.com

Multi-Drug-Resistant Tuberculosis Epidemic May Be Larger Than Previously Thought

2007-04-15T23:38:00.001-07:00

The epidemic of multidrug-resistant (MDR) tuberculosis (TB) may be larger than previously suspected, according to an Article in The Lancet. The study found anti-TB drug resistance in virtually all of the 79 countries surveyed, with particularly high levels in areas of the former Soviet Union and some provinces of China.

About a third of the worldвЂ™s population is infected with Mycobacterium tuberculosis, 8.9 million people develop the disease annually, and in 2004, 1.7 million deaths occurred. The emergence of drug-resistant strains occurs with the wide misuse of antimicrobials. MDR-TB is defined as resistance to at least the two most potent anti-TB drugs, isoniazid and rifampicin. In 1994, the Global Project on Anti-Tuberculosis Drug Resistance Surveillance was set up to determine the prevalence, patterns, and trends of anti-TB drug resistance around the world.

Mario Raviglione (World Health Organization) and colleagues analysed data on susceptibility to four anti-TB drugs, gathered in the third round of the Global Project from surveys or ongoing surveillance in 79 countries. The researchers estimate that 424 000 cases of MDR-TB emerged worldwide in 2004. Three countries - China, India, and Russia - account for over half of these cases. The median prevalence of MDR-TB in new cases was 1%. Eight countries, including Kazakhstan and Latvia, reported prevalence of multidrug resistance above 6.5%. A worrying increase in the prevalence of resistance to any drug, including MDR-TB was found in Botswana and Tomsk Oblast in Russia. The investigators found decreasing trends in multidrug resistance in the USA, Hong Kong, and Cuba.

Dr Raviglione concludes: вЂњMDR-TB is a precursor to XDR-TB, recently reported among HIV-infected people in South Africa. The findings of the Global Project emphasise the importance of implementing sound tuberculosis control activities to prevent further creation of MDR tuberculosis and the necessity of mainstreaming high-quality treatment for MDR tuberculosis into routine tuberculosis control programmes. Otherwise XDR-TB is bound to keep emerging as a fatal variant of TB, especially in high HIV prevalence settings.вЂќ

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Contact: Joe Santangelo
Lancet

HIV Patients Have Increased Risk Of Pneumonia, Death Following Surgery

2007-04-15T23:34:00.001-07:00

HIV-infected patients undergoing surgical procedures may be more likely to develop pneumonia after surgery and to die within 12 months than those without HIV, according to a report in the December issue of Archives of Surgery, one of the JAMA/Archives journals. In addition, HIV patients with a preoperative viral load (number of copies of the virus in the blood) greater than 30,000 per milliliter appear to have increased risk of surgical complications.

Since the development of medication regimens known as highly active antiretroviral therapy (HAART), HIV has become a chronic, manageable condition, according to background information in the article. "Consequently, many HIV-infected patients elect to undergo surgical procedures to correct physical ailments that would not have been treated previously, and undergo operative interventions in lieu of medical therapies for certain conditions," the authors write.

Michael A. Horberg, M.D., M.A.S., and colleagues at Kaiser Permanente Medical Care Program-Northern California, Oakland, studied surgical outcomes in 332 HIV-infected patients who underwent a variety of procedures (including abdominal, orthopedic and heart surgeries) between 1997 and 2002. For comparison, the researchers selected a group of 332 patients who did not have HIV but were the same age and sex and had a similar procedure at around the same time and at the same location as one of the HIV-infected patients. The investigators then used health plan databases to obtain clinical information about the HIV patients' disease and to track whether any of the patients had complications after surgery or died within 12 months.

The surgical procedures analyzed included abdominal or pelvic procedures (80.8 percent), cardiac or breast procedures (8.4 percent) and orthopedic procedures (10.8 percent). Most complications - including infections and delayed wound healing - occurred equally frequently in patients with and without HIV. No difference between the two groups was found in the length of hospital stay, number of complications or need for additional procedures to treat complications. However, more HIV patients developed pneumonia (eight or 2.4 percent vs. one or .3 percent) and more died within 12 months (10 or 3 percent vs. two or .6 percent). "The causes of death varied" in HIV patients, the authors write. "While none of the causes appeared to be a direct consequence of the operation, two deaths were within 30 days of the operation."

The researchers also examined risk factors for complications and death among HIV patients, including CD4 cell count response, a measure of the state of the immune system. The lower the CD4 count, the more likely a patient with HIV/AIDS is to develop secondary infections or illnesses. Those with a CD4 count of less than 50 cells per cubic millimeter of blood had more complications than those with higher CD4 counts. In addition, viral loads - measured as the number of copies of the virus in a milliliter of blood - of more than 30,000 were associated with a higher complication rate. Whether the patients were taking antiretroviral therapy did not appear to be related to their risk of developing complications. "Our results indicate that a higher HIV viral load seems to be a greater predictor of surgically related complications than either the CD4 cell count or the presence or absence of HAART use," the authors write.

"Patients with HIV are living longer and regaining a substantial amount of immune function," they conclude. "Many HIV-infected patients will require surgical attention because of a variety of disorders. In many cases, HIV serostatus [whether a person is infected with HIV or not] should not be a criterion when determining the need for surgery if patients have adequate viral control."

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(Arch Surg. 2006;141:1238-1245.)

This study was funded through the Kaiser Permanente-Northern California Community Benefits Program. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Contact: Michelle Ponte
JAMA and Archives Journals

Consumers Demand For Better Indoor Air Quality

2007-04-15T22:39:00.001-07:00

A number of epidemiological studies have shown that ambient fine particulates have an adverse effect on human health. Less attention has been paid to indoor particles and their impact on health, despite the fact that indoor air particle exposure may be even more harmful than exposure to ambient particulate pollution.

The FINE Particles (R) Technology, Environment and Health - Finnish National Technology Programme has extended knowledge of fine particles in indoor air, and introduced technologies to reduce them.

The results of the studies show that particle concentrations in indoor air, in many cases, can be roughly estimated from the particle concentrations in outdoor air. The efficient filtration of supply air, in particular, reduces the transport of particles from outside significantly.

The most promising air distribution methods for reducing exposure are personal ventilation systems, although these systems have encountered many practical problems in supplying fresh air directly to workstations in office environments.

Another interesting new technology studied in the FINE Programme is detecting mould damage using particle monitors. There is a large market worldwide for these types of services, but the reliability of the methods behind them needs to be scientifically demonstrated.

Good market potential

The demand for solutions to improve indoor air quality is growing due to the increased awareness of consumers. New information on the adverse health effects of fine particles, and measures introduced to reduce exposure to them, will create new market potential for ventilation systems and air filtering.

In Europe, the overall market volume for IAQ-related ventilation products is valued at around EUR 20 billion, of which Finland accounts for some EUR 500 million. The market volume for air filters is in the order of EUR 100-150 million for Europe as a whole.

The technology for supply air filtering and air cleaning developed in Finland is highly advanced, and will give Finnish companies a competitive edge. Measurement instruments represent another market opportunity.

The four-year FINE Programme launched in 2002 by Tekes, the Finnish Funding Agency for Technology and Innovation, was completed in the spring of 2006. The Programme involved over 50 individual projects and close to 60 companies and over 20 research institutions. Work of 11 FINE projects focused on indoor air quality.

For more information
http://www.tekes.fi/fine

Mitigating The Adverse Impact of Fine Particulate on Indoor Air
http://www.tekes.fi/julkaisut/Fine_SisГ¤ilma.pdf

The Future Of Asthma Research

2007-04-15T22:34:00.001-07:00

Asthma UK and the Royal Society of Medicine are offering people with asthma a unique opportunity to influence the future of asthma research.

Medicine and Me: Asthma Research will bring people with asthma, their families and carers, together with researchers and health professionals to exchange their views on the key challenges in basic asthma research.

The event aims to make science more accessible to people with asthma and ensure the strategy reflects their needs. It takes place on 19 February at the Royal Society of Medicine, London. Supported by AstraZeneca, it will include a mix of presentations and discussions, followed by an evening reception.

Medicine and Me: Asthma Research follows the hugely successful event, Medicine and Me: Asthma, which was held in 2004. It aims to provide a platform for Asthma UK to discuss its five-year Basic Asthma Research Strategy update (BARS II). The strategy was written after extensive consultation with expert asthma researchers and people with asthma over the last year and it is hoped this dialogue will have a direct impact on future research strategies.

The key areas identified in asthma research to be explored at the event are:

-- Genetics
-- Early Life and Environment
-- Immunology and Infection
-- Inflammation and Airway remodelling

People with asthma and researchers will discuss their views on how research can progress towards Asthma UK's vision of "control over asthma today, freedom from asthma tomorrow".

Donna Covey, Chief Executive of Asthma UK, said: "This is an excellent way to make medical science more accessible to people with asthma and help researchers understand the needs of people with asthma too. Asthma UK continues to increase the understanding of asthma, its causes and effects, and raise awareness of the needs of the 5.2 million people living with asthma."

Professor Tak Lee, Asthma UK Professor and Director of the MRC-Asthma UK Centre in Allergic Mechanisms of Asthma, chaired the BARS II consultation on behalf of Asthma UK said: "The key questions that have to be addressed to find a cure for asthma have now been identified. It is essential for funders to provide adequate support to researchers so these critical questions can be answered."

http://www.asthma.org.uk

EU Prioritises Allergic Diseases In The Seventh Framework Programme For Research

2007-04-15T21:37:00.001-07:00

GAВІLEN welcomes the vote of the European Parliament on the Seventh Framework Programme (FP7) on 30 November that acknowledges allergic diseases as major chronic diseases to be addressed in European research during the coming 7 years (2007 - 2013).

The European Parliament adopted the report of Prof. Jerzy Buzek that recognises вЂњrespiratory diseases including those induced by allergiesвЂќ as health priorities to be addressed by translational research. This will allow respiratory allergic diseases (including asthma) to be covered by the research programme under the health theme.

In the first drafts, only food allergies (8% of all allergies) were covered. Allergic diseases will now be tackled under both the health and food themes of the research programme which should allow scientists to progress towards the overall understanding that is needed to help control this epidemic through effective prevention and treatment.

вЂњAllergic diseasesвЂќ in all their different aspects - from hay fever to fatal attacks of asthma or reactions to peanuts - are taking lives daily and creating huge financial costs. According to the World Health Organization, asthma kills someone in Europe every hour. One child in three is allergic today and by 2015, half of the European population may be suffering from one or more allergic condition.

The European UnionвЂ™s next research programme known as the Seventh Framework Programme (FP7) begins on 1st January 2007 and will run for seven years until 2013 with a total budget of в‚¬54.6 billion.

GAВІLEN - the Global Allergy and Asthma European Network is a вЂњNetwork of ExcellenceвЂќ funded by the European Union 6th Research Framework Programme (FP6). It consists of 26 research centres spread throughout Europe, as well as the European Academy of Allergology and Clinical Immunology (EAACI) and the European Federation of Allergy and Airways Diseases Patients Associations (EFA). Close to 50 collaborating centres have joined the network since its launch in 2004.

http://www.ga2len.net

World Health Report 2003, вЂњShaping the FutureвЂќ. World Health Organization

Vietnam Study Probes The Role Of Gut Worms In Allergies

2007-04-15T21:34:00.001-07:00

Gut parasites could hold the key to increasingly common conditions such as eczema, asthma and hay fever, according to scientists at The University of Nottingham.

Gut parasites, such as hookworm, have evolved together with their human hosts for millions of years. Over time, these parasites have developed ways of surviving in the human gut by 'turning down' the immune response directed against them, prolonging their survival inside the host.

This reduction in immune response may also have the effect of reducing allergic tissue reactions that characterise asthma and other allergic conditions.

The latest study in this area of research is led by Dr Carsten Flohr, a clinical scientist from The University of Nottingham and Dr Luc Nguyen Tuyen, from the Khanh Hoa Provincial Health Service in central Vietnam. This work was supported through research grants from Asthma UK, the Bastow Award from the Special Trustees for Nottingham University Hospitals and a Fellowship from University College, University of Oxford.

Dr Flohr has examined the links between worms and allergic diseases in Vietnamese children and found that those with the highest level of hookworm infestation were the least likely to have an allergic response to house dust mites.

These findings support the hypothesis that gastrointestinal infection with either hookworms or other micro-organisms protects against allergy and add further weight to the so-called вЂhygiene hypothesisвЂ™.

Dr Lyn Smurthwaite, Research Development Manager for Asthma UK said: вЂњThe вЂhygiene hypothesisвЂ™ suggests that high rates of allergies and asthma in developed countries are a result of our immune systems becoming unbalanced due to improved sanitation and hygienic lifestyles that no longer expose us to the same array of bacteria, viruses or parasites. We look forward to future results in this area.вЂќ

The study involved 1,600 children aged six to 18, in four neighbouring rural communities in Khanh Hoa province, central Vietnam. Their lifestyles were studied, along with their sensitivity to common allergens and their level of infestation with hookworm and other parasites.

Following on from the study just reported online in the Journal of Allergy and Clinical Immunology, Dr Flohr and his colleagues in Vietnam have conducted an intervention study in the same population during which they regularly de-wormed schoolchildren to see whether this increased the prevalence of allergic diseases. This second study is now coming to a close and the results will be published early next year.

Dr Flohr said: вЂњThe results from such an intervention study will allow us to draw firmer conclusions as to whether gut worm infestation truly protects against allergic disease and sensitisation.вЂќ

Co-applicants on the Asthma UK research grant that is funding the work were Professors John Britton, David Pritchard, and Hywel Williams. The Nottingham team is collaborating with researchers from the Wellcome Trust Major Overseas Programme at the Oxford University Clinical Research Unit Hospital for Tropical Diseases in Ho Chi Minh City, where Dr Flohr has been based for his field work.

The University of Nottingham is leading the way in the investigation of links between hookworm infestation вЂ" or lack of it вЂ" and human illness. Two further currently ongoing trials are looking at the possibility that hookworm infection may alleviate symptoms of hay fever and CrohnвЂ™s Disease.

If these studies show positive results, future drugs that mimic the immunological effects of hookworm infection could provide promising therapeutic options for patients with allergic and other autoimmune diseases.

The University of Nottingham is Britain's University of the Year (The Times Higher Awards 2006). It undertakes world-changing research, provides innovative teaching and a student experience of the highest quality. Ranked by Newsweek in the world's Top 75 universities, its academics have won two Nobel Prizes since 2003. The University is an international institution with campuses in the United Kingdom, Malaysia and China.

Asthma UK is the charity dedicated to improving the health and well-being of the 5.2 million people in the UK whose lives are affected by asthma. It works together with people with asthma, health professionals and researchers to develop and share expertise to help people increase their understanding and reduce the effect of asthma on their lives.

The University of Nottingham

Depression Common Among Patients With Chronic Cough

2007-04-15T20:37:00.001-07:00

Patients who suffer from chronic cough may be at increased risk for depression, shows a new study. Researchers from Albert Einstein College of Medicine and Montefiore Medical Center in New York followed 100 patients with chronic cough for 3 months. Patients completed the Center for Epidemiological Studies Depression (CES-D) scale and provided subjective cough scores reflecting severity of their cough. Overall, 53 percent of patients scored "16 on the CES-D, indicating presence of significant depression. Of the 81 patients who completed the study, results indicated a statistically significant improvement in both cough and depression scores after 3 months of treatment. In addition, improvement in cough score correlated significantly with improvement in depression score. This study appears in the December issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians,

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Newsbriefs from the journal Chest, December 2006

Contact: Jennifer Stawarz
American College of Chest Physicians

Gender And Obesity Key Factors In Habitual Snoring

2007-04-15T20:34:00.001-07:00

A new study confirms that male gender, obesity, and weight gain are key determinants of habitual snoring in the adult population. In 1981, Australian researchers surveyed 967 nonsnoring adults aged 25 to 74 years regarding their gender, age, respiratory/allergy symptoms, and habits related to snoring, smoking, and alcohol, tea, and coffee consumption. Body size measurements and lung function were also measured. Participants completed a follow-up survey 14-years later. Overall, 13 percent of participants became habitual snorers at the 14-year follow up. Results indicated that male gender and baseline body max index (BMI) were significant predictors of developing habitual snoring. Change in BMI over the follow-up period, development of asthma, and initiation of smoking were additional independent risk factors for the development of habitual snoring. This study appears in the December issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.

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Newsbriefs from the journal Chest, December 2006

Contact: Jennifer Stawarz
American College of Chest Physicians

Study Reveals Clean Air Challenge For Major Asian Cities

2007-04-15T19:37:00.001-07:00

Hundreds of millions of city dwellers breathe air so polluted with chemicals, smoke and particles that it dramatically exceeds World Health Organization limits with major impacts on health and the environment.

A major study on the state of air pollution in 20 of AsiaвЂ™s key cities shows that while there have been improvements in achieving better air quality, air pollution still poses a threat to health and quality of life of many people.

The study led by the Stockholm Environment InstituteвЂ™s (SEI) centre at the University of York (UK) and the Clean Air Initiative for Asia Cities (CAI-Asia) was being published as Asian Environment Ministers held the first governmental meeting on urban air quality in Asia on 13-14 December in Yogyakarta, Indonesia as part of the Better Air Quality 2006 Workshop.

The World Health Organization estimates that 537,000 people in Southeast Asia and the Pacific die prematurely each year due to air pollution.

The study found that there has been a general improvement in the ability of Asia cities to manage urban air quality since the 1990s. But air quality in the majority of the cities examined still exceeds international guidelines for the protection of human health for certain pollutants. Concentrations of sulphur dioxide, the gas responsible for acid rain, have stabilized at a relative low level and rarely exceed health guidelines. However, the use of high sulphur fuel content in some countries may result in an increase in emissions.

Emissions of nitrogen dioxide and fine particulate matter, mainly from the transport sector, are of concern in all cities currently experiencing rapid motorization. In addition, tropospheric ozone, a main constituent of photochemical smog, will increase if motor vehicle use continues to rise.

The international collaborative effort was led by the Stockholm Environment InstituteвЂ™s (SEI) centre at the University of York (UK) and the Clean Air Initiative for Asia Cities (CAI-Asia) together with the Korea Environment Institute (KEI) (Seoul) and the United Nations Environment Programme (UNEP) (Nairobi). The study was funded by the Swedish International Development Co-operation Agency (Sida), the Korean Ministry of Environment and the Asian Development Bank (ADB).

The study examined the capability to manage air quality and collected air quality data for Bangkok, Beijing, Busan, Colombo, Dhaka, Hanoi, Ho Chi Minh City, Hong Kong, Jakarta, Kathmandu, Kolkata, Metro Manila, Mumbai, New Delhi, Seoul, Shanghai, Singapore, Surabaya, Taipei and Tokyo.

The assessment showed that while there are underlying similarities in the air pollution problems in each city, many differences still exist.

Bangkok, Seoul, Shanghai and Singapore, Taipei and Tokyo were identified as having excellent capacity to manage air quality. These cities have achieved major reductions in key emissions but still face the challenge of addressing moderate fine particulate pollution resulting from vehicles fumes.

Colombo, Ho Chi Minh City, Jakarta, Metro Manila and Mumbai were identified as having moderate capability in air quality management. They have achieved reductions in sulphur dioxide emissions but have the challenge of addressing transport-related emissions.

Dhaka, Hanoi, Surabaya and Kathmandu were identified has having limited capability to manage air quality. Air pollution data was limited for key pollutants. These cities have the challenge of improving air quality monitoring as well as further achieving reductions in emissions.

Dr Dieter Schwela, SEI, lead author, said: "Some cities have made tremendous progress in improving their air quality. However, more work needs to be done to address specific pollutants such as fine particulate matter which poses a real threat to human health."

"The study has shown that there is a great opportunity for those cities which need to develop further their air quality management capability to learn from cities such as Hong Kong and Tokyo that are further along the road to achieving better air quality."

The studyвЂ™s authors recommend further action is required to improve air quality in AsiaвЂ™s cities.

These include:

* Taking a more strategic approach to managing air quality to include all aspects of the problem

* Adopting more stringent vehicle emission standards

* Using more cleaner fuels for motor vehicles, industry and power plants

* Better inspection and source of emissions

* Stricter enforcement of legislation and more stringent standards for air quality

* Harmonization of air quality standards across Asia

* Development of more reliable inventories of air pollution emissions

* Regional approach to air pollution to address transboundary air pollution and global climate change

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* The study Urban Air Pollution in Asian Cities: Status, Challenges and Management by Dieter Schwela, Gary Haq, Cornie Huizenga, Wha-jin Han, Herbert Fabian and May Ajero (2006) is published by Earthscan: http://www.earthscan.co.uk/.

* The Stockholm Environment Institute is an International Independent research institute with its headquarters in Stockholm, Sweden (http://www.sei.se/). Its York Centre is based at the University of York (UK) (http://www.york.ac.uk/)

* The Clean Air Initiative for Asian Cities (CAI-Asia, http://www.cleanairnet.org/caiasia) is a multi-stakeholder network of institutions and individuals committed to improving air quality management (AQM) in Asia.

Contact: David Garner
University of York

Bird Flu Spreads In Egypt As Tenth Person Dies

2007-04-15T19:34:00.001-07:00

Authorities have confirmed that a tenth person has died of H5N1 bird flu infection in Egypt. A man, aged, 26, is the third person to die so far over the last four days. He was admitted to hospital with bird flu like symptoms, and died ten days later in hospital. Bird flu also killed a 15-year-old girl last Monday as well as a woman, aged 30, on Sunday. All three victims were biologically related and lived in the province of Gharbiya.

All three victims lived in the same house, along with 27 other relatives, said Egyptian authorities. The backyard of the house had a large number of ducks. According to the World Health Organization (WHO), the family members became ill after slaughtering the ducks in an attempt to stem the spread of bird flu in the area. Tests revealed that at least three of the ducks were infected with the virulent H5N1 bird flu virus strain.

Last February Egypt experienced a wave of bird flu infections, which died down around May. Many thought the problem had gone. The current outbreak is a major setback for many people in the country who depend on backyard poultry for their sustenance.

So far, other family members who live in the same house are healthy, according to the Ministry of Health and Population. The Ministry is carrying out further investigations.

Egypt is in the flight path of several migratory birds. This concerns scientists and health care professionals as it could mean a greater risk of the H5N1 virus strain finding its way into other countries.

Controlling the spread of an outbreak is more difficult in countries where backyard poultry is common. All households need to be educated, and then cooperate with authorities. If mass culls need to be done, it is only effective if every household cooperates.

There is no evidence from this latest outbreak that the H5N1 bird flu virus strain has mutated and become more transmissible from human-to-human.

Written by: Christian Nordqvist
Editor: Medical News Today

Tuberculosis Bacillus Hides From The Immune System In Its Host's Fat Cells

2007-04-15T18:37:00.001-07:00

A team from the Institut Pasteur has recently shown that the tuberculosis bacillus hides from the immune system in its host's fat cells. This formidable pathogen is protected against even the most powerful antibiotics in these cells, in which it may remain dormant for years. This discovery, published in PLoS ONE, sheds new light on possible strategies for fighting tuberculosis. Attempts to eradicate the bacillus entirely from infected individuals should take these newly identified reservoir cells into account.

Mycobacterium tuberculosis, the bacillus responsible for tuberculosis can hide, in a dormant state, in adipose cells throughout the body. The bacterium is protected in this cellular environment, to which the natural immune defences have little access, and is inaccessible to isoniazid, one of the main antibiotics used to treat tuberculosis worldwide. These results were obtained by Olivier Neyrolles* and his colleagues from the Mycobacterial Genetics Unit directed by Brigitte Gicquel at the Institut Pasteur, in collaboration with Paul FornГЁs, a pathologist from HГґpital EuropГ©en Georges Pompidou. They raise questions of considerable importance in the fight against tuberculosis.

Tuberculosis kills almost two million people worldwide every year and is considered by the World Health Organisation to represent a global health emergency. However, the bacillus is much more prevalent in the world's population than the statistics would lead us to believe, because only 5 to 10% of those infected actually develop tuberculosis. The bacillus may be present in a significant proportion of the population, remaining in a "dormant" state in the body, sometimes for years, and may be "reactivated" at any time. The risk of rea ctivation is particularly high in immunocompromised individuals, such as those infected with AIDS: the HIV virus and the tuberculosis bacillus make a formidable team, with each infectious agent facilitating the progression of the other.

Neyrolles' team first demonstrated, in cell and tissue cultures, that adipose cells served as a reservoir for Mycobacterium tuberculosis, and that this protected the bacillus against isoniazid. They then investigated whether the pathogen was present in adipose cells in humans. They did this by testing for traces of the genetic structure of the bacillus in samples from people considered not to be infected. Analyses were carried out on samples from deceased subjects from Mexico, where tuberculosis is endemic, and from Parisian districts reporting very few cases of tuberculosis.

The bacterium was detected in the adipose tissue of about a quarter of these people, all of whom were unaware they were infected, in both Mexico and France. These results suggest that the bacillus responsible for tuberculosis can remain protected in the adipose tissue of the body in the absence of any sign of disease.

This work has important implications for the prevention of this disease. It helps to explain how, many years after first testing positive for tuberculosis, people with no trace of the microbe in the lungs may develop some form of tuberculosis attacking the lungs, bones or genitals. It also suggests that isoniazid treatment, prescribed to the close friends and family of patients as a preventative measure, may in some cases not provide sufficient protection against the disease. This is particularly important for immunocompromised patients and for people with AIDS, for whom a secondary infection with tuberculosis bacillus may have very serious consequences.

This work highlights the importance of the search for new targeted therapeutic weapons, such as new antibiotics, which must be able to reach the dormant bacillus that has been hiding in adipose cells without our knowing it.

###

Disclaimer

The following press releases refer to a selection of the upcoming articles in PLoS ONE. They are contributed by the article authors and/or their institutions. The opinions expressed do not necessarily reflect the views of the staff or the editors of PLoS ONE.

* Olivier Neyrolles belongs to URA 2172, CNRS,

Citation: Neyrolles O, HernГЎndez-Pando R, Pietri-Rouxel F, FornГЁs P, Tailleux L, et al. (2006) Is Adipose Tissue a Place for Mycobacterium tuberculosis Persistence? PLoS ONE 1(1): e43. doi:10.1371/journal.pone.0000043

PLEASE ADD THE LINK TO THE PUBLISHED ARTICLE IN ONLINE VERSIONS OF YOUR REPORT: http://dx.doi.org/10.1371/journal.pone.0000043

Contact: Bruno Baron
Public Library of Science

Faropenem Phase III Clinical Trial Stopped To Consider Exclusion Of Ketek Comparator

2007-04-15T18:34:00.001-07:00

Adams Respiratory Therapeutics Seeks Approval For New Prescription Cough Suppressant

2007-04-15T17:37:00.001-07:00

HHS Pandemic Influenza Implementation Plan, USA

2007-04-15T17:34:00.001-07:00

STATEMENT BY SECRETARY LEAVITT

When the U.S. Department of Health & Human Services released the Pandemic Influenza Strategic Plan Part I, a year ago, I noted: вЂњWe are better prepared today than we were yesterday, and we will be better prepared tomorrow than we are today.вЂќ Indeed, we are better prepared this year than we were one year ago - and, by continuing to implement the plans we have outlined, we will continue to improve our readiness into the future.

Since the release of our report last November, Congress has allotted $5.5 billion to support our preparation efforts, and our progress has been unprecedented. HHS, for example, has conducted pandemic flu summits in every state and territory, engaging state, local and tribal leaders and community representatives in preparation for an effective response to a pandemic. We are building our vaccine production capacity by investing in new technology, while continuing to grow our stockpile of medical interventions and supplies needed for response. We launched http://www.pandemicflu.gov, a cross-governmental internet resource used by millions of Americans seeking planning and guidance tools to increase their personal and community preparedness. In addition, we facilitated and subsidized state purchase of antiviral drugs and provided millions of dollars to states to enhance their efforts to develop an exercise preparedness plan.

This substantial commitment and investment has taken us a long way down the path of preparedness - but this should not make us complacent. Though it has not yet achieved sustained transmission between humans, the H5N1 strain of avian influenza has reached dozens of countries and claimed more than one hundred-fifty lives. A pandemic remains a serious local and global threat, and there is more work to be done to prepare for it.

Preparation is a continuum. We remain fortunate that we have not yet been faced with a pandemic and can use this time to prepare. If we continue to be vigilant in our commitment to preparedness, we will be better prepared to limit the severity and duration of a pandemic. We have an opportunity to be the first generation in history to be prepared for a pandemic and to save millions of lives in this country and around the world as a result. We must renew our commitment to seize this opportunity.

Sincerely,

Michael O. Leavitt

PREFACE

An influenza pandemic has the capacity to affect individuals and disrupt society on multiple levels. Pandemic influenza preparedness is a public health priority and a shared responsibility of the U.S. Department of Health and Human Services (HHS), the World Health Organization (WHO), and other Federal and non-Federal stakeholders across the country and abroad. The global nature of an influenza pandemic compels Federal, State, local, and tribal governments, communities, corporations, institutions, families, and individuals to learn about, prepare for, and collaborate in efforts to slow, mitigate, and recover from a pandemic. The development, refinement, integration, exercise, and communication of pandemic influenza plans by all stakeholders are critical components of preparedness. To this end, the Federal Government has developed the following documents to guide the Nation's pandemic influenza preparedness planning and response activities:

-- National Strategy for Pandemic Influenza: On November 1, 2005, the President released the National Strategy for Pandemic Influenza, which provides a framework for the U.S. Government's pandemic influenza preparedness and response efforts. (click here.)
-- The National Strategy for Pandemic Influenza Implementation Plan: The White House Homeland Security Council (HSC) released the National Strategy for Pandemic Influenza Implementation Plan in May 2006. This Implementation Plan provides a common frame of reference for understanding the pandemic threat and summarizes key planning assumptions to set a framework for effective action. It also proposes that Federal Departments and Agencies take specific coordinated steps to achieve the goals of the National Strategy, and outlines expectations for Federal and non-Federal stakeholders in the U.S. and abroad. This plan directs all Federal Departments to develop a pandemic influenza plan. (click here.)

-- HHS Pandemic Influenza Plan: On November 2, 2005, HHS released Parts 1 and 2 of the HHS Pandemic Influenza Plan, which serves as a strategic blueprint for all HHS pandemic influenza preparedness planning and response activities. (click here) The Plan builds on the actions and expectations set out in the National Strategy and its Implementation Plan, and updates the August 2004 draft HHS Pandemic Influenza Preparedness and Response Plan. The Plan integrates the changes made in the 2005 WHO classification of pandemic phases and its concomitant expansion of international guidance. It also is consistent with the National Response Plan (NRP) published in December 2004. It includes:

- The HHS Strategic Plan (Part 1): Part 1 outlines Federal plans and preparation for public health and medical support in the event of a pandemic. It identifies the key roles of HHS and its agencies during a pandemic, and provides planning assumptions for Federal, State, and local health and public health operations plans.

- Public Health Guidance for State and Local Partners (Part 2): Part 2 provides detailed guidance to State and local health departments in 11 key areas. Parts 1 and 2 will be regularly updated and refined, and will serve as tools for continued engagement with all stakeholders, including State and local partners.

- HHS Implementation Plan (Part 3): This document implements the strategy laid out in Parts 1 and 2 and itemizes the specific roles and responsibilities of each of HHS' operational and staff divisions in planning for and responding to a pandemic. This document identifies specific steps that operationalize and implement the actions and expectations outlined for HHS in the HSC National Strategy for Pandemic Influenza Implementation Plan. In addition, it identifies additional actions that are required for successfully accomplishing the activities laid out in both the National Strategy and the HHS Strategic Plan. This plan itemizes the specific roles and responsibilities of each HHS operational and staff division in preparing for a pandemic, not necessarily responding to one. The HHS Implementation Plan is divided into two parts as follows:

1. Part I discusses Department-wide issues such as international activities, international and domestic surveillance, public health interventions, the medical response, vaccines, antiviral drugs, diagnostic devices and personal protective equipment (PPE), communications, and State and local preparedness, all of which require coordination of efforts across HHS operational divisions. It details the specific steps needed to meet the challenges of a pandemic response and the critical capabilities as identified in both the National Strategy Implementation Plan and the HHS Strategic Plan.

2. Part II includes detailed continuity of operations plans that ensure that the essential functions of each HHS operating division are identified and maintained in the presence of an expected decrease in staffing levels during a pandemic event.

The HHS Implementation Plan is a dynamic document that will be reviewed and revised as needed as HHS efforts in pandemic preparedness mature. The plan will be tested to identify preparedness weaknesses and to promote effective implementation. Throughout this process, the pandemic influenza response will be optimized by effectively engaging partners and stakeholders during all phases of pandemic planning and response.

EXECUTIVE SUMMARY

An influenza pandemic has the potential to cause more death and illness than any other public health threat. Although the timing, nature, and severity of the next pandemic cannot be predicted with any certainty, preparedness planning is imperative to lessen the impact of a pandemic. The unique characteristics and events of a pandemic will strain local, State, and Federal resources. For example, it is unlikely that there will be sufficient personnel, equipment, and supplies to simultaneously respond adequately in multiple areas of the country for a sustained period of time. Therefore, the minimization of social and economic disruption will require a coordinated response by the whole country. All governments, communities, and public- and private-sector stakeholders will need to anticipate and prepare for a pandemic by defining their roles and responsibilities, and developing continuity-of-operations plans. To this end, the President directed the Secretary of HHS to initiate a State and local preparedness process. HHS is actively working to help States, tribes, cities, schools, businesses, churches, individuals, and families across the country plan for a pandemic. HHS is collaborating with Governors' offices in every State to hold pandemic summits and exercises. HHS/Centers for Disease Control and Prevention (CDC) have developed checklists to aid in pandemic influenza preparations. These checklists provide specific guidance for State and local planning, businesses, health care providers, community organizations, individuals, and families. (www.pandemicflu.gov)

During a pandemic, and consistent with the National Response Plan (NRP), as head of Emergency Support Function (ESF) #8, Public Health and Medical Services, the Secretary of HHS will lead the Federal public health and medical response efforts. The HHS Pandemic Influenza Plan serves as a blueprint for all HHS pandemic influenza preparedness and response planning. Part 1, the Strategic Plan, describes a coordinated public health and medical care strategy to prepare for, and begin responding to, an influenza pandemic. Part 2, Public Health Guidance for State, Local, and Tribal Partners, provides guidance on specific aspects of pandemic influenza planning and response for the development of State, local, and tribal preparedness plans.

This document, Part 3, the HHS Implementation Plan, operationalizes the strategy described in the White House Homeland Security Council (HSC) National Strategy for Pandemic Implementation Plan by detailing Department-wide HHS pandemic preparedness actions and steps (Part I) and by outlining Agencies' continuity-of-business plans (Part II).

Part 1 - Pandemic Influenza Implementation Plan (PDF - 271 pages, 1.8MB)

Part I of the HHS Implementation Plan identifies eight cross-cutting issues that encompass many of the themes noted in the HHS Strategic Plan and Guidance for State and Local Partners. These themes include infection control, laboratory diagnostics, surveillance, health care planning, and workforce support. Each chapter outlines actions and specific steps the Department will undertake to fulfill the directives of the HSC and accomplish pandemic preparedness. The eight cross-cutting issue chapters are:

-- International Activities

-- Domestic Surveillance

-- Public Health Interventions

-- Federal Medical Response

-- Vaccines

-- Antiviral Drugs

-- Communications

-- State, Local, and Tribal Preparedness

The action steps in these eight chapters are organized by the three pillars identified in the National Strategy for Pandemic Influenza: preparedness and communication; surveillance and detection; and response and containment. The implementation of the HHS action steps is contingent upon the availability of resources.

International Activities

While a novel influenza virus could emerge anywhere in the world at any time, current concern focuses on the continued spread of avian influenza A/(H5N1), which is highly pathogenic in poultry and has caused sporadic cases of severe disease in humans.1,2,3 The emergence and intercontinental spread of avian influenza A/(H5N1) in birds underscores the interrelatedness of all countries and communities with respect to public health emergencies. Chapter 1 emphasizes the need to work in partnership with countries and provide technical assistance to enhance surveillance and response activities in low-resourced countries. International disease-surveillance efforts could permit the identification of the earliest stages of an evolution of avian or animal influenza virus into a human pathogen that is capable of human-to-human spread. The early detection of a pandemic virus will facilitate a rapid and well-orchestrated global public health containment response whose goal is the slowing or limiting of the spread of influenza. Slowing the spread of a pandemic overseas may also allow the United States to implement public health measures that might mitigate the impact of the disease when it arrives on U.S. shores. Continued surveillance, once a pandemic is underway, is important for monitoring and documenting changes in viral characteristics and pathogenesis. The HHS plan focuses on strengthening global surveillance and timely response capacity. It also emphasizes education of, and risk communication to, all stakeholders and partners.

Domestic Surveillance

Continuous surveillance, both domestic and abroad, will provide data on trends in disease activity and virus subtype circulation, and will inform policy and public health decisionmaking in the pre-pandemic and pandemic periods. Initially, domestic surveillance efforts are designed to detect influenza virus types and subtypes, including pandemic strains, circulating in the United States, and will focus on detecting initial cases and clusters of human illness. Early detection of initial cases ensures timely investigation and implementation of public health interventions to limit further spread of disease. Detection of early cases and appropriate laboratory investigation will facilitate the prompt identification of viral characteristics (antiviral susceptibility, antigenicity, transmissibility, and virulence) that can affect medical case management as well as public health response measures. It will also facilitate the development of both pre-pandemic and pandemic vaccines. Early delineation of viral characteristics will increase the likelihood that a vaccine could be available in a timely manner. Early identification of cases will also maximize the chances of delaying the spread of the pandemic across the country.

Surveillance requires that laboratory systems are in place to characterize viral subtypes, enable detection and investigation of suspected cases in a community, and detect sentinel increases in disease activity. Surveillance data will direct decisions on vaccine development, antiviral drug use, and the implementation and continuation of public health interventions, including diagnostic devices and personal protection equipment (PPE) use, to limit the spread of disease. Ongoing surveillance and the generation of real-time data can also help monitor the progression of a pandemic and the effectiveness of various interventions. Surveillance data may be used by researchers to model and project the trajectory of a pandemic.

HHS activities concentrate initially on continuing to build laboratory and epidemiologic capacity for surveillance and response; and on establishing comprehensive, integrated, timely, and sensitive surveillance systems; by building on existing systems and by initiating new systems where gaps currently exist. In addition, current HHS activities will support the faster development and deployment of new virus detection products. These rapid diagnostics may cut the time needed to confirm a human infection. If used at the point of care, rapid diagnostics could allow early recognition of infected individuals and promote the timely institution of appropriate medical care and public health measures.

Public Health Interventions

At the start of a pandemic, a vaccine may not be widely available, and the supply of antiviral drugs may be limited. Public health interventions, such as containment strategies (isolation of infected individuals and social distancing measures), could delay the introduction and/or spread of a novel, pandemic influenza virus in the United States. In the absence of available drugs, and before a pandemic vaccine is produced, public health interventions are the main defense mechanism against viral infection. The specific interventions implemented will depend on the pandemic phase. For example, early in a pandemic that emerges overseas-before the virus is detected in the United States-local containment strategies and travel-related actions (travel advisories and precautions, including entry and exit screening of persons arriving from infected countries or regions) could impede the establishment of the pandemic virus in this country. Later, after the virus is widespread in the United States, public health interventions such as closing schools, restricting public gatherings, quarantining exposed persons, isolating infected persons, and telecommuting or working from home could reduce the number of people infected with the virus. During this time, public health interventions that retard the spread of infection could mitigate the disruptive impact of a pandemic until such medical interventions became available. The HHS Plan outlines steps to develop recommendation protocols to implement and evaluate public health interventions throughout a pandemic cycle.

Federal Medical Response

An influenza pandemic will place extraordinary demands on the U.S. health care system. Efficient use of existing medical resources and expedient deployment of Federal medical assets, including personnel, are crucial in addressing the medical surge requirements imposed by a pandemic. Because the provision of health care is almost entirely a local responsibility, planning at the State and local level is essential for pandemic preparedness. Integration of the medical response across the local, State, and Federal levels becomes critical to optimize the use of scarce medical resources. HHS is working with its State, local, and tribal partners to increase surge capacity of medical materiel and personnel.

For the most efficient use of medical resources, effective response plans must be developed and tested at all levels. Plans must include a functional command structure consistent with the National Incident Management System (NIMS), a regional approach to the stockpiling and distribution of medical materiel, and a schedule of exercises for evaluating the effectiveness of the plans. Guidelines must be developed and disseminated to all partners. These guidelines should offer approaches for the allocation of scarce resources and the altering of medical care such that scarce resources are applied to benefit the greatest number of those in need. The success of the medical response to an influenza pandemic will be determined by how medical providers and facilities can implement interventions that enable them to meet the increased medical demands that result from a pandemic.

The HHS Implementation Plan describes specific steps to develop deployment strategies for Federal medical resources, including personnel, and steps to develop guidelines for the health care system to augment surge capacity, distribute medical resources, institute appropriate infection control measures, and review/modify standards of care without compromising clinical outcome.

Chapter 4, Federal Medical Response, primarily addresses the Federal medical response, and also addresses integrated planning across all jurisdictions. For additional preparedness guidance for State and local partners, see Part 2 of the HHS Pandemic Influenza Plan (Public Health Guidance for State and Local Partners) and Chapter 8, State, Local, and Tribal Preparedness, of this plan.

Vaccines

Historically, vaccination has been the most effective measure for minimizing the morbidity and mortality associated with influenza. Vaccines may also limit virus spread, and thus, the course of a pandemic. Since a pandemic vaccine can only be made once a pandemic virus is identified and isolated, it cannot be available during the early phases of a pandemic. Therefore, a pre-pandemic vaccine based on novel influenza viruses with pandemic potential that are known to be in circulation, and for which a vaccine has already been developed and stockpiled, may provide partial protection or immunologic priming of persons at high risk during the early phases of a pandemic.

When a pandemic is declared and a specific vaccine against the pandemic virus becomes available, its distribution and delivery will be a major focus of the pandemic response. Vaccines produced for a pandemic virus must be safe, produced in large quantities, delivered quickly, and be effective for the largest number of individuals possible to minimize mortality and morbidity. Thus, the rapid production and clinical evaluation of a pandemic vaccine and the tracking of its use and distribution, particularly if two or more doses are required, is an urgent priority of HHS pandemic planning and response preparations. HHS is currently working with private industry to increase the U.S. vaccine production capacity. The HHS Plan describes specific action steps HHS will take to facilitate vaccine development, production, and distribution. The Plan also identifies steps HHS will take to track vaccine efficacy and adverse events. Antiviral Drugs.

If used appropriately, antiviral drugs may limit the spread of influenza, reduce its morbidity and mortality, and thereby diminish the demands placed on the U.S. health care system during a pandemic. However, the susceptibility of the pandemic influenza virus strain to antiviral agents cannot be determined until the pandemic virus strain emerges. Assuming susceptibility, antivirals may also be used in attempts to contain small disease clusters and potentially slow the introduction and spread of the infection in and between communities. Indiscriminate use of antiviral drugs in a pandemic could deplete national and local supplies. Therefore, a comprehensive approach for the appropriate distribution and use of antiviral stocks is an essential component of HHS pandemic preparedness. The HHS Implementation Plan outlines the steps to facilitate the development, licensure/approval, production, and availability of pandemic influenza countermeasures. It also provides guidance for evaluating antiviral efficacy and developing prioritization, allocation, and distribution strategies for antiviral stockpiles.

Communications

Another critical component of HHS preparedness for an influenza pandemic is a clear communications strategy and campaign that informs the public and other stakeholders about this potential threat and provides a solid foundation of information upon which future actions can be based. To be effective, this strategy should be based on scientifically derived risk-communications principles that are developed before, during, and after an influenza pandemic. The HHS Plan outlines a communications strategy and campaign that effectively provides reliable information and guides the public-including individuals and families, the news media, health care providers, and other groups-in responding to outbreak situations appropriately by adhering to public health measures and undertaking actions that protect individuals and family members.

HHS is currently developing communications and outreach materials, messages, and procedures for implementing communications plans. In addition, HHS is developing strategies for health care providers and the public to address any psychosocial concerns. During a pandemic, HHS will provide accurate and timely information on the pandemic to the public. It will also monitor and evaluate its interventions, and will communicate lessons learned to health care providers and public health agencies on the effectiveness of clinical and public health responses.

State, Local, and Tribal Preparedness

An effective pandemic response requires planning and coordination among all levels of Government and all stakeholders. The country's success in responding to and recovering from a pandemic necessarily depends on preparedness by the State, local and tribal jurisdictions. State, local and tribal leaders will be responsible for conducting surveillance, epidemiologic investigation, disseminating information, implementing containment measures, and distributing countermeasures (vaccine and antiviral drugs). In addition, the provision of health care is almost entirely a local responsibility that is shared by both private and public sector entities. Planning for the preservation of societal functioning is also a critical local function.

Moreover, for pandemic influenza preparedness to be effective, it must be a multidisciplinary effort, engaging all stakeholders, including traditional public health and health care partners, as well as other sector partners, such as the business community, public safety and law enforcement, emergency management, education, transportation, social services, mental health and substance abuse services, public utilities, and community- and faith-based organizations. The duration, scope, and scale of the event will challenge infrastructure across most, if not all, sectors. Multi-sectored mutual aid agreements among local jurisdictions may aid in addressing the duration, scope, and scale of the pandemic.

In FY06, the U.S. Congress appropriated $350 million as part of an emergency supplemental appropriation to fund local and State preparedness. HHS is currently working with its State, local, and tribal partners to increase the health care surge capacity of medical materiel and personnel. With State Governors, HHS is co-hosting pandemic summits and exercises in every State. In addition, HHS has developed checklists to aid in community-level pandemic influenza preparations. These checklists provide specific guidance for State and local planning authorities, businesses, health care providers, community organizations, and individuals and families.

The HHS Implementation Plan addresses cross-cutting preparedness issues for which the Department will provide further assistance for State, local and tribal pandemic preparedness. This assistance includes the development of guidelines and operational plans for the distribution of available supplies of pandemic vaccine and antiviral drugs.

Part II

HHS provides and operates many essential services and programs for individuals across the United States. Disruption of business and community operations by a pandemic can seriously jeopardize the health and well-being of many Americans. Part II provides detailed continuity of operations plans for the Office of the Secretary (OS) and HHS agencies, including:

-- The Administration for Children and Families (ACF)
-- The Agency for Health care Research and Quality (AHRQ)
-- The Agency for Toxic Substances and Disease Registry (ATSDR)
-- The Administration on Aging (AOA)
-- The Centers for Disease Control and Prevention (CDC)
-- The Centers for Medicare and Medicaid Services (CMS)
-- The Food and Drug Administration (FDA)
-- The Health Resources and Services Administration (HRSA)
-- The Indian Health Service (IHS)
-- The National Institutes of Health (NIH)
-- The Substance Abuse and Mental Health Services Administration (SAMHSA)

In Part II, each HHS agency and the OS identify essential activities, programs, and personnel, and provide strategies to continue departmental operations in the face of significant absenteeism during a pandemic. Agencies' plans also include leadership succession, plans for the delegation of authority, and options and procedures for alternate worksites. In addition, each plan includes steps to protect the workforce (and the agency's customers) during a pandemic. Finally, each agency outlines its role and responsibilities in a coordinated inter-agency/departmental response to a pandemic.

Given its critical mission, HHS will occupy a central position in any Federal pandemic influenza response. However, a robust, comprehensive response consistent with the National Response Plan requires coordination across Federal Departments and with international partners of the United States. Moreover, an effective pandemic response that preserves human lives and societal infrastructure requires collaboration with all State, local, and tribal partners. This HHS Implementation Plan provides definitive guidance and action steps to maximize our collective efforts in preparing for and responding to pandemic influenza.

Footnotes

1 Chotpitayasunondh T, Ungchusak K, Hanshaoworakul W, Chunsuthiwat S, Sawanpanyalert P, Kijphati R, Lochindarat S, Srisan P, Suwan P, Osotthanakorn Y, Anantasetagoon T, Kanjanawasri S, Tanupattarachai S, Weerakul J, Chaiwirattana R, Maneerattanaporn M, Poolsavathitikool R, Chokephaibulkit K, Apisarnthanarak A, Dowell SF. Human disease from influenza A (H5N1), Thailand, 2004. Emerg Infect Dis. 2005 Feb;11(2):201-9.

2 Beigel JH, Farrar J, Han AM, Hayden FG, Hyer R, de Jong MD, Lochindarat S, Nguyen TK, Nguyen TH, Tran TH, Nicoll A, Touch S, Yuen KY; Writing Committee of the World Health Organization (WHO) Consultation on Human Influenza A/H5. Avian influenza A (H5N1) infection in humans. N Engl J Med. 2005 Sep 29;353(13):1374-85. Review.

3 Hien TT, de Jong M, Farrar J. Avian influenza-a challenge to global health care structures. N Engl J Med. 2004 Dec 2;351(23):2363-5.

Part 1 - Pandemic Influenza Implementation Plan (PDF - 271 pages, 1.8MB)

Part 1 - Overview (PDF - 11 pages, 178KB)

Asthma Medicine Halts Pancreatic Cancer Cell Growth

2007-04-15T16:37:00.001-07:00

A common asthma drug reduced pancreatic cancer cell growth in laboratory experiments and animal tests, a new study reports.

A protein called S100P is found in excess amounts in some cancers and is important for pancreatic cancer cell growth and survival. This protein also activates a cell surface protein receptor called RAGE that plays a role in Alzheimer disease, diabetes, and cancer.

A drug called cromolyn, an allergy and asthma treatment, has been shown to bind to proteins similar to S100P. To test cromolynвЂ™s effects on S100P in pancreatic cancer cells, Thiruvengadam Arumugam, Ph.D., Vijaya Ramachandran, Ph.D., and Craig D. Logsdon, Ph.D., of the University of Texas M. D. Anderson Cancer Center in Houston, conducted experiments with the drug in tissue cultures and in mice with implanted pancreatic cancer.

They found that cromolyn bound to S100P, halted the activation of RAGE, and slowed cancer cell growth and survival in cell lines. In mice, the drug slowed pancreatic tumor growth and improved the effectiveness of gemcitabine, a chemotherapy drug used to treat pancreatic cancer.

"Together, these data support the further investigation of cromolyn as a possible treatment for pancreatic cancer," the authors write.

Contact: Scott Merville, M. D. Anderson Cancer Center External Communications

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Other highlights in the December 20 JNCI

Note: The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the National Cancer Institute. Attribution to the Journal of the National Cancer Institute is requested in all news coverage. Visit the Journal online at http://jncicancerspectrum.oxfordjournals.org/.

Contact: Andrea Widener
Journal of the National Cancer Institute

Costs Of Long-Course Palliative Radiotherapy Acceptable In Late-Stage Lung Cancer

2007-04-15T15:37:00.001-07:00

A longer, less intense course of radiotherapy provides better value for the money than a shorter, more intense regimen when given to ease pain and other complaints in patients with late-stage non-small-cell lung cancer (NSCLC), according to a study in the Journal of the National Cancer Institute.

Patients with late-stage NSCLC are often too ill to receive intensive treatment for their cancer. Palliative radiotherapy is given to ease symptoms such as chest pain and difficulty breathing and swallowing. In 1999, Wilbert B. van den Hout, Ph.D., of Leiden University Medical Center in the Netherlands, and colleagues conducted a randomized clinical trial in 297 patients with inoperable stage IIIA/B or stage IV NSCLC to compare two palliative radiotherapy regimens - a short course, two treatments of 8 gray (Gy) of radiation each, with a long course, 10 treatments of 3 Gy each. They found that the long course better eased symptoms over time and improved 1-year survival compared with the short course.

However, that study did not take into account the higher costs of the longer treatment and the continued medical costs of the patients who survive longer with their cancer. For this new study, van den Hout and colleagues conducted a cost-utility analysis of the two treatments to see which offers the best value for the money. Using data from a patient questionnaire on factors such as their mobility, ability to perform usual activities, and pain and anxiety levels, the authors calculated that quality of life was roughly equal in both treatment groups. However, because life expectancy was longer in the long-course treatment group, that groupвЂ™s overall quality-of-life benefit was greater than that in the short-course group.

The researchers also estimated the costs associated with the treatment and other nontreatment costs, such as medical care for people who survived their cancer. They estimated that the lifetime societal costs of the long-course radiotherapy were $16,490 and the short-course radiotherapy costs were $11,164, a $5,326 difference. In their final calculations, the authors found that, although the dollar costs of the long-course radiotherapy were higher than those of the short course, the benefit in improved survival meant that the long-course treatment yielded benefit at an acceptable cost by current economic standards.

"In our group of poor-prognosis non-small-cell lung cancer patients, the additional costs of the protracted radiotherapy schedule were justified by longer survival rather than by improved quality of life," the authors conclude.

The authors point out that their study does not show that long-course radiotherapy reduces costs. In addition, areas with limited radiotherapy facilities may find it more efficient to treat patients with the shorter course. Finally, different countries and regions may have different economic factors that influence the decision of which radiotherapy regimen to use.

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Contact:

вЂў Leiden University Medical Center Communications Department

Citation:

вЂў van den Hout WB, Kramer GWPM, Noordijk EM, Leer JWH. Cost-utility analysis of short- versus long-course palliative radiotherapy in patients with non-small-cell lung cancer. J Natl Cancer Inst 2006; 98:1786-94.

Note: The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the National Cancer Institute. Attribution to the Journal of the National Cancer Institute is requested in all news coverage. Visit the Journal online at http://jncicancerspectrum.oxfordjournals.org/.

Contact: Andrea Widener
Journal of the National Cancer Institute

Minimum Legal Age To Purchase Tobacco To Rise From 16 To 18, UK

2007-04-15T15:34:00.001-07:00

The UK government is to raise the legal minimum age to purchase tobacco from 16 to 18 years old, Public Health Minister Caroline Flint announced today.

Raising the age of buying tobacco which will come into effect from 1 October 2007, will follow closely on the heels of the introduction of smokefree public places and workplaces on 1 July 2007. A campaign to raise awareness of the imminent change in age will be launched in the New Year.

About nine per cent of young people aged between 11 and 15 smoke, and government is determined to reduce this figure further. Raising the legal age to 18 will make it easier for retailers to spot under-age smokers and lead to a fall in the number of teenagers who get addicted to nicotine and continue to smoke into adulthood.

Bringing the legal age for the purchase of tobacco into line with that of alcohol will reinforce the dangers of smoking to young people, as well as helping retailers comply with the law. It would also bring England and Wales into line with Canada, Australia, New Zealand and the US.

Despite the reduction in the number of underage smokers from 13 per cent in 1996 to 9 per cent in 2005, tobacco is still too easy for older children and young people to buy. Only 23 per cent of those under 16 who tried to buy tobacco found it difficult to do so. Evidence shows that nearly 70 per cent of 11 to 15 year old smokers say they buy their cigarettes from small shops such as newsagents and corner shops.

Public Health Minister Caroline Flint said:

"Smoking is dangerous at any age, but the younger people start, the more likely they are to become life-long smokers and to die early. Someone who starts smoking aged 15 is three times more likely to die of cancer due to smoking than someone who starts in their late twenties.

"Buying cigarettes has been too easy for under 16s and this is partly due to retailers selling tobacco to those under the legal age.

"The law change demonstrates our determination to stop this and to reduce the number of teenagers who smoke. This, in turn, will reduce the number of people with preventable diseases and the incidence of health inequalities.

"The law change also sits well with our smokefree public spaces legislation which comes into effect from 1 July 2007, and it shows our commitment as a country to protecting our children."

The Government has made the law change after consulting with the public, the retail industry, the NHS, local authorities and other stakeholders.

Paul Ramsden, Deputy Chief Executive of the Trading Standards Institute, said:

"The Trading Standards Institute supports the change to the legal age limit on sales of tobacco. The Institute has previously called for such action based upon the growing concerns about the health risks of smoking among children and teenagers.

"The Institute also believe that changing the age of sale in line with the age limit on, for example, alcohol sales will help eliminate confusion among retailers.

"Across the country, trading standards colleagues already do an enormous amount of work to help educate and inform retailers of their responsibilities to comply with the law across the whole range of age-restricted products.

"The Trading Standards Institute believe that the change in the age of sale for tobacco, will make it more difficult for young people to purchase cigarettes."

And also from today, 1 January 2007, the NHS and government buildings will become smokefree.

The raising of the minimum age for buying tobacco from 16 to 18 will be effective from 1 October 2007.

The legal age for the purchase of tobacco products has been 16 since 1908. The current law controlling the sale of tobacco to children under 16 is set out in the Children and Young Persons Act 1933 as amended by the Children and Young Persons (Protection from Tobacco) Act 1991.

The Smoking, Drinking and Drug Use Among Young People in England Survey 2004 showed that nearly 70 per cent of 11 to 15 year old smokers say they buy their cigarettes from small shops such as newsagents and corner shops. The decision to increase the age from 16 to 18 follows a public consultation this summer. Click here to see the consultation document (PDF) Other EU countries to recently increase their minimum age for sale of tobacco products include Irelans, Malta and Spain.

The new measures will be supported with education for retailers on better compliance with underage sales law; guidance for magistrates and a communications programme for local authority enforcement.

Department of Health, UK

Oxymetazoline As An Anti-inflammatory Drug In Nose Sprays: Mode Of Action Now Clear

2007-04-15T14:37:00.001-07:00

Scientists from the GSF - Research Center for Environment and Health in Neuherberg near Munich have shown how oxymetazoline inhibits inflammation. The active ingredient in nose sprays has so far mainly been known as a substance reducing the swelling of the mucous membrane. The GSF experts have now elucidated the exact mechanism of an anti-inflammatory effect. This is an important contribution by the GSF to the transfer of knowledge from fundamental research to practical application.

When a patient has a cold (rhinitis), the body reacts to a viral infection by showing inflammatory reactions. Oxymetazoline interferes with this process in different ways: on the one hand it inhibits the enzyme 5-lipoxygenase, which is involved in the production of proinflammatory substances - so-called leukotrienes. The scientists from the GSF Institute of Inhalation Biology have shown this in vitro, i.e. in cell-free systems, and in body cells from lung tissue (alveolar macrophages). On the other hand oxymetazoline reduces the oxidative stress due to inflammatory reactions accompanying a cold, which damages the cells. This was shown by the scientists using stress marker substances in the alveolar macrophages.

The effects mentioned occurred even with relatively low concentrations, which - as the scientists think - are achieved by nose sprays. Preliminary studies had shown that high doses of oxymetazoline can inhibit inflammation. The exact mechanisms, however, were not yet known.

вЂњThe special feature of the mode of action is that proinflammatory processes are inhibited, but anti-inflammatory processes are not influenced,вЂќ says Dr. Ingrid Beck-Speier from the Institute of Inhalation Biology of the GSF. Thus, laboratory experiments have shown that 15-lipoxygenase is not inhibited. This is an enzyme involved in the production of anti-inflammatory substances.

The GSF - Research Center for Environment and Health investigates the foundations of a medicine of the future for the development of new approaches in prevention, diagnosis and therapy. The aim is to closely link research and application. This is also what this research project, cofunded by Merck Selbstmedikation, stands for. Merck uses oxymetazoline in nose sprays.

Beck-Speier, I., Dayal, N., Karg, E., Maier, K. L., Schumann, G., Semmler, M. and Koelsch, S. M.
"Oxymetazoline inhibits proinflammatory reactions: Effect on arachidonic acid-derived metabolite"
Journal of Pharmacology and Experimental Therapeutics 316, p 843-851 (2006)

www.gsf.de/neu/Aktuelles/Presse/2006/oxymetazolin_en.php

Tuberculosis Risks For Health Workers In Developing Countries

2007-04-15T14:34:00.001-07:00

Latent infection with tuberculosis is common and some infected people develop the active form of the disease. Health-care workers (HCWs) can become infected, develop active disease, and can pass their infection on to patients and others. Research published in PLoS Medicine shows that HCWs in developing countries are at particularly high risk. Over half were found to have latent TB.

One third of the world's population is infected with Mycobacterium tuberculosis, the bacterium that causes TB. In most people, the bug causes no health problems and it remains latent. But about 10% of infected people develop active, potentially fatal TB disease, most commonly in their lungs. More than 90% of the world's cases of TB occur in low- and middle-income countries. The researchers Rajnish Joshi at University of California Berkeley and colleagues conducted a systematic review, which involved a comprehensive search for studies that had collected data on TB infection in health-care workers in these countries. Averaged out over the 51 studies which they found, 54% of health workers had latent TB. The TB disease rates in health-care workers were also substantially higher than those in the general population of the same countries.

In high-income countries, measures are in place to reduce the TB infection risk faced by health workers. In contrast, most of the hospitals in the studies found by the researchers reported no or minimal TB control measures. The researchers say that research is needed to establish whether the control measures that have reduced TB transmission to health workers in high-income countries will work elsewhere, and whether they will be affordable.

"Tuberculosis among health-care workers in low- and middle-income countries: A systematic review"
Joshi R, Reingold AL, Menzies D, Pai M
(2006) PLoS Med 3(12): e494.
LINK TO ARTICLE ONLINE

About PLoS Medicine

PLoS Medicine is an open access, freely available international medical journal. It publishes original research that enhances our understanding of human health and disease, together with commentary and analysis of important global health issues. For more information, visit http://www.plosmedicine.org

About the Public Library of Science

The Public Library of Science (PLoS) is a non-profit organization of scientists and physicians committed to making the world's scientific and medical literature a freely available public resource. For more information, visit http://www.plos.org

Underground (subway) Air Might Cause DNA Damage

2007-04-15T13:37:00.001-07:00

Our everyday environments are full of airborne particles that are harmful to varying degrees when inhaled. Particularly damaging to our cellular DNA are the particles from the underground system in Stockholm, Sweden, according to a new doctoral thesis from Karolinska Institutet.

вЂњLuckily, most of them do not remain in the underground for any length of time,вЂќ says scientist Hanna Karlsson. вЂњHowever, particle levels are often very high. My results show that there is every reason to speed up the work being done to clean the air in the underground.вЂќ

Every year, some 5,300 Swedes die premature deaths from inhaling the microscopic particles of coal, asphalt, iron and other materials that pollute the cityвЂ™s air. These particles, which are the result of incomplete combustion, road surface attrition, etc. could be reduced if the right steps were taken; the problem is that it is not known which particle sources pose the greatest threat to human health.

To build up a picture of which particles are the most harmful, Dr Karlsson has compared how particles from a variety of sources affect cultured lung cells. The results, which are presented in her thesis Particularly harmful particles show that particles from the Stockholm underground are much more damaging to cellular DNA than the other sources tested (e.g. wood smoke and cars).

The airborne particles in the underground system largely comprise iron, and are formed by the abrasion of the train wheels against the rails. The damage is caused when these particles enter the body and form free radicals in the bodyвЂ™s cells. Free radicals are highly reactive molecules that can prove harmful to the cellвЂ™s DNA; although such damage can often be repaired by the cell, it can sometime remains untreated, and this increases the risk of cancer.

Another type of particle that stood out in the studies was that caused by the friction between car tyres and the road surface. The report shows that these particles trigger a powerful inflammatory response (i.e. a general defence reaction in the body). Levels of these particles are particularly high in the spring, when road surfaces dry out and cars are still fitted with studded winter tyres.

вЂњItвЂ™s a serious problem, as these particles exist in large concentrations in environments that people remain in for long periods,вЂќ says Dr Karlsson.

Apart from particles from the underground and the roads, the study also examined those released by the combustion of wood, pellets and diesel. None of the other types of particle tested were totally harmless. Modern wood- and pellet-burning boilers gave off much fewer emissions than old ones, but the particles produced were no less harmful.

Karolinska Institutet is one of the leading medical universities in Europe. Through research, education and information, Karolinska Institutet contributes to improving human health. Each year, the Nobel Assembly at Karolinska Institutet awards the Nobel Prize in Physiology or Medicine. For more information, visit http://www.ki.se.

Language Styles

British English
Underground refers to the underground, urban train system.
Subway вЂ" a pedestrian tunnel used for crossing streets and city squares

American English

Underground refers to anything that is under the ground вЂ" not a train system.
Subway refers to the underground, urban train system.

http://diss.kib.ki.se/2006/91-7140-972-6

Change In Guidelines Could Help Eliminate TB In U.S.

2007-04-15T13:34:00.001-07:00

To eliminate tuberculosis (TB) in the United States, current guidelines should be changed to reclassify all foreign-born residents from high-incidence countries as "high-risk," regardless of the amount of time they have lived in the U.S.

These findings appear in the first issue for January 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.

Kevin P. Cain, M.D., of the Division of Tuberculosis Elimination at the Centers for Disease Control and Prevention in Atlanta, and seven associates collected data on all 2004 TB cases listed in the U.S. National TB Surveillance database. The investigatorsвЂ™ aim was to understand why the number of annual cases of TB reported in U.S.-born persons declined by 93 percent from 1993 to 2004, while foreign-born cases increased by five-percent.

"For example, in 2004, a total of 14,517 cases of TB were reported," said Dr. Cain. "Of these, 3,444 or 24 percent were foreign-born persons who had entered the United States more than five years previously."

Present guidelines recommend only those residing in the U.S. for five years or less be targeted for tuberculin skin testing and treatment of latent TB infection.

The following countries of origin of U.S. immigrant residents had the largest number of TB cases in 2004: Mexico (1,976), Philippines (829), Vietnam (619), India (557), China (352), Haiti (248), South Korea (219), Guatemala (190), Ethiopia (169) and Peru (159).

"Twenty-five percent of all reported TB cases in the United States are among foreign-born persons who have lived in the U.S. for more than five years," said Dr. Cain. "There is no policy to test foreign-born persons for latent TB infection before entering the U.S., or to test them after they have lived here for more than five years. As such, present guidelines do not currently address the burden of latent TB infection in the foreign-born subgroup."

According to the authors, the goal of TB control efforts in the U.S. is eliminating the disease. They define elimination as less than one case reported per million in a given population. If achieved, the number of TB cases diagnosed in 2004 would have been less than 300, as contrasted to the 14,517 reported.

"Until we address the burden of latent TB infection in the foreign-born group, achieving TB elimination will not be possible," said Dr. Cain.

He noted that controlling and eliminating TB will require a comprehensive strategy, with varying approaches for immigrant populations from high-risk countries.

Founded in 1905, the American Thoracic Society is the worldвЂ™s leading medical association dedicated to advancing pulmonary, critical care and sleep medicine. The Society has more than 18,000 members who prevent and fight respiratory disease around the globe, through research, education, patient care and advocacy.

American Thoracic Society
61 Broadway, 4th Floor
New York, NY 10006-2755
www.thoracic.org

See you at ATS 2007-the 103rd International Conference, May 18-23 San Francisco, CA

Cough And Phlegm Cause Fourfold Increase In COPD Incidence

2007-04-15T12:37:00.001-07:00

Young adults (ages 20 to 44) with normal lung function who later develop chronic cough and phlegm have a fourfold higher risk of developing chronic obstructive pulmonary disease (COPD).

The results of this 10-year respiratory study appear in the first issue for January 2007 of the American Journal of Respiratory and Critical Care Medicine, published by the American Thoracic Society.

Isa Cerveri, M.D., of the Division of Respiratory Diseases at San Matteo Hospital and University of Pavia in Italy, and 19 associates showed that the presence of chronic cough and phlegm among study participants was an independent and statistically significant predictor of COPD. Of the 5,002 individuals in the study cohort, 123 were diagnosed with COPD. All participants had normal lung function at baseline.

COPD is the fourth leading cause of death in the United States, killing 122,283 Americans in 2003. It results from chronic bronchitis and emphysema, two lung diseases which frequently co-exist and cause obstruction to airflow that interferes with normal breathing. Smoking is the primary cause of COPD.

вЂњIn a large international cohort of individuals from ages 20 to 44, the 10-year cumulative incidence of COPD was 2.8 percent,вЂќ said Dr. Cerveri. вЂњIt was 4.6 percent in adults aged 40 to 44. This finding points out that COPD is a major health problem even in young adults who are usually not considered to be at risk. In agreement with previous research, we found that the progression toward airflow obstruction is a continuous and gradual process, where sudden changes are extremely unlikely.вЂќ

Among the study group, about 77 percent of the 123 COPD cases were smokers. In the sample as a whole, about 55 percent smoked.

The authors noted their results confirm that, from a public health perspective, the prevention of smoking and smoking cessation are the most effective strategies to deter the occurrence of COPD and reduce its burden.

вЂњOur results show that the presence of chronic cough and phlegm is not an innocent symptom, but is an early marker of airflow obstruction,вЂќ said Dr. Cerveri.

In addition to cough and phlegm in participants, researchers considered such factors as sex, age, dyspnea (breathlessness), smoking habits and level of education. All participants received lung function tests and blood workups at the beginning and end of the study.

In an editorial on the research in the same issue of the journal, JГёrgen Vestbo, M.D., of Hvidovre University Hospital in Denmark and the University of Manchester in the United Kingdom, wrote: вЂњThe virtue of the study by Drs. Cerveri and colleagues lies in its size and thus the ability to calculate estimates with acceptable reliability. In this respect, it adds to previous work from the same group and indicates that the statement вЂ15 percent of smokers will develop COPDвЂ™ is wrong and that lifetime risk of COPD in smokers is significantly higher, probably about 35 to 50 percent.вЂќ

He continued: вЂњThe predictive value of chronic cough and phlegm is probably more surprising given the fact that this cohort was young and had normal lung function at baseline.вЂќ

Dr. Vestbo concluded: вЂњHow does the study impact our understanding of the natural history of COPD? As recently reported in this journal, it has taken the respiratory community a painstakingly long time to do properly sized studies in young adults with sound methodology and state-of-the-art analysis. With COPD epidemiology growing in the European Community Respiratory Health Survey and other cohorts of young adults, we may get a better picture of early events in COPD---although our colleagues in pediatric epidemiology will probably continue to claim that we are still only looking at вЂthe elderlyвЂ™!вЂќ

Founded in 1905, the American Thoracic Society is the worldвЂ™s leading medical association dedicated to advancing pulmonary, critical care and sleep medicine. The Society has more than 18,000 members who prevent and fight respiratory disease around the globe, through research, education, patient care and advocacy.

American Thoracic Society
61 Broadway, 4th Floor
New York, NY 10006-2755
www.thoracic.org

See you at ATS 2007-the 103rdВ International Conference, May 18-23 San Francisco, CA

7 Things To Know About Preventing, Treating Winter Laryngitis

2007-04-15T12:34:00.001-07:00

With most cases of viral laryngitis occurring during the winter cold and flu season, a vocal health expert at the University of Michigan Health System is offering tips for preventing and treating the inflammation of the voice box.

"The type of voice change that can accompany the common cold and upper respiratory infection is something that is quite common, and IвЂ™m sure most everyone has experienced it at some point in their life," says Norman D. Hogikyan, M.D., F.A.C.S., director of the U-M Health SystemвЂ™s Vocal Health Center and associate professor of otolaryngology and music.

Hogikyan notes that viral laryngitis is contagious and passes the same way as common colds and flu bugs. He suggests ways to avoid getting laryngitis in the first place, ways to treat it and not to aggravate it further, and offers suggestions for caring for your voice even when itвЂ™s healthy.

7 things to know about laryngitis

Viral laryngitis is contagious as contagious, in fact, as a typical upper respiratory infection, Hogikyan says. "Avoiding getting viral laryngitis is really accomplished through the same ways you avoid getting a cold or a bug, and that means things like hand washing and avoiding direct contact with somebody who already has a cold or respiratory infection."

Causes of other types of laryngitis include acid reflux, which can cause an inflammation in the vocal cords; bacterial infections; fungal or yeast infections; smoking; chemical irritants; and even excessively loud or prolonged use of the voice.

Symptoms of a viral infection with laryngitis can include hoarseness, swollen glands in the neck and sometimes fever.

Treatment for viral laryngitis focuses on limiting the amount of injury caused to the voice, Hogikyan notes. "We canвЂ™t necessarily affect the viral infection itself, but we can try to limit the amount of irritation that it will cause to the voice, or, even more importantly, we can limit further injury that might occur by pushing the voice at a time when itвЂ™s already hoarse," he says. The best advice, he says, is to rest your voice during this time.

Another important aspect of treatment is hydration. Drink a lot of water and non-caffeinated beverages, Hogikyan says, because "moist is always good for the voice." A humidifier may also help.

Drinking warm beverages and gargling salt water donвЂ™t have any specific medicinal benefit, but they can feel soothing and comforting, Hogikyan says. "Also, having a good comfort level in your throat will prevent you from maybe using some voice or throat muscles in a way that might be more straining," he notes.

While most viral laryngitis cases get better without lasting damage, some can lead to further health problems, such as vocal cord bleeding or the development of a "hemorrhagic polyp," a lesion on the vocal cords. The risk for further problems is increased by not resting your voice when you have laryngitis.

Hogikyan is a proponent of caring for your voice even when not caring for conditions such as laryngitis. Most people take their voices for granted until they have a problem, he notes.

"ItвЂ™s important for you to take care of your voice all of the time," he says. "It is your natural instrument."

He recommends staying well hydrated, not screaming or yelling, using microphones and other amplification when speaking or performing in front of a crowd, not smoking, using good breath support when you speak by filling your lungs with air regularly, and warming up the voice before using it with exercises such as tongue trills and humming.

For more information, visit these Web sites

Vocal Health Center at the University of Michigan Health System http://www.med.umich.edu/oto/vocalhealthcenter

UMHS Health Tips A-Z: Laryngitis http://www.med.umich.edu/1libr/aha/aha_chronlar_crs.htm

MedlinePlus Medical Encyclopedia, information about laryngitis from the National Institutes of Health and U.S. National Library of Medicine http://www.nlm.nih.gov/medlineplus/ency/article/001385.htm

University of Michigan Health System
2901 Hubbard St., Ste. 2400
Ann Arbor, MI 48109-2435
United States
http://www.med.umich.edu/

After Drug-resistant Tuberculosis, Now XDR

2007-04-15T11:37:00.001-07:00

Studies of extensively drug-resistant (XDR) tuberculosis in an HIV-positive population in Kwazulu-Natal in South Africa have shown alarmingly high mortality rates.

If this were to become a durable phenomenon, the progress made year after year against tuberculosis could be jeopardized, not only as regards tuberculosis control, but also HIV/AIDS, as together they form a fearsome enemy.

World Health Organization (WHO)

Aerovance Announces Positive Top-Line Results From Phase 2a Trial Of Inhaled AEROVANT(TM) In Asthma Patients

2007-04-15T11:34:00.001-07:00

Aerovance, Inc. today announced positive top-line results from a Phase 2a trial of inhaled AEROVANT(TM) in asthma patients.

The 30-patient antigen challenge study met its primary endpoint of reducing the severity of late asthmatic response by a statistically significant 72 percent (p<0.001) compared to baseline following the twice- daily use of inhaled AEROVANT(TM) (IL-4 and IL-13 antagonist) for 27 days. The study also met the secondary endpoint of decreasing the forced expiratory nitric oxide in patients, indicating a reduction in airway inflammation. Aerovance plans to present the full study results at a scientific conference later this year.

"These are very promising data that show the clear-cut effects of inhaled AEROVANT(TM) in asthma patients," said Rick Fuller, M.D., Ph.D., Aerovance's executive vice president and chief operating officer. "Through the inhibition of the IL-4 and IL-13 receptors, AEROVANT(TM) targets the mechanism that is one of the root causes of asthma and other atopic diseases. We plan to initiate a Phase 2b study with a dry powder inhalation formulation in uncontrolled asthma patients later this year."

Mark Perry, Aerovance's executive chairman, added: "We are pleased with the results of this study and look forward to advancing our development of AEROVANT(TM). Based on these data, we are initiating strategic partnership discussions for this product."

Conducted in London, the Phase 2a trial was a randomized, double-blind, parallel-group, placebo-controlled study designed to assess the safety and efficacy of a 28-day treatment course of inhaled AEROVANT(TM). Thirty patients with mild to moderate asthma were randomized to receive 60 mg of nebulized AEROVANT(TM) or volume-matched placebo administered twice daily.

AEROVANT(TM) is a recombinant human IL-4 variant that is a potent inhibitor of both the IL-4 and IL-13 receptors. Aerovance acquired the worldwide rights to the drug candidate when the company was formed as a spin-out of Bayer Pharmaceuticals Corp. in 2004.

Aerovance, Inc. is a Berkeley, Calif.-based biopharmaceutical company focused on the development and commercialization of breakthrough therapies for the treatment of respiratory and inflammatory diseases. For more information, visit http://www.aerovance.com.

Aerovance, Inc.
http://www.aerovance.com

In-shell Vaccine For Chick Disease

2007-04-15T10:37:00.001-07:00

Infectious bronchitis virus (IBV) causes losses of ВЈ23.6M a year to the UK poultry industry but scientists are now developing a new way to vaccinate chicks against the disease one that can be delivered while they are still in their egg.

A pre-hatching prototype vaccine virus which provides immunity to IBV has been developed by scientists at the Institute for Animal Health (IAH) and vaccine company Intervet UK. It can be delivered to chicks still in the egg (in-ovo) using robotic 'vaccinators'.

IBV is the worst infectious disease in terms of economic loss to the UK poultry industry. Infection can lead to severe respiratory disease, dramatically reduce egg production and affect the quality and hatchability of eggs.

The researchers, funded by the Biotechnology and Biological Sciences Research Council (BBSRC), Department of the Environment, Food and Rural Affairs (Defra) and Intervet UK, used a 'reverse genetic' system to produce new vaccine strains. Existing strains, which are usually delivered by less efficient spray or drinking water dosage, can prevent chicks hatching if delivered in the egg.

The scientists have extracted a so-called spike protein from a pathogenic virus strain which triggers an immune response, and incorporated it into a harmless non-pathogenic strain. Dr Paul Britton, Head of the Coronavirus Group at IAH Compton, explained, "This hybrid virus was able to induce immunity when inoculated before hatching. When hatched chicks were exposed to the virulent M41 strain, we observed protection rates of up to 100 percent. With the UK poultry industry sustaining losses of ВЈ23.6M a year to infectious bronchitis virus we hope that our research could have a real impact on improving yields for UK farmers."

"We are currently trying to modify the vaccine further, in collaboration with Intervet, to make it suitable for commercial use," said Dr Britton.

Professor Julia Goodfellow, Chief Executive of BBSRC, said: "BBSRC research into endemic UK animal disease has the potential to save UK farmers and consumers millions of pounds each year. IBV is one of the severe animal diseases that BBSRC supports research into, and the work at the Institute for Animal Health shows real promise in delivering tangible improvements on the farm."

The Biotechnology and Biological Sciences Research Council (BBSRC) is the leading funding agency for academic research and training in the biosciences at universities and institutes throughout the UK.

Biotechnology and Biological Sciences Research Council (BBSRC)
http://www.bbsrc.ac.uk

Should Smokers Be Refused Surgery? BMJ

2007-04-15T10:34:00.001-07:00

Last year a primary care trust announced it would take smokers off waiting lists for surgery in an attempt to contain costs. In this week's BMJ, two experts go head to head over whether smokers should be refused surgery.

Denying operations is justified for specific conditions, argues Professor Matthew Peters from the Concord Repatriation General Hospital in Australia.

Professor Peters says that smoking up to the time of any surgery increases cardiac and pulmonary complications, impairs tissue healing, and is associated with more infections.

These effects increase the costs of care and also mean less opportunity to treat other patients, he writes. In healthcare systems with finite resources, preferring non-smokers over smokers for a limited number of procedures will therefore deliver greater clinical benefit to individuals and the community.

He believes that, as long as everything is done to help patients to stop smoking, it is both responsible and ethical to implement a policy that those unwilling or unable to stop should have low priority for, or be excluded from, certain elective procedures.

But Professor Leonard Glantz from Boston University School of Public Health believes it is unacceptable discrimination. "It is astounding that doctors would question whether they should treat smokers," he says.

"Doctors should certainly inform patients that they might reduce their risks of post-surgical complications if they stop smoking before the procedure. But should the price of not following the doctor's advice be the denial of beneficial surgery?"

Cost arguments are made to support the discriminatory non-treatment of smokers. But why focus our cost saving concerns on smokers? Patients are not required to visit fitness clubs, lose 25 pounds, or take drugs to lower blood pressure before surgery. And many non-smokers cost society large sums of money in health care because of activities they choose to take part in.

Discriminating against smokers has become an acceptable norm, he writes. It is shameful for doctors to be willing to treat everybody but smokers in a society that is supposed to be pluralistic and tolerant. Depriving smokers of surgery that would clearly enhance their wellbeing is not just wrong - it is mean, he concludes.

###

Contact: Catherine Binnie
BMJ-British Medical Journal

'Red Tide Toxins' Leave Beachgoers Breathless

2007-04-15T09:37:00.001-07:00

The ecological phenomenon, known as Florida red tide, can be harmful for people with asthma. Florida red tides, an annual event in areas along the Gulf of Mexico, are blooms of the ocean organism, Karenia brevis (K brevis), that are concentrated along shorelines and produce highly potent aerosolized toxins. New research reported in the January issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians (ACCP), shows that Florida red tide toxins (known as brevetoxins) can impact respiratory function and increase respiratory symptoms in patients with asthma.

"In the normal population, inhaled aerosolized red tide toxins can lead to eye irritation, rhinorrhea, nonproductive cough, and wheezing. However, these symptoms usually subside after leaving beach areas," said study author Lora E. Fleming, MD, PhD, University of Miami Rosenstiel School of Marine and Atmospheric Science, Miami, FL. "Our study shows that Florida red tide toxins may have a greater impact on patients with asthma, who experienced respiratory problems and decreased lung function after just one hour of beach exposure to the toxins."

Dr. Fleming and a team of researchers from seven academic, environmental, and government institutions evaluated the exposures and effects of aerosolized Florida red tide brevetoxins in 97 subjects with asthma. Participants, who were all residents of Sarasota, FL, spent at least one hour at Sarasota's Siesta Beach during active K brevis bloom (exposure period) and during a period when there was no bloom (nonexposure period). Detailed baseline information was collected, and all participants underwent pre- and post-beach evaluations, including medical history questionnaires, nasal swab sampling, and lung function testing (spirometry). Each participant also carried a personal air monitor while at the beach. Throughout exposure and nonexposure periods, researchers collected water and air samples and monitored air temperature, relative humidity, and wind speed and direction.

During active K brevis bloom exposure periods, significant differences were found for all participants between pre- and post-beach report of symptoms and pre- and post-spirometry. During exposure periods, participants reported a significant increase in symptoms, predominantly chest tightness, and differences were measured objectively on lung function testing. In contrast, no significant differences were observed between pre- and post- beach symptoms or spirometry during nonexposure periods.

Researchers further evaluated subpopulations based on area of residence and the use of asthma medication within 12 hours prior to the study. Inland residents were more likely than coastal residents to be severe asthmatics and had more reported symptoms and decreased respiratory function after toxin exposure. However, inland residents had higher baseline spirometry scores, compared with coastal residents, suggesting that coastal residents were already affected by the toxins through their environmental residential exposure even prior to study exposure, and, therefore, reacted less to the one-hour beach exposure. Furthermore, participants who reported using asthma medication within 12 hours prior to the study had similar post-exposure differences in spirometry and respiratory symptoms compared with those who did not use medication - even though a sheep model asthma study indicated that these medications have been shown to block the effects of the Florida red tide toxins.

"It is possible that coastal residents, who had less of a reaction to the toxins, have learned not to get exposed or may use more asthma medications to deal with red tides," said study coauthor Barbara Kirkpatrick, EdD, Mote Marine Laboratory, Sarasota, FL. "People with asthma, whether residents or tourists, need to be aware of the Florida red tides and their potential to exacerbate asthma, as well as their own personal reaction to Florida red tides." Florida residents and tourists can stay informed of Florida red tide conditions by checking with local environmental groups, including the Florida Department of Health and the Florida Marine Research Institute.

Other institutions that participated in the National Institute of Environmental Health Sciences (NIEHS)-funded study include Centers for Disease Control and Prevention, Atlanta, GA; Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH; Florida Department of Health, Tallahassee, FL; Harbor Branch Oceanographic Institution, Fort Pierce, FL; Lovelace Respiratory Research Institute, Albuquerque, NM; and the University of North Carolina, Wilmington, NC.

"Environmental asthma triggers, such as Florida red tide, can greatly impact the health of patients with asthma," said Mark J. Rosen, MD, FCCP, President of the American College of Chest Physicians. "It is important for patients with asthma or other chronic respiratory illness to understand their personal limitations regarding red tide toxins and take steps to reduce exposure during times when red tide levels are at their highest."

CHEST is a peer-reviewed journal published by the ACCP. It is available online each month at http://www.chestjournal.org. The ACCP represents 16,500 members who provide clinical respiratory, sleep, critical care, and cardiothoracic patient care in the United States and throughout the world. The ACCP's mission is to promote the prevention and treatment of diseases of the chest through leadership, education, research, and communication. For more information about the ACCP, please visit the ACCP Web site at http://www.chestnet.org .

American College of Chest Physicians
http://www.chestnet.org

Annual Gulf Coast Phenomenon May Trigger Respiratory Symptoms

2007-04-15T09:34:00.001-07:00

The ecological phenomenon, known as Florida red tide, can be harmful for people with asthma. Florida red tides, an annual event in areas along the Gulf of Mexico, are blooms of the ocean organism, Karenia brevis (K brevis), that are concentrated along shorelines and produce highly potent aerosolized toxins. New research reported in the January issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians (ACCP), shows that Florida red tide toxins (known as brevetoxins) can impact respiratory function and increase respiratory symptoms in patients with asthma.

"In the normal population, inhaled aerosolized red tide toxins can lead to eye irritation, rhinorrhea, nonproductive cough, and wheezing. However, these symptoms usually subside after leaving beach areas," said study author Lora E. Fleming, MD, PhD, University of Miami Rosenstiel School of Marine and Atmospheric Science, Miami, FL. "Our study shows that Florida red tide toxins may have a greater impact on patients with asthma, who experienced significant respiratory problems and decreased lung function after just one hour of beach exposure to the toxins."

Dr. Fleming and a team of researchers from seven academic, environmental, and government institutions evaluated the exposures and effects of aerosolized Florida red tide brevetoxins in 97 subjects with asthma. Participants, who were all residents of Sarasota, FL, spent at least one hour at Sarasota's Siesta Beach during active K brevis bloom (exposure period) and during a period when there was no bloom (nonexposure period). Detailed baseline information was collected, and all participants underwent pre- and post-beach evaluations, including medical history questionnaires, nasal swab sampling, and lung function testing (spirometry). Each participant also carried a personal air monitor while at the beach. Throughout exposure and nonexposure periods, researchers collected water and air samples and monitored air temperature, relative humidity, and wind speed and direction.

During active K brevis bloom exposure periods, significant differences were found for all participants between pre- and post- beach report of symptoms and pre- and post- spirometry. During exposure periods, participants reported a significant increase in symptoms, predominantly chest tightness, and differences were measured objectively on lung function testing. In contrast, no significant differences were observed between pre- and post- beach symptoms or spirometry during nonexposure periods.

Researchers further evaluated subpopulations based on area of residence and the use of asthma medication within 12 hours prior to the study. Inland residents were more likely than coastal residents to be severe asthmatics and had more reported symptoms and decreased respiratory function after toxin exposure. However, inland residents had higher baseline spirometry scores, compared with coastal residents, suggesting that coastal residents were already affected by the toxins through their environmental residential exposure even prior to study exposure, and, therefore, reacted less to the one-hour beach exposure. Furthermore, participants who reported using asthma medication within 12 hours prior to the study had similar post-exposure differences in spirometry and respiratory symptoms compared with those who did not use medication - even though a sheep model asthma study indicated that these medications have been shown to block the effects of the Florida red tide toxins.

"It is possible that coastal residents, who had less of a reaction to the toxins, have learned not to get exposed or may use more asthma medications to deal with red tides," said study coauthor Barbara Kirkpatrick, EdD, Mote Marine Laboratory, Sarasota, FL. "People with asthma, whether residents or tourists, need to be aware of the Florida red tides and their potential to exacerbate asthma, as well as their own personal reaction to Florida red tides." Florida residents and tourists can stay informed of Florida red tide conditions by checking with local environmental groups, including the Florida Department of Health and the Florida Marine Research Institute.

"Environmental asthma triggers, such as Florida red tide, can greatly impact the health of patients with asthma," said Mark J. Rosen, MD, FCCP, President of the American College of Chest Physicians. "It is important for patients with asthma or other chronic respiratory illness to understand their personal limitations regarding red tide toxins and take steps to reduce exposure during times when red tide levels are at their highest."

###

Other institutions that participated in the National Institute of Environmental Health Sciences (NIEHS)-funded study include Centers for Disease Control and Prevention, Atlanta, GA; Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH; Florida Department of Health, Tallahassee, FL; Harbor Branch Oceanographic Institution, Fort Pierce, FL; Lovelace Respiratory Research Institute, Albuquerque, NM; and the University of North Carolina, Wilmington, NC.

CHEST is a peer-reviewed journal published by the ACCP. It is available online each month at http://www.chestjournal.org/. The ACCP represents 16,500 members who provide clinical respiratory, sleep, critical care, and cardiothoracic patient care in the United States and throughout the world. The ACCP's mission is to promote the prevention and treatment of diseases of the chest through leadership, education, research, and communication. For more information about the ACCP, please visit the ACCP Web site at http://www.chestnet.org/.

Contact: Jennifer Stawarz
American College of Chest Physicians

ICU Quality Measure Easily Biased

2007-04-15T08:38:00.001-07:00

New research suggests that the standardized mortality ratio (SMR), the outcome-based measure of intensive care unit (ICU) performance, may be easily biased. Overall, an SMR greater than one indicates a higher than expected mortality and less than one indicates a lower than expected mortality. However, researchers from the University of Washington in Seattle speculated how hospital transfers might affect the SMR. A baseline SMR of 1.06 В± 0.19 was calculated for 85 ICUs and compared with an adjusted SMR that was based on a simulation of a set number of patients being transferred out of the ICU alive. In the simulation, increasing the number of transfers by 2 percent and 6 percent over baseline decreased the SMR by 0.10 В± 0.03 and 0.14 В± 0.03, respectively. In addition, results showed that transferring as few as one patient out of the ICU per month can create a bias greater than 0.1 in 27 ICUs. Researchers conclude that a greater understanding of the factors affecting the SMR is needed before it should be widely used to benchmark ICU outcomes.

This study appears in the January issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.

Contact: Jennifer Stawarz
American College of Chest Physicians

Beta Blockers Reduce Severity Of Central Sleep Apnea

2007-04-15T08:35:00.001-07:00

Beta blockers, commonly used to treat high blood pressure and other heart conditions, may help to control central sleep apnea (CSA) in patients with congestive heart failure (CHF). Japanese researchers examined the relationship between use of beta blockers and severity of CSA in 45 patients with CHF and CSA. Results showed that patients using beta blockers (n=27) had lower apnea-hypopnea index (AHI) and central apnea index (CAI) scores than those not using beta blockers (n=18). AHI and CAI were also negatively correlated with the dose of the beta blocker carvedilol. In addition, no use of beta blockers was independently associated with CAI. Researchers conclude that beta blocker therapy may dose-dependently suppress CSA in patients with CHF.

This study appears in the January issue of CHEST, the peer-reviewed journal of the American College of Chest Physicians.

Contact: Jennifer Stawarz
American College of Chest Physicians

Use Of Corticosteroid Inhalers For The Treatment Of Asthma And COPD To Increase

2007-04-15T07:34:00.001-07:00

Decision Resources, one of the world's leading research and advisory firms focusing on pharmaceutical and healthcare issues, finds that the use of corticosteroid inhalers will increase for the treatment of asthma and chronic obstructive pulmonary disease (COPD).

"Despite their criticisms of primary care physicians' use of inhaled corticosteroids, 39% of pulmonologists forecast that they will increase their use of these agents for treating COPD, presumably in large part because of the results of the TORCH study," said Decision Resources analyst Madhuri Borde, Ph.D. "For the treatment of asthma, physicians and experts concur that, over the next two years, they will likely increase their use of single-agent corticosteroid inhalers. Single-agent inhalers are becoming seen as the most appropriate first-line agent, though Advair use in this segment will continue to increase as well."

The findings come from two new reports from Decision Resources: Treatment Algorithms in Asthma and Treatment Algorithms in COPD. Information from the reports will be presented in a webinar on January 17th entitled "Using Patient-Level Data to Quantify Lines of Therapy within the Asthma and COPD Markets." For more information on how to attend the webinar, please contact Liz Marshall of Decision Resources at 781-296-2563.

About Treatment Algorithm Insight Series

Decision Resources combines in-depth primary research with the most extensive claims-based longitudinal patient-level data from PharMetrics(R) to provide exceptional insight into physicians' prescribing trends and the factors that drive therapy product choice, from diagnosis through multiple courses of treatment, for a specific disease.

For each disease examined, Decision Resources' Treatment Algorithm Insight Series provide the following:

-- Summary of U.S. medical practice based on interviews with leading experts in the field

-- Qualitative diagnosis/referral/treatment algorithm for the United States

-- Drug usage by lines of therapy (1st, 2nd, 3rd line)

-- Discussion of key freeform combinations by lines of therapy

-- Product share (class and specific compound level) within each line of therapy (1st, 2nd, 3rd line)

-- Progression of therapy from key 1st line products

-- Pathway to key therapies from previous therapies

-- Qualitative analysis of two-year forecast incorporating upcoming launches, changes in reimbursement, etc.

About Decision Resources

Decision Resources, Inc., (http://www.decisionresources.com) is a world leader in healthcare market research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets.

All company, brand, or product names contained in this document may be trademarks or registered trademarks of their respective holders.

Decision Resources, Inc.
http://www.decisionresources.com

New Diagnostics Help Fight Tuberculosis - FIND And Hain Lifescience Plan Worldwide Demonstration Projects

2007-04-15T07:31:00.001-07:00

The Foundation for Innovative New Diagnostics (FIND) and Hain Lifescience (Hain) announced today that the Hain "GenoType® MTBDR plus" test, a new improved molecular test for multidrug-resistant tuberculosis (MDR-TB), has been approved in Europe and that they have signed an agreement to begin large-scale demonstration projects of the test in high burden countries.

The announcement came just two months after an initial agreement between FIND and Hain Lifescience to fast-track the development of a new tool to address the recent outbreaks of MDR-TB and extensively drug resistant tuberculosis (XDR-TB). In the case of MDR-TB, the TB-bacilli are resistant to rifampicin and isoniazid, two of the most important drugs used to treat TB. XDR-TB organisms are also resistant to at least three "second-line" TB drugs used when "first-line" treatment has failed.

The new Hain "GenoType® MTBDR plus" test, which is CE marked, can be used both on culture-based isolates and directly on smear positive sputum samples from patients with pulmonary TB. Preliminary data suggest that the test can detect at least 90% of MDR-TB cases in only a few hours. Conventional methods of detecting drug resistance can take as long as two to three months to produce results. Consequently, this new test may revolutionize TB diagnostics.

According to the World Health Organization, two billion people or one-third of the world's total population are infected with the TB bacillus. Nearly nine million people develop TB disease each year, and an estimated 5,000 people die of the disease every day. TB is also the main cause of death among persons with HIV-infection. In Africa, Asia and Eastern Europe tuberculosis is becoming a major threat to public health and economy as it affects mostly young adults in their productive years.

"Efficient medical treatment depends on rapid and reliable diagnostics at an affordable price", says David Hain, General Manager of Hain Lifescience. "With FIND we are happy to have a partner who will help us to successfully roll out our "GenoType® MTBDR plus" test in high endemic regions of the world. We are very confident that we can soon supply local TB laboratories with our new test as well as with the required training and service. It is needed."

FIND will now organize and manage the new demonstration trials planned to be implemented in South Africa, Russia, Uzbekistan and Nepal, exemplifying its role as bridge between industry and the health system of developing countries. As part of the agreement, both Hain Lifescience and FIND have worked to make this test affordable for countries who are most affected by the disease.

"It is imperative to introduce effective and inexpensive tools as soon as possible for diagnosing MDR-TB, and by extension, XDR-TB, before this epidemic reaches unfathomable proportions," said Dr Giorgio Roscigno, FIND CEO. "We look forward to collaborating with Hain Lifescience on these demonstration trials."

These projects are expected to begin in the first quarter of 2007.

About FIND

The Foundation for Innovative New Diagnostics (FIND) is a non-profit Swiss foundation based in Geneva. Its purpose is to support and promote the health of people in developing countries by sponsoring the development and introduction of new but affordable diagnostic tools for poverty related diseases. FIND's current donors include the Bill & Melinda Gates Foundation, USAID, the European Union and the Dutch Government.
For more information: http://www.finddiagnostics.org

About Hain Lifescience

Hain Lifescience GmbH is an innovative manufacturer and supplier of modern diagnostic systems. The Hain assays are based on the DNAвЂўStrip® technology, a robust and reliable method for routine diagnostics of disease-associated polymorphisms, microbiological species differentiation and resistance determination. Founded and managed by the brothers David and Tobias Hain in 1986, Hain Lifescience has grown to 60 specialized employees in Nehren, Germany.
For more information: http://www.hain-lifescience.de

Race To Accelerate TB Drug Development

2007-04-15T06:36:00.001-07:00

Each year, tuberculosis kills nearly two million people while an estimated nine million develop the disease - with the hardest-hit areas in AIDS-afflicted developing nations. One of the most pressing challenges is the increase in drug-resistant TB. "No Time to Wait: Overcoming Gaps in TB Drug R&D," a symposium -В organized by the international medical humanitarian organization Doctors Without Borders/MГ©decins Sans FrontiГЁres (MSF) and supported by Howard P. Milstein and Weill Cornell Medical College's Abby and Howard P. Milstein Program in Chemical Biology - will bring together a wide range of infectious disease experts and organizations to discuss practical ways of overcoming the current bottlenecks in TB drug research and development.

В В В В В The event takes place today and tomorrow at the Cornell Club in Manhattan and will feature an introductory address by Howard P. Milstein, a member of the Board of Overseers of Weill Cornell Medical College and trustee emeritus and presidential councilor of Cornell University.

В В В В В В В В "An additional 450,000 new cases of multidrug-resistant TB are seen every year, including people recently diagnosed with particularly lethal new resistant strains," says Mr. Milstein. "We must urgently find new ways of developing new treatments, including fast-tracking clinical trials of promising anti-TB compounds as well as funding strategies for TB research and development initiatives."

В В В В В The drugs in today's standard TB treatment were developed in the 1950s and 1960s, and the most commonly used TB test - developed more than a century ago - manages to detect TB in only about half of the cases. Existing TB drugs and tests are even less adapted for use in people who also have HIV/AIDS. To respond to the devastating impact of TB, especially in developing countries, newer medicines will urgently need to get to patients by working with regulatory agencies, drug development initiatives and pharmaceutical companies to ensure fast-track clinical development and availability of new drugs.

В В В В В Other participating institutions and government agencies include the World Health Organization, National Institute of Allergy and Infectious Diseases (NIAID) /National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), GlaxoSmithKline, Novartis AG, Johns Hopkins University Bloomberg School of Public Health, Bill and Melinda Gates Foundation, Columbia University, Rockefeller Foundation, European and Developing Countries Clinical Trials Partnership (EDCTP), Brazilian Society of Respiratory Diseases, St. George's Hospital Medical School of London, Global Alliance for TB Drug Development, University of Illinois at Chicago, Institute for Tuberculosis Research University of Illinois at Chicago, Yale Law School, Drugs for Neglected Diseases Initiative (DNDi), Tibotec, Denver Health and Hospitals, Treatment Action Group, and the Consumer Project on Technology.

В В В В В In June 2006, the Milsteins donated $7.25 million to Weill Cornell Medical College to establish the Abby and Howard P. Milstein Chemistry Core Facility and the Abby and Howard P. Milstein Program in Chemical Biology of Infectious Disease.

В В В В В Howard Milstein is Chairman of New York Private Bank and Trust, as well as Co-Chairman, President and CEO of Emigrant Savings Bank. He serves as a Trustee of Cornell University, where he received his undergraduate degree in 1973. He has been a member of the Board of Overseers of Weill Cornell Medical College since 1989. The Milstein family has a long history of generosity in support of Weill Cornell. Over the years, Mr. Milstein has been a strong supporter of the Medical Center's neuroscience initiatives and its Cabaret! benefit events.

The Joan and Sanford I. Weill Medical College

The Joan and Sanford I. Weill Medical College - located in New York City - is committed to excellence in research, teaching, patient care and the advancement of the art and science of medicine. The Medical College, which is a principal academic affiliate of NewYork-Presbyterian Hospital, offers an innovative curriculum that integrates the teaching of basic and clinical sciences, problem-based learning, office-based preceptorships, and primary care and doctoring courses. Physicians and scientists of Weill Cornell Medical College are engaged in cutting-edge research in such areas as stem cells, genetics and gene therapy, geriatrics, neuroscience, structural biology, cardiovascular medicine, AIDS, obesity, cancer and psychiatry - and continue to delve ever deeper into the molecular basis of disease in an effort to unlock the mysteries behind the human body and the malfunctions that result in serious medical disorders. Weill Cornell Medical College is the birthplace of many medical advances - from the development of the Pap test for cervical cancer to the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., and most recently, the world's first clinical trial for gene therapy for Parkinson's disease. Weill Cornell's Physician Organization includes 650 clinical faculty, who provide the highest quality of care to their patients.

Joan and Sanford I. Weill Cornell Medical College
525 East 68th Street, Box 144
New York, NY 10021
http://www.med.cornell.edu
http://www.nyp.org

Asthma Sufferers Favor Quick Relief Over Long-term Control

2007-04-15T06:32:00.001-07:00

People who currently have asthma are much more likely to rely on drugs that offer quick relief for symptoms such as shortness of breath, wheezing, or coughing, than medications for long-term control, according to the latest News and Numbers issued by the Agency for Healthcare Research and Quality.

Approximately 31 percent of sufferers say that they use quick-relief medications to control symptoms of asthma, compared with about 14 percent who rely on longer-term preventive medicines for control. Another 31 percent use both types of medications and 24 percent use none.

The federal study further found that among people whose asthma was active when surveyed:

More than one-fourth reported having a peak flow meter at home for measuring their ability to expel air from their lungs.

Nearly half (48 percent) of adults said they had at least one asthma attack within the previous 12 months.

Women were more likely to have asthma attacks than men 50 percent versus 40 percent

AHRQ, a part of the U.S. Department of Health and Human Services, works to improve the quality, safety, efficiency and effectiveness of health care in the United States. The data in this AHRQ News and Numbers comes from the Agency's Medical Expenditure Panel Survey, a highly detailed source of information on the health services that Americans use, how frequently they use them, the cost of these services, and how they are paid.

For more information on this AHRQ News and Numbers see Asthma Treatment and Management among the U.S. Civilian Noninstitutionalized Population, 2004,MEPS Statistical Brief # 152.

Agency for Healthcare Research and Quality (AHRQ)
540 Gaither Rd.
Rockville, MD 20850
United States
http://www.ahrq.gov/

Asthma Blog Carnival

2007-03-12T09:56:00.000-07:00

Registered Nurses posted at http://arizonajobsandemployment.com

Allergic Asthma Treatment posted at http://www.allergyabc.com/blog

benefits of correct breathing posted at http://www.asthmacare.ie/blog

hyperventilation chronic or acute? posted at http://www.asthmacare.ie/blog

Costs Of Long-Course Palliative Radiotherapy Acceptable In Late-Stage Lung Cancer

2007-03-07T08:37:00.001-08:00

Minimum Legal Age To Purchase Tobacco To Rise From 16 To 18, UK

2007-03-07T08:33:00.001-08:00

Oxymetazoline As An Anti-inflammatory Drug In Nose Sprays: Mode Of Action Now Clear

2007-03-07T07:38:00.001-08:00

Tuberculosis Risks For Health Workers In Developing Countries

2007-03-07T07:33:00.001-08:00

Underground (subway) Air Might Cause DNA Damage

2007-03-07T06:37:00.001-08:00

Our everyday environments are full of airborne particles that are harmful to varying degrees when inhaled. Particularly damaging to our cellular DNA are the particles from the underground system in Stockholm, Sweden, according to a new doctoral thesis from Karolinska Institutet.

вЂњLuckily, most of them do not remain in the underground for any length of time,вЂќ says scientist Hanna Karlsson. вЂњHowever, particle levels are often very high. My results show that there is every reason to speed up the work being done to clean the air in the underground.вЂќ

Every year, some 5,300 Swedes die premature deaths from inhaling the microscopic particles of coal, asphalt, iron and other materials that pollute the cityвЂ™s air. These particles, which are the result of incomplete combustion, road surface attrition, etc. could be reduced if the right steps were taken; the problem is that it is not known which particle sources pose the greatest threat to human health.

To build up a picture of which particles are the most harmful, Dr Karlsson has compared how particles from a variety of sources affect cultured lung cells. The results, which are presented in her thesis Particularly harmful particles show that particles from the Stockholm underground are much more damaging to cellular DNA than the other sources tested (e.g. wood smoke and cars).

The airborne particles in the underground system largely comprise iron, and are formed by the abrasion of the train wheels against the rails. The damage is caused when these particles enter the body and form free radicals in the bodyвЂ™s cells. Free radicals are highly reactive molecules that can prove harmful to the cellвЂ™s DNA; although such damage can often be repaired by the cell, it can sometime remains untreated, and this increases the risk of cancer.

Another type of particle that stood out in the studies was that caused by the friction between car tyres and the road surface. The report shows that these particles trigger a powerful inflammatory response (i.e. a general defence reaction in the body). Levels of these particles are particularly high in the spring, when road surfaces dry out and cars are still fitted with studded winter tyres.

вЂњItвЂ™s a serious problem, as these particles exist in large concentrations in environments that people remain in for long periods,вЂќ says Dr Karlsson.

Apart from particles from the underground and the roads, the study also examined those released by the combustion of wood, pellets and diesel. None of the other types of particle tested were totally harmless. Modern wood- and pellet-burning boilers gave off much fewer emissions than old ones, but the particles produced were no less harmful.

Karolinska Institutet is one of the leading medical universities in Europe. Through research, education and information, Karolinska Institutet contributes to improving human health. Each year, the Nobel Assembly at Karolinska Institutet awards the Nobel Prize in Physiology or Medicine. For more information, visit http://www.ki.se.

Language Styles

British English
Underground refers to the underground, urban train system.
Subway вЂ" a pedestrian tunnel used for crossing streets and city squares

American English

Underground refers to anything that is under the ground вЂ" not a train system.
Subway refers to the underground, urban train system.

http://diss.kib.ki.se/2006/91-7140-972-6

Change In Guidelines Could Help Eliminate TB In U.S.

2007-03-07T06:33:00.001-08:00

Cough And Phlegm Cause Fourfold Increase In COPD Incidence

2007-03-07T05:37:00.001-08:00

7 Things To Know About Preventing, Treating Winter Laryngitis

2007-03-07T05:33:00.001-08:00

After Drug-resistant Tuberculosis, Now XDR

2007-03-07T04:37:00.001-08:00

Aerovance Announces Positive Top-Line Results From Phase 2a Trial Of Inhaled AEROVANT(TM) In Asthma Patients

2007-03-07T04:33:00.001-08:00